DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive. In light of the current claim amendments, a new grounds of rejection follows. While the new grounds of rejection use the same references, the references are interpreted in a different light in view of the amended claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims, the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 9-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ruckstuhl US 2010/0136709 in view of Boege et al. (hereinafter Boege) US 2006/0006344 cited in the IDS filed 10/18/2024.
Regarding claim 1, Ruckstuhl discloses an instrument for biological analysis, comprising: an excitation source (light source 10); an optical sensor (detector 17) configured to receive emissions from one or more biological samples in response to the excitation source; an excitation optical system (optical components 11 and 12) disposed along an excitation optical path; an emission optical system (collimator 4) disposed along an emission optical path; a sensor lens (optical component 15) configured to direct emissions from at least some of the biological sample onto the optical sensor; an illuminated surface disposed along the excitation optical path as shown in at least Fig. 8, the illuminated surface configured to produce reflected radiation comprising radiation from the excitation source that is reflected by the illuminated surface; and a radiation shield (reflector member 4), wherein: the radiation shield comprises a sensor aperture (aperture 16) disposed along the emission optical path and a blocking structure as shown in at least Fig. 2 configured to cooperate with the sensor aperture as discussed in at least paragraphs 13-20.
Ruckstuhl discloses a cover area that is suitable for reflecting light from the sensor surface disposed in the excitation path as discussed in the abstract. In an embodiment of the invention, a transparent, preferably flat (planar) substrate made of plastic or glass, for instance a microscopy cover glass, is integrated into the receptacle bottom. This is shown in FIG. 6. The substrate 19 may be bonded to the collimator by an optical adhesive 20. The substrate, the optical adhesive and the collimator preferably have similar indices of refraction discussed in paragraph 18.
Ruckstuhl also discloses a shell surface that is suitable for reflecting light, the shell surface of the collimator 4. See at least paragraphs 9, 18 and 19.
Ruckstuhl does not disclose that the cover area is heated to prevent condensation.
Boege teaches a luminescence detection system comprising a heated cover [30] disposed adjacent the base [70] and including a plurality of apertures [36] configured to correspond to the plurality of reaction regions (sample wells, 44). Acting as a heated cover, cover 30 can also serve a function to reduce condensation within the system. as discussed in at least paragraph 36.
It would have been obvious to one of ordinary skill in the art to modify Ruckstuhl with the heated cover including a plurality of apertures as taught by Boege to augment heating of biological samples and to reduce condensation within the system. In addition, allowing light to pass through cover and into biological samples in the sample wells.
Lastly, the radiation shield in cooperation with the sensor aperture of Ruckstuhl as modified is capable of providing an optical sensor such that only the radiation that is subsequently reflected by another surface of the instrument is received. Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 9, the rejection of claim 1 above is relied upon. The blocking structure of Ruckstuhl and Boege is capable of cooperating with the sensor aperture such that none of the reflected radiation impinges on the sensor lens that does not also reflect off another surface of the instrument.
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. In other words, absent evidence to the contrary, the device disclosed by Ruckstuhl and Boege would be able to perform the claimed functions.
Regarding claim 10, the rejection of claim 1 above is relied upon. The excitation source of Ruckstuhl and Boege is capable of providing a plurality of excitation beams to illuminate the biological samples.
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. In other words, absent evidence to the contrary, the device disclosed by Ruckstuhl and Boege would be able to perform the claimed functions.
The optional claim limitations, namely at least some of the emissions comprising a fluorescent emission from at least some of the biological samples in response to at least one of plurality of the excitation beams, are not required by the instant claim and therefore have not been treated on the merits.
Regarding claim 11, the rejection of claim 10 above is relied upon. The excitation source of Ruckstuhl and Boege is capable of producing a first excitation beam characterized by a first wavelength and a second excitation beam characterized by a second wavelength that is different from the first wavelength.
Regarding claim 12, the rejection of claim 10 above is relied upon. The device disclosed by Ruckstuhl and Boege is capable of providing a first excitation beam and the second excitation beam are temporally separated and/or spatially separated.
Regarding claim 13, the rejection of claim 9 above is relied upon. The device disclosed by Ruckstuhl and Boege is capable of providing a first excitation beam that comprises a first wavelength range over which an intensity, power, or energy of the first excitation beam is above a first predetermined value, and a second excitation beam that comprises a second wavelength range over which an intensity, power, or energy of the second excitation beam is above a second predetermined value, the first wavelength being at least one of: (1) a central wavelength of the first wavelength range or (2) a wavelength of maximum electromagnetic intensity, power, or energy over the first wavelength range, and the second wavelength being at least one of (1) a central wavelength of the second wavelength range; or (2) a wavelength of maximum electromagnetic intensity, power, or energy over the second wavelength range.
Regarding Claim 14, Ruckstuhl does not disclose wherein the excitation source comprises a plurality of individual excitation sources, and the plurality of individual excitation sources.
Boege also teaches wherein the excitation source comprises a plurality of individual excitation sources as discussed in at least paragraphs 6, 47, and 90.
It would have been obvious to one of ordinary skill in the art to modify Ruckstuhl with the filter wheel and the plurality of individual excitation sources of Boege in order to provide increased information handling via high throughput screening of various samples that require different light spectra for activation and detection.
The optional claim limitations, namely forming a two-dimensional array of individual excitation sources, are not required by the instant claim and therefore have not been treated on the merits.
Regarding Claim 15, Ruckstuhl does not disclose wherein the optical sensor comprises an array sensor, the array sensor optionally comprising at least one of a complementary metal-oxide-semiconductor sensor or a charge-coupled device sensor, and the optical sensor optionally comprising at least two array sensors.
Boege teaches the optical sensor (the detector 80 can be an array detector, for example, a charge injection device (CID), or a charge-coupled device (CCD)) comprises an array sensor as discussed in at least paragraph 80.
It would have been obvious to one of ordinary skill in the art to modify Ruckstuhl with the array sensor of Boege in order to provide increased information handling via high throughput screening of various samples that require different light spectra for activation and detection.
The optional claim limitations, namely the array sensor optionally comprising at least one of a complementary metal-oxide-semiconductor sensor or a charge-coupled device sensor, and the optical sensor optionally comprising at least two array sensors, are not required by the instant claim and therefore have not been treated on the merits.
Claims 2-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ruckstuhl US 2010/0136709 in view of Boege et al. (hereinafter Boege) US 2006/0006344 as applied to claims 1 and 9-15 above, further in view of Battrell US 2012/0115214, cited in the IDS filed 10/18/2024.
Regarding claim 2, Ruckstuhl does not disclose a beamsplitter disposed along both the excitation optical path and along the emission optical path.
Battrell teaches a beamsplitter [1334 and 1704] disposed along both the excitation optical path and along the emission optical path as discussed in at least paragraph 108.
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Ruckstuhl and Boege with a beamsplitter disposed along both the excitation optical path and along the emission optical path taught by Battrell in order to help distribute and manage optical signals efficiently.
Regarding claim 3, Ruckstuhl discloses an illuminated surface disposed along the excitation optical path as shown in at least Fig. 8, the illuminated surface configured to produce reflected radiation comprising radiation from the excitation source that is reflected by the illuminated surface; and a radiation shield (reflector member 4), wherein: the radiation shield comprises a sensor aperture (aperture 16) disposed along the emission optical path and a blocking structure discussed in at least paragraph 20 and shown in Fig. 2.
However, Ruckstuhl does not disclose a base configured to receive a sample holder comprising a plurality of spatially separated reaction regions for processing the one or more biological samples, wherein: the excitation optical path is between the excitation source and the sample holder; the emission optical path is between the sample holder and the optical sensor; the emission optical system is configured to direct the emissions from the biological samples to the optical sensor; the illuminated surface is disposed along the excitation optical path between the beamsplitter and the base; and the sensor aperture is disposed between the beamsplitter and the sensor lens.
Battrell teaches a base [1100 and 1410] configured to receive a sample holder [1201] comprising a plurality of spatially separated reaction regions for processing one or more biological samples as shown in FIG. 12 and discussed in at least paragraph 106; wherein: the excitation optical path is between the excitation source and the sample holder; the emission optical path is between the sample holder and the optical sensor; the emission optical system is configured to direct the emissions from the biological samples to the optical sensor; and the illuminated surface is disposed along the excitation optical path between the beamsplitter and the base as discussed in at least paragraphs 32 and 150.
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Ruckstuhl and Boege with a base configured to receive a sample holder comprising a plurality of spatially separated reaction regions for processing the one or more biological samples, wherein: the excitation optical path is between the excitation source and the sample holder; the emission optical path is between the sample holder and the optical sensor the illuminated surface is disposed along the excitation optical path between the beamsplitter and the base
As to the sensor aperture is disposed between the beamsplitter and the sensor lens, absent unexpected results, it would have been prima facie obvious to provide a sensor aperture between the beamsplitter and the sensor lens, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
With respect to the intended use limitations (the emission optical system being configured to direct the emissions from the biological samples to the optical sensor), the device disclosed by Ruckstuhl in view of and Boege and Battrell is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Ruckstuhl in view of and Boege and Battrell is capable of providing the operating conditions as listed in the intended use section of the claim.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding Claim 4, Ruckstuhl does not disclose wherein the base comprises a thermal controller.
Battrell teaches wherein the base comprises a sample block assembly [1410] configured to control the temperature of the sample holder or biological samples as discussed in at least paragraphs 116 and 159.
Regarding Claim 5, Ruckstuhl does not disclose wherein the thermal controller is configured to control a temperature of at least one of the base, the sample holder, or the separated biological samples, or the thermal controller comprises a thermal cycler configured to perform a PCR assay
Battrell teaches the base comprises a thermal cycler configured to perform a PCR assay as discussed in at least paragraphs 116 and 159, the abstract and claim 13.
With respect to the intended use limitations (temperature control), the device disclosed by Ruckstuhl in view of and Boege and Battrell is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Ruckstuhl in view of and Boege and Battrell is capable of providing the operating conditions as listed in the intended use section of the claim.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding Claim 6, Ruckstuhl not explicitly disclose a heated cover disposed adjacent the base, the heated cover including a plurality of apertures configured to correspond to the plurality of reaction regions.
Boege teaches a luminescence detection system comprising a heated cover [30] disposed adjacent the base [70] and including a plurality of apertures [36] configured to correspond to the plurality of reaction regions (sample wells, 44) as discussed in at least paragraph 36.
It would have been obvious to one of ordinary skill in the art to modify Ruckstuhl in view of Battrell with the heated cover including a plurality of apertures as taught by Boege to augment heating of biological samples and to reduce condensation within the system. In addition, allowing light to pass through cover and into biological samples in the sample wells.
Regarding Claim 7, Ruckstuhl does not disclose wherein the excitation optical system comprises a sample lens configured to direct the excitation beams toward the base; the sample lens comprises a field lens configured to extend over the plurality of spatially separated regions; and the sample lens is configured to provide a telecentric optical system for a least one of the sample holder, the spatially separated reaction regions, or the optical sensor.
Battrell teaches wherein the excitation optical system comprises comprising a sample lens [1332] configured to direct the excitation beams toward the base as discussed in at least paragraph 108; the sample lens comprises a field lens [1330 and 1705] configured to extend over the plurality of spatially separated regions.
With respect to the intended use limitations (providing a telecentric optical system for a least one of the sample holder, the spatially separated reaction regions, or the optical sensor), the device disclosed by Ruckstuhl in view of Boege and Battrell is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Ruckstuhl in view of Boege and Battrell is capable of providing the operating conditions as listed in the intended use section of the claim.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 8, Ruckstuhl does not disclose a beamsplitter.
Battrell teaches a beamsplitter [1334 and 1704] disposed along both the excitation optical path and along the emission optical path as discussed in at least paragraph 108.
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Ruckstuhl and Boege with a beamsplitter disposed along both the excitation optical path and along the emission optical path taught by Battrell in order to help distribute and manage optical signals efficiently.
The beamsplitter of Battrell is capable of providing a reflectance that is constant over a wavelength band from 450 nanometers to 680 nanometers.
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. In other words, absent evidence to the contrary, the device disclosed by Ruckstuhl in view of Boege and Battrell would be able to provide the claimed wavelength band.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796