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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2025 has been entered.
Status of the Claims
Claim 8 has been amended. Claims 1-7 and 10-20 were previously withdrawn. Claims 1-20 are currently pending and claims 8-9 are examined herein.
Status of the Rejection
The 35 U.S.C. § 112(b) and 35 U.S.C. § 112(a) rejections of claim 8 from the previous office action are withdrawn in view of the Applicant’s amendments. The 35 U.S.C. § 112(b) rejections of claim 9 are maintained.
The 35 U.S.C. § 101 rejections of Claims 8-9 are essentially maintained and modified only in response to the amendments to the claims.
All 35 U.S.C. § 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
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 35 U.S.C. 112 (pre-AIA ), 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 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, claim 9 recites “the Raman light” in line 5. However, it is unclear which Raman light is being referred to, since claim 8 previously recited “lowest Raman light intensity” and “measured Raman light intensities”. Therefore, the scope of claim 9 is indefinite.
Regarding claim 9, claim 9 recites “use a signal intensity at a specific wavelength contained in a signal intensity distribution of the Raman light” in lines 3-4. However, claim 8 previously recited “a measured Raman light intensity at a specific wavelength” in lines 15-16. It is unclear if the signal intensity and specific wavelength of claim 9 is the same or different than the Raman light intensity and specific wavelength of claim 8. Applicant should clarify their relationship. Therefore, the scope of claim 9 is indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 8-9 are rejected under 35 U.S.C. 101.
Regarding independent claim 8, claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) “a controller configured to: determine a lowest Raman light intensity among the measured Raman light intensities, determine a correction coefficient of each capillary by dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary, and correct a measured fluorescence signal at a specific wavelength of a sample for each of the capillaries based on the determined correction coefficient for each capillary”. This calculation is math which can be done mentally via an evaluation or mathematical equation, and therefore is an abstract idea. Both the determining steps and the correction step are abstract ideas as they are all evaluations and/or mathematical equations. This judicial exception is not integrated into a practical application because once the abstract ideas above are completed nothing else is done. Therefore, there is no application, much less a particular practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional structural elements in the capillary electrophoresis device are routine and conventional structures previously known to the pertinent industry such as the prior arts of Ota et al., Kumahara et al., Sagatelyan et al. and evidentiary reference Horiba et al.
Claim 8 is ineligible due to the following analysis:
Step 1 (Statutory Category): Claim 8 is directed to a multicapillary electrophoresis device, therefore, it is directed to a statutory category, i.e., a device (Step 1: YES).
Step 2A, Prong-1 (the claim(s) is evaluated to determine whether it is directed to a judicial-exception/abstract-idea): Claim 8 recites the limitations “a controller configured to: determine a lowest Raman light intensity among the measured Raman light intensities, determine a correction coefficient of each capillary by dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary, and correct a measured fluorescence signal intensity at a specific wavelength of a sample for each of the capillaries based on the determined correction coefficient for each capillary”. Both the determining steps and the correction step are abstract ideas as they are all evaluations and/or mathematical equations. Nothing precludes the above limitations from being done mentally via an evaluation or mathematical equation. We can see from the specification that correction coefficients are computed based on a signal intensity. This is a correlation or calculation and therefore also an abstract idea (Step 2A, Prong-1: YES).
Step 2A, Prong-2 (the claim(s) is evaluated to determine whether the judicial-exception/abstract-idea is integrated into a Practical Application): The abstract idea in claim 8 related to determining a lowest Raman light intensity, determining a correction coefficient and correcting a measured fluorescence signal, is not integrated into a practical application. Once the correction coefficient is determined the signal intensity is corrected. This is merely applying the correction coefficient and would not amount to a particular practical application [see MPEP 2106.05(f)]. Once the abstract ideas above are completed nothing else is done. Therefore, there is no application much less a particular practical application. Note that the measuring Raman light intensity for data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). The controlling, measuring, determining, and correcting are done by a controller, which is a general-purpose computer according to the specification [Para. 0018-0019 of the instant specification]. A general-purpose computer is not a particular machine, and performing the abstract idea on a general-purpose computer is not enough to integrate the exception into a practical application (MPEP 2106.05(b)I.). Regarding the correction factor, this is a calculation based on previously gathered data. The MPEP notes that mathematical calculations are abstract ideas (MPEP § 2106.04(a)) and automating such a process by using a computer is not considered a particular practical application (MPEP § 2106.05(f)). Furthermore, merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, does not integrate the judicial exception into a practical application. See MPEP § 2106.05(f). (Step 2A, Prong-2: NO, because there is no integration of the abstract idea into a practical application).
Step 2B (the claim(s) is evaluated to determine whether recites additional elements that amount to an inventive concept, or also, the additional elements are significantly more than the recited the judicial-exception/abstract-idea): Claim 8 recites the additional element(s): a capillary array including a plurality of capillaries, a light source, a photodetector, and a controller configured to control the light source to irradiate each of the capillaries filled with a same substance and measure a Raman light intensity at a specific wavelength of the same substance of each of the capillaries which are just routine and conventional structures previously known to the pertinent industry (as evidenced by the prior arts of Ota et al., Kumahara et al., Sagatelyan et al., and evidentiary reference Horiba et al. in the current non-final office action) and thus, the structure is a well-known device and would not amount to significantly more. The claims do not invoke any of the considerations that courts have identified as provided significantly more than an exception. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Therefore, the independent claim 8 does not include additional element(s) significantly more, and/or, does not amount to more than the judicial-exception/abstract-idea itself and the claim is not patent eligible (Step 2B: NO).
Regarding dependent claim 9, claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 9 depends on the independent claim 8, and therefore, it has the abstract idea of independent claim 8 and it also fails to cure the deficiencies of claim 8 above. Furthermore, claim 9 further defines and elaborates on the abstract idea by reciting the limitation(s) “to use a signal intensity at a specific wavelength contained in a signal intensity distribution of the Raman light to calculate the correction coefficients” and is not eligible based on an analysis under step 2A prong one.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ota et al. (JP2014194362A, English translation) in view of Sagatelyan et al. (WO-2010034017-A2) and Kumuhara et al. (JP2012168138A, English translation). Yotter et al. (A Review of Photodetectors for Sensing Light-Emitting Reporters in Biological Systems, 2003, IEEE SENSORS JOURNAL, VOL. 3, NO. 3, Pages 288 - 303) is used as evidence for claim 8 and was previously cited in the restriction requirement mailed on 07/02/2024. Horiba Scientific et al. (What is Raman Spectroscopy, 2024, Horiba, Pages 1-7, https://www.horiba.com/usa/scientific/technologies/raman-imaging-and-spectroscopy/raman-spectroscopy/) used as evidence for claims 8-9.
Regarding claim 8, a multicapillary electrophoresis device (Ota teaches an electrophoresis apparatus with a plurality of capillaries and thus corresponds to a multicapillary electrophoresis device, [Abstract, Fig. 1 and Para. 0011]) comprising:
a capillary array including a plurality of capillaries (Ota teaches a capillary array 205 consisting of an arrangement of a plurality of capillaries, [Figure 1 and Para. 0016]);
a light source irradiating the capillaries with excitation light (Ota teaches a laser light source 211 which irradiates the plurality of capillaries with an excitation laser light, [Para. 0019 and Figure 1]);
a photodetector detecting fluorescence in the capillaries (Ota teaches a photodetector detects fluorescence emitted light from a DNA sample in the capillaries, Para. 0004. Ota further teaches the fluorescence can be detected by a detection system 202 including a two-dimensional image sensor such as a CCD, [Para. 0019, 0024 and Fig. 1]. A CCD is a photodetector as evidenced by Yotter [Table 1 and Page 289, Col. 1, Para. 2 of Yotter]); and
The embodiment of Fig. 1 is silent to the following limitations: a controller configured to: A) control the light source to irradiate each of the capillaries filled with a same substance, B) measure a Raman light intensity at a specific wavelength of the same substance of each of the capillaries, C) determine a lowest Raman light intensity among the measured Raman light intensities, D) determine a correction coefficient of each capillary by dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary, and E) correct a measured fluorescence signal intensity at a specific wavelength of a sample for each of the capillaries based on the determined correction coefficient for each capillary.
However, Ota teaches a third embodiment which uses the irradiation system of the first or second embodiment [Para. 0032-0034]. This third embodiment teaches a correction method where the signal intensity is made uniform on software and the correction value is calculated and stored in memory [Para. 0032-0034 and 0038]. Ota also teaches it is possible to replace part of the configuration of one embodiment with the configuration of another embodiment and to add the configuration of another embodiment to the configuration of one embodiment, and possible to add, delete, or replace part of the configuration of each embodiment with other configurations [Para.0040].
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the capillary electrophoresis device of the embodiment of Fig. 1 of Ota by adding the correction method including a software and memory of the third embodiment of Ota, since Ota teaches this can be used to make the signal intensity uniform on software [Para. 0032-0034 and 0038]. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results, MPEP 2143[I][A].
Regarding the limitations A-C: “a controller configured to: control the light source to irradiate each of the capillaries filled with a same substance, measure a Raman light at a specific wavelength of the same substance of each of the capillaries, and determines a lowest Raman light intensity among the measured Raman light intensities”, modified Ota teaches a correction method that includes computing/calculating the correction index/coefficient using a software and memory [corresponding to a controller] based on a signal intensity of Raman light where each of the capillaries are irradiated with excitation light and filled with an same substance [the polymer, which is the separation medium] (see rejection above and Para. 0035-0037 in Ota). Modified Ota further teaches measuring Raman light intensity of the same substance for each capillary to obtain the Offset which is the minimum value of the baseline, the Offset corresponds to a lowest/minimum Raman intensity among the baseline/measured Raman scattered light [Para. 0035-0037 in Ota]. The examiner notes that when the measuring of the Raman light intensity is performed, when the sample is irradiated with light it is inherently measured/performed at a specific wavelength since the light source which is used to irradiate the sample, inherently has a specific wavelength, as evidenced by Horiba Scientific et al., which states “Raman is a light scattering technique whereby a molecule scatters incident light from a high intensity laser light source” and “same wavelength as the laser source” [Page 1, Para. 2]. As modified Ota discloses the calculating the correction index is done by software with a memory, it therefore inherently has a controller for containing the software and memory which determines a lowest Raman light intensity among the measured Raman light intensity, after measuring a Raman light intensity at a specific wavelength of the same substance of each of the capillaries and after the light source irradiates each of the capillaries filled with the same substance [Para. 0032-0034 and 0036-0038 in Ota]. Additionally, to provide a mechanical or automatic means to replace manual activity, which accomplishes the same result, is within the ambit of a person of ordinary skill in the art. See In re Venner, 120 USPQ 192 (CCPA 1958) (see MPEP § 2144.04).
In the alternative, Sagatelyan discloses systems and methods for normalizing signals from detection zones in a capillary electrophoresis device based on detection and analysis of a Raman line resulting from Raman scattering of excitation light from the buffer solution in the detection zone, where such normalization can account for systematic variations that if not corrected, do not allow quantitative analysis of results from different capillaries, and such normalization can be achieved using the same excitation light and detection zone as used for detecting analyte samples such as dye-labeled DNA fragments “fluorescence signals” [Abstract; Para. 0001, 0005-0006, 00082]. Sagatelyan teaches measuring a Raman light intensity at a specific wavelength of the same substance of each of the capillaries and determining the Raman light intensity of each of the capillaries for comparison and normalization of the signals by scaling down or scaling up [Fig. 11-13 and Paras. 0106-0110]. The signal processor is configured so as to facilitate characterization of a selected Raman line resulting from said Raman scatter signal and the information about Raman scattering based normalization can be stored in a storage device typically associated with operation of computerized equipments [Para. 00116 and 0025-0027]. As the processor is further configured so as to facilitate combining of the characterized Raman lines from the plurality of detection zones so as to yield a combined value and Sagatelyan specifically discloses there are a number of other parameters that can represent the collection of such Raman intensity values and determining a response value representative of the plurality of detection zones, the processor “controller” is inherently configured to determine the lowest Raman intensity among the measured Raman light intensities as it determines all the measured Raman light intensities, averages the Raman intensity values, and does a comparison and correction of the intensity values, thus determining the lowest Raman light intensity [Paras. 0106-0110 and 0025-0027; Figs. 11-13].
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and capillary electrophoresis device of modified Ota, to be configured to measure a Raman light intensity at a specific wavelength of the same substance of each of the capillaries and determine a lowest Raman light intensity among the measured Raman light intensity, as taught by Sagatelyan, since Sagatelyan teaches it would be beneficial for performing quantitative comparison of results obtained from different capillaries and is a suitable alternative configuration for normalizing signals from detection zones in a capillary electrophoresis device [Abstract and Para. 0005 of Sagatelyan]. Furthermore, the use of a known technique (i.e., measuring Raman light of each of the capillaries and determining the lowest Raman light intensity, taught by Sagatelyan) to improve similar devices in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Regarding the limitation D: “a controller configured to determine a correction coefficient of each capillary by dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary”, modified Ota teaches a correction method that includes calculating/determining a signal intensity of the fluorescence of each capillary according to a signal obtained for each capillary by the two-dimensional image sensor, which is a CCD photodetector, [Para. 0024 and 0035 – 0037 in Ota, see rejection above]. Modified Ota further teaches correcting the signal intensity according to a correction value [corresponding to a correction coefficient] that is determined for each capillary and differs for each capillary, which is done by software and the corrected value is calculated and stored in memory, [Para. 0037 -0038 in Ota]. The correction value is determined for each capillary based on the lowest Raman light intensity and the measured Raman light intensity of each capillary, because the correction value includes the signal intensity which is the Peak- Offset, where the Offset is the minimum/lowest Raman light intensity among the baseline/measured Raman light intensity of each capillary [Para. 0035-0038 in Ota]. As modified Ota discloses the correction method and calculating are done by software with a memory, it therefore inherently has a controller for containing the software and memory and is configured to determine a correction coefficient/value [Para. 0032-0034 and 0038 in Ota].
Modified Ota is silent to determine a correction coefficient of each capillary by dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary.
Sagatelyan teaches normalization of the Raman data by a parameter that can represent the collection of the Raman intensity values and there are a number of other parameters besides the average value [Para. 00106-00110]. Raman scatter responses are obtained from a plurality of detection zones, a parameter representative of the plurality of detection zones is determined and responses corresponding to the capillary detection zones are adjusted “corrected” based on the parameter representative of the detection zone [Para. 00109 and Fig. 12]. Normalization can be achieved, for example, when the Raman intensity value corresponding to detection zone 1 is higher than the parameter value by scaling down and similarly, when the Raman intensity value corresponding to detection zone 4 is lower than the parameter value normalizing by scaling up and this is done for each of the 16 capillaries in the array [this normalization technique corresponds to determining a correction coefficient by dividing the determined Raman representative intensity parameter by the measured Raman light intensity] [Para. 00108 and Figs. 11-12].
Kumahara discloses a capillary electrophoresis device with a multi-capillary array 114 with plurality of capillaries 102, a light source 111, an optical detector [a photodetector] 112, and a control computer 125 [Figure 1; Abstract, Para. 0028, 0038, 0025]. The control computer 125 is connected to the electrophoresis apparatus main body 101 and controls each function of the apparatus, and transmits and receives data detected by the optical detector 112 [Para. 0027 and 0025]. The control computer 125 calculates the signal intensities and displays the signal intensity of each capillary after application of the light integration time coefficient which reduces the difference in fluorescence intensity between capillaries [corresponding to a correction coefficient], Para. 0075-0077. Kumahara teaches measuring the signal intensity of each capillary and correcting the intensities by a correction coefficient that is calculated by dividing the highest signal intensity by the measured light intensity of each capillary in order to reduce the difference in intensity between capillaries [Fig. 5 and Paras. 0042-0045]. Kumahara further teaches a specific fixed value determined in advance, or an average value of the signal strength of each capillary, or a minimum value “lowest” of the signal intensity of the capillaries may be used instead of the maximum value of the signal strength of each capillary [Para. 0045 and 0091].
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of modified Ota which determines a correction coefficient of each capillary, to be configured to be determined by dividing the determined Raman representative intensity parameter by the measured Raman light intensity of each respective capillary, as taught by Sagatelyan, since Sagatelyan teaches it would be beneficial for performing quantitative comparison of results obtained from different capillaries and is a suitable alternative configuration for normalizing signals from detection zones in a capillary electrophoresis device [Abstract and Para. 0005 of Sagatelyan]. Furthermore, the use of a known technique (i.e., normalizing Raman light intensities by dividing the determined Raman representative intensity parameter by the measured Raman light intensity, taught by Sagatelyan) to improve similar devices in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Given the teachings of Sagatelyan regarding normalization “correction” of the Raman data by a parameter that represents the collection of the Raman intensity values and there are a number of other parameters besides the average value [Para. 00106-00110 of Sagatelyan] and the teachings of Kumahara regarding a specific fixed value determined in advance, or an average value of the signal strength of each capillary, or a minimum value “lowest” of the signal intensity of the capillaries may be used instead of the maximum value of the signal strength of each capillary for the correction [Para. 0045 and 0091 of Kumahara], it would have been further obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the determined Raman representative intensity parameter of modified Ota to be a lowest light intensity, where correction coefficient of each capillary is determined by dividing the lowest light intensity by the measured light intensity of each respective capillary, as taught by Kumahara, since Kumahara teaches it would be beneficial in order to reduce the difference in intensity between capillaries [Fig. 5 and Paras. 0042-0045 of Kumahara]. Furthermore, the use of a known technique (i.e., dividing the lowest light intensity by the measured light intensity of each respective capillary, taught by Kumahara) to improve similar devices in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Therefore, Modified Ota yields determining a correction coefficient of each capillary by dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary [see rejection above].
Regarding the limitation E: “a controller configured to correct a measured fluorescence signal intensity at a specific wavelength of a sample for each of the capillaries based on the determined correction coefficient for each capillary”, modified Ota teaches a correction method that includes calculating/determining a signal intensity of the fluorescence of each capillary according to a signal obtained for each capillary by the two-dimensional image sensor, which is a CCD photodetector, [Para. 0024 and 0035 – 0037 in Ota, see rejection above]. Modified Ota further teaches correcting the signal intensity according to a correction value [corresponding to a correction coefficient] that is determined for each capillary and differs for each capillary, which is done by software and the corrected value is calculated and stored in memory, [Para. 0037 -0038 in Ota]. The fluorescence signal intensity is multiplied by the correction value during detection so that the measured fluorescence signal intensity is corrected at a specific wavelength of the light of the sample for each capillary based on the determined correction value, which differs for each capillary and Modified Ota teaches the specific correction coefficient as outlined above [Para. 0035-0038 in Ota; see rejection of claim above]. Modified Ota as outlined in the rejection above yields the correction value is determined for each capillary by dividing the lowest Raman light intensity by the measured Raman light intensity of each capillary [see rejection above]. As modified Ota discloses the correction method and calculating are done by software with a memory, it therefore inherently has a controller for containing the software and memory and is configured to correct the measured fluorescence signal intensity at a specific wavelength based on the determined correction coefficient for each capillary [Para. 0032-0034 and 0038 in Ota and see rejection of claim 8 above].
In the alternative, the limitations of a controller are further rejected in view of Kumuhara in the following.
Kumahara discloses a capillary electrophoresis device with a multi-capillary array 114 with plurality of capillaries 102, a light source 111, an optical detector [a photodetector] 112, and a control computer 125 [Figure 1; Abstract, Para. 0028, 0038, 0025]. The control computer 125 is connected to the electrophoresis apparatus main body 101 and controls each function of the apparatus, and transmits and receives data detected by the optical detector 112 [Para. 0027 and 0025]. Kumahara further teaches the control computer 125 calculates the signal intensities and displays the signal intensity of each capillary after application of the light integration time coefficient which reduces the difference in fluorescence intensity between capillaries [corresponding to a correction coefficient], Para. 0075-0077.
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the capillary electrophoresis device which includes the functions of A) control the light source to irradiate each of the capillaries filled with a same substance, B) measure a Raman light intensity at a specific wavelength of the same substance of each of the capillaries, C) determine a lowest Raman light intensity among the measured Raman light intensities, D) determine a correction coefficient of each capillary by dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary, and E) correct a measured fluorescence signal intensity at a specific wavelength of a sample for each of the capillaries based on the determined correction coefficient for each capillary of modified Ota by adding the control computer connected to the electrophoresis apparatus main body taught by Kumahara for performing the listed functions above and controlling each function of the electrophoresis apparatus, since Kumahara teaches the control computer 125 is beneficial for controlling each function of the apparatus, and transmitting and receiving data detected by the optical detector 112 [Para. 0027 and 0025 of Kumahara]. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results, MPEP 2143[I][A]. The added computer corresponds to the claimed controller.
Regarding claim 9, the multicapillary electrophoresis device according to Claim 8, wherein the controller is configured to use a signal intensity at a specific wavelength contained in a signal intensity distribution of the Raman light to calculate the correction coefficients (Modified Ota teaches the software and memory contained in the computer/controller uses a signal intensity at a specific wavelength [the Offset which is the minimum value of the Raman scattered light/lowest Raman light intensity among the measured Raman light intensity] to calculate the correction value of the signal intensity [Para. 0036-0036 of Ota, see rejection of claim 9 above]. Modified Ota as outlined in the rejection of claim 8 above yields a controller configured to measure a Raman light intensity at a specific wavelength and use a signal intensity at the specific wavelength of the Raman light to determine/calculate the correction coefficient of each capillary [see rejection above and Paras. 00160-00109 and Figs. 11-12 of Sagatelyan]. The Raman scattered light inherently contains a signal intensity distribution, as evidenced by Horiba, which states that Raman scattering features a number of peaks at different wavelengths and intensities [Page 1 last paragraph, and Page 2 first paragraph of Horiba], and thus, modified Ota teaches selecting the minimum value of the Raman scattered light which corresponds to the signal intensity at a specific wavelength contained in a signal intensity distribution of the Raman light to calculate the correction coefficient/value. Further, the modification of Modified Ota by Kumahara yields a control computer corresponding to the controller for performing the calculation of the correction value and performing the correction functions [see rejection of claim 8 above].
Response to Arguments
Applicant's arguments, see Remarks Pgs. 10-12, filed 04/28/2025, with respect to the 35 U.S.C. § 101 rejections have been fully considered and are not persuasive.
Applicant's arguments, see Remarks Pgs. 12-14, filed 04/28/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered and all 103 rejections from the previous office action are withdrawn.
Applicant’s Argument #1:
Applicant argues on pages 10-12 that the courts do not distinguish between the types of technology when determining the invention improved technology. Further, the improvement explained above is explained in the specification and recited in the claims. The Office essentially concludes that because correction itself is an abstract idea then there is no practical application recited of the abstract idea. However, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field. Further, when considering whether the improvement is reflected in the claim, 'it is critical that examiners look at the claim "as a whole," in other words, the claim should be evaluated "as an ordered combination, without ignoring the requirements of the individual steps." The improvement, for the Step 2A Prong Two analysis, is not an improvement to determining a lowest Raman light intensity, determining a correction coefficient of each capillary, or correcting a measured Raman light intensity at a specific wavelength of a sample for each of the capillaries based on the determined correction coefficient for each capillary. Rather, these are the limitations which provide the improvement in combination with the additional elements. While "the claim must include the components or steps of the invention that provide the improvement described in the specification," "the claim itself does not need to explicitly recite the improvement described in the specification. Therefore, claim 8, when considered as a whole, integrates the alleged abstract idea into a practical application at least because these claims recite additional elements that provide an improvement to multicapillary electrophoresis devices, as discussed above. Therefore, under the Step 2A Prong Two analysis, claim 8 is directed to patent-eligible subject matter and the rejection of claims 8 and 9 under 35 U.S.C. §101 should be withdrawn.
Examiner’s Response #1:
The examiner respectfully disagrees. The controlling, measuring, determining, and correcting are done by a controller, which is a general-purpose computer according to the specification [Para. 0018-0019 of the instant specification]. A general-purpose computer is not a particular machine, and performing the abstract idea on a general-purpose computer is not enough to integrate the exception into a practical application (MPEP 2106.05(b)I.). Note that the measuring Raman light intensity for data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Thus, there is no integration of the abstract idea into a practical application. Furthermore, the limitation of determining the correction coefficient is part of the abstract ideas and thus, the claim does not recite elements which are significantly more than the abstract idea. Additionally, the measuring of Raman light is well understood, routine and conventional and therefore does not amount to significantly more as evidenced by the non-final rejection above, see e.g., Ota et al., Kumahara et al., Sagatelyan et al., and Horiba et al. .). Regarding the correction factor, this is a calculation based on previously gathered data. The MPEP notes that mathematical calculations are abstract ideas (MPEP § 2106.04(a)) and automating such a process by using a computer is not considered a particular practical application (MPEP § 2106.05(f)). Furthermore, merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, does not integrate the judicial exception into a practical application. See MPEP § 2106.05(f).
With regard to 2106.04(d) and the integration of the judicial exception into a particular practical application, it is unclear what is seen as the integration. It appears Applicant is merely pointing to this section but not demonstrating how the abstract idea is actually integrated into a particular practical application nor are they showing any improvement to the computer or technical field of endeavor.
The abstract idea in claim 8 related to determining a lowest Raman light intensity, determining a correction coefficient and correcting a measured fluorescence signal, is not integrated into a practical application. Both the determining steps and the correction step are abstract ideas as they are all evaluations and/or mathematical equations. Nothing precludes the above limitations from being done mentally via an evaluation or mathematical equation. We can see from the specification that correction coefficients are computed based on a signal intensity. This is a correlation or calculation and therefore also an abstract idea. Once the correction coefficient is determined the signal intensity is corrected. This is merely applying the correction coefficient and would not amount to a particular practical application [see MPEP 2106.05(f)]. Correcting of the measured fluorescence signal intensity still does not appear to be sending any signal and is just a correction “based on” the determined correction coefficient. Once the abstract ideas above are completed nothing else is done. Therefore, there is no application of the abstract idea, much less a particular practical application.
The Applicant has stated there is an improvement, but has not disclosed what the improvement actually is. The examiner directs Applicant to MPEP 2106.04(d) which gives examples of what could be considered applying the judicial exception. The examiner requests applicant to point out which of the following is being used within the claim:
•An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. See MPEP 2106.04(d)(1).
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., "thereby increasing the bandwidth of the channel"). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim "as a whole," in other words, the claim should be evaluated "as an ordered combination, without ignoring the requirements of the individual steps." When performing this evaluation, examiners should be "careful to avoid oversimplifying the claims" by looking at them generally and failing to account for the specific requirements of the claims. See MPEP 2106.04(d)(1).
Therefore, the 101 rejection has not been overcome and is maintained.
Applicant’s Argument #2:
Applicant argues on pages 12-14 that the combination of Ota, Kumuhara, Yotter and Horiba do not render claim 1 obvious. The claimed invention uses a simpler process and there are two differences from Ota. First, in the claimed invention, the correction coefficient is obtained in one step by using Raman light intensities: a lowest Raman light intensity and the Raman light intensity of the respective capillary. In contrast, Ota first calculates signal strengths of each capillary and then the signal strengths are used to determine a correction value. The signal strengths are obtained by subtracting a baseline Raman scattered light from a peak fluorescent dye signal. That is, signal strength = Peak (fluorescent dye signal) - Offset (Raman scattered light). This calculation is different than dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary. Ota obtains a correction value based on signal strength ratios using the highest signal strength among the signal strengths of the capillaries. This calculation is also different than dividing the lowest Raman light intensity by the measured Raman light intensity of each respective capillary. Ota does not use the lowest Raman light intensity and each Raman light intensity for each capillary to obtain the correction values.
Additionally, one having ordinary skill in the art would not be taught by the above multistep process in Ota to arrive at the above limitation but for impermissible hindsight reasoning using the Applicant's disclosure.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s Argument #3:
Applicant argues on page 14 that the dependent claims are also allowable over the cited combination of documents at least due to the dependency of these claims from an allowable base claim, as well as for the additional features that each recites.
Examiner’s Response #3:
Applicant’s arguments have been fully considered. Based on the Examiner’s Response #2 above, applicant’s arguments regarding the amended claim 8 are moot in view of the new grounds of rejection. Regarding applicant’s arguments of the dependent claim patentability due to the additional features it recites, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yokoyama et al. (US20150337360A1) discloses a technique for performing spectral calibration simultaneously with electrophoresis of an actual sample to be analyzed, without performing electrophoresis using a special matrix standard, where according to Example 4 of the invention is characterized by using the Raman spectra measured before electrophoresis, instead of the spectra of the size standard, for determining the shift amount from the reference fluorescence spectra [Abstract; Fig. 27-28; Para. 0247, 0235, 0111-0112]
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/S.Y.O./Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794
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