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 Amendment and Status of Application
This notice is in response to the amendments filed 02 July 2026. Claims 1-20 are pending in the instant application where claims 1, 8, 10, 13, 15-16, and 18 have been amended. Applicant’s amendments to the drawings and specification have overcome the objection to the drawings set forth in the Non-Final Office Action dated 04 May 2026, and are hereby withdrawn. Applicant’s amendments to the claims have overcome each and every objection and rejection under 35 U.S.C. 112(b) set forth in the same Non-Final Action named above and are hereby withdrawn.
Response to Arguments
Applicant’s arguments with respect to independent claim(s) 1 and 15 (remarks page 2 section “Independent claim 1” and page 5 section “Independent claim 15”) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. This is in regards to arguments directed toward newly added limitations comprising at least “output[ing] at least one of a molecular marker prediction and a genetic marker prediction”, with respect to a machine learning model (claim 1) and instructions executable by a processor to output said predictions (claim 15). No reference previously cited is used to teach this limitation.
The remaining arguments are various recitations that the other cited prior art references within the Non-Final Office Action dated 04 May 2026 do not teach the underlined limitations above.
Drawings
The replacement drawings were received on 02 July 2026, required due to objection set forth in the previous action. These drawings are acceptable.
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 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 1-5, 10-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0021724 A1 by Anita Mahadevan-Jansen et al. (herein after “Jansen”) in view of US 6,095,982 A by Rebecca Richards-Kortum et al. (herein after “Kortum”), and further in view of US 12,293,821 B2 by Michael Barnes et al. (herein after “Barnes”).
Regarding claim 1, Jansen discloses an on-spot abnormal tissue detection system (Jansen [0002] discloses field of invention relating to diagnosis of normal and cancerous skin lesion [on-spot] of living subject; [0012] discloses target of interest including tissues of living subject [abnormal tissue detection system]) comprising:
a light source (Jansen [0068]-[0069] and fig. 1 discloses light source 110; fig. 2 and [0083] discloses a handheld probe 200 as a compact replica of the system shown in fig. 1);
a housing (Jansen fig. 2 and [0083] discloses handheld probe 200, [0084] comprising casing 210 [housing]);
a light fiber connected to the light source that carries light from the light source into the housing (Jansen fig. 1 label 131 and [0084], fig. 2 show a single mode optical fiber SMF 231; [0091] discloses port 211 which receives light from light source and couples it to the probe body [light fiber connected to light source, carries light into housing]);
a collimating lens positioned inside the housing to receive the light carried by the light fiber (Jansen fig. 1 label 121 C1/fig. 2 label 220 (also C1) and [0085] discloses collimation lens C1 that receives beam of light entering housing from light fiber 231)
one or more beam combining mirrors positioned inside the housing in a light path from the collimating lens, the one or more beam combining mirrors reflecting light below a particular wavelength and transmitting light above the particular wavelength (Jansen fig. 1 labels D1, D2 and fig. 2 label D discloses beam combining mirrors (combining beams from multiple light sources, see fig. 1) which receive(s) light from collimating lens C1; [0086] discloses that mirror D (and D1 [0075]) reflects Raman excitation light and transmits light other than the excitation light; given the wavelength of the Raman excitation light, light being transmitted through the mirror is above the particular wavelength of the excitation light, given the existence of the EM spectrum above and below whatever excitation wavelength is chosen and the ability for the beam combining mirror to transmit other than excitation light);
one or more achromatic doublet lenses positioned inside the housing that focus each wavelength of light reflected from the target area (Jansen fig. 2 and [0085] discloses objective lens OL 228 that [0091] collects light scattered/reflected from target of interest 290 [focus wavelength of light reflected from target area]; [0087] the objective lens is an achromatic doublet objective lens; incident light is composed of a plurality of wavelengths ([0013] broadband light), therefore the objective lens focuses each wavelength of light reflected from the target area);
a spectrometer (Jansen fig. 1 shows a spectrograph 155 obtained [i.e. obtained by a spectrometer]);
a fiber optic cable that carries light from the one or more achromatic doublet lenses to the spectrometer (Jansen fig. 1 and [0080] discloses light along sixth optical path 146 (i.e. obtained from target of interest via objective lens) is directed to a fiber 135 via lens 127 to obtain spectrograph [fiber optic cable carries light from achromatic doublet lens to the spectrometer]); and
a computing system comprising a processor, storage, and instructions stored on the storage (Jansen fig. 3 and [0102] discloses a computer 370 that is in communication with the probe 340 analogous to the probe 200 of fig. 2 ([0092] discloses the probe 200 being connected to a main system control unit placed on a cart [main system control unit here is the computer 370 of fig. 3 – associating the computer of fig. 3 [also disclosed as being on a pushcart, see [0044]] with the probe 200 of fig. 2 is not a combination of embodiments since the probe 200 is disclosed as being in communication with a main system control unit]); the spectrograph obtained via probe 200 and system 100 is obtained via computer 370, or an equivalent thereof; processor, storage, and instructions are all components of a computer, as recognized by one of ordinary skill in the art) that when executed by the processor, cause the computing system to:
receive wavelength intensity pairs for one or more spot locations of the target area from the spectrometer (Jansen [0101] discloses acquired Raman scattering light [obtained via probe 200, see [0091]] is processed into a frequency spectrum [spectrograph/from spectrometer] where a plurality of intensity peaks are shown at a plurality of wavelengths, where each intensity peak is associated with a specific aspect of the target of interest [wavelength intensity pairs for one or more spot locations of the target area]), and
send [information] for the one or more spot locations of the target area to a display (Jansen [0103] discloses that images obtained and Raman scattering spectra are visualized in a display [i.e. the computer display of computer 370 seen in fig. 3])
Jansen is silent to one or more focusing optic lenses positioned inside the housing in the light path from the one or more beam combining mirrors, the one or more focusing lenses focusing the transmitted light from the one or more beam combining mirrors onto a target area, and
determine a standard deviation and variance measurement of the wavelength intensity pairs for the one or more spot locations of the target area from the spectrometer;
determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs; and
send the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue to a display.
However, Kortum does address this limitation. Jansen and Kortum are considered to be analogous to the present invention because they are in the same field of optical inspection and detection via Raman measurements of normal and abnormal tissue samples.
Kortum discloses “one or more focusing optic lenses positioned inside the housing in the light path from the one or more beam combining mirrors, the one or more focusing lenses focusing the transmitted light from the one or more beam combining mirrors onto a target area” (Kortum fig. 2 a Raman spectroscopy device comprising a light source emitting light via fiber 201 and directing the light to a sample containing cuvette; fig. 2 shows a focusing lens along the incident light optical path before the sample [one or more focusing optic lenses]; the lens focuses the incident light onto the cuvette [lens focuses light onto a target area]; given the geometry already disclosed by Jansen regarding the housing, incorporating the focusing lens to focus the light onto the target area from within the housing would be obvious to one of ordinary skill in the art);
“determine a standard deviation and variance measurement of the wavelength intensity pairs for the one or more spot locations of the target area from the spectrometer” (Kortum col. 1 ll. 64 – col. 2 ll. 18 discloses the data regarding differentiation between normal and abnormal tissues using the spectroscopic methods disclosed; col. 10 ll. 23-30 and equation 1 discloses the use of mean and standard deviation within obtained data and col. 8 ll. 55-58 and equation 3 discloses the determination of variance of the dataset [determine standard deviation and variance measurement] – the standard deviation and variance measurements ultimately rely upon the data collected from the one or more target areas/targets of interest of both Jansen and Kortum);
“determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs” (Kortum col. 1 ll. 64 – col. 2 ll. 18 discloses the data regarding differentiation between normal and abnormal tissues [abnormal tissues being squamous intraepithelial lesions (SIL) [tumor] using the spectroscopic methods disclosed, see also Appendix 1– the disclosed data obtained is at a minimum based on the standard deviation and variance (equations 3 and 6), and thus the determination of whether the tissue type is of a tumor or normal is disclosed by Kortum); and
“send the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue to a display” (Jansen has disclosed sending both images and scattering spectra obtained by its probe to a display – since the scattering spectra are sent to the display, it follows that determination of tissue type would be obviously displayed on the controller).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate one or more focusing optic lenses positioned inside the housing in the light path from the one or more beam combining mirrors, the one or more focusing lenses focusing the transmitted light from the one or more beam combining mirrors onto a target area,
determine a standard deviation and variance measurement of the wavelength intensity pairs for the one or more spot locations of the target area from the spectrometer;
determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs; and
send the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue to a display as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and Appendix I).
Jansen when modified by Kortum is silent to the computing system comprising instructions to cause the computing system to: determine, using a machine learning model, whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue, wherein the machine learning model further outputs at least one of a molecular marker prediction and a genetic marker prediction.
However, Barnes does address this limitation. Jansen, Kortum, and Barnes are considered to be analogous to the present invention because they are in the same field of optical inspection and detection via image analysis of normal and abnormal tissue samples.
Barnes discloses “the computing system comprising instructions to cause the computing system to: determine, using a machine learning model, whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue, wherein the machine learning model further outputs at least one of a molecular marker prediction and a genetic marker prediction” (Barnes col. 3 ll. 27-43 discloses the use of machine learning as a diagnostic means for classifying image features based on image data and patient outcome data for control and variable groups using a multivariate Cox model [machine learning model]; col. 8 ll. 6-37 defines biomarker within Barnes as a measurable indicator/metric of some biological state or condition in at least a prognostic setting, and col. 26 ll. 5-17 discloses the use of the Cox model to determine relevant metrics most relevant in prognostically predicting patient outcomes via predicted value of image metrics, and/or via a data-driven diagnostic feature discovery method – the use of the Cox model within the prognostic module results in the machine learning model outputting at least one of a molecular marker prediction and genetic marker prediction, given the definition of biomarker provided by col. 8 ll. 6-37).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum to incorporate the computing system comprising instructions to cause the computing system to: determine, using a machine learning model, whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue, wherein the machine learning model further outputs at least one of a molecular marker prediction and a genetic marker prediction as suggested by Barnes for the advantage of incorporating a prognostic feature derivation module, such that the patient response accuracy may be increased via the machine learning aspect of the prognostic derivation module (Barnes col. 26 ll. 3-17), thereby improving patient care.
Regarding claim 2, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1. Jansen is silent to the on-spot abnormal tissue detection system of claim 1, wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to determine a probability of the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs.
However, Kortum does address this limitation.
Kortum discloses the on-spot abnormal tissue detection system of claim 1, “wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to determine a probability of the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs” (Kortum col. 3 ll. 24-36 discloses the calculation of a probability that the sample is abnormal; as noted in claim 1 above, the disclosed data (various spectra) obtained is at a minimum based on the standard deviation and variance (equations 3 and 6), and thus the determination of the probability that the tissue type is of a tumor or normal is disclosed by Kortum).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to determine a probability of the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and Appendix I).
Regarding claim 3, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1. Jansen is silent to the on-spot abnormal tissue detection system of claim 1, wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
receive a previous pathology report for the target area;
extract information from the previous pathology report for the target area; and
create a feature vector based on the information extracted from the previous pathology report for the target area;
wherein the instructions that determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs comprise instructions that determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation, the variance measurement of the wavelength intensity pairs, and the feature vector based on the information extracted from the previous pathology report for the target area.
However, Kortum does address this limitation.
Kortum discloses the on-spot abnormal tissue detection system of claim 1, wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
“receive a previous pathology report for the target area” (Kortum col. 10 ll. 46 – col. 11 ll. 10 discloses the use of an original data set to obtain a calibration data set and a prediction data set for analysis with the ‘current’ group of samples being analyzed [the original data set is considered “previous pathology report”]; additionally, MPEP §2114 I discloses the limits of functional limitations within apparatus claims – in this case, the prior art structure [processor able to process and analyze spectral data obtained from a tissue sample, etc.] inherently possess the functionally defined limitations and does not make a contribution over the prior art – see In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432 and In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971); the italicized text here applies to all below functional limitations below);
“extract information from the previous pathology report for the target area” (Kortum col. 10 ll. 46 – col. 11 ll. 10; calibration data set and prediction data set utilize information contained within the “previous pathology report”; also, see functional limitations under MPEP §2114 I. above); and
“create a feature vector based on the information extracted from the previous pathology report for the target area” (Kortum col. 10 ll. 46 – col. 11 ll. 10; either or both of the calibration data set or prediction data set may be considered as a feature vector, as they are both based on information from the “previous pathology report”; also, see functional limitations under MPEP §2114 I. above);
“wherein the instructions that determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs comprise instructions that determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation, the variance measurement of the wavelength intensity pairs, and the feature vector based on the information extracted from the previous pathology report for the target area” (Kortum col. 1 ll. 64 – col. 2 ll. 18 discloses the data regarding differentiation between normal and abnormal tissues [abnormal tissues being squamous intraepithelial lesions [tumor] using the spectroscopic methods disclosed, see also Appendix 1– the disclosed data obtained is at a minimum based on the standard deviation and variance (equations 3 and 6), and thus the determination of whether the tissue type is of a tumor or normal is disclosed by Kortum, based on the standard deviation, variance, and the feature vector, as mapped above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
receive a previous pathology report for the target area;
extract information from the previous pathology report for the target area; and
create a feature vector based on the information extracted from the previous pathology report for the target area;
wherein the instructions that determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs comprise instructions that determine whether tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue based on the standard deviation, the variance measurement of the wavelength intensity pairs, and the feature vector based on the information extracted from the previous pathology report for the target area as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and Appendix I).
Regarding claim 4, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1. Jansen is silent to the on-spot abnormal tissue detection system of claim 1 wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
receive light scattering properties for the one or more spot locations of the target area from the spectrometer; and
in response to a determination that the tissue for the one or more spot locations of the target area is a tissue type of a tumor, determine whether the tissue is cancerous or benign based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer.
However, Kortum does address this limitation.
Kortum discloses the on-spot abnormal tissue detection system of claim 1 wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
“receive light scattering properties for the one or more spot locations of the target area from the spectrometer” (Kortum col. 18 ll. 18-36 discloses obtaining spectra for samples investigated by the system, where the spectra are generated due to Raman interactions where the Raman scattering spectra are indicative of light scattering properties for the sample within the cuvette receive light scattering properties for the one or more spot locations of the target area]; additionally and as with the preceding claims, MPEP §2114 I discloses the limits of functional limitations within apparatus claims based on the same rationale in claim 3) and
“in response to a determination that the tissue for the one or more spot locations of the target area is a tissue type of a tumor, determine whether the tissue is cancerous or benign based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer” (Kortum col. 1 ll. 64 – col. 2 ll. 18 discloses the data regarding differentiation between normal and abnormal tissues [abnormal tissues being squamous intraepithelial lesions (SIL) [tumors] using the spectroscopic methods disclosed, where at least the high grade SIL are moderate to severe dysplasia carcinoma [cancerous] and normal tissues are benign; these determinations are based on the obtained data from at least Raman interaction of the cuvette [determine whether tissue is cancerous or benign based on light scattering properties]; as with the preceding claim, also, see functional limitations under MPEP §2114 I. above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
receive light scattering properties for the one or more spot locations of the target area from the spectrometer; and
in response to a determination that the tissue for the one or more spot locations of the target area is a tissue type of a tumor, determine whether the tissue is cancerous or benign based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and Appendix I).
Regarding claim 5, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 4. Jansen is silent to the on-spot abnormal tissue detection system of claim 4 wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to determine a probability of the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of cancerous, benign, or normal based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer.
However, Kortum does address this limitation.
Kortum discloses the on-spot abnormal tissue detection system of claim 4 “wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to determine a probability of the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of cancerous, benign, or normal based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer” (Kortum at least col. 23 ll. 1-18 (see also claim 2 for a probability determination) discloses that analysis of the spectrum obtained of the samples enables a calculation of the probability that a tissue is normal, low or high grade SIL via Raman spectroscopy; additionally and as with the preceding claims, MPEP §2114 I discloses the limits of functional limitations within apparatus claims based on the same rationale in claim 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to determine a probability of the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of cancerous, benign, or normal based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and Appendix I).
Regarding claim 10, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1, and Jansen further teaches the system further comprising one or more noise reduction filters positioned on an optical path between the spectrometer and the one or more beam combining mirrors, the one or more noise reduction filters removing light from the light source that is not reflected from the target area (Jansen fig. 2 and [0090] discloses notch filter NF 223 [noise reduction filter] which minimizes residual scattered light not Raman scattered [removing light from the light source that is not reflected from the target area]; fig. 1 shows the notch filter NF placed between a means for acquiring a Raman spectrograph and beam combining mirror D2 [one or more noise reduction filter positioned between spectrometer and one or more beam combining mirrors]).
Regarding claim 11, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1, and Jansen further teaches the system wherein the one or more beam combining mirrors comprise a dichroic mirror (Jansen [0075], fig. 1 and fig. 2 discloses the one or mirrors D1, D2, D are dichroic mirrors).
Regarding claim 14, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1. Jansen is silent to the on-spot abnormal tissue detection system of claim 1 wherein the light from the light source comprises a wavelength of light ranging from 350 nm to 700 nm.
However, Kortum does address this limitation.
Kortum discloses the on-spot abnormal tissue detection system of claim 1 “wherein the light from the light source comprises a wavelength of light ranging from 350 nm to 700 nm” (Kortum fig 2 and col. 4 ll. 57-64 discloses the use of laser with wavelengths of 380 nm and 460 nm [both of which fall within the claimed wavelength range from 350nm to 700nm]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate wherein the light from the light source comprises a wavelength of light ranging from 350 nm to 700 nm as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and appendix I)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Kortum, in view of Barnes, and further in view of US 2018/0012356 A1 by Anant Madabhushi et al. (herein after “Anant”).
Regarding claim 6, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1, but is silent to the system wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to generate a 3D pathological map using the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue and a location of each of the one or more spot locations within the target area.
However, Anant does address this limitation. Jansen, Kortum, Barnes, and Anant are considered to be analogous to the present invention because they are in the same field of disease characterization and identification of cancerous tissues via an optical method.
Anant discloses the on-spot abnormal tissue detection system of claim 1 “wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to generate a 3D pathological map using the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue and a location of each of the one or more spot locations within the target area” (Anant fig. 7 and [0018] discloses a 3D histological reconstruction of a region of tissue [3D pathological map]; [0019] discloses the formulation of the slices of fig. 7 into a fused CT image, where invasive adenocarcinoma (IA) -see abstract- is identified [determination of whether tissue for the one or more spot locations of the target area is normal/tumor]; additionally and as with the preceding claims, MPEP §2114 I discloses the limits of functional limitations within apparatus claims based on the same rationale first appearing in claim 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum and Barnes to incorporate wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to generate a 3D pathological map using the determination of whether the tissue for the one or more spot locations of the target area is a tissue type of a tumor or normal tissue and a location of each of the one or more spot locations within the target area as suggested by Anant for the advantage of increasing a registration accuracy for identifying cancerous tumors utilizing the three dimensional fused image and enables identification of cancerous vs benign tissues (Anant [0022]-[0023])
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Kortum, in view of Barnes, and further in view of US 2007/0161876 A1 by Shabbir Bikir Bambot et al. (herein after “Bambot”).
Regarding claim 7, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1, and Jansen further teaches the system further comprising one or more cameras coupled to an outside of the housing and positioned to capture the target area during use of the on-spot abnormal tissue detection system (Jansen [0093] discloses a CCD camera that may be placed on the side of the probe casing, where the fact of the placement captures the target area during use of the probe would be obvious to one of ordinary skill in the art [camera coupled to an outside of the housing and positioned to capture the target area during use of the on-spot abnormal tissue detection system]).
Jansen when modified by Kortum and Barnes is silent to the on-spot abnormal tissue detection system of claim 1, further comprising the one or more cameras coupled to a surgical display that displays a video feed captured by the one or more cameras.
However, Bambot does address this limitation. Jansen, Kortum, Barnes, and Bambot are considered to be analogous to the present invention because they are in the same field of optical inspection and detection via image analysis of normal and abnormal tissue samples.
Bambot discloses the on-spot abnormal tissue detection system of claim 1, “further comprising the one or more cameras coupled to a surgical display that displays a video feed captured by the one or more cameras” (Bambot fig. 1A and [0068] discloses an illumination device 76 and an imaging device 78 for target tissue investigation; imaging device 78 is shown in the figure, as a Panasonic color board camera with 480 horizontal TV lines, and is mounted offset from the illumination and collection pathways [analogous to being mounted outside the housing, as disclosed by Jansen]; [0126] discloses imaging device 78 sends a video signal viewed with a computer or video monitor allowing for the physician to properly align the device [camera coupled to a surgical display that displays a video feed captured by the one or more cameras]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum and Barnes to incorporate the one or more cameras coupled to a surgical display that displays a video feed captured by the one or more cameras as suggested by Bambot for the advantage of enabling the proper alignment for the medical device with the specific part of a patient’s body under optical investigation or medical procedure, in this case a cervical inspection (Bambot [0126]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Kortum, in view of Barnes, and further in view of US 2021/0223526 A1 by Michael Knop et al. (herein after “Knop”).
Regarding claim 8, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1, and Jansen further teaches the system wherein the one or more achromatic doublet lenses are located within the housing (Jansen fig. 2A discloses the achromatic doublet objective lens 228 within the casing of the probe 200 [achromatic doublet lens is located within the housing]).
Jansen when modified by Kortum and Barnes is silent to the on-spot abnormal tissue detection system of claim 1 wherein the one or more achromatic doublet lenses are further positioned on an optical path between the spectrometer and the one or more beam combining mirrors.
However, Knop does address this limitation. Jansen, Kortum, Barnes, and Knop are considered to be analogous to the present invention because they are in the same field of inspection and detection of biological tissues via optical methods and using optical devices.
Knop discloses the on-spot tissue detection system of claim 1 “wherein the one or more achromatic doublet lenses are further positioned on an optical path between the spectrometer and the one or more beam combining mirrors” (Knop [0093] discloses achromatic doublet lens 57, which is between a beam splitting mirror 45 and a fluorescence correlation spectrometer (FCS) camera [doublet lens positioned on an optical path between spectrometer and the one or more beam combining mirrors]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum and Barnes to incorporate wherein the one or more achromatic doublet lenses are further positioned on an optical path between the spectrometer and the one or more beam combining mirrors as suggested by Knop for the advantage of increasing the time resolution during image acquisition, and extending a field of view of the camera (Knop [0094]).
Regarding claim 9, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1 but is silent to the system wherein the one or more focusing optic lenses are apochromat lenses.
However, Knop does address this limitation.
Knop discloses the on-spot abnormal tissue detection system of claim 1, “wherein the one or more focusing optic lenses are apochromat lenses” (Knop fig. 1A and [0059] discloses the use of an apochromat objective illumination lens to project a focused illumination light beam to a sample [one or more focusing optic lens is an apochromatic lens, where the focusing optic lens focuses light to the target area]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum and Barnes to incorporate wherein the one or more focusing optic lenses are apochromat lenses as suggested by Knop for the advantage of obtaining a better correction of chromatic and spherical aberration, at least partially due to refractive index changes (Knop [0102]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Kortum, in view of Barnes, and further in view of US 2010/0176925 A1 by Steven Tethrake et al. (herein after “Tethrake”).
Regarding claim 12, Jansen when modified by Kortum and Barnes discloses the on-spot abnormal tissue detection system of claim 1 but is silent to the system further comprising a plurality of navigational fiducials positioned inside the housing that provide a location of the housing to the computing system.
However, Tethrake does address this limitation. Jansen, Kortum, Barnes, and Tethrake are considered to be analogous to the present invention because they are related to systems within a medical and/or surgical environment used for probing or operating on human specimens, including tissues.
Tethrake discloses the on-spot abnormal tissue detection system of claim 1 “further comprising a plurality of navigational fiducials positioned inside the housing that provide a location of the housing to the computing system” (Tethrake generally discloses the tracking and identification of surgical instruments using embedded radio-frequency identification tags (RFID tags); [0040] and figs. 4-6 disclose the embedding of the RFID tag within a surgical instrument [here, the RFID tags are navigational fiducials; they are embedded within the handle of an instrument, and would therefore be “inside the housing” of Jansen in view of Kortum and Barnes]; figs. 7-13, the placement of a plurality of RFID tags within a single device is shown [plurality of navigational fiducials]; fig. 10 specifically shows a device similar to the handheld probe of Jansen, demonstrating where RFID tags may be embedded within the housing; one of ordinary skill recognizes one of the functions fulfilled by an RFID tag being to track a location of whatever device the tag is embedded within [provide a location of the housing to the computing system]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum and Barnes to incorporate further comprising a plurality of navigational fiducials positioned inside the housing that provide a location of the housing to the computing system as suggested by Tethrake for the advantage of minimizing or eliminating the obtrusion to a person using the equipment or a person/animal/thing the equipment is being used on (Tethrake [0043]), whereas external fiducial markers may exacerbate an obtrusion to the user or subject
Regarding claim 13, Jansen when modified by Kortum, Barnes, and Tethrake discloses the on-spot abnormal tissue detection system of claim 12, and Jansen further teaches the system wherein the light source is communicatively coupled to the computing system (Jansen fig. 1 shows a first light source connected to an OCT fiber coupler, where an OCT detector is also communicatively coupled with the fiber coupler; [0022] and fig. 3 disclose the OCT detector being communicatively coupled with a data acquisition member DAQ that feeds to the computer 370 – therefore, the light source is communicatively coupled to the computing system; one of ordinary skill in the art also recognizes that coupling a light source to a computing system within an optical device is well-known and widely practiced apparatus configuration), wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
receive a pre-registered image of the target area;
receive timing information describing when the light from the light source is sent or received; and
determine, from the timing information, the location of the housing, and the pre-registered image of the target area, a spot location of the light reflected from the target area (MPEP §2114 I discloses the limits of functional limitations within apparatus claims – in this case, the prior art structure [processor able to process instructions and cause a computing system to perform certain functional limitations] inherently possess the functionally defined limitations and does not make a contribution over the prior art, as first noted in claim 3 above).
Claims 15-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Kortum, in view of Tethrake, and further in view of Barnes.
Regarding claim 15, Jansen discloses an on-spot abnormal tissue detection system (Jansen [0002] discloses field of invention relating to diagnosis of normal and cancerous skin lesion [on-spot] of living subject; [0012] discloses target of interest including tissues of living subject [abnormal tissue detection system]) comprising:
a computing system comprising a processor, storage, and instructions stored on the storage (Jansen fig. 3 and [0102] discloses a computer 370 that is in communication with the probe 340 analogous to the probe 200 of fig. 2 ([0092] discloses the probe 200 being connected to a main system control unit placed on a cart [main system control unit here is the computer 370 of fig. 3 – associating the computer of fig. 3 [also disclosed as being on a pushcart, see [0044]] with the probe 200 of fig. 2 is not a combination of embodiments since the probe 200 is disclosed as being in communication with a main system control unit]); the spectrograph obtained via probe 200 and system 100 is obtained via computer 370, or an equivalent thereof; examiner notes that the computer represented within fig. 3 is known by one of ordinary skill to comprise a processor, storage, and instructions stored on the storage)
a light source (Jansen [0068]-[0069] and fig. 1 discloses light source 110; fig. 2 and [0083] discloses a handheld probe 200 as a compact replica of the system shown in fig. 1);
a housing (Jansen fig. 2 and [0083] discloses handheld probe 200, [0084] comprising casing 210 [housing]);
a light fiber connected to the light source that carries light from the light source into the housing (Jansen fig. 1 label 131 and [0084], fig. 2 show a single mode optical fiber SMF 231; [0091] discloses port 211 which receives light from light source and couples it to the probe body [light fiber connected to light source, carries light into housing]);
a collimating lens positioned inside the housing to receive the light carried by the light fiber (Jansen fig. 1 label 121 C1/fig. 2 label 220 (also C1) and [0085] discloses collimation lens C1 that receives beam of light entering housing from light fiber 231)
one or more beam combining mirrors positioned inside the housing in a light path from the collimating lens, the one or more beam combining mirrors reflecting light below a particular wavelength and transmitting light above the particular wavelength (Jansen fig. 1 labels D1, D2 and fig. 2 label D discloses beam combining mirrors (combining beams from multiple light sources, see fig. 1) which receive(s) light from collimating lens C1; [0086] discloses that mirror D (and D1 [0075]) reflects Raman excitation light and transmits light other than the excitation light; given the wavelength of the Raman excitation light, light being transmitted through the mirror is above the particular wavelength of the excitation light, given the existence of the EM spectrum above and below whatever excitation wavelength is chosen and the ability for the beam combining mirror to transmit other than excitation light);
one or more achromatic doublet lenses positioned inside the housing that focus each wavelength of light reflected from the target area (Jansen fig. 2 and [0085] discloses objective lens OL 228 that [0091] collects light scattered/reflected from target of interest 290 [focus wavelength of light reflected from target area]; [0087] the objective lens is an achromatic doublet objective lens; incident light is composed of a plurality of wavelengths ([0013] broadband light), therefore the objective lens focuses each wavelength of light reflected from the target area);
a spectrometer (Jansen fig. 1 shows a spectrograph 155 obtained [i.e. obtained by a spectrometer]);
a fiber optic cable that carries light from the one or more achromatic doublet lenses to the spectrometer (Jansen fig. 1 and [0080] discloses light along sixth optical path 146 (i.e. obtained from target of interest via objective lens) is directed to a fiber 135 via lens 127 to obtain spectrograph [fiber optic cable carries light from achromatic doublet lens to the spectrometer]).
Jansen is silent to one or more focusing optic lenses positioned inside the housing in the light path from the one or more beam combining mirrors, the one or more focusing lenses focusing the transmitted light from the one or more beam combining mirrors onto a target area.
However, Kortum does address this limitation. Jansen and Kortum are considered to be analogous to the present invention because they are in the same field of optical inspection and detection via Raman measurements of normal and abnormal tissue samples.
Kortum discloses “one or more focusing optic lenses positioned inside the housing in the light path from the one or more beam combining mirrors, the one or more focusing lenses focusing the transmitted light from the one or more beam combining mirrors onto a target area” (Kortum fig. 2 a Raman spectroscopy device comprising a light source emitting light via fiber 201 and directing the light to a sample containing cuvette; fig. 2 shows a focusing lens along the incident light optical path before the sample [one or more focusing optic lenses]; the lens focuses the incident light onto the cuvette [lens focuses light onto a target area]; given the geometry already disclosed by Jansen regarding the housing, incorporating the focusing lens to focus the light onto the target area from within the housing would be obvious to one of ordinary skill in the art);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate one or more focusing optic lenses positioned inside the housing in the light path from the one or more beam combining mirrors, the one or more focusing lenses focusing the transmitted light from the one or more beam combining mirrors onto a target area as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and Appendix I).
Jansen when modified by Kortum is silent to the on-spot abnormal tissue detection system of claim 1 further comprising a plurality of navigational fiducials positioned inside the housing that provide a location of the housing to the computing system.
However, Tethrake does address this limitation. Jansen, Kortum, and Tethrake are considered to be analogous to the present invention because they are related to systems within a medical and/or surgical environment used for probing or operating on human specimens, including tissues.
Tethrake discloses a plurality of navigational fiducials positioned inside the housing that provide a location of the housing to the computing system” (Tethrake generally discloses the tracking and identification of surgical instruments using embedded radio-frequency identification tags (RFID tags); [0040] and figs. 4-6 disclose the embedding of the RFID tag within a surgical instrument [here, the RFID tags are navigational fiducials; they are embedded within the handle of an instrument, and would therefore be “inside the housing” of Jansen in view of Kortum]; figs. 7-13, the placement of a plurality of RFID tags within a single device is shown [plurality of navigational fiducials]; fig. 10 specifically shows a device similar to the handheld probe of Jansen, demonstrating where RFID tags may be embedded within the housing; one of ordinary skill recognizes one of the functions fulfilled by an RFID tag being to track a location of whatever device the tag is embedded within [provide a location of the housing to the computing system of Jansen]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum to incorporate a plurality of navigational fiducials positioned inside the housing that provide a location of the housing to the computing system as suggested by Tethrake for the advantage of minimizing or eliminating the obtrusion to a person using the equipment or a person/animal/thing the equipment is being used on (Tethrake [0043]), whereas external fiducial markers may exacerbate an obtrusion to the user or subject.
Jansen when modified by Kortum and Tethrake is silent to wherein the instructions stored on the storage that when executed by the processor, cause the computing system to output at least one of a molecular marker prediction and a genetic marker prediction.
However, Barnes does address this limitation. Jansen, Kortum, Tethrake, and Barnes are considered to be analogous to the present invention because they are related to systems within a medical and/or surgical environment used for probing or operating on human specimens, including tissues.
Barnes discloses “wherein the instructions stored on the storage that when executed by the processor, cause the computing system to output at least one of a molecular marker prediction and a genetic marker prediction” (Barnes col. 35 ll. 26-41 discloses the use of a computer, comprising computer program instructions encoded on storage medium that are executable by processor(s); col. 3 ll. 27-43 discloses the use of a multivariate Cox model as a diagnostic means for classifying image features based on image data and patient outcome data; col. 8 ll. 6-37 defines biomarker within Barnes as a measurable indicator/metric of some biological state or condition in at least a prognostic setting, and col. 26 ll. 5-17 discloses the use of the Cox model to determine relevant metrics most relevant in prognostically predicting patient outcomes via predicted value of image metrics, and/or via a data-driven diagnostic feature discovery method [instructions are executed to output at least one of a molecular marker prediction and a genetic marker prediction).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum and Tethrake to incorporate wherein the instructions stored on the storage that when executed by the processor, cause the computing system to output at least one of a molecular marker prediction and a genetic marker prediction as suggested by Barnes for the advantage of incorporating a prognostic feature derivation module, such that the patient response accuracy may be increased via the machine learning aspect of the prognostic derivation module (Barnes col. 26 ll. 3-17), thereby improving patient care.
Regarding claim 16, Jansen when modified by Kortum, Tethrake, and Barnes discloses the on-spot abnormal tissue detection system of claim 15, and Jansen further teaches the system wherein the instructions stored on the storage that when executed by the processor (processor, storage, and instructions are all components of a computer, as recognized by one of ordinary skill in the art), further cause the computing system to:
receive a pre-registered image of the target area;
receive timing information describing when the light from the light source is sent or received; and
determine, from the timing information, the location of the housing, and the pre-registered image of the target area, a spot location of the light reflected from the target area (MPEP §2114 I discloses the limits of functional limitations within apparatus claims – in this case, the prior art structure [processor able to process and analyze spectral data obtained from a tissue sample, and obtain and display images of target areas (see Jansen figs. 8 and fig. 10-12 [0049] and [0051]-[0053] at least)] inherently possess the functionally defined limitations and does not make a contribution over the prior art – see In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432 and In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971); the italicized text here applies to all functional limitations in the claim)
Regarding claim 18, Jansen when modified by Kortum, Tethrake, and Barnes discloses the on-spot abnormal tissue detection system of claim 15, and Jansen further teaches the system wherein the instructions stored on the storage (see claim 15 for computing system and its components) that when executed by the processor, further cause the computing system to:
receive wavelength intensity pairs for one or more spot locations of the target area from the spectrometer (Jansen [0101] discloses acquired Raman scattering light [obtained via probe 200, see [0091]] is processed into a frequency spectrum [spectrograph/from spectrometer] where a plurality of intensity peaks are shown at a plurality of wavelengths, where each intensity peak is associated with a specific aspect of the target of interest [wavelength intensity pairs for one or more spot locations of the target area]), and
send [information of the tissue] to a display (Jansen [0103] discloses that images obtained and Raman scattering spectra are visualized in a display [i.e. the computer display of computer 370 seen in fig. 3]).
Jansen is silent to the on-spot abnormal tissue detection system of claim 15, wherein the instructions stored on the storage that when executed by the processor further cause the computing system to:
determine a standard deviation and variance measurement of the wavelength intensity pairs for the one or more spot locations of the target area from the spectrometer;
determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs;
determine a probability of the determination of whether the tissue of the target area is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs; and
send the determination of whether the tissue of the target area is a tumor or normal tissue and the determination of the probability of the determination of whether the tissue is a tumor or normal tissue to a display.
However, Kortum does address these limitations.
Kortum discloses the on-spot abnormal tissue detection system of claim 15, further comprising instructions that, when executed by the processor, cause the computing system to:
“determine a standard deviation and variance measurement of the wavelength intensity pairs from the spectrometer” (Kortum col. 1 ll. 64 – col. 2 ll. 18 discloses the data regarding differentiation between normal and abnormal tissues using the spectroscopic methods disclosed; col. 10 ll. 23-30 and equation 1 discloses the use of mean and standard deviation within obtained data and col. 8 ll. 55-58 and equation 3 discloses the determination of variance of the dataset [determine standard deviation and variance measurement] – the standard deviation and variance measurements ultimately rely upon the data collected from the one or more target areas/targets of interest of both Jansen and Kortum).
“determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs” (Kortum col. 1 ll. 64 – col. 2 ll. 18 discloses the data regarding differentiation between normal and abnormal tissues [abnormal tissues being squamous intraepithelial lesions [tumor] using the spectroscopic methods disclosed, see also Appendix 1– the disclosed data obtained is at a minimum based on the standard deviation and variance (equations 3 and 6), and thus the determination of whether the tissue type is of a tumor or normal is disclosed by Kortum)
“determine a probability of the determination of whether the tissue of the target area is a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs” (Kortum col. 3 ll. 24-36 discloses the calculation of a probability that the sample is abnormal; as noted above, the disclosed data (various spectra) obtained is at a minimum based on the standard deviation and variance (equations 3 and 6), and thus the determination of the probability that the tissue type is of a tumor or normal is disclosed by Kortum); and
“send the determination of whether the tissue of the target area is a tumor or normal tissue and the determination of the probability of the determination of whether the tissue is a tumor or normal tissue to a display” (Jansen has disclosed sending both images and scattering spectra obtained by its probe to a display – since the scattering spectra are sent to the display, it follows that determination of tissue type would be obviously displayed on the controller, along with probability calculations disclosed above by Kortum).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate instructions that, when executed by the processor, cause the computing system to:
determine a standard deviation and variance measurement of the wavelength intensity pairs for the one or more spot locations of the target area from the spectrometer;
determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs;
determine a probability of the determination of whether the tissue is a tissue type of a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs; and
send the determination of whether the tissue of the target area is a tumor or normal tissue and the determination of the probability of the determination of whether the tissue of the target area is a tumor or normal tissue to a display, as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and appendix I).
Regarding claim 19, Jansen when modified by Kortum, Tethrake, and Barnes discloses the on-spot abnormal tissue detection system of claim 18. Jansen is silent to the on-spot abnormal tissue detection system of claim 18, wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
receive a previous pathology report for the target area;
extract information from the previous pathology report for the target area; and
create a feature vector based on the information extracted from the previous pathology report for the target area;
wherein the instructions that determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs comprise instructions that determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation, the variance measurement of the wavelength intensity pairs, and the feature vector based on the information extracted from the previous pathology report for the target area.
However, Kortum does address this limitation.
Kortum discloses the on-spot abnormal tissue detection system of claim 18, further comprising instructions that, when executed by the processor, cause the computing system to:
“receive a previous pathology report for the target area” (Kortum col. 10 ll. 46 – col. 11 ll. 10 discloses the use of an original data set to obtain a calibration data set and a prediction data set for analysis with the ‘current’ group of samples being analyzed [the original data set is considered “previous pathology report”]; additionally, MPEP §2114 I discloses the limits of functional limitations within apparatus claims – in this case, the prior art structure [processor able to process and analyze spectral data obtained from a tissue sample, etc.] inherently possess the functionally defined limitations and does not make a contribution over the prior art – see In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432 and In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971); the italicized text here applies to all below functional limitations below);
“extract information from the previous pathology report for the target area” (Kortum col. 10 ll. 46 – col. 11 ll. 10; calibration data set and prediction data set utilize information contained within the “previous pathology report”; see functional limitations under MPEP §2114 I. above); and
“create a feature vector based on the information extracted from the previous pathology report for the target area” (Kortum col. 10 ll. 46 – col. 11 ll. 10; either or both of the calibration data set or prediction data set may be considered as a feature vector, as they are both based on information from the “previous pathology report”; also, see functional limitations under MPEP §2114 I. above);
“wherein the instructions that determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs comprise instructions that determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation, the variance measurement of the wavelength intensity pairs, and the feature vector based on the information extracted from the previous pathology report for the target area” (Kortum col. 1 ll. 64 – col. 2 ll. 18 discloses the data regarding differentiation between normal and abnormal tissues [abnormal tissues being squamous intraepithelial lesions (SIL) [tumor] using the spectroscopic methods disclosed, see also Appendix 1– the disclosed data obtained is at a minimum based on the standard deviation and variance (equations 3 and 6), and thus the determination of whether the tissue type is of a tumor or normal is disclosed by Kortum, based on the standard deviation, variance, and the feature vector, as mapped above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate instructions that, when executed by the processor, cause the computing system to:
receive a previous pathology report for the target area;
extract information from the previous pathology report for the target area; and
create a feature vector based on the information extracted from the previous pathology report for the target area;
wherein the instructions that determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation and variance measurement of the wavelength intensity pairs comprise instructions that determine whether tissue of the target area is a tumor or normal tissue based on the standard deviation, the variance measurement of the wavelength intensity pairs, and the feature vector based on the information extracted from the previous pathology report for the target area as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and appendix I).
Regarding claim 20, Jansen when modified by Kortum, Tethrake, and Barnes discloses the on-spot abnormal tissue detection system of claim 18. Jansen is silent to the on-spot abnormal tissue detection system of claim 18, wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
receive light scattering properties from the spectrometer for the one or more spot locations of the target area; and
in response to a determination that the tissue is a tumor, determine whether the tissue is cancerous or benign based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer.
However, Kortum does address this limitation.
Kortum discloses the on-spot abnormal tissue detection system of claim 18, wherein the instructions stored on the storage that when executed by the processor, further cause the computing system to:
“receive light scattering properties from the spectrometer for the one or more spot locations of the target area” (Kortum col. 18 ll. 18-36 discloses obtaining spectra for samples investigated by the system, where the spectra are generated due to Raman interactions where the Raman scattering spectra are indicative of light scattering properties for the sample within the cuvette receive light scattering properties for the one or more spot locations of the target area]; additionally and as with the preceding claims, MPEP §2114 I discloses the limits of functional limitations within apparatus claims based on the same rationale in claims 16 and 18); and
“in response to a determination that the tissue is a tumor, determine whether the tissue is cancerous or benign based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer” (Kortum col. 1 ll. 64 – col. 2 ll. 18 discloses the data regarding differentiation between normal and abnormal tissues [abnormal tissues being squamous intraepithelial lesions (SIL) [tumors] using the spectroscopic methods disclosed, where at least the high grade SIL are moderate to severe dysplasia carcinoma [cancerous] and normal tissues are benign; these determinations are based on the obtained data from at least Raman interaction of the cuvette [determine whether tissue is cancerous or benign based on light scattering properties]; also, as with the preceding claims, see functional limitations under MPEP §2114 I. above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen to incorporate instructions stored on the storage that when executed by the processor, further cause the computing system to:
receive light scattering properties from the spectrometer for the one or more spot locations of the target area; and
in response to a determination that the tissue is a tumor, determine whether the tissue is cancerous or benign based on the light scattering properties for the one or more spot locations of the target area received from the spectrometer, as suggested by Kortum for the advantage of obtaining optimal excitation wavelengths for use in identifying types of precancers, given the ability to differentiate normal tissues from abnormal tissues with sensitivities exceeding 80% and specificities exceeding 70%, while specific tissue types exceeded sensitivity of 90% and specificity of 80% (Kortum col. 2 ll. 3-15 and Appendix I)
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Kortum, in view of Tethrake, in view of Barnes, and further in view of Bambot.
Regarding claim 17, Jansen when modified by Kortum, Tathrake, and Barnes discloses the on-spot abnormal tissue detection system of claim 15, and Jansen further teaches the system further comprising one or more cameras coupled to an outside of the housing and positioned to capture the target area during use of the on-spot abnormal tissue detection system (Jansen [0093] discloses a CCD camera that may be placed on the side of the probe casing, where the fact of the placement captures the target area during use of the probe would be obvious to one of ordinary skill in the art [camera coupled to an outside of the housing and positioned to capture the target area during use of the on-spot abnormal tissue detection system).
Jansen when modified by Kortum, Tethrake, and Barnes is silent to the on-spot abnormal tissue detection system of claim 15, further comprising the one or more cameras coupled to a surgical display that displays a video feed captured by the one or more cameras.
However, Bambot does address this limitation. Jansen, Kortum, Tethrake, Barnes, and Bambot are considered to be analogous to the present invention because they are related to systems within a medical and/or surgical environment used for probing or operating on human specimens, including tissues.
Bambot discloses the on-spot abnormal tissue detection system of claim 15 “further comprising the one or more cameras coupled to a surgical display that displays a video feed captured by the one or more cameras” (Bambot fig. 1A and [0068] discloses an illumination device 76 and an imaging device78 for target tissue investigation; imaging device 78 is shown in the figure, as a Panasonic color board camera with 480 horizontal TV lines, and is mounted offset from the illumination and collection pathways [analogous to being mounted outside the housing, as disclosed by Jansen]; [0126] discloses imaging device 78 sends a video signal viewed with a computer or video monitor allowing for the physician to properly align the device [camera coupled to a surgical display that displays a video feed captured by the one or more cameras]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jansen in view of Kortum, Tethrake, and Barnes to incorporate the one or more cameras coupled to a surgical display that displays a video feed captured by the one or more cameras as suggested by Bambot for the advantage of enabling the proper alignment for the medical device with the specific part of a patient’s body under optical investigation or medical procedure, in this case a cervical inspection (Bambot [0126]).
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 JOSHUA M CARLSON whose telephone number is (571)270-0065. The examiner can normally be reached Mon-Fri. 8:00AM - 5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur R Chowdhury can be reached at (571) 272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSHUA M CARLSON/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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