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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 34 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 34, the claim recites "performing image analysis on the skin lesion to detect at least one characteristic indicative of skin cancer, wherein the at least one characteristic is chosen from asymmetry, border irregularity, non-uniformity of color, and texture patterning” which is not adequately described in the specification, drawings, nor incorporated documents. In fact, the only relevant information in the specification can be found at [0003] and [0027]-[0028] which do not provide any substantive details that could qualify as adequate description of the sort that would allow one of ordinary skill in the art to make or use an invention commensurate with the scope of the claims. More specifically this presents two separate issues of inadequate description. First, the specification never mentions that the calibration of claim 21/normalized ESS spectra nor any other ESS data that may be gathered by the claims can be used to form an image nor does the specification contain any description of any image analysis of any ESS image at all. In fact, the only sort of image analysis mentioned in the specification is analysis of additional images gathered by other modalities such as microscopy or photography (e.g. see [0027]-[0028] describing that the image analysis is not even performed on any data gathered by the ESS system nor present in any claim, and this analysis itself is also not adequately described) and this sort of analysis is not adequately described even if it were applicable to the claims which does not have such additional images. Secondly, there is no description of how to apply analysis based on “asymmetry, border irregularity, non-uniformity of color, texture patterning” to the actually claimed ESS data (i.e. the singular stored spectra and the received reference sample, there being no other data that is gathered and stored by the invention). That is, morphology-based processing such as asymmetry, border irregularity, non-uniformity of color, or texture patterning analysis requires at least 2D images and neither the claims nor the specification describes how to apply these sorts of image analysis to the single stored spectra of claim 21. Given as much, the originally filed disclosure does not clarify to the reader that the applicant possessed such an invention nor does it describe in adequate detail how the reader could make or use such algorithms and, given that portions of this claim were added by amendment, the claim is equally held to contain new matter.
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 34 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 34, it is unclear how the invention performs “image analysis on the skin lesion” as there has not been data collected or formed into an image at this point in the claims. This appears to be at least an issue of lacking essential steps under MPEP § 2172.01 since there is neither the relevant data gathering nor image formation steps. Likewise, it is also unclear how or if “asymmetry, border irregularity, non-uniformity of color, or texture patterning” could be assessed from the data that has been gathered, i.e. from the stored single spectrum of the skin lesion or the reference sample signal, given that these do not appear to be capable of being used to form an image that would have details of the lesion’s size and shape. Therefore, the claim will be examined below as best understood.
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.
Claim(s) 21, 23, 27-29, 32, and 34-35 are rejected under 35 U.S.C. 103 as obvious over Diagnosis and Demarcation of Skin Malignancy using Elastic Light Single-Scattering Spectroscopy: A Pilot Study by Canoplat et al. (hereafter Canoplat) further in view of WO 2019/142136 A1 by Yadaz et al. (hereafter Yadaz).
Regarding claim 21, Canoplat teaches: 21. A method for calibrating intensity of a light source in a system for evaluating a skin lesion using Elastic-Scattering Spectroscopy (ESS) (see Canpolat’s Abstract and Experimental Methods section which establish that this is for ESS and includes a calibration per se), the method comprising:
illuminating a sample of the skin lesion with a first pulse from the light source adjusted to a … light output setting (see Canpolat’s Experimental Methods section which states in salient part on page 217 that “the probe was gently placed on the skin lesion tissue to take the ELSSS spectra of the lesion”. In regards to this being “a maximum light output setting” the examiner notes that Canpolat’s system uses only a single output setting because, without further modification, it modulates received intensity instead of output intensity. This teaches a first pulse/first output setting, with the output intensity being modulated and with the intensity being set to the maximum both being addressed below in the 103(a) analysis);
receiving a first return signal comprising an elastic scattering spectrum resulting from illuminating the sample of the skin lesion at the … light output setting (see Canpolat’s Experimental Methods section which states in salient part on page 217 that “the probe was gently placed on the skin lesion tissue to take the ELSSS spectra of the lesion”);
determining whether the first return signal has an intensity that is greater than a saturation threshold associated with at least one optical detection sensor (see Canpolat’s Experimental Methods section which states in salient part on page 217 that “if the maximum intensity of the tissue spectrum exceeds the saturation value of the spectrometer, the software ignores it, reduces the integration time of the spectrometer to half the original value, and takes another spectrum”);
in response to determining that the first return signal does not have an intensity greater than the saturation threshold: storing an elastic scattering spectrum resulting from illuminating the sample of the skin lesion at the … light output setting (this can best be seen by viewing any or all of the Data Analysis section and Discussion section of pages 218-222 wherein the data, after being treated is used in tissue characterization and compared across multiple acquisitions, as such it is necessarily stored for later use);
illuminating a reference sample using the … light output setting; receiving a reference sample signal comprising an elastic scattering spectrum resulting from illuminating the reference sample at the … light output setting (regarding both of these, see the first paragraph of Canpolat’s Experimental Methods section on page 217 which iterates illuminating and receiving light from the reference sample); and
computing normalized spectral data for the sample of the skin lesion based on the stored elastic scattering spectrum and the reference sample signal (see Canpolat’s Experimental Methods section on page 217 and note that the spectra are each normalized to the amount of integration time, relevant to the modification, but this can also simply and directly be seen in the Spectral Analysis section of Canpolat’s page 218 which both describes and depicts as equation (1) the normalization of the spectra of skin lesion data by the reference sample data); and …
Canoplat additionally teaches the newly added limitations of “in response to determining that the first return signal has an intensity greater than the saturation threshold: illuminating the sample of the skin lesion with a second pulse from the light source adjusted to a fifty percent … setting; determining whether the last received return signal has an intensity greater than the saturation threshold; illuminating the sample of the skin lesion using a third pulse from the light source adjusted to a reduced … setting in response to determining that the last received return signal has an intensity greater than the saturation threshold; illuminating the sample of the skin lesion using a third pulse from the light source adjusted to an increased … setting in response to determining that the last received return signal has an intensity less than the saturation threshold; and receiving a return signal comprising an elastic scattering spectrum resulting from illuminating the sample of the skin lesion at the current output setting” (first, see MPEP 2111.04(II) and note that this contingency holds no patentable weight/is not a required limitation under the broadest reasonable interpretation and note above that the examiner has rejected the other/alternative condition. Therefore, Canpolat simply teaches all required claim limitations without further addressing the limitations that follow after. For compact prosecution purposes the examiner also/alternatively notes for compact prosecution purposes that Canpolat’s page 217 or see the citations above wherein the halving and, if not within the threshold, additional intensity modifications are clearly taught as these are just repetitions of the foregoing with reduced intensity which Canoplat performs, though this being “output” intensity is separately addressed below in the 103(a)).
However in the foregoing the, examiner omitted two claimed features indicated by ellipsis, that the setting is a “maximum” setting or that it is the output “intensity” that is adjusted because Canoplat alone does not teach these limitations.
More specifically Canpolat’s acquisition of the tissue and reference spectra are always done at the same output intensity in the foregoing teachings, thus without further modification Canpolat’s acquisitions are independent of each other and can be conducted in either order. Additionally, and relevant to the dependent claims, Canpolat’s modulation of the intensity is done by altering the received intensity instead of the output intensity and as such Canpolat’s adjustments are also different than the claim adjustments. However, these differences are resolved by one modification. Specifically, if one modulated the output intensity instead of the received intensity than in order to gather the reference spectra at the same intensity then one would need to do this step after or in response to determining that the intensity would yield an unsaturated spectrum of the tissue. To that end, the examiner notes that it was recognized in the art that one could simply substituting a known method of intensity modulating with a different known method of intensity modulation in a predictable manner would be obvious. Initially the examiner notes that this would be a suitable substitution for basic logical reasons that do not seemingly require prior art and can serve as additional considerations, i.e. the amount of output intensity necessarily affects the amount of received intensity regardless of any other factor and the total amount of time of an output or input necessarily affects the total intensity regardless of any other factor. However, the examiner also notes that this suitability has been documented in the prior art. As such, the examiner turns to Yadav, who in the related field of spectroscopy (see Yadav’s Abstract) teaches solving the same problem of preventing sensor saturation by modulating either output power or input power (see Yadav’s page 7 which sums up nicely in lines 2-20 that saturation/blooming is an issue and that it can be solved by adaptively determining the excitation power and tissue/CCD exposure time and see also Yadav’s pages 5-6 where lines 19-13 respectively describe that either the output power or input time can be used to modulate the intensity showing that this can predictable be used to generate results). See MPEP 2143(B).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to substitute Canpolat’s modulation of received intensity for modulation of emitted intensity as taught by Yadaz in order to obtain predictable results.
From there the examiner notes that there is still one difference between the claimed invention and the teachings of Canpolat. Specifically, because Canpolat did not initially modulate output intensity it is the case that Canpolat does not state that he starts his calibration using a maximum intensity setting or any other particular intensity setting. However, choosing the maximum intensity setting would be obvious to try. Specifically, for the problem of needing to choose a starting point when no starting point is disclosed, one can immediately discern that there are a finite number of solutions as there is a finite range of powers at which the light source can operate. Likewise, each of these solutions would be both predictable and would have seemingly a guaranteed success as Canpolat iteratively adjusts the intensity until the intensity is acceptable regardless of where the starting point is (see Canpolat’s page 217 noting “We have modified the operating software of the spectrometer to change the integration time automatically to keep the spectral intensity below a saturation value of 40,000 counts and above 10,000 counts. If the maximum intensity value of the tissue spectrum exceeds the saturation value of the spectrometer, the software ignores it, reduces the integration time of the spectrometer to half the original value, and takes another spectrum. If the maximum intensity of the spectrum is less than 10,000 counts, the software increases the integration time of the spectrometer and takes a new spectrum”). Lastly and as an additional data point that would preferentially motivate the maximum versus other values the examiner notes that the signal to noise ration is, by definition, higher when the signal is higher. As such starting from the maximum would yield a higher SNR than starting from other points. See MPEP 2143(E).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to choose to use a maximum output setting as the initial output setting.
Regarding claim 23, Canpolat as modified further teaches: 23. The method of claim 21, wherein: the reduced intensity setting is computed based on the previous light output setting, according to the formula reduced intensity setting=previous light output setting−(100/2.sup.N+1) %, wherein N is a counter variable that is initially set to 1, and that increments each time the intensity setting is adjusted (see Canpolat’s page 217 noting that “If the maximum intensity value of the tissue spectrum exceeds the saturation value of the spectrometer, the software ignores it, reduces the integration time of the spectrometer to half”, where as per the modification this would change the output intensity instead of the received intensity. While this is worded differently, this has identically the same scope as 50%-25% then 25%-12.5% etc. are also simply halving the value. For compact prosecution purposes the examiner notes that Canpolat’s acceptable range of 40k to 10k spans a factor of four and the reductions are a factor of two); and the increased intensity setting is computed based on the previous light output setting, according to the formula increased intensity setting=previous light output setting−(100/2.sup.N+1) % (from a first perspective, see MPEP 2111.04(II) and note that this does not appear required as there is no clear indication that overshoot would occur and where Canpolat as modified would start at the maximum. However and for compact prosecution purposes the examiner notes that, at least as best understood given the current lain drafting, that because Canpolat states that he increases the setting without describing by how much, that Canpolat has taught a general amount of increase which is necessarily in the vicinity of the claim (note, the value of N is not specified it could decrement/cause doubling, it could be a constant, etc.) given the breadth of the claim and therefore at least approaches in the manner described by MPEP 2144.05 and therefore would be prima facie obvious to one of ordinary skill in the art.).
Regarding claim 27, Canpolat as modified further teaches: 27. The method of claim 21, wherein the saturation threshold comprises a preset intensity level based on capabilities of the at least one optical detection sensor (see Canpolat’s page 217 noting the saturation threshold is “of the spectrometer” and is preset to 40,000 counts).
Regarding claim 28, Canpolat as modified further teaches that the saturation threshold is both based on the optical detection sensor (see Canoplat’s page 217) and can be a percentage of the possible sensitivity (see Yadaz’s page 6 lines 1-13 noting that the maximum intensity can be set to 90% of the spectrometer/CCD dynamic range). However Canoplat as modified did not choose 80% exactly and therefore fails to fully teach: “wherein the saturation threshold is 80% of the possible sensitivity of the at least one optical detection sensor”.
However both the amount being based on the sensor saturation and the amount being 90% of the possible sensitivity are ranges which approach the claim limitation of 80%. See MPEP 2144.05(I). And the examiner also notes that this is also a result effective variable per se (see Yadaz’s pages 10-11 lines 1 to 12 respectively which is a section titled Signal to Noise Ratio and Yadaz’s page 7 lines 2-20 which is a section titled Saturation/Blooming which together establish that the SNR is improved/results are improved the more signal you can get and the data is corrupted/has 0-SNR if one sets the value such that saturation occurs. As such the results of the system depend on choosing a threshold which is high but not so high that saturation occurs). See MPEP 2144.05(II).
Therefore it would have been prima facie obvious to one of ordinary skill in the art to choose a threshold of 80% of the possible sensitivity as the threshold of unknown or 90% used by Canoplat and Yadaz either because these thresholds approach the claimed value and/or because the threshold is a result effective variable which one of ordinary skill in the art would seek to optimize.
Regarding claim 29, Canpolat as modified further teaches: 29. The method of claim 21, wherein the reference sample comprises a material that exhibits approximately Lambertian reflectance (see Canpolat’s page 217 noting the reference sample is made of Spectralon).
Regarding claim 32, Canpolat as modified further teaches: 32. The method of claim 21, wherein the light source comprises a fiber optic illumination source in contact with the skin lesion, wherein elastic scattering spectra are received from a fiber optic collector coupled to the at least one optical detection sensor (see Canpolat’s Fig. 1 noting the optical fiber being used to deliver and receive illumination and its relation to the other structures).
Regarding claim 34, Canpolat as modified further teaches: 34. The method of claim 21, further comprising performing image analysis on the skin lesion to detect at least one characteristic indicative of skin cancer (Canpolat performs additional imaging and does image analysis thereon to separately characterize and verify the tissue classification as cancerous or not as per the Morphometric Analysis section on page 218 which specifically shows that the calibrated system can be used to make repetitive measurements over an area in order to allow an image to be formed and the performance of analysis of the size and shape of the lesions (i.e. morphometric analysis) to be used).
In this instance the examiner notes that Canoplat teaches a genus to the claimed species and therefore does not expressly teach the same “wherein the at least one characteristic is chosen from asymmetry, border irregularity, non-uniformity of color, and texture patterning” now claimed. However, Canoplat implicitly teaches the claim limitations. That is, the examiner notes that Canoplat’s “morphology analysis” is a genus to each claimed species and at least “Asymmetry”, “Border irregularity”, and “non-uniformity of Color” are archetypical to the point of being immediately envisaged from the mere mention of morphology analysis, at least because these are expressly known as the ABCs of dermatology and are both the most widely used and most rudimentary types of morphological analysis that can be used for cancer detection. See also MPEP 2131.02(III). Therefore Canoplat at least implicitly teaches the claim limitation for the reasons and in view of the citations to his Morphology Analysis section set forth above. For compact prosecution purposes the examiner notes that a reference has been added to the conclusion section to further clarify why the examiner views this to be implicit as something that would be at once envisaged.
Regarding claim 35, Canoplat teaches: 35. An elastic-Scattering Spectroscopy (ESS) system (see Canoplat’s Abstract), comprising:
a light source (see Canoplat’s Fig. 1 noting the labeled light source);
at least one optical detection sensor (see Canoplat’s Fig. 1 noting the spectrometer);
…; and
a processor coupled to the at least one memory device (see Canoplat’s Fig. 1 noting the laptop computer), wherein the processor is configured with processor-executable instructions to:
illuminate a sample of a skin lesion with a first pulse from the light source … light output setting; receive a first return signal comprising an elastic scattering spectrum resulting from illuminating the sample of the skin … (regarding both of these, see Canpolat’s Experimental Methods section which states in salient part on page 217 that “the probe was gently placed on the skin lesion tissue to take the ELSSS spectra of the lesion”); determine whether the first return signal has an intensity that is greater than a saturation threshold associated with at least one optical detection sensor (see Canpolat’s Experimental Methods section which states in salient part on page 217 that “if the maximum intensity of the tissue spectrum exceeds the saturation value of the spectrometer, the software ignores it, reduces the integration time of the spectrometer to half the original value, and takes another spectrum”); and …
store an elastic scattering spectrum resulting from illuminating the sample of the skin lesion …(this can best be seen by viewing any or all of the Data Analysis section and Discussion section of pages 218-222 wherein the data, after being treated is used in tissue characterization and compared across multiple acquisitions, as such it is necessarily stored for later use); illuminate a reference sample using the …; receive a reference sample signal comprising an elastic scattering spectrum resulting from illuminating the reference sample …(regarding both of these, see the first paragraph of Canpolat’s Experimental Methods section on page 217 which iterates illuminating and receiving light from the reference sample); and compute normalized spectral data for the lesion sample based on the stored elastic scattering spectrum and the reference sample signal (see Canpolat’s Experimental Methods section on page 217 and note that the spectra are each normalized to the amount of integration time, relevant to the modification, but this can also simply and directly be seen in the Spectral Analysis section of Canpolat’s page 218 which both describes and depicts as equation (1) the normalization of the spectra of skin lesion data by the reference sample data).
in response to determining that the first return signal has an intensity greater than the saturation threshold: illuminate the sample of the skin lesion with a second pulse from the light source adjusted to a fifty percent output setting; determine whether the last received return signal has an intensity greater than the saturation threshold; illuminate the sample of the skin lesion using a third pulse from the light source adjusted to a reduced intensity setting in response to determining that the last received return signal has an intensity greater than the saturation threshold; illuminate the sample of the skin lesion using a third pulse from the light source adjusted to an increased intensity setting in response to determining that the last received return signal has an intensity less than the saturation threshold; and receive a return signal comprising an elastic scattering spectrum resulting from illuminating the sample of the skin lesion at the current output setting (regarding each of the foregoing, see Canpolat’s page 217 wherein the halving and, if not within the threshold, additional received intensity modifications are clearly taught).
In the foregoing the examiner omitted the “voltage divider circuit”, various references to the light output being at or adjusted to “the maximum light output setting”, and that the terminal options are done “in response to determining that the first return signal does not have an intensity greater than the saturation threshold” because Canpolat alone does not teach these limitations. In more detail, Canpolat’s acquisition of the tissue and reference spectra are always done at the same intensity in the foregoing teachings, thus without further modification Canpolat’s acquisitions are independent of each other and can be conducted in either order. Additionally, and relevant to the voltage divider and maximum output setting, Canpolat’s modulation of the intensity is done by altering the received intensity instead of the output intensity and as such Canpolat’s adjustments are also different than the claim adjustments. However, these differences are resolved by one modification. Specifically, if one modulated the output intensity instead of the received intensity than in order to gather the reference spectra at the same intensity then one would need to do this step after or in response to determining that the intensity would yield an unsaturated spectrum of the tissue. To that end, the examiner notes that it was recognized in the art that one could simply substituting a known method of intensity modulating with a different known method of intensity modulation in a predictable manner would be obvious. Initially the examiner notes that this would be a suitable substitution for basic logical reasons that do not seemingly require prior art and can serve as additional considerations, i.e. the amount of output intensity necessarily affects the amount of received intensity regardless of any other factor and the total amount of time of an output or input necessarily affects the total intensity regardless of any other factor. However, the examiner also notes that this suitability has been documented in the prior art. As such, the examiner turns to Yadav, who in the related field of spectroscopy (see Yadav’s Abstract) teaches solving the same problem of preventing sensor saturation by modulating either output power or input power (see Yadav’s page 7 which sums up nicely in lines 2-20 that saturation/blooming is an issue and that it can be solved by adaptively determining the excitation power and tissue/CCD exposure time and see also Yadav’s pages 5-6 where lines 19-13 respectively describe that either the output power or input time can be used to modulate the intensity showing that this can predictable be used to generate results). See MPEP 2143(B).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to substitute Canpolat’s modulation of received intensity for modulation of emitted intensity as taught by Yadaz in order to obtain predictable results.
From there the examiner notes that there are still two differences between the claimed invention and the teachings of Canpolat. First, because Canpolat modulated the received light intensity Canpolat did not use the structure of a voltage divider to control the output power. However, the examiner notes that variable and adjustable voltage dividers, i.e. potentiometers, of the sort that would be able to do in voltage that which Canoplat did in time are old and well known.
Therefore implementing the change as a voltage divider instead of a timer would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention.
Lastly, while Canpolat did not initially modulate output intensity it is the case that Canpolat does not state that he starts his calibration using a maximum intensity setting or any other particular intensity setting. However, choosing the maximum intensity setting would be obvious to try. Specifically, for the problem of needing to choose a starting point when no starting point is disclosed, one can immediately discern that there are a finite number of solutions as there is a finite range of powers at which the light source can operate. Likewise, each of these solutions would be both predictable and would have seemingly a guaranteed success as Canpolat iteratively adjusts the intensity until the intensity is acceptable regardless of where the starting point is (see Canpolat’s page 217 noting “We have modified the operating software of the spectrometer to change the integration time automatically to keep the spectral intensity below a saturation value of 40,000 counts and above 10,000 counts. If the maximum intensity value of the tissue spectrum exceeds the saturation value of the spectrometer, the software ignores it, reduces the integration time of the spectrometer to half the original value, and takes another spectrum. If the maximum intensity of the spectrum is less than 10,000 counts, the software increases the integration time of the spectrometer and takes a new spectrum”). Lastly and as an additional data point that would preferentially motivate the maximum versus other values the examiner notes that the signal to noise ratio is, by definition, higher when the signal is higher. As such starting from the maximum would yield a higher SNR than starting from other points. See MPEP 2143(E).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to choose to use a maximum output setting as the initial output setting.
Regarding claim 37, Canoplat as modified further teaches: 37. The ESS system of claim 35, wherein the processor is further configured with processor-executable instructions such that: the reduced intensity setting is computed based on the previous light output setting, according to the formula reduced intensity setting=previous light output setting−(100/2.sup.N+1) %, wherein N is a counter variable that is initially set to 1, and that increments each time the intensity setting is adjusted (see Canpolat’s page 217 noting that “If the maximum intensity value of the tissue spectrum exceeds the saturation value of the spectrometer, the software ignores it, reduces the integration time of the spectrometer to half”, where as per the modification this would change the output intensity instead of the received intensity. While this is worded differently, this has identically the same scope as 50%-25% then 25%-12.5% etc. are also simply halving the value. For compact prosecution purposes the examiner notes that Canpolat’s acceptable range of 40k to 10k spans a factor of four and the reductions are a factor of two); and the increased intensity setting is computed based on the previous light output setting, according to the formula increased intensity setting=previous light output setting−(100/2.sup.N+1) % (from a first perspective, see MPEP 2111.04(II) and note that this does not appear required as there is no clear indication that overshoot would occur and where Canpolat as modified would start at the maximum. However and for compact prosecution purposes the examiner notes that, at least as best understood given the current lain drafting, that because Canpolat states that he increases the setting without describing by how much, that Canpolat has taught a general amount of increase which is necessarily in the vicinity of the claim (note, the value of N is not specified it could decrement/cause doubling, it could be a constant, etc.) given the breadth of the claim and therefore at least approaches in the manner described by MPEP 2144.05 and therefore would be prima facie obvious to one of ordinary skill in the art.).
Claim(s) 31 is rejected under 35 U.S.C. 103 as being unpatentable over Canoplat IVO Yadaz as applied to claim 21 above, as evidenced by Particle size analysis of turbid media with a single optical fiber in contact with the medium to deliver and detect white light by Canpolat et al. (hereafter Canpolat2).
Regarding claim 31, Canpolat further teaches: 31. The method of claim 21, wherein the light source comprises at least one broadband light source (see Canpolat’s page 217 noting this is “a tungsten halogen white light source”) and the optical detection sensor comprises a charge coupled device (CCD) (see Canpolat’s page 217 noting “the system is described in detail elsewhere. 17”. then see Canpolat2 noting that the first paragraph of the Methods section iterates “Collected light was dispersed by a spectrograph … onto a two-dimensional, thermoelectrically cooled CCD array”. See also MPEP 2131.01 as one would not understand what Canpolat’s reference to 17 disclosing the system details unless one consulted Canpolat2).
Claim(s) 30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Canoplat IVO Yadaz as applied to claim 21 above, and further in view of US 20130253335 A1 by Noto et al. (hereafter Noto).
Regarding claim 30, Canpolat as modified teaches the basic invention as given above in regards to claim 21; however, Canpolat uses a broad-spectrum light source and therefore fails to teach: “wherein the light source comprises at least one discrete narrow-band light source”.
However, Noto in the same or eminently related field of cancer detection using ESS (see Noto’s Abstract) teaches that one can utilize discrete narrow-band light sources for this same sort of ESS imaging for cancer detection (see Noto’s [0022]) which is advantageous (see Noto’s [0024] noting that discrete sources with specific wavelengths allows one to select wavelengths that are based on the specific tissue type of interest).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the date of invention to improve the invention of Canoplat with the use of one or more discrete narrow band light sources because these can advantageously be used to target specific cancers.
Regarding claim 33, Canpolat as modified teaches the basic invention as given above in regards to claim 21 and Canpolat further teaches generating an output based on a classification of the skin lesion (see Canpolat’s Results section on pages 218-220 and note that this is used, with high specificity, to classify lesions as malignant or benign and then see the Discussion section on pages 220-222 noting that the classification is output in real time to the clinician); however, Canpolat does not mention whether or not the data is sent to others and therefore fails to teach: “sending a result of the classification to a third-party medical provider”.
However, Noto in the same or eminently related field of cancer detection using ESS (see Noto’s Abstract) teaches that one can send data to third-parties (see Noto’s claims 8 or 19) which advantageously allows the invention to be usable as an in-home, in-office, or remote form which allows for early melanoma detection aid as the presence of a doctor is not required if the data can be sent to a doctor (see Noto’s [0005]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the date of invention to improve Canpolat with the use of sending data to third parties as taught by Noto in order to advantageously allow for increased accessibility of the device.
Allowable Subject Matter
Claims 24-26 and 38-39 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. More specifically, the closest prior art to the current claims is Canpolat which teaches a very similar base calibration to the current invention including incrementing the light intensity up or down then re-comparing the results in order to ensure that the light intensity does not saturate the light sensor while also ensuring that adequate signal is gathered. However, Canpolat’s measurements and adjustments are performed automatically and in real time and proceed until the signal is of appropriate intensity to be usable. As such there is no realistic way to modify Canpolat to use a counter that can result in the calibration stopping this process early as this could only result decreased system performance or oversaturated data. Likewise, there are no other prior arts that the examiner could find that would motivate such a modification.
Response to Arguments
Applicant’s arguments with respect to the 102(a)(1) rejection of claim(s) 21 have been considered but are moot. Specifically, the applicant has moved claim 22 into claim 1 and therefore the examiner has issued a rejection along the lines of claim 22, i.e. one under 103(a) instead, which was already an alternative ground of rejection for claim 21.
Applicant's arguments filed 04/14/2026 with regards to all other topics have been fully considered but they are not persuasive, with each argument being responded to in the order presented as follows:
On page 10 the applicant opines that the subject matter of claim 34 is fully and adequately supported by the original disclosure. As an initial matter the examiner notes that the amendment causes the examiner to remove and amend portions of the rejection, but that the argument as a whole is not convincing. More specifically, the examiner notes that the applicant conspicuously has not responded to portions of the rejection such as “First, the specification never mentions that the calibration of claim 21/normalized ESS spectra not any other data that may be gathered by the claims can be used to form an image”. This is simply true and not debated by the applicant which causes the argument to fall apart on its face. It also appears that the whole argument is spurious as the applicant is arguing for an ESS image that was neither gathered by nor formed in the claims nor even presented in the specification. Likewise, the applicant then turns to cite [0027] in part as evidence of support. Even with the applicant’s choice of selective citation the quote provided simply does not provide what the applicant characterizes it as providing by any reasonable reading. Moreover, when one takes the whole citation of [0027] into account, or worse reads it in the context of the surrounding paragraphs, it is abundantly clear that the applicant does not disclose any sort of “asymmetry, border irregularity, non-uniformity of color, texture patterning” image analysis being applied to an ESS image. Therefore, the applicant’s argument is unconvincing.
On page 11 the applicant argues that all 112(b) rejections are overcome. This is convincing in part, as the three previous issues are indeed overcome, but not convincing entirely as the amendment requires a new 112(b) rejection to be raised for the new claim 34 wording.
Noting that as cited above the 102 is withdrawn/moot those arguments will not be responded to further.
Regarding the 103(a) of the same claims that was already raised as an alternative for claim 21 and already raised directly for claim 35, the applicant opines that the modification changes the principle of operation of the invention. This is not correct. The invention of Canoplat, regardless of modification, emits and revives light, compares the intensity to a threshold, then stores as much for calibration in the same manner as the claim. The only substantive differences between the claims and Canoplat is that Canoplat changes the intensity by changing integration time (i.e. received intensity) instead of output voltage (i.e. output intensity). This is not a change in any fundamental utility or core operation of the invention of Canoplat, rather it is the use of another, well known and rote equivalent (i.e. the applicant’s sensor/processor would not know if the intensity changed due to lower light being emitted or a shorter illumination period), means to modulate the light intensity. The examiner also notes that this is expressly already evidenced of record as Yadav shows that one can use either output or received intensity modulation to change the received power to avoid oversaturation which is not debated by the applicant and thus derails this and all other arguments provided. The applicant then argues that starting at the highest/max intensity is not obvious. In this instance the applicant has not debated the merits of the examiner’s ‘obvious to try’ rational under MPEP 2143(E) so this argument is spurious. The applicant then opines that the conditional limitations, while admitted to be conditional on pages 22-23 of the remarks, should not be held conditional as they define a calibration workflow. This is not a legally sound argument (i.e. the applicant does not rebut or even attempt to argue that if the initial/first return signal is below the saturation threshold than any steps relating to modifying the output intensity will occur) and therefore is at best prima facie unconvincing because it does not address the structure of the claims and instead opines that having all optional limitations together “defines a calibration workflow” which is not relevant to the rejection. The applicant then turns to Yadav and instead of addressing the reasons the examiner cited Yadav, which renders the argument spurious, the applicant argues that Yadav teaches that one should start at the lowest measure of intensity and work upwards. The applicant includes two full paragraph citations which, notably, do not contain such a statement nor anything that could be construed as providing that scope. As such the argument cannot be convincing in addition to being spurious as the examiner brought in Yadav only to show that it was recognized in the art that there were known equivalent and substitutable means for changing intensity which the applicant did not debate. Therefore and for the myriad foregoing reasons the examiner is not convinced by the applicant’s arguments.
Lastly, the applicant concludes by arguing that the remaining 103(a) rejections of dependent claims and the art cited therein does not remedy the above alleged deficiencies and that these and all other dependent claims are therefore patentable at least by virtue of dependency. In response the examiner notes that they are not convinced by the arguments against the 103(a) of the parent claims for the above listed reasons and are therefore not convinced that the claims are ripe for patentability by dependency at this juncture.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Computer aided Melanoma skin cancer detection using Image Processing by Jain et al. (hereafter Jain) is a similar reference in the related field of optical imaging of skin for skin cancer detection (i.e. dermoscopy) that solves the same problem Canoplat attempts to solve using morphology analysis and describes the particulars and common practices there. Since the applicant has neither specific claim language about their analysis in claim 34 nor does the specification provide specific issues for the examiner to examine the examiner has not currently utilized as a 103(a) reference but notably could be if the applicant narrows their claim 34 language and it certainly useful to place on record as it affirms the examiner position taken in regards to claim 34. For example Jain’s very Abstract states “The Lesion Image analysis tools checks for the various Melanoma parameters Like Asymmetry, Border, Colour, Diameter,(ABCD) etc. by texture, size and shape analysis for image segmentation and feature stages. The extracted feature parameters are used to classify the image as Normal skin and Melanoma cancer lesion.” Therefore clarifying that these four claimed measures are known in the art and that the first 3 are in fact the ABCs of dermatology. More information on why this works and how it has historically been used in the field can be found in the Related Works section of Jain and the remainder of the document is certainly useful for fully fleshing out exactly how this sort of morphological analysis is conducted to classify tissues as cancerous or not.
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 Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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