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.
Claims 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 using at least one characteristic detection algorithm” 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 [0014] which merely reiterates the claim language without any further details and as such does not 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, the claim requires the use of a “characteristic detection algorithm”; however, there is simply no relevant details about what sort of algorithms for characteristic detection the applicant may have possessed at the time of filing. That is, none of the incorporated documents contain the term or appear to disclose such an algorithm in other terms, and the specification does not ever mention the term again beyond the mere restatement of the claim terminology in section [0014]. For compact prosecution purposes the examiner notes that the general term “algorithm” is used in the specification nine times, but these sections have been revied in detail and none of these sections ever discloses any details about any algorithms that the applicant possessed at the time of filing, with the closest thing to supporting evidence coming from [0055] which again refers to/relies upon an image analysis that is not disclosed and is separate from any ESS measurements and states that this “may be developed” which implies that it has not been developed and certainly does not clarify to the reader that the applicant possessed such algorithms no describe in adequate detail how the reader could make or use such algorithms.
Therefore, the examiner concludes that claim 34 contains subject matter that was not adequately described in the originally filed disclosure.
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.
Claims 23, 26, 33, and 37 are 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 each of claims 23, 26, and 37 the claims each use a variable N without defining it, which calls into question the scope of the claims as it is unclear what this term N is or represents. While limitations of the specification cannot be read into the claims, for compact prosecution purposes the examiner will interpret N as: a counter variable which is initially set to 1 and increments each time the intensity setting is either increased or reduced.
Regarding claim 33, the claim states “the result” and “the comparison” in lines 3. There is insufficient antecedent basis for these terms in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-39 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
In more detail and regarding initially only claims 21 and 35, the claims are directed to a method and apparatus respectively and therefore are to a process or machine and thus pass step 1 of the eligibility analysis flow chart set forth in MPEP 2106(II).
These claims both recite three steps of: “determining whether the first return signal has an intensity that is greater than a saturation threshold”, “storing an elastic scattering spectrum resulting from illuminating the sample of the skin lesion”, and “computing normalized spectral data for the sample of the skin lesion based on the stored elastic scattering spectrum and the reference sample signal” which are each abstract ideas. Specifically, see MPEP 2106.04(a)(2) noting that the first and last of these are a mathematical relationship and calculation respectively and thus are explicit examples of abstract ideas per se. Likewise simply storing data is a mental process. This could be performed in one’s mind (it’s a single spectrum), or by using paper but would not amount to more than merely remembering data. Therefore step 2A of the eligibility analysis flowchart is also passed.
From there, we must re-introduce the claim limitations that are not abstract ideas, specifically the data gathering steps of “illuminating a sample of the skin lesion”, “receiving a first return signal”, “illuminating a reference sample”, and “receiving a reference sample signal” in claim 21 and the associated structures for such data gathering in claim 35 including the “a light source”, “at least one optical detection sensor”. Each of these steps and structures are the fundamental steps and structures related to gathering data. See MPEP 2106.05(g) and note that these sorts of structures cannot cause the invention to be significantly more than the abstraction as they are per se necessary to data gathering (e.g. see example 3 or see Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015)). Additionally, and regarding claim 35 there are two remaining structures to address. The voltage divider still falls under the guidance of MPEP 2106.05(g) because it is well-known and used for selecting particular data, though unlike the light source and optical detection sensor it is not truly inherent as one could have changed the intensity in other ways, but it is still fundamentally used to select the data to be gathered. The computer is presented at a high level of generality and serves to only enact the otherwise abstract ideas in the manner set forth in MPEP 2106.04(a)(2)(III)(C) and, insofar as a computer is not required by still may be used in the method claims see MPEP 2106.04(a)(2)(III)(D). That is, the computer itself, does not cause the invention to recite materially more than the processes it performs.
Therefore, it can be seen that both claims 21 and 35 are not patent eligible.
Turning to the dependent claims, the examiner notes:
Claims 22 and 36 simply reiterate the data gathering steps and determination at different light levels. These limitations have already been addressed above and are insignificant data gathering steps and the same abstract idea and therefore the claims are also patent ineligible.
Claims 23, 26, and 37 each state what the light level should be. In this instance they require one to compute according to a formula having only one variable and therefore clearly fall under the purview of an abstract idea, specifically a mathematical relationship or calculation as set forth in MPEP 2106.04(a)(2).
Claims 24-25 and 38-39 present the same sort of limitations as are addressed for claims 22 and 36; however, these claims additionally add a counter and stop the calibration if the counter exceeds a threshold. The examiner notes that comparing a number to a threshold and incrementing a number by one is clearly an abstract idea, specifically a mathematical relationship or calculation as set forth in MPEP 2106.04(a)(2).
Claims 27-28 merely describe what the saturation level is, therefore they do not add any meaningful limitation to this analysis.
Claim 29 merely iterates what the reference sample is and therefore does not add any meaningful limitation to this analysis.
Claims 30-32 add more definition to the structure of the light source and light sensor. In this instance the structures remain generic to many such systems and therefore still fall under the guidance set forth in MPEP 2106.05(g).
Claim 33 recites “generating an output based on a classification of the skin lesion; and sending the result of the comparison to a third-party medical provider”. In this instance the claim only positively recites the output and thus this also falls under the guidance provided by MPEP 2106.05(g); however and for compact prosecution purposes the examiner notes that an additional step of classifying the skin lesions would need to be addressed separately once it is positively recited but that, without more, this would still not rise to the level of being substantially more than the abstraction in light of MPEP 2106.04(d)(2) as classification/diagnosis is not enough unless it is integrated into a treatment.
Claim 34 recites “performing image analysis on the skin lesion using at least one characteristic detection algorithm”. In this instance this is the rote application of an algorithm per se, and therefore this still appears to represent an abstract idea as set forth in MPEP 2106.04(a)(2). In this instance the examiner remarks that both the claims and specification do not give any detail about what sort of algorithm this is, and as such the examiner notes that at least some algorithms (e.g. comparing the spectral slope to a threshold) are clearly practicable in one’s head or on paper.
As such and in light of the foregoing analysis, all of claims 21-39 are not patent eligible.
Claim Rejections - 35 USC § 102 & 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Diagnosis and Demarcation of Skin Malignancy using Elastic Light Single-Scattering Spectroscopy: A Pilot Study by Canoplat et al. (hereafter Canoplat) or, in the alternative, under 35 U.S.C. 103 as obvious over 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 maximum 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 fact can be used to both teach and obviate the maximum setting limitation, wherein if there is only one output setting then this setting is by necessity the maximum (and also minimum) setting, and thus from a first perspective Canpolat simply teaches the claim limitation directly given the breadth of the claim language being such that it does not specify any other output setting options need exist. For compact prosecution purposes the examiner notes that a modification which obviates this limitation is also/alternatively provided below);
receiving a first return signal comprising an elastic scattering spectrum resulting from illuminating the sample of the skin lesion at the maximum 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”); and
in response to determining that the first return signal does not have an intensity greater than the saturation threshold (from a first perspective, see MPEP 2111.04(II) and note that this contingency holds no patentable weight/is not a required limitation under the broadest reasonable interpretation. Therefore, Canpolat simply teaches all required claim limitations without further addressing the limitations that follow after. For compact prosecution purposes the examiner has obviated these limitations in an alternative grounds of rejection below):
In the foregoing the examiner establishes the Canpolat teaches all required claim limitations; and Canpolat additionally teaches: storing an elastic scattering spectrum resulting from illuminating the sample of the skin lesion at the maximum 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 maximum light output setting; receiving a reference sample signal comprising an elastic scattering spectrum resulting from illuminating the reference sample at the maximum 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).
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 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 22-23, 27-29, 32, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Canoplat IVO Yadaz.
Regarding claim 22, Canpolat as modified above further teaches: 22. The method of claim 21, further comprising, 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 output 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 intensity 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 intensity 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 (see Canpolat’s page 217 or see the citation above in the rejection of claim 21 wherein the halving and, if not within the threshold, additional modifications are clearly taught).
Regarding claim 23, Canpolat as modified further teaches: 23. The method of claim 22, 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) % (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 using at least one characteristic detection algorithm (as best understood this is analysis on the ESS image data and thus Canpolat teaches this by using the spectral slope as a discriminator for the characteristic of malignancy, see e.g. Fig. 4 noting the key thereto. Additionally or alternatively, the examiner notes for compact prosecution purposes that Canpolat performs additional imaging and does image analysis thereon to separately characterize and verify the tissue classification as per the Morphometric Analysis section on page 218).
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 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 36, Canoplat as modified further teaches: 36. The ESS system of claim 35, wherein the processor is further configured with processor-executable instructions to, 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 (see Canpolat’s page 217 or see the citation above in the rejection of claim 21 wherein the halving and, if not within the threshold, additional modifications are clearly taught).
Regarding claim 37, Canoplat as modified further teaches: 37. The ESS system of claim 36, 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) % (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 the result of the comparison 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.
Examiner’s Note Regarding Claims 24-26 and 38-39
In this instance the examiner has declined to issue an indication of allowable subject matter because the claims in question are rejected under 101. However, the examiner also notes that claims 24-26 and 38-39 are not subject to a rejection under 103(a) as the claims are unobvious over the prior art. 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.
Conclusion
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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/MICHAEL S KELLOGG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798