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 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 1-16, 18, 20-21, 23 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.
Claims 1 and 23 (the rest by dependency) recite “the enhanced optical image”. There is insufficient antecedent basis for this limitation.
Claim 2 recites “a step of computer-aided diagnosis after step e”. It is unclear what is being diagnosed.
Claim 6 recites “averaging… adjacent optical images”. It is unclear what it means to average an image.
Claim 10 recites “averaging at least two adjacent optical images”. It is unclear what it means to average an image. Further, it is unclear in the context of the claims what it means for images to be adjacent to each other.
Claim 13 recite “confetti melanin” and “grain melanin”. It is unclear what these terms mean as these are not well known terminology. For the purposes of examination, Examiner notes that grain melanin will be considered melanin with diameter between 0.5-3.3 um and confetti melanin will be considered melanin with diameter >3.3 um.
Claim 23 recites “the background signals”. There is insufficient antecedent basis for this limitation.
Claim 23 recites “image of the skin”. There is insufficient antecedent basis for this limitation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 20-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 20 and 21 further limit the skin condition which relates to the intended use of the device. These claims fail to structurally limit claim 15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-16, 18, 20-21, 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) quantifying the feature of the object. The abstract idea is part of the Mathematical Concepts and/or Organizing Human Activity group(s) identified in the Ninth Edition, Revision 10.2019 (revised June 2020) of the Manual of Patent Examination Procedure (MPEP). This judicial exception is not integrated into a practical application because they amount to simply implementing the abstract idea on a computer; data-gathering steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity; there is no improvement to a computer or other technology; does not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition; does not apply the abstract idea with, or by use of, a particular machine. The additional elements are identified as follows: optical imager, processor, display and storage. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, when considered both individually and as a whole, do not amount to significantly more than the abstract idea. The additional computer and data-gathering elements, which are recited at a high level of generality, provide conventional computer and data-gathering functions that do not add meaningful limitations to practicing the abstract idea.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by non-patent literature of record in the application as well as Chen et al. FULL FIELD OPTICAL COHERENCE TOMOGRAPHY IMAGE DENOISING USING DEEP LEARNING WITH SPATIAL COMPOUNDING; 2020 IEEE 17th International Symposium on Biomedical Imaging (ISBI) April 3-7, 2020, Iowa City, Iowa, USA and Chen et al. Computer-Aided Detection (CADe) System with Optical Coherent Tomography for Melanin Morphology Quantification in Melasma Patients Diagnostics (Basel). 2021 Aug 19;11(8):1498
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
When considered in combination, the additional elements (generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. The Federal Circuit has held that combining additional elements for data-gathering with abstract ideas does not make a claim patent-eligible. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data gathering that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known data-gathering equipment/functions is not significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 7-12, 15, 18, 20, 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keerthan et al. (Skin Cancer Detection Using Image Processing; JETIR June 2020; Vol 7 Issue 6 – cited by Applicant), hereinafter Keerthan.
Regarding Claim 1, Keerthan teaches: A method of processing optical image of a skin (title) comprising
a) receiving an optical image of a skin that contains a feature of an object (section II.A);
b) optionally performing a noise reduction to reduce the noise of the optical image (Examiner notes this is not a required step; section II.B);
c) contrast-enhancing the feature's signals of the object from background signals (section II.B);
d) segmenting the object in the enhanced optical image through at least one threshold value of the feature (section II.C);
e) optionally categorizing the segmented object (Examiner notes that this is not a required step; figure 3); and
f) quantifying the feature of said object from the optical image of the skin (section II.C and II.D).
Regarding Claim 2, Keerthan teaches: The method of claim 1, further comprising a step of computer-aided diagnosis after step e (section II.E).
Regarding Claim 7, Keerthan teaches: The method of claim 1, wherein the object is melanin, melanosomes, melanocyte, melanophage, activated melanocyte, or combinations thereof (abstract).
Regarding Claim 8, Keerthan teaches: The method of claim 7, wherein the feature is brightness, particle area, particle size, particle shape, or distribution position in the skin (section II.B).
Regarding Claim 9, Keerthan teaches: The method of claim 8, wherein the feature is brightness (section II.B).
Regarding Claim 10, Keerthan teaches: The method of claim 1, wherein the optical image is acquired by averaging at least two adjacent optical images (section II.B – Examiner broadly interprets greyscale conversion, i.e. the combination of a red, green and blue image, as averaging adjacent images).
Regarding Claim 11, Keerthan teaches: The method of claim 7, wherein the object is melanin, melanocyte, or activated melanocyte (abstract).
Regarding Claim 12, Keerthan teaches: The method of claim 11, wherein the object is melanin (abstract).
Regarding Claim 15, Keerthan teaches: A computer-aided system for skin condition diagnosis (abstract) comprising an optical imager configured to provide an optical image of a skin (figure 3; section III); a processor coupled to the imager (figure 3; section II), a display coupled to the processor configured to output the diagnosis (figure 3; section II), and a storage coupled to the processor (inherent, section II.A), the storage carrying program instructions which, when executed on the processor, cause it to carry out the method of claim 2 (figure 3; section II).
Regarding Claim 18, Keerthan teaches: The computer-aided system of claim 15, wherein the storage comprises a cloud based storage (section II.A; official notice is being taken that a raspberry pi can connect to cloud storage).
Regarding Claim 20, Keerthan teaches: The computer-aided system of claim 15, wherein the skin condition is a skin cancer, or a skin pigment disorder (title; abstract).
Regarding Claim 23, Keerthan teaches: A method of identifying a pigment disorder of a skin comprising
1) receiving an optical image of a suspected pigment disorder skin (figure 3);
2) optionally performing a noise reduction to reduce the noise of the optical image (section II);
3) contrast-enhancing the feature's signals of an object from the background signals (section II) wherein said object is melanin, melanosomes, melanocyte, melanophage, activated melanocyte, or combinations thereof (abstract);
4) segmenting the object in the enhanced optical image through at least one threshold value of the feature (section II);
5) quantifying the feature of the object from the optical image of the skin (section II); and
6) identifying the suspected pigment disorder skin through the quantified value (figure 3).
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.
Claim(s) 3-6, 14, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keerthan in view of Chen et al. (FULL FIELD OPTICAL COHERENCE TOMOGRAPHY IMAGE DENOISING USING DEEP LEARNING WITH SPATIAL COMPOUNDING; 2020 IEEE 17th International Symposium on Biomedical Imaging (ISBI) April 3-7, 2020, Iowa City, Iowa, USA), hereinafter Chen.
Regarding Claim 3, Keerthan teaches: The method of claim 1, but does not mention wherein step b reduces the noise of the optical image through a spatial compounding-based denoising convolutional neural network (SC-DnCNN).
Chen teaches step b reduces the noise of the optical image through a spatial compounding-based denoising convolutional neural network (SC-DnCNN) (figure 2). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method wherein step b reduces the noise of the optical image through a spatial compounding-based denoising convolutional neural network (SC-DnCNN) as the substitution of one noise reduction technique for another would have yielded predictable results to one of ordinary skill.
Regarding Claim 4, Keerthan in view of Chen teach: The method of claim 3, wherein the SC-DnCNN is trained to distinguish the noise of the optical image (Chen - section 2.2).
Regarding Claim 5, Keerthan in view of Chen teach: The method of claim 4, wherein the SC-DnCNN is trained by a database containing noisy images and clean images (section 2.1-2.2).
Regarding Claim 6, Keerthan in view of Chen teach: The method of claim 5. While Chen mentions averaging adjacent images (section 2 and 3), Chen does not explicitly mention the clean image is acquired by averaging N number of adjacent optical images, the noisy image is acquired by averaging M number of adjacent optical images, and N is greater than M. However, Examiner notes that it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method the clean image is acquired by averaging N number of adjacent optical images, the noisy image is acquired by averaging M number of adjacent optical images, and N is greater than M as this is merely a design choice as Applicant has failed to show any criticality with respect to the values M and N. Examiner notes it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).”.
Regarding Claim 14, Keerthan teaches: The method of claim 1. Keerthan does not mention wherein the optical image is an optical coherence tomography (OCT) image, a reflectance confocal microscopy (RCM) image, or a confocal optical coherence tomography image.
Chen teaches the use of OCT (title). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method to include wherein the optical image is an optical coherence tomography (OCT) image, a reflectance confocal microscopy (RCM) image, or a confocal optical coherence tomography image as the substitution of one image type for another would have yielded predictable results to one of ordinary skill.
Regarding Claim 16, Keerthan teaches: The computer-aided system of claim 15, but does not mention wherein the imager is an optical coherence tomography (OCT) device, a reflectance confocal microscopy (RCM) device, or a confocal optical coherence tomography device.
Chen teaches the use of OCT (title). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system to include wherein the optical image is an optical coherence tomography (OCT) image, a reflectance confocal microscopy (RCM) image, or a confocal optical coherence tomography image as the substitution of one image type for another would have yielded predictable results to one of ordinary skill.
Claim(s) 13, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keerthan in view of Wu et al. (Confetti-like Sparing A Diagnostic Clinical Feature of Melasma; J Clin Aesthet Dermatol. 2016 Feb 1;9(2):48–57 – cited by Applicant), hereinafter Wu.
Regarding Claim 13, Keerthan teaches: The method of claim 12, but does not mention wherein Step e comprises categorizing the object to a grain melanin, or confetti melanin. Wu teaches that confetti-like sparing is a diagnostic feature of melasma (title; abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method to include wherein Step e comprises categorizing the object to a grain melanin, or confetti melanin in order to diagnose melasma.
Regarding Claim 21, Keerthan teaches: The computer-aided system of claim 20, but does not mention wherein the pigment disorder is albinism, melasma, or vitiligo.
Wu teaches that confetti-like sparing is a diagnostic feature of melasma (title; abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system to include wherein the pigment disorder is albinism, melasma, or vitiligo in order to diagnose additional health conditions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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