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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes “the step of” without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such a claim limitation is: “the step of applying image processing techniques to enhance the visibility of retinal structures in the CT scans” in claim 4 lines 1-2.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-7 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.
Claim 1 recites the limitation "…the angle…" in line 5. There is insufficient antecedent basis for this limitation in the claim. There is no previous mention of an “angle,” as such, it is unclear as to what this is referring to.
The limitation "…the angle…" in line 5 shall be read as "…an angle…"
Claim 1 recites the limitation "…extracting the segmented globes from the remainder of each rotated axial image by cropping and masking the segmented globes…" in lines 6-7. It is unclear how there can be a remainder of each rotated axial image. The only precious process for the axial images is the rotation process in line 5. However, per that limitation, each of the images experiences rotation. As such, it is unclear how there can be a remainder.
What is it the remainder caused by? Are not all of the axial images rotated as was suggested by the previous claim limitations? On page 13 lines 9-15, the specification introduces the indication that remainder is related to the size of globes. Is that the indication for the remainder?
In line with page 13, “the remainder” described in line 6 will be read as “a subgroup”
Claim 1 recites the limitation "…the abnormalities…" in line 5. There is insufficient antecedent basis for this limitation in the claim. There is no previous mention of an “abnormalities,” as such, it is unclear as to what this is referring to.
The limitation "… the abnormalities …" in line 5 shall be read as "…abnormalities …"
Claim 3 recites the limitation "…the CT scans…" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no previous mention of an “CT scans,” as such, it is unclear as to what this is referring to.
The limitation "… the CT scans …" in line 1 shall be read as "…CT scans …"
Claim 7 recites the limitation "…the detection of retinal hemorrhages aids in the diagnosis of conditions such as abusive head trauma in patients…" in lines 1-2. It is unclear what the limitation is suggesting, the application of the retinal hemorrhage detection is not clearly defined. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 8 is rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Niemeijer et al. (US publication 20160292856 A1; hereinafter “Niemeijer”).
In re to claim 8, Niemeijer teaches wherein: A system for detecting retinal hemorrhages ([0029] discloses the detection of features of interest, such as dot hemorrhages (understood as a retinal hemorrhages)) comprising a CT ([0045] lines 8-10 discloses that the system can be used to process computed tomography images) scanner (scanner input; [0073] lines 1-5 discloses the inclusion of a scanner as input to the system.) and a computing device equipped with a deep learning model trained to identify retinal hemorrhages from CT scans ([0038] discloses the use of a processor for the neural network model leveraged for detection by the system).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Niemeijer in view of Umapathy et al. (non-patent literature titled “Fully automated segmentation of globes for volume quantification in CT images of Orbits using deep learning”; hereinafter “Umapathy”).
In re to claim 9 [dependent on claim 8], Niemeijer does not explicitly teach wherein: the deep learning model includes an algorithm for segmenting ocular globes from the CT scans.
However, in a related field of endeavor, Umapathy teaches wherein: the deep learning model includes an algorithm for segmenting ocular globes from the CT scans (subsection “Discussion” states that the deep learning network performs detection of globe contours, which as shown in Fig. 3 and Fig. 4, is applied to CT images (understood as scans)).
Umapathy, like Niemeijer, teaches a processing system that utilizes deep learning to analyze images containing eyes.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Niemeijer to include the segmentation of ocular globes from CT scans, as taught by Umapathy, to arrive at the claimed invention discussed above. The motivation for the proposed modification would be to enable the system to process eye image data taken from an image that includes the full head of a patient, expanding the range of input image data usable by the system.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Niemeijer teaches a system that performs detection of abnormalities in the eye of a subject, such as retinal hemorrhages. However, it does not perform rotation of axial image data while further extracting globes using cropping and masking for the further formation of a 3D image.
Umapathy teaches the segmentation of CT image data for globes of a subject, but it does not explicitly perform further rotation based on the angle between globes. Nor does it perform the cropping and masking in the manner required by the limitations.
Cheung et al. (US publication 20240071063 A1; hereinafter “Cheung”) teaches a system that processes 3D OCT image data that may be used for classification retinal image data. However, it does not perform rotation of axial image data while further extracting globes using cropping and masking for the further formation of a 3D image.
Additionally, the other known prior art of record does not address all the limitation of claims 1, without the use of impermissible hindsight, either alone or in an obvious and reasonable combination.
Conclusion
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/KEVIN M COOMBER/Examiner, Art Unit 2663
/GREGORY A MORSE/Supervisory Patent Examiner, Art Unit 2698