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 .
Election/Restrictions
Applicant’s election without traverse of Species II (claims 10-20) in the reply filed on 1/14/2026 is acknowledged.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are not known since the claim appears to be incomplete and is not directed to any specific limitation.
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 10-15 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) a method of characterization of a tissue environment using a global density metric, a first localised quantitative metric and a second localised quantitative metric.
The limitation of using at least one global density metric which is characteristic of the tissue environment of the breast, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. That is, nothing in the claim element precludes the step from practically being performed in the mind. For example, “using” in the context of this claim encompasses the user thinking and selecting a global density metric to use for calculations. Similarly, the limitation of using a first localized quantitative metric within a single localised region of interest centred on and inclusive of the biopsy or lesion location covers the same principle of a person thinking and selecting a global density metric to use for calculations. Furthermore, the limitation of using a second localized quantitative metric of a peri-lesional environment, where the regions of interest are inclusive or exclusive of the informed biopsy or lesion, encompasses the same idea of manually selecting and thinking about a metric. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above, the claimed elements are mere ways to apply the exception. The claim is not patent eligible.
The dependent claims 11-15 as a whole are further expansions of using generic computer components to apply the abstract idea without adding any meaningful improvement to the judicial exception. Accordingly, these claims are also not patent eligible.
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.
Claim(s) 10-11, 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wenqing et al. (“Enhancing deep convolutional neural network scheme for breast cancer diagnosis with unlabeled data”, from hereon Wenqing).
(1) regarding claim 10:
Wenqing discloses a method of characterization of a tissue environment within a quantitative medical image of a breast to predict risk of benign or malignant lesions, diagnostic biopsy outcomes or risk of lesion progression, via informed associations of a biopsy or lesion (page 5, left column, section 2.1); comprising:
using at least one global density metric which is characteristic of the tissue environment of the breast and a plurality of regions of interest in the tissue environment (page 5, right column, lines 16-19, where a global feature density metric is used for the region of interest and surrounding area);
using a first localized quantitative metric within a single localised region of interest centred on and inclusive of the biopsy or lesion location (page 5, right column, lines 20-24, where a metric in reference to a single area of the lesion location is used); and
using a second localized quantitative metric of a peri-lesional environment, where the regions of interest are inclusive or exclusive of the informed biopsy or lesion (page 5, right column, lines 27-32, where areas surrounding the lesion are used to perform a diagnosis).
(2) regarding claim 11:
Wenqing further discloses wherein the first localized quantitative metric is the percentage of dense tissue volume or area or absolute dense tissue volume or area within the single localised region of interest centred on the biopsy or lesion location (page 5, right column, lines 20-24, tissue area).
(3) regarding claim 13:
Wenqing further discloses designing the single localised region of interest centred on the biopsy or lesion location to have a size and shape according to the informed biopsy or lesion (page 5, right column, lines 6-19, where the region of interest have a size and shape according to the detected lesion and the surrounding area).
(4) regarding claim 14:
Wenqing further discloses wherein the second localized quantitative metric is percentage of dense tissue volume or area or absolute dense tissue volume or area of the peri-lesional environment (Fig. 1 in page 6, shows the percentage of the tissue volume).
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(s) 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wenqing et al. (“Enhancing deep convolutional neural network scheme for breast cancer diagnosis with unlabeled data”, from hereon Wenqing) in view of Otsuka et al. (“Local breast density at lesion sites in diagnostic and previous screening mammograms”, hereon Otsuka).
(1) regarding claim 12:
Wenqing discloses all the subject matter as described above except designing the single localised region of interest centred on the biopsy or lesion location to have a dimension between 2 mm and 30 mm according to the informed biopsy or lesion or restricted by dimensions of the compressed breast.
However, Otsuka teaches designing the single localised region of interest centred on the biopsy or lesion location to have a dimension between 2 mm and 30 mm according to the informed biopsy or lesion or restricted by dimensions of the compressed breast (in methods, where a square region of 5mm is used).
Having a system of Otsuka reference and then given the well-established teaching of Wenqing reference, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wenqing to include the limitations as taught by Otsuka because with this an uniform area of tissue is always selected for calculation purposes, in that way an accurate comparison between data can be achieved, thus a better diagnosis can be achieved.
(2) regarding claim 15:
Wenqing discloses all the subject matter as described above except designing the distance in range of 2 mm to 30 mm from the peripheral edge of the informed lesion to the perimeter of each of the regions of interest.
However, Otsuka teaches designing the distance in range of 2 mm to 30 mm from the peripheral edge of the informed lesion to the perimeter of each of the regions of interest (in methods, where a square region of 5mm is used).
Having a system of Otsuka reference and then given the well-established teaching of Wenqing reference, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wenqing to include the limitations as taught by Otsuka because with this an uniform area of tissue is always selected for calculation purposes, in that way an accurate comparison between data can be achieved, thus a better diagnosis can be achieved.
Allowable Subject Matter
Claims 17-20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENNIN R RODRIGUEZ whose telephone number is (571)270-1678. The examiner can normally be reached Monday-Thursday 9:00am-7:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abderrahim Merouan can be reached at 571-270-5254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LENNIN R RODRIGUEZGONZALEZ/ Primary Examiner, Art Unit 2683
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