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 § 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 1-2, 4-6, 8-9, 11-13, 15-16 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claims 1, 8 and 15 recite analyzing a set of images to determine a patient-specific threshold to use to detect abnormal tissue of the patient. The limitation of analyzing a set of images to determine a patient-specific threshold, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “one or more processors configured to” (claim 1), “computer-implemented” (claim 8), or “at least one processor” (claim 15), nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “one or more processors”, “computer-implemented” and “at least one processor” language, “analyzing” in the context of the claims encompasses the user manually determining a threshold to use to detect abnormal tissue of the patient. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then 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, taking claim 1 as an example, the claims only recite two additional elements –a medical imaging device configured to produce a set of images of an anatomy of a patient, and one or more processors configured to receive the set of images. The “one or more processors”/”at least one processor” are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of receiving data) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additionally recited elements of producing and receiving a set of images amount to no more than insignificant extra-solution activities. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claims 1, 8 and 15 are therefore directed to an abstract idea and are not patent eligible.
Regarding dependent claims 2, 9 and 16, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea. The limitation of “analyzing a set of images by calculating, using a pixel comparator…to generate a set of representative values” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a pixel comparator”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “pixel comparator” language, “analyzing” in the context of the claims encompasses the user manually calculating a representative intensity value for each image to generate a set of representative intensity values. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using the pixel comparator for the calculating step amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. Therefore, the claims are not patent eligible as drafted.
Regarding dependent claims 4, 11 and 18, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea. The limitation of “wherein in the images are surgical site images” as drafted, amounts to no more than insignificant extra-solution activity. Accordingly, the claims recite an abstract idea and are not patent eligible.
Regarding dependent claims 5, 12, and 19, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea. The limitation “identify one or more groups of abnormal cells…based on the calculated threshold” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “an image analysis system”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “image analysis system” language, “identify” in the context of the claims encompasses the user manually identifying groups of abnormal cells in the image by visual analysis. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. The additional limitations of producing a new surgical site image and displaying one or more locations of identified one or more groups of abnormal cells using a display amount to no more than insignificant extra-solution activities. Therefore, the claims are not patent eligible as drafted.
Regarding dependent claims 6, 13 and 20, the limitation of selecting a pixel comparator from a group of pixel comparators amounts to no more than insignificant extra-solution activities. The claim is therefore directed to an abstract idea and not patent eligible.
Regarding dependent claims 3, 7, 10, 14, 17 and 21, the claims include elements which integrate the abstract idea into a practical application and are therefore not rejected under 35 USC 101.
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 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, 4-5, 8-9, 11-12, 15-16 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. PG Pub. 2016/0025632 (hereinafter “Lee”; applicant-submitted prior art).
Regarding claim 1, Lee discloses a system for determining a patient-specific threshold used to detect abnormal cells, the system comprising (Lee, ¶0045-0047, 0050, 0188-0189):
a medical imaging device configured to produce a set of images of an anatomy of a patient (Lee, ¶0051, 0057, 0112; “optical detection techniques are used in conjunction with the administration of a molecular imaging probe for diagnostic purposes” wherein the optical detection technique uses a detector, “such as a laproscope, endoscope, probe, fiber optic cables, or the like.”);
an image analysis system comprising one or more processors configured to: receive the set of images; and analyze the set of images to determine a patient-specific threshold to use to detect abnormal tissue of the patient (Lee, ¶0045-0047, 0057, 0188-0189; “After a predetermined time interval, the resected tumor and the portion of healthy tissue are imaged. The algorithm will analyze the fluorescence intensity distribution of both images pixel-by-pixel and will determine an appropriate intensity threshold to discriminate between tumor and healthy tissue based on the minimum fluorescence intensity from the tumor. Then, the tumor bed is imaged and each pixel value is compared against the threshold and a false color is assigned to those pixels above the threshold for visual recognition in the monitor display.” The system implements software algorithms for image analysis, inherently necessitating the use of one or more processors.).
Regarding claim 2, claim 1 is incorporated, and Lee further discloses wherein the image analysis system is configured to analyze the set of images by calculating, using a pixel comparator, a representative intensity value for each image in the set of images that represents the pixel intensity values of the associated image to generate a set of representative intensity values (Lee, ¶0188-0189; “The algorithm will analyze the fluorescence intensity distribution of both images pixel-by-pixel and will determine an appropriate intensity threshold to discriminate between tumor and healthy tissue based on the minimum fluorescence intensity from the tumor.” Lee uses the rate of change of fluorescence intensity between consecutive images to establish the intensity rate of change between cancer and muscle cells in a pixel-by-pixel basis.).
Regarding claim 4, claim 1 is incorporated, and Lee further discloses wherein the images are surgical site images of a surgical site of the patient (Lee, ¶0046-0047, 0188; “After a predetermined time interval, the resected tumor and the portion of healthy tissue are imaged.” The resected tumor corresponds to a surgical site of the patient.).
Regarding claim 5, claim 4 is incorporated, and Lee further discloses wherein: the medical imaging device is configured to produce a new surgical site image; the image analysis system is further configured to identify one or more groups of abnormal cells in the new surgical site image based on the calculated threshold; and the system comprises a display configured to indicate one or more locations of the identified at least one of the one or more groups of abnormal cells (Lee, ¶0046, 0050-0051, 0057, 0188; “The algorithm will analyze the fluorescence intensity distribution of both images pixel-by-pixel and will determine an appropriate intensity threshold to discriminate between tumor and healthy tissue based on the minimum fluorescence intensity from the tumor. Then, the tumor bed is imaged and each pixel value is compared against the threshold and a false color is assigned to those pixels above the threshold for visual recognition in the monitor display.”).
Claim 8 recites a method having features corresponding to the elements recited in system claim 1, the rejection of which is applicable here.
Claim 9 recites a method having features corresponding to the elements recited in system claim 2, the rejection of which is applicable here.
Claim 11 recites a method having features corresponding to the elements recited in system claim 4, the rejection of which is applicable here.
Claim 12 recites a method having features corresponding to the elements recited in system claim 5, the rejection of which is applicable here.
Claim 15 recites a computer-readable storage medium comprising computer-executable instructions having features corresponding to the elements recited in system claim 1, the rejection of which is applicable here.
Claim 16 recites a computer-readable storage medium comprising computer-executable instructions having features corresponding to the elements recited in system claim 2, the rejection of which is applicable here.
Claim 18 recites a computer-readable storage medium comprising computer-executable instructions having features corresponding to the elements recited in system claim 4, the rejection of which is applicable here.
Claim 19 recites a computer-readable storage medium comprising computer-executable instructions having features corresponding to the elements recited in system claim 5, the rejection of which is applicable here.
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.
Claims 3, 10 and 17 are rejected under 35 U.S.C. 103, as being unpatentable over Lee, as applied to claims 1, 8 and 15 above, in view of U.S. PG Pub. 2014/0016845 (hereinafter “Gazit”).
Regarding claim 3, claim 2 is incorporated, and Lee does not expressly teach the limitations as further claimed, but, in an analogous field of endeavor, Gazit does as follows.
Gazit teaches wherein the image analysis system is configured to: select a subset of the set of representative intensity values based on a predetermined criterion that is used to filter out one or more of the representative intensity values in the set of representative intensity values; average the selected subset of representative intensity values to calculate an averaged intensity value; and calculate the patient-specific threshold for the patient based on the averaged intensity value and an adjustment factor associated with the pixel comparator (Gazit, ¶0064-0066; “thresholds for the lesion in the target set of data are computed, according to the intensity statistics collected from the input data in stage 1, and applied to the target set of data to form a threshold mask. The thresholds for the lesion in the target study are preferably computed to select voxels that have intensities that are more likely to be lesion than background, according to the statistics computed from the initial lesion. Specifically but as a non-limiting optional example, an upper threshold is selected to define the intensity at which a voxel becomes more likely to be background than lesion (given a normal distribution of lesion and background intensities), and a lower threshold is selected that is either the lesion mean minus two STDs” – The claimed subset of the set of representative values is interpreted here to correspond to Gazit’s initial lesion and background segmentation from which statistics (i.e., averaged intensity) are computed and further used to determine the threshold for lesion detection.).
Gazit is considered analogous art because it pertains to lesion segmentation in medical images. 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 the system taught by Lee to determine the lesion detection threshold based on statistics calculated based on a segmented lesion area, as taught by Gazit, in order to perform a more accurate and reliable identification and segmentation of the lesion from the image background (Gazit, ¶0002).
Claim 10 recites a method having features corresponding to the elements recited in system claim 3. Therefore, the recited elements of Claim 10 are mapped to the proposed combination in the same manner as the corresponding elements in Claim 3. Additionally, the rationale and motivation to combine the Lee and Gazit references presented in the rejection of Claim 3 apply to this claim.
Claim 17 recites a computer-readable storage medium comprising computer-executable instructions having features corresponding to the elements recited in system claim 3. Therefore, the recited elements of Claim 17 are mapped to the proposed combination in the same manner as the corresponding elements in Claim 3. Additionally, the rationale and motivation to combine the Lee and Gazit references presented in the rejection of Claim 3 apply to this claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,793,594. Although the claims at issue are not identical, they are not patentably distinct from each other because, aside from minor differences in claim language, the claims of the instant application are anticipated by claim 1 of the patent.
Claims 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,793,594. Although the claims at issue are not identical, they are not patentably distinct from each other because, aside from minor differences in claim language, the claims of the instant application are anticipated by claim 9 of the patent.
Claims 15 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,793,594. Although the claims at issue are not identical, they are not patentably distinct from each other because, aside from minor differences in claim language, the claims of the instant application are anticipated by claim 17 of the patent.
Claims 4-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, respectively, of U.S. Patent No. 11,793,594. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are anticipated by the claims of the patent.
Claims 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-13, respectively, of U.S. Patent No. 11,793,594. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are anticipated by the claims of the patent.
Claims 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-21 of U.S. Patent No. 11,793,594. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are anticipated by the claims of the patent.
Allowable Subject Matter
Claims 6, 13 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if (1) rewritten to overcome the 35 USC 101 rejection set forth above, and (2) rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 7, 14 and 21 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, and if the non-statutory double patenting rejection set forth above is overcome.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, either alone or in combination, does not expressly teach or render obvious the limitations additionally recited. With regard to claims 6, 13 and 20, the closest prior art of record does not expressly teach selecting a pixel comparator from a group consisting of the particular comparators claimed. With regard to claims 7, 14 and 21, the closest prior art of record does not expressly teach training a plurality of pixel comparators on a training set of images to calculate a set of results for each and analyzing the results in order to select the pixel comparator based on the analysis, as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMAH A BEG whose telephone number is (571)270-7912. The examiner can normally be reached M-F 9 AM - 5 PM.
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/SAMAH A BEG/Primary Examiner, Art Unit 2676