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 .
Status of Claims
This action is a final rejection
Claims 1-20 are pending
Claims 1, 4-18 are rejected under 35 USC § 101
Claims 1-20 are rejected under 35 USC § 103
Priority
Acknowledgement is made of Applicant’s claim for a domestic priority date of 4-30-2022
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3-24-2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-20 are not patent eligible because the claimed invention is directed to an abstract idea without significantly more.
Analysis
First, claims are directed to one or more of the following statutory categories: a process, a machine, a manufacture, and a composition of matter. Regarding claims 1, 4-18 the claims recite an abstract idea of “breast tumor margin assessment”.
Independent Claims 1 and 14 are rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claim 1 recites a method, for breast tumor margin assessment.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
administering a radiotracer containing a radioisotope of zinc to a patient
acquiring positron emission data from the region-of-interest;
receiving the positron emission data;
determining, ..., a tumor margin in the region-of-interest from the positron emission data;
generating a report indicating the determined tumor margin;
wherein the report includes an overlay of the positron emission data on medical images acquired from the region-of-interest and at least one of
(1) different colors, shadings, or pattern for each of a healthy tissue and a cancerous tissue in the tumor margin,
(2) a heat map indicating the positron emission data in the determined tumor margin, or
(3) position data measured by one or more position trackers on the positron detection probe
belong to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “breast tumor margin assessment”. Alternatively the claims belong to certain methods of organizing human activity under managing personal behavior or relationships or interrelations between people as it recites “breast tumor margin assessment”. The justification for the latter is that the claim invention is a method that is used to assess breast tumor margin. Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO).
Claim 1 recites:
positioning a positron detection probe proximate a region-of-interest in a breast of the patient;
using the positron detection probe;
using the computer system;
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two, claim 1 recites:
Claim 1 recites:
positioning a positron detection probe proximate a region-of-interest in a breast of the patient;
using the positron detection probe;
using the computer system;
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
-Step 1 (Does the claim fall within a statutory category? YES): claim 14 recites a method of breast tumor margin assessment.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
receiving positron emission data wherein the positron emission data comprise measurements of positron emissions from breast tissues in a region-of- interest that have taken up a previously administered radiotracer containing a zinc radioisotope
generating from the positron emission data, ..., a tumor margin map that depicts a spatial distribution of the positron emissions in the region-of- interest overlayed on medical images acquired from the region-of-interest, wherein the tumor margin map includes at least one of
(1) different colors, shadings, or pattern for each of a healthy tissue and a cancerous tissue in the tumor margin,
(2) a heat map indicating the positron emission data in the determined tumor margin, or
(3) position data measured by one or more position trackers on a positron detection probe used to acquire the positron emission data;
displaying the tumor margin map.
belong to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “breast tumor margin assessment”. Alternatively the claims belong to certain methods of organizing human activity under managing personal behavior or relationships or interrelations between people as it recites “breast tumor margin assessment”. The justification for the latter is that the claim invention is a method that is used to assess breast tumor margin. Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO).
Claim 14 recites:
computing system;
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception..
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two, claim 1 recites:
Claim 14 recites:
computing system;
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Dependent Claims:
Step 2A Prong One:
The following dependent claims do not recite a product of nature or natural phenomenon and as a result the judicial exception does not apply and hence are not rejected under 35 USC § 101 since Zinc-63 is a synthetic, not naturally occurring. It has a short half life of about 38 minutes and emits positrons
Claims 2 & 19: wherein the radioisotope of zinc is 63Zn
Claims 3 & 20: wherein the radiotracer comprises 63Zn-zinc citrate
The following dependent claims recite additional limitations that further define the abstract idea of “breast tumor margin assessment”. The claim limitations include:
Claim 4: wherein the radiotracer is administered to the patient 20 to 30 minutes prior to acquiring the positron emission data
Claim 8: wherein the positron emission data indicates preferential uptake of the radiotracer in tissues within the region-of-interest;
Claim 9: wherein determining the tumor margin comprises differentiating healthy tissue from tumor tissue by analyzing the positron emission data relative to a threshold level of radiotracer uptake
Claim 10: wherein tissues having positron emissions above the threshold level are determined as part of the tumor margin
Claim 11: wherein the report comprises a tumor margin map depicting a spatial distribution of the tumor margin as determined from the positron emission data
Claim 12: , wherein the tumor margin map includes pixels that are highlighted to represent tumor tissue in the determined tumor margin relative to healthy tissue not part of the tumor margin;
Claim 13: wherein the report is generated in real-time as the positron emission data are being acquired from the region-of-interest
Claim 15: wherein the positron emission data are received
Claim 16: wherein the tumor margin is determined based on a preferential uptake of the radiotracer by tissues in the region-of-interest
Claim 17: wherein the tumor margin is determined based on comparing the measurement of positron emissions in the positron emission data with a threshold indicating the preferential uptake of the radiotracer;
Claim 18: wherein the positron emission data comprise measurements of radioisotope activity concentration
Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). The following dependent claims recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claims as a whole do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims include:
Claim 5: wherein the positron detection probe is a handheld positron detection probe;
Claim 6: wherein the positron detection probe is coupled to a robotic arm of a surgical robot
Claim 7: wherein positioning the positron detection probe proximate the region-of-interest comprises inserting the positron detection probe into a tumor resection cavity in the breast of the patient. ;
Claim 15: the computer system from a positron detection probe;
Step 2B (Does the additional elements of the claim provide an inventive concept?: NO). As discussed previously with respect to Step 2A Prong Two, the following dependent claims recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible. The claims include:
Claim 5: wherein the positron detection probe is a handheld positron detection probe;
Claim 6: wherein the positron detection probe is coupled to a robotic arm of a surgical robot
Claim 7: wherein positioning the positron detection probe proximate the region-of-interest comprises inserting the positron detection probe into a tumor resection cavity in the breast of the patient. ;
Claim 15: the computer system from a positron detection probe;
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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
non-obviousness.
Claims 1-8, 11, 13-16, 18-20 are rejected under 35 U.S.C. 103 as being un-patentable by Daghighian et.al. (US 20100198061) hereinafter “Daghighian” in view of Degrado et.al (US 20160175465 A1) hereinafter “Degrado”, in further view of Liu et.al. (Computers in Biology and Medicine 126 (2020) -Elsevier) hereinafter “Liu”.
Regarding claim 1 Daghighian teaches:
A method for breast tumor margin assessment, the method comprising: (See at least [0057] via: " ... finding postoperative, cancer-positive margins, provides meaningful reduction in the re-operative rate for breast cancer patients ... ")
administering a radiotracer containing a radioisotope [of zinc] to a patient; (See at least [0124] via: " ... injecting the patient with F-18 FDG [F-18 labeled fluorodeoxyglucose], or any other beta emitting radio-tracers used for cancer detection.")
positioning a positron detection probe proximate a region-of-interest in a breast of the patient; (See at least [0124] via: " ... injecting the patient with F-18 FDG [F-18 labeled fluorodeoxyglucose], or any other beta emitting radio-tracers used for cancer detection.");
acquiring positron emission data from the region-of-interest using the positron detection probe; (See at least [0057] via: "Positrons emitted from 18F in FDG [fluorodeoxyglucose] can guide the beta probe to detect these residual tumor cells.")
receiving the positron emission data with a computer system; (Fig 3, element 32; See at least [0071] via: "Software provided in a data processing unit 32 generates uniformity look-up tables 'and other corrections necessary to enable the data generated by the camera 34 ... ")
determining, using the computer system, a tumor margin in the region-of-interest from the positron emission data; (See at least [0057] via: " ... finding postoperative, cancer-positive margins ... “; in addition see at least [0093] via: “... "Counts, updated each second, are then passed through a data processor 32 where they are electronically processed and displayed on a visual screen or monitor 42 so that the surgeon can identify, isolate and remove the labeled cells...") and
generating a report indicating the determined tumor margin using the computer system. (Fig 3, elements 32, 36; See at least [0071] via: " ... the signal processing electronics 32 and a display screen 36 to provide a visual display of the beta counts detected.").
However, Daghighian does not explicitly teach that the radioisotope is a radioisotope of zinc as taught by Degrado:
administering a radiotracer containing a radioisotope of zinc to a patient (See at least [0013] via: " ... a method for detecting or ruling out cancer in a patient... The medical imaging technique can be positron emission tomography.."; in addition see at least [0008] via: " ... radiolabeled 63 Zn zinc, as a PET imaging biomarker of ... cancer.,"
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Daghighian to incorporate the teachings of Degrado. Those in the art would have recognized that Daghighian’s teaching regarding any other beta emitting radio-tracers used for cancer detection (paragraph [0124], does not explicitly teach that the radioisotope is a radioisotope of zinc as taught by Degrado It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to use a radioisotope of zinc as the radioisotope in the method of Daghighian, as taught by Degrado, to improve reliability of the biomarker while being noninvasive (see Degrado at paragraph [0008], " ... overcomes the aforementioned drawbacks by providing reliable noninvasive markers ... ")
However, Daghighian and Degrado do not teach the following limitation as taught by Liu:
wherein the report includes an overlay of the positron emission data on medical images acquired from the region-of-interest and at least one of: (See at least [Page 3, Fig. 2] via: " ...Schematic diagram of the proposed PET/CT data visualization method. It consists of three main modules: colorization, fusion and blending. The PET image is firstly colorized. The CT and the PET images are then fused in grayscale. Finally, the visualization result is obtained by blending the fused image and the colorized PET image...”)
(1) different colors, shadings, or pattern for each of a healthy tissue and a cancerous tissue in the tumor margin, (See at least [Page 3, Fig. 2] via: " ...Schematic diagram of the proposed PET/CT data visualization method. It consists of three main modules: colorization, fusion and blending. The PET image is firstly colorized. The CT and the PET images are then fused in grayscale. Finally, the visualization result is obtained by blending the fused image and the colorized PET image...”; in addition see at least [Page 9, Fig. 12] via: " ... Visualization results of different methods on a pair of PET and CT brain images that contain a metastatic brain tumor from lung cancer. The first and second images shows the input CT and PET images, respectively. The third, fourth and fifth images shows the results obtained by the ClearCanvas, CT-underlay and proposed methods, respectively. A close-up focusing on the tumor is provided for better comparison ..”; in addition see at least [Page 6, paragraph 1 ] via: " results of the method using the presented PET colorization approach but with the CT image as underlay (denoted as CT-underlay)....”)
(2) a heat map indicating the positron emission data in the determined tumor margin, or
(3) position data measured by one or more position trackers on the positron detection probe
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Daghighian and Degrado to incorporate the teachings of Liu. Those in the art would have recognized that Daghighian’s teaching regarding any other beta emitting radio-tracers used for cancer detection (paragraph [0124], does not explicitly teach the proposed PET/CT data visualization method consisting of colorization, fusion and blending as taught by Liu It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to use a PET/CT data visualization method consisting of colorization, fusion and blending in the method of Daghighian, as taught by Liu, to improve visualization of tumors.
Regarding claim 2 & 19 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claims 1 and 14 respectively. Daghighian is silent the following claim that is taught by Degrado:
wherein the radioisotope of zinc is 63Zn. (See at least [0010], "The positron emitting zinc cation may be 63 Zn...")
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Daghighian and Liu to incorporate the teachings of Degrado. Those in the art would have recognized that Daghighian’s teaching regarding any other beta emitting radio-tracers used for cancer detection (paragraph [0124]), does not explicitly teach that the radioisotope is a radioisotope of zinc as taught by Degrado It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to use a radioisotope of zinc as the radioisotope in·the method of Daghighian, as taught by Degrado, to improve reliability of the biomarker while being noninvasive (see Degrado at paragraph [0008], " ... overcomes the aforementioned drawbacks by providing reliable noninvasive markers ... ")
Regarding claims 3 & 20 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claims 1&2 and 14&19 respectively. Daghighian is silent the following claim that is taught by Degrado:
wherein the radiotracer comprises 63Zn-zinc citrate. (See at least [0010] via: "The zinc cation can be reacted with an anion to produce a positron emitting zinc compound. Preferably, the anion is citrate.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Daghighian and Liu to incorporate the teachings of Degrado. Those in the art would have recognized that Daghighian’s teaching regarding any other beta emitting radio-tracers used for cancer detection (paragraph [0124]), does not explicitly teach that the radioisotope is a radioisotope of zinc as taught by Degrado It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to use a radioisotope of zinc as the radioisotope in·the method of Daghighian, as taught by Degrado, to improve reliability of the biomarker while being noninvasive (see Degrado at paragraph [0008], " ... overcomes the aforementioned drawbacks by providing reliable noninvasive markers ... ")
Regarding claim 4 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1. Daghighian also teaches:
wherein the radiotracer is administered to the patient [20 to 30 minutes] prior to acquiring the positron emission data. (See at least [0104] via: "Sixty minutes latter the beta probe 16 was positioned perpendicular to the surface of both normal tissue and tumor ... ")
However, Daghighian, Defrado and Liu do not explicitly teach administering radiotracer 20 to 30 minutes prior to acquiring data. It would have been obvious to a person having ordinary skill in the art, at the time of invention, to administer radiotracer 20 to 30 minutes prior to acquiring data in the method of Daghighian in view of Degrado in view of Liu, as Daghighian discloses a waiting period between administering radiotracer and acquiring data, and when the general conditions of a claim are disclosed by the prior art finding an optimum or workable range is a matter of routine experimentation
Regarding claim 5 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1. Daghighian also teaches:
wherein the positron detection probe is a handheld positron detection probe. (See at least [0095] via: "The beta camera 34 described herein which can be hand held ... ")
Regarding claim 6 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1. Daghighian also teaches:
wherein the positron detection probe is a handheld positron detection probe. (See at least [0095] via: "The beta camera 34 described herein which can be hand held ... ")
Regarding claim 7 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1. Daghighian also teaches:
wherein positioning the positron detection probe proximate the region-of-interest comprises inserting the positron detection probe into a tumor resection cavity in the breast of the patient. (See at least [0093] via: "The beta probe 16 ... is highly sensitive to minute amounts of cancer cells that may be located within a millimeter of the surgical margin and effective in detecting small amounts of tumor at the margin of resection..."; in addition see at least [0095], "This beta camera 34 is capable of providing an image of the radioactive concentrations near the surface of the surgical field...” )
Regarding claim 8 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1. Daghighian also teaches: wherein the positron emission data indicates preferential uptake of the radiotracer in tissues within the region-of-interest. (See at least (0127] via: " ... the imaging of metabolic function, as indicated by increased radiotracer uptake ... ")
Regarding claim 11 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1. Daghighian also teaches:
wherein the report comprises a tumor margin map depicting a spatial distribution of the tumor margin as determined from the positron emission data. (See at least [0057] via: " ... finding postoperative, cancer-positive margins ... ) in addition see at least [0093] via: "Counts, updated each second, are then passed through a data processor 32 where they are electronically processed and .displayed on a visual screen or monitor 42 so that the surgeon can identify, isolate and remove the labeled cells.")
Regarding claim 13 Daghighian and Degrado teach the invention as detailed above with respect to claim 1. Daghighian also teaches:
wherein the report is generated in real-time as the positron emission data are being acquired from the region-of-interest. (See at least [0095] via: "The beta camera 34 described herein which can be hand held or built into a probe or catheter provides real time imaging of positron emissions.")
Regarding claim 14 Daghighian teaches:
A method of breast tumor margin assessment (See at least [0057] via: " ... finding postoperative, cancer-positive margins, provides meaningful reduction in the re-operative rate for breast cancer patients ... "),, the method comprising the steps of:
receiving positron emission data with a computer system, wherein the positron emission data comprise measurements of positron emissions from breast tissues in a region-of- interest that have taken up a previously administered radiotracer containing a (zinc) radioisotope; (See at least [0057] via: "Positrons emitted from 18F in FDG [fluorodeoxyglucose] can guide the beta probe to detect these residual tumor cells...") (Fig 3, element 32; See at least [0071] via: "Software provided in a data processing unit 32 generates uniformity look-up tables and other corrections necessary to enable the data generated by the camera 34 ... "), (See at least [0124] via: " ... the intravascular probe 230 or other one dimensional beta cameras built with SSPMs [solid state photomultipliers] as described above can be used for intra-ductal detection of cancer in the breast ... ") (See at least [0124] via: " ... injecting the patient with F-18 FDG [F-18 labeled fluorodeoxyglucose], or any other beta emitting radiotracers used for cancer detection·.");
generating from the positron emission data, using the computing system, a tumor margin map that depicts a spatial distribution of the positron emissions in the region-of- interest; (See at least [0057] via: " ... finding postoperative, 1 cancer-positive margin's ... ) (Fig 3, elements 32, 36; See at least [0071], " ... the signal processing electronics 32 and a display screen 36 to provide a visual display of the beta counts detected..."); and
displaying the tumor margin map with the computer system (See at least [0093], "..Counts, updated each second, are then passed through a data processor 32 where they are electronically processed and displayed on a visual screen or monitor 42 so that the surgeon can identify, isolate and remove the labeled cells...").
However, Daghighian does not explicitly teach that the radioisotope is a radioisotope of zinc as taught by Degrado:
administering a radiotracer containing a radioisotope of zinc to a patient (See at least [0013] via: " ... a method for detecting or ruling out cancer in a patient... The medical imaging technique can be positron emission tomography.."; in addition see at least [0008] via: " ... radiolabeled 63 Zn zinc, as a PET imaging biomarker of ... cancer.,"
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Daghighian to incorporate the teachings of Degrado. Those in the art would have recognized that Daghighian’s teaching regarding any other beta emitting radio-tracers used for cancer detection (paragraph [0124], does not explicitly teach that the radioisotope is a radioisotope of zinc as taught by Degrado It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to use a radioisotope of zinc as the radioisotope in·the method of Daghighian, as taught by Degrado, to improve reliability of the biomarker while being noninvasive (see Degrado at paragraph [0008], " ... overcomes the aforementioned drawbacks by providing reliable noninvasive markers ... ")
However, Daghighian and Degrado do not teach the following limitation as taught by Liu:
a spatial distribution of the positron emissions in the region-of- interest overlayed on medical images acquired from the region-of-interest, wherein the tumor margin map includes at least one of: (See at least [Page 3, Fig. 2] via: " ...Schematic diagram of the proposed PET/CT data visualization method. It consists of three main modules: colorization, fusion and blending. The PET image is firstly colorized. The CT and the PET images are then fused in grayscale. Finally, the visualization result is obtained by blending the fused image and the colorized PET image...”)
(1) different colors, shadings, or pattern for each of a healthy tissue and a cancerous tissue in the tumor margin, (See at least [Page 3, Fig. 2] via: " ...Schematic diagram of the proposed PET/CT data visualization method. It consists of three main modules: colorization, fusion and blending. The PET image is firstly colorized. The CT and the PET images are then fused in grayscale. Finally, the visualization result is obtained by blending the fused image and the colorized PET image...”; in addition see at least [Page 9, Fig. 12] via: " ... Visualization results of different methods on a pair of PET and CT brain images that contain a metastatic brain tumor from lung cancer. The first and second images shows the input CT and PET images, respectively. The third, fourth and fifth images shows the results obtained by the ClearCanvas, CT-underlay and proposed methods, respectively. A close-up focusing on the tumor is provided for better comparison ..”; in addition see at least [Page 6, paragraph 1 ] via: " results of the method using the presented PET colorization approach but with the CT image as underlay (denoted as CT-underlay)....”)
(2) a heat map indicating the positron emission data in the determined tumor margin, or
(3) position data measured by one or more position trackers on the positron detection probe
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Daghighian and Degrado to incorporate the teachings of Liu. Those in the art would have recognized that Daghighian’s teaching regarding any other beta emitting radio-tracers used for cancer detection (paragraph [0124], does not explicitly teach the proposed PET/CT data visualization method consisting of colorization, fusion and blending as taught by Liu It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to use a PET/CT data visualization method consisting of colorization, fusion and blending in the method of Daghighian, as taught by Liu, to improve visualization of tumors.
Regarding claim 15 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 14. Daghighian also teaches:
wherein the positron emission data are received by the computer system from a positron detection probe. (Fig 3, elements 18, 20, 22, 32; See at least [0093] via: " ... the dual detector beta probe 18 comprises two detectors, a first detector 20 that detects (counts) both positrons and gamma rays and a second detector 22 that detects (counts) only gamma rays. These counts are then transmitted to first and second SSPMs 12 ... the counts of the second detector 22 are subtracted from the counts from the first detector 20 so that only the counts generated by the positrons remain. Because positrons can travel only a couple of millimeters, this corrected count is an indication of local concentration of FDG. Counts, updated each second, are then passed through a data processor 32 where they are electronically processed ... ").
Regarding claim 16 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 14. Daghighian also teaches:
wherein the tumor margin is determined based on a preferential uptake of the radiotracer by tissues in the region-of-interest. (See at least [0127] via: " ... the imaging of metabolic function, as indicated by increased radiotracer uptake ... ")
Regarding claim 18 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 14. Daghighian also teaches:
wherein the positron emission data comprise measurements of radioisotope activity concentration. (See at least [0095] via: "The beta camera 34 described herein which can be hand held or built into a probe or catheter provides real time imaging of positron emissions. This beta camera 34 is capable of providing an image of the radioactive concentrations near the surface of the surgical field... ")
Claims 9-10, 17 are rejected under 35 U.S.C. 103 as being un-patentable by Daghighian, in view of Degrado, in view of Liu, in further in view of Richter et.al (US 2020/0245960 A1) hereinafter “Richter”.
Regarding claim 9 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1&8. Daghighian, Degrado and Liu are silent the following claim that is taught by Richter:
wherein determining the tumor margin comprises differentiating healthy tissue from tumor tissue by analyzing the positron emission data relative to a threshold level of radiotracer uptake. (See at least [0002] via: " ... automated identification of one or more particular regions of interest (e.g., corresponding to specific organs or tissue) within images of a subject..."; in addition see at least [0223] via: "Since intensities of functional images, such as PET (positron emission tomography] ... images map spatial distribution of radiopharmaceutical accumulation in a patient's body, by accurately identifying specific 3D volumes in functional images that correspond to specific tissue regions intensities of voxels within those 3D volumes can be used determine a measure of uptake of radiopharmaceulical probes within the specific tissue regions to which they correspond. Since radiopharmaceutical probes can be designed to selectively accumulate in cancerous tissue (e.g., via enhanced affinity to biomolecules that are overexpressed in cancerous tissue ... ")
It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to modify the method of Daghighian in view of Degrado in view of Liu so that determining the tumor margin comprises differentiating healthy tissue from tumor tissue by analyzing the positron emission data relative to a threshold level of radiotracer uptake, as taught by Richter, in order to improve efficiency and accuracy of automated tissue identification (see Richter at para [0010] via: " ... an image analysis system to consistently, efficiently, and accurately detect anatomical 'regions, including soft tissue organs ... ").
Regarding claim 10 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1&8&9. Daghighian, Degrado and Liu are silent the following claim that is taught by Richter:
wherein tissues having positron emissions above the threshold level are determined as part of the tumor margin. (See at least [0238] via: " ... quantifying overall uptake in a particular volume within the functional image, localized hotspots (localized regions of relatively high intensity) are detected ...hotspots are detected, via a thresholding approach-by comparing intensities of voxels within the functional image to one or more thresholds values. Groupings of voxels with intensities above a threshold may be detected as hotspots.")
It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to modify the method of Daghighian in view of Degrado in view of Liu so that determining the tumor margin comprises differentiating healthy tissue from tumor tissue by analyzing the positron emission data relative to a threshold level of radiotracer uptake, as taught by Richter, in order to improve efficiency and accuracy of automated tissue identification (see Richter at para [0010] via: " ... an image analysis system to consistently, efficiently, and accurately detect anatomical 'regions, including soft tissue organs ... ")
Regarding claim 17 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 14&16. Daghighian, Degrado and Liu are silent the following claim that is taught by Richter:
wherein the tumor margin is determined based on comparing the measurement of positron emissions in the positron emission data with a threshold indicating the preferential uptake of the radiotracer. (See at least [0002] via: " ...automated identification of one or more particular regions of interest (e.g., corresponding to specific organs or tissue) within images of a subject..."; in addition See at least [0223] via: "Since intensities of functional images, such as PET [positron emission tomography] ... images map spatial distribution of radiopharmaceutical accumulation in a patient's body, by accurately identifying specific 3D volumes in functional images that correspond to specific tissue regions intensities of voxels within those 3D volumes can be used determine a measure of uptake of radiopharmaceutical probes within the specific tissue regions to which they correspond. Since radiopharmaceutical probes can be designed to selectively accumulate in cancerous tissue (e.g., via enhanced affinity to biomolecules that are overexpressed in cancerous tissue ... ")
It would have been obvious to a person having ordinary skill in the art, at the time of invention, to modify the method of DAGHIGHIAN in view of DEGRADO in view of Liu so that the tumor margin is determined based on comparing the measurement of positron emissions in the positron emission data ·with a threshold indicating the preferential uptake of the radiotracer, as taught by Richter, in order to improve efficiency and accuracy of automated tissue identification (see Richter See at least [0010]," ... an image analysis system to consistently, efficiently, and accurately detect anatomical regions, including soft tissue organs ... ").
Claim 12 is rejected under 35 U.S.C. 103 as being un-patentable by Daghighian, in view of Degrado, in further in view of Boone et.al (US 20080187095 A 1) hereinafter “Boone”.
Regarding claim 12 Daghighian, Degrado and Liu teach the invention as detailed above with respect to claim 1&11. Daghighian, Degrado and Liu are silent the following claim that is taught by Boone:
wherein the tumor margin map includes pixels that are highlighted to represent tumor tissue in the determined tumor margin relative to healthy tissue not part of the tumor margin. (See at least [0004] via " ...imaging of a patient's breast, and more particularly to improved methods and apparatus for breast diagnosis, evaluation and therapy through CT imaging..."; in addition see at least [0197] via: " ... with suitable processing, a dual energy subtraction image can be produced which highlights the tumor and makes it more visible from the background breast tissues").
It would have been obvious to a person having ordinary skill in the art, at the lime of invention, to modify the method of Daghighian in view of Degrado in view of Liu so that the tumor margin map includes pixels that are highlighted to represent tumor tissue in the determined tumor margin relative to healthy tissue not part of the tumor margin, as taught by Boone, to improve surgical effectiveness as being the use of a known image enhancement step, in the same surgical procedure, to obtain a predictable result.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure, and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
FACCINI (US 20150359499 A1) - INTRAOPERATIVE DETECTION OF TUMOR RESIDUES USING BETA-RADIATION AND CORRESPONDING PROBES- teaches: he invention relates to the use of β.sup.− emitting radiolabeled tracers for administration to a patient prior to radio-guided surgery, and to the corresponding probes designed to intraoperatively detect β.sup.− decays from cancerous tissues so as to locate even small cancerous remnants still present after resection of the main cancerous lesions. The β.sup.− emitting radiolabeled tracer is labeled with a radioisotope undergoing exclusively β.sup.− decays or a radioisotope undergoing β.sup.− decays and having no more than 10-11% of γ rays decays. The corresponding probe has an extension direction along a longitudinal axis and has one or more blocks of scintillating material, each one having a main extension parallel to the longitudinal axis and transversal dimensions smaller than 3 mm, with each of the blocks being partially shielded by a material that is inactive with respect to β.sup.− radiation.
Response to Arguments
Applicant's arguments filed 3-2-2026, have been fully considered but they are found not
persuasive.
Applicant amended independent claims 1, 14, as posted in the above analysis with additions underlined and deletions as .
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 101.
Several steps are taken in the analysis as to whether an invention is rejected under 101. The first step is to determine if the claim falls within a statutory category. In this case it does for claims 1 and 14 since the claims recite a method of breast tumor margin assessment.
The second step under 2A prong one is to determine if the claims recite an abstract idea, which would be the case if the invention can be grouped as either: a) mathematical concepts; (b) mental processes; or (c) certain methods of organizing human activity (encompassing (i) fundamental economic principles, (ii) commercial or legal interactions or (iii) managing personal behavior or relationships or interactions between people). The current invention is classified as an abstract idea since it may be grouped as certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “breast tumor margin assessment”. Alternatively the current invention is classified as an abstract idea since it may be grouped as mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “breast tumor margin assessment”.
The third step under 2A Prong Two is to determine if additional elements in the claim imposes a meaningful limit on the abstract idea in order to integrate it into a practical idea. The current invention does not represent a practical idea since the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a generic computer as a tool to implement the abstract idea.
the fourth step under 2B is to determine if additional elements of the claim provide an inventive concept. An invention may be classified as an inventive concept if a computer-implemented processes is determined to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic, and non-conventional even if generic computer operations on a generic computing device is used to implement the abstract idea. The current invention does not represent an inventive concept since the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a generic computer as a tool to implement the abstract idea.
Step 2A Prong ONE
The Applicant argues that claims 1 & 14 are not directed to a judicial exception Under Step 2A, Prong One for the following reasons:
The claims do not attempt to claim a zinc radioisotope or any natural product. Rather, the zinc isotope is a tool used within a multi-step method directed to generating clinically actionable tumor-margin information. Therefore, the claims are not directed to a product of nature.
the claims are not directed to a mental process or method of organizing human activity since they cannot be performed in the human mind. Specifically: Acquiring positron-emission data requires a positron-detection probe, a specialized PET-derived device with sensors and electronics; Receiving positron-emission data requires a computer system to process electronic detector output; Determining a tumor margin from positron-emission data requires computational analysis; and Generating a report including overlays, heat maps, and position-tracker data necessarily requires image-processing hardware and software. Thus, the claims are not directed to an abstract idea
The Examiner agrees with the Applicant that the claims are not directed to a product of nature. Hence the 101 rejection based on claims being directed to a product of nature are withdrawn. Nevertheless the Examiner does not find the Applicants arguments to be persuasive related to claims not directed to a mental process or method of organizing human activity.
The method used to select the abstract idea, is to strip the additional elements from the claims. As seen below the recited boldened words constitute the abstract idea after stripping the un-boldened additional elements of amended limitation of claim 1:
Claim 1:
administering a radiotracer containing a radioisotope of zinc to a patient;
positioning a positron detection probe proximate a region-of-interest in a breast of the patient;
acquiring positron emission data from the region-of-interest using the positron detection probe;
receiving the positron emission data with a computer system;
determining, using the computer system, a tumor margin in the region-of-interest from the positron emission data; and
generating a report indicating the determined tumor margin using the computer system;
wherein the report includes an overlay of the positron emission data on medical images acquired from the region-of-interest and at least one of
(1) different colors, shadings, or pattern for each of a healthy tissue and a cancerous tissue in the tumor margin,
(2) a heat map indicating the positron emission data in the determined tumor margin, or
(3) position data measured by one or more position trackers on the positron detection probe
Claim 14:
receiving positron emission data with a computer system, wherein the positron emission data comprise measurements of positron emissions from breast tissues in a region-of- interest that have taken up a previously administered radiotracer containing a zinc radioisotope;
generating from the positron emission data, using the computing system, a tumor margin map that depicts a spatial distribution of the positron emissions in the region-of- interest overlayed on medical images acquired from the region-of-interest, wherein the tumor margin map includes at least one of
(1) different colors, shadings, or pattern for each of a healthy tissue and a cancerous tissue in the tumor margin,
(2) a heat map indicating the positron emission data in the determined tumor margin, or
(3) position data measured by one or more position trackers on a positron detection probe used to acquire the positron emission data;and
displaying the tumor margin map with the computer system.
The selected abstract idea (boldened limitations) of claims 1 & 14 belong to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “breast tumor margin assessment”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
Step 2A Prong TWO
The Applicant argues that even is claims 1 &14 recited an abstract idea the claims integrate any such exception into a practical application since the claims recite specific, technical application steps that transform any alleged exception into a practical real-world medical technique, such as administering a zinc radiotracer to a patient, acquiring in vivo positron-emission data using a physical detection probe, generating a tumor-margin map overlaid on medical images, generating overlays using distinctive colors, shading patterns, heat maps, or position-tracker data. These limitations directly improve intraoperative breast-cancer margin assessment, providing a real-world diagnostic and surgical-guidance improvement. Furthermore the amended independent claims 1 and 14 explicitly recite overlays of positron-emission data on medical images, and enhanced visualization features (colors/patterns distinguishing healthy vs. cancerous tissue, heat maps, and probe-position data). These amendments explicitly tie the claims to technical imaging improvements. Thus, the § 101 rejection is moot and should be withdrawn
The Examiner disagrees with the Applicant since the arguments provided are not persuasive. What is required for the invention to be directed to a practical application is a demonstration of improvement to the functioning of a computer, or to any other technology or technical field that the invention has recited. The Applicant’s arguments relate to a colloquial interpretation of a practical idea which is not equivalent to the definition of practical idea under 101.
The Examiner restates that claims 1 & 14 do not integrate the abstract idea into a practical application. Claims 1 & 14 do not recite additional elements that impose a meaningful limit on the abstract idea:
Claim 1 recites the following additional elements:
positioning a positron detection probe proximate a region-of-interest in a breast of the patient;
using the positron detection probe;
using the computer system.
Claim 14 recites the following additional elements:
computing system;
The elements as recited above for claims 1 & 14 amount to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
In order to integrate the abstract idea into a practical idea the Applicant could demonstrate at least one of the conditions enumerated below applies:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
The Applicant has not demonstrated any of the above listed conditions. As a result, the Examiner restates the rejection of the invention under 35 USC §101.
Step 2B
Similar to the analysis under Step 2A Prong Two, the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). The use of generic computer components, in combination, do not perform functions that are not merely generic, and non-conventional even if the generic computer operations on a generic computing device is used to implement the abstract idea. Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
In order evaluate whether the claim recites additional elements that amount to an inventive concept what could be shown is:
Adding a specific limitation (unconventional other than what is well-understood, routine, conventional (WURC) activity in the field - see MPEP 2106.05(d)
The Applicant has not demonstrated the above listed condition.
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 103.
The applicant's arguments with respect to claims 1 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
For reasons of record and as set forth above, the examiner maintains the rejection of claims 1-20 as being directed to a judicial exception without significantly more, and thereby being directed to non-statutory subject matter under 35 USC §101 in addition to maintaining the rejection under 35 USC §103 of claims 1-20. In reaching this decision, the Examiner considered all evidence presented and all arguments actually made by Applicant.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE L MACCAGNO whose telephone number is (571)270-5408. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PIERRE L MACCAGNO/Examiner, Art Unit 3687
/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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