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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/08/2026 has been entered.
Response to Amendment
The amendment of 09/08/2026 has been entered and fully considered by the examiner. No claim has been amended. Claims 1-32 are currently pending with claims 1 being the independent claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-9, are rejected under 35 U.S.C. 103 as being unpatentable over Villongco et al. (U.S. Publication No. 2023/0038493) hereinafter “Villongco” in view of Burchert et al. (“Oxygen-15-water PET assessment of muscular blood flow in peripheral vascular disease, J. Nuc. Med, 1997) hereinafter “Burchert”.
Regarding claim 1, Villongco discloses a method for quantifying skeletal muscle perfusion in a tissue of a subject [see abstract of Villongco and [0021] disclosing monitoring skeletal muscle activity through monitoring its perfusion using PET imaging], comprising:
administering to the subject [see [0028] disclosing injection of a radioactive dye into the blood stream] an effective amount of a fluorine-18-labeled radionuclide agent; [see [0028] disclosing that the dye can be FDG which is a Fluorine 18 labeled radionuclide agent]
dynamically imaging the subject on a positron emission tomography (PET) system [see [0028] and FIG. 1]; and
performing modeling of the PET imaging data following steps (i) and (ii). [see [0028]; a 3D modeling is performed after imaging]
Villongco does not expressly disclose quantifying absolute measures of skeletal muscle perfusion in the tissue; wherein the kinetic modeling is one-tissue compartment kinetic modeling; wherein step (ii) is performed for a period of time ranging from at least 2 to 10 minutes.
Burchert, directed towards kinetic modeling of muscle tissue using PET imaging [see abstract of Burchert] further discloses quantifying absolute measures of skeletal muscle perfusion in the tissue; wherein the kinetic modeling is one-tissue compartment kinetic modeling; [see abstract disclosing that the modeling is done using one compartment tissue modeling] wherein step (ii) is performed for a period of time ranging from at least 2 to 10 minutes. [see page 94, left column, section under “Data acquisition” disclosing the time duration of the image acquisition to 5 minutes which is in the claimed range]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco further such quantifying absolute measures of skeletal muscle perfusion in the tissue; wherein the kinetic modeling is one-tissue compartment kinetic modeling; wherein step (ii) is performed for a period of time ranging from at least 2 to 10 minutes according to the teachings of Burchert in order to visualize and determine properties of blood flow in peripheral skeletal muscles. [see page 93, right column, first 2 paragraphs of Burcher]
Regarding claim 2, Villongco in view of Burchert discloses all the limitations of claim 1 [see rejection of claim 1 above]
Burchert further discloses that wherein step (ii) is performed for a period of time ranging from about 2 to about 10 minutes. [see page 94, left column, section under “Data acquisition” disclosing the time duration of the image acquisition to 5 minutes which is in the claimed range]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco further such that the step (ii) is performed for a period of time ranging from at least 2 to 5 minutes according to the teachings of Burchert in order to visualize and determine properties of blood flow in peripheral skeletal muscles. [see page 93, right column, first 2 paragraphs of Burcher]
Regarding claim 3, Villongco in view of Bertoldo discloses all the limitations of claim 1 [see rejection of claim 1 above]
Burchert further discloses that wherein step (ii) begins 1 to 5 seconds prior to step (i). [see page 94, left column, section under Data acquisition disclosing the time for injection before imaging is 7 minutes]
Villongco in view of Burchert does not expressly discloses that wherein step (ii) begins 1-5 seconds prior to step (i). However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the range of timing for the period of imaging of step (ii) since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 4, Villongco further discloses wherein the fluorine-18 labeled radionuclide is 18F-sodium fluoride (NaF) and/or 18F-2-deoxy-2-fluoro-D-glucose (FDG). [see [0028] disclosing that the dye can be FDG
Regarding claim 6, Villongco further discloses that the tissue is a muscle or group of muscles of the subject. [see [0021] disclosing that the issue could be a heart which comprise of a group of muscles or a skeletal muscle which is a single muscle]
Regarding claim 7, Villongco further discloses that step (i) comprises administering the fluorine-18-labeled radionuclide agent via intra-venous or intra-arterial injection or infusion. [see [0028]; the administration of the FDG is via injection to the bloodstream which is either the veins or arteries]
Regarding claim 8, Villongco further discloses that the positron emission tomography (PET) system is a PET/computed tomography (PET/CT) [see [0028] and [0030
Disclosing both PET and CT imaging] or PET/magnetic resonance (PET/MR) system. [see [0028] and [0033]; the system includes both a PET and MRI imaging modalities]
Regarding claim 9, Villongco further discloses that subsequent to step (ii), (iv) generating at least one pixelwise perfusion map of the tissue, by parametric mapping. [see FIG. 3 and [0028]; image of the perfusion of the heart is shown; it is inherent that an image generated by the computer would be made of pixels and therefore, it would be a pixelwise perfusion map; since the image 3 show the perfusion as its parameter, it is considered parametric mapping]
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Villongco et al. (U.S. Publication No. 2023/0038493) hereinafter “Villongco” in view of Burchert et al. (“Oxygen-15-water PET assessment of muscular blood flow in peripheral vascular disease, J. Nuc. Med, 1997) hereinafter “Burchert” as applied to claim 1 above and further in view of Kesner et al. (“Optimal dose for whole-body 18F-Fluorodeoxyglucose PET/CT”, JACR, 2014) hereinafter “Kesner”.
Regarding claim 5, Villongco in view of Burchert discloses all the limitations of claim 1 [see rejection of claim 1 above]
Villongco in view of Burchert does not expressly disclose wherein in step (i), the effective amount of the fluorine-18 labeled radionuclide provides a dose in a range of 1 mCi to 10 mCi during at least the first 20 seconds of step (i).
Kesner, directed towards body dual modality scanning using FDG tracer [see abstract of Kesner] further discloses wherein in step (i), the effective amount of the fluorine-18 labeled radionuclide provides a dose in a range of about 1 mCi to about 10 mCi during at least the first 20 seconds of step (i). [see page 920, left column, second pargarph in section “answer” discsloes the dose to be b etween 4 to 20 mCi during the entire injection which includes the first 20 seconds]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco as modified by Burchert further such that in step (i), the effective amount of the fluorine-18 labeled radionuclide provides a dose in a range of about 1 mCi to about 10 mCi during at least the first 20 seconds of step (i) according to the teachings of Kesner in order to [see page 920, left column, second paragraph]
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Villongco et al. (U.S. Publication No. 2023/0038493) hereinafter “Villongco” in view of Burchert et al. (“Oxygen-15-water PET assessment of muscular blood flow in peripheral vascular disease, J. Nuc. Med, 1997) hereinafter “Burchert” as applied to claim 1 above and further in view of Velt-Haibach et al. (“CT perfusion in peripheral arterial disease-hemodynamic differences before and after revascularization”, Eur. Radiol. 2021) hereinafter “Velt-Haibach”.
Regarding claim 10, Villongco in view of Burchert discloses all the limitations of claim 1 [see rejection of claim 1 above]
Villongco in view of Burchert does not expressly disclose that the patient has a disease selected from the group consisting of a neuromuscular disease, an ischemic disease, and a degenerative muscle disease.
Velt-Haibach directed towards monitoring perfusion in peripheral arterial disease [see abstract of Velt-Haibach] further discloses that the patient has a disease selected from the group consisting of a neuromuscular disease, an ischemic disease, and a degenerative muscle disease. [the patients have peripheral artery disease (PAD) disease which is an ischemic disease; see page 5508, right column, section under “Materials and Methods”]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco as modified by Buchert further such that the patient has a disease selected from the group consisting of a neuromuscular disease, an ischemic disease, and a degenerative muscle disease according to the teachings of Velt-Haibach in order to characterize the potential role of the non-invasive CT perfusion imaging for quantitative in vivo assessment of limb ischemia disease [see page 5508, right column, second paragraph]
Regarding claim 11, Villongco in view of Burchet and Velt-Haibach discloses all the limitations of claim 1 [see rejection of claim 1 above]
Velt-Haibach further discloses that ischemic disease is selected from the group consisting of peripheral artery disease (PAD), [the patients have peripheral artery disease (PAD) disease which is an ischemic disease; see page 5508, right column, section under “Materials and Methods”] Charcot-Marie-Tooth syndrome (CMT), exertional compartment syndrome, ischemic myopathy, ischemic rhabdomyolysis, chronic limb-threatening ischemia (CLTI), ischemic necrosis, ischemic fasciitis, and ischemic myositis, or a combination thereof.
Regarding claim 12, Villongco in view of Burchert discloses all the limitations of claim 1 [see rejection of claim 1 above]
Villongco in view of Bertoldo does not expressly disclose that the method is performed on the subject prior to and following a surgical or endovascular revascularization procedure.
Velt-Haibach further discloses that the method is performed on the subject prior to and following a surgical or endovascular revascularization procedure. [see page 5508-5509; section under “Hemodynamic assessment”]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco as modified by Burchert further such that the method is performed on the subject prior to and following a surgical or endovascular revascularization procedure according to the teachings of Velt-Haibach in order to characterize the potential role of the non-invasive CT perfusion imaging for quantitative in vivo assessment of limb ischemia [see page 5508, right column, second paragraph]
Regarding claim 13, Villongco in view of Burchert discloses all the limitations of claim 1 [see rejection of claim 1 above]
Villongco in view of Burchert does not expressly disclose that the method is performed on the subject prior to and following a regenerative medicine therapy.
Velt-Haibach further discloses that the method is performed on the subject prior to and following a regenerative medicine therapy. [see page 5508-5509; section under “Hemodynamic assessment”]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco as modified by Burchert further such that the method is performed on the subject prior to and following a regenerative medicine therapy according to the teachings of Velt-Haibach in order to characterize the potential role of the non-invasive CT perfusion imaging for quantitative in vivo assessment of limb ischemia [see page 5508, right column, second paragraph]
Claims 24-25, and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Villongco et al. (U.S. Publication No. 2023/0038493) hereinafter “Villongco” in view of Burchert et al. (“Oxygen-15-water PET assessment of muscular blood flow in peripheral vascular disease, J. Nuc. Med, 1997) hereinafter “Burchert” as applied to claim 1 above and further in view of Parghane et al. (“Dual-time point 18F-FDG-PET and PET/CT for differentiating benign from malignant musculoskeletal lesions: opportunities and limitations”., Nuc. Med. 2017) hereinafter “Parghane”.
Regarding claim 24, Villongco in view of Burchert discloses all the limitations of claim 1 [see rejection of claim 1 above]
Villongco in view of Burchert further disclose that the fluorine-18labeled radionuclide is 18F- sodium fluoride (NaF),
Villongco in view of Burchert does not disclose and wherein the method further comprises:(v) following step (ii), imaging the subject a second time using the PET system, wherein a second dose of the fluorine-18labeled radionuclide or another fluorine 18-labeled radionuclide agent is not administered to the subject between steps (ii) and (v), and(vi) following step (v), quantifying active vascular calcification in the subject's blood vessel.
Parghane, directed towards dual time point radiotracer imaging [see abstract of Parghane] further discloses that (c) following step (b), imaging the subject a second time using the positron emission tomography (PET) system, wherein a second dose of fluorine-18-labeled sodium fluoride or another fluorine-18-labeled radionuclide agent is not administered to the subject between step (ii) and (v). [see pager 380; section under dual-time poing FDG imaging continued in right column and FIGs. 1-5]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco further such that it includes (c) following step (b), imaging the subject a second time using the positron emission tomography (PET) system, wherein a second dose of fluorine-18-labeled sodium fluoride or another fluorine-18-labeled radionuclide agent is not administered to the subject between step (b) and (c) according to the teachings of Parghane in order to decrease background activity with the delayed image and provide better image quality and better lesion to background distinction images [see page 380; right column, section under “potentials of DTP FDG”]
Regarding claim 25, Villongco in view of Burchert and Parghane discloses all the limitations of claim 24 [see rejection of claim 24 above]
Parghane further discloses that the imaging in step (v) is performed at least 45 minutes to 75 minutes following step (i). [see page 381; caption under FIG. 1 showing a wait time of 60 minutes before taking the image (step b)]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco further such that step (v) is performed at least 45 minutes to 75 minutes following step (i) according to the teachings of Parghane in order to decrease background activity with the delayed image and provide better image quality and better lesion to background distinction images [see page 380; right column, section under “potentials of DTP FDG”]
Regarding claim 27, Villongco further disclose that step (i) comprises administering the fluorine-18- labeled sodium fluoride via intra-venous or intra-arterial injection or infusion. [see [0028]; the administration of the FDG is via injection to the bloodstream which is either the veins or arteries]
Regarding claim 28, Villongco further disclose that the positron emission tomography (PET) system is a PET/computed tomography (PET/CT) or PET/magnetic resonance (PET/MR) system. [see abstract of Villongco and [0021] disclosing monitoring skeletal muscle activity through monitoring its perfusion using PET imaging],
Regarding claim 29, Villongco further disclose that the fluorine-18labeled radionuclide is fluorine- 18-labeled glucose or an analog thereof selected from the group consisting of 18F-2-deoxy-2-NWCH 2022-040-02 USfluoro-D-glucose (FDG), 18F-FDGal (fluorodeoxygalactose), 18F-FDMan (fluorodeoxymannose), 18F-FET (fluoroethyltyrosine), and 18F-FDOPA (fluorodihydroxyphenylalanine). [see [0028] disclosing that the dye can be FDG which is a Fluorine 18 labeled radionuclide agent]
Regarding claim 30, Villongco further disclose that the fluorine-18labeled radionuclide is fluorine-18- labeled glucose or an analog thereof, [see [0028] disclosing that the dye can be FDG which is a Fluorine 18 labeled radionuclide agent]
Villongco in view of Burchert does not disclose and wherein the method further comprises:(v) following step (ii), imaging the subject a second time using the PET system, wherein a second dose of the fluorine-18labeled radionuclide or another fluorine 18-labeled radionuclide agent is not administered to the subject between steps (ii) and (v), and(vi) following step (v), quantifying active vascular calcification in the subject's blood vessel.
Parghane, directed towards dual time point radiotracer imaging [see abstract of Parghane] further discloses that (c) following step (b), imaging the subject a second time using the positron emission tomography (PET) system, wherein a second dose of fluorine-18-labeled sodium fluoride or another fluorine-18-labeled radionuclide agent is not administered to the subject between step (ii) and (v). [see pager 380; section under dual-time poing FDG imaging continued in right column and FIGs. 1-5]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco further such that it includes (c) following step (b), imaging the subject a second time using the positron emission tomography (PET) system, wherein a second dose of fluorine-18-labeled sodium fluoride or another fluorine-18-labeled radionuclide agent is not administered to the subject between step (b) and (c) according to the teachings of Parghane in order to decrease background activity with the delayed image and provide better image quality and better lesion to background distinction images [see page 380; right column, section under “potentials of DTP FDG”]
Regarding claim 31, the imaging in step (v) is performed for at least 5 minutes to 60 minutes following step (i). [see page 381; caption under FIG. 1 showing a wait time of 60 minutes before taking the image (step b)]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco further such that step (v) is performed at least 5 minutes to 60 minutes following step (i) according to the teachings of Parghane in order to decrease background activity with the delayed image and provide better image quality and better lesion to background distinction images [see page 380; right column, section under “potentials of DTP FDG”]
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Villongco et al. (U.S. Publication No. 2023/0038493) hereinafter “Villongco” in view of Burchert et al. (“Oxygen-15-water PET assessment of muscular blood flow in peripheral vascular disease, J. Nuc. Med, 1997) hereinafter “Burchert” Parghane et al. (“Dual-time point 18F-FDG-PET and PET/CT for differentiating benign from malignant musculoskeletal lesions: opportunities and limitations”., Nuc. Med. 2017) hereinafter “Parghane” as applied to claim 24 above and further in view of Kesner et al. (“Optimal dose for whole-body 18F-Fluorodeoxyglucose PET/CT”, JACR, 2014) hereinafter “Kesner”.
Regarding claim 26, Villongco in view of Burchert and Parghane discloses all the limitations of claim 24 [see rejection of claim 24 above]
Villongco in view of Burchert and Parghane does not expressly disclose wherein in step (i), the effective amount of the fluorine-18 labeled radionuclide provides a dose in a range of 1 mCi to 10 mCi during at least the first 20 seconds of step (i).
Kesner, directed towards body dual modality scanning using FDG tracer [see abstract of Kesner] further discloses wherein in step (i), the effective amount of the fluorine-18 labeled radionuclide provides a dose in a range of about 1 mCi to about 10 mCi during at least the first 20 seconds of step (i). [see page 920, left column, second pargarph in section “answer” discsloes the dose to be b etween 4 to 20 mCi during the entire injection which includes the first 20 seconds]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco as modified by Burchert and Parghane further such that in step (i), the effective amount of the fluorine-18 labeled radionuclide provides a dose in a range of about 1 mCi to about 10 mCi during at least the first 20 seconds of step (i) according to the teachings of Kesner in order to [see page 920, left column, second paragraph]
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Villongco et al. (U.S. Publication No. 2023/0038493) hereinafter “Villongco” in view of Burchert et al. (“Oxygen-15-water PET assessment of muscular blood flow in peripheral vascular disease, J. Nuc. Med, 1997) hereinafter “Burchert” Parghane et al. (“Dual-time point 18F-FDG-PET and PET/CT for differentiating benign from malignant musculoskeletal lesions: opportunities and limitations”., Nuc. Med. 2017) hereinafter “Parghane” as applied to claim 24 above and further in view of Bertoldo et al. (“Kinetic modeling of [18F] FDG in skeletal muscle by PET: a four compartment five rate constant model”) hereinafter “Bertoldo”.
Regarding claim 32, Villongco in view of Burchert and Parghane discloses all the limitations of claim 24 [see rejection of claim 24 above]
Villongco in view of Burchert and Parghane does not expressly disclose step (iv) is performed by three-tissue compartment kinetic modeling of the imaging data following step (v).
Bertoldo further disclose that the kinetic modeling is one-tissue compartment or three-tissue compartment kinetic modeling. [see page 526, right column, the two last paragraphs and FIG. 2 disclosing 3-tissue compartments]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the method of Villongco further such that the kinetic modeling is one-tissue compartment or three-tissue compartment kinetic modeling according to the teachings of Bertoldo in order to provide insight into the system structure and function [see page 526, left column, second paragraph]
Response to Arguments
Applicant's arguments filed 09/08/2026 have been fully considered but they are not persuasive.
With regards to the fluorine base FDG tracer which is used in the primary reference Villongco, the applicant has argued that Villongco uses the FDG tracer to detect the metabolism changes and not the perfusion, and therefore, does not read on the language of the claim.
In response, the examiner respectfully notes that the claims merely requiring “administering to the subject an effective amount of a fluorine 18-labeled radionuclide agent”. There is no limitation in the claim that requires that the quantification of the absolute measure of skeletal muscles be due to the monitoring of the same tracer. The claim does not exclude the use of other tracers in the perfusion detection either. Therefore, Villongco reads on the language of the claim since the teaching of administering the FDG tracer as well as quantifying perfusion both are taught in Villongco. The applicant is advised to use more specific language that would tie the tracer which is used for quantification of absolute perfusion to the FDG tracer.
The applicant has further argued that there is no reason for combining the teachings of Villongco with the one compartment kinetic modeling of Burchert.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation is to apply a known method of once compartment kinetic modeling of Burchert to a method of perfusion detection of Villongco which is directed towards the same goal of perfusion study using dynamic PET imaging which is ready for improvement (KSR Rationale B).
The applicant has further argued that there is no reason for an ordinarily skilled in the art to look for the teachings of Burchert since Burchert is related to O-Water based PET assessment and not FDG based megaloblastic study of Villongco.
In response, the examiner notes that the applicant neglects to note that many of the features that form the bases of applicant’s arguments are NOT reflected in the claim language. In particular, the claim does NOT require that the quantification of the perfusion is based on the uptake of FDG or any fluorine labeled agent. It merely requires that the method would include injection of a fluorine labeled agent (which Villongco reference does). The applicant is advised to use more specific language regarding in the claim to overcome the prior art of record.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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