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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 11, the limitation “a region of interest corresponding to radiation effects” renders the claim indefinite because it is unclear whether this is part of or separate from the at least one region of interest recited in claim 1. The at least one region of interest recited in claim 1 is recited as also corresponding to radiation effects. Further clarification is required.
Regarding claim 13, the limitation “a region of interest corresponding to tumor progession” renders the claim indefinite because it is unclear whether this is part of or separate from the at least one region of interest recited in claim 1. The at least one region of interest recited in claim 1 is recited as also corresponding to tumor progression. Further clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 7, 11-14, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kondziolka et al. (US 2017/0216624, August 3, 2017).
Regarding claims 1 and 14, Kondziolka discloses a method (and corresponding system) (“Methods, systems, and apparatuses are disclosed for radiation treatment of tumors based at least in part on patient-specific imaging information. The methods, systems and apparatuses include computer programs encoded on computer-readable media.” Abstract), comprising:
receiving, by at least one processor (processing arrangement 310 in Fig. 4 and corresponding description), a magnetic resonance dataset comprising at least one scan (“imaging data is obtained before and after a surgical procedure, such as stereotactic radiosurgery (SRS). While stereotactic radiosurgery techniques such as GKRS can be generally effective for treating metastases (e.g., intracranial metastases), such techniques generally rely almost solely on post-contrast MRI” [0038]);
performing, by the at least one processor (processing arrangement 310 in Fig. 4 and corresponding description), golden-angle radial sparse parallel (GRASP) imaging on the magnetic resonance dataset to output one or more images (“golden-angle radial sparse parallel (GRASP) MRI can be used, for example, to provide high resolution imaging of tumors” [0038]); and
identifying, by the at least one processor (processing arrangement 310 in Fig. 4 and corresponding description), at least one region of interest in the one or more images (“The benefits of GRASP MRI have been experimentally confirmed via imaging performed on 32 patients collectively having 56 metastases. Imaging data was obtained from 20 of the patients collectively having 36 lesions, 66±20 days after stereotactic radiosurgery (here, GKRS). Lesions which were under 0.5 cm, lesions with hemorrhaging, or those with prior surgery or radiotherapy were excluded. Regions of interest were drawn in a solid enhancing tumor with image co-registration.” [0039]), the at least one region of interest corresponding to at least one of tumor progression or radiation effects (“Conventional imaging demonstrated a continued increase in the size of the heterogeneously enhancing metastatic lesion. In contrast, GRASP imaging showed an initial rightward shift of the enhancement time curve, which may reflect an increasing breakdown of the blood-brain barrier [radiation effects] following stereotactic radiosurgery. Subsequent GRASP assessment, however, demonstrated a leftward shift of this curve, as reflected in FIGS. 3C-3D in particular. This leftward shift of the curve likely reflects neoangiogenesis and is therefore suggestive of tumor recurrence [tumor progression]. A biopsy later confirmed the tumor recurrence indicated by the GRASP imaging.” [0042]). Regarding claim 14, in particular, Kondziolka also discloses a memory, with computer code instructions stored thereon, the computer code instructions, when executed by the at least one processor, cause the at least one processor to ([0044], [0045], [0050], and [0051]).
Regarding claim 2, Kondziolka further discloses further comprising extracting, by the at least one processor (processing arrangement 310 in Fig. 4 and corresponding description), one or more signal-time curves (“FIGS. 3A-3D depict experimental data immediately before stereotactic radiosurgery (in these experiments, GKRS), using permeability parameters derived from GRASP MRI. A 1.5×1.2 cm sized heterogeneously enhancing lesion was treated using stereotactic radiosurgery and imaged (FIG. 3A). The lesion was imaged subsequently at 83 days (FIG. 3B), 169 days (FIG. 3C), and 280 days (FIG. 3D) using GRASP. GRASP images were post processed using Olea Sphere software (Olea Medical, LaCiotat). An enhancement-time graph (based on region-of-interest, ROI) analysis of the solid component of the lesions was performed, before and after treatment.” [0041]; also see Figs. 3A-D and corresponding descriptions).
Regarding claims 7 and 18, Kondziolka further discloses further comprising differentiating, by the at least one processor, the at least one region of interest between tumor progression and radiation effects (“Conventional imaging demonstrated a continued increase in the size of the heterogeneously enhancing metastatic lesion. In contrast, GRASP imaging showed an initial rightward shift of the enhancement time curve, which may reflect an increasing breakdown of the blood-brain barrier [radiation effects] following stereotactic radiosurgery. Subsequent GRASP assessment, however, demonstrated a leftward shift of this curve, as reflected in FIGS. 3C-3D in particular. This leftward shift of the curve likely reflects neoangiogenesis and is therefore suggestive of tumor recurrence [tumor progression]. A biopsy later confirmed the tumor recurrence indicated by the GRASP imaging.” [0042]; also see “it is difficult to distinguish tumor recurrence from radiation-induced change utilizing imaging following stereotactic radiosurgery. At least one implementation allows for evaluation of metastases before and after stereotactic radiosurgery, to achieve higher temporal resolution and more complete coverage.” [0038]).
Regarding claims 11 and 19, Kondziolka further discloses wherein: the at least one region of interest corresponds to tumor progression; and the at least one region of interest corresponding to tumor progression has a faster wash-in than a region of interest corresponding to radiation effects (“Permeability parameters including wash-in, wash-out, peak and area under the curve (AUC) for contrast enhancement were compared with unpaired t-tests.” [0039]; also see “GRASP imaging showed an initial rightward shift of the enhancement time curve, which may reflect an increasing breakdown of the blood-brain barrier following stereotactic radiosurgery. Subsequent GRASP assessment, however, demonstrated a leftward shift of this curve, as reflected in FIGS. 3C-3D in particular. This leftward shift of the curve likely reflects neoangiogenesis and is therefore suggestive of tumor recurrence. A biopsy later confirmed the tumor recurrence indicated by the GRASP imaging.” [0042]).
Regarding claims 12 and 20, Kondziolka further discloses wherein the at least one region of interest corresponds to radiation effects, the radiation effects comprising radiation necrosis (“GRASP imaging showed an initial rightward shift of the enhancement time curve, which may reflect an increasing breakdown of the blood-brain barrier following stereotactic radiosurgery” [0042]; also see “it is difficult to distinguish tumor recurrence from radiation-induced change utilizing imaging following stereotactic radiosurgery. At least one implementation allows for evaluation of metastases before and after stereotactic radiosurgery, to achieve higher temporal resolution and more complete coverage.” [0038]).
Regarding claim 13, Kondziolka further discloses wherein: the at least one region of interest corresponds to radiation effects, the radiation effects comprising radiation necrosis; and the at least one region of interest corresponding to radiation necrosis has a slower wash-in than a region of interest corresponding to tumor progression (“it is difficult to distinguish tumor recurrence from radiation-induced change utilizing imaging following stereotactic radiosurgery. At least one implementation allows for evaluation of metastases before and after stereotactic radiosurgery, to achieve higher temporal resolution and more complete coverage.” [0038]; also see “Permeability parameters including wash-in, wash-out, peak and area under the curve (AUC) for contrast enhancement were compared with unpaired t-tests.” [0039]; also see “GRASP imaging showed an initial rightward shift of the enhancement time curve, which may reflect an increasing breakdown of the blood-brain barrier following stereotactic radiosurgery. Subsequent GRASP assessment, however, demonstrated a leftward shift of this curve, as reflected in FIGS. 3C-3D in particular. This leftward shift of the curve likely reflects neoangiogenesis and is therefore suggestive of tumor recurrence. A biopsy later confirmed the tumor recurrence indicated by the GRASP imaging.” [0042]).
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.
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 3-4 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kondziolka as applied to claim 1 above and further in view of Fatterpekar, G M et al., “Permeability Imaging of Parotid Tumors with Golden-Angle radial Sparse Parallel MR Imaging (GRASP),” Clinical Head and Neck Imaging (2016), 65: 44-45 (incorporated by reference in Kondziolka in [0038]).
Regarding claims 3 and 15, Kondziolka discloses the limitations of claims 1 and 14, respectively, as stated above. Kondziolka further discloses extracting, by the at least one processor (processing arrangement 310 in Fig. 4 and corresponding description), one or more signal-time curves (“FIGS. 3A-3D depict experimental data immediately before stereotactic radiosurgery (in these experiments, GKRS), using permeability parameters derived from GRASP MRI. A 1.5×1.2 cm sized heterogeneously enhancing lesion was treated using stereotactic radiosurgery and imaged (FIG. 3A). The lesion was imaged subsequently at 83 days (FIG. 3B), 169 days (FIG. 3C), and 280 days (FIG. 3D) using GRASP. GRASP images were post processed using Olea Sphere software (Olea Medical, LaCiotat). An enhancement-time graph (based on region-of-interest, ROI) analysis of the solid component of the lesions was performed, before and after treatment.” [0041]; also see Figs. 3A-D and corresponding descriptions).
Although Kondziolka suggests calculating, by the at least one processor, a slope of the one or more signal-time curves during wash-in (“Permeability parameters including wash-in, wash-out, peak and area under the curve (AUC) for contrast enhancement were compared with unpaired t-tests. Metastatic lesions showed a 41.3% reduction in AUC (P=0.055) and 51.1% reduction in wash-in kinetics (P<0.0001) following stereotactic radiosurgery. Melanoma metastases had 84.5% greater AUC (P=0.1248) and 28.1% shorter wash-in kinetics (P=0.2024) compared to lung metastases at baseline. After stereotactic radiosurgery, melanoma metastases demonstrated larger reductions in AUC (39.1% vs 20.1%, P=0.1881). Substantial reductions in AUC and wash-in were observed for intracranial metastases approximately 60 days following stereotactic radiosurgery.” [0039]), Kondziolka fails to disclose to explicitly disclose calculating, by the at least one processor, a slope of the one or more signal-time curves during wash-in.
However, Fatterpekar, which is incorporated by reference by Kondziola in [0038], teaches, in the same field of endeavor, calculating, by the at least one processor, a slope of the one or more signal-time curves during wash-in (“Numerous features of the contrast curve can be easily assessed, such as the wash-in and wash-out contrast slopes, the time-to-maximum enhancement, area under the curve, and peak enhancement.” page 44, section titled “GRASP”).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kondziolka with calculating, by the at least one processor, a slope of the one or more signal-time curves during wash-in as taught by Fatterpekar in order to provide a non-invasive method of interrogating tumors (page 44, section titled “GRASP” of Fatterpekar).
Regarding claims 4 and 16, Kondziolka discloses the limitations of claims 1 and 14, respectively, as stated above. Kondziolka further discloses extracting, by the at least one processor (processing arrangement 310 in Fig. 4 and corresponding description), one or more signal-time curves (“FIGS. 3A-3D depict experimental data immediately before stereotactic radiosurgery (in these experiments, GKRS), using permeability parameters derived from GRASP MRI. A 1.5×1.2 cm sized heterogeneously enhancing lesion was treated using stereotactic radiosurgery and imaged (FIG. 3A). The lesion was imaged subsequently at 83 days (FIG. 3B), 169 days (FIG. 3C), and 280 days (FIG. 3D) using GRASP. GRASP images were post processed using Olea Sphere software (Olea Medical, LaCiotat). An enhancement-time graph (based on region-of-interest, ROI) analysis of the solid component of the lesions was performed, before and after treatment.” [0041]; also see Figs. 3A-D and corresponding descriptions).
Although Kondziolka suggests calculating, by the at least one processor, a slope of the one or more signal-time curves during wash-out (“Permeability parameters including wash-in, wash-out, peak and area under the curve (AUC) for contrast enhancement were compared with unpaired t-tests. Metastatic lesions showed a 41.3% reduction in AUC (P=0.055) and 51.1% reduction in wash-in kinetics (P<0.0001) following stereotactic radiosurgery. Melanoma metastases had 84.5% greater AUC (P=0.1248) and 28.1% shorter wash-in kinetics (P=0.2024) compared to lung metastases at baseline. After stereotactic radiosurgery, melanoma metastases demonstrated larger reductions in AUC (39.1% vs 20.1%, P=0.1881). Substantial reductions in AUC and wash-in were observed for intracranial metastases approximately 60 days following stereotactic radiosurgery.” [0039]), Kondziolka fails to disclose to explicitly disclose calculating, by the at least one processor, a slope of the one or more signal-time curves during wash-out.
However, Fatterpekar, which is incorporated by reference by Kondziola in [0038], teaches, in the same field of endeavor, calculating, by the at least one processor, a slope of the one or more signal-time curves during wash-out (“Numerous features of the contrast curve can be easily assessed, such as the wash-in and wash-out contrast slopes, the time-to-maximum enhancement, area under the curve, and peak enhancement.” page 44, section titled “GRASP”).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kondziolka with calculating, by the at least one processor, a slope of the one or more signal-time curves during wash-out as taught by Fatterpekar in order to provide a non-invasive method of interrogating tumors (page 44, section titled “GRASP” of Fatterpekar).
Claims 5-6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kondziolka as applied to claim 1 above and further in view of Souchon et al. (US 2024/0193779, corresponding PCT filed April 27, 2022).
Regarding claim 5, Kondziolka discloses the limitations of claim 1 as stated above. Although Kondziolka further discloses wash-in kinetics of the at least one region of interest (“Permeability parameters including wash-in, wash-out, peak and area under the curve (AUC) for contrast enhancement were compared with unpaired t-tests. Metastatic lesions showed a 41.3% reduction in AUC (P=0.055) and 51.1% reduction in wash-in kinetics (P<0.0001) following stereotactic radiosurgery. Melanoma metastases had 84.5% greater AUC (P=0.1248) and 28.1% shorter wash-in kinetics (P=0.2024) compared to lung metastases at baseline. After stereotactic radiosurgery, melanoma metastases demonstrated larger reductions in AUC (39.1% vs 20.1%, P=0.1881). Substantial reductions in AUC and wash-in were observed for intracranial metastases approximately 60 days following stereotactic radiosurgery.” [0039]). Kondziolka fails to disclose further comprising normalizing, by the at least one processor, a wash-in slope of the at least one region of interest.
However, Souchon teaches, in the same field of endeavor, further comprising normalizing, by the at least one processor, a wash-in slope of the at least one region of interest (“In a variant, the normalized wash-in or normalized wash-out rate is calculated by calculating, for each first portion of each second image, a mean value of the T1-weighed signals of all pixels within the first portion and by generating a normalized curve of the means values of the first portion calculated as a function of time. The generated time curve has the same overall shape as those of each pixel, since the means contrast agent concentration in the first portion considered increases and then decreases over time. In this case, the wash-in rate value is a slope, notably a maximum or average slope, of the increasing part of the generated time curve, and the normalized wash-out rate is a slope, for example a maximum slope or an average slope, of the decreasing part of the curve.” [0086]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kondziolka with further comprising normalizing, by the at least one processor, a wash-in slope of the at least one region of interest as taught by Souchon in order to enable easy comparison between wash-in or wash-out rates obtained from different MRI machines ([0081] of Souchon).
Regarding claim 6, Kondziolka discloses the limitations of claim 1 as stated above. Although Kondziolka further discloses wash-out kinetics of the at least one region of interest (“Permeability parameters including wash-in, wash-out, peak and area under the curve (AUC) for contrast enhancement were compared with unpaired t-tests. Metastatic lesions showed a 41.3% reduction in AUC (P=0.055) and 51.1% reduction in wash-in kinetics (P<0.0001) following stereotactic radiosurgery. Melanoma metastases had 84.5% greater AUC (P=0.1248) and 28.1% shorter wash-in kinetics (P=0.2024) compared to lung metastases at baseline. After stereotactic radiosurgery, melanoma metastases demonstrated larger reductions in AUC (39.1% vs 20.1%, P=0.1881). Substantial reductions in AUC and wash-in were observed for intracranial metastases approximately 60 days following stereotactic radiosurgery.” [0039]). Kondziolka fails to disclose further comprising normalizing, by the at least one processor, a wash-out slope of the at least one region of interest.
However, Souchon teaches, in the same field of endeavor, further comprising normalizing, by the at least one processor, a wash-out slope of the at least one region of interest (“In a variant, the normalized wash-in or normalized wash-out rate is calculated by calculating, for each first portion of each second image, a mean value of the T1-weighed signals of all pixels within the first portion and by generating a normalized curve of the means values of the first portion calculated as a function of time. The generated time curve has the same overall shape as those of each pixel, since the means contrast agent concentration in the first portion considered increases and then decreases over time. In this case, the wash-in rate value is a slope, notably a maximum or average slope, of the increasing part of the generated time curve, and the normalized wash-out rate is a slope, for example a maximum slope or an average slope, of the decreasing part of the curve.” [0086]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kondziolka with further comprising normalizing, by the at least one processor, a wash-out slope of the at least one region of interest as taught by Souchon in order to enable easy comparison between wash-in or wash-out rates obtained from different MRI machines ([0081] of Souchon).
Regarding claim 17, Kondziolka discloses the limitations of claim 14 as stated above. Although Kondziolka further discloses wash-in kinetics of the at least one region of interest (“Permeability parameters including wash-in, wash-out, peak and area under the curve (AUC) for contrast enhancement were compared with unpaired t-tests. Metastatic lesions showed a 41.3% reduction in AUC (P=0.055) and 51.1% reduction in wash-in kinetics (P<0.0001) following stereotactic radiosurgery. Melanoma metastases had 84.5% greater AUC (P=0.1248) and 28.1% shorter wash-in kinetics (P=0.2024) compared to lung metastases at baseline. After stereotactic radiosurgery, melanoma metastases demonstrated larger reductions in AUC (39.1% vs 20.1%, P=0.1881). Substantial reductions in AUC and wash-in were observed for intracranial metastases approximately 60 days following stereotactic radiosurgery.” [0039]). Kondziolka fails to disclose further comprising wherein: the computer code instructions, when executed by the at least one processor, cause the at least one processor to: normalize at least one of a wash-in slope or a wash-out slope of the at least one region of interest.
However, Souchon teaches, in the same field of endeavor, wherein: the computer code instructions, when executed by the at least one processor, cause the at least one processor to: normalize at least one of a wash-in slope or a wash-out slope of the at least one region of interest (“In a variant, the normalized wash-in or normalized wash-out rate is calculated by calculating, for each first portion of each second image, a mean value of the T1-weighed signals of all pixels within the first portion and by generating a normalized curve of the means values of the first portion calculated as a function of time. The generated time curve has the same overall shape as those of each pixel, since the means contrast agent concentration in the first portion considered increases and then decreases over time. In this case, the wash-in rate value is a slope, notably a maximum or average slope, of the increasing part of the generated time curve, and the normalized wash-out rate is a slope, for example a maximum slope or an average slope, of the decreasing part of the curve.” [0086]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Kondziolka with wherein: the computer code instructions, when executed by the at least one processor, cause the at least one processor to: normalize at least one of a wash-in slope or a wash-out slope of the at least one region of interest as taught by Souchon in order to enable easy comparison between wash-in or wash-out rates obtained from different MRI machines ([0081] of Souchon).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kondziolka.
Regarding claim 8, Kondziolka discloses the limitations of claim 1 as stated above and Kondziolka further discloses further comprising differentiating, by the at least one processor, the at least one region of interest between tumor progression and radiation effects with a sensitivity of greater than 90% (“Conventional imaging demonstrated a continued increase in the size of the heterogeneously enhancing metastatic lesion. In contrast, GRASP imaging showed an initial rightward shift of the enhancement time curve, which may reflect an increasing breakdown of the blood-brain barrier [radiation effects] following stereotactic radiosurgery. Subsequent GRASP assessment, however, demonstrated a leftward shift of this curve, as reflected in FIGS. 3C-3D in particular. This leftward shift of the curve likely reflects neoangiogenesis and is therefore suggestive of tumor recurrence [tumor progression]. A biopsy later confirmed the tumor recurrence indicated by the GRASP imaging.” [0042]; also see “it is difficult to distinguish tumor recurrence from radiation-induced change utilizing imaging following stereotactic radiosurgery. At least one implementation allows for evaluation of metastases before and after stereotactic radiosurgery, to achieve higher temporal resolution and more complete coverage.” [0038]).
Although Kondziolka performs the differentiation using GRASP DCE-MRI at various timepoints as stated above, which suggests a sensitivity of greater than 90% based on applicant’s disclosure in paragraphs [0038]-[0040] of the pre-grant publication of the instant application, Kondziolka fails to explicitly disclose a sensitivity of greater than 90%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a sensitivity greater than 90%, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05(II)(A).
Regarding claim 9, Kondziolka discloses the limitations of claim 1 as stated above and Kondziolka further discloses further comprising differentiating, by the at least one processor, the at least one region of interest between tumor progression and radiation effects with a specificity of greater than 90% (“Conventional imaging demonstrated a continued increase in the size of the heterogeneously enhancing metastatic lesion. In contrast, GRASP imaging showed an initial rightward shift of the enhancement time curve, which may reflect an increasing breakdown of the blood-brain barrier [radiation effects] following stereotactic radiosurgery. Subsequent GRASP assessment, however, demonstrated a leftward shift of this curve, as reflected in FIGS. 3C-3D in particular. This leftward shift of the curve likely reflects neoangiogenesis and is therefore suggestive of tumor recurrence [tumor progression]. A biopsy later confirmed the tumor recurrence indicated by the GRASP imaging.” [0042]; also see “it is difficult to distinguish tumor recurrence from radiation-induced change utilizing imaging following stereotactic radiosurgery. At least one implementation allows for evaluation of metastases before and after stereotactic radiosurgery, to achieve higher temporal resolution and more complete coverage.” [0038]).
Although Kondziolka performs the differentiation using GRASP DCE-MRI at various timepoints as stated above, which suggests a specificity of greater than 90% based on applicant’s disclosure in paragraphs [0038]-[0040] of the pre-grant publication of the instant application, Kondziolka fails to explicitly disclose a specificity of greater than 90%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a specificity greater than 90%, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05(II)(A).
Regarding claim 10, Kondziolka discloses the limitations of claim 1 as stated above and Kondziolka further discloses further comprising differentiating, by the at least one processor, the at least one region of interest between tumor progression and radiation effects with a specificity of 100% (“Conventional imaging demonstrated a continued increase in the size of the heterogeneously enhancing metastatic lesion. In contrast, GRASP imaging showed an initial rightward shift of the enhancement time curve, which may reflect an increasing breakdown of the blood-brain barrier [radiation effects] following stereotactic radiosurgery. Subsequent GRASP assessment, however, demonstrated a leftward shift of this curve, as reflected in FIGS. 3C-3D in particular. This leftward shift of the curve likely reflects neoangiogenesis and is therefore suggestive of tumor recurrence [tumor progression]. A biopsy later confirmed the tumor recurrence indicated by the GRASP imaging.” [0042]; also see “it is difficult to distinguish tumor recurrence from radiation-induced change utilizing imaging following stereotactic radiosurgery. At least one implementation allows for evaluation of metastases before and after stereotactic radiosurgery, to achieve higher temporal resolution and more complete coverage.” [0038]).
Although Kondziolka performs the differentiation using GRASP DCE-MRI at various timepoints as stated above, which suggests a specificity of 100% based on applicant’s disclosure in paragraphs [0038]-[0040] of the pre-grant publication of the instant application, Kondziolka fails to explicitly disclose a specificity of 100%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a specificity of 100%, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05(II)(A).
Conclusion
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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