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 Objections
Claims 1-13 objected to because of the following informalities:
Claims 1, recites “…uptake of the parotid gland. If criterion of…” in lines 10-11 As per MPEP 608.01 (m), each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. Correction is required. Claim 9 recites similar limitation and should be corrected.
Claims 1-13 recite “[18F]-FACBC”, “[18F]-FACBC”, or just “FACBC” throughout the claims. Correction is required to one format for identifying the compound.
Claim 1 recited “a potential lesion” in lines 6, 9, 10 and “the potential lesion” in line 12. Correction to is needed. Claim 9 recites similar limitations and should be corrected.
Claims 1, 9 recites “the criteria”, “the scan of field”. Correction to ---a criteria--- and ----a scan of field--- is needed.
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 1-13 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Following is the analysis under 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 7,
Step 1: Claims 1-9 are directed to a “A method of using [18F]-FACBC…” (a process), and thus meets the requirements for step 1 since the claims are directed toward one of the four statutory categories of invention.
Step 2A, prong one: Independent claim 1 recites the following limitations that when given their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas for the reasons set forth below:
“visually analysing the one or more PET scan images by comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake in the parotid glands or pituitary of the head region” (a human can practically perform this limitation in the mind or with the aid of pen and paper by having a knowledge about comparisons, and uptake values by visually / looking at PET images)
“determining whether the criterion of a minimum of predetermined size of craniocaudally visualized parotid gland on the scan field of view is met;” (a human can practically perform this limitation in the mind or with the aid of pen and paper by having a knowledge about comparisons, and uptake values by visually / looking at PET images and having an idea of sizes, like small large medium, visible, not visible, etc).
“comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake of the parotid gland, if criterion of (i) is not met, comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake of the pituitary in the head region” (a human can practically perform this limitation in the mind or with the aid of pen and paper by having a basic knowledge about comparisons of values)
“determining whether the potential lesion is a brain lesion based on the analysis of step (c)” (a human can practically perform this limitation in the mind or with the aid of pen and paper by having a basic knowledge about comparisons of values, whether one value is large or not. Further, a trained professional can perform the claimed determination as to whether the readings are abnormal, normal, outliners, etc)
Independent claim 6, similar to claim 1, further recites the following limitations that when given their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas for the reasons set forth below
“ (c) analysing the one or more PET scan images by comparing a standardized uptake value (SUV) of [18F]-FACBC uptake in a potential lesion against a reference threshold standardized uptake value (SUV)threshold of the pituitary glands” (a human can practically perform this limitation in the mind or with the aid of pen and paper by having a basic knowledge about comparisons of values); and
Independent claim 9, similar to claim 1, additionally recites the following limitations that when given their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas for the reasons set forth below
“if in step (c) the [18F]-FACBC uptake in a potential lesion of the head region of the subject is visually close to [18F]-FACBC uptake in parotid glands or pituitary of the head region, comparing a standardized uptake value (SUV) of [18F]-FACBC uptake in a potential lesion against a reference threshold standardized uptake value (SUV)threshold of the pituitary” (a human can practically perform this limitation in the mind or with the aid of pen and paper by having a basic knowledge about comparisons of values)
Step 2A, prong two: Claims 1, 6, 9 recites the following additional elements that when considered individually and as a whole do not integrate the judicial exception into a practical application for the reasons set forth below:
“(a) administering a detectable amount of [18F]-FACBC to a subject;” (merely adding insignificant pre-solution activity to the abstract idea- see MPEP 2106.05(g) for generating PET images);
“(b) acquiring one or more positron emission tomography (PET) scan images of a head region of the subject;” (merely adding insignificant pre-solution activity to the abstract idea- see MPEP 2106.05(g), i.e. generating images for analysis)
Step 2B: Claims 1, 6, 9 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and as a whole, they do not add an inventive concept for the same reasons set forth above in step 2A, prong two. Additionally, when reconsidering the limitations that were considered insignificant extra-solution activity, the following evidence shows the limitations are well-understood, routine and conventional functions:
“(a) administering a detectable amount of [18F]-FACBC to a subject;(b) acquiring one or more positron emission tomography (PET) scan images of a head region of the subject” (The administration and acquiring of PET images is well-understood, routine, and conventional, see abstract of US 20230126453 A1, WO 2017051519 A1, WO 2019027033 A1)
Dependent claims 2 and 3 also been rejected because they recite additional limitations that when given their broadest reasonable interpretation fall within the mental processes grouping of abstract ideas. Claims 7-11, 31, and 37 also rejected because they include limitations that further limit the extra solution activity.
Claims 48-51 should have also been rejected because they include limitations that further limit the abstract idea set forth above by merely specifying particular rules.
Dependent Claims
The following dependent claims merely further define the abstract idea and are,
therefore, directed to an abstract idea for similar reasons:
defining the potential lesion type (claims 2, 7, 10)
defining the step of visual comparison (claims 3-4, 11-12).
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
describing the pre-solution of the obtaining PET (claims 5, 8, 13)
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way.
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 3-4, 11-12 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.
Claims 3, 11 recite “the predetermined threshold”. There is insufficient antecedent basis for this limitation in the claim. Claims 4, 12 depend on claims 3, 11 and are rejected in view of the dependency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, rejected under 35 U.S.C. 102 (a) (1) and 102 (a) (2) as being anticipated by Teoh [US 20230126453 A1].
As per claim 1, Teoh teaches a method of using [18F]-FACBC (Teoh ¶0001), comprising the steps of:
(a) administering a detectable amount of [18F]-FACBC to a subject (Teoh ¶0044);
(b) acquiring one or more positron emission tomography (PET) scan images of a head region of the subject (Teoh ¶0044-¶0045);
(c) visually analysing the one or more PET scan images by comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake in the parotid glands or pituitary of the head region (Examiner chooses comparing with parotid gland. Teoh ¶0042 “Visual comparison of the uptake of [.sup.18F]-FACBC uptake in a potential lesion against [.sup.18F]-FACBC uptake in the parotid glands”) by
(i) determining whether the criterion of a minimum of predetermined size of craniocaudally visualized parotid gland on the scan field of view is met (Teoh Fig 2 visually comparing upper and lower arrows, see ¶0038. “axial, sagittal and coronal [18F]-FACBC PET corresponds to the claimed craniocaudally, interpreted as corresponding to applicant’s PET camera field of view images of Figs 3-4. Here, the claimed predetermined size broadly encompasses any size that can be visualized. Since the uptake in Parotid is visualized and marked as arrows, it is determined that the claimed minimum criteria is met); and
(ii), if the criterion of (i) is met, comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake of the parotid gland (Teoh ¶0044 “Visual comparison of the uptake of [.sup.18F]-FACBC uptake in a potential lesion against [.sup.18F]-FACBC uptake in the parotid glands may allow for a more accurate diagnosis of the lesion”)
if criterion of (i) is not met, comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake of the pituitary in the head region (As per MPEP 2111.04 “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed … If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A” In the instant case, the claim requires only that the first condition to occur or not. Hence, the claimed invention may be practiced with either, the steps that needs to be performed when criteria is met, or, the steps that needs to be performed when criteria is not met. Examiner choses first option, as discussed above, and hence these limitations are not required to practice the invention), and
(d) determining whether the potential lesion is a brain lesion based on the analysis of step (c) (Teoh ¶0044 “Visual comparison of the uptake of [.sup.18F]-FACBC uptake in a potential lesion against [.sup.18F]-FACBC uptake in the parotid glands may allow for a more accurate diagnosis of the lesion”, ¶0083 “Once image data has been collected from the second PET scan, the first and second PET scan images can be visualised together and used to view the change in extent and location of [18F]-FACBC uptake by a potential lesion within the subject, allowing for the diagnosis or monitoring of metastatic brain cancer.”).
As per claim 2, Teoh further teaches wherein the brain lesion is a metastatic brain lesion (Teoh ¶0042 “present disclosure using blood pool and/or parotid glands as a background reference can provide for more accurate diagnoses of the presence of a brain lesion, e.g., a cancerous brain lesion, such as a malignant or metastatic brain lesion”).
Claims 6, 8 rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Ali [Distinguishing Progression from Pseudoprogression in Glioblastoma Using 18F-Fluciclovine PET, The Journal Of Nuclear Medicine, Vol. 64, No. 6, June 2023].
As per claim 6, Ali teaches a method of using [18F]-FACBC (Ali Title, note as admitted in applicant spec, 18F-Fluciclovine is another name for [18F]-FACBC), comprising the steps of:
(a) administering a detectable amount of [18F]-FACBC to a subject and (b) acquiring one or more positron emission tomography (PET) scan images of a head region of the subject (Ali page 853 LHS “patients underwent preoperative multiparametric MRI and 60 min of dynamic brain PET/CT after intravenous administration of 18F-fluciclovine”);
(c) analysing the one or more PET scan images by comparing a standardized uptake value (SUV) of [18F]-FACBC uptake in a potential lesion against a reference threshold standardized uptake value (SUV)threshold of the pituitary glands (Ali page 853 RHS “Normal-tissue volumes of interest and SUVmean measurements were made in the contra lateral normal brain, pituitary gland, and superior sagittal sinus. The volumes of interest in the contralateral normal brain were 20 mm in diameter, whereas those in the pituitary and superior sagittal sinus were 15 mm in diameter….Time–activity curves of 18F-fluciclovin SUVpeak uptake in the tumor were generated by application…”. See Table 2, specifically, item SUVmax/pituitary); and
(d) determining whether the potential lesion is a brain lesion based on the analysis of step (c) (Ali page 854 LHS “PET variables (6 summed images and normalized to normal .. pituitary,…was used to determine the variables most predictive of viable tumor percentage on histopathology”).
As per claim 8, The method of any claims of claims 6, wherein FACBC brain images of the methods are obtained about 15-25 minutes post-injection of FACBC (Ali page 853 RHS “Measurements were taken .. at 20–30, 30–40, 40–50, 50–60, 40–60, and 30–60 min after injection (g/mL units).”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5 rejected under 35 U.S.C. 103 as being unpatentable over Teoh.
As per claim 5, Teoh does not expressly teach wherein FACBC brain images of the methods are obtained about 15-25 minutes post-injection of FACBC. However, Teoh teaches acquisition can start 8 to 12 minutes after the end of the injection (Teoh ¶0059). Applicant, discloses this range also without specifically pointing out any particular advantage for the claimed 15-25 minute over the other ranges of 5-15, 10-20 or 15-30 (See for e.g. see spec, page 5 lines 10-16). As per MPEP2144.05 “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Further, the specification does not set forth evidence that such ranges are critical, and of both statistical and practical significance. Hence it would be an obvious modification, to pick acquisition times for different reading and analysis.
Claims 7, 9, 10, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ali in view of Teoh.
As per claim 9, Ali teaches a method of using [18F]-FACBC, comprising the steps of: (a) administering a detectable amount of [18F]-FACBC to a subject;(b) acquiring one or more positron emission tomography (PET) scan images of a head region of the subject (Ali page 853 LHS “patients underwent preoperative multiparametric MRI and 60 min of dynamic brain PET/CT after intravenous administration of 18F-fluciclovine”);
comparing a standardized uptake value (SUV) of [18F]-FACBC uptake in a potential lesion against a reference threshold standardized uptake value (SUV)threshold of the pituitary (Ali page 853 RHS “Normal-tissue volumes of interest and SUVmean measurements were made in the contra lateral normal brain, pituitary gland, and superior sagittal sinus. The volumes of interest in the contralateral normal brain were 20 mm in diameter, whereas those in the pituitary and superior sagittal sinus were 15 mm in diameter….Time–activity curves of 18F-fluciclovin SUVpeak uptake in the tumor were generated by application…”. See Table 2, specifically item SUVmax/pituitary, and (e) determining whether the potential lesion is a brain lesion based on the analysis of steps (Ali page 854 LHS “PET variables (6 summed images and normalized to normal .. pituitary,…was used to determine the variables most predictive of viable tumor percentage on histopathology”).
Ali does not expressly teach (c) visually analysing the one or more PET scan images by comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake in the parotid glands or pituitary of the head region by (i) determining whether the criterion of a minimum of predetermined size of craniocaudally visualised parotid gland on the scan field of view is met; and (ii), if the criterion of (i) is met, comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake of the parotid gland. If criterion of (i) is not met, comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake of the pituitary in the head region; (d) if in step (c) the [18F]-FACBC uptake in a potential lesion of the head region of the subject is visually close to [18F]-FACBC uptake in parotid glands or pituitary of the head region.
Teoh, in a similar field of technology teaches (c) visually analysing the one or more PET scan images by comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake in the parotid glands or pituitary of the head region (Examiner chooses comparing with parotid gland. Teoh ¶0042 “Visual comparison of the uptake of [.sup.18F]-FACBC uptake in a potential lesion against [.sup.18F]-FACBC uptake in the parotid glands”) by
(i) determining whether the criterion of a minimum of predetermined size of craniocaudally visualized parotid gland on the scan field of view is met (Teoh Fig 2 visually comparing upper and lower arrows, see ¶0038. “axial, sagittal and coronal [18F]-FACBC PET corresponds to the claimed craniocaudally, interpreted as corresponding to applicant’s PET camera field of view images of Figs 3-4. Here, the claimed predetermined size broadly encompasses any size that can be visualized. Since the uptake in Parotid is visualized and marked as arrows, it is determined that the claimed minimum criteria is met)
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the method in Ali by using intake information from Parotid gland. Teoh discloses that visually comparing to [18F]-FACBC activity in the blood pool and/or parotid glands is advantageous to analyses and determine whether the potential lesion is a metastatic brain lesion in order to diagnose brain metastasis (Teoh ¶0035). Hence the motivation would be to analyze or determine brain metastasis.
Ali in view of Teoh does not expressly teach i) determining whether the criterion of a minimum of predetermined size of craniocaudally visualised parotid gland on the scan field of view is met; and (ii), if the criterion of (i) is met, comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake of the parotid gland. If criterion of (i) is not met, comparing [18F]-FACBC uptake in a potential lesion of the head region of the subject against [18F]-FACBC uptake of the pituitary in the head region; (d) if in step (c) the [18F]-FACBC uptake in a potential lesion of the head region of the subject is visually close to [18F]-FACBC uptake in parotid glands or pituitary of the head region. However, as per MPEP 2111.04, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. … If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. As can be seen from claim, the step d is occurring whether or not the contingent limitation of step c is occurring, i.e. comparison with the SUC for pituitary is performed, irrespective of claim limitations of step c (i) and (ii). Hence, the invention may be practiced without the claimed contingent limitations.
As per claims 7, 10, Ali does not expressly teach that the brain lesion is a metastatic brain lesion. However, in combination with Teoh as discussed above, the claimed limitation would have been obvious.
As per claim 13, wherein FACBC brain images of the methods are obtained about 15-25 minutes post-injection of FACBC (Ali page 853 RHS “Measurements were taken .. at 20–30, 30–40, 40–50, 50–60, 40–60, and 30–60 min after injection (g/mL units)”).
Status of claims 3-4, 11-12
As per claims 3-4, 11-12, the references made of record in PTO does not specifically teach considering predetermined threshold of visualised parotid gland to be in specific size (diameter, radius, volume) on the scan field of view to be within 0.8-1.2 cm or about 1cm. Further, examiner does not find any motivation for a person of ordinary skill to check for these diameters before making determination regarding uptake values for parotid / pituitary. Purohit [FDG-PET/CT pitfalls in oncological head and neck imaging, Insights Imaging (2014) 5:585–602], Kim [Evaluating diagnostic accuracy and determining optimal diagnostic thresholds of different approaches to [68Ga]‑DOTATATEPET/MRI analysis in patients with meningioma, Scientific Reports (2022),12:9256], and Park [Diagnostic Criteria on 18F-FDG PET/CT for Differentiating Benign from Malignant Focal Hypermetabolic Lesions of Parotid Gland, Nucl. Med Mol Imaging (2012) 46:95–101] are related art to the invention in that they disclose PET for lesion diagnosis, but does not disclose checking gland size thresholds /criteria or checking for them, as required in claim. However, the allowability of these claims cannot be completely determined in view of the pending 101, 112 rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/Primary Examiner, Art Unit 3797
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