DETAILED ACTION
Claims 1-20 are currently pending.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-5, 7-15, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9-14, 16, 19 and 20 of U.S. Patent No. 11,883,184 in view of Henneghan (“Cortical Brain Age from Pre-Treatment to Post-chemotherapy in Patients with Breast Cancer” Neurotoxicity Research 2020).
Regarding claim 1,
A method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s predicted age difference (PAD), the method comprising:
(1) acquiring at least one medical brain image of a patient’s brain before a chemotherapy treatment; (‘184, claim 1, scanning the individual’s brain with a scanning device so as to acquire at least one medical brain image at the beginning of treatment)
(2) processing the medical brain image of a patient’s brain before a chemotherapy treatment; (‘184 claim 1, processing the medical brain image to obtain at least one feature of the image)
(3) generating a PAD value of the individual based on the at least one feature of the image; (‘184 claim 1, generating a PAD value of the individual based on at least one feature of the image) and
(4) predicting an effect of the chemotherapy treatment on a cancer patient’s cognitive status using the PAD value. (‘184 claim 1, predicting the therapeutic effects of the treatment for cognitive impairment using a comparison result of the PAD value and the reference value)
Although the ‘184 patent fails to explicitly claim chemotherapy treatment as claimed, at the time of filing, it would have been obvious to apply the predicted age difference based on chemotherapy (rather than claimed cognitive impairment treatment) in view of Henneghan (“Cortical Brain Age from Pre-treatment to Post-chemotherpy in Patients with Breast Cancer”). Hennegahn teaches the determination of brain age after a chemotherapy treatment. See Abstract. The rationale for the combination is applying known technique to yield the predictable result of predicted brain age after chemotherapy treatment.
Regarding claim 2,
The method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 1, wherein: the at least one image is a brain MRI image. (‘184 claim 2, the at least one image is a brain MRI image)
Regarding claim 3,
The method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 2, wherein: the brain MRI image comprises an MRI image of a gray matter region of the individual’s brain. (‘184 claim 3, the brain MRI image comprises an MRI of a gray matter region of the individual’s brain)
Regarding claim 4,
The method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 1, wherein: step (4) comprising comparing the PAD value with a reference index; and the reference index comprises at least one PAD value of an individual who does not receive the chemotherapy treatment. (‘184 claim 1, comparing the PAD value with a reference value, claim 4, the reference value comprises a predetermined PAG value that differentiates individuals demonstrating positive responses to the treatment from individuals demonstrating negative responses to the treatment)
Regarding claim 5,
The method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 1, wherein: the chemotherapy treatment is used for treating at least one of eye or ocular cancer, rectal cancer, colon cancer, cervical cancer, prostate cancer, breast cancer, bladder cancer, oral cancer, benign and malignant tumors, stomach cancer, liver cancer, pancreatic cancer, lung cancer, corpus uteri, ovary cancer, prostate cancer, testicular cancer, renal cancer, brain/cns cancer (e.g., gliomas), throat cancer, skin melanoma, acute lymphocytic leukemia, acute myelogenous leukemia, Ewing's Sarcoma, Kaposi's Sarcoma, basal cell carinoma and squamous cell carcinoma, small cell lung cancer, choriocarcinoma, rhabdomyosarcoma, angiosarcoma, hemangioendothelioma, Wilms Tumor, neuroblastoma, mouth/pharynx cancer, esophageal cancer, larynx cancer, lymphoma, neurofibromatosis, tuberous sclerosis, hemangiomas, and lymphangiogenesis.
Although the ‘184 patent fails to explicitly claim chemotherapy treatment as claimed, at the time of filing, it would have been obvious to apply the predicted age difference based on chemotherapy (rather than claimed cognitive impairment treatment) in view of Henneghan (“Cortical Brain Age from Pre-treatment to Post-chemotherpy in Patients with Breast Cancer”). Hennegahn teaches the determination of brain age after a chemotherapy treatment. See Abstract. The rationale for the combination is applying known technique to yield the predictable result of predicted brain age after chemotherapy treatment.
Regarding claim 7,
The method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 1, wherein: the PAD value of the individual is generated using a pre-established prediction model; and the pre-established prediction model comprises at least a brain age model. (‘184 claim 6, the PAD value of the individual is generated using a pre-established prediction model; and the pre-established prediction model comprises at least a brain age model)
Regarding claim 8,
The method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 1, wherein: the step of processing of the medical brain image comprises at least one step of correcting the artifacts of the medical brain image. ( ‘184 claim 9 the step of processing the medical brain image comprises at least one step of spatial normalization process)
Regarding claim 9,
The method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 8, wherein: the step of processing of the medical brain image further comprises at least one step of spatial normalization process. ( ‘184 claim 9 the step of processing the medical brain image comprises at least one step of spatial normalization process)
Regarding claim 10,
The method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 9, wherein: the step of processing of the medical image further comprises at least one step of feature quantification process. (‘184 claim 10, the step of processing of the medical image further comprises at least one step of feature quantification process)
Regarding claim 11,
A non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s predicted age difference (PAD), the process comprising:
(1) acquiring at least one medical brain image of a patient’s brain before a chemotherapy treatment; (‘184, claim 1, scanning the individual’s brain with a scanning device so as to acquire at least one medical brain image at the beginning of treatment)
(2) processing the medical brain image of a patient’s brain before a chemotherapy treatment; (‘184 claim 11, processing a medical brain image of an individual to obtain at least one feature of the image)
(3) generating a PAD value of the individual based on the at least one feature of the image; (‘184 claim 11, generating a PAD value of the individual based on the at least one feature of the image) and
(4) predicting an effect of the chemotherapy treatment on a cancer patient’s cognitive status using the PAD value. (‘184 claim 11, predicting the therapeutic effects of the treatment for cognitive impairment using the comparison result of the PAD value and the reference value)
Although the ‘184 patent fails to explicitly claim chemotherapy treatment as claimed, at the time of filing, it would have been obvious to apply the predicted age difference based on chemotherapy (rather than claimed cognitive impairment treatment) in view of Henneghan (“Cortical Brain Age from Pre-treatment to Post-chemotherpy in Patients with Breast Cancer”). Hennegahn teaches the determination of brain age after a chemotherapy treatment. See Abstract. The rationale for the combination is applying known technique to yield the predictable result of predicted brain age after chemotherapy treatment.
Regarding claim 12,
The non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 11, wherein: the at least one image is a brain MRI image. (‘184 claim 12, the at least one image is a brain MRI image)
Regarding claim 13,
The non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 12, wherein: the brain MRI image comprises an MRI image of a gray matter region of the individual’s brain. (‘184 claim 13, the brain MRI image comprises an MRI image of a gray matter region of the individual’s brain)
Regarding claim 14,
The non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according claim 11, wherein: step (4) comprising comparing the PAD value with a reference index; and the reference index comprises at least one PAD value of an individual who does not receive the chemotherapy treatment. (‘184, claim 11, comparing the PAG value with a reference value, claim 14, the reference value comprises a predetermined PAD value that differentiates individuals demonstrating positive responses to the treatment from individuals demonstrating poor responses to the treatment)
Regarding claim 15,
The non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 11, wherein: the chemotherapy treatment is used for treating at least one of eye or ocular cancer, rectal cancer, colon cancer, cervical cancer, prostate cancer, breast cancer, bladder cancer, oral cancer, benign and malignant tumors, stomach cancer, liver cancer, pancreatic cancer, lung cancer, corpus uteri, ovary cancer, prostate cancer, testicular cancer, renal cancer, brain/cns cancer (e.g., gliomas), throat cancer, skin melanoma, acute lymphocytic leukemia, acute myelogenous leukemia, Ewing's Sarcoma, Kaposi's Sarcoma, basal cell carinoma and squamous cell carcinoma, small cell lung cancer, choriocarcinoma, rhabdomyosarcoma, angiosarcoma, hemangioendothelioma, Wilms Tumor, neuroblastoma, mouth/pharynx cancer, esophageal cancer, larynx cancer, lymphoma, neurofibromatosis, tuberous sclerosis, hemangiomas, and lymphangiogenesis.
Although the ‘184 patent fails to explicitly claim chemotherapy treatment as claimed, at the time of filing, it would have been obvious to apply the predicted age difference based on chemotherapy (rather than claimed cognitive impairment treatment) in view of Henneghan (“Cortical Brain Age from Pre-treatment to Post-chemotherpy in Patients with Breast Cancer”). Hennegahn teaches the determination of brain age after a chemotherapy treatment. See Abstract. The rationale for the combination is applying known technique to yield the predictable result of predicted brain age after chemotherapy treatment.
Regarding claim 17,
The non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 11, wherein: the PAD value of the individual is generated using a pre-established prediction model; and the pre-established prediction model comprises at least a brain age model. (‘184 claim 16, the PAD value of the individual is generating using a pre-established prediction model; and the pre-established prediction model comprises at least a brain age model)
Regarding claim 18,
The non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 11, wherein: the step of processing of the medical brain image comprises at least one step of correcting the artifacts of the medical brain image. (‘184 claim 19, the step of processing the medical brain image comprises at least one step of spatial normalization process)
Regarding claim 19,
The non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 18, wherein: the step of processing of the medical brain image further comprises at least one step of spatial normalization process. (‘184 claim 19, the step of processing the medical brain image comprises at least one step of spatial normalization process)
Regarding claim 20,
The non-transitory computer readable medium storing a program causing a computer to execute a process for a method of predicting an effect of a chemotherapy treatment on a cancer patient’s cognitive status using the patient’s PAD according to claim 19 wherein: the step of processing of the medical image further comprises at least one step of feature quantification process. (‘184 claim 20, the step of processing the medical image further comprises at least one step of feature quantification process)
Allowable Subject Matter
The claims are not rejected under the prior art and would be in condition for allowance if the above double patenting claims were overcome.
Regarding claim 1, neither the closest known prior art, nor any reasonable combination thereof teaches:
(4) predicting an effect of the chemotherapy treatment on a cancer patient’s cognitive status using the PAD value.
Henneghan teaches:
(1) acquiring at least one medical brain image of a patient’s brain before a chemotherapy treatment; (Henneghan, page 789, Patients were assessed at three time points-prior to any treatment including surgery with general anesthesia… See also page 790, MRI were acquired on the same day as cognitive testing using a GE discovery MR 750 3.0 Tesla whole body scanner))
(2) processing the medical brain image of a patient’s brain before a chemotherapy treatment; (Henneghan, page 790 segmentation of subcortical white matter and cortical gray matter)
(3) generating a PAD value of the individual based on the at least one feature of the image; (Henneghan page 790, Gray matter measured were entered into the Brain-Age Regression Analysis and Computation Utility Software (BARACUS version V1.1.2), which calculated predicted brain age (PBA) in years )and
In the study of Henneghan they observed correlations between brain age and cognitive impairment in breast cancer patients. See Page 792. However, Henneghan does not make any predictions about a patient based on brain age alone, all cognitive impairment was observed at a time post treatment. Therefore, Henneghan fails to teach step (4) as claimed.
Claims 2-10 depend from claim 1 and would be allowable.
Claim 11 would be allowable for similar reasons to claim 1, and therefore dependent claims 12-20 would also be allowable.
Examiner notes claim 6 and 16 are not rejected under double patenting above and are objected to as being dependent upon a rejected base claim and would be allowable if rewritten in independent form, including all intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Refer to PTO-892, Notice of References Cited for a listing of analogous art.
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/Molly Wilburn/Primary Examiner, Art Unit 2666
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