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 .
Information Disclosure Statement
Information Disclosure Statement (IDS) submitted on 03/21/2025 has been entered and fully considered by the examiner.
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 1-16 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.
Claims 1 and 16 recite the term “radioactivity” in the language of the claim requiring the determination of “radioactivity of the radioactive source”. However, it is entirely unclear and indefinite as to what “radioactivity” is. The specification does not define the term, and further, the term “radioactivity” is not a well-known parameter in the field. As a result, the metes and bounds of the claims are not clear and the claims are considered to be indefinite. For the purposes of examination, the broadest reasonable interpretation of the term has been used.
Claims 2-15 depend upon indefinite claims 1 and 16 and are considered to be indefinite as well due to their dependency.
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.
Claims 1, and 4-11 are rejected under 35 U.S.C. 103 as being obvious over Knowland et al. (U.S. Publication No. 2015/0276937) hereinafter “Knowland” in view of Rozenfeld et al. (U.S. 2008/0161632) hereinafter “Rozenfeld”, and Keppel et al. (U.S. Patent No. 7,711,409) hereinafter “Keppel”.
Regarding claim 1, Knowland discloses a method for the ex vivo real-time determination over a period of time of amount of a radioactive source in a body by measuring radiation that decays in vivo emitted by a subject [see abstract of Knowland]; Knowland uses ex-vivo real time detection of the radioactive tracers which have been administered to the patient], the method comprising:
(i)applying one or more ex vivo radiation measurement sensors [ ex-vivo measuring sensor 11; see [0162] of Knowland] proximate an area of interest on the subject [see [0123] of Knowland disclosing that the measuring sensors are placed in various areas of the body including directly on the tumor];
(iii) detecting radiation over the period of time and producing signal data associated with the period of time; [see[0124] of Knowland]
(iv) amplifying the signal data using a signal amplifier [amplifier 33; see [0087]] in operable communication with each of the one or more ex vivo radiation measurement sensors [see [0093]-[0094] the amplifier receives signal from the sensor output], wherein the one or more ex vivo radiation measurement sensors has at least one sensor output for such amplified signal data, and outputting the amplified signal data; [see [0094] of Knowland]
(v) processing the amplified signal data using a computer processor [control processor 42] in operative communication with a non-transient memory [see [0095]; a local memory, external memory remote computer memory, network memory, or internet memory] and the at least one sensor output by performing the steps of:
(a) receiving the amplified signal data associated with the period of time; [see [0095] of Knowland]
(b) comparing the amplified signal data to a set of expected signal data for radioactive sources of various radioactivity, locations, and volumes within the subject at the position determined by the one or more rangefinders; [see [0103] of Knowland]
(c) determining radioactivity in the body over the period of time by fitting the amplified signal data to the most likely set of expected signal data [Knowland discloses proper or improper administration of the radioactive material by fitting the data at the site of the injection. It is inherent that any determination of radioactivity provides an estimate of the amount of radioactive material (i.e. radioactivity) see FIG. 11 and [0011],[0017], [0123]-[0124] and [0177]-[178].]
Knowland does not disclose applying one or more rangefinders proximate an area of interest on a patient for determining a position of the subject relative to the one or more radiation measurement sensors and estimating a location of the radioactive source in the body and determining a volume of radioactive source in the body, and determination of radioactivity, location and volume of the radioactive source.
Rozenfeld, directed towards determining a dose rate [see abstract of Rozenfeld], discloses applying one or more rangefinders proximate an area of interest on a patient for determining a position of the subject relative to the one or more radiation measurement sensors and estimating a location of the radioactive source in the body [see [0028]-[0031] of Rozenfeld; “the method includes determining the location of said source from increases detected by detectors for which the greatest increase in observed”; see also [0095] disclosing “the three coordinates of the seed are then deduced derived from the three detector readings”; since the source in Rozenfeld is located within the body, the determination of the location of source with respect to the sensors would give the position of the subject relative to the sensors as well.] and determining radioactivity, and location of the radioactive source in the body over the period of time. [see [0028]-[0031] of Rozenfeld discloses determination of a dose rate of the radioactive material which is defined as the radiation delivered per unit time. Radioactivity has been taken to be equivalent to dose rate since it is a measure of the amount of radiation. The examiner notes that the specification does not define the term radioactivity, and further, it is not known to what quantity the term is referring therefore, in the broadest reasonable interpretation of the term, it has been taken to be equivalent to dose rate]
Keppel, directed towards in diagnosis and biopsy of radioactive tracers with a detector in a subject [see abstract of Keppel] further discloses determining a volume of radioactive source in the body [see [0064]; the background noise is subtracted from the spectra, resulting in a value which can be directly proportional to the volume]
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 method of Knowland further such that it includes estimating a location of the radioactive source in the body according to the teachings of Rozenfeld in order to allow for monitoring radiation dose or source location and allows for controlling the dose in the exact desired location [see [0011] of Rozenfeld].
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 method of Knowland further such that it includes estimating a volume of the radioactive source in the body according to the teachings of Keppel in order to help with the diagnosis of the tumors and distinguish true-positive cases from false positive cases in the diagnosis process [see [0062] of Keppel]
Regarding claim 4, Knowland further discloses using the determined radioactivity, location, and volume of radioactive source in the body to make one or more of a clinical decision or diagnosis. [change in tumor size is determined which allows a determination whether treatment is working or not; see [0011], [0108] and [0124] of Knowland]
Regarding claim 5, Knowland further discloses an array comprising two or more ex vivo radiation measurement sensors. [see [0108] of Knowland disclosing at least 2 measurement sensors 11]
Knowland does not disclose that two or more rangefinders are utilized.
Rozenfeld further discloses that two or more rangefinders are utilized. [see [0081]; detectors 20a-20d are used to detect the relative location of the source of radioactive material]
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 method of Knowland further such that it includes two or more rangefinders according to the teachings of Rozenfeld in order to be able to triangulate the location of the source of radioactive material using multiple rangefinder detectors.
Regarding claim 6, Knowland further discloses that array of two or more radiation measurement sensors are disposed in a substantially symmetric geometry about the radioactive source in the body [ see [0123] and FIG. 11 of Knowland].
Knowland does not disclose rangefinders.
Rozenfeld further discloses that two or more rangefinders are disposed in a substantially symmetric geometry about the radioactive source in the body [see FIG. 6B and [0092] of Rozenfeld]
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 method of Knowland further such that the two or more rangefinders are disposed in a substantially symmetric geometry about the radioactive source according to the teachings of Rozenfeld in order to be able to triangulate the location of the source of radioactive material using multiple rangefinder detectors
Regarding claim 7, Knowland further discloses that the two or more radiation measurement sensors are disposed proximate a first measurement location, and further wherein the first measurement location comprises at least a first radiation measurement sensor disposed relatively closer to the radioactive source than a second radiation measurement sensor. [see [0123] and FIG. 11 of Knowland]
Regarding claim 8, Knowland further discloses that a second radioactivity, location, and volume is determined for a second radiation source in the body. [see [0011], [0108] and [0124] of Knowland]
Regarding claim 9, Knowland further discloses comparing the determined radioactivity, location, and volume of the two or more radioactive sources, and making a clinical decision or diagnosis based on the comparison. [change in tumor size is determined which allows a determination whether treatment is working or not; see [0011], [0108] and [0124]]
Regarding claim 10, Knowland further discloses that the clinical decision or diagnosis is also based on one or more prior determinations or comparisons of the subject [see [0103] of Knowland]
Regarding claim 11, Knowland further discloses that the clinical decision or diagnosis is further based on a comparison to a table comprising data from a population of other subjects. [see [0103] of Knowland; the data is collected from both the patient and the other population of patients]
Regarding claim 13, Knowland as modified by Rozenfeld and Keppel discloses all the limitations of claim 1 above [see rejection of claim 1]
Rozenfeld further discloses that the one or more rangefinders comprises an optical detector. [see [0087] of Rozenfeld.]
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 method of Knowland further such that that the one or more rangefinders comprises an optical detector according to the teachings of Rozenfeld since doing so would have been a simple substitution of one type of detector with another and would have been obvious to a person of ordinary skill level in the art.(KSR rationale B)
Regarding claim 14, Knowland as modified by Rozenfeld and Keppel discloses all the limitations of claim 1 above [see rejection of claim 1]
Rozenfeld further discloses that the one or more rangefinders comprise a camera and laser system for determining the position of the subject [see [0087] of Rozenfeld]
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 method of Knowland further such that the one or more rangefinders comprise a camera and laser system for determining the position of the subject according to the teachings of Rozenfeld since doing so would have been a simple substitution of one type of detector with another and would have been obvious to a person of ordinary skill level in the art.(KSR Rationale B)
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Knowland et al. (U.S. Publication No. 2015/0276937) hereinafter “Knowland”, Rozenfeld et al. (U.S. 2008/0161632) hereinafter “Rozenfeld”, and Keppel et al. (U.S. Patent No. 7,711,409) hereinafter “Keppel” as applied to claim 1 above, and further in view of Desogere et al. (U.S. Publication No. 2017/0360967) hereinafter “Desogere”.
Regarding claim 2, Knowland as modified by Rozenfeld and Keppel discloses all the limitations of claim 1 above [see rejection of claim 1]
Knowland as modified by Rozenfeld and Keppel does not disclose that a Maximum Likelihood Expectation Maximization method is used to fit the most likely radioactivity, location and volume of the radioactive source in the body.
Desogere, directed towards using MLEM to determine location of the source of radioactive [see abstract of Desogere] further discloses that a Maximum Likelihood Expectation Maximization method is used to fit the most likely magnitude, location, and volume of the radioactive source in the body; [see [0074] and [0343] of Desogere]
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 method of Knowland as modified by Rozenfeld and Keppel further and use a Maximum Likelihood Expectation Maximization method is used to fit the most likely magnitude, location and volume of the radioactive source in the body according to the teachings of Desogere in order to determine the concentrations of radioactive materials.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Knowland et al. (U.S. Publication No. 2015/0276937) hereinafter “Knowland” in view of Rozenfeld et al. (U.S. 2008/0161632) hereinafter “Rozenfeld”, and Keppel et al. (U.S. Patent No. 7,711,409) hereinafter “Keppel” as applied to claim 1 above, and further in view of Suddarth et a. (U.S. Publication No. 20050287065) hereinafter “Suddarth”.
Regarding claim 3, Knowland as modified by Rozenfeld and Keppel discloses all the limitations of claim 1 above [see rejection of claim 1]
Knowland, as modified by Rozenfeld and Keppel does not disclose determining a radiation dose of radioactivity to an area of tissue proximate the location of the radioactive source.
Suddarth, directed towards dose determination proximate a location of radioactive source [see abstract of Suddarth] further discloses determining a dose of radioactivity to an area of tissue proximate the location of the radioactive source. [see [0002],[0020], and [0110] of Suddarth]
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 method of Knowland as modified by Rozenfeld and Keppel further and determine a dose of radioactivity to an area of tissue proximate the location of the radioactive source according to the teachings of Suddarth in order to allow for monitoring therapeutic response or delivery of radiolabeled agents to the body.
Claims 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over
Knowland et al. (U.S. Publication No. 2015/0276937) hereinafter “Knowland”, in view of Rozenfeld et al. (U.S. 2008/0161632) hereinafter “Rozenfeld”, and Keppel et al. (U.S. Patent No. 7,711,409) hereinafter “Keppel” as applied to claim 1 above and further in view of Kimchy et al. (U.S. Patent No. 8,565,860) hereinafter “Kimchy”.
Regarding claim 12, Knowland as modified by Rozenfeld and Keppel discloses all the limitations of claim 1 above. [see rejection of claim 1]
Knowland as modified by Rozenfeld and Keppel does not disclose that the one or more rangefinders comprises an ultrasound transducer and detector.
Kimchy further discloses that the one or more rangefinders comprises an ultrasound transducer and detector. [see column 18, lines 1-18 of Kimchy]
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 method of Knowland as modified by Rozenfeld and Keppel further such that the one or more rangefinders comprise an ultrasound transducer and detector according to the teachings of Kimchy in order to provide a method of position tracking and imaging at the same time using ultrasound imaging. Doing so would have been applying a known position detection method of ultrasound imaging to the device of Knowland which was ready for improvement resulting in predictable and improved results which would have been obvious to try by a person of ordinary skill level in the art.
Regarding claim 15, Knowland as modified by Rozenfeld and Keppel discloses all the limitations of claim 1 above. [see rejection of claim 1]
Knowland as modified by Rozenfeld and Keppel does not disclose utilizing the position of the subject to estimate a position of bone within the subject.
Kimchi further discloses utilizing the position of the subject to estimate a position of bone within the subject. [see column 15, lines 32-48 disclosing providing an image of the bone (the method is performed utilizing the tracking system). Since imaging an anatomy localizes it, it has been considered in the broadest reasonable interpretation as exultant to locating the bone]
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 method of Knowland as modified by Rozenfeld and Keppel further and utilize the position of the subject to estimate a position of bone within the patient according to the teachings of Kimchi in order to create an image of internal structures such as bone to determine the source of the radiation with greater accuracy [see column 15, lines 40-45 of Kimchi]
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Knowland et al. (U.S. Publication No. 2015/0276937) hereinafter “Knowland” in view of Fymat et al. (U.S. patent No. 4,682,604) hereinafter “Fymat”, Rozenfeld et al. (U.S. 2008/0161632) hereinafter “Rozenfeld”, and Keppel et al. (U.S. Patent No. 7,711,409) hereinafter “Keppel”.
Regarding claim 16, Knowland discloses a system for the ex vivo real-time detection over a period of time of radiation emitted by a subject from the administration of a radioactive analyte that decays in vivo [see abstract of Knowland], the system comprising:
two or more ex vivo radiation measurement sensors [see FIG. 11 and [0123] disclosing placing the radiation sensor 11 at various points on the body] to detect radiation over the period of time and to produce signal data associated with the period of time, [see [0118]; radiation over a desired period is detected and recoded in storage] the two or more ex vivo radiation measurement sensors adapted to sensing radiation proximate to a point of administration on the subject of the radioactive analyte [see FIG. 11 and [0123] disclosing placing the radiation sensor 11 at various points on the body including directly over the tumor] and
a signal amplifier [amplifier 33; see [0087]] in operable communication with the two or more ex vivo radiation measurement sensors [see [0093]-[0094] the amplifier receives signal from the sensor output], the signal amplifier adapted to amplify the signal data, the two or more ex vivo measurement sensors having at least one sensor output for such amplified signal data[see [0094] of Knowland];
at least one computer processor [control processor 42] and a non-transient memory, the computer processor in operable communication with the non-transient memory [see [0095]; a local memory, external memory remote computer memory, network memory, or internet memory] and the sensor output; wherein the non-transient memory includes computer program code executable by the at least one computer processor, the computer program code configured for performing the steps of receiving the amplified signal data with the period of time, [see [0095] of Knowland], and using the amplified signal data to estimate a function of radioactive material proximate the point of injection as a function of time from a time of injection to time t. [Knowland discloses proper or improper administration of the radioactive material by fitting the data at the cite of the injection. It is inherent that any determination of radioactivity provides an estimate of the amount of radioactive material see FIG. 11 and [0011],[0017], [0123]-[0124] and [0177]-[178]]
wherein the radioactive material proximate the point of administration at time t is measured using the two or more ex vivo radiation measurement sensors [see FIG. 11 and [0123] disclosing placing the radiation sensor 11 at various points on the body including directly over the tumor]
and further wherein radioactivity of the radioactive material being measured can be determined [Knowland discloses proper or improper administration of the radioactive material by fitting the data at the site of the injection. It is inherent that any determination of radioactivity provides an estimate of the amount of radioactive material see FIG. 11 and [0011],[0017], [0123]-[0124] and [0177]-[178].]
Knowland does not disclose that the ex vivo radiation measurement sensors are disposed within a deformable cuff comprising two or more detector plates, wherein the two or more detector plates are joined by a pivot point between each pair of detector plates having a sensor for measuring a relative angle between the pair of detector plates in real time such that the relative positions of the two or more sensors disposed within the two or more detector plates are known in real time; and further wherein a radioactivity, location, and volume of the radioactive material being measured can be determined
Fymat, directed towards radiation detector arrays [see abstract of Fymat] discloses that the radiation detectors are disposed within a deformable cuff comprising two or more detector plates,[see FIG. 3 of Fymat] wherein the two or more detector plates are joined by a pivot point between each pair of detector plates [see FIG. 2 of Fymat] having a sensor for measuring a relative angle between the pair of detector plates in real time such that the relative positions of the two or more sensors disposed within the two or more detector plates are known in real time;[see column 7, lines 20-30 of Fymat]
Rozenfeld, directed towards determining a dose rate [see abstract of Rozenfeld], discloses estimating a location of the radioactive source in the body [see [0028]-[0031] of Rozenfeld; “the method includes determining the location of said source from increases detected by detectors for which the greatest increase in observed”; see also [0095] disclosing “the three coordinates of the seed are then deduced derived from the three detector readings”]
Keppel, directed towards in diagnosis and biopsy of radioactive tracers with a detector in a subject [see abstract of Keppel] further discloses determining a volume of radioactive source in the body [see [0064]; the background noise is subtracted from the spectra, resulting in a value which can be directly proportional to the volume]
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 system of Knowland further and make it such that the radiation detectors are disposed within a deformable cuff comprising two or more detector plates, wherein the two or more detector plates are joined by a pivot point between each pair of detector plates having a sensor for measuring a relative angle between the pair of detector plates in real time such that the relative positions of the two or more sensors disposed within the two or more detector plates are known in real time according to the teachings of Fymat in order to form an arrangement for the array of detectors with known angles and locations from each other and increase the accuracy of radiation source location.
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 method of Knowland further such that it includes estimating a location of the radioactive source in the body according to the teachings of Rozenfeld in order to allow for monitoring radiation dose or source location and allows for controlling the dose in the exact desired location [see [0011] of Rozenfeld].
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 method of Knowland further such that it includes estimating a volume of the radioactive source in the body according to the teachings of Keppel in order to help with the diagnosis of the tumors and distinguish true-positive cases from false positive cases in the diagnosis process [see [0062] of Keppel]
Conclusion
No claim is allowed.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795