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 Interpretation
Several of the claims use the term “proximate” to describe spatial relationships. This term has two similar but distinct meanings when describing spatial relationships. It can be interpreted to mean either that two elements are adjacent, or that they are near to each other. The claims use this term for elements that are disclosed be adjacent (“electron emitter positioned proximate the irradiation target” claim 1) but also for elements that are separated by an additional elements (“irradiation target positioned proximate the end of the neutron generator” claim 1, where there is known to be a moderator between the end of the neutron generator and the irradiation target in the disclosed embodiment, and “an electron emitter positioned proximate an end of the neutron generator” claim 10, wherein it is known that the irradiation target and neutron moderator are located between). Therefore, examiner will treat the term “proximate” to mean near each other, rather than adjacent.
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(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0255353 (Heibel) in view of US 10,441,815 (Akabori et al.).
Regarding claim 1, Heibel discloses a device for delivering delta radiation to a target region of an object using prompt neutron capture gamma radiation, the device comprising:
a neutron generator configured to generate a neutron flux field from an end of the neutron generator (fig. 1, element 32);
an irradiation target configured to emit gamma radiation in response to exposure to the neutron flux field, the irradiation target positioned proximate the end of the neutron generator (fig. 2, element 26, wherein “In another embodiment the first material 26 of the irradiation target 10 comprises a thin layer of natural Hafnium metal” P 30);
an electron emitter configured to emit delta radiation in response to exposure to the gamma radiation, the electron emitter positioned proximate the irradiation target, wherein the irradiation target is intermediate the electron emitter and the end of the neutron generator (fig. 2, element 28, wherein “In another embodiment the first material of the irradiation target comprises Hafnium metal; and a second material is a high atomic number such as Platinum or Gold. When hafnium absorbs a neutron, it immediately releases gamma photons … these photons collides with the electron clouds surrounding the Platinum or Gold atoms. This results in the release of many Compton and photoelectrical scattered electrons in the multi-MeV energy range.” P 18-19); and
radiation shielding, wherein the radiation shielding is configured to prevent at least some of the gamma radiation from exiting the device (“Preferably, the therapeutic source of highly ionizing, but weakly penetrating radiation is configured so it substantially only irradiates the carcinoma cells. To achieve that end a radiation shield material is formed on a side of the therapeutic source not facing the carcinoma cells.” P 8);
wherein the irradiation target comprises an irradiation target material having a high thermal neutron cross section (“In another embodiment the first material 26 of the irradiation target 10 comprises a thin layer of natural Hafnium metal” P 30).
The radiation shielding of Heibel does not surround at least a portion of the device, the at least a portion of the device comprising the end of the neutron generator and the irradiation target. Akabori et al. discloses a neutron capture therapy device with a radiation shielding surrounding at least a portion of the device, the at least a portion of the device comprising the end of the neutron generator and beam outlet (fig. 1, element 14C).
It would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the radiation shielding in Heibel to take the form disclosed in Akabori et al. because surrounding radiation shielding of Akabori shields not just from the gamma rays that are emitted by the irradiation target but from the neutron beams and the any additional secondary or tertiary radiation formed by the interactions at the irradiation target, moderator, or neutron generator (“The shielding body 14C shields the generated neutron rays N, secondary radiant rays, such as the gamma rays G generated in the target 14A with the generation of the neutron rays N, secondary radiant rays, such as the gamma rays G generated in the moderator 14B when the neutron rays N are decelerated by the moderator 14B, and suppresses emission of these radiant rays”).
Regarding claim 2, Heibel in view of Akabori et al. disclose the claimed invention except for the use of gadolinium-157 as the irradiation target material. Gadolinium-157 is known in the art to be an isotope that emits gamma radiation when irradiated with neutrons. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute gadolinium-157 for the Hafnium of Heibel because gadolinium-157 has a larger neutron cross-section and therefore more effectively converts the neutron beam into a gamma radiation.
Regarding claim 3, Heibel in view of Akabori et al. discloses the device of Claim 1, wherein the electron emitter comprises an electron emitter material, the electron emitter material comprising a high-Z material (“second material is a high atomic number such as Platinum or Gold.” P 18).
Regarding claim 4, Heibel in view of Akabori et al. disclose the claimed invention except for the electron emitter material being tungsten, or lead, or a combination thereof. Tungsten and lead are both well-known high-Z materials, and it would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute tungsten or lead for the gold or platinum because tungsten and lead are cheaper than gold and platinum.
Regarding claim 5, Heibel in view of Akabori et al. discloses the device of Claim 1, wherein the at least a portion of the device surrounded by the radiation shielding further comprises the electron emitter (obvious to surround this area to shield against radiation exiting through the sides of the electron emitter), and wherein the radiation shielding comprises an opening proximate the electron emitter (necessary for the electrons to reach target).
Regarding claim 6, Heibel in view of Akabori et al. discloses the device of Claim 1, wherein the radiation shielding is configured to prevent at least some of the neutron flux field from exiting the machine generator (“The shielding body 14C shields the generated neutron rays N, … suppresses emission of these radiant rays” Akabori et al.).
Regarding claim 7, Heibel in view of Akabori et al. discloses the device of Claim 1, further comprising a neutron moderator positioned between the end of the neutron generator and the irradiation target, wherein the neutron moderator is configured to optimize the exposure of the irradiation target to the neutron flux field (fig. 1, element 16).
Regarding claim 8, Heibel in view of Akabori et al. discloses the device of Claim 1, wherein the object is a patient and the target region is cancerous tissue (intended use, also elements 12 and 22).
Regarding claim 9, Heibel in view of Akabori et al. discloses the device of Claim 1, wherein the object is a semiconductor material (intended use).
Regarding claim 10, Heibel discloses a method for operating a device to deliver delta radiation using prompt neutron capture gamma radiation, wherein the device comprises a neutron generator, an electron emitter positioned proximate an end of the neutron generator, an irradiation target positioned intermediate the electron emitter and the end of the neutron generator, and radiation shielding, and the irradiation target (fig. 1, as a whole), wherein the method comprises:
generating, by the neutron generator, a neutron flux field from the end of the neutron generator (“In another embodiment this device uses electronic neutron generators to produce neutrons” P 7);
emitting, by the irradiation target comprising an irradiation target material having a high thermal neutron cross section, gamma radiation in response to exposure to the neutron flux field (“When Hafnium absorbs a neutron, it immediately releases a fairly high energy gamma photon.” P 7); and
emitting, by the electron emitter, delta radiation in response to exposure to the gamma radiation (“In addition to the gamma photon damage, when the gamma radiation collides with the dense electron clouds in the surrounding layers of material, large numbers of high energy Compton and photoelectrical scattered electrons are created.” P 7).
The radiation shielding of Heibel does not surround at least a portion of the device, the at least a portion of the device comprising the end of the neutron generator and the irradiation target. Akabori et al. discloses a neutron capture therapy device with a radiation shielding surrounding at least a portion of the device, the at least a portion of the device comprising the end of the neutron generator and beam outlet (fig. 1, element 14C).
It would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the radiation shielding in Heibel to take the form disclosed in Akabori et al. because surrounding radiation shielding of Akabori shields not just from the gamma rays that are emitted by the irradiation target but from the neutron beams and the any additional secondary or tertiary radiation formed by the interactions at the irradiation target, moderator, or neutron generator (“The shielding body 14C shields the generated neutron rays N, secondary radiant rays, such as the gamma rays G generated in the target 14A with the generation of the neutron rays N, secondary radiant rays, such as the gamma rays G generated in the moderator 14B when the neutron rays N are decelerated by the moderator 14B, and suppresses emission of these radiant rays”).
Regarding claim 11, Heibel in view of Akabori et al. disclose the claimed invention except for the use of gadolinium-157 as the irradiation target material. Gadolinium-157 is known in the art to be an isotope that emits gamma radiation when irradiated with neutrons. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute gadolinium-157 for the Hafnium of Heibel because gadolinium-157 has a larger neutron cross-section and therefore more effectively converts the neutron beam into a gamma radiation.
Regarding claim 12, Heibel in view of Akabori et al. disclose the method of claim 11, wherein the electron emitter comprises an electron emitter material, the electron emitter material comprising a high-Z material (“second material is a high atomic number such as Platinum or Gold.” P 18).
Regarding claim 13, Heibel in view of Akabori et al. disclose the claimed invention except for the electron emitter material being tungsten, or lead, or a combination thereof. Tungsten and lead are both well-known high-Z materials, and it would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute tungsten or lead for the gold or platinum because tungsten and lead are cheaper than gold and platinum.
Regarding claim 14, Heibel in view of Akabori et al. discloses the method of Claim 10, further comprising minimizing, by radiation shielding, the gamma radiation that escapes the device from the irradiation target in a direction away from the electron emitter (“The shielding body 14C shields the generated neutron rays N, secondary radiant rays, such as the gamma rays G generated in the target 14A with the generation of the neutron rays N, secondary radiant rays, such as the gamma rays G generated in the moderator 14B when the neutron rays N are decelerated by the moderator 14B, and suppresses emission of these radiant rays”).
Regarding claim 15, Heibel in view of Akabori et al. discloses the method of Claim 10, further comprising, preventing, by the radiation shielding, at least some of the neutron flux field from exiting the device (“The shielding body 14C shields the generated neutron rays N, … suppresses emission of these radiant rays” Akabori et al.).
Regarding claim 16, Heibel in view of Akabori et al. discloses the method of Claim 10, wherein the device further comprises a neutron moderator intermediate the irradiation target and the end of the neutron generator (fig. 1, element 16), the method further comprising optimizing, by a neutron moderator, the exposure of the irradiation target to the neutron flux field (“The method may also include the step of using a neutron moderating material between the electric neutron generator and the therapeutic source to adjust the neutron energy to optimize the highly ionizing, but weakly penetrating radiation produced by the therapeutic source.”).
Regarding claim 17, Heibel in view of Akabori et al. discloses the method of Claim 10, further comprising delivering the delta radiation to a target region within an object (“The system employs one or more therapeutic source material 10 (FIG. 2) with sufficient surface area to ensure that the entire volume of the localized carcinoma cells will be affected by the radiation emitted when exposed to a neutron field.” P 26).
Regarding claim 18, Heibel in view of Akabori et al. discloses the method of Claim 17, wherein delivering the delta radiation to the targe region comprises delivering a dose of delta radiation to the target region (“The dose of neutron irradiation applied.”).
Heibel in view of Akabori et al. does not disclose whether the dose is no less than 4000R in 2 minutes. However, Heibel does disclose that the dose is adjustable (“The dose of neutron irradiation applied can also be adjusted via neutron generator power according to the desired therapeutic effect in combination with the geometry of neutron generators 32 and neutron moderator 16. Likewise, the duration of irradiation can also be adjusted.”) and it would have been obvious to a person having ordinary skill in the art at the time the application was filed to control the dose to be less than 4000R in 2 minutes because higher doses result in more complete removal of the cancerous growths.
Regarding claim 19, Heibel in view of Akabori et al. discloses the claimed method except it is silent as to whether the target region receives a dose of the gamma radiation less than 2.5 REM. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to limit the dose of gamma radiation to less than 2.5 REM because gamma radiation has a higher incidence of damage to surrounding tissues, so converting as much of the gammas to delta radiation/electrons is preferrable to prevent such damage (see Heibel, “Since the range of the electrons produced is still very small relative to gamma radiation treatments, the damage to healthy tissue surrounding the cancerous area is minimized.”).
Regarding claim 20, Heibel in view of Akabori et al. discloses the method of Claim 10, further comprising, containing, by the electron emitter, the gamma radiation within the device (“A significant fraction of these photons collides with the electron clouds surrounding the Platinum or Gold atoms. This results in the release of many Compton and photoelectrical scattered electrons in the multi-MeV energy range. Since the range of the electrons produced is still very small relative to gamma radiation treatments, the damage to healthy tissue surrounding the cancerous area is minimized.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZA W OSENBAUGH-STEWART whose telephone number is (571)270-5782. The examiner can normally be reached 10am - 6pm Pacific Time M-F.
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/ELIZA W OSENBAUGH-STEWART/Primary Examiner, Art Unit 2881