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 .
Claims 1 – 27 are presented for examination.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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, 7, 10-13, 16, 19-20, 22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chien et al. “Bubble Technique for Evaluating Effective Dose of Diagnostic X-rays: a Feasibility Study”, J. Radiat. Res., Vol. 50, No. 5, 2009, pg.449-456 as evidence by Harper et al. “Superheated Drop, “Bubble”, Dosimeters, U.S. Naval Academy, Annapolis, MD, 1991, pg.107 – 124.
Regarding claim 1, Chien et al. disclose: A phantom for radiotherapy and/or medical imaging systems, the phantom (pg.449 abstract) comprising: one or more simulated anatomical structures comprised of a tissue mimicking soft material (pg.450 col.2 Table 1); and a radiosensitive inclusion, wherein the radiosensitive inclusion is configured to form a bubble when exposed to radiation, wherein the bubble is detectable via imaging with the medical imaging system (pg.449 abstract, BTI-GAMMA bubble detector, Intro. superheated liquid droplet detector). On of ordinary in the art therefore recognizes that the BTI-GAMMA bubble detector of Chien et al. is a radiosensitive inclusion, wherein the radiosensitive inclusion is configured to form a bubble when exposed to radiation, wherein the bubble is detectable via imaging with the medical imaging system as evidence by Harper et al. (pg.107 Intro teaches Superheated Drop Dosimeters that can be vaporized, pg.110 last para. teaches BTI, pg.109 teaches the bubbles can be re-compressed under applied external pressure), thereby fully anticipating the limitations recited in the claim.
Regarding claim 2, Chien et al. disclose: the phantom is configured to be pressurized such that the bubble is re-compressed into liquid form (the claim is rejected on the same basis as claim 1).
Regarding claim 7, Chien et al. as evidence by Harper et al. disclose: the radiosensitive inclusion is positioned inside at least one of the one or more simulated anatomical structures (pg.450 col.1 3rd para., col.2 Table 1).
Regarding claim 10, Chien et al. as evidence by Harper et al. disclose: the radiosensitive inclusions require high linear energy transfer radiation as the radiation to vaporize (see pg.107 Intro. of Harper et al.).
Regarding claim 11, Chien et al. as evidence by Harper et al. disclose: the radiosensitive inclusion comprises a superheated droplet at room temperature (pg.449 Abstract & Intro.).
Regarding claim 12, Chien et al. as evidence by Harper et al. disclose: a simulated bone having a greater hardness than the tissue mimicking soft material (pg.453 col.2 2nd para. teaches a rib).
Regarding claim 13, Chien et al. as evidence by Harper et al. disclose: A method for making a phantom for radiotherapy and/or medical imaging, the method comprising: providing a first material with a second material therein, wherein the second material is different than the first material and comprises a tissue mimicking soft material; and providing a radiosensitive inclusion within at least one of the first material and the second material, wherein the radiosensitive inclusion is configured to form a bubble when exposed to radiation, and wherein the bubble is detectable via imaging with the medical imaging system (the claim is rejected on the same basis as claim 1, additionally see pg.453 of Chien et al. col.2 2nd para. teaches different materials like soft tissue, rib, spine).
Regarding claim 16, Chien et al. as evidence by Harper et al. disclose: when the radiosensitive inclusion has been vaporized to form the bubble, pressurizing the phantom such that the bubble is re-compressed into liquid form (the claim is rejected on the same basis as claim 2).
Regarding claim 19, Chien et al. as evidence by Harper et al. disclose: the bubble is one of multiple bubbles that the radiosensitive inclusion is configured to form when exposed to radiation, further comprising calibrating the radiosensitive inclusion so that a number of the multiple bubbles vaporized indicates a radiation dose (pg.450 col.2 2nd para.).
Regarding claim 20, Chien et al. as evidence by Harper et al. disclose: irradiating the phantom with high linear energy transfer radiation to cause the radiosensitive inclusion to vaporize and form the bubble; and pressurizing the phantom such that the bubble is re-compressed into liquid form (pg.107 Intro., pg.109 Devices Tested of Harper et al.).
Regarding claim 22, Chien et al. as evidence by Harper et al. disclose: providing a simulated bone within the first material, the simulated bone having a greater hardness than the tissue mimicking soft material (the claim is rejected on the same basis as claim 1, additionally see pg.453 of Chien et al. col.2 2nd para. teaches different materials like soft tissue, rib, spine, ribs are surrounded by soft tissue).
Claims 23-24, 26-27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Boutchko et al. (US 2010/0167251 A1; pub. Jul. 1, 2010).
Regarding claim 23, Boutchko et al. disclose: A phantom for radiotherapy and/or medical imaging systems, the phantom comprising: a first material; a simulated anatomical structure positioned within the first material (para. [0030] human torso around the rib cage), wherein the anatomical structure is comprised of a second material that is different than the first material and comprises a tissue mimicking soft material (para. [0030] teaches mimicking a real rib cage, item 110 represents a human torso, a human torso is primarily made of soft tissue), wherein the simulated anatomical structure comprises a simulated gastrointestinal tract (para. [0039]); and at least two ports in fluid communication with the simulated gastrointestinal tract (para. [0039]), wherein the at least two ports allow fluid to flow through the phantom (para. [0039]).
Regarding claim 24, Boutchko et al. disclose: plugs operable to seal the at least two ports to selectively seal a liquid and/or a gas within the simulated gastrointestinal tract (para. [0039]).
Regarding claim 26, Boutchko et al. disclose: a simulated bone within the first material, the simulated bone having a greater hardness than the tissue mimicking soft material (the claim is rejected on the same basis as claim 23).
Regarding claim 27, Boutchko et al. disclose: at least partially filling the simulated gastrointestinal tract with a known volume via at least one of the two ports and imaging the phantom while the simulated gastrointestinal tract is partially filled with the known volume (para. [0039]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 3-4, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chien et al. “Bubble Technique for Evaluating Effective Dose of Diagnostic X-rays: a Feasibility Study”, J. Radiat. Res., Vol. 50, No. 5, 2009, pg.449-456 as evidence by Harper et al. “Superheated Drop, “Bubble”, Dosimeters, U.S. Naval Academy, Annapolis, MD, 1991, pg.107 – 124.
Regarding claim 3, Chien et al. as evidence by Harper et al. disclose: the phantom is configured to be pressurized (see rejection of claim 2). The combined references are silent about: the phantom is configured to withstand at least 100 PSIG for at least 10 minutes. However, "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Chien et al. as evidence by Harper et al. disclose: the phantom comprises a simulated lung, and wherein the simulated lung is configured to withstand the at least 100 PSIG for the at least 10 minutes (the claim is rejected on the same basis as claim 1, additionally see pg.450 col.2 table 1 & pg.453 col.1 1st para.).
Regarding claim 21, Chien et al. as evidence by Harper et al. disclose: providing a simulated lung within the first material, and further comprising, when the radiosensitive inclusion has been vaporized to form the bubble, pressurizing the phantom such that the bubble is re-compressed into liquid form (Chien et al. teach simulated lungs in pg.452 col.2 last para. – pg.453 col.1 1st para., Harper et al. teach that the Bubble detectors are re-compressed by applying external pressure in pg.109, pg.112 teaches the Bubble detectors are used in phantoms). The combined references are silent about: the simulated lung is configured to withstand at least 100 PSIG for at least 10 minutes without damage thereto while the bubble is re-compressed into the liquid form. However, "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 5-6, 9, 14-15, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chien et al. “Bubble Technique for Evaluating Effective Dose of Diagnostic X-rays: a Feasibility Study”, J. Radiat. Res., Vol. 50, No. 5, 2009, pg.449-456 as evidence by Harper et al. “Superheated Drop, “Bubble”, Dosimeters, U.S. Naval Academy, Annapolis, MD, 1991, pg.107 – 124 in view of Boutchko et al. (US 2010/0167251 A1; pub. Jul. 1, 2010).
Regarding claim 5, the combined references are silent about: the one or more simulated anatomical structures comprise a simulated gastrointestinal tract having at least two ports that allow fluid to flow through the phantom.
In a similar field of endeavor Boutchko et al. disclose: the one or more simulated anatomical structures comprise a simulated gastrointestinal tract having at least two ports that allow fluid to flow through the phantom (para. [0039]) motivated by the benefits for a real time dosimetry for the purpose of radiation therapy planning experiments (Boutchko et al. para. [0019]).
In light of the benefits a real time dosimetry for the purpose of radiation therapy planning experiments as taught by Boutchko et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Chien et al. and Harper et al. with the teachings of Boutchko et al.
Regarding claim 6, the combination of Chien et al., Harper et al. and Boutchko et al. disclose: plugs operable to seal the at least two ports to selectively seal a liquid and/or a gas therein (the claim is rejected on the same basis as claim 5 because the use of plugs is obvious in light of the teachings of Boutchko et al. for preventing leaks during measurements).
Regarding claim 9, the combined references are silent about: the one or more simulated anatomical structures include a simulated gastrointestinal tract configured to be at least partially fillable.
In a similar field of endeavor Boutchko et al. disclose: the one or more simulated anatomical structures include a simulated gastrointestinal tract configured to be at least partially fillable (para. [0039]) motivated by the benefits for a real time dosimetry for the purpose of radiation therapy planning experiments (Boutchko et al. para. [0019]).
In light of the benefits a real time dosimetry for the purpose of radiation therapy planning experiments as taught by Boutchko et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Chien et al. and Harper et al. with the teachings of Boutchko et al.
Regarding claim 14, the combined references are silent about: providing a simulated gastrointestinal tract through the phantom such that the simulated gastrointestinal tract extends from an entrance to an exit each open at an outside of the phantom, allowing flow through the phantom.
In a similar field of endeavor Boutchko et al. disclose: providing a simulated gastrointestinal tract through the phantom such that the simulated gastrointestinal tract extends from an entrance to an exit each open at an outside of the phantom, allowing flow through the phantom (para. [0039]) motivated by the benefits for a real time dosimetry for the purpose of radiation therapy planning experiments (Boutchko et al. para. [0019]).
In light of the benefits a real time dosimetry for the purpose of radiation therapy planning experiments as taught by Boutchko et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Chien et al. and Harper et al. with the teachings of Boutchko et al.
Regarding claim 15, Boutchko et al. disclose: at least partially filling the simulated gastrointestinal tract with a liquid and/or a gas and closing the entrance and the exit to seal the liquid and/or gas therein (the claim is rejected on the same basis as claim 5 because the use of a seal is obvious in light of the teachings of Boutchko et al. for preventing leaks during measurements).
Regarding claim 17, Chien et al. as evidence by Harper et al. disclose: applying external pressure to the bubble detectors to re-compress them for reuse (see rejection of claim 1). The combined references are silent about: providing a simulated gastrointestinal tract through the phantom such that the simulated gastrointestinal tract extends from an entrance to an exit each open at an outside of the phantom, further comprising unsealing at least one of the entrance and the exit before pressurizing the phantom such that pressure inside the simulated gastrointestinal tract equilibrates with the outside of the phantom.
In a similar field of endeavor Boutchko et al. disclose: providing a simulated gastrointestinal tract through the phantom such that the simulated gastrointestinal tract extends from an entrance to an exit each open at an outside of the phantom (para. [0039]) motivated by the benefits for a real time dosimetry for the purpose of radiation therapy planning experiments (Boutchko et al. para. [0019]).
In light of the benefits a real time dosimetry for the purpose of radiation therapy planning experiments as taught by Boutchko et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Chien et al. and Harper et al. with the teachings of Boutchko et al.
Boutchko et al. are silent about: unsealing at least one of the entrance and the exit before pressurizing the phantom such that pressure inside the simulated gastrointestinal tract equilibrates with the outside of the phantom. However, it would have been obvious to one of ordinary in the art to: unsealing at least one of the entrance and the exit before pressurizing the phantom such that pressure inside the simulated gastrointestinal tract equilibrates with the outside of the phantom since bubble detectors are re-compressed in order to reuse them.
Regarding claim 18, the combined references are silent about: pressurizing the phantom comprises applying at least 100 PSIG of pressure for at least 10 minutes. However, "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chien et al. “Bubble Technique for Evaluating Effective Dose of Diagnostic X-rays: a Feasibility Study”, J. Radiat. Res., Vol. 50, No. 5, 2009, pg.449-456 as evidence by Harper et al. “Superheated Drop, “Bubble”, Dosimeters, U.S. Naval Academy, Annapolis, MD, 1991, pg.107 – 124 in view of Ansell et al. (WO 2017/017426 A1; pub. Feb. 2017).
Regarding claim 8, the combined references are silent about: the one or more simulated anatomical structures include at least one simulated lung having high acoustic impedance.
In a similar field of endeavor Ansell et al. disclose: the one or more simulated anatomical structures include at least one simulated lung having high acoustic impedance (para. [00246]) motivated by the benefits for real-time organ monitor (Ansell et al. para. [0020]).
In light of the benefits for real-time organ monitor as taught by Ansell et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Chien et al. and Harper et al. with the teachings of Ansell et al.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Boutchko et al. (US 2010/0167251 A1; pub. Jul. 1, 2010) in view of Ansell et al. (WO 2017/017426 A1; pub. Feb. 2017).
Regarding claim 25, Boutchko et al. are silent about: the one or more simulated anatomical structures further comprise at least one simulated lung having high acoustic impedance.
In a similar field of endeavor Ansell et al. disclose: the one or more simulated anatomical structures further comprise at least one simulated lung having high acoustic impedance (para. [00246]) motivated by the benefits for real-time organ monitor (Ansell et al. para. [0020]).
In light of the benefits for real-time organ monitor as taught by Ansell et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Boutchko et al. with the teachings of Ansell et al.
Conclusion
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/MAMADOU FAYE/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884