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 .
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims status: amended claims: 1, 10; canceled claims: 2, 11; the rest is unchanged.
Response to Arguments
Applicant’s arguments filed 07/27/2026 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a newly found primary reference.
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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 1, 4-6, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015).
Regarding claim 1, Sarazin et al. disclose: ß-ray therapy apparatus (fig.1B), comprising a therapy apparatus body(fig.1B), and a conformable assembly (fig.2A item 140), wherein the therapy apparatus body comprises a ß-ray source (fig.1B item 155, para. [0101]), and a ß- ray shielding assembly provided with a mounting chamber (fig.1B item 130) and a window (fig.1B item 145) communicating with the mounting chamber; the ß-ray source is mounted in the mounting chamber; the conformable assembly comprises a conformable frame and a plurality of conformable sheets (the collimator 140 as shown in fig.2A comprises two opposing sheets to define aperture 145), a transmission area is formed in a middle of the conformable frame (fig.1B item 1145), wherein the conformable frame is an annular frame (fig.1B item 140), is configured to fit on a skin surface at one side of the conformable frame and buckle the therapy apparatus body at another side of the conformable frame (para. [0034], 0071]) a hollow region of the annular frame is the transmission area (fig.1B items 140 & 145),
Sarazin et al. are silent about: the plurality of conformable sheets are arranged on the conformable frame, and are able to move towards or away from the transmission area; a conformable area surrounding a site to be treated is formed in the transmission area by adjusting positions of the plurality of conformable sheets; and the ß-ray source emits ß-rays towards the conformable area through the window; the plurality of conformable sheets are divided into two groups, and two groups of the plurality of conformable sheets are slidingly arranged on two opposite sides of the annular frame, respectively
In a similar field of endeavor Kobayashi et al. the plurality of conformable sheets are arranged on the conformable frame, and are able to move towards or away from the transmission area; a conformable area surrounding a site to be treated is formed in the transmission area by adjusting positions of the plurality of conformable sheets (fig.15A & B items 11, A5 & A6); and the radiation source emits rays towards the conformable area through the window; the plurality of conformable sheets are divided into two groups, and two groups of the plurality of conformable sheets are slidingly arranged on two opposite sides of the annular frame, respectively (fig.15A & B items 11, A5 & A6) motivated by the benefits a scalable radiation beam.
In light of the benefits for a scalable radiation beam, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the conformable frame of Kobayashi et al. in the apparatus of Sarazin et al.
Regarding claim 4, the combination of Sarazin et al. and Kobayashi et al. disclose: a β-ray irradiation window, wherein the β-ray irradiation window is mounted at the window, and comprises one or more blocking sheets; and the blocking sheets move with respect to the window to change a size and shape of the window for adjusting an irradiation range of the β-ray emitted by the β-ray source (the claim is rejected on the same basis as claim 1).
Regarding claim 5, the combination of Sarazin et al. and Kobayashi et al. disclose: the one or more blocking sheets are arranged on the β-ray shielding assembly in a penetrating manner, and move towards or away from the window to shield or open the window (the claim is rejected on the same basis as claim 1).
Regarding claim 6, the combination of Sarazin et al. and Kobayashi et al. disclose: when a plurality of blocking sheets are provided, the plurality of blocking sheets are divided into two groups, and the two groups of blocking sheets are slidingly arranged on two opposite sides of the p-ray shielding assembly, respectively (the claim is rejected on the same basis as claim 1).
Regarding claim 19, the combination of Sarazin et al. and Kobayashi et al. disclose: a β-ray irradiation window, wherein the β-ray irradiation window is mounted at the window, and comprises one or more blocking sheets; and the blocking sheets move with respect to the window to change a size and shape of the window for adjusting an irradiation range of the p-rays emitted by the β-ray source (the claim is rejected on the same basis as claim 1).
Claims 3 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) and further in view of Xie et al. (CN115920253A; pub. Apr. 7, 2023).
Regarding claim 3, the combined references are silent about: a periphery of the β-ray shielding assembly is provided with a plurality of first binding ring buckles, a periphery of the conformable frame is provided with a plurality of second binding ring buckles, and the first binding ring buckles and the second binding ring buckles are respectively configured for connecting with elastic straps.
In a similar field of endeavor Xi et al. disclose: a periphery of the β-ray shielding assembly is provided with a plurality of first binding ring buckles, a periphery of the conformable frame is provided with a plurality of second binding ring buckles, and the first binding ring buckles and the second binding ring buckles are respectively configured for connecting with elastic straps (para. [0018], [0034]) motivated by the benefits for a shielding frame that is easy to attached on a patient (Xi et al. para. [0017]-[0018]).
In light of the benefits for a shielding frame that is easy to attached on a patient as taught by Xi 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 use the shielding frame of Xie et al. in the apparatus of Sarazin et al. and Kobayashi et al.
Regarding claim 20, the combination of Sarazin et al., Kobayashi et al. and Xi et al. disclose: a ß- ray irradiation window, wherein the ß-ray irradiation window is mounted at the window, and comprises one or more blocking sheets; and the blocking sheets move with respect to the window to change a size and shape of the window for adjusting an irradiation range of the ß-rays emitted by the ß-ray source (the claim is rejected on the same basis as claim 3).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) and further in view of Kasper et al. (US 7,386,099 B1; pub. Jun. 10, 2008).
Regarding claim 7, the combined references are silent about: the two groups of blocking sheets are arranged in one-to-one correspondence to form a plurality of pairs of blocking sheets; in each pair of blocking sheets, one blocking sheet is provided with a V-shaped protrusion, and an other blocking sheet is provided with a V-shaped groove in fit with the V-shaped protrusion; and the V-shaped protrusion and the V-shaped groove extend in a width direction of the window.
In a similar field of endeavor Kasper et al. disclose: the two groups of blocking sheets are arranged in one-to-one correspondence to form a plurality of pairs of blocking sheets; in each pair of blocking sheets, one blocking sheet is provided with a V-shaped protrusion, and an other blocking sheet is provided with a V-shaped groove in fit with the V-shaped protrusion; and the V-shaped protrusion and the V-shaped groove extend in a width direction of the window (col.4 L44-57) motivated by the benefits for a scalable beam.
In light of the benefits for a scalable beam, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the V-shaped groove Kasper et al. in the apparatus of Sarazin et al. and Kobayashi et al.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) and further in view of Roberts et al. (US 2016/0184605 A1; pub. Jun. 30, 2016).
Regarding claim 8, the combined references are silent about: a controller, wherein the controller is mounted on an outer side of the ß-ray shielding assembly, and comprises a display screen, an operation button, a dose measuring assembly, and an alerting or alarming assembly.
In a similar field of endeavor Roberts et al. disclose: a controller, wherein the controller is mounted on an outer side of the β-ray shielding assembly, and comprises a display screen (para. [0056]), an operation button (para. [0057] teaches a computer a computer has operation buttons), a dose measuring assembly (para. [0016]), and an alerting or alarming assembly (para. [0074]) motivated by the benefits for improved radiation dose delivery accuracy.
In light of the benefits for improved radiation dose delivery accuracy, 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 Sarazin et al. and Kobayashi et al. with the teachings of Roberts et al.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) in view of Roberts et al. (US 2016/0184605 A1; pub. Jun. 30, 2016) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) in view of Masteller et al. (US 2022/0176154 A1; pub. Jun. 9, 2022) and further Yu et al. (US 2022/0249042 A1; pub. Aug. 11, 2022).
Regarding claim 9, the combined references are silent about: an auxiliary device, wherein the auxiliary device comprises a supporting base, a host, and a mechanical arm; the supporting base is provided with a groove for placing the therapy apparatus body, the host is fixedly mounted on the mechanical arm, the host is provided with a closed storage area, and the mechanical arm is provided with a clamp for clamping the therapy apparatus body.
In a similar field of endeavor Roberts et al. disclose: an auxiliary device (fig.8 the capsule (1), the arm (26) the part that arm (26) is attached to), wherein the auxiliary device comprises a host (the part opposite to the capsule (1) and attached to the other end of the arm (26)), and a mechanical arm (fig.8 arm (26)); the host is fixedly mounted on the mechanical arm, and the mechanical arm is provided with a clamp for clamping the therapy apparatus body (para. [0123]) motivated by the benefits for improved radiation dose delivery accuracy.
In light of the benefits for improved radiation dose delivery accuracy, 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 Sarazin et al. and Kobayashi et al. with the teachings of Roberts et al.
Roberts et al. are silent about: the auxiliary device comprises a supporting base, the supporting base is provided with a groove for placing the therapy apparatus body, the host is provided with a closed storage area.
In a similar field of endeavor Masteller et al. disclose: the auxiliary device comprises a supporting base (fig.6A item 213, para. [0093]), the supporting base is provided with a groove for placing the therapy apparatus body (fig.6A items 218 & 214) motivated by the benefits for securing the therapy apparatus body.
In light of the benefits for securing the therapy apparatus body, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the supporting base of Masteller et al. in the apparatus of Sarazin et al., Kobayashi et al. and Roberts et al.
Masteller et al. are silent about: the host is provided with a closed storage area.
In a similar field of endeavor Yu et al. disclose: the host is provided with a closed storage area (fig.16 shows a mobile cart, mobile carts are known in the art to have a storage area, para. [0123]) motivated by the benefits for a compact therapy apparatus that is easy maneuver.
In light of the benefits for a compact therapy apparatus that is easy maneuver, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the host of Yu et al. in the apparatus of Sarazin et al., Kobayashi et al., Roberts et al. and Masteller et al.
Claims 10, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) and further in view of Ali et al. “A new 3D printed applicator with radioactive gel for conformal brachytherapy of superficial skin tumors”, 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), IEEE Oct. 2019, pg. 6979 – 6982.
Regarding claim 10, the combination of Sarazin et al. and Kobayashi et al. disclose all the limitations of claim 10 except (see rejection of claim 1) for applying ointment or gel to the site to be treated.
In a similar field of endeavor Ali et al. disclose: applying ointment or gel to the site to be treated (pg.6980 col.2 III Results) motivated by the benefits for uniform radiation (Ali et al. pg.6980 col.2 III Results).
In light of the benefits for uniform radiation as taught by Ali 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 use the ointment of Ali et al. in the method of Sarazin et al. and Kobayashi et al.
Regarding claim 13, the combination of Sarazin et al., Kobayashi et al. and Ali et al. disclose: a β-ray irradiation window, wherein the β-ray irradiation window is mounted at the window, and comprises one or more blocking sheets; and the blocking sheets move with respect to the window to change a size and shape of the window for adjusting an irradiation range of the p-rays emitted by the β-ray source (the claim is rejected on the same basis as claim 10).
Regarding claim 14, the combination of Sarazin et al., Kobayashi et al. and Ali et al. disclose: the one or more blocking sheets are arranged on the p-ray shielding assembly in a penetrating manner, and move towards or away from the window to shield or open the window (the claim is rejected on the same basis as claim 10).
Regarding claim 15, the combination of Sarazin et al., Kobayashi et al. and Ali et al. disclose: a plurality of blocking sheets are provided, the plurality of blocking sheets are divided into two groups, and the two groups of blocking sheets are slidingly arranged on two opposite sides of the p-ray shielding assembly, respectively (the claim is rejected on the same basis as claim 10).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) and further in view of Ali et al. “A new 3D printed applicator with radioactive gel for conformal brachytherapy of superficial skin tumors”, 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), IEEE Oct. 2019, pg. 6979 – 6982 and further in view of Xie et al. (CN115920253A; pub. Apr. 7, 2023).
Regarding claim 12, the combination of Sarazin et al., Kobayashi et al. and Ali et al. are silent about: a periphery of the β-ray shielding assembly is provided with a plurality of first binding ring buckles, a periphery of the conformable frame is provided with a plurality of second binding ring buckles, and the first binding ring buckles and the second binding ring buckles are respectively configured for connecting with elastic straps.
In a similar field of endeavor Xi et al. disclose: a periphery of the β-ray shielding assembly is provided with a plurality of first binding ring buckles, a periphery of the conformable frame is provided with a plurality of second binding ring buckles, and the first binding ring buckles and the second binding ring buckles are respectively configured for connecting with elastic straps (para. [0018], [0034]) motivated by the benefits for a shielding frame that is easy to attached on a patient (Xi et al. para. [0017]-[0018]).
In light of the benefits for a shielding frame that is easy to attached on a patient as taught by Xi 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 use the shielding frame of Xie et al. in the apparatus of Sarazin et al., Kobayashi et al. and Ali et al.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) in view of Ali et al. “A new 3D printed applicator with radioactive gel for conformal brachytherapy of superficial skin tumors”, 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), IEEE Oct. 2019, pg. 6979 – 6982 and further in view of Kasper et al. (US 7,386,099 B1; pub. Jun. 10, 2008).
Regarding claim 16, the combined references are silent about: the two groups of blocking sheets are arranged in one-to-one correspondence to form a plurality of pairs of blocking sheets; in each pair of blocking sheets, one blocking sheet is provided with a V-shaped protrusion, and an other blocking sheet is provided with a V-shaped groove in fit with the V-shaped protrusion; and the V-shaped protrusion and the V-shaped groove extend in a width direction of the window.
In a similar field of endeavor Kasper et al. disclose: the two groups of blocking sheets are arranged in one-to-one correspondence to form a plurality of pairs of blocking sheets; in each pair of blocking sheets, one blocking sheet is provided with a V-shaped protrusion, and an other blocking sheet is provided with a V-shaped groove in fit with the V-shaped protrusion; and the V-shaped protrusion and the V-shaped groove extend in a width direction of the window (col.4 L44-57) motivated by the benefits for a scalable beam.
In light of the benefits for a scalable beam, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the V-shaped groove Kasper et al. in the method of Sarazin et al., Kobayashi et al. and Ali et al.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) in view of Ali et al. “A new 3D printed applicator with radioactive gel for conformal brachytherapy of superficial skin tumors”, 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), IEEE Oct. 2019, pg. 6979 – 6982 and further in view of
Regarding claim 17, the combined references are silent about: a controller, wherein the controller is mounted on an outer side of the ß-ray shielding assembly, and comprises a display screen, an operation button, a dose measuring assembly, and an alerting or alarming assembly.
In a similar field of endeavor Roberts et al. disclose: a controller, wherein the controller is mounted on an outer side of the β-ray shielding assembly, and comprises a display screen (para. [0056]), an operation button (para. [0057] teaches a computer a computer has operation buttons), a dose measuring assembly (para. [0016]), and an alerting or alarming assembly (para. [0074]) motivated by the benefits for improved radiation dose delivery accuracy.
In light of the benefits for improved radiation dose delivery accuracy, 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 Sarazin et al., Kobayashi et al. and Ali et al. with the teachings of Roberts et al.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sarazia et al. (US 2024/0207640 A1; pub. Jun. 74, 2024) in view of Kobayashi et al. (US 2015/0272520 A1; pub. Oct. 1, 2015) in view of Ali et al. “A new 3D printed applicator with radioactive gel for conformal brachytherapy of superficial skin tumors”, 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), IEEE Oct. 2019, pg. 6979 – 6982 in view of Roberts et al. (US 2016/0184605 A1; pub. Jun. 30, 2016) in view of Masteller et al. (US 2022/0176154 A1; pub. Jun. 9, 2022) and further Yu et al. (US 2022/0249042 A1; pub. Aug. 11, 2022).
Regarding claim 18, the combined references are silent about: an auxiliary device, wherein the auxiliary device comprises a supporting base, a host, and a mechanical arm; the supporting base is provided with a groove for placing the therapy apparatus body, the host is fixedly mounted on the mechanical arm, the host is provided with a closed storage area, and the mechanical arm is provided with a clamp for clamping the therapy apparatus body.
In a similar field of endeavor Roberts et al. disclose: an auxiliary device (fig.8 the capsule (1), the arm (26) the part that arm (26) is attached to), wherein the auxiliary device comprises a host (the part opposite to the capsule (1) and attached to the other end of the arm (26)), and a mechanical arm (fig.8 arm (26)); the host is fixedly mounted on the mechanical arm, and the mechanical arm is provided with a clamp for clamping the therapy apparatus body (para. [0123]) motivated by the benefits for improved radiation dose delivery accuracy.
In light of the benefits for improved radiation dose delivery accuracy, 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 Sarazin et al., Kobayashi et al. and Ali et al. with the teachings of Roberts et al.
Roberts et al. are silent about: the auxiliary device comprises a supporting base, the supporting base is provided with a groove for placing the therapy apparatus body, the host is provided with a closed storage area.
In a similar field of endeavor Masteller et al. disclose: the auxiliary device comprises a supporting base (fig.6A item 213, para. [0093]), the supporting base is provided with a groove for placing the therapy apparatus body (fig.6A items 218 & 214) motivated by the benefits for securing the therapy apparatus body.
In light of the benefits for securing the therapy apparatus body, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the supporting base of Masteller et al.in the method of Sarazin et al., Kobayashi et al., Ali et al. and Roberts et al.
Masteller et al. are silent about: the host is provided with a closed storage area.
In a similar field of endeavor Yu et al. disclose: the host is provided with a closed storage area (fig.16 shows a mobile cart, mobile carts are known in the art to have a storage area, para. [0123]) motivated by the benefits for a compact therapy apparatus that is easy maneuver.
In light of the benefits for a compact therapy apparatus that is easy maneuver, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the host of Yu et al. in the method of Sarazin et al., Kobayashi et al., Ali et al., Ali et al. and Masteller et al.
Conclusion
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/MAMADOU FAYE/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
