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 .
Status of Claims
Claims 1–19 are under examination.
Response to Amendment
Applicant’s amendments overcome the 112(b) rejections of claims 9 and 17, which are withdrawn.
Allowable Subject Matter
Claims 2 and 3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claims 2 and 3 essentially recite that the scanning pattern (claim 2) and generatrixes (claim 3) extend along an axis that is transverse to the two previously recited transverse axes, meaning the features are in three dimensions. Brown as cited teaches horizontal and vertical movement but does not reasonably teach the remaining transverse axis, which would be into and out of the page. Nor would it appear that such a modification would be possible with Brown’s equipment or desirable.
Response to Arguments
Applicant's arguments, see Remarks dated 10/09/2025, have been fully considered but they are not persuasive for the reasons detailed below.
Applicant argues that the cited focuser (Brown, fig. 2, focuser including magnets 108) cannot read on the claim 1 limitation where the focuser is configured to focus the scanned beam over a plane towards a point located on the irradiation axis, wherein the plane is defined by said irradiation axis and a transverse (perpendicular) axis. This argument fails for two reasons:
Applicant states that the beam only follows the straight (90 degree) path 118 when the magnets 108 are essentially off. Applicant argues that this means the magnets 108 and their associated controlling mechanisms cannot therefore focus the scanned beam on the straight path. Examiner disagrees. The magnets 108 control the degree of deflection of beam 104 which includes upper/lower maximum deflections at 116/114 and no deflection at 118. This means that the amount of current, including “essentially no current” (Brown, ¶ 20) controls the amount of deflection of the beam 104. The controller 112 setting a current level of essentially zero is still a controller that is controlling the amount of deflection of the beam 104. In other words, the controller 112 controls the magnets 108, and the controller may be set to allow the beam 104 to pass along undeflected on path 118; therefore, the focusing magnets 108 still control the deflection level of beam 104, even when there is essentially no current passing through them.
Brown discloses claim 1 even if path 118 is not the embodiment cited. Brown discloses claim 1 when upper deflection path 116 or lower deflection path 114 are cited as the “irradiation axis.” The “focuser” clause in claim 1 simply states that there exists an imaginary plane that may be drawn perpendicular to the beam path. Such a plane may be drawn for any of the paths 116, 118, or 114.
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.
Claims 18 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 18 recites both a method (lines 1-3 and lines 30-33) and an apparatus (lines 4-29). A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). In Katz, a claim directed to “A system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. In re Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
Any claim not specifically addressed in this section that depends from a rejected claim is also rejected under 35 U.S.C. 112(b) for its dependency upon an above–rejected claim and for the same reasons.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18 and 19 are rejected under 35 U.S.C. 101 because
the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 18 recites both a method (lines 1-3 and lines 30-33) and an apparatus (lines 4-29).
Any claim not specifically addressed in this section that depends from a rejected claim is also rejected under 35 U.S.C. 101 for its dependency upon an above–rejected claim and for the same reasons.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code 103 not included in this action can be found in a prior Office action.
Claims 1, 4–7, 9–16, and 18–19 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2012/0025105) in view of Freudenberger (US 2020/0187339).
Regarding claim 1, Brown discloses (fig. 1) a system for producing radioisotopes, the system comprising: an electron accelerator (102) configured to generate an electron beam (104) of accelerated electrons along an irradiation axis (any axis within the range defined by upper and lower limits 116 and 114); a scanner (106, which begins just to the right of the arrow at the end of 104) configured to deviate the electron beam along a scanning pattern to form a scanned beam (122); a focuser (108 and its associated control mechanisms 110, 112, 132) comprising one or more magnets (108) configured to focus the scanned beam over an irradiation plane towards a focusing point (the focusing point may be any point, shown by range 134, on the vertical platform that holds mount 128; this point is controlled by instructions provided via the monitoring system 132 to the controller 112 and ultimately to the magnets 108) located on the irradiation axis, to form a focused beam, wherein the irradiation plane is defined by the irradiation axis and a transverse axis, the transverse axis being perpendicular to the irradiation axis (an imaginary plane may be drawn that is perpendicular to the point where the path [within the range defined between 116 and 114] contacts the vertical platform holding 128); a converting unit (124) located between the focuser and the focusing point, and comprising one or more bremsstrahlung converters (“a converter plate 124, such as a Bremsstrahlung converter,” ¶ 22), the converting unit configured to convert the focused beam into a photon beam (“x-rays,” ¶ 23), wherein each of the one or more bremsstrahlung converters is shaped such that the focused beam intersects the one or more bremsstrahlung converters (within 124) with an intersecting angle between 65° and 115° degrees at a plurality of points (e.g., focused electron beam on path 118 intersects with converter 124 at 90°, and paths 114 and 116 appear to form an intersection angle with 124 at about 5-7° below 90°; other points will be within this range defined by where 116 and 114 intersect 124); a converter cooling system (“simply cooled Bremsstrahlung converters,” ¶ 32) configured to cool the one or more bremsstrahlung converters; and a target holder (128) configured for holding a target (126), wherein the electron accelerator, the scanner, the focuser, the converting unit, and the target holder are aligned along the irradiation axis and arranged in sequence along a direction of the electron beam (as shown by the dotted lines in in fig. 1).
Brown does not explicitly state wherein said one or more bremsstrahlung converters have a shape that is curved.
Freudenberger does. Freudenberger is in the same art area of converting electron beams to photon radiation (abstract) and teaches (e.g., one suitable embodiment shown in Fig. 7) using a converter (4) with a curved shape. A purpose for this teaching is, as described by Freudenberger (¶ 54), because “a curved shape, which increases the surface impacted by electrons and consequently increases the amount of x-ray radiation produced.”
The combination of the curved shape of Freudenberger with the converter of Brown would have produced a radioisotope production system wherein electrons impacted a curved plate to produce bremsstrahlung photons, i.e., Applicant's claimed invention.
This combination would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, as it produces no unexpected results. In view of the prior art teachings of Brown, a person of ordinary skill would have predicted that combining Freudenberger’s curved shape with Brown's converter plate would have produced Applicant's claimed invention of an electron-to-photon conversion system utilizing a curved converter plate. The skilled person’s motivation for the combination would have been the expectation of, as described by Freudenberger (¶ 54), because “a curved shape, which increases the surface impacted by electrons and consequently increases the amount of x-ray radiation produced.”
Regarding claim 4, Brown in view of Freudenberger teaches all the elements of the parent claim, and Brown additionally teaches wherein the focuser (108) is configured for forming the focused beam (the electron beam 104 enters the scan horn 106 and exits it 122, capable of staying on path 118 or deviating towards 114 or 116, ¶ 21), with a focusing half-angle formed at the focusing point with the irradiation axis on the irradiation plane.
Brown in view of Freudenberger does notexplicitly recite that this angle maybe optimized to be between 20 and 55°. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have optimized the angle to be within the claimed range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Examiner finds no evidence of record that the optimization of the claimed angle to be within the claimed range would have a surprising or unexpected result to the ordinary skilled artisan. Moreover, because the skilled artisan would have been motivated to utilize the curved shape of Freudenberger for the reasons described above in response to claim 1, the skilled artisan would therefore also be motivated to optimize the curvature based on the desired amount of photon radiation desired, as described by Freudenberger in ¶ 54, where they note that more curvature means more impact surface area: “a curved shape, which increases the surface impacted by electrons and consequently increases the amount of x-ray radiation produced.”
Regarding claim 5, Brown in view of Freudenberger teaches all the elements of the parent claim, and this combination additionally teaches wherein each of the one or more bremsstrahlung converters (Brown, 124) has a curved cross-section (e.g., as taught by Freudenberger in Fig. 9) in the first irradiation plane defined by a substantially circular arc of radius centered on the first focusing point, wherein the substantially circular arc includes a curved segment having a radius of curvature that is not more than 10% over a length of the curved cross-section.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have optimized the degree of curvature variation to be more like that shown in Freudenberger’s Figure 7, Figure 8, or Figure 9, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Examiner finds no evidence of record that the optimization of the claimed curvature variation to be within the claimed range would have a surprising or unexpected result to the ordinary skilled artisan. Moreover, because the skilled artisan would have been motivated to utilize the curved shape of Freudenberger for the reasons described above in response to claim 1, the skilled artisan would therefore also be motivated to optimize the curvature and variation thereof based on the desired amount of photon radiation desired, as described by Freudenberger in ¶ 54, where they note that the degree of curvature means more impact surface area: “a curved shape, which increases the surface impacted by electrons and consequently increases the amount of x-ray radiation produced.”
Regarding claim 6, Brown in view of Freudenberger teaches all the elements of the parent claim, and this combination additionally teaches wherein the irradiation plane is a first irradiation plane; the curved cross-section is a first curved cross-section; the focusing point is a first focucsing point; and each of the one or more bremsstrahlung converters (Brown, 124) has a second curved cross-section in the second irradiation plane defined by a substantially circular arc of radius centered on the second focusing point, wherein the second focusing point is the same as the first focusing point (e.g., as modified by the curvatures taught by Freudenberger in Fig. 7 or Fig. 8 or Fig. 9).
The skilled artisan would have been motivated to utilize the curved shape of Freudenberger for the reasons described above in response to claim 1.
Regarding claim 7, Brown in view of Freudenberger teaches all the elements of the parent claim, and this combination additionally teaches wherein each of the one or more bremsstrahlung converters (Brown, 124) has a thickness along a radius of curvature (as modified above by Freudenberger), the thickness being not more than 3 millimeters: Brown teaches that the converter has a thickness (“the x-ray intensity is a function of the thickness of material that the electrons must pass through,” ¶ 22), and Brown suggests no more than 25 microns (¶ 59).
The skilled artisan would have been motivated to utilize the curved shape of Freudenberger for the reasons described above in response to claim 1.
Regarding claim 9, Brown in view of Freudenberger teaches all the elements of the parent claim, and Brown additionally teaches wherein the one or more bremsstrahlung converters (124) comprise no more than eight bremsstrahlung converters (1 is no more than 8) and when the one or more bremsstrahlung converters comprise at least two bremsstrahlung converters, the at least two bremsstrahlung converters are separated from one another by cooling channels (everything following when is optional, see MPEP 2143.03 (“Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art.”); however, Examiner notes that Brown teaches cooling channels: “simply cooled Bremsstrahlung converters,” ¶ 32).
Regarding claim 10, Brown in view of Freudenberger teaches all the elements of the parent claim, and Brown additionally teaches wherein the converter cooling system comprises gas or liquid forced cooling (“simply cooled Bremsstrahlung converters,” ¶ 32; Examiner notes that this process refers to passing water or gas over the surface of the converter).
Regarding claim 11, Brown in view of Freudenberger teaches all the elements of the parent claim, and Brown additionally teaches wherein the one or more bremsstrahlung converters are made of tantalum or tungsten or titanium (“tungsten or tantalum,” ¶ 22).
Regarding claim 12, Brown in view of Freudenberger teaches all the elements of the parent claim, and Brown additionally teaches wherein the intersecting angle is between 75° and 105° (e.g., focused electron beam on path 118 intersects with converter 124 at 90°, and paths 114 and 116 appear to form an intersection angle with 124 at about 5-7° below 90°).
Regarding claim 13, Brown in view of Freudenberger teaches all the elements of the parent claim, and Freudenberger additionally teaches wherein each of the one or more bremsstrahlung converters is in a shape of a spherical cap (as suggested by Freudenberger in the embodiments shown in Figs. 7-9). The skilled artisan would have been motivated to utilize the curved shape of Freudenberger for the reasons described above in response to claim 1.
Regarding claim 14, Brown in view of Freudenberger teaches all the elements of the parent claim, and Brown additionally teaches the focusing half-angle, as cited above in response to claim 14.
Brown in view of Freudenberger does explicitly recite that this angle maybe optimized to be between 30° and 45°.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have optimized the angle to be within the claimed range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Examiner finds no evidence of record that the optimization of the claimed angle to be within the claimed range would have a surprising or unexpected result to the ordinary skilled artisan. Moreover, because the skilled artisan would have been motivated to utilize the curved shape of Freudenberger for the reasons described above in response to claim 1, the skilled artisan would therefore also be motivated to optimize the curvature based on the desired amount of photon radiation desired, as described by Freudenberger in ¶ 54, where they note that more curvature means more impact surface area: “a curved shape, which increases the surface impacted by electrons and consequently increases the amount of x-ray radiation produced.”
Regarding claims 15 and 16, Brown in view of Freudenberger teaches all the elements of the parent claims, and this combination additionally teaches wherein each of the one or more bremsstrahlung converters has a thickness: Brown teaches that the converter has a thickness (“the x-ray intensity is a function of the thickness of material that the electrons must pass through,” ¶ 22), and Brown suggests no more than 25 microns (¶ 59 and “Other thicknesses are also possible.”).
This combination does not explicitly suggest the optimized ranges being between 0.2 and 2.5 millimeters or between 0.5 and 1.5 millimeters
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have optimized the thickness to be within the claimed ranges, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Examiner finds no evidence of record that the optimization of the claimed thickness to be within the claimed ranges would have a surprising or unexpected result to the ordinary skilled artisan. As noted by Brown, the skilled artisan would have been motivated to utilize the desired thickness based on the x-ray intensity: “the x-ray intensity is a function of the thickness of material that the electrons must pass through,” ¶ 22. Brown also states that “Other thicknesses are also possible,” ¶ 59.
Regarding claim 18, Brown discloses a method (Fig. 1) for producing a radioisotope of a target, the method comprising: providing a system for producing radioisotopes, the system comprising: an electron accelerator (102) configured to generate an electron beam (104) of accelerated electrons along an irradiation axis (any axis within the range defined by upper and lower limits 116 and 114); a scanner (106, which begins just to the right of the arrow at the end of 104) configured to deviate the electron beam along a scanning pattern to form a scanned beam (122); a focuser (108 and its associated control mechanisms 110, 112, 132) comprising one or more magnets (108) configured to focus the scanned beam over an irradiation plane towards a focusing point (the focusing point may be any point, shown by range 134, on the vertical platform that holds mount 128; this point is controlled by instructions provided via the monitoring system 132 to the controller 112 and ultimately to the magnets 108) located on the irradiation axis, to form a focused beam, wherein the irradiation plane is defined by the irradiation axis and a transverse axis, the transverse axis being perpendicular to the irradiation axis (an imaginary plane may be drawn that is perpendicular to the point where the path [within the range defined between 116 and 114] contacts the vertical platform holding 128); a converting unit (124) located between the focuser and the focusing point, and comprising one or more bremsstrahlung converters (“a converter plate 124, such as a Bremsstrahlung converter,” ¶ 22), the converting unit configured to convert the focused beam into a photon beam (“x-rays,” ¶ 23), wherein each of the one or more bremsstrahlung converters is shaped such that the focused beam intersects the one or more bremsstrahlung converters (within 124) with an intersecting angle between 65° and 115° degrees at a plurality of points (e.g., focused electron beam on path 118 intersects with converter 124 at 90°, and paths 114 and 116 appear to form an intersection angle with 124 at about 5-7° below 90°; other points will be within this range defined by where 116 and 114 intersect 124); a converter cooling system (“simply cooled Bremsstrahlung converters,” ¶ 32) configured to cool the one or more bremsstrahlung converters; and a target holder (128) configured for holding a target (126), wherein the electron accelerator, the scanner, the focuser, the converting unit, and the target holder are aligned along the irradiation axis and arranged in sequence along a direction of the electron beam (as shown by the dotted lines in in fig. 1) loading the target (126) onto the target holder (128); scanning and focusing an accelerated electron beam (104) onto the converting unit (124) to produce X-ray (“x-rays,” ¶ 23); and irradiating the target (126) with the X-ray (“x-rays,” ¶ 23).
Regarding claim 19, Brown in view of Freudenberger teaches all the elements of the parent claim, and Brown additionally teaches wherein the target includes one of 226Ra for producing 225Ac, or 100Mo for forming 99'Tc or 186W for producing 187Re or 134Xe to form 131I, or 68Zn for producing 67Cu (Brown, ¶ 30).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Brown with Freudenberger, as combined above, further in view of Rotsch (US 2023/0040941).
Regarding claims 8 and 17, Brown in view of Freudenberger teaches all the elements of the parent claim, and Brown additionally teaches bremsstrahlung converter (124, Fig. 1) but does not explicitly teach a second converter, although it is implied (e.g., “Bremsstrahlung converters can be used,” ¶ 32).
Rotsch is in the same art area of generating photons from an electron beam via converters and teaches (Fig. 2) using multiple converters (e.g., 120A, 120M, 120R), wherein the one or more bremsstrahlung converters comprise at least two bremsstrahlung converters (e.g., 120R and 120A), a first one (120R) of the at least two bremsstrahlung converters located nearest the target holder (124) having a larger thickness than a second one (120A)of the at least two bremsstrahlung converters located nearest the focuser/electron beam entrance, and wherein the at least two bremsstrahlung converters comprise three, four, or five bremsstrahlung converters (Rotsch Fig. 2 shows 17 converts 120n, which includes three, four, or five).
The skilled artisan would have been motivated to utilize multiple converters of increasing thickness as taught by Rotsch because, as explained by Rotsch in ¶ 16, this optimization creates a beneficial scenario “such that the peak heat density deposited in each plate due to an incoming electron beam is approximately equal. Such optimization more evenly distributes heat throughout the converter and reduces both the maximum and average temperature of the converter, compared to converter plates of equal thickness. Moreover, the converter design can result in fewer electrons reaching the target (downstream of the converter), depending on the total thickness of the converter plates, therefore reducing heat at the target and improving target survival.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LILY C GARNER whose telephone number is (571)272-9587. The examiner can normally be reached 9-5 CT.
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LILY CRABTREE GARNER
Primary Examiner
Art Unit 3646
/LILY C GARNER/ Primary Examiner, Art Unit 3646