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 .
Drawings
The replacement drawing filed 11/17/25 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The shape, channels, orientation, and positioning of the cooling module as shown in the new drawings are not supported by the original disclosure.
Applicant is required to cancel the new matter in the reply to this Office Action.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the movable closure must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a cooling module” in claim 1; and
“a filtration stage contiguous to the outlet opening and also surrounded by the reflective cover, to filter the neutron beam before it exits the device via the said outlet opening ; where said filtration stage comprises at least three layers: a rapid neutron filtration layer, a thermal neutron filtration layer and a gamma-radiation filtration layer” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 1-5, 7-12, 14-17, and 19-23 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 1-5, 7-12, 14-17, and 19-23 are further rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the claim limitation “cooling module ” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a nonce term – module, describes a function – cooling, and the claims recite insufficient structure/material/steps to achieve said function. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claims are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Further, the claim lacks written description support and is rejected under 35 U.S.C. 112(a).
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-5, 7-12, 14-17, 19-21, 23 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/164408 A1 [Tsuchida] in view of Rasouli, Fatemeh S., S. Farhad Masoudi, and Yaser Kasesaz. "Design of a model for BSA to meet free beam parameters for BNCT based on multiplier system for D–T neutron source." Annals of Nuclear Energy 39.1 (2012): 18-25 [hereinafter Rasouli].
Regarding Claim 1:
Tsuchida teaches a device for the production, moderation and configuration of a neutron beam, based on the production of neutrons from a proton beam (abstract), comprising:
an inlet opening through which the proton beam is directed (see inset annotated Fig. 2 (A));
a target arranged in the path of direction of the proton beam in order to nuclearly interact with said beam and produce a neutron beam which defines a main axis of propagation (Fig. 2 (5));
a cooling module (“ a coolant channel for cooling the target material by flowing cooling water is formed inside the metal substrate”);
a moderator contiguous to the target (Fig. 2 (21A)), with a thickness (W2) from the target and in the direction of the beam to a filtration stage, of between 19.62 and 23.98 cm (“The moderator main body 21A preferably has a thickness (length in the irradiation direction of the charged particle beam 6) (LB) of 20.0 cm or more and 35.0 cm or less”), where the neutrons produced in the nuclear interaction are moderated to energies of the epithermal range (“when the moderator (21A, 21B) is made of magnesium fluoride, the neutron beam emitted from the target 5 is mainly decelerated to the energy band of the epithermal neutron beam, and most of the fast neutrons are absorbed. Therefore, the mixing rate of fast neutrons can be reduced, and high intensity epithermal neutron beams can be emitted”),
a reflective cover surrounding the moderator to redirect diverted neutrons to the main axis and increase the epithermal neutron flux (Fig. 2 (22));
an outlet opening through which the neutron beam exits (see inset annotated Fig. 2 (B)); and
a shield arranged around the outlet opening to suppress the neutrons and gamma-radiation that do not exit the device via said outlet opening (Fig. 2 (23)).
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However, Tsuchida fails to teach a filtration stage contiguous to the outlet opening and also surrounded by the reflective cover, to filter the neutron beam before it exits the device via the said outlet opening ; where said filtration stage comprises at least three layers: a rapid neutron filtration layer, a thermal neutron filtration layer and a gamma-radiation filtration layer.
This limitation is interpreted under 35 USC 112(f) to correspond to the three plus layer filtering structure shown in Fig. 1 (L1-L3) and described in the instant spectification.
Rasouli teaches a neutron beam source (abstract) further comprising a filtration stage contiguous to the outlet opening (Fig. 11(4-6)) and also surrounded by the reflective cover (surrounded by reflective Pb), to filter the neutron beam before it exits the device via the said outlet opening (as explained in section 3.1); where said filtration stage comprises at least three layers: a rapid neutron filtration layer ((4)), a thermal neutron filtration layer ((5)) and a gamma-radiation filtration layer ((6)).
It would have been obvious to one of ordinary skill in the art before the effective time of filing to add the filtering structure of Rasouli to Tsuchida. One would have been motivated to do so in order to improve the beam parameters for treatment purposes. Rasouli section 3.1.
Regarding Claim 2:
The modified invention of claim 1 teaches the device according to the preceding claim, wherein the total thickness of the moderator (L4+L5) is comprised between 24.64 and 36.96 cm, covering the target and part of the tube of the accelerator to the inlet opening (Tsuchida Fig. 2, “The moderator main body 21A preferably has a thickness (length in the irradiation direction of the charged particle beam 6) (LB) of 20.0 cm or more and 35.0 cm or less”).
Regarding Claim 3:
The modified invention of claim 2 teaches the device according to the preceding claim, wherein the moderator (3) is manufactured with at least one of the following materials: graphite, D2O, AlF3 CaF2, Li2CO3, MgF2, Al2O3, or combinations thereof (Tsuchida “Both the moderator main body 21A and the upstream side moderator 21B are preferably made of magnesium fluoride (MgF2)”).
Regarding Claim 4:
The modified invention of claim 3 teaches the device according to the preceding claim, wherein the moderator (3) is manufactured with MgF2 (Tsuchida “Both the moderator main body 21A and the upstream side moderator 21B are preferably made of magnesium fluoride (MgF2)”).
Regarding Claim 5:
The modified invention of claim 1 teaches the device for the production, moderation and configuration of a neutron beam according to claim 1, but fails to teach that the rapid neutron filtration layer comprised in the filtration stage has a thickness (L1) of 1.00 cm ±15%.
Optimizing the thickness of the filtration layers is well within the bounds of normal experimentation. See MPEP 2144.05 II (A). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.” In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In the case at hand, Rasouli teaches a 4 cm thickness of Fe, but demonstrates in Fig. 7 that the layer’s thickness is a variable which achieves a recognized result. Therefore, the prior art teaches adjusting the thickness and identifies said thickness as result-effective variables. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective time of filing to optimize the thickness to meet the claimed 1 cm since it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.
Regarding Claim 7:
The modified invention of claim 1 teaches the device for the production, moderation and configuration of a neutron beam according to claim 1, but fails to teach that the gamma-radiation filtration layer comprised in the filtration stage (5) has a thickness (L3) of 1.00 cm ±15%
Optimizing the thickness of the filtration layers is well within the bounds of normal experimentation. See MPEP 2144.05 II (A). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.” In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In the case at hand, Rasouli teaches a 2.6 cm thickness of Bi, but demonstrates in Fig. 10 that the layer’s thickness is a variable which achieves a recognized result. Therefore, the prior art teaches adjusting the thickness and identifies said thickness as result-effective variables. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective time of filing to optimize the thickness to meet the claimed 1 cm since it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.
Regarding Claim 8:
The modified invention of claim 5 teaches the device according to claim 5, characterized in that the rapid neutron filtration layer comprises Al, Fe or Ni. Rasouli Fig. 11 (4) is Fe.
Regarding Claim 9:
The modified invention of claim 8 teaches the device according to the preceding claim, but fails to teach that the rapid neutron filtration layer is manufactured with Al. However, Tsuchida teaches manufacturing reinforcing materials in layers out of Aluminum. As such, it would have been obvious to one of ordinary skill in the art before the effective time of filing to manufacture the rapid neutron filtration layer with an Al reinforcing layer in order to stabilize its structure.
Regarding Claim 10:
The modified invention of claim 5 teaches the device according to claim 5, characterized in that the thermal neutron filtration layer comprises 10B, 6Li, Gd, Cd or LiF. Rasouli Fig. 11 (5) is Li.
Regarding Claim 11:
The modified invention of claim 10 teaches the device according to the preceding claim, but fails to teach that the thermal neutron filtration layer is manufactured with LiF. Tsuchida teaches manufacturing neutron filtering materials in layers out of LiF. As such, it would have been obvious to one of ordinary skill in the art before the effective time of filing to manufacture the thermal neutron filtration layer with LiF in order to effectively moderate neutron beams.
Regarding Claim 12:
The modified invention of claim 5 teaches the device according to claim 5, characterized in that the gamma-radiation filtration layer comprises Pb or Bi. Rasouli Fig. 11 (6) is Bi.
Regarding Claim 14:
The modified invention of claim 5 teaches the device according to claim 5, wherein the gamma-radiation filtration layer is arranged last according to the direction of travel of the neutron beam produced. Rasouli Fig. 11 (6).
Regarding Claim 15:
The modified invention of claim 14 teaches the device according to the preceding claim, wherein the rapid neutron filtration layer, the thermal neutron filtration layer and the gamma-radiation filtration layer are arranged in that order according to the direction of travel of the neutron beam produced. Rasouli Fig. 11 (4)-(6) are so arranged.
Regarding Claim 16:
The modified invention of claim 1 teaches the device according to claim 1, but fails to teach that the reflective cover surrounding the moderator to redirect diverted neutrons to the main axis, has a thickness of 25.00 cm ±40% from the moderator to the inlet opening, in the direction of the beam.
Optimizing the thickness of the reflective layers is well within the bounds of normal experimentation. See MPEP 2144.05 II (A). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.” In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In the case at hand, Tsuchida teaches a 20 cm thickness of reflector at Lu, and explain that the layer’s thickness is a variable which achieves a recognized result with respect to fast neutron contamination rate. Therefore, the prior art teaches adjusting the thickness and identifies said thickness as result-effective variables. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective time of filing to optimize the thickness to meet the claimed 25 cm since it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.
Regarding Claim 17:
The modified invention of claim 1 teaches the device according to claim 1, wherein the reflective cover (4) comprises at least one of the following materials: Ni, Pb, BeO or Bi. (Tsuchida -“The reflector 22 is made of a material having a large neutron scattering cross section. Examples of the material of the reflector 22 include graphite, iron, lead, and beryllium.”).
Regarding Claim 19:
The modified invention of claim 1 teaches the device according to claim 1,
with an outlet opening having a diameter A±2δ, having the following radial dimensions: (Tsuchida 8-20cm)
Diameter (Ø2) of the rear part of the moderator: A±2δ+36 cm ±10% (Tsuchida 40-60cm)
Inner radius (R1) of the collimator of the front shield (7): (0.5 A±δ+3 cm ±10%) (Tsuchida 8-20cm in diameter, thus 4-10 in radius)
Outer radius (R2) of the collimator of the front shield (7): (0.5 A±δ+22.5 cm ±50%) (Tsuchida 40-60cm, thus 20-30 in radius).
However, the modified invention fails to teach that
the Diameter (Ø3) of the cover: A±2δ+106 cm ±15% and
the Diameter (Ø4) of the device: A±2δ+116 cm ±20%.
Optimizing the diameters of the cover and device is well within the bounds of normal experimentation. See MPEP 2144.05 II (A). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.” In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In the case at hand, Rasouli teaches the effect of the reflective material, and explain that the layer’s radius is a variable which achieves a recognized result with respect to reflective capabilities. Therefore, the prior art teaches adjusting the diameter and identifies said diameter as result-effective variables. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective time of filing to optimize the device to meet the claimed diameters since it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.
Regarding Claim 20:
The modified invention of claim 1 teaches the device according to claim 1, wherein the target comprises 7Li and the nuclear interaction with the incident proton beam is 7Li(p,n)7Be. As described in Tsuchida “When lithium or beryllium is used as a target material…”
Regarding Claim 21:
The modified invention of claim 1 teaches the device according to claim 1, wherein the outlet opening for the neutron beam comprises at least one section with one of the following geometries: cylindrical, conical, prismatic, truncated pyramid. Tsuchida Fig. 2.
Regarding Claim 23:
The modified invention of claim 1 teaches the device according to claim 1, wherein the shield arranged around the outlet opening for the neutron beam comprises at least one of the following materials: LiF, 6LiF, B4C, polyethylene, Pb, Bi. Tsuchida - “Moreover, you may comprise only with the shielding material made from a cadmium or a cadmium alloy, and you may use together the shielding material made from bismuth.”
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/164408 [Tsuchida] in view of Rasouli, Fatemeh S., S. Farhad Masoudi, and Yaser Kasesaz. "Design of a model for BSA to meet free beam parameters for BNCT based on multiplier system for D–T neutron source." Annals of Nuclear Energy 39.1 (2012): 18-25 [hereinafter Rasouli] as applied to claim 1, and further in view of US 5,433,693 [Ott].
Regarding Claim 22:
The above modified invention teach the device according to claim 1, but fails to teach that the outlet opening for the neutron beam comprises a movable closure to stop irradiation.
Ott teaches a neutron capture therapy system including a vertically slidable shutters at the outlet to stop irradiation (5:39-45). It would have been obvious to one of ordinary skill in the art before the effective time of filing to add the shutters of Ott to the above modified invention. One would have been motivated to do so since this would improve user control of target irradiation.
Response to Arguments
Applicant's arguments filed 11/17/25 have been fully considered but they are not persuasive.
The replacement drawings submitted are new matter. The sections of the disclosure cited to support the structures shown therein are inadequate.
Applicant argues that the “movable closure” feature of claim 22 need not be illustrated because it is recited as an optional feature in the specification. This is an erroneous reading of the relevant rules and laws. The applicant has chosen to claim this feature, so it is clearly not optional. As such, an illustration must be provided.
Applicant argues that neither “cooling module” nor “movable closure” should be interpreted under 35 USC 112(f). With respect to “movable closure,” this is persuasive, as closures, without any particular functional limitations attached thereto, are sufficiently well understood by one of ordinary skill in the art. On the other hand, “cooling module” is still interpreted under 35 USC 112(f). One of ordinary skill in the art could not reasonably ascertain what particular assembly is being referenced by such a phrase, nor could they determine how it is arranged in a device for producing neutrons. A “module” is clearly a placeholder or nonce term, and it is attached to the function of cooling. Further, the claims provide no structure or materials or acts that could otherwise perform such a function. As such, interpretation under 35 USC 112(f) is necessary.
Since “cooling module” is still interpreted under 35 USC 112(f), the 112(a) and (b) rejections thereof related to the insufficiency of the disclosure are maintained.
Applicant argues that Tsuchida fails to teach a shield arranged around the outlet opening, because it is arranged before the outlet opening. This is not persuasive. The broadest reasonable interpretation of “around” is not “surround”, but rather includes situations such as this one, where the shield is adjacent to the opening along an axial direction while encompassing the axial space of the opening in a radial direction. This is a common usage of “around” in most any context, for example, “there is a parking lot around the store” does not imply that the store is buried in the parking lot, but rather that parking lot defines an area that the store is encompassed by.
Applicant argues that the preferred ranges of Tsuchida teach away from the claimed ranges. This is not persuasive, as one of ordinary skill in the art would have easily considered the whole scope of the disclosure, not just the preferred embodiments.
Applicant argues that the prior art fails to adequately teach the cooling module. This is not persuasive, as there is no indicated difference between prior art references’ cooling module and the cooling module disclosed in the instant specification.
Applicant argues that the references individually fail to teach the various claimed measurements. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the references, when taken together by one of ordinary skill in the art, at least suggest the dimensions claimed.
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 WYATT A STOFFA whose telephone number is (571)270-1782. The examiner can normally be reached M-F 0700-1600 EST.
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WYATT STOFFA
Primary Examiner
Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881