DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
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 frame unit in claim 2, because it uses “unit” (MPEP 2181.I.A) coupled with functional language “for attaching and detaching the phantom and the radiation measurement instrument to/from the cylindrical casing in an integrated state” without citing sufficient structure to achieve the function. Furthermore the “unit” is not preceded by a structural modifier.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Regarding the frame unit, paragraphs 0052 discloses " The frame unit 50 is formed by combining a plurality of frames such that the frame unit 50 has a rectangular parallelepiped shape as a whole. For example, the water equivalent phantoms 40 and the radiation measurement instrument 41 are inserted into the frame unit 50 from above into the inside.” Thus, for the purpose of examination, the frame unit is interpreted to be a the structure described in paragraph 0052 and shown in figure 7.
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 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 2-5, 10, and 13 is 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.
Regarding claim 2, the claim limitation “a frame unit for attaching and detaching the phantom and the radiation measurement instrument to/from the cylindrical casing in an integrated state” is indefinite insofar as the examiner is unclear about the structure of “a frame unit for attaching and detaching the phantom and the radiation measurement instrument to/from the cylindrical casing in an integrated state” and it is impossible to determine the intending scope of the structure of “a frame unit for attaching and detaching the phantom and the radiation measurement instrument to/from the cylindrical casing in an integrated state” in claim 2. The claim states that the phantom and measurement instrument are both separate and removable from the casing and then also in “an integrated state” with the casing. The phantom and measurement instrument cannot be both separate and integral with the casing.
For the purpose of examination “in an integrated state” will be ignored.
Regarding claim 3 the limitation “an entrance window through which radiation is made incident is opened in a part of a cylindrical circumferential surface of the cylindrical casing” (emphasis added) is indefinite because it is a product and process in the same claim (see MPEP 2173.05(p)). This limitation is unclear when infringement begins because it is unclear if infringement occurs when one creates the apparatus that allows the user to execute the method or infringement occurs when the user actually executes the method. These ambiguities render the claim indefinite.
Regarding claim 4, the limitation “wherein a slit for checking a position of the radiation measurement instrument from outside is opened in a part of a cylindrical bottom surface of the cylindrical casing” (emphasis added) is indefinite because it is a product and process in the same claim (see MPEP 2173.05(p)). This limitation is unclear when infringement begins because it is unclear if infringement occurs when one creates the apparatus that allows the user to execute the method or infringement occurs when the user actually executes the method. These ambiguities render the claim indefinite.
Regarding claim 5, the limitation “a reader that is provided on the base and serves as a reference at a time of reading the scale” (emphasis added) is indefinite because it is a product and process in the same claim (see MPEP 2173.05(p)). This limitation is unclear when infringement begins because it is unclear if infringement occurs when one creates the apparatus that allows the user to execute the method or infringement occurs when the user actually executes the method. These ambiguities render the claim indefinite.
Regarding claim 10, the phrase "the base can be installed " renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In other words, is the pedestal apart of the claimed invention or merely the ability for the base to be placed on a pedestal.
Regarding claim 13 the limitation “A radiation measurement method to be executed by using the radiation-measurement-instrument support device according to claim 1, the radiation measurement method comprising steps of: installing the radiation-measurement-instrument support device inside a rotating gantry of a particle beam therapy system; adjusting orientation of the radiation measuring instrument by rotating the cylindrical casing in accordance with rotation of the rotating gantry; and measuring radiation emitted from an irradiation port of the rotating gantry by using the radiation measurement instrument.” is indefinite because it is a product and process in the same claim (see MPEP 2173.05(p)). This limitation is unclear when infringement begins because it is unclear if infringement occurs when one creates the apparatus that allows the user to execute the method or infringement occurs when the user actually executes the method. These ambiguities render the claim indefinite.
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.
Claims 1-2, 4-8, 10-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Olcott et al. WO 2018/081420 in view of Dyk et al. US 2005/00134063.
Regarding claim 1, Olcott teaches a radiation-measurement-instrument support device comprising: a cylindrical casing (#201) configured to house at least one phantom (#204) and a radiation measurement instrument (#206; para. 0031 “radiographic films” or “In some variations, the phantom module 200 may additionally or alternatively comprise radiation detectors (e.g., two-dimensional silicon, diamond, calorimetric or plastic scintillation detector arrays, thin-film detectors or sensors, etc.) located between two or more of the disk”) and formed in a cylindrical shape (figs. 2, 8D, 9C, 11); and a rotatable base (para. 0042).
Olcott fails to explicitly teach a base configured to rotatably support the cylindrical casing in a circumferential direction in a state where a cylindrical axis of the cylindrical casing is directed in a horizontal direction and fix the cylindrical casing at an arbitrary rotation angle in the circumferential direction; and an angle display configured to display the rotation angle.
Dyk teaches a base (figs. 2, 3 #13, 15, 16) configured to rotatably support the phantom casing (#11) and fix the casing at an arbitrary rotation (fig. 5b steps J-K); and an angle display configured to display the rotation angle (fig. 2; angle markers on #13, 16) for the purpose of aligning the phantom device (para. 0029).
Olcott and Dyk does not explicitly disclose the base supporting in a circumferential direction in a state where a cylindrical axis of the cylindrical casing is directed in a horizontal direction, however, it has been judiciarily determined that rearrangement of parts has been obvious to one of ordinary skill in the art (MPEP 2144.04.IV.C). Rearrangement of parts is insufficient to establish patentability over the prior art of record unless it changes the operation of the device in some unexpected way. Since this device appears to operate in a similar manner to the prior art device, the rearrangement of parts is not of patentable significance.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a base configured to rotatably support the cylindrical casing in a circumferential direction in a state where a cylindrical axis of the cylindrical casing is directed in a horizontal direction and fix the cylindrical casing at an arbitrary rotation angle in the circumferential direction; and an angle display configured to display the rotation angle as taught by Dyk in the device of Olcott for the purpose of aligning the phantom device.
Regarding claim 2, Olcott teaches a frame unit (#202) for attaching and detaching the phantom and the radiation measurement instrument to/from the cylindrical casing (para. 0006) in an integrated state.
Regarding claim 4, Olcott teaches a slit (para. 0044-0045, 0051) for checking a position of the radiation measurement instrument from outside (para. 0044-0045, 0051; apparatus claims cover what the device is not what it does, Olcott teaches a slit on the casing for the measurement instrument. Using the slit to check a position does not distinguish from the prior art since there is no structural distinction. See MPEP 2114.II.) is opened in a part of a cylindrical bottom surface of the cylindrical casing.
Regarding claim 5, Olcott fails to teach wherein the angle display comprises: a scale provided on a circumferential edge of a cylindrical bottom surface of the cylindrical casing; and a reader that is provided on the base and serves as a reference at a time of reading the scale.
Dyk teaches wherein the angle display comprises: a scale (fig. 2 #13, 16); and a reader that is provided on the base and serves as a reference at a time of reading the scale (fig. 2 #13, 16; scale implies reference point) for the purpose of alignment.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have wherein the angle display comprises: a scale provided on a circumferential edge of a cylindrical bottom surface of the cylindrical casing; and a reader that is provided on the base and serves as a reference at a time of reading the scale as taught by Dyk in the device of Olcott for the purpose of alignment.
Regarding claim 6, Dyk teaches a scale which a user uses to measure and read the rotation angle (fig. 2 #13, 16), but fails to teach a sensor that detects the rotation angle; and a computer-display that displays the rotation angle depending on a signal outputted by the sensor. However, it has been judiciarily determined that automating a manual activity has been obvious to one of ordinary skill in the art (MPEP 2144.III.). Automating a manual activity is insufficient to establish patentability over the prior art of record unless it changed the operation of the device in some unexpected way. Since this device appears to operate in a similar manner to the prior art device, the duplication of parts is not of patentable significance.
Regarding claim 7, Olcott teaches a driver configured to rotate the cylindrical casing (para. 0042); and a computer configured to control the driver (para. 0042; a motor and actuator implies a computer to control said motor and actuator).
Regarding claim 8, Olcott teaches the at least one phantom comprises a plurality of phantoms (fig. 2 #204); the plurality of phantoms are solid water equivalent phantoms (para. 0032 “Similarly, because the outer surface of a disk may be made of a plastic (i.e., non-PET-avid material and/or a material that is dosimetrically similar to water)”); a plurality of plate-shaped water equivalent phantoms are stacked one on top of the other (fig. 2); and a holding portion for holding the water equivalent phantoms and the radiation measurement instrument alongside is formed inside the cylindrical casing (fig. 2).
Regarding claim 10, Olcott fails to teach wherein: the base can be installed on an upper surface of a pedestal; an adjuster is provided at each of three or more locations on a bottom surface of the base.
Dyk teaches the base is on an upper surface of a pedestal (fig. 2 #15); an adjuster is provided at each of three or more locations on a bottom surface of the base (#23; para. 0032; claim 2) to properly level the device (para. 0032).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have wherein: the base can be installed on an upper surface of a pedestal; an adjuster is provided at each of three or more locations on a bottom surface of the base as taught by Dyk in the device of Olcott for the purpose of properly leveling the device.
Regarding claim 11, Olcott teaches the radiation-measurement-instrument support device according to claim 1 (see claim 1); and the radiation measurement instrument including a two-dimensional detector in which a plurality of detection elements are two-dimensionally arranged to form a plate shape (fig. 2 #206; para. 0032 “detector array”).
Regarding claim 13, Olcott teaches a radiation measurement method to be executed by using the radiation-measurement-instrument support device according to claim 1 (see claim 1), the radiation measurement method comprising steps of: installing the radiation-measurement-instrument support device inside a rotating gantry of a particle beam therapy system (para. 0030); adjusting orientation of the radiation measuring instrument by rotating the cylindrical casing in accordance with rotation of the rotating gantry (para. 0042); and measuring radiation emitted from an irradiation port of the rotating gantry by using the radiation measurement instrument (para. 0030).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Olcott et al. WO 2018/081420 and Dyk et al. US 2005/00134063 in further view of Sturesson US 2023/016058.
Regarding claim 3, Olcott teaches a holding portion for holding the at least one phantom and the radiation measurement instrument is formed inside the cylindrical casing (fig. 2; space in the casing 201 which houses phantoms 204 and measurement instruments 206); the at least one phantom comprises a plurality of phantoms (fig. 2 #204); and the phantoms are provided on both a front side and a rear side of the radiation measurement instrument (fig. 2; phantoms 204 sandwich measurement instruments 206), when a side facing the entrance window is defined as the front side of the radiation measurement instrument.
Olcott and Dyk fails to teach an entrance window through which radiation is made incident is opened in a part of a cylindrical circumferential surface of the cylindrical casing.
Sturesson teaches an entrance window (fig. 1 #4) through which radiation is incident (para. 0033) for the purpose of improving noise to signal ratios by filtering out secondary radiation (para. 0033-0034).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have an entrance window through which radiation is made incident is opened in a part of a cylindrical circumferential surface of the cylindrical casing as taught by Sturesson in the device of Olcott and Dyk for the purpose of improving noise to signal ratios by filtering out secondary radiation.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Olcott et al. WO 2018/081420 and Dyk et al. US 2005/00134063 in further view of Alquist et al. US 2020/0101327.
Regarding claim 9, Olcott and Dyk discloses the phantom is water; and the container is configured to accommodate the water and the radiation measurement instrument alongside (fig. 2) except that Olcott uses a solid water equivalent (para. 0032) instead of water, Alquist shows that water and water equivalents are equivalent structures known in the art (para. 0027; also in the name ‘water equivalent’). Therefore, because these two phantoms were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute water for the water equivalent.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Olcott et al. WO 20/18/081420 and Dyk et al. US 2005/00134063 in further view of McCoy et al. US 2018/0250526.
Regarding claim 12, Olcott and Dyk discloses the radiation measurement apparatus of claim 12 except that the dosimeter is housed in a chamber of solids and liquids instead of a chamber filled with gas and an ion chamber having an electrode configured to detect ionization of the gas, McCoy shows that ion chambers and gas chambers and solid and liquid chambers are equivalent structures known in the art (para. 0004). Therefore, because these two dosimeters were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a chamber filled with gas and an ion chamber having an electrode configured to detect ionization of the gas for the solid/liquid chamber.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard Toohey whose telephone number is (703)756-5818. The examiner can normally be reached Mon-Fri: 7:30am – 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, the applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached on (571)272-2995. The fax number for the organization where this application or processing is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD O TOOHEY/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
Prosecution Insights