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 Numbering
The numbering of the claims is not in compliance with 37 C.F.R. § 1.75(g) which states in part “all dependent claims should be grouped together with the claim or claims to which they refer to the extent practicable.” See also MPEP § 608.01(n)(IV). Claims 7-8 are unnecessarily separated from claim 2. The numbering of the claims should not be changed now. Examiner will correct the numbering of the claims if still necessary if the application is allowed. Due to the irregular numbering of the claims, the following rejections of the claims may not necessarily be in numerical order.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. § 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. § 112(f) 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), 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) 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) 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. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. § 112(f), 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), Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. § 112(f) (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).
Claims 1, 7-8, 10-11, 16, and 19
Claims 1, 7-8, 10-11, 16, and 19 are interpreted under 35 U.S.C. § 112(f).
Claims 1 and 16
Regarding claims 1 and 16, the limitation “radiation delivery device” uses the generic placeholder “device” 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. Accordingly, this limitation is interpreted under 35 U.S.C. § 112(f) as corresponding to a casing and a radiation generation system, wherein the radiation generation system is disposed within the casing and is configured to generate and emit treatment radiation, wherein the casing is mounted to a guide rail, wherein the guide rail arranged within the shielding cabin and configured to be movable along a length direction of the treatment site, wherein the radiation delivery device is connected to the guide rail, wherein the radiation generation system is configured such that an emission angle of the treatment radiation is adjustable, wherein the radiation generation system comprises: an electron beam generator configured to generate electron beams; an electron beam accelerator configured to accelerate the electron beams derived from the electron beam generator, a target component configured to generate the treatment radiation using the accelerated electron beams, and a collimation device configured to adjust a beam shape of the treatment radiation, wherein the target component is unspecified, wherein the collimation device comprises a multi-leaf collimator, a fiber collimator, or a spherical lens collimator (Applicant’s specification, ¶ 46; Claims 2 and 7-8 as originally filed) and equivalents thereof. Regarding the interpretations of claims using generic placeholders, see MPEP § 2181(I)(A). As Applicant’s disclosure does not identify the target component used, any target configured to perform the claimed functions has been considered.
Claim 7
Regarding claim 7, limitation “radiation generation system” is interpreted as described above regarding claims 1 and 16.
Claim 8
Regarding 8, limitations “target component” and “collimation device” are interpreted as described above regarding claims 1 and 16.
Claim 10
The limitation “imaging device” uses the generic placeholder “device” 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. Accordingly, this limitation is interpreted under 35 U.S.C. § 112(f) as corresponding to an unspecified radiographic imaging device, an unspecified electronic portal imaging device (EPID), an unspecified cone-beam computed tomography device (Applicant’s specification, ¶ 51) and equivalents thereof. As Applicant’s disclosure does not identify the radiographic imaging device, electronic portal imaging device (EPID), or cone-beam computed tomography device used, any imaging device configured to perform the claimed functions has been considered.
Claim 11
The limitation “control device” uses the generic placeholder “device” 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. Accordingly, this limitation is interpreted under 35 U.S.C. § 112(f) as corresponding to as corresponding to any means capable of performing the claimed function because no corresponding structure is described in Applicant’s specification.
Claim 19
Regarding claim 19, the limitations “imaging device” and “control device” are interpreted as described above regarding claims 10 and 11, respectively.
Claim Rejections — 35 U.S.C. § 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 1-20
Claims 1-20 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.
Claims 1, 7-8, 10-11, 16, and 19
Regarding claims 1, 7-8, 10-11, 16, and 19, for each claim:
One or more claim limitations invoke 35 U.S.C. § 112(f). 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, as described above. Therefore, the claim is indefinite and is rejected under 35 U.S.C. § 112(b).
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);
(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.
Examiner recommends amending “target component” to --target--, “imaging device” to --imager--, “control device” to --controller-- in the claims.
Claims 2-15 and 17-20
Regarding claims 2-15 and 17-20, the claims are rejected due to their dependence.
Claim Rejections — 35 U.S.C. § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §§ 102–103 (or as subject to pre-AIA 35 U.S.C. § 102–103) is incorrect, any correction of the statutory basis 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.
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 C.F.R. § 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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1 (1966), that are applied 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 1-6, 9-11, and 16-19
Claims 1-6, 9-11, and 16-19 are rejected under 35 U.S.C. § 103 as being unpatentable over Dai (US 2021/0316160 A1) in view of Kilby (US 2017/0252579 A1), Urano (US 2007/0297566 A1), and Ahn (US 7,949,094 B2).
Claims 1-2 and 7-8
Regarding claims 1-2 and 7-8, as best understood, Dai discloses a radiotherapy apparatus (¶¶ 2, 39; Fig. 1), comprising:
a shielding cabin (of 200, surrounded by shielding plates 220, 240, 530), configured to shield radiation, in which a treatment site is disposed (¶ 24: “the radiotherapy device of the present application has self-shielding function”; ¶ 39: “a gantry 200 fixed on the base 100 and having a hollow frame structure, wherein the hollow portion of the frame structure is formed as a treatment cabin”; paragraph 51 describes the shielding plates and how “Through the self-shielding design of the present application, the radiation can be constrained to the inside of the radiotherapy device to the greatest extent, and thus the radiation dose outside the treatment cabin is greatly reduced, thereby reducing the protection requirements on the design of the radiation machine room and the construction cost of the machine room”); and
a radiation delivery device (400), movably housed within the shielding cabin and configured to generate treatment radiation (x-rays) and direct the treatment radiation to a target position (tumor target area) at the treatment site,
wherein the radiation delivery device (400) comprises:
a radiation generation system (410, 420),
wherein the radiation generation system is configured to generate and emit treatment radiation (x-rays),
wherein the radiation delivery device (400) is mounted to a guide rail (300), wherein the guide rail (300) arranged within the shielding cabin, wherein the radiation delivery device (400) is connected to the guide rail (300),
wherein the radiation generation system (410, 420) is configured such that an emission angle of the treatment radiation is adjustable (¶ 40: “the treatment head can slide on the guide rail to adjust the position and angle of the beam”), wherein the radiation generation system comprises:
a radiation source (410) which is “an x-ray source generated by a linear accelerator (such as MV level) or electron beam source” (¶ 56); and
a collimation device configured to adjust a beam shape of the treatment radiation, wherein the collimation device comprises a collimator (420; ¶¶ 39-57; Figs. 1-5).
Dai does not expressly disclose:
the radiation generation device comprises a housing, wherein the radiation generation system is disposed within the casing, such that it is the housing which is mounted to the guide rail;
the guide rail is configured to be movable along a length direction of the treatment site;
the radiation source comprises an electron beam generator configured to generate electron beams; an electron beam accelerator configured to accelerate the electron beams derived from the electron beam generator; and a target component configured to generate the treatment radiation using the accelerated electron beams;
the collimator is a multi-leaf collimator, a fiber collimator, or a spherical lens collimator.
However, these limitations were well-known in the art. For example, Kilby discloses a radiation generation device (102) comprises a housing (105) and a radiation generation system (collimator 104, source 118; ¶ 26; Fig. 1B), wherein the housing (105) is mounted to a movement means (103; ¶¶ 19, 26; Figs. 1A-B), wherein the collimator (104) is a multi-leaf collimator (¶ 25).
It would have been obvious before the effective filing date of Applicant’s claimed invention to a person having ordinary skill in the art to which Applicant’s claimed invention pertains to have modified the invention of Dai, in view of the teachings of Kilby, so that the radiation generation device comprises a housing, wherein the radiation generation system is disposed within the casing, such that it is the housing which is mounted to the guide rail; and the collimator is a multi-leaf collimator.
One would have been motivated to do so to use a housing to protect and provide shielding from the radiation source, and one would have been motivated to use a multi-leaf collimator to permit computer-controlled radiation beam shaping to precisely target tumors.
Urano discloses a radiation source (16) for therapeutic radiation comprises an electron beam generator (inherently required) configured to generate electron beams (57); an electron beam accelerator (51) configured to accelerate the electron beams (57) derived from the electron beam generator; and a target component (52) configured to generate the treatment radiation using the accelerated electron beams, along with a primary collimator (53), a flattening filter (54), a secondary collimator (55), and a multi-leaf collimator (56; ¶ 56; Fig. 3).
It would have been obvious before the effective filing date of Applicant’s claimed invention to a person having ordinary skill in the art to which Applicant’s claimed invention pertains to have modified the invention of Dai, in view of the teachings of Urano, so that the radiation source comprises an electron beam generator configured to generate electron beams; an electron beam accelerator configured to accelerate the electron beams derived from the electron beam generator; and a target component configured to generate the treatment radiation using the accelerated electron beams.
One would have been motivated to do so to provide easily adjustable x-ray parameter by adjusting acceleration voltage and current. The disclosure in Urano of a multi-leaf collimator is further evidence of its obviousness.
Ahn discloses a means for positioning an x-ray tube source (201) comprising a guide rail (200) on which the x-ray tube source (201) is mounted, wherein the guide rail (200) is configured to be movable (via rail 300) along a length direction of an imaging site (col. 5, l. 16 - col. 7, l. 67; Fig. 5).
It would have been obvious before the effective filing date of Applicant’s claimed invention to a person having ordinary skill in the art to which Applicant’s claimed invention pertains to have modified the invention of Dai, in view of the teachings of Ahn, so that the guide rail is configured to be movable along a length direction of the treatment site.
One would have been motivated to do so to provide a convenient means for positioning the radiation delivery device.
Claims 3-5
Regarding claims 3-5, as best understood, Dai modified teaches the radiotherapy apparatus according to claim 1, further comprising a guide rail arranged around the treatment site, wherein the radiation delivery device is connected to the guide rail, wherein the radiation delivery device is configured to be movable relative to the guide rail (via rotation of the radiation delivery device), wherein the radiation delivery device is configured to be fixed (via tube arm 206 of Ahn) relative to the guide rail and move along with the guide rail (when not rotating the radiation delivery device; see the teachings of Dai and Ahn in the rejection of claims 1-2 and 7-8 above).
Claim 6
Regarding claim 6, as best understood, Dai modified teaches the radiotherapy apparatus according to claim 1, wherein the radiation delivery device is configured to perform a spiral motion around the treatment site (Dai, ¶ 49).
Claim 9
Regarding claim 9, as best understood, Dai modified teaches the radiotherapy apparatus according to claim 1, wherein the shielding cabin comprises a shielding cabin chamber (within 220, 240, 530) and a shielding cabin door (500, 530), the shielding cabin door being operably mounted to the shielding cabin chamber, the shielding cabin door and the shielding cabin chamber jointly enclosing and forming an accommodating space, the treatment site being located inside the accommodating space (Dai, ¶¶ 41, 51; Figs. 1-3).
Claim 10
Regarding claim 10, as best understood, Dai modified teaches the radiotherapy apparatus according to claim 1, further comprising an imaging device (600) configured to acquire an image of a region of interest (target area of the patient) at the target position, wherein the imaging device (600) is a radiographic imaging device or a cone-beam computed tomography (CBCT) device (Dai, ¶¶ 46-48; Figs. 1-2).
Claim 11
Regarding claim 11, as best understood, Dai modified teaches 11. The radiotherapy apparatus according to claim 10, further comprising a control device (automatic control device) communicatively connected to the imaging device and the radiation delivery device, and configured to control a position and/or an orientation of the radiation delivery device based on the image acquired by the imaging device (Dai, ¶¶ 45, 57).
Claims 16-17
Regarding claims 16-17, see the rejection of claims 1-2 and 7-8 above, mutatis mutandis.
Claim 18
Regarding claim 18, see the rejection of claim 9 above, mutatis mutandis.
Claim 19
Regarding claim 19, see the rejections of claims 10-11 above, mutatis mutandis.
Claims 12-13
Claims 12-13 are rejected under 35 U.S.C. § 103 as being unpatentable over Dai in view of Kilby, Urano, and Ahn as applied to claim 10 above, and further in view of Mason (US 2024/0245932 A1).
Claim 12
Regarding claim 12, as best understood, Dai modified teaches the radiotherapy apparatus according to claim 10, but does not expressly disclose the imaging device is positioned orthogonally to the radiation delivery device relative to the target position.
Mason discloses a radiotherapy apparatus comprising a radiation delivery device (202) and a CBCT imaging device (218, 222), wherein the imaging device (218, 222) is positioned orthogonally to the radiation delivery device (202) relative to a target position of the radiation delivery device (202; i.e., 204 and 214 are arranged orthogonally to 218 and 222; ¶¶ 68-70, Fig. 2B).
It would have been obvious before the effective filing date of Applicant’s claimed invention to a person having ordinary skill in the art to which Applicant’s claimed invention pertains to have modified the invention of Dai, in view of the teachings of Mason, so that the imaging device is positioned orthogonally to the radiation delivery device relative to the target position.
One would have been motivated to do so as Mason discloses such an arrangement is “typical” and used for image guided radiotherapy (IGRT; Mason, ¶ 70).
Claim 13
Regarding claim 13, as best understood, Dai modified teaches the radiotherapy apparatus according to claim 12, wherein the imaging device is configured such that a position and/or orientation of the imaging device is adjustable relative to the treatment site synchronously with the radiation delivery device (Mason, ¶¶ 62-70; Figs. 2A-B).
Claim 14
Claim 14 is rejected under 35 U.S.C. § 103 as being unpatentable over Dai in view of Kilby, Urano, and Ahn as applied to claim 1 above, and further in view of Urano (US 2008/0170663 A1).
Regarding claim 14, as best understood, Dai modified teaches the radiotherapy apparatus according to claim 1, but does not expressly disclose the radiation delivery device is configured to be rotatable within a spherical angle range.
Urano discloses a radiation delivery device (16) is configured to be rotatable within a spherical angle range (¶ 65, Fig. 2).
It would have been obvious before the effective filing date of Applicant’s claimed invention to a person having ordinary skill in the art to which Applicant’s claimed invention pertains to have modified the invention of Dai, in view of the teachings of Urano, so that the radiation delivery device is configured to be rotatable within a spherical angle range.
One would have been motivated to do so as Urano discloses doing so “can meet the irradiation angle shown by the treatment plan created by the treatment planning portion (Urano, ¶ 65).
Claim 15
Claim 15 is rejected under 35 U.S.C. § 103 as being unpatentable over Dai in view of Kilby, Urano, and Ahn as applied to claim 1 above, and further in view of Zheng (US 2012/0198624 A1).
Regarding claim 15, as best understood, Dai modified teaches the radiotherapy apparatus according to claim 1, wherein the shielding is configured to allow for a sitting or standing posture of an object (patient; Dai, ¶ 24).
Dai modified does not expressly disclose the shielding cabin is configured to be rotated to allow for a supine or standing posture of an object.
Zheng discloses a radiotherapy apparatus (¶ 1) configured to be rotated to allow for a supine or standing posture of an object (patient 2; ¶ 23; Figs. 2A-B).
It would have been obvious before the effective filing date of Applicant’s claimed invention to a person having ordinary skill in the art to which Applicant’s claimed invention pertains to have modified the invention of Dai, in view of the teachings of Zheng, so that the shielding cabin is configured to be rotated to allow for a supine or standing posture of an object.
One would have been motivated to do so as Zheng discloses doing so provides for easier embarking and disembarking of the patient (Zheng, ¶ 23).
Claim 20
Claim 20 is rejected under 35 U.S.C. § 103 as being unpatentable over Dai in view of Kilby, Urano, and Ahn as applied to claim 16 above, and further in view of Willcut (US 2019/0076671 A1).
Regarding claim 20, as best understood, Dai modified does not expressly disclose a non-transitory computer-readable storage medium storing instructions, wherein the instructions, when executed by a processor, cause the processor to perform the radiation delivery method according to claim 16.
Willcut discloses a non-transitory computer-readable storage medium storing instructions, wherein the instructions, when executed by a processor, cause the processor to perform a radiation delivery method (¶ 8).
It would have been obvious before the effective filing date of Applicant’s claimed invention to a person having ordinary skill in the art to which Applicant’s claimed invention pertains to have modified the invention of Dai, in view of the teachings of Willcut, to make a non-transitory computer-readable storage medium storing instructions, wherein the instructions, when executed by a processor, cause the processor to perform the radiation delivery method.
One would have been motivated to do so to avoid the need to manually perform the method each time it is needed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kuang (US 2018/0236267 A1) discloses a radiation therapy system a radiation shielded (¶ 10) wherein a protective enclosure 136 can cover and enclose a gantry 118 and a stage 126 (¶ 152, Fig. 1).
Chao (US 2013/0289400 A1) discloses a radiation therapy system with shielding (¶ 76).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAKE RIDDICK whose telephone number is (571)270-1865. The examiner can normally be reached M - Th 6:30 am - 5:00 pm ET, with flexible scheduling.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, 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 at 571-272-2995. The fax phone number for the organization where this application or proceeding 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.
Blake C. Riddick, Ph.D.
Primary Examiner
Art Unit 2884
/BLAKE C RIDDICK/Primary Examiner, Art Unit 2884
Prosecution Insights