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: “instructions for rotating a patient rotation system” in claim 31.
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 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 29 and 31 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.
Regarding claim 29, the limitation “the system of claim 25 structured to rotate said reference target around an axis orthogonal to an axis between a source and a detector” renders the claim indefinite. The claim fails to define how the reference target is rotated. As currently written, the claim states that the system is structured. However, the structure that is capable of rotating the reference target is not claimed. The Examiner has interpreted the claim as the patient support is able rotate the reference target.
Regarding claim 31, claim limitation “instructions for rotating a patient rotation system” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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. The specification is devoid of adequate structure to perform the claimed function. In particular, the specification discloses that the software component has the instructions. However, a software component is not adequate structure to perform the claimed function because it does not describe a particularly structure. The specification does not provide sufficient details such that one of ordinary skill in the art would understand which structure performs the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
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.
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.
Claim 31 is 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. As described above, the disclosure does not provide adequate structure to perform the claimed function of rotating the patient rotation system. Th specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 25-26, 29, and 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tulik (U.S. 2019/0001156).
Regarding claim 25:
Tulik discloses a system comprising:
a medical radiation system (Fig. 1, 1); and
a reference target comprising a body (Fig. 1, M1) and one or more markers fixed to the body in a prearranged configuration (Fig. 1, M1, has multiple markers within it).
Regarding claim 26:
Tulik discloses the system of claim 25 further comprising a detector (fig. 1, 6).
Regarding claim 29, as best understood:
Tulik discloses the system of claim 25, further comprising a patient support system that is able to rotate (Fig. 1, support 10 is able to rotate as shown by the arrow).
Regarding claim 31, as best understood:
Tulik discloses the system of claim 25 further comprising a software component comprising instructions (This element is interpreted under 35 U.S.C. 112(f) as any structure that is able perform controlling of an imaging system. Tulik discloses a computer in [0074]) for rotating a patient rotation system about a rotation axis; controlling a radiation beam; receiving a signal and/or data from a detector for producing images; analyzing the images to determine a displacement of the patient support assembly relative to the rotation axis; analyzing images to locate an isocenter of a radiation beam relative to the rotation axis; and/or determining a displacement of the central axis of a radiation beam relative to the rotation axis.
Regarding claim 32:
Tulik discloses the system of claim 25 further comprising a component (Fig. 1, 11) structured to adjust the patient support assembly to align the patient support assembly relative to a rotation axis of the patient support assembly ([0073], patient support is able to be rotated).
Regarding claim 33:
Tulik discloses the system of claim 25 further comprising a component (Fig. 1, 5) structured to adjust the position of a radiation source and/or a position of a beam produced by said radiation source ([0072]-[0073], gantry is able to rotate about axis 16 and 17).
Claim Rejections - 35 USC § 103
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 1-4, 11-12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tulik (U.S. 2019/0001156) in view of Yamada (U.S. 2015/0289829).
Regarding claim 1:
Tulik discloses method of aligning a medical radiation system comprising a patient rotation system and a radiation source, the method comprising:
rotating the patient rotation system about a rotation axis ([0072], gantry rotation);
detecting a radiation beam from the radiation source to produce images ([0074], images obtained by detector) of a reference target located on a patient support assembly of the patient rotation system ([0074], images of the phantom and calibration object);
analyzing the images to determine a patient support assembly relative to the rotation axis ([0085], position of patient support is determined.
However, Tulik fails to disclose analyzing the images to determine a displacement of the patient support assembly relative to the rotation axis; and adjusting the patient support assembly to align the patient support assembly relative to the rotation axis.
Yamada teaches analyzing the images to determine a displacement of the patient support assembly relative to the rotation axis ([0062]-[0064], deviation amount determined using CT images); and
adjusting the patient support assembly to align the patient support assembly relative to the rotation axis ([0064], top plate moved based on deviation amount).
It would have been obvious to one of an ordinary skill in the before the effective filing date to combine the method of Tulik with the table adjustment taught by Yamada. One would have been motivated to make such combination in order to improve image quality and reduce radiation exposure by increasing positional accuracy. Therefore, it would have been obvious to combine the method of Tulik with the table adjustment taught by Yamada to yield predictable results. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 2:
The combination of Tulik and Yamada discloses the method of claim 1, wherein the displacement is determined by comparing a location and an orientation of the reference target relative to the rotation axis (Yamada; [0043], deviation between center position of gantry and phantom).
It would have been obvious to one of an ordinary skill in the before the effective filing date to combine the method of Tulik with the table adjustment taught by Yamada. One would have been motivated to make such combination in order to improve image quality and reduce radiation exposure by increasing positional accuracy. Therefore, it would have been obvious to combine the method of Tulik with the table adjustment taught by Yamada to yield predictable results. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 3:
The combination of Tulik and Yamada discloses the method of claim 1, wherein adjusting the patient support assembly comprises aligning a center of rotation of the reference target with the rotation axis (Yamada; [0064], top plate moved based on deviation amount).
It would have been obvious to one of an ordinary skill in the before the effective filing date to combine the method of Tulik with the table adjustment taught by Yamada. One would have been motivated to make such combination in order to improve image quality and reduce radiation exposure by increasing positional accuracy. Therefore, it would have been obvious to combine the method of Tulik with the table adjustment taught by Yamada to yield predictable results. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 4:
The combination of Tulik and Yamada discloses the method of claim 1, further comprising:
analyzing the images to locate a central axis of the radiation beam relative to the rotation axis (Tulik; [0046], position and orientation of the source is determined) ; and
adjusting the radiation source such that the central axis of the radiation beam intersects the rotation axis (Tulik; [0048], movement of the source).
Regarding claim 11:
The combination of Tulik and Yamada discloses the method of claim 1, wherein the medical radiation system further comprises an imaging device (Tulik; Fig. 1, 6, detector) for detecting the radiation beam and producing the images of the reference target, the imaging device being located opposite the radiation source relative to the patient support assembly (Tulik; Fig. 1, source 3 is opposite of detector 6).
Regarding claim 12:
The combination of Tulik and Yamada discloses the method of claim 1, wherein the images of the reference target comprise at least two images of the reference target produced for different angles of rotation of the patient rotation system (Tulik; [0054], multiple images).
Regarding claim 20:
The combination of Tulik and Yamada discloses the method of claim 1, wherein the medical radiation system further comprises a second radiation source (Yamada; Fig. 2, 13 and 14).
It would have been obvious to one of an ordinary skill in the before the effective filing date to combine the method of Tulik with the table adjustment taught by Yamada. One would have been motivated to make such combination in order to improve image quality and reduce radiation exposure by increasing positional accuracy. Therefore, it would have been obvious to combine the method of Tulik with the table adjustment taught by Yamada to yield predictable results. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Tulik (U.S. 2019/0001156) in view of Yoshida (U.S. 2008/0144913).
Regarding claim 27:
Tulik discloses the system of claim 25 further comprising a patient support assembly (Fig. 1, 10).
However, Tulik fails to disclose wherein said patient support assembly comprises an interface structured to accept said reference target.
Yoshida teaches wherein said patient support assembly comprises an interface structured to accept said reference target (Fig. 3, Adjusting table T).
It would have been obvious to one of an ordinary skill in the art before the effective filing date to combine the support assembly of Tulik with the interface taught by Yoshida. One would have been motivated to make such combination in order to improve alignment correction by not allowing the reference target or phantom to move during imaging. Therefore, it would have been obvious to combine the support assembly of Tulik with the interface taught by Yoshida to yield predictable results. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Allowable Subject Matter
Claims 21-22 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:
The closest prior arts are Tulik (U.S. 2019/0001156) in view of Yamada (U.S. 2015/0289829).
Regarding claim 21:
The combination of Tulik and Yamada discloses the method of claim 20.
However, the combination of Tulik and Yamada fails to disclose further comprising: detecting a second radiation beam from the second radiation source to produce additional images of the reference target; analyzing the additional images to locate a central axis of the second radiation beam relative to the rotation axis; and adjusting the second radiation source such that the central axis of the second radiation beam intersects the rotation axis.
Since the prior art of record fails to teach the details above, nor is there any reason to modify or combine prior art elements absent of applicant’s disclosure, the claim is deemed patentable over the prior art of record, if rewritten in independent form to include all of the limitations of the base claim and any intervening claim. Claim 22 is allowable by virtue of its dependency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOORENA KEFAYATI whose telephone number is (469)295-9078. The examiner can normally be reached M to F, 7:30 am to 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Makiya can be reached at 571-272-2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.K./Examiner, Art Unit 2884
/DAVID J MAKIYA/Supervisory Patent Examiner, Art Unit 2884
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