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 .
Election/Restrictions
Applicant's election with traverse of Group I directed to claims 1-7, 9, 10, 12 and 13 in the reply filed on 20 July 2026 is acknowledged. The traversal is on the ground(s) that the shared technical feature in the restriction requirement is identified too broadly and “overlooks the fact that the two groups require selecting central k-space data and generating a beam gating control signal based on the central k-space data. This is not found persuasive because Group I is drawn to a radiotherapy device that requires a radiation source; a MR imaging apparatus and a controller that is merely configured to select central k-space data and generate a beam gating signal based on the data, which is not the same as a method claim (Group II) that positively requires method steps of selecting central k-space data and generating a beam gating signal based on the data.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 17 November 2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Therefore, DE-102013206315A1 has been lined through.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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: “controller…configured to: select central k-space data….and…generate a beam gating control signal” in claim 1, the equivalent structure of which is disclosed at least at paragraphs [0037] and [0045] of the instant publication.
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 Objections
9. Claims 4 and 9 are objected to because of the following informalities: at line 3 of claim 4, “the of” should apparently read –the--; at line 5 of claim 9, “gating window;” should apparently read –gating window; and--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 7, 10 and 12 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.
12. Claim 7 at line 7 recites “and/or comprises…” in two instances. It is unclear what limitation/element “and/or comprises” is referring back to.
13. Claim 10 recites “…and optionally wherein the controller is configured to determine the self-gating signal by performing principal component analysis on the projection data”. It is unclear if this “optional” step would be in addition to the step of “determining a self-gating signal based on the central k-space data” already recited in claim 9, of if this “optional” step in claim 10 is implying that the “determining a self-gating signal based on the central k-space data” step in claim 9 would be performed by principal component analysis.
Claim Rejections - 35 USC § 102
14. 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 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.
15. Claims 1-7 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torres et al. (WO 2020/219814). Regarding claim 1, Torres et al. (hereinafter Torres) teaches a radiotherapy device comprising: a radiation source (“emitting device”) configured to generate a radiotherapy beam for irradiating a subject ([0052] and [0070], [0021]-[0023] and [0034]);
a magnetic resonance (MR) imaging apparatus configured to apply a three-dimensional (3D) MR pulse sequence to obtain k-space data for the subject ([0024], [0051]-[0052], [0062] and [0070]-[0071]); and
a controller 110 communicatively coupled to the radiation source and the MR imaging apparatus (Fig. 1 and [0070]), wherein the controller is configured to:
select central k-space data from the k-space data ([0062], [0064], [0066] and claim 5); and
generate a beam gating control signal based on the central k-space data ([0097]-[0098] and Fig. 10).
Regarding claim 2, the controller is configured to: generate the beam gating control signal independently of reconstructing an image of the subject based at least in part on the k-space data ([0064], [0098], and [0097]: “[t]he online motion signature may be generated without the relatively computationally-intense image reconstruction that may be performed during online signature generation”; [0033]: “…generated without image reconstruction…”).
Regarding claim 3, the controller is configured to transmit the beam gating control signal to the radiation source, and wherein the radiation source is configured to gate the radiotherapy beam based on the beam gating control signal [0098].
Regarding claim 4, the central k-space data comprises a single pixel at a k-space center, and/or wherein the central k-space data comprises a plurality of pixels at and surrounding the of k-space center (Fig. 3A; [0062] and [0007]).
Regarding claim 5, the controller is configured, after generating the beam gating control signal, to reconstruct an image of the subject based at least in part on the k-space data ([0098]-[0099] and Fig. 10).
Regarding claim 6, the MR imaging apparatus is configured to obtain additional k-space data, and wherein the controller is configured to update the reconstructed image of the subject based at least in part on the additional k-space data (offline) ([0010], [0039], [0056]-[0057], [0059], [0063], [0066], [0069], [0072]-[0075]).
Regarding claim 7, the 3D MR pulse sequence is arranged to repetitively sample a k-space center as part of a k-space trajectory of the 3D MR pulse sequence, or wherein the 3D MR pulse sequence comprises a radial stack-of-stars sampling trajectory in which the 3D MR pulse sequence is arranged to repetitively sample the k-space center by sampling along a plurality of spokes, each of the spokes being rotated by an angular increment relative to a previous spoke, and/or comprises a stack-of-spirals sampling trajectory, and/or comprises a 3D Koosh ball trajectory ([0062], [0066] and [0072]).
Regarding claim 13, the radiation source is configured to apply the radiotherapy beam to a tumor in at least one of a liver, pancreas, heart, or esophagus of the subject [0058].
Claim Rejections - 35 USC § 103
16. 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.
17. 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.
18. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Torres et al. (WO 2020/219814). Regarding claim 9, while Torres does not disclose explicitly that the controller is configured to: determine a self-gating signal based on the central k-space data; determine whether the self-gating signal is within a gating window; and generate the beam gating control signal in response to determining that the self-gating signal is not within the gating window, Torres makes such obvious as Torres discloses that adjustments to the radiotherapy, such as turning on/off/pausing the beam delivery, may be continuously adapted to track target movements of the organ/subject in real-time ([0005], [0058] and [0098]) for improved real-time beam adaptation in an MR-linac system [0073]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a controller to determine a self-gating signal is within a gating window and generate a beam signal in response to determining the self-gating signal is not within the window in order to halt the radiotherapy delivery in real-time conditions when movement of the subject’s organs or target arises, so as to prevent delivery/exposure of healthy tissue to a toxic dose of radiation during application [0074].
Allowable Subject Matter
19. Claims 10 and 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. Pub. No. 2015/0080704; U.S. Pub. No. 2015/0217136; U.S. Patent No. 12,092,716; U.S. Pub. No. 2019/0091487; 2020/0142018; and U.S. Patent No. 10,433,760.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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