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 .
Information Disclosure Statement
The information disclosure statement filed March 6, 2024 regarding the copending applications, fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement filed March 6, 2024, pertaining to the 400+ cited references, has been considered by the examiner through a cursory search. Per MPEP 609.04(a)III, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
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 Objections
Claims 9 and 23 are objected to because of the following informalities:
Claim 9, lines 9-10, recites “said heart being for each multiplanar image of the first sequence at a first position”, but examiner suggests --said heart being at a first position for each multiplanar image of the first sequence-- for grammatical clarity.
Claim 9, lines 16-17, recites “said heart being for each multiplanar image of the second sequence at a second position”, but examiner suggests --said heart being at a second position for each multiplanar image of the second sequence-- for grammatical clarity.
Claim 23, line 2, recites “the start” but should read --a start--.
Appropriate correction is required.
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 9-24 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.
Claim 9, lines 12-13, recites the limitation "said first set of positions". There is insufficient antecedent basis for this limitation in the claim.
Claim 9, line 20, recites the limitation "said second set of positions". There is insufficient antecedent basis for this limitation in the claim.
Claims 10-13 inherit the same deficiencies.
Claim 10, line 3, recites the limitation "the respiratory motion phase intended for future treatment delivery". There is insufficient antecedent basis for this limitation in the claim.
Claim 12, line 3, recites the limitation "said known respiratory state". There is insufficient antecedent basis for this limitation in the claim.
Claim 13, lines 2-3, recites the limitation "the respiratory motion phase intended for future treatment delivery". There is insufficient antecedent basis for this limitation in the claim.
Claim 14, lines 7-8, recites the limitation “for each of the reference multiplanar images of said reference series of multiplanar images”. There is insufficient antecedent basis for this limitation in the claim. Lines 9-10 recite “for each reference multiplanar image of said reference series of multiplanar images”. The recitation of “each reference multiplanar image” should be consistent.
Claims 15 and 16 inherit the same deficiency.
Claim 17, lines 5-6, recites the limitation “for each of the reference multiplanar images of said reference series of multiplanar images”. There is insufficient antecedent basis for this limitation in the claim. Lines 7-8 recite “for each reference multiplanar image of said reference series of multiplanar images”. The recitation of “each reference multiplanar image” should be consistent.
Claims 18-24 inherit the same deficiency.
Claim 21 recites the limitation "said known respiratory state". There is insufficient antecedent basis for this limitation in the claim.
Claim 22 inherits the same deficiency.
Claim Rejections - 35 USC § 102
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.
(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 9, 10, and 13-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sumanaweera (US20080177279A1).
Regarding claim 9, Sumanaweera discloses a method for determining a position of cardiac structures in a known three-dimensional coordinate system (Abstract), comprising: providing a multiplanar imaging probe (Paragraph [0064]) and a localization system for tracking said multiplanar imaging probe in three-dimensional space (Paragraph [0064]); providing instructions on a tangible, non-transitory medium (Paragraph [0092]), said instructions comprising: acquiring a first sequence of multiplanar images of a heart with said multiplanar imaging probe over a duration of at least one heartbeat (Paragraph [0065], Continuous acquisition of ultrasound pairs) said heart being for each multiplanar image of the first sequence at a first position (Paragraph [0065]); during the step of acquiring said first sequence, localizing said multiplanar imaging probe with said localization system to define a first set of room coordinates at said first set of positions (Paragraph [0065]); acquiring a second sequence of multiplanar images of said heart with said multiplanar imaging probe over a duration of at least one heartbeat aid heart being for each multiplanar image of the second sequence at a second position (Paragraph [0065] For each set of ultrasound image pairs, the position and orientation is recorded); during the step of acquiring said second sequence, localizing said multiplanar imaging probe with said localization system to define a second set of room coordinates at said second set of positions (Paragraph [0065]); identifying a first set of representative multiplanar images from said first sequence of multiplanar images and a second set of representative multiplanar images from said second sequence of multiplanar images, said first set of representative multiplanar images and said second set of representative multiplanar images corresponding to a known combination of a cardiac motion phase and/or a respiratory motion phase (Paragraph [0069]); aligning said second set of room coordinates with said first set of room coordinates; and quantifying a translational displacement and a rotational displacement of said second set of representative multiplanar images relative to said first set of representative multiplanar images within the aligned first and second set of room coordinates (Paragraphs [0070] and [0104] The ultrasound images are registered to CT images to determine translational displacement and rotational displacement of the target for treatment).
Regarding claim 10, Sumanaweera discloses said known combination of cardiac motion phase and respiratory motion phase in the step of identifying correspond with the respiratory motion phase intended for future treatment delivery (Paragraphs [0097] and [0115]).
Regarding claim 13, Sumanaweera discloses the step of acquiring said first sequence of multiplanar images of said instructions is performed at the respiratory phase intended for future treatment delivery (Paragraph [0065] The ultrasound images are acquired continuously).
Regarding claim 14, Sumanaweera discloses a method for enabling and gating a therapy beam (Abstract), comprising: coupling a multiplanar imaging probe (Paragraph [0064]) and a probe localization system (Paragraph [0064]) to a gating controller (Paragraph [0091]), said gating controller including a set of instructions on a non-transitory computer readable medium for execution in real time (Paragraph [0092]), said instructions including: (a) acquiring a series of reference multiplanar images of a beating heart within a patient with a multiplanar imaging probe (Paragraph [0064]); (b) during step (a), acquiring a reference position of said imaging probe for each of the reference multiplanar images of said reference series of multiplanar images (Paragraph [0065]); (c) identifying a cardiac phase for each reference multiplanar image of said reference series of multiplanar images (Paragraph [0069]); (d) acquiring a live multiplanar image with said multiplanar imaging probe during beam therapy treatment of said patient (Paragraph [0064]);(e) during step (d), acquiring a live position of said multiplanar imaging probe (Paragraph [0064]); (f) identifying a cardiac phase of said live multiplanar image (Paragraph [0069]); and (g) performing a rigid registration of said live multiplanar image and said live position to a corresponding reference image of said reference series of multiplanar images and a corresponding reference position[[s]] associated with said corresponding reference image (Paragraph [0070]), said corresponding reference image being representative of said cardiac phase of said live multiplanar image, said rigid registration providing a live heart position of said beating heart during said beam therapy treatment of said patient relative to a three- dimensional coordinate system to provide a live displacement of said beating heart between relative to said reference position (Paragraphs [0070]-[0086])).
Regarding claim 15, Sumanaweera discloses said instructions of said gating controller includes generating a status condition based on a comparison of said displacement with a predetermined threshold value (Paragraph [0105]).
Regarding claim 16, Sumanaweera discloses configuring said non-transitory computer readable medium with said instructions (Paragraph [0092]).
Regarding claim 17, Sumanaweera discloses a method for inferring displacement of a heart of a patient for beam therapy treatment (Abstract), comprising: (a) acquiring a series of reference multiplanar images of a beating heart within a patient with a multiplanar imaging probe (Paragraph [0064]); (b) during step (a), acquiring a reference position of said imaging probe for each of the reference multiplanar images of said reference series of multiplanar images (Paragraph [0065]); (c) identifying a cardiac phase for each reference multiplanar image of said reference series of multiplanar images (Paragraph [0069]); (d) acquiring a live multiplanar image with said multiplanar imaging probe during beam therapy treatment of said patient (Paragraph [0064]);(e) during step (d), acquiring a live position of said multiplanar imaging probe (Paragraph [0064]); (f) identifying a cardiac phase of said live multiplanar image (Paragraph [0069]); and (g) performing a rigid registration of said live multiplanar image and said live position to a corresponding reference image of said reference series of multiplanar images and a corresponding reference position[[s]] associated with said corresponding reference image (Paragraph [0070]), said corresponding reference image being representative of said cardiac phase of said live multiplanar image, said rigid registration providing a live heart position of said beating heart during said beam therapy treatment of said patient relative to a three- dimensional coordinate system to provide a live displacement of said beating heart between relative to said reference position (Paragraphs [0070]-[0086])).
Regarding claim 18, Sumanaweera discloses generating a status condition based on a comparison of said displacement with a predetermined threshold value (Paragraph [0105]).
Regarding claim 19, Sumanaweera discloses affixing said multi planar imaging probe to a thorax of said patient for use during execution of a reference simulation (Paragraphs [0088]-[0090]).
Regarding claim 20, Sumanaweera discloses affixing said multi planar imaging probe to a thorax of said patient for use during execution of a treatment stage (Paragraphs [0064], [0088])
Regarding claim 21, Sumanaweera discloses instructing said patient to breath hold over at least one cardiac cycle to effect said known respiratory state (Paragraph [0062]).
Regarding claim 22, Sumanaweera discloses said known respiratory state is an end-expiration respiratory phase (Paragraph [0106]).
Regarding claim 23, Sumanaweera discloses said reference series of multiplanar images is acquired at the start of a treatment process (Paragraph [0064]).
Regarding claim 24, Sumanaweera discloses said reference series of multiplanar images is acquired during a simulation stage prior to a treatment stage (Paragraphs [0089]-[0090]).
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US20080177279A1) in view of Carol (US 5411026 A).
Regarding claim 11, Sumanaweera discloses moving the radiation device on a gantry in accordance with said translational displacement and said rotational displacement but does not disclose said instructions in the step of providing instructions include displacing a patient support in accordance with said translational displacement and said rotational displacement. Carol discloses a method for verifying the position of a lesion while the patient lays on the treatment table of a linear accelerator (Abstract). Carol further discloses the patient support is moved if the ultrasound images do not align with the diagnostic ultrasound images (Col 11, lines 22-43). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Sumanaweera, with displacing a patient support in accordance with said translational displacement and said rotational displacement as taught by Carol, since such a modification would provide the predictable results of conforming the position of the lesion to the desired position of lesion required by the radiation treatment plan (Carol, Col 11, lines 41-43).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US20080177279A1) in view of Rubin (US 20050177044 A1).
Regarding claim 12, Sumanaweera discloses instructing said patient to breath hold over at least one cardiac cycle during the acquisition of the CT images (Paragraph [0062]) but does not disclose instructing said patient to breath hold over at least one cardiac cycle during the step of acquiring said first sequence of multiplanar images to effect said known respiratory state. Rubin discloses using ultrasound to gate CT image acquisition (Abstract), wherein the patient is asked to accomplish multiple breath holds (Paragraph [0049]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Sumanaweera, with displacing a patient support in accordance with instructing said patient to breath hold over at least one cardiac cycle during the step of acquiring said first sequence of multiplanar images to effect said known respiratory state as taught by Rubin, since such a modification would provide the predictable results of providing a way to acquire image data if the patient has an arrhythmia (Paragraph [0049]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Toume (US 20190365348 A1) discloses an multiplanar ultrasound device that affixes to the patient for monitoring.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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, 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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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
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