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 .
Status of Claims
Claims 1-10, 12-20 are elected with traverse. Claim 11 is withdrawn. No claims have been newly added or cancelled. Claims 1-20 remain pending.
Election/Restrictions
Applicant's election with traverse of Group I (claim 1-10 and 12-20) in the reply filed on 06/29/2026 is acknowledged. The traversal is on the ground(s) that “if the search and examination of all the claims in an application may be made without serious burden, then the examiner must examine them on the merits, even though they may include claims directed to independent or distinct inventions” (REMARKS, p. 10). The examiner respectfully disagrees. The examiner does not find the applicant’s arguments persuasive because common classification does not, by itself, negate a serious search and examination burden. Under MPEP 808.02, a different field of search alone is a sufficient basis. Group I is directed to a method/device/system that uses a trained AI-based model and optical image data to adapt and check the collimation of an x-ray device, whereas the non-elected invention of claim 11 is directed to generating (training) that AI-based model. These require independent searches: Group I in A61B6/06+ and directed to a collimator control, optical patient imaging, and dynamic radiography, whereas the training method of Group II is searched in the machine-learning art (G06N3/08, G06N 20/00, G06T7/00; model training) and is directed to labelled training data, model training, and validation.
Accordingly, the requirement is still deemed proper and is therefore made FINAL.
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.
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:
“adaption unit configured to generate an adapted collimation …” in claim 12 ([0030, 0033, 0085, 0088]; generates the adapted collimation A-CL and the re-adapted collimation RA-CL from the optical image data ID and the criteria data CD, realized as a hardware or software module per [0036]); and
“a checking unit configured to perform an automatic check …” in claim 12 (FIG 4; [0032, 0033, 0036, 0087, 0088]; performs the explicit check EC or the implicit AI-based check ID of the acquired x-ray frame XF against the second criteria of the criteria data CD, realized as a hardware software module per [0036]).
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 1-10 and 12-20 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 12 recites the phrase “adaption unit”, which invokes 112(f) as set forth above under Claim Interpretation. The supporting disclosure fails to clearly link or associate the disclosed structure, material, or acts to the claimed function. The specification describes in paragraph [0036]:
“[s]ome units or modules of the adaption device mentioned above, in particular the adaption unit, the checking unit and the input interface and the output interface, can be completely or partially realized as software modules running on a processor of a respective computing system, e.g. of a control device of a medical imaging system”.
Thus, the claim fails to make clear whether the adaption unit and potential sub-units are hardware or software. See MPEP 2181(III). The same rationale applies to the claim phrase “check unit” and the claims further are rejected for these reasons. Furthermore, the disclosure does not provide written support for the algorithm associated with the computer-implemented function, per the requirements of MPEP 2181(II)(B). See the rejection under 112(a) below for more details.
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.
Claims 1-10 and 12-20 are 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.
Claim 1 recites the phrases
“generating an adapted collimation based on the optical image data and the first criteria”; and
“performing an automatic check of the adapted collimation of the x-ray frame by checking whether the adapted collimation meets that second criteria based on the x-ray frame”.
The specification does not disclose the algorithm for performing said function. The specification discloses the “generating” function only as being “performed based on an AI-based model” (AI-M1)(specification [0054]), the operation and training of which are not disclosed (FIG. 1 identifies the AI-M1 landmark identification as prior art, and the disclosed training method of FIG. 3 trains only AI-M2 and AI-M3). The specification discloses the implicit form of the automatic check only as the application of an undisclosed end-to-end artificial neural network (AI-M2) that outputs a pass/fail result with not disclosed algorithm ([0022, 0023, 0033, 0042, 0050]). The AI-based models are black-boxes. That is, the disclosure recites the desired results without describing how they were achieved, and does not reasonably convey that the invention had possession of the full scope of the claimed generating and checking functions. The balance of claims are rejected based on dependence.
Similarly, claim 12 recites the phrases:
“an adaption unit configured to generate an adapted collimation based on the optical image data and the first criteria”;
“a checking unit configured to perform an automatic check of the X-ray frame by checking whether the X-ray frame meets the second criteria”.
Each phrase invokes 112(f) as set forth above under Claim Interpretation. Furthermore, each phrase is a computer-implemented means-plus-function limitation (CIMPFL). MPEP 2181(II) explains that a CIMPFL must have a corresponding hardware and algorithm supporting the claimed function in the disclosure. However, the supported disclosures of these “units” are described as AI-based models (e.g. end-to-end ANNs), wherein the AI-based models are black boxes that have no clearly described process, flowchart, steps, algorithms or otherwise ([0041]). As explained above, the specification fails to provide written description for the claim limitations (see MPEP 2161.01(I); 2181(II)(B)).
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.
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.
Claims 1-10 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over JOCKEL et al. (US 20150228071 A1).
Regarding claim 1, JOCKEL discloses a method for automatically adapting a collimation for a dynamic X- ray imaging (abstract; [0012-0013]), the method comprising:
receiving, from a library, criteria data for adapting the collimation, wherein the criteria data are assigned to a selected examination protocol (database or LUT with specific landmarks associated with different exam types accessed by user selection of exam type; [0016]) and the criteria data include
first criteria that are relevant for generating an adapted collimation based on optical image data from an examination object (retrieved exam-type landmarks of body parts are used to define collimation window from the optical 3D image data; [0013, 0016, 0052]), and
second criteria that are relevant for generated a re-adapted collimation based on an x-ray frame of the object (a plurality of landmarks, and thus criteria, are suggested as used; [0013, 0016]);
acquiring the optical image data from the examination object using an optical image recording device (3D optical image data of patient using range camera/sensor and adjusting the collimator to that window received at input port IN of controller 130; [0022, 0044, 0052]);
generating an adapted collimation based on the optical image data and the first criteria (image analyzer computes collimation window by detecting anatomical landmarks from 3D image data and adjusted the window to fit; [0044, 0045, 0052, 0074]);
acquiring an X-ray frame from the examination object with the adapted collimation using a dynamic X-ray imaging device (acquires x-ray projection image with collimator set to the computed window ([0044]; step S385) and does so repeatedly for a series of windows during patient movement (i.e. dynamic imaging; [0080]));
generating, in response to the automatic check not being passed, a re-adapted collimation such that the second criteria are more likely fulfilled by a next acquired X-ray frame (generates a re-adapted collimation when its check is not passed upon detecting movement, loops back and an updated collimator window is computed and applied. It’s noted that this is triggered an optical check rather than an x-ray frame check; [0080]); and
maintaining the adapted collimation in response to the automatic check being passed (maintains current collimation when its check is pass; [0080]).
JOCKEL does not specify requiring that the automatic check and the resulting re-adaptation be performed on or based on the acquired x-ray frame. JOCKEL instead discloses this step as based on the optical 3D image ([0079-0080]). It would have been obvious to one of ordinary skill in the art at the time of filing to apply JOCKEL’s disclosed check-and-re-adapt feedback loop ([0080]) to the acquired x-ray frame, as an obvious substitution of one known feedback input (the acquired x-ray frame) for another (the 3D optical image) to obtain the predictable result of a correctly-collimated series of frames (MPEP 2143(I)(B)), in order to verity and maintain a correct, ROI-limited collimation through the dynamic x-ray imaging while minimizing unnecessary exposure ([0023]). KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 2, JOCKEL discloses wherein the acquiring an X-ray frame, the performing an automatic check, and the generating a re-adapted collimation are repeated with an unchanged adapted collimation when the automatic check is passed, or the acquiring an X-ray frame, the performing an automatic check, and the generating a re-adapted collimation are repeated with the re-adapted collimation as the adapted collimation when the re-adapted collimation is generated, until the dynamic X-ray imaging is completed (FIG 3; S320-S360; [0074-0080]).
Regarding claim 3, JOCKEL discloses the check is performed on the optical 3D image and does not apply a trained AL-based model to an x-ray frame ([0079-0080]). Per the arguments provided in claim 1 above it would have been obvious to perform at least the explicit check by comparing the acquired x-ray frame to the second criteria.
Regarding claim 4, JOCKEL discloses wherein the criteria data comprise: a determined anatomical structure is visible in the optical image data or the X-ray frame, and a size of a collimation area assigned to a possibly re-adapted collimation is minimized ([0003, 0013, 0016]).
Regarding claim 5, JOCKEL discloses wherein the explicit check is performed and the explicit check comprises: trying to detect landmarks related to a defined anatomical structure for determining whether the defined anatomical structure is visible; and determining a size of a collimation area assigned to a possibly re-adapted collimation based on detected and not detected landmarks ([0052-0057]). JOCKEL does not disclose the landmark detection performed on the x-ray frame but on the 3D visible image. Performing the same landmark-based sizing on the acquired x-ray frame would have been obvious for the arguments set forth in the claims 1 and 3.
Regarding claim 6, JOCKEL discloses wherein landmark detection is automatically performed based on a quasi-model-less approach ([0055-0057]). Using an AI-based model for such landmark detection would have been obvious, as AI-model-based detection is an art-recognized technique (MPEP 2143).
Regarding claim 7, JOCKEL discloses wherein the size of the collimation area assigned to a possibly re-adapted collimation is determined such that the collimation area includes defined landmarks (computes collimation area such that detected landmarks are part of the area; [0013]). Applying this to the x-ray-frame-based sizing of claims 1 and 5 would have been obvious for the reasons previously provided.
Regarding claim 8, JOCKEL discloses updating a collimation window to track the patient across subsequent frames ([0080]) but does not extrapolate landmark positions in the x-ray frames or estimate the window length and width therefrom. This would have been an obvious extension of JOCKEL’s landmark-based tracking to the successive frames (MPEP 2143).
Regarding claim 9, JOCKEL does not perform an implicit (AI-based) of the x-ray frame. Determining whether the collimation area should be made larger or smaller from the acquired x-ray frame would have been obvious for the reasons given in claim 1.
Regarding claim 10, JOCKEL performs a check at user-adjustable intervals ([0080]). Performing the check at each frame or a subset of every Nth frame is a result-effective choice of update frequency (MPEP 2144.05).
Regarding claim 12, JOCKEL discloses an adaption device (FIG 1), comprising:
an input interface (controller 130; input IN receiving the criteria and 3D image data; [0016, 0052]) configured to:
receive, from a library, criteria data for adapting a collimation, wherein the criteria data are assigned to a selected examination protocol (database or LUT with specific landmarks associated with different exam types accessed by user selection of exam type; [0016]), and
wherein the criteria data includes: first criteria that are relevant for generating an adapted collimation based on optical image data from an examination object (retrieved exam-type landmarks are used to define collimation window from the optical 3D image data; [0013, 0016, 0052]),
receive the optical image data from the examination object (3D optical image data of patient using range camera/sensor and adjusting the collimator to that window received at input port IN of controller 130; [0022, 0044, 0052]), and
repeatedly receive an X-ray frame from the examination object from an X-ray imaging device (acquires x-ray projection image with collimator set to the computed window in a dynamic imaging (repeated)([0044, 0080]; step S385);
an adaption unit configured to generate an adapted collimation based on the optical image data and the first criteria (Controller 130 then processes said patient 3D image data in a manner described in more detail below to output position data that define a collimation window W outlining the desired region of interest ROI; [0044]; step S385);
an output interface configured to output the adapted collimation to the X-ray imaging device for adapting the collimation of the X-ray imaging device (position data is translated into desired imager alignment data that correspond to the collimation window position data; [0044]); and
a checking unit configured to perform an automatic check of the X-ray frame by checking whether the X-ray frame meets the second criteria (step S365 it is determined by comparison with the previous 3D image data whether there was patient movement; [0080]); wherein
the adaption unit is further configured to:
generate a re-adapted collimation such that the second criteria are more likely fulfilled in response to the automatic check not being passed (flow control loop S320-360; FIG 3; [0080]), and
maintain the adapted collimation in response to the automatic check being passed (maintains current collimation when its check is pass; [0080]; FIG 3), and
the output interface is further configured to output the maintained adapted collimation or the re-adapted collimation to the X-ray imaging device for re-adapting the collimation of the X-ray imaging device (FIG 3; [0080]).
JOCKEL does not specify requiring that the automatic check and the resulting re-adaptation be performed on or based on the acquired x-ray frame. JOCKEL instead discloses this step as based on the optical 3D image ([0079-0080]). It would have been obvious to one of ordinary skill in the art at the time of filing to apply JOCKEL’s disclosed check-and-re-adapt feedback loop ([0080]) to the acquired x-ray frame, as an obvious substitution of one known feedback input (the acquired x-ray frame) for another (the 3D optical image) to obtain the predictable result of a correctly-collimated series of frames (MPEP 2143(I)(B)), in order to verity and maintain a correct, ROI-limited collimation through the dynamic x-ray imaging while minimizing unnecessary exposure ([0023]). KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 13, JOCKEL discloses a medical imaging system, comprising: an X-ray imaging device; a library including criteria data for adapting a collimation of the X-ray imaging device; an optical imaging device configured to record optical image data from an examination object; and an adaption device according to claim 12, the adaption device configured to control the collimation of the X-ray imaging device (FIG 3).
Regarding claims 14 and 15, JOCKEL discloses a non-transitory computer program product/medium including instructions that, when executed by a computer, cause the computer to carry out the method of claim 1 ([0081]).
Regarding claim 16, JOCKEL discloses the check is performed on the optical 3D image and does not apply a trained AL-based model to an x-ray frame ([0079-0080]). Per the arguments provided in claim 1 above it would have been obvious to perform at least the explicit check by comparing the acquired x-ray frame to the second criteria.
Regarding claim 17, JOCKEL discloses wherein the criteria data comprise: a determined anatomical structure is visible in the optical image data or the X-ray frame, and a size of a collimation area assigned to a possibly re-adapted collimation is minimized ([0003, 0013, 0016]).
Regarding claim 18, JOCKEL discloses wherein the explicit check is performed and the explicit check comprises: trying to detect landmarks related to a defined anatomical structure for determining whether the defined anatomical structure is visible; and determining a size of a collimation area assigned to a possibly re-adapted collimation based on detected and not detected landmarks ([0052-0057]). JOCKEL does not disclose the landmark detection performed on the x-ray frame but on the 3D visible image. Performing the same landmark-based sizing on the acquired x-ray frame would have been obvious for the arguments set forth in the claims 1 and 3.
Regarding claim 19, JOCKEL discloses wherein the size of the collimation area assigned to a possibly re-adapted collimation is determined such that the collimation area includes defined landmarks (computes collimation area such that detected landmarks are part of the area; [0013]). Applying this to the x-ray-frame-based sizing of claims 1 and 5 would have been obvious for the reasons previously provided.
Regarding claim 20, JOCKEL discloses updating a collimation window to track the patient across subsequent frames ([0080]) but does not extrapolate landmark positions in the x-ray frames or estimate the window length and width therefrom. This would have been an obvious extension of JOCKEL’s landmark-based tracking to the successive frames (MPEP 2143).
Relevant Art
BEHIELS (US 20190239845 A1) discloses a patient movement and tracking system in a radiography system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY BRYANT whose telephone number is (571)270-7329. The examiner can normally be reached M-F // 7-3P EST.
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CASEY BRYANT
Primary Examiner
Art Unit 2884
/CASEY BRYANT/Primary Examiner, Art Unit 2884
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