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 .
Note: all citations with respect to the specification of present application are citing the paragraph numbers in the Pre-Grant Publication US 2023/0172630 A1.
Claim Objections
Claim 1 – 7 and 14 are objected to because of the following informalities:
Claim 1 line 6, limitation "at least one of said holes" should read "at least one of said plurality of holes".
Claim 1 line 15, limitation "the suitability of the candidate position of the grid template" should read "the suitability of the corresponding candidate position and/or orientation of the grid template".
Claim 1 line 27, limitation "said grid hole trajectories" should read "said plurality of grid hole trajectories".
Claim 2 line 4, limitation "the grid hole trajectories" should read "said plurality of grid hole trajectories".
Claim 3 line 7, limitation "said grid hole trajectories for the candidate position and/or orientation" should read "said plurality of grid hole trajectories for the corresponding candidate position and/or orientation".
Claim 4 line 1 – 2, limitation "a total number of intersecting grid hole trajectories" should read "a total number of intersecting grid hole trajectories of said plurality of grid hole trajectories".
Claim 5 line 10 – 11, limitation "said grid hole trajectories for the candidate position and/or orientation" should read "said plurality of grid hole trajectories for the corresponding candidate position and/or orientation".
Claim 6 line 1 – 2, limitation "a total number of intersecting grid hole trajectories" should read "a total number of intersecting grid hole trajectories of said plurality of grid hole trajectories".
Claim 7 line 4, limitation "a grid hole trajectory" should read "one of said plurality of grid hole trajectories".
Claim 14 line 6, limitation "at least one of said holes" should read "at least one of said plurality of holes".
Claim 14 line 16 – 17, limitation "the suitability of the candidate position of the grid template" should read "the suitability of the corresponding candidate position and/or orientation of the grid template".
Claim 14 line 22, limitation "said grid hole trajectories" should read "said plurality of grid hole trajectories".
Appropriate correction is required.
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:
Limitation “anatomical spatial information processing unit” in claim 1;
Limitation “grid position sampler” in claim 1, 11;
Limitation “quality calculator” in claim 1, 3, 5, 7 and 8;
Limitation “position selector” in claim 1, 8, 10 and 12;
Limitation “grid template alignment evaluator” in claim 12 and 13.
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.
Regarding limitation “anatomical spatial information processing unit” in claim 1, the corresponding structural disclosure in the specification of present application is recited as: “The device may comprise a computer, e.g. specifically programmed for implementing the device as described” in [0081]; “The device is not necessary limited to a general-purpose computer, but may also comprise an application specific integrated circuit (ASIC) and/or configurable processing hardware, e.g. a field-programmable gate array (FPGA). Furthermore, the device may be comprised in a single processing device, e.g. a computer, but also distributed over a plurality of such devices that are operably connected to each other, e.g. such that the processing described herein is carried out by the joint action of a server and a client device, or of a parallel processing system, such as a computing cluster” in [0082]; “Thus, the processing device 1 comprises an anatomical spatial information processing unit 2 for receiving and/or processing data representative of at least one target spatial volume in the body of the patient; and optionally also at least one spatial volume at risk in the body” in [0090]; see Fig.1, the claimed processing unit is part of the computer or equivalent device 1 programed to perform the claimed function.
Regarding limitation “grid position sampler” in claim 1, 11, the corresponding structural disclosure in the specification of present application is recited as: “The device may comprise a computer, e.g. specifically programmed for implementing the device as described” in [0081]; “The device is not necessary limited to a general-purpose computer, but may also comprise an application specific integrated circuit (ASIC) and/or configurable processing hardware, e.g. a field-programmable gate array (FPGA). Furthermore, the device may be comprised in a single processing device, e.g. a computer, but also distributed over a plurality of such devices that are operably connected to each other, e.g. such that the processing described herein is carried out by the joint action of a server and a client device, or of a parallel processing system, such as a computing cluster” in [0082]; “The processing device comprises a grid position sampler 4 for generating a plurality of candidate positions of the grid template with respect to the volume(s) of interest, e.g. in a (implicitly or explicitly) shared reference coordinate system” in [0094]; see Fig.1, the claimed sampler is part of the computer or equivalent device 1 programed to perform the claimed function.
Regarding limitation “quality calculator” in claim 1, 3, 5, 7 and 8, the corresponding structural disclosure in the specification of present application is recited as: “The device may comprise a computer, e.g. specifically programmed for implementing the device as described” in [0081]; “The device is not necessary limited to a general-purpose computer, but may also comprise an application specific integrated circuit (ASIC) and/or configurable processing hardware, e.g. a field-programmable gate array (FPGA). Furthermore, the device may be comprised in a single processing device, e.g. a computer, but also distributed over a plurality of such devices that are operably connected to each other, e.g. such that the processing described herein is carried out by the joint action of a server and a client device, or of a parallel processing system, such as a computing cluster” in [0082]; “The device 1 comprises a quality calculator 5 for calculating, for each candidate position of the plurality of candidate positions, at least one quality metric representative of the suitability of the candidate position of the grid template for the interventional procedure” in [0101]; see Fig.1, the claimed calculator is part of the computer or equivalent device 1 programed to perform the claimed function.
Regarding limitation “position selector” in claim 1, 8, 10 and 12, the corresponding structural disclosure in the specification of present application is recited as: “The device may comprise a computer, e.g. specifically programmed for implementing the device as described” in [0081]; “The device is not necessary limited to a general-purpose computer, but may also comprise an application specific integrated circuit (ASIC) and/or configurable processing hardware, e.g. a field-programmable gate array (FPGA). Furthermore, the device may be comprised in a single processing device, e.g. a computer, but also distributed over a plurality of such devices that are operably connected to each other, e.g. such that the processing described herein is carried out by the joint action of a server and a client device, or of a parallel processing system, such as a computing cluster” in [0082]; “The device 1 comprises a position selector 6 for selecting a position and/or orientation from the plurality of candidate positions/orientations based on the at least one quality metric, e.g. for selecting a position/orientation for which an extremum (maximum or minimum) is reached for one of the at least one quality metric and/or for the composite quality metric” in [0121]; see Fig.1, the claimed selector is part of the computer or equivalent device 1 programed to perform the claimed function.
Regarding limitation “grid template alignment evaluator” in claim 12 and 13, the corresponding structural disclosure in the specification of present application is recited as: “The device may comprise a computer, e.g. specifically programmed for implementing the device as described” in [0081]; “The device is not necessary limited to a general-purpose computer, but may also comprise an application specific integrated circuit (ASIC) and/or configurable processing hardware, e.g. a field-programmable gate array (FPGA). Furthermore, the device may be comprised in a single processing device, e.g. a computer, but also distributed over a plurality of such devices that are operably connected to each other, e.g. such that the processing described herein is carried out by the joint action of a server and a client device, or of a parallel processing system, such as a computing cluster” in [0082]; “The device 1 may comprise a grid alignment evaluator 9 for receiving a position signal indicative of a position and/or orientation of the physical grid template with respect to the body of the patient, and for providing a feedback signal indicative of the position and/or orientation selected by the position selector 6” in [0126]; see Fig.1, the claimed evaluator is part of the computer or equivalent device 1 programed to perform the claimed function.
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.
Claim 1 – 8 and 10 – 15 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 1 recites limitation “such grid hole trajectory” in line 5, it is unclear the above trajectory is one of the “corresponding plurality of grid hole trajectories” or other grid hole trajectory.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable grid hole trajectory.
Claim 1 recites limitation “each grid hole trajectory” in line 20, it is unclear the above “each” trajectory is a single or any one trajectory for each grid template candidate position and/or orientation, or is a single trajectory for each hole in the plurality holes of the grip template in a single position/orientation. Since there are multiple grid template candidate positions and/or orientations, and in the mean while there are multiple holes in any single grid template candidate position and/or orientation, the term “each” can be interpreted as different categories.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable grid hole trajectory.
Claim 3 recites limitation “each grid hole trajectory” in line 3, it is unclear the above “each” trajectory is a single or any one trajectory for each grid template candidate position and/or orientation, or is a single trajectory for each hole in the plurality holes of the grip template in a single position/orientation. Since there are multiple grid template candidate positions and/or orientations, and in the mean while there are multiple holes in any single grid template candidate position and/or orientation, the term “each” can be interpreted as different categories.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable grid hole trajectory.
Claim 4 recites the limitation "the line segments" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites limitation “each grid hole trajectory” in line 5, it is unclear the above “each” trajectory is a single or any one trajectory for each grid template candidate position and/or orientation, or is a single trajectory for each hole in the plurality holes of the grip template in a single position/orientation. Since there are multiple grid template candidate positions and/or orientations, and in the mean while there are multiple holes in any single grid template candidate position and/or orientation, the term “each” can be interpreted as different categories.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable grid hole trajectory.
Claim 6 recites the limitation "the line segments" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites limitation “such grid hole trajectory” in line 5, it is unclear the above trajectory is one of the “corresponding plurality of grid hole trajectories” or other grid hole trajectory.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable grid hole trajectory.
Claim 14 recites limitation “each grid hole trajectory” in line 13, it is unclear the above “each” trajectory is a single or any one trajectory for each grid template candidate position and/or orientation, or is a single trajectory for each hole in the plurality holes of the grip template in a single position/orientation. Since there are multiple grid template candidate positions and/or orientations, and in the mean while there are multiple holes in any single grid template candidate position and/or orientation, the term “each” can be interpreted as different categories.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable grid hole trajectory.
Therefore, claim 1, 3 – 6, 14 and all corresponding dependent claim 2, 7, 8, 10 – 13 and 15 are rejected under 35 U.S.C. 112(b), as being indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 15 is directed to a computer program product.
Claim 15 recites “A computer program product for implementing the computer-implemented method in accordance with claim 14, when executing the computer program product on a processor.” The preamble clearly states a computer program product. Limitation “for implementing the computer-implemented method in accordance with claim 14” describes an intended use which does not positively provide any tangible form. Limitation “when executing the computer program product on a processor” describes a condition which also does not positively provide any tangible form.
As the courts' definitions of machines, manufactures and compositions of matter indicate, a product must have a physical or tangible form in order to fall within one of these statutory categories. Digitech, 758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the Federal Circuit has held that a product claim to an intangible collection of information, even if created by human effort, does not fall within any statutory category. Digitech, 758 F.3d at 1350, 111 USPQ2d at 1720 (claimed “device profile” comprising two sets of data did not meet any of the categories because it was neither a process nor a tangible product). Similarly, software expressed as code or a set of instructions detached from any medium is an idea without physical embodiment. See Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible). Thus, a product claim to a software program that does not also contain at least one structural limitation (such as a “means plus function” limitation) has no physical or tangible form, and thus does not fall within any statutory category. See MPEP 2106.03.
Therefore, claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Allowable Subject Matter
Claim 1 – 8 and 10 – 14 would be allowable if rewritten or amended 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.
The following is a statement of reasons for the indication of allowable subject matter:
Yu et al. (US 2003/0130573 A1; published on 07/10/2003) (hereinafter “Yu”) and Kruecker et al. (US 2017/0304644 A1; published on 10/26/2017) are cited as most relevant prior arts to the claimed invention.
The claimed invention is directed to a system and method for interventional procedure planning. More specifically, the planning requires the positioning of the grid template. Plurality of candidate poses of grid template must be considered during the planning. On the other hand, most prior arts are using candidate trajectories in the planning without any pose adjustment of the grid template. Although grid hole trajectories are both required during planning, the claimed invention is fundamentally different from the conventional planning.
Prior art Yu teaches a device and method for brachytherapy planning using candidate needles positions. A grid template is used for needle insertion but there is no teaching of changing grid template pose. Instead, different holes combinations are related to generate candidate needle positions.
Prior art Kruecker teaches another approach. Instead of generating candidate trajectories, Kruecker uses the target boundary profile to directly calculate the position and/or orientation for the grid template. There is no teaching of any candidate selection.
Thus, neither cited prior arts nor other search results in combination teach the invention as claimed.
Regarding independent claim 1, Yu, Kruecker and other search results collectively neither teach nor fairly well suggest a processing device comprising: “a grid position sampler for generating a plurality of candidate positions and/or orientations of the grid template with respect to the at least one target spatial volume in the body; a quality calculator for calculating, for each candidate position and/or orientation of the plurality of candidate positions and/or orientations, at least one quality metric representative of the suitability of the candidate position of the grid template for the interventional procedure, and a position selector for selecting a position and/or orientation from the plurality of candidate positions and/or orientations based on the at least one quality metric, wherein said quality calculator is adapted for determining, for each candidate position and/or orientation, a spatial relationship between each grid hole trajectory of the grid template, when positioned in accordance with the candidate position and/or orientation, and said at least one target volume”, in combination with other limitations as recited in the amended claim 1.
Claim 2 – 8 and 10 – 13 are directly or indirectly dependent on claim 1 and therefore inherently include the allowable subject matter as discussed above.
Regarding independent claim 14, Yu, Kruecker and other search results collectively neither teach nor fairly well suggest a computer-implemented method, comprising: “generating a plurality of candidate positions and/or orientations of the grid template with respect to the at least one target spatial volume in the body, determining, for each candidate position and/or orientation, a spatial relationship between each grid hole trajectory of the grid template, when positioned in accordance with the candidate position and/or orientation, and said at least one target volume, calculating, for each candidate position and/or orientation of the plurality of candidate positions and/or orientations, at least one quality metric representative of the suitability of the candidate position of the grid template for the interventional procedure by taking, at least, a value indicative of a treatment efficacy measure of the medical interventional procedure when constrained by said determined spatial relationship into account”, “selecting a position and/or orientation from the plurality of candidate positions and/or orientations based on said at least one quality metric”, in combination with other limitations as recited in the amended claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Glossop (US 2016/0008074 A1; published on 01/14/2016) teaches a system and method for interventional procedures using custom templates. Instead of changing the pose of grid template, a template is manufactured according to the result of optimized treatment plan.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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