DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Oath/Declaration
Oath/Declaration as filed on September 30, 2024 is noted by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
The claim recites limitation term “an organ” in tenth line of the claim, but it’s not exactly clear whether the limitation term is referring to same organ recited in seventh line of the claim, or to a different organ. In addition, claim recites limitation term “the supplemental image” in tenth line of the claim, but it’s not exactly clear whether the limitation term is referring to same supplement image recited in thirteenth line of the claim, or to a different image. Therefore, Examiner suggests the limitations should be amended, without adding new matter, in a manner that clarifies exactly what the terms are referring to. Accordingly, any claims dependent on claim 1 are objected to based on same above reasoning.
Claim 3 is objected to because of the following informalities:
In particular, limitation term “whole-body segmentation” recited in second line of the claim, renders the claim indefinite, because the meaning of the coined term “whole-body segmentation” is not apparent in light of the specification. See MPEP § 2173.05(a). Examiner recommends applicant amend the claim, without adding new matter, to positively recite in definite terms more clearly what “whole-body segmentation” actually is. In addition, the claim recites limitation term “at least one baseline image” in third line of the claim, but it’s not exactly clear whether the limitation term is referring to same at least one baseline image previously recited in eighth thru ninth lines of claim 1, or to a different at least one baseline image. Therefore, Examiner suggests the limitation should be amended, without adding new matter, in a manner that clarifies exactly what the term is referring to. Accordingly, any claim(s) dependent on claim 3 are objected to based on same above reasoning.
Claim 4 is objected to because of the following informalities:
The claim recites limitation “the registering step” in second line of the claim, but there is insufficient antecedent basis for the above limitation in the claim because the claim uses term “the registering step” for a first time without previously reciting the term in the claim 4, or in a claim from which the claim 4 depends. Therefore, Examiner suggests the limitation should be amended, without adding new matter, in a manner that resolves the antecedent basis issue. In addition, claim recites limitation term “the supplement image” in third thru fourth lines of the claim, but it’s not exactly clear whether the limitation term is referring to same at least one supplement image recited in third thru fourth line of claim 3, or to same supplement image recited in thirteenth line of claim 1. Therefore, Examiner suggests the limitation should be amended, without adding new matter, in a manner that clarifies exactly what the term is referring to. Accordingly, any claims dependent on claim 4 are objected to based on same above reasoning.
Claim 5 is objected to because of the following informalities:
In particular, limitation term “whole-body segmentation” recited in fourth thru fifth lines of the claim, renders the claim indefinite, because the meaning of the coined term “whole-body segmentation” is not apparent in light of the specification. See MPEP § 2173.05(a). Examiner recommends applicant amend the claim, without adding new matter, to positively recite in definite terms more clearly what “whole-body segmentation” actually is. Accordingly, any claim(s) dependent on claim 5 are objected to based on same above reasoning.
Claim 9 is objected to because of the following informalities:
The claim recites limitation term “the identified barycenter of the lesion of interest” in third thru fourth lines of the claim, but it’s not exactly clear whether the limitation term is referring to same barycenter of the lesion of interest recited in second line of the claim 9, or to same barycenter of the lesion of interest recited in fourth line of the claim 6. Therefore, Examiner suggests the limitation should be amended, without adding new matter, in a manner that clarifies exactly what the term is referring to.
Claim 10 is objected to because of the following informalities:
The claim recites limitation term “an organ” in fifteenth line of the claim, but it’s not exactly clear whether the limitation term is referring to same organ recited in twelfth line of the claim, or to a different organ. In addition, claim recites limitation term “the supplemental image” in twenty-fifth line of the claim, but it’s not exactly clear whether the limitation term is referring to same supplement image recited in eighteenth line of the claim, or to a different image. Therefore, Examiner suggests the limitations should be amended, without adding new matter, in a manner that clarifies exactly what the terms are referring to. Accordingly, any claims dependent on claim 10 are objected to based on same above reasoning.
Claim 12 is objected to because of the following informalities:
In particular, limitation term “whole-body segmentation” recited in second line of the claim, renders the claim indefinite, because the meaning of the coined term “whole-body segmentation” is not apparent in light of the specification. See MPEP § 2173.05(a). Examiner recommends applicant amend the claim, without adding new matter, to positively recite in definite terms more clearly what “whole-body segmentation” actually is. In addition, the claim recites limitation term “at least one baseline image” in third line of the claim, but it’s not exactly clear whether the limitation term is referring to same at least one baseline image previously recited in eighth thru ninth lines of claim 1, or to a different at least one baseline image. Therefore, Examiner suggests the limitation should be amended, without adding new matter, in a manner that clarifies exactly what the term is referring to. Accordingly, any claim(s) dependent on claim 12 are objected to based on same above reasoning.
Claim 13 is objected to because of the following informalities:
The claim recites limitation term “the supplement image” in fourth line of the claim, but it’s not exactly clear whether the limitation term is referring to same at least one supplement image recited in third thru fourth line of claim 12, or to same supplement image recited in eighteenth line of claim 10. Therefore, Examiner suggests the limitation should be amended, without adding new matter, in a manner that clarifies exactly what the term is referring to. Accordingly, any claims dependent on claim 13 are objected to based on same above reasoning.
Claim 14 is objected to because of the following informalities:
In particular, limitation term “whole-body segmentation” recited in fourth thru fifth lines of the claim, renders the claim indefinite, because the meaning of the coined term “whole-body segmentation” is not apparent in light of the specification. See MPEP § 2173.05(a). Examiner recommends applicant amend the claim, without adding new matter, to positively recite in definite terms more clearly what “whole-body segmentation” actually is. Accordingly, any claim(s) dependent on claim 14 are objected to based on same above reasoning.
Claim 18 is objected to because of the following informalities:
The claim recites limitation term “the identified barycenter of the lesion of interest” in third thru fourth lines of the claim, but it’s not exactly clear whether the limitation term is referring to same barycenter of the lesion of interest recited in second line of the claim 18, or to same barycenter of the lesion of interest recited in fifth line of the claim 15. Therefore, Examiner suggests the limitation should be amended, without adding new matter, in a manner that clarifies exactly what the term is referring to.
Claim 19 is objected to because of the following informalities:
The claim recites limitation term “an organ” in twelfth thru thirteenth line of the claim, but it’s not exactly clear whether the limitation term is referring to same organ recited in ninth line of the claim, or to a different organ. Therefore, Examiner suggests the limitation should be amended, without adding new matter, in a manner that clarifies exactly what the term are referring to.
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 2 is 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 pre-AIA the applicant regards as the invention. In particular, claim 2 recites limitation term “the data” in second line of the claim but the limitation term is unclear at least because there is insufficient antecedent basis for the above limitation term in the claim given that the claim uses the limitation term for a first time without previously reciting the limitation term in the claim 2 or in a claim from which the claim 2 depends, which even further creates lack of clarity in regard to exactly what the limitation term is referring to. Therefore, Examiner suggests the limitations should be amended, without adding new matter, in a manner that resolves the antecedent basis issues. Accordingly, any claims dependent on claim 2 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, based on same above reasoning.
Claim 11 is 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 pre-AIA the applicant regards as the invention. In particular, claim 11 recites limitation term “the data” in second line of the claim but the limitation term is unclear at least because there is insufficient antecedent basis for the above limitation term in the claim given that the claim uses the limitation term for a first time without previously reciting the limitation term in the claim 11 or in a claim from which the claim 11 depends, which even further creates lack of clarity in regard to exactly what the limitation term is referring to. Therefore, Examiner suggests the limitations should be amended, without adding new matter, in a manner that resolves the antecedent basis issues. Accordingly, any claims dependent on claim 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, based on same above reasoning.
Potentially Allowable Subject Matter
Claims 1, 10, and 19 would be allowable if rewritten to overcome applicable rejection(s) objection(s) indicated above, because for each of the claims the prior art references of record do not teach the combination of all element limitations as presently claimed. For example, in regard to claim 1, the prior art of record at least does not expressly teach concept of identifying, by the processor, correspondence between one or more anatomical locations in the at least one annotated baseline image and a supplement image in the set of supplement images to establish an image pair; aligning, by the processor, the at least one baseline image and the supplement image of the image pair to generate aligned images; registering, by the processor, the aligned images of the image pair to identify coordinates of the lesion of interest; performing, by the processor, universal lesion segmentation on the registered image pair based on attributes of the supplemental image to predict new lesion contours for the lesion of interest; extracting, by the processor, biomarkers from the registered image pair based on the new lesion contours associated with the lesion of interest; and generating, by the processor, an output signal including the biomarkers. For example, in regard to claim 10, the prior art of record at least does not expressly teach concept of identify, by the processor, correspondence between one or more anatomical locations in the at least one annotated baseline image and a supplement image in the set of supplement images to establish an image pair; align, by the processor, the at least one annotated baseline image and the supplement image of the image pair; register, by the processor configured to execute a phase-agnostic algorithm, the aligned images of the image pair to identify coordinates of the lesion of interest; perform, by the processor, universal lesion segmentation on the registered image pair based on attributes of the supplemental image to predict new lesion contours for the lesion of interest; extract, by the processor, biomarkers from the registered image pair based on the new lesion contours associated with the lesion of interest; and generate, by the processor, an output signal including the biomarkers. Still for example, in regard to claim 19, the prior art of record at least does not expressly teach concept of identifying, by the at least one processor, correspondence between one or more anatomical locations in the at least one annotated baseline image and a supplement image in the set of supplement images to establish an image pair; aligning, by the at least one processor, the annotated baseline image and the supplement image of the of the image pair; registering, by the at least one processor executing a phase-agnostic algorithm, the aligned images of the image pair to identify coordinates of the lesion of interest; performing, by the processor, universal lesion segmentation on the registered images of the image pair to predict new lesion contours for the lesion of interest; extracting, by the at least one processor, biomarkers from the registered and aligned images of the image pair based on the new lesion contours associated with the lesion of interest; and generating, by the processor, an output signal including the biomarkers. In addition, claims 2-9, and 11-18 would be allowable if rewritten to overcome applicable rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd paragraph, if any, and objection(s) indicated above because for each of claims 2-9, and 11-18, at least in light of their dependency on their respective independent claim, the prior art references of record do not teach the combination of all element limitations as presently claimed.
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure and include the following:
Taerum et al., U.S. Patent Application Publication 2020/0085382 A1 (hereinafter Taerum) teaches an automated end-to-end pipeline for accurate lesion detection and segmentation.
Richter et al., U.S. Patent Application Publication 2020/0245960 A1 (hereinafter Richter) teaches a system that provides for automated analysis of three-dimensional (3D) medical images of a subject in order to automatically identify specific 3D volumes within the 3D images that correspond to specific anatomical regions (e.g., organs and/or tissue).
Golden et al., U.S. Patent Application Publication 2020/0380675 A1 (hereinafter Golden) teaches an automated end-to-end pipeline for accurate lesion detection and segmentation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL-SAMAD A ADEDIRAN whose telephone number is (571)272-3128. The examiner can normally be reached on Monday through Thursday, 8:00 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amr Awad can be reached on 571-272-7764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL-SAMAD A ADEDIRAN/Primary Examiner, Art Unit 2621
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