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 .
Notice to Applicants
This action is in response to the Restriction Election filed on 01/28/2026.
Claims 1-20 are pending.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 02/20/2024 has been fully considered by the examiner.
Restriction/Election
The examiner thanks Applicant for their careful consideration of the Restriction Requirement. Applicant’s election without traverse of Group I (Claims 1-7 and 16-20) in the reply filed on 01/28/2026 is acknowledged. Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/28/2026.
Claim Objections
Claim 6 is objected to.
Regarding claim 6, in line 3, the one of the acquisition parameters is acceptance angle should read the one of the acquisition parameters is an acceptance angle (emphasis added via underline).
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.
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:
“Processing unit”, present in claims 1-7 and 16-20, with corresponding structure found in at least paragraphs 0015, 0034, 0062-0064, 0068, and Processing Unit(s) 722 of Figure 7 of the originally filed specification.
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 5 and 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.
Regarding claim 5, in line 3, the term “the third molecular imaging data” lacks antecedent basis in the claim.
Regarding claim 20, in line 5, the term “the third molecular imaging data” lacks antecedent basis in the claim.
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.
Claims 1, 4, 16, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
Analysis for claim 1 is provided in the following. Claim 1 is reproduced in the following (annotation added):
A molecular imaging scanner comprising:
a plurality of photon detectors;
and a processing unit to:
determine an anatomical image of an object;
input the anatomical image to a trained neural network to generate a synthetic functional image;
acquire molecular imaging data of the object based on acquisition parameters;
reconstruct a functional image based on the molecular imaging data;
and determine a difference between the functional image and the synthetic functional image.
Step 1: Does the claim belong to one of the statutory categories? Claim 1 is directed to a machine, which is a statutory category of invention (YES).
Step 2A Prong One: Does the claim recite a judicial exception? Parts d and h can be regarded as reciting mental processes, such as observations, evaluations, judgements, or opinions, that can be practically performed in the human mind. Part d recites determining an anatomical image of an object, which, as claimed, can be fulfilled by any mental determination or selection of an image of an anatomical object. Part h recites determining a difference between the functional and synthetic functional images, which can also be fulfilled by any mental determinations or observations by looking at said images (YES).
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? Parts a-c recite a computerized system and molecular scanner at a high level of generality. Part e recites an additional element of using a trained neural network to generate the synthetic functional image, which does not integrate the judicial exceptions into a practical application. Part f recites mere data gathering. Part g recites reconstructing the functional image based on the gathered molecular imaging data, which does not integrate the judicial exceptions into a practical application (NO).
Step 2B: Does the claim as a whole amount to significantly more than the recited exception? The claim as a whole recites additional elements involving the necessary hardware of the molecular imaging scanner and details of the generation of the functional and synthetic functional images, but the claim as a whole only employs these additional elements for the ultimate purpose of performing mental processes that can be practically performed in the human mind. The claim does not actively apply the results of performing the aforementioned mental processes (NO). Claim 1 is not eligible.
Similar analysis is applicable to independent claim 16. Claim 16 instead recites a non-transitory medium storing program code executable by at least one processing unit, which still amounts to a computerized system at a high level of generality. Claim 16 is not eligible.
Claims 2 and 17 recite changing the acquisition parameters based on the determined difference, acquiring new molecular imaging data using the changed acquisition parameters, and reconstructing a new functional image with the new molecular imaging data, which does integrate the judicial exceptions into a practical application. Claims 2 and 17 are eligible.
Claims 3 and 18 introduce additional elements with no new judicial exceptions. Claims 3 and 18 are eligible based on their dependence on claims 2 and 17, respectively.
Claims 4 and 19 introduce additional elements that do not integrate the judicial exceptions into a practical application. Claims 4 and 19 are not eligible.
Claim 5 introduces additional elements with no new judicial exceptions. Claim 5 is eligible based on its dependence on claim 2.
Claim 6 narrows the type of determined difference, but also narrows the changed acquisition parameters. Claim 6 is eligible based on its dependence on claim 2.
Claim 7 adds an additional element of a table to support the object, and narrows the determined difference and changed acquisition parameters. Claim 7 is eligible based on its dependence on claim 2.
Claim 20 introduces additional elements with no new judicial exceptions. Claim 20 is eligible based on its dependence on claim 17.
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.
Claims 1-2, 4, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (U.S. Publ. US-2022/0192619-A1) in view of Kraus (U.S. Publ. US-2022/0301289-A1).
Regarding claim 1, Sun discloses a molecular imaging scanner (see figure 1, medical device 110) comprising:
a plurality of photon detectors (see paragraph 0045);
and a processing unit (see figure 1, processing device 120 and figure 2, processor 210) to:
determine an anatomical image of an object (see paragraphs 0038-0039, where the medical device can include a multi-modality system that can obtain anatomical images of an object, such as CT images);
acquire molecular imaging data of the object based on acquisition parameters (see figure 5, step 540 and paragraph 0094);
reconstruct a functional image based on the molecular imaging data (see figure 5, step 550 and paragraph 0095);
Sun fails to disclose input the anatomical image to a trained neural network to generate a synthetic functional image; and determine a difference between the functional image and the synthetic functional image.
Pertaining to the same field of endeavor, Kraus discloses determine an anatomical image of an object (see figure 1, step REC-1 and paragraph 0161, where "first medical image data" is received; paragraph 0092 specifies that the first medical image data can be of many types, such as anatomical images including CT or MR images);
input the anatomical image to a trained neural network to generate a synthetic functional image (see figure 1, step DET-1 and paragraph 0169, where the first medical image data is applied to a trained function to generate synthetic image data; paragraphs 0082-0084 specify how the synthetic image data is generated to be of the same presentation/modality as the forthcoming second imaging data; figures 5-6 and paragraphs 0200-0204 illustrate an example of first image IM_1 being transformed into synthetic image IM_sy that shares the same presentation/modality with second image IM_2);
and determine a difference between the functional image and the synthetic functional image (see figure 1, step REC-2 and paragraph 0162, where "second medical image data" is obtained; paragraph 0092 specifies that the second medical imaging data can be of many types, such as functional images including PET or SPECT images; then see figure 1, step DET-2 and paragraph 0170, where the synthetic image and second image are compared to analyze their differences).
Sun and Kraus are considered analogous art, as they are both directed to image analysis for multi-modality medical imaging systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Kraus into Sun because doing so allows for obtaining additional imaging data for analysis without subjecting the patient to additional radiation (see Kraus paragraphs 0004-0005).
Regarding claim 2, Sun in view of Kraus discloses change one of the acquisition parameters based on the difference (first see Sun paragraphs 0079-0080, where a prior information database includes previous scan data of the patient, such as PET/functional scan data; then see Sun figure 6, step 610 and paragraph 0100, where a plurality of simulation values of acquisition parameters are obtained from the database; then see Sun figure 6, step 620 and paragraphs 0112-0116, where a plurality of simulated images are generated by applying the simulation values to previous scan data in the database; finally see Sun figure 6, step 630 and paragraphs 0117-0119, where updated acquisition parameters are selected based on comparisons between the plurality of simulated images);
acquire second molecular imaging data of the object based on the changed acquisition parameters (see Sun figure 5, step 540 and paragraph 0093, where the updated acquisition parameters are used to obtain new scan data);
and reconstruct a second functional image based on the second molecular imaging data (see Sun figure 5, step 550 and paragraph 0095, where the new scan data is reconstructed to generate the final functional image; paragraph 0096 specifies that once the functional image is complete, the database can be updated with the new scan data, thus this process can be repeated with successive images of the patient over time).
Regarding claim 4, Sun in view of Kraus discloses wherein reconstruction of the functional image and determination of the difference occur during acquisition of second molecular imaging data of the object based on the acquisition parameters (see Sun paragraph 0042, where the acquisition parameters generated during new scans can be used to continuously update and/or optimize the database for use during subsequent scans).
Regarding claim 16, Sun discloses a non-transitory medium storing program code, the program code executable by at least one processing unit to cause a computing system to (see paragraph 0021).
The remainder of claim 16 recites steps identical to those of claim 1. Therefore, Sun in view of Kraus discloses claim 16 as applied to claim 1 above.
Regarding claim 17, Sun in view of Kraus discloses claim 17 as applied to claim 2 above.
Regarding claim 19, Sun in view of Kraus discloses claim 19 as applied to claim 4 above.
Claims 3, 5, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (U.S. Publ. US-2022/0192619-A1) in view of Kraus (U.S. Publ. US-2022/0301289-A1), and further in view of Li et al. (U.S. Publ. US-2019/0122400-A1).
Regarding claim 3, Sun in view of Kraus fails to disclose the limitations of claim 3.
Pertaining to the same field of endeavor, Li discloses wherein the second functional image is reconstructed based on the molecular imaging data and the second molecular imaging data (see paragraphs 0043-0044, where, if acquisition parameters are updated, reconstruction is executed using both the new imaging data and all previous imaging data).
Sun and Li are considered analogous art, as they are both directed to image analysis for acquisition parameter adjustment in medical systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Li into Sun and Kraus because doing so reduces the radiation dose administered to the patient (see Li paragraph 0045).
Regarding claim 5, Sun in view of Kraus fails to disclose the limitations of claim 5.
Pertaining to the same field of endeavor, Li discloses wherein the second functional image is reconstructed based on the molecular imaging data, the second molecular imaging data and the third molecular imaging data (see paragraphs 0043-0044, where, if acquisition parameters are updated, reconstruction is executed using both the new imaging data and all previous imaging data).
Sun and Li are considered analogous art, as they are both directed to image analysis for acquisition parameter adjustment in medical systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Li into Sun and Kraus because doing so reduces the radiation dose administered to the patient (see Li paragraph 0045).
Regarding claim 18, Sun in view of Kraus and Li discloses claim 18 as applied to claim 3 above.
Regarding claim 20, Sun in view of Kraus discloses wherein reconstruction of the functional image and determination of the difference occur during acquisition of second molecular imaging data of the object based on the acquisition parameters (see Sun paragraph 0042, where the acquisition parameters generated during new scans can be used to continuously update and/or optimize the database for use during subsequent scans),
Sun in view of Kraus fails to disclose and the second functional image is reconstructed based on the molecular imaging data, the second molecular imaging data and the third molecular imaging data.
Pertaining to the same field of endeavor, Li discloses and the second functional image is reconstructed based on the molecular imaging data, the second molecular imaging data and the third molecular imaging data (see paragraphs 0043-0044, where, if acquisition parameters are updated, reconstruction is executed using both the new imaging data and all previous imaging data).
Sun and Li are considered analogous art, as they are both directed to image analysis for acquisition parameter adjustment in medical systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Li into Sun and Kraus because doing so reduces the radiation dose administered to the patient (see Li paragraph 0045).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sun (U.S. Publ. US-2022/0192619-A1) in view of Kraus (U.S. Publ. US-2022/0301289-A1), and further in view of Grass et al. (U.S. Publ. US-2020/0337668-A1).
Regarding claim 7, Sun in view of Kraus fails to disclose the limitations of claim 7.
Pertaining to the same field of endeavor, Grass discloses further comprising a table to support the object (see figure 1, table top 118),
wherein the difference is less activity in a region of the functional image than in the region of the synthetic functional image, the one of the acquisition parameters is a speed of the table, and the change is a decrease in the speed of the table (see figure 5 and paragraph 0040, where if a decrease in contrast agent concentration/activity is detected by comparing successive scan planes/images, the speed of the table top is accordingly reduced).
Sun and Grass are considered analogous art, as they are both directed to image analysis for acquisition parameter adjustment in medical systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Grass into Sun and Kraus because doing so allows for ensuring a desired, predetermined amount of activity occurs in each successive image during scanning (see Grass paragraph 0031).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 6, although Sun in view of Kraus generally disclose medical imaging systems for changing acquisition parameters based on the difference between acquired and synthetic functional images (see 103 rejections of claims 1-2 above), the prior art fails to disclose or reasonably suggest doing so specifically by decreasing the acceptance angle with respect to a region that has greater activity in the acquired functional image than in the synthetic functional image, as required by claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS JOHN HELCO whose telephone number is (703)756-5539. The examiner can normally be reached on Monday-Friday from 9:00 AM to 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella, can be reached at telephone number 571-272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS JOHN HELCO/Examiner, Art Unit 2667
/MATTHEW C BELLA/Supervisory Patent Examiner, Art Unit 2667