DETAILED ACTION
Summary
Claims 1-20 are pending in the application. Claims 1-20 are rejected under 35 USC 112(b). Claim 19 is rejected under 35 USC 101.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/6/2026 has been entered.
Claim Objections
Claims 1, 3, 9, and 14 objected to because of the following informalities:
Claim 1 recites “provide the image quality indicator, indicative whether” in line 16. It should recite “provide the image quality indicator, indicative of whether”.
Claim 3 recites “the at least a portion” in line 5. It should recite “the at least the portion”.
Claim 9 recite “is implemented at least one of” in line 2. It should recite “is implement as at least one of”.
Claim 14 recites “providing the image quality indicator, indicative whether” in line 13. It should recite “providing the image quality indicator, indicative of whether”.
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 1-20 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 “the image quality indicator indicates that the subject may be dismissed” in line 14. However, lines 16-17 state “the image quality indicator, indicative whether the subject is to be dismissed”. “May be dismissed” and “is to be dismissed” are not synonyms, and it is therefore unclear whether the claim is referring to the same image quality indicators. Clarification is required. For the purposes of examination, the claim will be interpreted as if they are referring to the same image quality indicators.
Claim 10 recite “a predetermined criterion” in line 4. It is not clear if this is referring to the same predetermined criterion set forth in claim 1, or if this is setting forth a new predetermined criterion. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 11 recites the limitation "the operator" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as referring to “an operator”.
Claim 11 recite “an operator” in line 6. It is not clear if this is referring to the operator previously set forth, or if this is setting forth a new operator. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 11 recites “a predetermined criterion” in line 7. It is not clear if this is referring to the predetermined criterion set forth in claim 1, or if this is setting forth a new predetermined criterion. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 14 recites “the image quality indicator indicates that the subject may be dismissed” in lines 11-12. However, lines 13-14 state “the image quality indicator, indicative whether the subject is to be dismissed”. “May be dismissed” and “is to be dismissed” are not synonyms, and it is therefore unclear whether the claim is referring to the same image quality indicators. Clarification is required. For the purposes of examination, the claim will be interpreted as if they are referring to the same image quality indicators.
Claim 16 recites “an operator” in line 4. It is not clear if this is referring to the operator set forth in claim 14, or if this is setting forth a new operator. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 16 recites “a predetermined criterion” in line 5. It is not clear if this is referring to the predetermined criterion set forth in claim 14, or if this is setting forth a new predetermined criterion. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 18 recites the limitation "the operator" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as reciting “an operator”.
Claim 19 recites “wherein the subject is discharged before reconstruction of the tomographic image”. This is a method step (i.e. discharging the subject). The claim therefore contains a method step and an apparatus (the medical instrument) in the same claim (See MPEP 2173.05(p)(II)). For the purposes of examination, the claim will be interpreted as the processor is configured to perform the recited steps.
Claim 19 recites “wherein the subject is discharged before reconstruction of the tomographic image”. It is not clear how this claim limits the medical instrument, as the subject is not a part of the medical instrument, and the medical instrument does not perform the reconstruction. Clarification is required. For the purposes of examination, the claim will be interpreted as the processor of the instrument being configured to perform the claimed method.
Claim 20 recite “The medical instrument of claim 1, wherein reconstruction of the tomographic image is performed by a remote processing system separate from the medical instrument”. It is not clear how this claim limits the medical instrument, as the remote processing system is not a part of the medical instrument. Clarification is required. For the purposes of examination, the claim will be interpreted as the instrument being part of a system with the remote processing system.
All claims dependent from the above claims rejected under 35 USC 112(b) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 19 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 19 recites “wherein the subject is discharged before reconstruction of the tomographic image”. This is defining the reconstruction based on the subject. By the broadest reasonable interpretation, the subject can be a human, and the instrument therefore encompasses the human. The Examiner recommends amending the claim to make it clear the subject is not a part of the instrument.
Allowable Subject Matter
Claims 1-18, and 20 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.
Claim 1 recites “wherein the tomographic data assessment module is configured for generating the image quality indicator in response to inputting the measured tomographic data, wherein the image quality indicator is received and evaluated before reconstruction of the tomographic image, and wherein satisfaction of a predetermined criterion by the image quality indicator indicates that the subject may be dismissed before reconstruction of the tomographic image; and provide the image quality indicator, indicative whether the subject is to be dismissed and whether the reconstruction of the tomographic image reconstruction is to be executed, using an operator signaling system, wherein the processor is further configured to enable reconstruction of the tomographic image from the measured tomographic data at a time after the subject is dismissed”. These limitations, in combination with the other limitations, are not taught by the prior art without the benefit of improper hindsight reasoning.
Moriyasu teaches a system which determines the quality of raw data. However, Moriyasu does not teach “wherein satisfaction of a predetermined criterion by the image quality indicator indicates that the subject may be dismissed before reconstruction of the tomographic image” or “wherein the processor is further configured to enable reconstruction of the tomographic image from the measured tomographic data at a time after the subject is dismissed”. Becker teaches a system which analyzes raw imaging data. While Becker outputs an alarm signal based on the data, the alarm signal does not have a predetermined criteria “wherein satisfaction of a predetermined criterion by the image quality indicator indicates that the subject may be dismissed before reconstruction of the tomographic image”. Furthermore, Becker is silent as to the timing of reconstructing the image. Palma discloses retaking tomosynthesis data before a patient is dismissed. However, Palma does not teach “wherein satisfaction of a predetermined criterion by the image quality indicator indicates that the subject may be dismissed before reconstruction of the tomographic image” or “wherein the processor is further configured to enable reconstruction of the tomographic image from the measured tomographic data at a time after the subject is dismissed”. None of the other cited references teach the cited limitations.
Claim 1 is therefore non-obvious over the prior art, and would be allowable if amended to overcome the rejections under 35 USC 112(b). Claim 14 recites similar limitations, and would also be allowable if amended to overcome the rejections under 35 USC 112(b). Dependent claims 2-13, 15-18 and 20 contain all the limitations of the allowable base claim, and would be allowable by virtue of their dependency.
Response to Arguments
Applicant’s arguments, see pages 10-12, filed 8/6/2026, with respect to claim 1 have been fully considered and are persuasive. The rejections of claims 1-15 under 35 USC 103 have been withdrawn. As detailed above, claims 1-18 and 20 would be allowable if amended to overcome the rejections under 35 USC 112(b).
Conclusion
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/SEAN D MATTSON/ Primary Examiner, Art Unit 3798
