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 .
Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to an apparatus and method for determining a dynamic imaging capability based on a relation with a required imaging capability for a predetermined dynamic analysis, classified in A61B6/583.
II. Claims 20-23, drawn to an apparatus and method for determining a dynamic imaging capability of a radiography apparatus comprising preparing a model whose radiolucency and movement speed are changeable, classified in A61B6/585.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination does not require: the steps of preparing a model whose radiolucency and movement speed are changeable, acquiring a plurality of images continuously captured by irradiation of the model while selecting a combination of the radiolucency and the movement speedo the model, comparing a resolution of each of a plurality of images acquired and a reference value set for each imaging purpose,. The subcombination has separate utility such as determining, based on a result of the comparison, whether or not the radiography apparatus has a required imaging capability.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The different inventions I and II would require separate and non-overlapping searches and examinations on the merits.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Elections
During a telephone conversation with Shintaro Yamada on 02/14/2026 a provisional election was made without traverse to prosecute the invention of I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 20-23 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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:
“an acquirer” in claim 16,
“an output” in claim 16.
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 1-19 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 the phrase “imaging capability” in lines 3 and 5 of the claim. The claim fails to make clear what kind of “imaging capability” is referenced in the claims. Furthermore, the specification fails to provide further definition of the scope of the phrase. One of ordinary skill in the art would not be apprised of the scope of the claim. Independent claim 16 further recites the phrase and is rejected accordingly. The balance of claims are rejected on dependence.
Claim 3 recites the phrase “the imaging capability for each dynamic analysis” in line 4. The instant phrase lack antecedent basis in the claims. Claim 1 previously recites “a predetermined dynamic analysis”, but does not disclose more than one. The phrase “each” implies more than one.
Claim 16 recites the phrases “acquirer” and “output”, and each invokes 112(f) as set forth above under “Claim Interpretation”. However, the disclosure fails to clearly link or associate the disclosed structure, material or acts to the claimed function, per the requirements of MPEP 2181(III). Accordingly, the claims are indefinite.
Claim 16 recites the phrases “acquirer” and “output”, and each invokes 112(f) as set forth above under “Claim Interpretation”. However, the disclosure fails to clearly link or associate the disclosed structure, material or acts to the claimed function, per the requirements of MPEP 2181(III). Accordingly, the claims lack written description. See MPEP 2181(IV) for further details.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 3, 4, 5, 6, 7, 8, 11, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by NAGATSUKA (US Pub # 20220398713).
Regarding claims 1 and 16, NAGATSUKA discloses a capability determination apparatus (system 100; FIG 1) and method of using (FIGURE 3, 5) comprising: acquiring an imaging capability from an image obtained by a radiation detector by irradiation of a model with radiation (steps S3/S22 obtains image data by capturing a phantom, [0096, 0109]; Step S4/S23 the controller 21 generated the information on quality control regarding smoothness of the dynamic image based on image data, [0078, 0111]); and outputting the acquired imaging capability in such a manner as to indicate a relation with a required imaging capability for a predetermined dynamic analysis (S5/S24 describes outputting information on quality control smoothness of dynamic image, [0095-0096, 0115]).
Regarding claim 2, NAGATSUKA discloses wherein the outputting includes outputting a comparison result between the acquired imaging capability and the required imaging capability for the predetermined dynamic analysis (controller 21 displays information indicating whether quality control regarding the smoothness of the dynamic image is within the appropriate range; [0098, 0119, 0123]).
Regarding claim 3, NAGATSUKA discloses the required imaging capability for the predetermined dynamic analysis is an imaging capability for the dynamic analysis, and the outputting includes outputting whether or not the imaging capability for the dynamic analysis is included (S5/S24 describes outputting information on quality control smoothness of dynamic image, [0095-0096, 0115]).
Regarding claim 4, NAGATSUKA discloses the imaging capability is an imaging capability of the radiation detector (dynamic image data includes frame rate, which is a detector capability; [0083]).
Regarding claim 5, NAGATSUKA discloses wherein the imaging capability is an imaging capability of a radiography apparatus (dynamic image data includes frame rate, which is a radiography apparatus capability; [0083]).
Regarding claim 6, NAGATSUKA discloses the radiography apparatus includes a radiation generating apparatus and the radiation detector (generation device 3; FIG 1; [0031-0037]).
Regarding claim 7, NAGATSUKA discloses the radiography apparatus further includes a console (console 2; FIG 1; [0027]).
Regarding claim 8, NAGATSUKA wherein the model includes a plurality of regions having different radiolucencies (FIG 4; phantom F includes different radiolucencies, including absorbing site F1; [0075]).
Regarding claim 11, NAGATSUKA does not disclose wherein the imaging capability includes a time resolution that is a frame rate (dynamic image data includes frame rate; [0083]).
Regarding claim 17, NAGATSUKA computer-readable recording medium storing a capability determination program for causing a computer to execute the capability determination method according to claim 1 ([0014]).
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.
Claim(s) 9, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over NAGATSUKA (US Pub # 20220398713) in view of NAGATSUKA et al. (hereafter N2)(US Pub # 20220351358).
Regarding claim 18, NAGATSUKA discloses phantom used as a model in the capability determination method according to claim 1, the phantom comprising: a plurality of regions having different radiolucencies. NAGATSUKA does not disclose the phantom comprising a plurality of granules having different sizes, the plurality of granules being disposed at positions downstream of the plurality of regions along passing radiation. In the same field of endeavor, N2 discloses a phantom for dynamic imaging comprising a plurality of regions having different radiolucencies (radiolucent disc 62a, metal discs 62b, etc.; [0082-0091]) and a plurality of granules having different sizes (FIG 3A-B show dynamic phantom 6 having granules of different sizes, e.g. numbers 62c and discs 62b), the plurality of granules being disposed at positions downstream of the plurality of regions along passing radiation (subject to the alignment of phantom to imaging system), with the benefit of enhanced quality control within dynamic imaging. In light of the teachings of N2, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of NAGATSUKA.
Regarding claims 9 and 19, N2 discloses wherein the plurality of granules having different sizes are movable ([0082-0091]; FIG 3A-3B).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over NAGATSUKA (US Pub # 20220398713) in view of NAGATSUKA et al. (hereafter N3)(US Pub # 20220346739).
Regarding claim 10, NAGATSUKA does not disclose wherein the imaging capability includes a contrast resolution that is an amount of change in contrast of a captured image. In the same field of endeavor, N3 discloses it is known in the art of dynamic radiography to perform a quality check based on a contrast resolution ([0135, 0151]), with the benefit of improved image quality. In light of the teachings of N3, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of NAGATSUKA.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over NAGATSUKA (US Pub # 20220398713) in view of STETTNER (AT 524993 A1).
Regarding claim 12, NAGATSUKA does not disclose wherein the imaging capability includes a spatial resolution that is an image resolution of a captured image. In the same field of endeavor, STETTNER discloses it is known in the art of radiography to perform a quality check based on a spatial resolution (abstract), with the benefit of improved image quality. In light of the teachings of STETTNER, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of NAGATSUKA.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over NAGATSUKA (US Pub # 20220398713) in view of Fyles et al.1
Regarding claims 13, 14 and 15, NAGATSUKA does not disclose wherein the predetermined dynamic analysis is a dynamic analysis relevant to pulmonary embolism, valve regurgitation or heart failure, with required imaging capability in contrast resolution, spatial resolution, and a frame rate for a body thickness of 5 cm. However, it is well known in the art to apply dynamic chest radiography (DCR) when analyzing a respiratory condition (e.g. embolism, valve regurgitation, etc.) or cardiovascular condition (e.g. arrest, failure, etc.), as taught by Fyles (abstract; Introduction: page 2, col. 1, para. 2). Furthermore, Fyles discloses it is known in the art to provide sufficient resolution and frame rate for a given measurement condition (Introduction: page 2, col. 1, para. 1). Based on the application at hand, it would have been obvious to one of ordinary skill in the art at the time of the invention to select optimal imaging parameters (contrast, resolution, frame rate, etc.) for a given imaging to balance known constraints including image quality, patient dose, and computational burden.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UZMA ALAM can be reached at 571-272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CASEY BRYANT
Primary Examiner
Art Unit 2884
/CASEY BRYANT/ Primary Examiner, Art Unit 2884
1 Fyles et al., “Dynamic chest radiography: a state-of-the-art review”, Insights into Imaging (2023), 14:107