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 .
Priority
It is noted, however, that applicant has not filed a certified copy in the English language for the EP21172677.3 application.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the time points depicted by FIGS. 3 (a) and 3 (b); the liver artery (A) in FIG. 3 (b); the liver via the veins (V); the contrast agent reaches the liver via the veins (V) and the time point depicted in FIG. 3 (c); the time point depicted in FIG. 3 (c); and the venous blood vessels (V) stand out from the liver tissue (L) and the reference tissue (R) in FIG. 3 (d); as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “L” has been used to designate both healthy liver cells and liver tissue (see [0229] of the PG Pub). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-18 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 limitations "the contrast enhancement", "the decreasing contrast enhancement", "the increasing enhancement", "the gradient" in lines 16-21. There are insufficient antecedent bases for these limitations in the claim. As claim 1 does not recite previously “a contrast enhancement”, “a decreasing contrast enhancement”, “a increasing enhancement” nor “a gradient” earlier in the claim.
Further, claim 1 recites “wherein at least one representation of the plurality of representations represents the liver or the part of the liver and the reference tissue during a portal venous phase of a dynamic contrast-enhanced magnetic resonance imaging examination, and wherein at least one representation of the plurality of representations represents the liver or the part of the liver and the reference tissue during a transitional phase of the dynamic contrast-enhanced magnetic resonance imaging examination; wherein the control and calculation unit is configured to identify one or more regions in the liver”, “a representation of the liver or the part of the liver” in lines 7-23, which renders the claim indefinite because it is unclear if the at least one representation of the plurality of representations represents the liver or the part of the liver and the reference tissue during the transitional phase of the dynamic contrast-enhanced magnetic resonance imaging examination is the same at least one representation of the plurality of representations represents the liver or the part of the liver and the reference tissue during the portal venous phase of a dynamic contrast-enhanced magnetic resonance imaging examination as recited previously in the claim. Similarly, it is unclear if the part of the liver represented in the wherein at least one representation of the plurality of representations during the transitional phase is the same part of the represented in the wherein at least one representation of the plurality of representations during the portal venous phase. It is also unclear if the representation of the liver or the part of the liver that is output in the last step of claim 1 is one of the plurality of representations recited earlier in the claim.
Claims 4, 5, 6, 7, 8, 9, and 10 are also rejected for reciting the same and/or similar limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Claim 4 recites the limitation "the multiple regions in the liver" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 does not recite previously “multiple regions” in the liver.
Further, claim 4 recites “at least two representations of the plurality of representations represent the liver or the part of the liver and the reference tissue during the transitional phase” in lines 7-9, which renders the claim indefinite because it is unclear if the at least two representations during the transitional phase are the same at least two representations of the plurality of representations during the portal venous phase, as recited earlier in the claim.
Claim 5 recites the limitations "the region/regions", "the following features" in lines 6-7. There are insufficient antecedent bases for these limitations in the claim. Parent claim 1 does not recite previously “a region/region” nor “following features”.
Further, claim 5 recites “receiving at least one representation”, “wherein the at least one representation represents…a first and/or second reference tissue during an arterial phase of the dynamic contrast-enhanced magnetic resonance imaging examination”, “identifying one or more regions in the liver”, “contrast agent leads in the arterial phase”, “contrast agent leads in the portal venous and/or transitional phase” in lines 3-7, 8, 11, which renders the claim indefinite because it is unclear if the “at least one representation” is one of the least one representations recited in parent claim 1 and if the first and/or second reference tissue is the same as the ”reference tissue” recited in parent claim 1, or if these are different reference tissue(s).
And it is unclear if the first and/or second reference tissue represented during an arterial phase of the dynamic contrast-enhanced magnetic resonance imaging examination are the same reference tissue recited in parent claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-11 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sperandio et al. (US20220318991, hereafter “Sperandio”).
Regarding claims 1, 4, 5, 6, 7, 8, 9, and 10, Sperandio discloses a computer system (106), a computer-implemented method (abstract), a non-transitory computer readable storage medium storing instructions ([0090] a computer readable storage medium that is not transitory) that, a contrast agent for use in a dynamic contrast-enhanced magnetic resonance imaging examination method, the use of a contrast agent in a dynamic contrast-enhanced magnetic resonance imaging examination method, and the stored instructions that, when executed by one or more processors of a computer system ([0089]-[0090]), the stored instructions that, when executed by one or more processors of a computer system ([0089]-[0090]), cause the computer system to and wherein the examination method comprising:
a receiving unit (108),
a control and calculation unit ([0048], [0109], the computing device 108 both receives and processes, e.g., by the liver assessment module 110, the liver exam image data 106; the computing device having a processor which refers to an integrated circuit, an application specific integrated circuit (ASIC), a digital signal processor (DSP), a field programmable gate array (FPGA), a programmable logic controller (PLC), a complex programmable logic device (CPLD), a discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions as disclosed), and
an output unit (UI 134 having display 136),
wherein the control and calculation unit is configured to prompt± the receiving unit to receive a plurality of representations ([0064] the plural image data 106 is received by 108 in FIG. 1, where a notification can prompt the reviewer to manually review and characterize presence or absence of the feature and/or manually evaluate the pathology of lesion/potential lesion), wherein the plurality of representations represents
a liver of a patient or part of the liver* of the patient (see FIGS. 3-9), and
reference tissue of the patient ([0059], [0063] the lesion detection component 118 of the computing unit 108 determines for a lesion in the liver or part of the liver, the size, shape, diameter, relative position of the lesion relative, e.g., with respect to one or more anatomical features of reference such as adjacent liver parenchyma),
wherein at least one representation of the plurality of representations represents the liver or the part of the liver and the reference tissue during a portal venous phase of a dynamic contrast-enhanced magnetic resonance imaging examination ([0037]-[0038] the different physiological phases can be based on contrast injection in multiphase MR image data captured in the portal venous phase (PVP) as illustrated by the liver and adjacent tissues in the figures), and
wherein at least one representation of the plurality of representations represents the liver or the part of the liver and the reference tissue during a transitional phase of the dynamic contrast-enhanced magnetic resonance imaging examination ([0037]-[0038] the different physiological phases can be based on contrast injection in multiphase MR image data captured in the transitional phase (TP) as illustrated by the liver and adjacent tissues in the figures);
wherein the control and calculation unit is configured to identify one or more regions in the liver ([0023], [0060], FIG. 4, the AI tools can include one or more segmentation algorithms configured to identify and segment abnormalities (e.g., lesions and potential lesions) depicted on/in a portion of the detected observation/region of interest in the image data):
*in which contrast agent leads in the portal venous phase to a lower contrast enhancement than in the reference tissue (([0037], [0053]-[0054], FIG. 3, after administration of the contrast agent, different tissues and structures reach peak enhancement at different times. This allows the acquisition of images during different time ranges or “dynamic phases” to highlight these differences and to distinguish between images corresponding to different pre-defined hepatic vascular phase, in FIG. 3 the liver exam image data 106 corresponding to different phases, such as the different series corresponding to the different phases shown in the four different windows of the graphical user interface 300, where the PHP shows a lower contrast enhancement, i.e., the vein is darker than the adjacent/reference tissue); and
In another embodiment disclosed by Sperandio, Sperandio discloses wherein the control and calculation unit is configured to prompt the output unit to output a representation of the liver or the part of the liver, wherein in the representation the identified region is highlighted or the identified regions are highlighted ([0028]-[0029], [0076]-[0076], FIGS. 7-8, the defined liver observations/regions based on the mark-up of the image data as displayed via the graphical user interface, the mark-up image data being with highlighting, with color, with indica point to the feature, etc., that depicts the detected imaging feature and provide information describing the detected imaging features in the response of the specific icon being selected).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the computer system, the computer-implemented method, the non-transitory computer readable storage medium storing instructions, the contrast agent for use in a dynamic contrast-enhanced magnetic resonance imaging examination method, the use of a contrast agent in a dynamic contrast-enhanced magnetic resonance imaging examination method disclosed by Sperandio with the step of wherein the control and calculation unit is configured to prompt the output unit to output a representation of the liver or the part of the liver, wherein in the representation the identified region is highlighted or the identified regions are highlighted disclosed by another embodiment taught by Sperandio in order to provide the user with a dialog-box of with a list ancillary features that can be selectively applied to a particular observation which include pre-defined ancillary features favoring malignancy in general (not HCC in particular), ancillary features favoring malignancy for HCC in particular, and ancillary features favoring benignity ([0077] of Sperandio).
And with specific regard to claim 5, Sperandio discloses the limitations of claim 5 requiring receiving at least one representation, wherein the at least one representation represents the liver or the part of the liver and a first reference tissueꝉ during an arterial phase of the dynamic contrast-enhanced magnetic resonance imaging examination ([0037]-[0038], FIGS. 3-9, the different physiological phases can be based on contrast injection in multiphase MR image data captured in the arterial phase (AP) as illustrated by the liver and adjacent tissues in the figures).
And with specific regard to claim 10, Sperandio discloses the limitations of claim 10 requiring a kit comprising a contrast agent ([0037] a contrast agent is administered by injection into the subject) and the non-transitory computer readable storage medium of 7 ([0090]).
±For the purposes of examination, the term “prompt” henceforth has been interpreted as defined by the Oxford Dictionary of Computer Science to mean “a change to the contents of a computer display to indicate that input is required from the operator”.
*For the purposes of examination, all limitations(s) recited in the alternative form, i.e., reciting “and/or” have been interpreted in the alternative, and thus do not require each alternative for each step and do not require each step recited in separate stanzas which have been recited in the alternative, e.g., “in which…, and/or”. Similarly, for the three steps of identifying outlined after line 13 reciting “identifying one or more regions in the liver;” where each of the later recited three steps are recited in the three separate stanzas starting with “in which…” have also been interpreted in the alternative and thus the claim doses not require the combination of each of the three steps to be performed.
ꝉFor the purposes of examination, the limitation has been interpreted in the alternative, requiring a first reference tissue during an arterial phase of the dynamic contrast-enhanced magnetic resonance imaging examination; or requiring a second reference tissue during an arterial phase of the dynamic contrast-enhanced magnetic resonance imaging examination.
Regarding claims 2 and 11, Sperandio substantially discloses all the limitations of the claimed invention, specifically, Sperandio discloses wherein the contrast agent is a hepatobiliary contrast agent ([0037]-[0038], FIGS. 3-9, as illustrated in the figures, the contrast agent is taken up by various structures of the liver, therefore the contrast agent is a hepatobiliary contrast agent).
Regarding claim 3, Sperandio substantially discloses all the limitations of the claimed invention, Sperandio wherein the reference tissue is muscle tissue ([0063] the reference tissue being adjacent liver parenchyma which is known in the art to contain smooth muscle tissue)
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Sperandio, as applied to claims 2 and 10 above, in view of Berger et al. (US20190083659, hereafter “Berger”).
Regarding claims 12, and 13, Sperandio substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the contrast agent is a disodium salt of gadoxetic acid.
However, in the same field of endeavor, Berger teaches wherein the contrast agent is a disodium salt of gadoxetic acid ([0509] the contrast agent is gadoxetate disodium of gadoxetic acid, which is commercially known as Primovist®).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the computer system, the computer-implemented method, the non-transitory computer readable storage medium storing instructions, the contrast agent for use in a dynamic contrast-enhanced magnetic resonance imaging examination method, the use of a contrast agent in a dynamic contrast-enhanced magnetic resonance imaging examination method disclosed by Sperandio with the contrast agent being a disodium salt of gadoxetic acid as taught by Berger to so that the contrast agent is taken up and are also excreted partially via the liver due to the enhancement of liver parenchyma caused by the contrast agent uptake in hepatocytes ([0004] of Berger).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Hoekstra can be reached on (571) 272-7232. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S./Examiner, Art Unit 3798
/JEFFREY G HOEKSTRA/SPE, Art Unit 3798