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 .
Response to Amendment
Applicant's submission filed on 03/10/2026 has been entered. Accordingly, claims 1-2, 4-7, and 10-13 remain pending, claims 1-2* and 4-7* and have been amended, claims 3* and 8-9* have been canceled.
*It is noted that while only claim 1 is indicated as being amended as filed 03/10/2026, claims 2, 4-7 appear to also have been amended and claims 3 and 3-9 appear to have been canceled. While applicant presented amendments on 07/24/2026, those amendments were not entered as applicant was notified in the noncompliant notice mailed 10/10/2025 and discussed with the applicant during the interview conducted on 10/02/2025, 10/07/2025, as documented in the interview summary form mailed 10/10/2025. The lack of proper status indicators and amendment markings in the presently amended claims as filed 03/10/2026 has been interpreted as typographical errors and have been examined.
Response to Arguments
Priority
The priority documents filed 03/10/2026 have been accepted.
Drawing Objections
In light of the drawing amendments filed 03/10/2026, the previous drawing objections have been rendered moot and have been withdrawn.
Rejections under 35 USC 112
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive, with the exception of claim 1. The presently filed amendments to claim 1 remedy the previous issues outlined in the previous rejection of claim 1, rendering the rejection moot and it has been withdrawn. However, the newly filed claim amendments also now introduced new clarity issues to the claims. See the new rejection for claim 1, other claims reciting similar unclear subject matter, and those for the dependent claims thereof, as outlined below.
Regarding the previous rejections of claims 4-5, applicant’s amendments have not remedied the outstanding rejections. Accordingly, the rejections of these claims have been updated to reflect the newly presented claim language and also to provide further clarity and simplification in the rejection analysis. See the updated rejections for claims 4-5 below.
Rejections under 35 USC 103
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive. It is noted that applicant appears to rely on arguments previously filed 07/24/2025, applicant is reminded that the response filed on that date was not entered. Nonetheless, the responses provided are responded to below.
Applicant argues in the second-final paragraphs of page 10 through the third paragraph of page 11 of the response filed 07/24/2025
“The 103 rejection to be withdrawn because Sperandio does not disclose or suggest ‘identifying one or more regions of the liver: in which contrast agent leads in the portal venous phase and the transitional phase to a lower contrast enhancement then in the first reference tissue,’ or ‘receiving a plurality of representations, wherein the plurality of representations represents: a liver of a patient or a part of the liver of the patient, and first reference tissue of the patient, wherein the first reference tissue is muscle tissue’ as required a representative claim 1.
With respect to ‘identify one or more regions of the liver: in which contrast agent leads to the portal venous phase and the transitional phase to a lower contrast enhancement than in the first reference tissue,’ paragraphs [0037], [0053], and [0054], of Sperandio are relied upon for allegedly teaching this limitation. (Action p. 9). However, paragraphs [0037] discloses the acquisition of images in different phases of a dynamic contrast enhancement MRI examination. The acquisition of images are not the same thing as ‘identifying’ one more regions in the liver in which contrast agent leads in the portal venous phase and the transitional phase to a lower contrast enhancement than in the first reference tissue. Further, paragraphs [0053] and [0054] disclosed that a phase identification of component 114 can automatically separate different image series from one another based on different phases identified by the phase identification component. The identification of different phases in the imaging data is different than the identification of one or more regions of the liver in which contrast agent leads in the portal venous phase and/or the transitional phase to a lower contrast enhancement than in the reference tissue. The remainder of Sperandio’s disclosure fails to cure the deficiencies of these paragraphs.
Accordingly, because Sperandio does not disclose or suggest ‘identifying one or regions in the liver: in which contrast agent leads in the portal venous phase and the transitional phase to a lower contrast enhancement than in the first reference tissue,’ the 103 rejection should be withdrawn with respect to representative claim 1. In turn, since Sperandio does not disclose that respected regions are identified, it follows that Sperandio does not disclose ‘outputting at least one representation of the plurality of representations of the liver part of the liver, in which the one or more regions are highlighted.’ The 103 rejection should also be withdrawn with respect to claim 1 for this reason.
Further, Sperandio does not disclose or suggest ‘receiving a plurality of representations, where the plurality representation represents: a liver of the patient or a part of the liver of the patient, and the first reference tissue of the patient, wherein the first reference tissue is muscle tissue’ as previously recited independent claim 3. In the Action, the Examiner relies on Sperandio’s disclosure of using ‘adjacent liver parenchyma’ as the reference tissue in rejecting the claim and contends that the liver parenchyma is noted in the art to contain smooth muscle tissue. (Action p. 12). Applicant respectfully disagrees. A person of ordinary skill would recognize that liver parenchyma does not contain any muscle tissue. The liver is primarily composed of hepatocytes, which are specialized epithelial cells, along with other cell types such as Kupffer cells (macrophages), endothelial cells, and stellate cells. The liver structure is designed for its specific functions such as metabolism and detoxification, rather than for movement or contraction, which is the role of muscle tissue. Therefore, Sperandio’s disclosure of using the liver parenchyma as a reference tissue does not teach or suggest ‘wherein the first reference tissue is muscle tissue’ as required by amended claim 1. Accordingly, the 103 rejection with respect to claim 1 should be withdrawn”.
In response, it is noted that applicant presents arguments for amended claim limitations which had not yet been presented for examination, and therefore had not yet been examined, at the time applicant filed the above response. Therefore, applicant’s references applicant’s above arguments made to certain portions of the previous office action for purportedly rejecting the unexamined limitations with specific portions of the prior art does not apply to the previous rejection in the previously mailed office action nor to the rejection that is newly presented below.
As a preliminary matter, applicant is reminded that “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). (See MPEP 2145(X)(D)(1)).
Accordingly, it is noted that the arguments presented are unsupported by objective evidence. Applicant is reminded that arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
Further, applicant’s remarks on pages 10-11, characterize the field of endeavor more narrowly than is appropriate. As noted in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009), “This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests in specific scientific fields in a way that deem entire classes of prior art teachings irrelevant, or discount significant abilities of artisans of ordinary skill in an advanced area of art”.
In response to applicant’s argument that “[a] person of ordinary skill would recognize that liver parenchyma does not contain any muscle tissue”, it appears, although it is unclear, that applicant has in mind a singular meaning or singular type of “muscle tissue” and/or a singular type of smooth muscle tissue. For applicant’s benefit and clarity of the record, please see the following which provides clarifying and contextual information about the anatomical structures and tissues cited in the prior art. It is well known by one of ordinary skill in the art of histology that different types of and embryological origins of different smooth muscle and their associated anatomical structures and their functions, nuance of the above are well-known and understood by one of ordinary skill in the art of anatomy and physiology and the art of histological anatomy.
Further, as support, applicant is directed to the definition of the term “parenchyma” which is defined in Anatomy & Physiology, 2E (Corvallis, OR, 2025) by Biga et al., which has been defined in pages 179 and 1833 to mean/to be inclusive of “the functional cells, blood vessels, and nerves of the organ” (emphasis added).
Additionally, also see on page 1849 and 1857, where Biga et al. defines the following terms, including but not limited to:
“smooth muscle” is defined as – “nonstriated, mononucleated muscle in the skin that is associated with hair follicles; assists in moving materials in the walls of internal organs, blood vessels, and internal passageways”;
“liver” is defined as – “largest gland in the body whose main digestive function is the production of bile”; and
“tissue” is defined as – “group of cells that are similar in form and perform related functions”.
Biga et al. also discloses on page 1369 that the liver “as three main components: hepatocytes, bile canaliculi, and hepatic sinusoids. A hepatocyte is the liver’s main cell type, accounting for around 80 percent of the liver’s volume. These cells play a role in a wide variety of secretory, metabolic, and endocrine functions. Plates of hepatocytes called hepatic laminae radiate outward from the portal vein in each hepatic lobule” and continues to disclose on page 1370 that “[a] hepatic sinusoid is an open, porous blood space formed by sinusoidal capillaries from nutrient-rich hepatic portal veins and oxygen-rich hepatic arteries. Hepatocytes are tightly packed around the sinusoidal endothelium of these spaces, giving them easy access to the blood. From their central position, hepatocytes process the nutrients, toxins, and waste materials carried by the blood. Materials such as bilirubin are processed and excreted into the bile canaliculi. Other materials including proteins, lipids, and carbohydrates are processed and secreted into the sinusoids or just stored in the cells until called upon. The hepatic sinusoids combine and send blood to a central vein. Blood then flows through a hepatic vein into the inferior vena cava. This means that blood and bile flow in opposite directions. The hepatic sinusoids also contain star-shaped reticuloendothelial cells (Kupffer cells), phagocytes that remove dead red and white blood cells, bacteria, and other foreign material that enter the sinusoids. The portal triad is a distinctive arrangement around the perimeter of hepatic lobules, consisting of three basic structures: a bile duct, a hepatic artery branch, and a hepatic portal vein branch”.
Therefore, as defined by one of ordinary skill in the art of anatomy and physiology, the above cited meanings of the terms common in the art of anatomy and physiology, when taken together with the cited disclosure of primary reference Sperandio – it is clear that the parenchyma is at least in part comprised of/including smooth muscle tissue which in part makes up the vascular tissue that present in the liver – and specifically, the specifically, at/in the vascular structures located at the center of each lobule.
See below for a reproduction of FIG. 23.5. from Biga et al which provides a gross and microscopic overview of the liver and the structures within each lobule of the liver (as described above):
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While applicant’s remarks that “[t]he liver is primarily composed of hepatocytes, which are specialized epithelial cells, along with other cell types such as Kupffer cells (macrophages), endothelial cells, and stellate cells” are correct, applicant appears, although it is unclear, to be unfamiliar with hepatic histology and therefore, the molecular structure(s) and functional relationships of/between the molecular structures of the liver.
And applicant’s further argument that “[t]he liver structure is designed for its specific functions such as metabolism and detoxification, rather than for movement or contraction, which is the role of muscle tissue. Therefore, Sperandio’s disclosure of using the liver parenchyma as a reference tissue does not teach or suggest ‘wherein the first reference tissue is muscle tissue’ as required by amended claim 1” appears to be made without full knowledge of hepatic anatomy, physiology, and pathophysiology, as it is via movement of the contents into and out of the blood vessels and the bile ducts, among other structures of the liver, by which the “functions such as metabolism and detoxification” of the liver are able to be carried out.
While applicant may act as their own lexicographer when redefining a term that is different than its common meaning in the art, it is noted that applicant discloses the phrase “liver tissue” fifty-two times throughout the specification but does not define or disclose what applicant has meant to include or exclude as being “liver tissue”. Accordingly, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “liver tissue” in claim 1 is used by the claim to mean “hepatocytes,” while the accepted meaning is “group of cells that are similar in form and perform related functions” such as the cells that constitute the lobules, and therefore, the parenchyma of the liver, the parenchyma including “the functional cells, blood vessels, and nerves” of the liver. Therefore, as evidence of the well-known meaning of the terms of “parenchyma”, “liver”, “smooth muscle”, and “tissues” have been provided above, the terms are interpreted as defined by the common meanings in the art of anatomy and physiology as provided by the disclosure of Biga et al.
Accordingly, primary reference Sperandio does disclose “wherein the first reference tissue is muscle tissue”. Please see the updated rejection below, which has been updated with the newly presented claim language and corresponding reference citations.
Finally, in response, it is noted that the features upon which applicant relies (i.e., “identification of one or more regions of the liver in which contrast agent leads in the portal venous phase and/or the transitional phase to a lower contrast enhancement than in the reference tissue”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, the claims remain rejected and the rejection is made final.
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 1-2, 4-7, and 10-13 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 has been amended to recite “outputting at least one representation of the plurality of representations of the liver or the part of the liver, in which the [[the]] one or more identified regions are highlighted” in lines 22-23, which renders the claim indefinite because it is unclear if the at least one representation of the plurality of representations of the liver or the part of the liver that is output in the present limitation is meant to refer to either the at least one representation of the plurality of representations represents the liver or the part of the liver and the first reference tissue during a portal venous phase of a dynamic contrast-enhanced magnetic resonance imaging examination or the at least another one representation of the plurality of representations represents the liver or the part of the liver and the first reference tissue during a transitional phase of the dynamic contrast-enhanced magnetic resonance imaging examination, both of which are recited earlier in the claim.
Claims 4, 5, 6, 7, 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 has been amended to recite “at least two representations of the plurality of representations represent the liver or the part of the liver and the first reference tissue during the portal venous phase”, “at least another two representations of the plurality of representations represent the liver or the part of the liver and the first reference tissue during the transitional phase”, “in which the contrast enhancement in the portal venous phase and the transitional phase drops more rapidly than in the reference tissue, wherein the reference tissue does not comprise hepatocytes, and/or in which the absolute value of the gradient of the decreasing contrast enhancement in the portal venous phase and the transitional phase is greater than the absolute value of the gradient of the increasing contrast enhancement in healthy liver tissue”, “outputting the at least one representation of the plurality of representations of the liver or the part of the liver which the one or more identified regions are highlighted” in lines 5-14, which renders the claim indefinite because it is unclear if the at least two representations and/or at least another two representations during the transitional phase are meant include the at least one representation or the at least another representation recited in parent claim 1, on which claim 4 is dependent, and/or if the limitations under investigation are meant to to refer to the identifying one or more regions of the liver in which the contrast agent is in the portal venous phase and the transitional phase or when the absolute value of a gradient of a decreasing contrast enhancement in the portal venous phase and the transitional phase, both of which are also recited in parent claim 1. Similarly, it is unclear if the step of outputting in the last stanza of the present claim is meant to refer to or is the same outputting step recited in the last stanza of parent claim 1.
Claim 5 is also rejected for reciting the same and/or limitations outlined above.
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, 2, 4-7, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sperandio et al. (US20220318991, hereafter “Sperandio”)ꝉ.
ꝉSupported by the disclosure of Guyot et al. (“Hepatic fibrosis and cirrhosis: The (myo)fibroblastic cell subpopulations involved”, hereafter “Guyot”).
Regarding claims 1, 4, 5, 6, 7, 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), wherein the reference tissue is muscle tissue** ([0063]-[0064] the reference tissue being adjacent liver parenchyma, adjacent meaning/being inclusive of information obtained from one lobule that is adjacent to another lobule under examination using enhancement pattern information based on the number of voxels for each sub-component by evaluating presence or absence of the non-rim APHE, the liver parenchyma includes vascular tissue , which is known in the art mammalian histological anatomy to be comprised of a type of smooth muscle tissue, in addition to other types of smooth muscle being present in the hepatic parenchyma as can be found in both healthy and various diseased states, please see as illustrated and shown by electron microscopy in Guyot, pages 137-138, FIGS. 1(a)-(c), where the parenchyma is divided into the functional units called lobules and at the center of each lobule is the centrolobular vein, the hepatocyte plates of a given lobule radiate out from each centrolobular vein of the given lobule to the corresponding perimeter of that lobule), and
first 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 first reference tissue during a portal venous phase of a dynamic contrast-enhanced magnetic resonance imaging examination ([0027], [0036]-[0038], FIG. 2, table 200, 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, the resulting image data includes different sets or series of medical images captured in association with each of the different phases), and
wherein at least another one representation of the plurality of representations represents the liver or the part of the liver and the first reference tissue during a transitional phase of the dynamic contrast-enhanced magnetic resonance imaging examination ([0036]-[0038], [0052]-[0055], FIG. 2, table 200, FIGS. 3-4, the different physiological phases can be based on contrast injection in multiphase MR image data captured in the transitional phase (TP), see 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 and the transitional phase to a lower contrast enhancement than in the first reference tissue ([0037]-[0038], [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, the imaging data is captured both the portal venous phase (PVP) and the transitional phase (TP)); and
In another embodiment disclosed by Sperandio, Sperandio discloses wherein the control and calculation unit is configured to prompt the output unit to output at least one representation of the pluralities of representations of liver or the part of the liver, in which the one or more 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 further representation, wherein the at least one further representation represents the liver or the part of the liver and the 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”.
**For the purposes of examination, the term “muscle tissue” has been interpreted under the broadest reasonable interpretation as known in the art of mammalian histological anatomy to be inclusive of known type of muscle tissue and not limited to a certain type of any particular bodily system, and be located in any location and be of any size, as the specification originally as filed has not defined the term to be drawn to any specific type of muscle nor to specific muscle group nor organ nor to be located at any specific location.
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).
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. 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
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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