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 .
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.
Claims 1, 5-10, 12, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US 2015/0342177 A1; search report) and Panconesi (Biomedicines, 2011; search report).
Regarding claims 1 and 14, Hassanein teaches a method for ultrasonic evaluation of an isolated organ from a human or animal received in an organ preservation container made of an ultrasound transparent material [[0007] organ chamber assembly that is mounted to the chassis and is adapted to contain a liver during perfusion; [0258] area of the membrane in the intermediate lid … flexible membrane can be selected so that an operator can perform an ultrasound of the liver through the membrane while maintaining the sterility and/or environment of the chamber], said method comprising:
holding an ultrasound imaging probe against said organ preservation container to perform ultrasound imaging of said isolated organ through said organ preservation container [[0005] liver care system; [0007] organ care system; [0305] probes and/or sensors can be obtained from standard commercial sources; [0258] flexible membrane can be selected so that an operator can perform an ultrasound of the liver through the membrane while maintaining the sterility and/or environment of the chamber; [0325] extra infusion port can be included for the user to provide an imaging contrast medium to the perfusion fluid so that imaging of the liver can be enhanced. For example, an ultrasound contrast medium can be infused to perform a contrast-enhanced ultrasound];
imaging said isolated organ by an ultrasound imaging system communicating with said ultrasound imaging probe [[0187] control system can include an onboard computer system that is connected to one or more of the components in the system 600 and to one or more sensors; [0304-0305] pressure/flow probes; [0472] performing an ultrasound or other imaging test on the liver], to obtain at least one ultrasound image of said isolated organ [[0317] in addition to using the foregoing sensors in a feedback loop to control the system 600, some or all of the sensors can also be used to determine the viability of the liver for transplant; [0472] operator can conduct an evaluation of the liver functions, such as for example, performing an ultrasound or other imaging test on the liver, measuring arterial and venous blood gas levels and other evaluative tests; [0501]; [0517] information displayed to the user on the system 600 can be transmitted (e.g., either the underlying data and/or the image itself)].
Hassanein does not explicity teach and yet Panconesi teaches automatically determining at least one quantitative index representing viability of said isolated organ, said at least one quantitative index being calculated from anatomical, tissue and/or vascular parameters obtained from said at least one ultrasound image [[abstract] several parameters targeting hepatocyte or cholangiocyte function or metabolism have been recently suggested as potential viability tests before organ transplantation. We summarize here a current status of respective machine perfusion tests, and report their clinical relevance.; [pg. 2] most authors suggest a combination of “viability” tests, by composite scores based on quantification of different perfusates parameters [12–17]. However, as most series have only a limited number of events, the correlation of biomarkers with postsurgical outcome remains difficult [18–23]. In this article, we first discuss the clinical relevance of individual parameters, considered for viability testing during machine perfusion before liver transplantation; [table 1] [column] parameters in clinical use, [row] ultrasound; [sec 6.1. Perfusion Quality and Hemodynamic Parameter] parameters of perfusion quality … Fibroscan Entire Liver Level of fibrosis 30 min].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the parameter measurement as taught by Panconesi so that the viability of the organ to be transplanted can be assessed (Panconesi) [[title]].
[[claim 14] is an apparatus form of the method recited in claim 1 and is therefore rejected for similar reasons].
Regarding claim 5, Hassanein teaches the method according to claim 1, wherein said isolated organ is chosen among a heart, a kidney and a liver [[0258] flexible membrane can be selected so that an operator can perform an ultrasound of the liver through the membrane while maintaining the sterility and/or environment of the chamber].
Regarding claims 6 and 16, Hassanein does not explicity teach and yet Panconesi teaches the method according to claim 1 and the apparatus of claim 14, wherein said at least one quantitative index is a rheological index determined by elastography through said ultrasound imaging probe and ultrasound imaging system [note: Fibroscan is the use of transient elastography for the measurement of liver fibrosis; [table 1] Fibroscan Entire Liver Level of fibrosis 30 min].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the parameter measurement as taught by Panconesi so that the viability of the organ to be transplanted can be assessed (Panconesi) [[title]].
Regarding claim 7, Hassanein does not explicity teach and yet Panconesi teaches the method according claim 6, wherein said isolated organ includes fibers and said at least one quantitative index includes a rheological elasticity parameter measured along said fibers and a rheological elasticity parameter measured perpendicular to said fibers [[table 1] Fibroscan Entire Liver Level of fibrosis 30 min].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the parameter measurement as taught by Panconesi so that the viability of the organ to be transplanted can be assessed (Panconesi) [[title]].
Regarding claim 8, Hassanein does not explicity teach and yet Panconesi teaches the method according to claim 1, wherein said at least one quantitative index is representative of vascular flows in the isolated organ under perfusion [[0005] system can circulate an oxygenated, nutrient enriched perfusion fluid to the liver at or near physiological temperature, pressure, and flow rate. In some embodiments, the system employs a blood product-based perfusion fluid to more accurately mimic normal physiologic conditions; [0464] pressure can be controlled or increased by using one or more vasodilators (e.g., a vasodilator can be used to increase or decrease vascular tone and thereby the pressure within the vessel); [0501] various other methods known in the art can be used to assess the liver viability. In some specific embodiments, ultrasound analysis of the liver can be conducted to assess liver parenchyma, intra- and extra-hepatic biliary tree. Other non-limiting examples of imaging techniques include Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Positron Emission Tomography (PET), fluoroscopy, Transjugular Intrahepatic Portosystemic Shunt (TIPS), all of which can be used to assess the liver and detect abnormalities. For example, when examining an ultrasound of the liver, the doctor can examine sinusoidal dimensions, potential obstructions in the bile duct, and/or generalized blood flow].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the parameter measurement as taught by Panconesi so that the viability of the organ to be transplanted can be assessed (Panconesi) [[title]].
Regarding claim 9, Hassanein does not explicity teach and yet Panconesi teaches the method according to claim 1, wherein said at least one quantitative index is representative of vascular network geometry in said isolated organ under perfusion [[0005][0464][0501] generalized blood flow].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the parameter measurement as taught by Panconesi so that the viability of the organ to be transplanted can be assessed (Panconesi) [[title]].
Regarding claim 10, Hassanein teaches the method according to claim, wherein said isolated organ is perfused with a solution including a contrast agent adapted to enhance contrast for ultrasound imaging [[0325] some embodiments an extra infusion port can be included for the user to provide an imaging contrast medium to the perfusion fluid so that imaging of the liver can be enhanced. For example, an ultrasound contrast medium can be infused to perform a contrast-enhanced ultrasound].
Regarding claims 12 and 18, Hassanein teaches the method according to claim 1 and the apparatus of claim 14, wherein said organ preservation container is made of an ultrasound transparent and rigid material [[0255] in some embodiments, the front piece 2816 and lid 2820 is rigid enough to protect the liver 101 from physical contact, indirect or direct.; [0258]].
Regarding claim 17, Hassanein does not explicity teach and yet Panconesi teaches the apparatus according to claim 14, wherein said at least one quantitative index is chosen among: a quantitative index representative of vascular flows in the isolated organ; a quantitative index representative of vascular network geometry in said isolated organ; a property related to ultrasound backscatter [[0005][0464][0501] generalized blood flow].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the parameter measurement as taught by Panconesi so that the viability of the organ to be transplanted can be assessed (Panconesi) [[title]].
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US 2015/0342177 A1) and Panconesi (Biomedicines, 2011) as applied to claims 1 and 14 above, and further in view of Hysi (US 2023/0050956 A1; related to search report).
Regarding claim 2, Hassanein does not explicitly teach and yet Hysi teaches the method according to claim 1, wherein said ultrasound imaging probe is automatically moved by a holder device during said imaging, to obtain different images of said isolated organ as said ultrasound imaging probe is moved [[fig. 5] shows organ in container of saline bath; [0017] a moveable mount that is affixed to a moveable portion of the probe for moving the aperture of the probe during PA imaging; and a motor that is operably connected to the moveable mount to move the moveable mount so that the aperture moves according to a scan trajectory during PA imaging of the object; [0018] object is a tumour, or tissue, or an organ; [0094] images may be acquired at multiple wavelengths (A); [0098]; [0150]].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with movable ultrasound probe as taught by Hysi so the trajectory of a target organ can be automatically scanned (Hysi) [[0017]].
Regarding claim 15, Hassanein does not explicitly teach and yet Hysi teaches the apparatus according to claim 14, wherein said holder device is adapted to automatically move said ultrasound imaging probe [[0098] motor and a moveable mount for the probe; [0150] saline bath serves as the coupling medium for acoustic propagation (see FIGS. 4A, 5A, 7A and 8A). Once the kidney is positioned below the probe, the laser and ultrasound are turned on and imaging commences], and wherein said ultrasound imaging system communicates with said holder device and is adapted to control said ultrasound imaging probe to obtain different images of said isolated organ as said ultrasound imaging probe is moved [[fig. 5][0017][0018][0094]].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with movable ultrasound probe as taught by Hysi so the trajectory of a target organ can be automatically scanned (Hysi) [[0017]].
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US 2015/0342177 A1) and Panconesi (Biomedicines, 2011) as applied to claims 1 and 14 above, and further in view of Greis (2011; Clinical Hemorheology and Microcirculation).
Regarding claim 3, Hassanein does not explicitly teach and yet Greis teaches the method according to claim 2, wherein predetermined anatomic areas of said isolated organ are automatically identified from said different images and said at least one quantitative index is automatically computed in at least one area of interest among said predetermined anatomic areas [[abstract] ultrasound scanners with contrast-specific software, the specific microbubble derived echo signals can be separated from tissue signals in realtime, allowing selective imaging of the contrast agent … assessment of relative blood volume … time/intensity curves (TIC) can be calculated from single pixels or user-defined regions of interest (ROI). Characteristic parameters of these TICs (e.g. peak intensity, area under the curve, wash-in rate, etc.) can be displayed as color-coded parametric maps on top of the anatomical image, to identify cold and hot spots with abnormal perfusion; [sec 2. quantitative assessment of blood volume]; [sec. 3. quantitative assessment of blood flow velocity] derive quantitative perfusion parameters from these values, a mathematically described curve corresponding to a kinetic model has to be found, which appropriately reflects the measured values (curve fitting).].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the quantitative tissue imaging using ultrasound as taught by Greis so that areas of abnormal perfusion (i.e., blood flow) may be identified (Greis) [[sec. 10] using anatomical structures or abnormal perfusion characteristics, specific user-defined ROIs can be placed in different areas of the image and the respective TICs can be displayed and compared (Fig. 7c). The curve parameters (e.g. peak intensity, time to peak, area under the curve, wash-in rate, etc.) are given as numerical values, to allow comparison of blood flow and perfusion between different regions, different patients or within one patient over time (longitudinal follow-up)].
Regarding claim 4, Hassanein does not explicitly teach and yet Greis teaches the method according to claim 1, wherein said at least one quantitative index is determined for several predetermined areas of said isolated organ and shown on a parametric map of said isolated organ [[abstract][sec. 2][sec. 3]].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the quantitative tissue imaging using ultrasound as taught by Greis so that areas of abnormal perfusion (i.e., blood flow) may be identified (Greis) [[sec. 10] using anatomical structures or abnormal perfusion characteristics, specific user-defined ROIs can be placed in different areas of the image and the respective TICs can be displayed and compared (Fig. 7c). The curve parameters (e.g. peak intensity, time to peak, area under the curve, wash-in rate, etc.) are given as numerical values, to allow comparison of blood flow and perfusion between different regions, different patients or within one patient over time (longitudinal follow-up)].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US 2015/0342177 A1) and Panconesi (Biomedicines, 2011) as applied to claim 1 above, and further in view of Ho (2011, Ultrasonics; search report).
Regarding claim 11, Hassanein does not explicitly teach and yet Ho teaches the method according to claim 1, wherein said at least one quantitative index is a property related to ultrasound backscatter [[keywords] backscattering; [abstract] image has been shown to be useful for characterizing scatterers in tissues by reflecting the echo statistics, and hence the Nakagami image may serve as a functional imaging tool for quantifying rat liver fibrosis … backscattered-signal envelopes of the acquired raw ultrasound signals were used for Nakagami imaging].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with the ultrasound backscatter imaging as taught by Ho because current findings indicate that the ultrasound Nakagami image has great potential as a functional imaging tool to complement the use of the conventional B-scan in animal studies of liver fibrosis (Ho) [[abstract]].
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US 2015/0342177 A1) and Panconesi (Biomedicines, 2011) as applied to claims 1 and 14 above, and further in view of Gessner (US 2019/0242896 A1; related to search report).
Regarding claim 13, Hassanein does not explicitly teach and yet Gessner teaches the method according to claim 1, wherein said organ preservation container has a cylindrical shape adapted to perform multidirectional imaging of the isolated organ [[fig. 2] shows #101 cylindrical container with #102 organ tissue and #103 ultrasound transducer probe; [0050] desirable to image engineered tissue scaffold 102 from several directions by mounting probe (e.g., ultrasound transducer) 103 on a 3D motion stage; [0108] imaging transducer under the desired bioreactor(s) and in proximity to one or more acoustically transmissible regions (e.g., windows) of the bioreactor(s)].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with movable ultrasound probe and cylindrical container as taught by Gessner so that imaging can be performed from multiple directions using a 3D motion stage (Gessner) [[0050]].
Regarding claim 19, Hassanein does not explicitly teach and yet Gessner teaches apparatus according to claim 18, wherein said organ preservation container has a geometric shape adapted to perform multidirectional imaging of the isolated organ [[fig. 2] shows #101 cylindrical container with #102 organ tissue and #103 ultrasound transducer probe; [0050] desirable to image engineered tissue scaffold 102 from several directions by mounting probe (e.g., ultrasound transducer) 103 on a 3D motion stage]].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to combine the organ chamber assembly and ultrasound probe as taught by Hassanein, with movable ultrasound probe and cylindrical container as taught by Gessner so that imaging can be performed from multiple directions using a 3D motion stage (Gessner) [[0050]].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D ARMSTRONG whose telephone number is (571)270-7339. The examiner can normally be reached M - F 9am-5pm.
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/JONATHAN D ARMSTRONG/ Examiner, Art Unit 3645
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