DETAILED ACTION
Response to Amendment
Receipt is acknowledged of the amendment filed 11/26/2025. Claims 1-24 are pending. Claims 1-2, 13, and 17 were amended. Claims 21-24 were added.
The previous rejection to claims 1-10 and 12-19 are withdrawn in view of arguments. The term “stacked” will be broadly interpreted to include arrangements as disclosed in Figs. 2A,B and 3A,B wherein materials are arranged side-by-side.
Claims 11 and 20 remain rejected under 35 USC 112(b) as outlined below. In view of the Applicant’s arguments to the previous rejection of claims 11 and 12.
Response to Arguments
112(b):
Regarding claim 11 and 20, the Applicant states on page 1 of arguments:
…. Regarding claims 11 and 20, the Office Action has not established that the noted functional aspects attributed to the claimed structure do not provide a valid rational under § 112 and controlling law. For instance, M.P.E.P. §2173.05(g) states that: "a functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used. A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step."
Notwithstanding the above, Applicant has presented amendments herein that should assist the Examiner's understanding and further define the relative characteristics of the respectively-claimed components. Applicant submits that the § 112 rejections are no longer applicable.
The Examiner notes claims 11 and 20 were not amended and the Applicant’s arguments provided no further explanation as to how to determine the scope of the claim. While it is understood by the Examiner, that functional limitations must be evaluated and considered just like any other limitation of the claim, the claim is indefinite as it is unclear what is would fairly convey to a person of ordinary skill in the art in the context in which it is used.
MPEP 2173.05(g) states:
Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234, 55 USPQ 381 (1942) (holding indefinite claims that recited substantially pure carbon black "in the form of commercially uniform, comparatively small, rounded smooth aggregates having a spongy or porous exterior"). Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim.
The claims would not be rejected for indefiniteness if the specification provided guidance as to how the spatial extent occupies by the regions and materials were “selected and positioned relative to other tissue-mimicking regions” to facilitate the functional language, however, the claim remains indefinite as the Applicant provides no guidance as to how “a spatial extent occupied by the region and materials therein are selected or positioned” to achieve the functional limitations as claimed. It is unclear whether the prior art would inherently read on the functional limitation, what modifications of the spatial extent and materials would meet the limitations, or if the limitations would be obvious to one of ordinary skill in the art. The specification provides little instruction as to guide one of ordinary skill in the art to reasonable determine and understand the scope of the claim.
For example, paragraph [0021] of the pending specification recites:
[0021] Particular embodiments are directed toward an MRE phantom that enables an MR user to measure the stiffness of multiple materials with different known stiffness values in a single MRE scan. The spatial extent occupied by components of different material stiffness is selected and positioned relative to other materials in the phantom in a way that facilitates accurate measurement of the stiffness of each material, for instance using an MRE system that operates with a specific excitation wavelength and frequency. The overall size of the MRE phantom may be sufficiently small to enable easy positioning of the phantom in the MR system and relative to MR elastography hardware being utilized. (Emphasis provided by Examiner).
This merely states that the size may be sufficiently small to enable easy position of the phantom in the MR system and relative to MR elastography hardware being utilized. At best this suggests the limitation constitutes common sense and/or a mere change of size and shape. It would be common sense for one of ordinary skill in the art that a phantom must fit into a MR system for measurements to be performed. Furthermore, it is well understood in the art that only certain materials may be imaged in magnetic resonance systems, e.g. 1H, 13C, 17O, 19F, to name a few, and it would be obvious to one of ordinary skill in the art to determine the appropriate excitation wavelength and frequency. If the claims are merely relying on changes of size, shapes, and proportions, it has been held that changes of size, shape, and proportions would be obvious to one of ordinary skill in the art. See MPEP 2144.04 IV. A. and B..
Further, paragraph [0023] of the pending specification states:
[0023] A phantom of a particular embodiment has stacked regions of different tissue properties, such as stiffness. The stacked regions may facilitate utilization of a set compartment depth and/or diameter to ensure quantitative accuracy for a given compartment stiffness and excitation frequency. The stiffness or other tissue property of each layer may be measured using a multi-slice MRE approach, where each slice is prescribed to lie within each layer.
However, there is no guidance as to what depths and/or diameters are necessary to “ensure quantitative accuracy for a given compartment stiffness and excitation frequency”, or provide any scope for defining “quantitative accuracy”. At best the claims require only routine optimizations a user’s preference as to what is acceptable accuracy.
Further, the application is silent as to what is meant by “passive driver type and format” and how “a spatial extent occupied by the region and materials therein are selected and position relative to the other tissue-mimicking regions to facilitate measurement of stiffness of the material in the tissue-mimicking region, based on … passive driver type and format.
As best understood by the Examiner, no other paragraphs provide guidance as to how one of ordinary skill in the art would reasonably interpret the scope of the claim.
Therefore, the claims stand rejected under 35 USC 112(b) as outlined below.
102/103:
Applicant' s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Examiner recommends amendments focusing on the embodiment as disclosed in Fig. 5.
Claims 1-24 are rejected as outlined below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “interlocking features” as recited in claim 21 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Added claim 23 recites, “wherein the first and second compartments have interlocking features configured to lock the respective compartments together.” The only reference made of “interlocking features” in the original disclosure filed 10/4/2022 is in paragraph [0051] which recites:
[0051] As may be implemented with the apparatus shown in FIGS. 5A and 5B or otherwise, an integrated driver may function similar to passive drivers for MRE active driving systems that may include a tubing connector interface, an air flow cavity, and a thin plastic, semi-flexible membrane that contacts tissue (or a phantom) of interest. This may facilitate the flow of pulses of air from an air supply system, trough the tubing, and into the air cavity. The air pressure fluctuations move the membrane, which transfers mechanical waves through the tissue of interest. This may be integrated with a phantom using a passive driver with a cylindrical shape, so that it can interlock with the tissue mimic stacks and end caps. Such end caps may be plastic hemispherical cavities filled with a liquid or water-based gels (e.g., for an MR signal). They may have interlocking features so that they can connect to the stacks.
As best understood by the examiner, the “interlocking features” as disclosed in the specification correspond to features of the end caps, not features of the phantom as recited in claim 21. The original disclosure does not provide examples of such “interlocking features” nor do the drawings illustrate any interlocking features. Further, the disclosure recites wherein the interlocking features perform the function of connecting the end caps to the stacks. As best understood by the examiner, the end caps which is disclosed as comprising interlocking features correspond to components of the integrated driver which “contacts tissue (or a phantom) of interest” and is not a component of the phantom itself. The original disclosure makes no reference of “interlocking features configured to lock the respective compartments together” as recited in new claim 23.
The only other recitation provided in the original disclosure is found in [0048] which recites “The phantom 500 includes stackable, interlocking, cylindrical containers 501, 502 and 503, which can be aligned along an axis.” Again, this does not recite “interlocking features” nor teaches or suggests how such interlocking features are implemented, nor to the drawings illustrate any example of “interlocking features configured to lock the respective compartments together” as recited in new claim 23.
Therefore, the limitation as claimed amounts to new matter.
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 3, 11 and 20 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.
Regarding claims 11 and 20, the claims recite:
“wherein for each tissue-mimicking region, a spatial extent occupied by the region and materials therein are selected and positioned relative to the other tissue-mimicking regions to facilitate measurement of stiffness of the material in the tissue-mimicking region, based on one or more characteristics of an imaging system selected from the group of: excitation wavelength, frequency, passive driver type and format, and a combination thereof.”
It is unclear how the underlined limitation is intended to further limit the structure of the claimed apparatus, or what technical feature(s) enable the phantom to “facilitate” the limitations as claimed. As best understood by the examiner, the features of “measurement of stiffness of the material in the tissue-mimicking region, based on one or more characteristics of an imaging system selected from the group of: excitation wavelength, frequency, passive driver type and format, and a combination thereof” are a consequence of measurements performed using magnetic resonance elastography (MRE).
The claim and disclosure provide little guidance as to how “a spatial extent occupied by the region and materials therein are selected or positioned” to achieve the functional limitations as claimed. It is unclear whether the prior art would inherently read on the functional limitation, what modifications of the spatial extent and materials would meet the limitations, or if the limitations would be obvious to one of ordinary skill in the art. The specification provides little instruction as to guide one of ordinary skill in the art to reasonable determine and understand the scope of the claim.
For example, paragraph [0021] of the pending specification recites:
[0021] Particular embodiments are directed toward an MRE phantom that enables an MR user to measure the stiffness of multiple materials with different known stiffness values in a single MRE scan. The spatial extent occupied by components of different material stiffness is selected and positioned relative to other materials in the phantom in a way that facilitates accurate measurement of the stiffness of each material, for instance using an MRE system that operates with a specific excitation wavelength and frequency. The overall size of the MRE phantom may be sufficiently small to enable easy positioning of the phantom in the MR system and relative to MR elastography hardware being utilized. (Emphasis provided by Examiner).
This merely states that the size may be sufficiently small to enable easy position of the phantom in the MR system and relative to MR elastography hardware being utilized. At best this suggests the limitation constitutes common sense and/or a mere change of size and shape. It would be common sense for one of ordinary skill in the art that a phantom must fit into a MR system for measurements to be performed. Furthermore, it is well understood in the art that only certain materials may be imaged in magnetic resonance systems, e.g. 1H, 13C, 17O, 19F, to name a few, and it would be obvious to one of ordinary skill in the art to determine the appropriate excitation wavelength and frequency. If the claims are merely relying on changes of size, shapes, and proportions, it has been held that changes of size, shape, and proportions would be obvious to one of ordinary skill in the art. See MPEP 2144.04 IV. A. and B..
Further, paragraph [0023] of the pending specification states:
[0023] A phantom of a particular embodiment has stacked regions of different tissue properties, such as stiffness. The stacked regions may facilitate utilization of a set compartment depth and/or diameter to ensure quantitative accuracy for a given compartment stiffness and excitation frequency. The stiffness or other tissue property of each layer may be measured using a multi-slice MRE approach, where each slice is prescribed to lie within each layer.
However, there is no guidance as to what depths and/or diameters are necessary to “ensure quantitative accuracy for a given compartment stiffness and excitation frequency”, or provide any scope for defining “quantitative accuracy”. At best the claims require only routine optimizations a user’s preference as to what is acceptable accuracy.
Further, the application is silent as to what is meant by “passive driver type and format” and how “a spatial extent occupied by the region and materials therein are selected and position relative to the other tissue-mimicking regions to facilitate measurement of stiffness of the material in the tissue-mimicking region” based on a passive driver type and format.
For the purpose of examination, the claim is interpreted wherein it would obvious to one of ordinary skill in the art to modify the size, shape, and materials such that the phantom is suitable for magnetic resonance elastography measurements.
Regarding claim 3, the claim recites, “the phantom has a shell having an outer surface and an inner surface within which the tissue-mimicking regions reside; and respective surface portions of each of the tissue-mimicking regions collectively forming an outer surface of the tissue-mimicking regions having a shape that follows a shape of the inner surface of the shell.” Claim 1 recites compartments for the first and second tissue regions. It is unclear how the limitations of the claims are combined in view of the disclosure.
It was understood how the limitations of claim 3 would be achieved absent the claimed compartments, see for example claims [0025], [0027] of the pending specification.
However, [0032] teaches “the phantom may include a housing with the regions and/or phantom housing having a circular cross-section and/or cylindrical outer shell that facilitates transmission of concentric mechanical waves throughout the tissue mimicking region. As best understood by the examiner, this description would best correspond to the embodiment of Fig. 5A, however, Fig. 5A does not illustrate a shell as recited in the claim. Fig. 5B shows “stackable, interlocking cylindrical containers 501, 502, 503 connected to passive driver, but fails to disclose a shell. It is unclear what new, useful, or unexpected result is provided by further including a shell surrounding containers 501, 502, and 503, in light of the pending disclosure.
Further, the only drawing featuring a shell is shell 405 in Figs. 4A and 4B. Paragraph [0047] recites “FIGS. 4A and 4B respectively show perspective and cross-sectional views of a spherical phantom apparatus 400, in accordance with one or more embodiments. The apparatus 400 has stacked layers 410, 420, 430 and 440 within a shell 405. The stacked layers 410, 420, 430 and 440 may, for example, be chambers enclosing a tissue mimicking material.” This embodiment does not include “compartments” as recited in claim 1. It is not clearly understood what embodiment the limitations of claim 3 combined with claim 1 is directed to or what new or useful feature is provided by including a housing surrounding disparate self-contained compartments “with the first and second compartments respectively having external surface areas interfacing with one another” as recited in claim 1.
As best understood by the examiner, any additional housing provided around a phantom would read on a shell as claimed.
Regarding claim 4, the claim recites “wherein an external surface of the first tissue-mimicking region interfaces with an external surface of the second tissue-mimicking region to form a contiguous portion of an outer surface of the tissue-mimicking regions.” If the first and second tissues are arranged inside a first and second compartments as recited in claim 1, then the first and second tissue-mimicking regions would not be able to form a contiguous portion of an outer surface of the tissue-mimicking region. For the purpose of examination, the claims will be interpreted wherein the tissue-mimicking regions or the compartments for a contiguous portion of an outer surface of the tissue mimicking region.
Regarding claim 8, the claim recites “the tissue-mimicking regions and the phantom housing have cylindrical outer shells that facilitate transmission of concentric mechanical waves throughout the tissue-mimicking region.” Claim 8 depends on claim 6 which depends on claim 1. The claim is rejected for similar reasons as claim 3 above. While Fig. 4 shows a shell around a spherical phantom, it is unclear how the shell of Fig. 4 would “facilitate transmission of concentric mechanical waves throughout the tissue-mimicking region” as claimed. Figs. 5A and B show a configuration wherein the tissue regions are formed within stackable, interlocking cylindrical containers and an integrated MRE passive driver, but no housing. It is unclear how a passive drive would be integrated with the spherical phantom of Fig. 4 and it is unclear what new, useful, or unexpected result would be obtained by providing a shell around the containers of Figs. 5A,B.
As best understood by the examiner, any additional housing provided around a phantom would read on a shell as claimed.
Regarding claim 10, the claim recites “wherein at least one of the tissue-mimicking regions includes a thermoset material, cross-linked polymeric material, or gel-based material that has a melting point higher than its gel point, and is configured to set in response to being heated and subsequently cooled, therein facilitating the application of another type of material onto a previously formed material while mitigating changes in properties of the previously formed material.”
Claim 10 depends on claim 1 was amended to recite “a first tissue-mimicking region having a first compartment filled with a first tissue mimicking material” and “a second tissue-mimicking region having a second compartment filled with a second tissue mimicking material”. Since the first material is in the first compartment and the second material is in the second compartment, claim 1 would not allow for the application of another type of material onto a previously formed material as recited in claim 10.
For the purpose of examination, Madsen teaches an equivalent tissue mimicking material and would be an obvious matter of design choice to use such a material if desired.
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.
Claim(s) 1-2, 4-6, 9, 11, 13-15, 17-22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0365034 (Neogi) in view of US 20108/0008401 (Mallozzi).
Regarding claim 1, Neogi teaches a phantom apparatus (phantom comprising three tissue phantoms; see Fig. 16) comprising:
a first tissue-mimicking region filled with a first tissue-mimicking material exhibiting a first tissue property (Fig. 16 depicts a three layer tissue phantom with different bulk modulus and density stacked horizontally for elastic bulk modulus elastography measurements including a first tissue, wherein the tissues mimic soft tissues, healthy tissues, calcified or hardened tissues, or tumor-like tissues; see Fig. 16; see [0081], [0103]); and
at least one additional tissue-mimicking region, including a second tissue-mimicking region having filled with a second tissue-mimicking material exhibiting a second tissue property that is different than the first tissue property, the second tissue-mimicking region being stacked on the first tissue-mimicking region with the first and second region respectively having external surface areas interfacing with one another (Fig. 16 depicts a three layer tissue phantom with different bulk modulus and density stacked horizontally for elastic bulk modulus elastography measurements including second and third tissues wherein the external surface areas interface with one another wherein the tissues mimic soft tissues, healthy tissues, calcified or hardened tissues, or tumor-like tissues; see Fig. 16; see [0081], [0103]).
Neogi fails to teach a first tissue-mimicking region having a first compartment; a second tissue-mimicking region having a second compartment; and the first and second compartments respectively having external surface areas interfacing with one another.
Mallozzi teaches a first tissue-mimicking region having a first compartment; a second tissue-mimicking region having a second compartment; and the first and second compartments respectively having external surface areas interfacing with one another (an aggregate phantom is built out of several light-weight sections with Figs. 1, 2, 3A-D showing two separate, independently transportable, self-contained sections, and FIGS. 4, 5, 6A and 6B show an aggregate phantom 30 includes three sections: a top section 32, a middle section 34 and a bottom section 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Mallozzi into Neogi in order to gain the advantage of an aggregate sample formed by combining multiple, independently transportable, self-contained phantom sections into one aggregate phantom, a large field-of-view may be covered, while avoiding excess weight. The sections of the aggregate phantom of the present invention can be individually transported and handled, and then can be reassembled on the patient table of the imaging system. Once reassembled, the sections are meant to function collectively as a single large aggregate phantom.
Regarding claim 13, Neogi teaches a method for analyzing an imaging system (a method of non-destructive evaluation of mechanical properties of an imaging system; see [0004]; [0046]-[0048]), the method comprising:
imaging a phantom apparatus (effective bulk modulus elastography (EBME) imaging; see [0055], [0103]) having:
a first tissue-mimicking region having a first compartment filled with a first tissue-mimicking material exhibiting a first tissue property (Fig. 16 depicts a three layer tissue phantom with different bulk modulus and density stacked horizontally for elastic bulk modulus elastography measurements including a first tissue which mimics soft tissues, healthy tissues, calcified or hardened tissues, or tumor-like tissues wherein the tissues mimic soft tissues, healthy tissues, calcified or hardened tissues, or tumor-like tissues; see Fig. 16; see [0081], [0103]); and
at least one additional tissue-mimicking region, including a second tissue-mimicking region filled with a second tissue-mimicking material exhibiting a second tissue property that is different than the first tissue property, the second tissue-mimicking region being stacked on the first tissue-mimicking region with the first and second region respectively having external surface areas interfacing with one another (Fig. 16 depicts a three layer tissue phantom with different bulk modulus and density stacked horizontally for elastic bulk modulus elastography measurements including second and third tissues wherein the external surface areas interface with one another wherein the tissues mimic soft tissues, healthy tissues, calcified or hardened tissues, or tumor-like tissues; see Fig. 16; see [0081], [0103]); and
analyzing the imaging system based on images of the respective tissue-mimicking regions (EBME imaging is based on the tissues; see [0059], [0081]; see Fig. 16).
Neogi fails to teach a first tissue-mimicking region having a first compartment; a second tissue-mimicking region having a second compartment; and the first and second compartments respectively having external surface areas interfacing with one another.
Mallozzi teaches a first tissue-mimicking region having a first compartment; a second tissue-mimicking region having a second compartment; and the first and second compartments respectively having external surface areas interfacing with one another (an aggregate phantom is built out of several light-weight sections with Figs. 1, 2, 3A-D showing two separate, independently transportable, self-contained sections, and FIGS. 4, 5, 6A and 6B show an aggregate phantom 30 includes three sections: a top section 32, a middle section 34 and a bottom section 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Mallozzi into Neogi in order to gain the advantage of an aggregate sample formed by combining multiple, independently transportable, self-contained phantom sections into one aggregate phantom, a large field-of-view may be covered, while avoiding excess weight. The sections of the aggregate phantom of the present invention can be individually transported and handled, and then can be reassembled on the patient table of the imaging system. Once reassembled, the sections are meant to function collectively as a single large aggregate phantom.
Regarding claim 17, Neogi teaches a method of manufacturing a phantom (a method of synthesizing materials for a phantom; see Fig. 16; see [0103]-[0104]), the method comprising:
forming a first tissue-mimicking region filled with a first tissue-mimicking material exhibiting a first tissue property (Fig. 16 depicts a three-layer tissue phantom with different bulk modulus and density stacked horizontally for elastic bulk modulus elastography measurements including a first tissue wherein the tissues mimic soft tissues, healthy tissues, calcified or hardened tissues, or tumor-like tissues; see Fig. 16; see [0081], [0103]); and
forming at least one additional tissue-mimicking region, including a second tissue-mimicking region filled with a second tissue-mimicking material exhibiting a second tissue property that is different than the first tissue property, the second tissue-mimicking region being stacked on the first tissue-mimicking region with the first and second region respectively having external surface areas interfacing with one another (Fig. 16 depicts a three layer tissue phantom with different bulk modulus and density stacked horizontally for elastic bulk modulus elastography measurements including second and third tissues wherein the external surface areas interface with one another wherein the tissues mimic soft tissues, healthy tissues, calcified or hardened tissues, or tumor-like tissues; see Fig. 16; see [0081], [0103]).
Neogi fails to teach a first tissue-mimicking region having a first compartment; a second tissue-mimicking region having a second compartment; and the first and second compartments respectively having external surface areas interfacing with one another.
Mallozzi teaches a first tissue-mimicking region having a first compartment; a second tissue-mimicking region having a second compartment; and the first and second compartments respectively having external surface areas interfacing with one another (an aggregate phantom is built out of several light-weight sections with Figs. 1, 2, 3A-D showing two separate, independently transportable, self-contained sections, and FIGS. 4, 5, 6A and 6B show an aggregate phantom 30 includes three sections: a top section 32, a middle section 34 and a bottom section 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Mallozzi into Neogi in order to gain the advantage of an aggregate sample formed by combining multiple, independently transportable, self-contained phantom sections into one aggregate phantom, a large field-of-view may be covered, while avoiding excess weight. The sections of the aggregate phantom of the present invention can be individually transported and handled, and then can be reassembled on the patient table of the imaging system. Once reassembled, the sections are meant to function collectively as a single large aggregate phantom.
Regarding claims 2, 14, and 18, the combination of Neogi and Mallozzi teaches wherein respective surface portions of each of the first and second compartments of the tissue-mimicking regions collectively form an outer surface of a portion of the phantom apparatus that consists of the tissue-mimicking regions, each tissue-mimicking region having such a surface portion of the respective compartments that is contiguous with such a surface portion of another of the tissue-mimicking regions (the limitation is taught by providing each tissue of Neogi with a separate compartment as taught in Mallozzi and is rejected in an equivalent manner as claims 1, 13, and 17).
Regarding claim 4, Neogi teaches wherein an external surface of the first tissue-mimicking region interfaces with an external surface of the second tissue-mimicking region to form a contiguous portion of an outer surface of the tissue-mimicking regions (the outer surfaces of tissues 1-3 form a contiguous outer surface; see Fig. 15).
Regarding claim 5, Neogi teaches wherein each of the tissue-mimicking regions has a consistent tissue property throughout the tissue-mimicking region (tissues 1-3 are formed from different gelatin ratios as “axially uniform” and each would reasonably be understood to have the same tissue property through out. For example, tissue 1 would reasonably have the same tissue property throughout the shole portion of tissue 1; see Fig. 16; see [1013], [0104]).
Regarding claims 6, 15, and 19, Neogi teaches wherein the tissue-mimicking regions are arranged in a stacked configuration selected from the group of: cylindrically stacked, spherically stacked, cylindrically stacked with rounded ends, concentrically stacked, stacked slab, stacked centrally split, and a combination thereof; and wherein: the tissue-mimicking regions are arranged in a configuration selected from the group of: a stacked configuration, a concentric configuration, a centrally split configuration, and a combination thereof, and analyzing the imaging system includes generating images or a measurement of each region (tissue 1-3 are in a horizontally stacked slab configuration; see Fig. 16).
Regarding claim 9, the combination of Neogi and Mallozzi teaches wherein each tissue-mimicking region includes a compartment, with one or more compartments being stacked on a first compartment, and with each compartment being filled with a material having a tissue property that is different from material filling another one of the compartments (see rejection of claim 1).
Regarding claims 11 and 20, Neogi fails to explicitly teach wherein for each tissue-mimicking region, a spatial extent occupied by the region and materials therein are selected and positioned relative to the other tissue-mimicking regions to facilitate measurement of stiffness of the material in the tissue-mimicking region, based on one or more characteristics of an imaging system selected from the group of: excitation wavelength, frequency, passive driver type and format, and a combination thereof, however, Neogi teaches wherein the tissue materials are configured adjacent to each other for determining properties related to stiffness including bulk modulus (See [0054]-[0056]). As outlined in the 112(b) rejection above, the pending disclosure provides no specific examples of modification of a spatial extent occupied by the region and materials which facilitate the functional limitations as claimed beyond what would be common sense and routine optimization. For example, it would be a matter of common sense and routine optimization for one of ordinary skill in the art to form the phantom to be an appropriate size and of a material capable of detection at MRI frequencies to facilitate measurements of stiffness as claimed.
Regarding claim 21, Neogi fails to teach wherein the first and second compartments have exterior surface areas that respectively form an exterior surface of the entire first tissue- mimicking region and the entire second tissue-mimicking region, including the external surface areas that interface with one another and further external surface areas that collectively provide an external surface of the phantom apparatus.
Mallozzi teaches wherein the first and second compartments have exterior surface areas that respectively form an exterior surface of the entire first tissue- mimicking region and the entire second tissue-mimicking region, including the external surface areas that interface with one another and further external surface areas that collectively provide an external surface of the phantom apparatus (Each section of the aggregate phantom may have a housing 21, cast or otherwise formed, for example, from a clear urethane material. The housing fully encloses the support structure, fiducial features, other features, and background fill or fluid of the section, rendering each section self-contained. See [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Mallozzi into Neogi in order to gain the advantage of an aggregate sample formed by combining multiple, independently transportable, self-contained phantom sections into one aggregate phantom, a large field-of-view may be covered, while avoiding excess weight. The sections of the aggregate phantom of the present invention can be individually transported and handled, and then can be reassembled on the patient table of the imaging system. Once reassembled, the sections are meant to function collectively as a single large aggregate phantom.
Regarding claims 22 and 24, Neogi teaches each tissue-mimicking region is filled with tissue-mimicking material that is different than tissue-mimicking material in at least one of the other tissue-mimicking regions (the tissue regions include three different tissues; see Fig. 16).
Neogi fails to teach wherein: each tissue-mimicking region has a compartment filled with tissue-mimicking material; and each compartment, including the first and second compartments, has exterior surface areas that respectively form an exterior surface of the entire tissue-mimicking region of which the compartment is part of, including external surface areas that interface with another one of the compartments and further external surface areas that collectively provide an external surface of the phantom apparatus in its entirety.
Mallozzi teaches each tissue-mimicking region has a compartment filled with tissue-mimicking material; and each compartment, including the first and second compartments, has exterior surface areas that respectively form an exterior surface of the entire tissue-mimicking region of which the compartment is part of, including external surface areas that interface with another one of the compartments and further external surface areas that collectively provide an external surface of the phantom apparatus in its entirety (Each section of the aggregate phantom may have a housing 21, cast or otherwise formed, for example, from a clear urethane material. The housing fully encloses the support structure, fiducial features, other features, and background fill or fluid of the section, rendering each section self-contained. See [0080]; see Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Mallozzi into Neogi in order to gain the advantage of an aggregate sample formed by combining multiple, independently transportable, self-contained phantom sections into one aggregate phantom, a large field-of-view may be covered, while avoiding excess weight. The sections of the aggregate phantom of the present invention can be individually transported and handled, and then can be reassembled on the patient table of the imaging system. Once reassembled, the sections are meant to function collectively as a single large aggregate phantom.
Claim(s) 3, 7-8, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0365034 (Neogi) in view of US 20108/0008401 (Mallozzi), and in further view of US 2021/0364590 (Roldan).
Regarding claim 3, Neogi fails to teach wherein: the phantom has a shell having an outer surface and an inner surface within which the tissue-mimicking regions reside; and respective surface portions of each of the tissue-mimicking regions collectively forming an outer surface of the tissue-mimicking regions having a shape that follows a shape of the inner surface of the shell.
Roldan teaches wherein: the phantom has a shell having an outer surface and an inner surface within which the tissue-mimicking regions reside (a phantom 10 has a housing 12 which surrounds the compartments 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Roldan into Neogi in order to gain the advantage of a housing comprises a recessed region 18 sized to receive a passive driver for MRI imaging.
While the prior art of record fails to explicitly recite respective surface portions of each of the tissue-mimicking regions collectively forming an outer surface of the tissue-mimicking regions having a shape that follows a shape of the inner surface of the shell, it would have been obvious to one of ordinary skill in the art to provide a housing around the phantom as disclosed in Neogi and Mallozzi as claimed such that the housing may provide a passive driver for the phantom in elastography measurements.
Regarding claims 7-8, Neogi and Mallozzi fails to teach wherein: the phantom includes a housing; and the tissue-mimicking regions and the phantom housing have a circular cross-section that facilitates transmission of concentric mechanical waves throughout the tissue-mimicking region; and the tissue-mimicking regions and the phantom housing have cylindrical outer shells that facilitate transmission of concentric mechanical waves throughout the tissue-mimicking region.
Roldan teaches the phantom includes a housing (container 12 comprises bottom, walls, faces, and ends 14-18 and the sections 25-27 are configured in an equivalent manner as claimed; see Fig. 1; see [0053]-[0054]); the tissue-mimicking regions and the phantom housing have a circular cross-section that facilitates transmission of concentric mechanical waves throughout the tissue-mimicking region; and the tissue-mimicking regions and the phantom housing have cylindrical outer shells that facilitate transmission of concentric mechanical waves throughout the tissue-mimicking region (a phantom 10 comprises a cylindrical housing 12 and a recessed region 18, wherein the phantom is used for MRE measurements and recessed region 18 is used for generating mechanical waves in a region of interest; see Fig. 3; see [0051]-[0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Roldan into Neogi and Mallozzi in order to gain the advantage of a phantom configured for MRE measurements such that the phantom is adapted with a recessed region to receive a passive driver for MRE imaging. A phantom having multiple tissue-mimicking regions what are stacked for elastography measurements is known in the art as taught in Neogi. Forming a phantom with different tissue regions having their own disparate and interlocking compartments is known in the art as disclosed in Mallozzi. Forming the phantoms to have a circular cross-section would require a mere change of shape. See MPEP 2144.04 IV.B.. Since the claim phantom is an obvious variation of a known phantom used in elastography imaging, it would be obvious for one of ordinary skill in the art to modify the phantom for MRE measurements as disclosed in Mallozzi in view of a broadest reasonable interpretation. Further, it is not entirely clear how a shell/housing is combined with a phantom having multiple compartments as claimed, the disclosure does not provide any examples of materials for the compartment which would not interfere with elastography imaging, or disclose any embodiment which incorporates all the limitations of claims 1, 6, and 7 or 8.
Regarding claim 16, Neogi teaches wherein the tissue-mimicking regions are stacked on one another (see Fig. 16).
As best understood by the examiner, the limitations as “wherein the tissue-mimicking regions are stacked on one another, and analyzing the imaging system includes assessing mechanical stiffness of each tissue-mimicking region using a multi-slice magnetic resonance elastography (MRE) approach in which one or more slices lie in a stacked region that is different than a stacked region in which another one of the slices lies” correspond to an intended use and would be a direct consequence of performing MRE imaging as taught in Roldan on the phantom as disclosed in Neogi. Since the limitations are a mere intended use, they do not further limit the structure of the phantom apparatus. See MPEP 2114 II. “‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.”
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0365034 (Neogi) in view of US 20108/0008401 (Mallozzi), and in further view of US 2002/0012999 (Madsen).
Regarding claim 10, Neogi and Mallozzi fail to teach the limitations of claim 10.
Madsen teaches wherein at least one of the tissue-mimicking regions includes a thermoset material, cross-linked polymeric material, or gel-based material (see [0007], [0013]-[0020]), and is configured to set in response to being heated and subsequently cooled, therein facilitating the application of another type of material onto a previously formed material while mitigating changes in properties of the previously formed material (gels are formed by heating the material then cooling, see [0059], and “Each test phantom had a container of the type shown in FIGS. 22 and 23, but was first half filled with one type of tissue-mimicking material 37 and then with a second type of tissue-mimicking material 38 after the first tissue-mimicking material was allowed to stand and congeal for 24 hours, with the materials 37 and 38 in contact with each other at an interface 40.” See [0073].).
Madsen fails to teach explicitly teaches wherein at least one of the tissue-mimicking regions includes a thermoset material, cross-linked polymeric material, or gel-based material that has a melting point higher than its gel point, however, the limitation would be understood by one of ordinary skill in the art for the gels used in Madsen such that a first gel may be formed and congealed, then a second gel may be layered on the first gel at an interface 40 after the first gel has congealed. The properties as claimed would be necessary to form the two materials in contact with each other at an interface. If the above properties where not present for the first material, then the addition of the second material would melt the congealed first material and would not result in an interface as recited in Madsen and shown in Figs. 22 and 23.
It would be obvious to one of ordinary skill in the art to use a tissue-mimicking region as disclosed in Madsen in order to form a second tissue-mimicking material directly onto a second tissue-mimicking material with a common interface.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0365034 (Neogi) in view of US 20108/0008401 (Mallozzi), in view of US 2021/0373108 (Charlton).
Regarding claim 12, Neogi teaches wherein at least one of the tissue-mimicking regions is configured to mimic mechanical stiffness (the three tissues 1-3 of the phantoms have different bulk modulus which reasonably mimic mechanical stiffness; see [0103]; see Fig. 16).
Madsen fails to teach wherein at least one of the tissue-mimicking regions is configured to simultaneously mimic both mechanical stiffness and magnetic resonance imaging (MRI) proton density fat fraction.
Charlton teaches wherein at least one of the tissue-mimicking regions is configured to simultaneously mimic both mechanical stiffness and magnetic resonance imaging (MRI) proton density fat fraction (Phantoms are designed to mimic body tissue including proton density fat fraction which may be varied using a function of volume percent of peanut oil. As best understood by the examiner, stiffness is a physical property of gels, so any phantom configured to mimic a fat fraction would also mimic a stiffness based on the desired properties to be mimicked. See [0024], [0026], [0030], [0046]]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Charlton into Neogi in order to gain the advantage of a phantom configured mimic a tissue, wherein the tissue has desired stiffness and fat fraction properties.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0365034 (Neogi) in view of US 20108/0008401 (Mallozzi), in view of US 2019/0029633 (Broggio).
Regarding claim 23, Neogi fails to teach wherein the first and second compartments have interlocking features configured to lock the respective compartments together. Mallozzi teaches wherein the two compartments are connected together, but fails to teach interlocking features as claimed.
Broggio wherein the first and second compartments have interlocking features configured to lock the respective compartments together (a phantom 1 comprises multiple parts which are interlocked together using a fitting together system 13, 14; see [0097]; see Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Broggio into Neogi in order to gain the advantage of a phantom configured to be assembled from multiple pieces using interlocking features to securely interlock the components together.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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 STEVEN LEE YENINAS whose telephone number is (571)270-0372. The examiner can normally be reached M - F 10 - 6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Judy Nguyen can be reached at (571) 272-2258. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN L YENINAS/Primary Examiner, Art Unit 2858