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 .
Claim Objections
Claims 7 and 20 objected to because of the following informalities:
In claim 7, line 3, “prevent a fluid communication” should read “prevent said fluid communication” as the limitation has antecedence in claim 1.
In claim 20, line 21, “a container” should read “said container” as the limitation has antecedence in line 5.
In claim 20, line 21, “an inner compartment” should read “said inner compartment”.
In claim 20, lines 21-22, “a first chamber and a second chamber” should read “said first chamber and said second chamber”.
In claim 20, line 25, “preferably one or more wires” appears to be incorrect. Based on figures 13A-14, the recitation appears to be mistranslated and should read “preferably one or more tubes”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means,” and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Such claim limitation(s) is/are: “closing means” in claim 7, line 2; “opening means” in claim 12, line 5; “return means” in claim 13, line 2, and “shutter means” in claim 20, line 25.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“closing means” – Interpreted as a bulkhead, barrier, or film that can be removed either by tearing it away or moving it out of the way per paragraph 0070.
“opening means” – Interpreted as a tip or protrusion for tearing or breaking the fluid capsule per paragraph 0089.
“return means” – Interpreted as elastic springs for pushing the fluid capsule in a “return direction”/upwards away from the opening means to create a gap for fluid to flow per paragraphs 0094-0097.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. For instance, claims use the terminology “suitable for” and uses the word “obtain[ed]” seemingly to mean “positioned” or “located” which is not a known or traditional definition or usage of the terminology. Therefore, claims 1-20 are rejected under 35 U.S.C 112(b).
Claim 4 recites the limitations “said outer frame comprising a cartridge seat in which the cartridge is accommodated, and a reproduction seat in which the three-dimensional physical reproduction is housed”. However, claim 1 states the three-dimensional physical reproduction is placed at an access zone of the container to the second chamber wherein the second chamber is part of the cartridge, so it is unclear how the “reproduction seat” is separate from the cartridge accommodated in the cartridge seat and/or how the “reproduction seat” differs from the access zone. As claimed, claim 4 appears to recite the cartridge seat and the reproduction seat being two different portions of the outer frame yet claim 1 recites the 3D reproduction being connected to the container. This lack of clarity renders the claim language as indefinite as one of ordinary skill in the art cannot determine the subject matter which the inventor or a joint inventor regards as the invention. Claims 5-6 are rejected by virtue of their dependency.
Claim limitation “shutter means”, in claim 20, line 25, has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because of the recitation “preferably one or more wires” which is an optional limitation but also recites sufficient structure for performing the claimed function of “being inserted into said one or more fluid communication openings and for extending into the second chamber”. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6, 10, 15-16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Pirlot et al. (US PGPub 20210350723), hereinafter referred to as Pirlot.
With regard to claim 1, Pirlot teaches a surgical simulation device comprising:
a three-dimensional physical reproduction suitable for simulating at least partially an anatomical part of a human body (Paragraphs 0085-0088 teach a physical simulator device simulating the body of a patient including a patient-specific cartridge mimicking an internal organ and anatomical parts), and
a cartridge comprising a container defining an inner compartment of the cartridge, said inner compartment being divided into at least a first chamber and a second chamber (Figs 10-11, 14; Paragraphs 0088, 0100, 0103-0104, 0107-0109 teach the simulator includes a tank into which the cartridge can be inserted wherein the tank includes a side wall (ref 1489) dividing the simulator into the cartridge (second chamber) and a tank and fluid control system (first chambers, examiner notes that as claimed, the tank and fluid control system could both be considered a separate “chamber” from the cartridge and therefore the “first” chamber) and other spaces of the housing);
wherein said container comprises an access zone to the second chamber and wherein the three-dimensional physical reproduction is placed at said access zone, so that creating a passage, optionally the passage being a surgical cut, in the three-dimensional physical reproduction, access is allowed from an outside to said second chamber through said access zone (Figs 3, 8, 11; Paragraphs 0086-0087, 0092, 0096, 0104 teaches the cartridge including the 3D anatomical model/reproduction can be placed in the tank which has an opening on top (access zone) through which the user can access the model including inserting catheters (passage) or using other surgical tools),
wherein said cartridge further comprises a simulation material contained in said second chamber and suitable for simulating an internal tissue of the human body (Paragraphs 0084, 0091-0092, 0124 teach the cartridge includes material for replicating visual and biomechanical properties of biological tissues thereby including material in the cartridge (second chamber) simulating internal human tissue),
wherein said first chamber is suitable for containing a simulation fluid suitable for simulating a body fluid (Paragraphs 0092, 0096, 0109 teach the system includes a fluid control system which can circulate simulated blood/fluid through the tank and cartridge/model), and
wherein the first chamber is in fluid communication with the second chamber by one or more fluid communication openings suitable for allowing a passage of fluid from said first chamber to said second chamber (Paragraphs 0108-0109, 0171, 0173 teach the simulator includes fluidic openings in the sidewall which allow fluid flow between the tank, fluid control system, and the cartridge/model such that the tank, control system and model are in fluidic communication and allowing fluid flow/passage between the portions of the simulator).
With regard to claim 2, Pirlot further teaches wherein the container further comprises a dividing wall separating said first chamber and said second chamber, and wherein said one or more fluid communication openings are obtained in said dividing wall (Paragraphs 0108-0109, 0171, 0173 teach the simulator includes fluidic openings in the sidewall (dividing wall) which allow fluid flow between the tank, fluid control system, and the cartridge/model such that the tank, control system and model are in fluidic communication and allowing fluid flow/passage between the portions of the simulator).
With regard to claim 4, Pirlot further teaches further comprising an outer frame, said outer frame comprising a cartridge seat in which the cartridge is accommodated, and a reproduction seat in which the three-dimensional physical reproduction is house (Figs. 3, 7, 10-11; Paragraphs 0086-0088, 0103-0105 teach the simulator includes a station and frame (outer frame) forming in part the tank (cartridge seat) that can receive the cartridge and the heart/anatomical model (physical reproduction)).
With regard to claim 5, Pirlot further teaches wherein the cartridge is accommodated in the cartridge seat in extractable manner (Paragraphs 0104, 0183 teaches the cartridge/model can be installed in the tank such that it can be removed (extractable) and replaced for “plug-and-play” functionality).
With regard to claim 6, Pirlot further teaches wherein the container comprises a based, and wherein the cartridge is extractable from the cartridge seat along an extraction direction perpendicular to said base (Figs 10 and 11 show the device and tank have a bottom/base wherein the cartridge is inserted into the top of the device and tank thereby being “extractable” in a direction perpendicular to the base).
With regard to claim 10, Pirlot further teaches wherein the container further comprises a side wall having a side wall portion facing the second chamber, and wherein said side wall portion has protrusions and/or depressions suitable for generating friction and acting as a support for the simulation material placed in the second chamber (Figs. 10, 11, 14; Paragraphs 0108, 0176, 0182-0184 teach the tank (second chamber) includes a side wall wherein the side wall can include magnets (protrusions) and openings/ports which can be connected to the model thereby supporting the model and generating friction wherein portions of the system and device can be mounted using a friction fit).
With regard to claim 15, Pirlot further teaches a surgical simulation learning system comprising the surgical simulation device of claim 1 (see prior art rejection of claim 1 above), and a simulation fluid suitable for simulating a body fluid, preferably fake blood, housed in the first chamber of the cartridge of said surgical simulation device (Paragraphs 0092, 0097, 0109 teaches the system includes blood simulation fluid stored in the tank and pumped through the fluid control system).
With regard to claim 16, wherein the simulation fluid is directly accommodated in the first chamber, the simulation fluid contained in the first chamber being at least partially directly in contact with the container (Paragraphs 0092, 0171-0173 teach the blood simulating fluid can be in the tank and can be pumped through the fluid control system including a pump, filter, and chamber).
With regard to claim 18, Pirlot teaches a cartridge comprising a container defining an inner compartment of the cartridge, said container being divided into at least a first chamber and a second chamber (Figs 10-11, 14; Paragraphs 0088, 0100, 0103-0104, 0107-0109 teach the simulator includes a tank into which the cartridge can be inserted wherein the tank includes a side wall (ref 1489) dividing the simulator into the cartridge (second chamber) and a tank and fluid control system (first chambers, examiner notes that as claimed, the tank and fluid control system could both be considered a separate “chamber” from the cartridge and therefore the “first” chamber) and other spaces of the housing),
wherein said cartridge comprises a simulation material contained in said second chamber and suitable for simulating an internal tissue of a human body (Paragraphs 0084, 0091-0092, 0124 teach the cartridge includes material for replicating visual and biomechanical properties of biological tissues thereby including material in the cartridge (second chamber) simulating internal human tissue),
wherein said first chamber is suitable for containing a simulation fluid suitable for simulating a body fluid (Paragraphs 0092, 0097, 0109 teaches the system includes blood simulation fluid stored in the tank and pumped through the fluid control system in order to simulate blood flow (body fluid)), and
wherein the first chamber and the second chamber are in fluid communication by one or more fluid communication openings suitable for allowing a passage of fluid from said first chamber to said second chamber (Paragraphs 0108-0109, 0171, 0173 teach the simulator includes fluidic openings in the sidewall which allow fluid flow between the tank, fluid control system, and the cartridge/model such that the tank, control system and model are in fluidic communication and allowing fluid flow/passage between the portions of the simulator).
Claim(s) 1-2, 4-6, 10-11, 14-15, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Eherenfeldt et al. (US PGPub 20210129393), hereinafter referred to as Eherenfeldt.
With regard to claim 1, Eherenfeldt teaches a surgical simulation device (Abstract; Paragraphs 0068-0069, 0091 teaches a surgical simulation system including an anatomical model) comprising:
a three-dimensional physical reproduction suitable for simulating at least partially an anatomical part of a human body (Figs. 21, 27; Paragraphs 0068, 0091, 0101 teaches the system includes the anatomical model which can include layers of material simulating a vessel or organ and skin tissue/layers encasing the anatomical components), and
a cartridge comprising a container defining an inner compartment of the cartridge, said inner compartment being divided into at least a first chamber and a second chamber (Fig. 28; Paragraphs 0104-0105 teaches the system can include an enclosure (cartridge) including a receiving chamber (second chamber) for receiving a modular insert and a reservoir (first chamber));
wherein said container comprises an access zone to the second chamber and wherein the three-dimensional physical reproduction is placed at said access zone, so that creating a passage, optionally the passage being a surgical cut, in the three-dimensional physical reproduction, access is allowed from an outside to said second chamber through said access zone (Figs. 40-42B; Paragraphs 0101-0102, 0127-0128 teach the housing of the modular insert can include a surface of simulated skin which can be cut or slit to create an opening (passage) through the layers to access the vessel or organ and show the window/view into the model (access zone)),
wherein said cartridge further comprises a simulation material contained in said second chamber and suitable for simulating an internal tissue of the human body (Paragraphs 0068, 0088, 0101-0102 teach the housing/insert includes simulated tissues including adipose, nerve, muscle, and skin tissues (internal tissues) which are included in the insert which can be placed in the receiving chamber (second chamber)),
wherein said first chamber is suitable for containing a simulation fluid suitable for simulating a body fluid (Fig. 28; Paragraphs 0087-0089, 0091, 0105 teach the system can include a fluid reservoir storing a liquid for simulating blood flow (body fluid)), and
wherein the first chamber is in fluid communication with the second chamber by one or more fluid communication openings suitable for allowing a passage of fluid from said first chamber to said second chamber (Fig. 28; Paragraphs 0087-0089, 0091, 0105 teach the modular insert can be inserted into the receiving chamber and connected with the fluid flow connectors via holes in the housing and chamber thereby allowing fluid communication from the reservoir (first chamber) to the receiving chamber/modular insert (second chamber).
With regard to claim 2, Eherenfeldt further teaches wherein the container further comprises a dividing wall separating said first chamber and said second chamber, and wherein said one or more fluid communication openings are obtained in said dividing wall (Figs 28, 35A, 38; Paragraphs 0087-0089, 0091, 0105, 0126-0127 teach the receiving chamber is comprised of walls (dividing wall) which as shown separate the receiving chamber and modular insert from the reservoir wherein the fluid flow connectors are positioned in the wall of the receiving chamber).
With regard to claim 4, Eherenfeldt further teaches further comprising an outer frame (Fig 46; Paragraph 0134 teaches the system can include a device enclosure having top, side, and bottom surfaces), said outer frame comprising a cartridge seat in which the cartridge is accommodated (Fig 46; Paragraph 0134 teaches the top surface can be removed allowing for internal components such as the fluid reservoir to be accessed and removed wherein the top surface includes the receiving chamber wherein the enclosure is a “cartridge seat” for housing the components), and a reproduction seat in which the three-dimensional physical reproduction is housed (Fig 46; Paragraphs 0134-0135 teach the top surface includes the receiving chamber (reproduction seat) which receives the modular insert including the simulated skin cover (physical reproduction)).
With regard to claim 5, Eherenfeldt further teaches wherein the cartridge is accommodated in the cartridge seat in extractable manner (Paragraphs 0088, 0107, 0112, 0134 teach the modular insert and/or the receiving chamber and top surface can be removed/unattached from the enclosure).
With regard to claim 6, Eherenfeldt further teaches wherein the container comprises a base, and wherein the cartridge is extractable from the cartridge seat along an extraction direction perpendicular to said base (Fig. 46; Paragraphs 0134-0135 teach enclosure has surfaces which would include a base/bottom surface and the top surface including the receiving chamber can be completely separated from the enclosure thereby allowing for “extraction” vertically (perpendicular to said base)).
With regard to 10, Eherenfeldt further teaches wherein the container further comprises a side wall having a side wall portion facing the second chamber and wherein said side wall portion has protrusions and/or depressions suitable for generating friction and acting as a support for the simulation material placed in the second chamber (Fig 43; Paragraph 0133 teaches the receiving chamber includes walls that the modular insert fits snugly creating a friction fit supporting the modular insert including the simulated skin and organ wherein the wall can have size and material selection for the snug fit and include the fluid flow connectors (protrusions/depressions).
With regard to claim 11, Eherenfeldt further teaches wherein the container is formed by a first cartridge portion and a second cartridge portion, wherein the first cartridge portion and the second cartridge portion are distinct bodies assembled together to form the container, so that the first chamber and the second chamber are formed upon assembling the first and second cartridge portions (Figs 43-46; Paragraphs 0129, 0132, 0134 teach the system can include a liftable top (first cartridge portion) having the receiving chamber which is removable and distinct from the device enclosure (second cartridge portion) including the reservoir wherein the top can be connected to the portions of the enclosure including fluid communication connectors thereby “forming” the connected chambers upon assembling/placing the top/liftable portion on the enclosure).
With regard to claim 14, Eherenfeldt further teaches wherein one or more fluid conduits are formed in the simulation material, which extend from said one or more fluid communication openings into the simulation material in the second chamber, said one or more fluid conduits being suitable for allowing an infiltration of the simulation fluid from said one or more fluid communication openings into the simulation material (Fig 28; Paragraphs 0071, 0087, 0091, 0105 teaches the modular insert comprises an anatomical model and/or component including vessels (fluid conduits) within the simulated material and layers wherein the vessels are connected to holes in the modular insert which are connected to the corresponding fluid flow connectors of the receiving chamber allowing the simulation fluid to flow through the anatomical component/model).
With regard to claim 15, Eherenfeldt teaches a surgical simulation learning system comprising the surgical simulation device of claim 1 (see prior art rejection of claim 1 above), and a simulation fluid suitable for simulating a body fluid preferably fake blood, housed in the first chamber of the cartridge of said surgical simulation device (Paragraphs 0087-0088, 0105 teaches the system includes simulation fluid wherein the fluid can simulate blood and blood flow and pressure through the anatomical model/component and through the simulated modular insert/material wherein the fluid can be stored in a fluid reservoir (first chamber)).
With regard to claim 18, Eherenfeldt teaches a cartridge comprising a container defining an inner compartment of the cartridge, said container being divided into at least a first chamber and a second chamber (Fig. 28; Paragraphs 0104-0105 teaches the system can include an enclosure (cartridge) including a receiving chamber (second chamber) for receiving a modular insert and a reservoir (first chamber)),
wherein said cartridge comprises a simulation material contained in said second chamber and suitable for simulating an internal tissue of a human body (Paragraphs 0068, 0088, 0101-0102 teach the housing/insert includes simulated tissues including adipose, nerve, muscle, and skin tissues (internal tissues) which are included in the insert which can be placed in the receiving chamber (second chamber)),
wherein said first chamber is suitable for containing a simulation fluid suitable for simulating a body fluid (Fig. 28; Paragraphs 0087-0089, 0091, 0105 teach the system can include a fluid reservoir storing a liquid for simulating blood flow (body fluid)), and
wherein the first chamber and the second chamber are in fluid communication by one or more fluid communication openings suitable for allowing a passage of fluid from said first chamber to said second chamber (Fig. 28; Paragraphs 0087-0089, 0091, 0105 teach the modular insert can be inserted into the receiving chamber and connected with the fluid flow connectors via holes in the housing and chamber thereby allowing fluid communication from the reservoir (first chamber) to the receiving chamber/modular insert (second chamber).
With regard to claim 19, Eherenfeldt further teaches wherein one or more fluid conduits are formed in the simulation material, which extend from said one or more fluid communication openings into the simulation material in the second chamber, said fluid conduits being suitable for allowing an infiltration of the simulation fluid from said one or more fluid communication openings into the simulation material (Fig 28; Paragraphs 0071, 0087, 0091, 0105 teaches the modular insert comprises an anatomical model and/or component including vessels (fluid conduits) within the simulated material and layers wherein the vessels are connected to holes in the modular insert which are connected to the corresponding fluid flow connectors of the receiving chamber allowing the simulation fluid to flow through the anatomical component/model).
With regard to claim 20, Eherenfeldt teaches a method for producing a cartridge (Paragraphs 0069-0075 teach creating the anatomical model/component of the modular insert using known techniques including molding) for a surgical simulation device (Abstract; Paragraphs 0068-0069, 0091 teaches a surgical simulation system including an anatomical model) that comprises:
a three-dimensional physical reproduction suitable for simulating at least partially an anatomical part of a human body (Figs. 21, 27; Paragraphs 0068, 0091, 0101 teaches the system includes the anatomical model which can include layers of material simulating a vessel or organ and skin tissue/layers encasing the anatomical components), and
a cartridge comprising a container defining an inner compartment of the cartridge, said inner compartment being divided into at least a first chamber and a second chamber (Fig. 28; Paragraphs 0104-0105 teaches the system can include an enclosure (cartridge) including a receiving chamber (second chamber) for receiving a modular insert and a reservoir (first chamber));
wherein said container comprises an access zone to the second chamber and wherein the three-dimensional physical reproduction is placed at said access zone, so that creating a passage, optionally the passage being a surgical cut, in the three-dimensional physical reproduction, access is allowed from an outside to said second chamber through said access zone (Figs. 40-42B; Paragraphs 0101-0102, 0127-0128 teach the housing of the modular insert can include a surface of simulated skin which can be cut or slit to create an opening (passage) through the layers to access the vessel or organ and show the window/view into the model (access zone)),
wherein said cartridge further comprises a simulation material contained in said second chamber and suitable for simulating an internal tissue of the human body (Paragraphs 0068, 0088, 0101-0102 teach the housing/insert includes simulated tissues including adipose, nerve, muscle, and skin tissues (internal tissues) which are included in the insert which can be placed in the receiving chamber (second chamber)),
wherein said first chamber is suitable for containing a simulation fluid suitable for simulating a body fluid (Fig. 28; Paragraphs 0087-0089, 0091, 0105 teach the system can include a fluid reservoir storing a liquid for simulating blood flow (body fluid)), and
wherein the first chamber is in fluid communication with the second chamber by one or more fluid communication openings suitable for allowing a passage of fluid from said first chamber to said second chamber (Fig. 28; Paragraphs 0087-0089, 0091, 0105 teach the modular insert can be inserted into the receiving chamber and connected with the fluid flow connectors via holes in the housing and chamber thereby allowing fluid communication from the reservoir (first chamber) to the receiving chamber/modular insert (second chamber),
the method comprising, in order, the following steps:
providing a container defining an inner compartment divided into a first chamber and a second chamber (Fig. 28; Paragraphs 0104-0105 teaches the system can include an enclosure (cartridge) including a receiving chamber (second chamber) for receiving a modular insert and a reservoir (first chamber)), said first and second chambers being in fluid communication with each other by one or more fluid communication openings (Fig. 28; Paragraphs 0087-0089, 0091, 0105 teach the modular insert can be inserted into the receiving chamber and connected with the fluid flow connectors via holes in the housing and chamber thereby allowing fluid communication from the reservoir (first chamber) to the receiving chamber/modular insert (second chamber);
providing one or more shutter means, preferably one or more wires, suitable for being inserted into said one or more fluid communication openings and for extending into the second chamber (Paragraphs 0078, 0086 teach the anatomical mold used to create the modular insert (second chamber) can include a rod (shutter means) for extending the mold and creating the vessels that connect to the holes of the insert/housing (fluid communication openings) wherein the rods can be removed after the layers of material have been added);
inserting said one or more shutter means into said one or more fluid communication openings, so that said one or more shutter means close said one or more fluid communication openings and occupy part of the second chamber (Paragraphs 0078, 0086 teach the anatomical mold used to create the modular insert (second chamber) can include a rod (shutter means) for extending the mold and creating the vessels that connect to the holes of the insert/housing (fluid communication openings) thereby occupying part of the insert during the creation process and wherein the rods can be removed after the layers of material have been added such that the holes are blocked from material being added in order to create the negative space);
casting the simulation material into the second chamber, so that said simulation material occupies a volume of the second chamber not occupied by said one or more shutter means (Paragraphs 0072-0074, 0078 teach the process includes applying one or more layers of material (casting) such as silicone to the mold to create the simulated anatomical organ/component wherein the material would be occupying space around the mold and rod (shutter means));
waiting for cooling of said simulation material in the second chamber, until said simulation material thickens and sets completely (Paragraphs 0073, 0076, 0078 teach the layers are given time to cure to form a desired consistency (cooling)); and
removing said one or more shutter means by sliding the one or more shutter means through said one or more fluid communication openings, so that one or more fluid conduits are formed, extending from the one or more fluid communication openings into the simulation material, said one or more fluid conduits being suitable for allowing an infiltration of the simulation fluid from the first chamber into the simulation material (Paragraphs 0078, 0086-0087, 0091, 0105 teach the rods and model can be removed from the material/layers by pulling them out to create the void/negative space corresponding to the desired component/vessel (fluid conduits) wherein the vessels allow fluid flow through the modular insert via the connected holes and connection).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pirlot in view of Stone et al. (US PGPub 20240029587), hereinafter referred to as Stone.
With regard to claim 20, Pirlot teaches a method for producing a cartridge for a surgical simulation device (Paragraphs 0124, 0146 teach fabricating the patient specific model) that comprises:
a three-dimensional physical reproduction suitable for simulating at least partially an anatomical part of a human body (Paragraphs 0085-0088 teach a physical simulator device simulating the body of a patient including a patient-specific cartridge mimicking an internal organ and anatomical parts), and
a cartridge comprising a container defining an inner compartment of the cartridge, said inner compartment being divided into at least a first chamber and a second chamber (Figs 10-11, 14; Paragraphs 0088, 0100, 0103-0104, 0107-0109 teach the simulator includes a tank into which the cartridge can be inserted wherein the tank includes a side wall (ref 1489) dividing the simulator into the cartridge (second chamber) and a tank and fluid control system (first chambers, examiner notes that as claimed, the tank and fluid control system could both be considered a separate “chamber” from the cartridge and therefore the “first” chamber) and other spaces of the housing);
wherein said container comprises an access zone to the second chamber and wherein the three-dimensional physical reproduction is placed at said access zone, so that creating a passage, optionally the passage being a surgical cut, in the three-dimensional physical reproduction, access is allowed from an outside to said second chamber through said access zone (Figs 3, 8, 11; Paragraphs 0086-0087, 0092, 0096, 0104 teaches the cartridge including the 3D anatomical model/reproduction can be placed in the tank which has an opening on top (access zone) through which the user can access the model including inserting catheters (passage) or using other surgical tools),
wherein said cartridge further comprises a simulation material contained in said second chamber and suitable for simulating an internal tissue of the human body (Paragraphs 0084, 0091-0092, 0124 teach the cartridge includes material for replicating visual and biomechanical properties of biological tissues thereby including material in the cartridge (second chamber) simulating internal human tissue),
wherein said first chamber is suitable for containing a simulation fluid suitable for simulating a body fluid (Paragraphs 0092, 0096, 0109 teach the system includes a fluid control system which can circulate simulated blood/fluid through the tank and cartridge/model), and
wherein the first chamber is in fluid communication with the second chamber by one or more fluid communication openings suitable for allowing a passage of fluid from said first chamber to said second chamber (Paragraphs 0108-0109, 0171, 0173 teach the simulator includes fluidic openings in the sidewall which allow fluid flow between the tank, fluid control system, and the cartridge/model such that the tank, control system and model are in fluidic communication and allowing fluid flow/passage between the portions of the simulator),
the method comprising, in order, the following steps:
providing a container defining an inner compartment divided into a first chamber and a second chamber (Figs 10-11, 14; Paragraphs 0088, 0100, 0103-0104, 0107-0109 teach the simulator includes a tank into which the cartridge can be inserted wherein the tank includes a side wall (ref 1489) dividing the simulator into the cartridge (second chamber) and a tank and fluid control system (first chambers, examiner notes that as claimed, the tank and fluid control system could both be considered a separate “chamber” from the cartridge and therefore the “first” chamber) and other spaces of the housing), said first and second chambers being in fluid communication with each other by one or more fluid communication openings (Paragraphs 0108-0109, 0171, 0173 teach the simulator includes fluidic openings in the sidewall which allow fluid flow between the tank, fluid control system, and the cartridge/model such that the tank, control system and model are in fluidic communication and allowing fluid flow/passage between the portions of the simulator).
Pirlot further teaches the anatomical/patient-specific model may be formed using 3D printing and/or casting (Paragraphs 0124, 0146, 0163) but may not explicitly teach providing one or more shutter means, preferably one or more wires, suitable for being inserted into said one or more fluid communication openings and for extending into the second chamber; inserting said one or more shutter means into said one or more fluid communication openings, so that said one or more shutter means close said one or more fluid communication openings and occupy part of the second chamber; casting the simulation material into the second chamber, so that said simulation material occupies a volume of the second chamber not occupied by said one or more shutter means; waiting for cooling of said simulation material in the second chamber, until said simulation material thickens and sets completely; and removing said one or more shutter means by sliding the one or more shutter means through said one or more fluid communication openings, so that one or more fluid conduits are formed, extending from the one or more fluid communication openings into the simulation material, said one or more fluid conduits being suitable for allowing an infiltration of the simulation fluid from the first chamber into the simulation material. However, Stone teaches a system and method for simulating surgical procedures including creating simulated organs/models which can be organs including a bladder, liver, kidney, heart, brain, etc. wherein the organ/model is made by creating a negative of the organ being modeled, placing wires entering the mold representing arteries and veins, filling the mold with a simulating material such as a hydrogel polymer, allowing the material to crosslink/cure, and removing the wires to leave behind voids/negative space simulating blood vessels which can be connected to a fluid source allowing simulated blood to flow through the vessels and model (Paragraphs 0029, 0033-0034, 0047).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pirlot to incorporate the teachings of Stone by applying the technique of creating an anatomical model by filling a mold with a simulating material wherein wires are used to leave voids simulating blood vessels/fluid conduits of Stone to create the simulated patient organ/anatomical organs and vessels of Pirlot, as both references and the claimed invention are directed to surgical simulation systems using simulated organs made using casting. One of ordinary skill in the art would modify Pirlot by casting the anatomical component/organ including placing wires to create the negative/void space for blood vessels wherein the wires are removed after allowing the material to set/cure wherein the location of the wires would correspond to the fluid connectors of Pirlot to allow fluid to flow through the fluid control system and pump through the anatomical organ. Upon such modification, the method and system of Pirlot would include providing one or more shutter means, preferably one or more wires, suitable for being inserted into said one or more fluid communication openings and for extending into the second chamber; inserting said one or more shutter means into said one or more fluid communication openings, so that said one or more shutter means close said one or more fluid communication openings and occupy part of the second chamber; casting the simulation material into the second chamber, so that said simulation material occupies a volume of the second chamber not occupied by said one or more shutter means; waiting for cooling of said simulation material in the second chamber, until said simulation material thickens and sets completely; and removing said one or more shutter means by sliding the one or more shutter means through said one or more fluid communication openings, so that one or more fluid conduits are formed, extending from the one or more fluid communication openings into the simulation material, said one or more fluid conduits being suitable for allowing an infiltration of the simulation fluid from the first chamber into the simulation material. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Stone with Pirlot’s system and method in order to provide further blood vessels in the model and improve the manufacturing process for the model to allow simulated blood flow.
Conclusion
Accordingly, claims 1-20 are rejected.
Examiner notes that claims 3, 7-9, 12-13, and 17 are rejected under 35 U.S.C. 112 but are not rejected under 35 U.S.C. 102 or 103 in view of the prior art and would be allowable if rewritten to overcome the outstanding 112 rejections and in the independent form including all of the limitations of the base claim and any intervening claims. Claim 3 recites the one or more fluid communication openings are obtained in the dividing wall along superimposed levels, which is interpreted as being layered on parallel planes parallel to the base wherein the holes overlap with each other when viewed vertically. While Pirlot and Eherenfeldt teach fluid openings in the walls, both fail to teach the plurality of holes overlapping/being superimposed and as Pirlot explicitly teaches the holes being positioned to mimic the vessels connections of a organ and Eherenfeldt teaches the housing being relatively condensed and no further searched or cited references teach the limitation, even if a reference did explicitly teach the limitation, there would be no motivation to modify Pirlot or Eherenfeldt to teach the claimed limitation. No further searched art was found teaching the limitation in a related or relevant art or field of endeavor. Claim 7 recites “closing means” for preventing a fluid communication between the first and second chambers wherein the closing means is interpreted as a bulkhead or film for blocking the fluid communication openings. Pirlot and Eherenfeldt do not teach the fluid communication openings/systems being blocked or prevented in any way as the fluid flow is controlled by pumps and do not teach a bulkhead or film covering the fluid openings. Even if another searched reference was found teaching the limitation, there would be no motivation to modify the references using the teaching as the modification would render the references incapable of performing their intended purpose. Claims 8 and 9 depend from claim 7 and thereby include the subject matter found to overcome the prior art.
Claim 12 recites a capsule seat and a fluid capsule opened using an opening means, interpreted as a tip or protrusion for piercing the fluid capsule. Pirlot and Eherenfeldt fail to teach the limitation as both references recite the fluid storage as a reservoir or tank holding the fluid and do not teach an insertable fluid capsule. Reeh (US PGPub 20200090550) teaches an anatomical model which can include an attachable fluid cartridge for providing simulated blood to the model but fails to teach a capsule seat or opening means. Further, there is no motivation to apply the teachings of Reeh to the cited references and Reeh fails to teach all the limitations of the claims from which claim 12 depends. Claim 13 depends from claim 12 and thereby includes the subject matter found to overcome the prior art. Claim 17 similar to claim 12 recites a capsule seat and a fluid capsule housed in said capsule seat. As discussed above, the cited references fail to teach a fluid capsule and capsule seat and no further searched or cited references teaches the limitation and motivations for modifying the cited references. Examiner further notes the following relevant art: Wu (US 20190223778) teaches a head model including a method of making and using the head model including casting a brain model including fluid flow supplied by a tank in fluid communication with the model, and Okayama (US PGPub 20170103682) teaches a medical simulator including a tank filled with liquid housing an organ model connected to fluid communication pipes for supplying fluid from an attached pump/tank. Okayama, as with Pirlot and Eherenfeldt, demonstrates the traditional functionality and structure of organ/surgical simulators that supply simulated blood flow using an active pump and fluid tank/storage system. By comparison, the instant application recites a passive fluid communication supplied by a fluid capsule allowing fluid to flow through conduits and openings. Okayama and similar references also do not teach the chambers being placed directly next to each other as shown in the drawings, though not claimed, of the instant application. Therefore, no combination of cited or searched art teaches the limitations of claims 3, 7-9, 12-13, and 17 of the claimed invention as a whole. As no cited or searched prior art sufficiently teaches the limitations or teachings for combining such limitations, the limitations are indicated as allowable over the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims and correcting the outstanding 35 U.S.C. 112 rejections.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
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/CORRELL T FRENCH/Examiner, Art Unit 3715
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