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 .
Election/Restrictions
This application contains claims directed to the following patentably distinct species
The physical model is created using image data
The physical model is created using the VTDO
The physical model is created using the TDO
The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species as to how the physical model is created. Paragraph 108 of the specification lists all three as alternatives. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Robert Rosasco (Reg 69703) on 8/12/2026 a provisional election was made without traverse to prosecute the invention of species I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claims 1, 7, 11, and 14 are objected to because of the following informalities:
In claim 1; the abbreviation VTDO should be defined as virtual three-dimensional object before the abbreviation is subsequently used.
In claim 1; the abbreviation TDPM should be defined as three-dimensionally printed model before the abbreviation is subsequently used.
In claim 1; the abbreviation XR should be defined as extended reality before the abbreviation is subsequently used.
In claim 7; the abbreviation OTDO should be defined as optical three-dimensional object before the abbreviation is subsequently used.
In claim 11; the abbreviation MID should be defined as medical imaging device before the abbreviation is subsequently used.
In claim 14; the abbreviation VTDO should be defined as virtual three-dimensional object before the abbreviation is subsequently used.
In claim 14; the abbreviation TDO should be defined as three-dimensional object before the abbreviation is subsequently used.
In claim 14; the abbreviation TDPM should be defined as three-dimensionally printed model before the abbreviation is subsequently used.
In claim 14; the abbreviation OTDO should be defined as optical three-dimensional object before the abbreviation is subsequently used.
In claim 14; the abbreviation XR should be defined as extended reality before the abbreviation is subsequently used.
Appropriate correction is required.
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 7 and 10 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 claim 7, the claim recites “the VDO”. There is insufficient antecedent basis for this limitation in the claim. No VDO has previously been set forth. For examination purposes, this limitation will be interpreted as referring to the previously set forth VTDO.
Regarding claim 7, the claim recites the abbreviation VDO. The abbreviation is not defined in the claims or in the specification, therefore, it is unclear what this abbreviation means.
Regarding claim 10, the claim recites the abbreviation MR Device. The abbreviation is not defined in the claims or in the specification and the abbreviation MR has multiple relevant definitions in this field of endeavor. For example mixed reality device or magnetic resonance device. For examination purposes, this limitation will be interpreted as referring to a mixed reality device.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 5 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 5, the claim is considered to be directed towards a human organism because the claim positively recites an in vivo patient or subject as a structural requirement of the claim.
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.
Claims 1-7, 10-12, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Villain et al. (US20210059755, hereafter Villain).
Regarding claim 1, Villain discloses a system for visually guided in-vitro procedures, comprising:
one or more image data having a file format (Villain, Para 44; “wherein the physical model is a patient-specific physical model created based on medical image data”), the one or more image data including a first tissue or organ and a second tissue or organ that is different from the first tissue or organ (Villain, Para 54; “In FIG. 2, the medical image acquisition is denoted by reference numeral 200. From the acquired medical image data, a digital representation of the anatomical structure of interest can be extracted in step 201. In the given example, the anatomical structure of interest is a human heart 2. The extracted data can now be used to manufacture a physical, i.e. a real-world model of the anatomical structure in step 202. Optionally, the system 1 may comprise an additive manufacturing device such as a 3D printer adapted to generate the physical model 11 of the anatomical structure 2 based on the medical image data. The system 1 can comprise an interface for receiving medical image data of the anatomical structure”) (Villain, Para 50; “Hence, a mix-reality solution can be provided for merging printed organs with a biophysics model”) (Villain, Para 23; “a virtual model can provide functional information of the anatomical structure that can go beyond purely physical models, such as blood flow inside vessels, electrical current in muscles, heat transfer.”) (Villain, Para 32; “The virtual or digital biophysics organ model can be indicative of a functionality in particular a dynamic functionality or behavior of the anatomical structure, e.g. pulsating vessels or a beating heart. For example, it may simulate a blood flow and thereby alleviate the need for an experimental physical setup e.g. including a pumping system that mimics blood flow in printed physical organ models as indicated in the introductory section”);
one or more physical models (Villain, Para 44; “The system comprises a physical model 11 of an anatomical structure 2”); and
one or more viewing devices (Villain, Para 47; “The system 1 can further comprise a display device 50 such as a monitor or glasses comprising a display such as augmented reality glasses that can be worn by a physician.”);
wherein the one or more image data is configured to provide a virtual three-dimensional object (VTDO) including the first tissue or organ and the second tissue or organ (Villain, Para 44; “wherein the virtual model is a patient-specific model based on medical image data.”) (Villain, Para 47; “The manipulation can be visualized on the display 50 as a virtual manipulation of the virtual model 21 of the anatomical structure 2 with the virtual representation 22 of the interventional tool 3. The virtual model of the anatomical structure can also be referred to as a digital biophysics model”),
wherein the VTDO is configured to provide a visualization viewable on the one or more viewing devices (Villain, Para 47; “The manipulation can be visualized on the display 50 as a virtual manipulation of the virtual model 21 of the anatomical structure 2 with the virtual representation 22 of the interventional tool 3. The virtual model of the anatomical structure can also be referred to as a digital biophysics model”);
wherein the one or more image data is utilized to generate the one or more physical models comprising a three-dimensionally printed model (TDPM) (Villain, Para 29; “An additive manufacturing device can be a 3D-printer. The physical model of the anatomical structure may for example be generated in an additive manufacturing process based on plastic or silicon”), the TDPM including the first tissue or organ and the second tissue or organ (Villain, Para 44; “wherein the physical model is a patient-specific physical model created based on medical image data”) (Villain, Para 46; “The processor can be configured to perform the steps of registering the physical model 11 of the anatomical structure 2 with the virtual model 21 of the anatomical structure 2 and registering the physical representation 12 of the interventional tool 3 with a virtual representation 22 of the interventional tool 3 based on the position of the physical representation 12 of the interventional tool 3 with respect to the physical model 11 of the anatomical structure 2. In particular, the processor 40 can be configured to perform the registration based on an interaction of the physical representation 12 of the interventional tool 3 with the physical model 11 of the anatomical structure 2”);
wherein the visualization, when viewed through the one or more viewing devices comprising an XR device and harmonized with the TDPM synchronizes the first tissue or organ and the second tissue or organ both through the visualization and physically on the TDPM (Villain, Para 30; “Thy system can comprise glasses such as augmented reality glasses to superimpose the virtual and physical models of the anatomical structure and/or of the interventional tool”) (Villain, Para 60; “augmented reality glasses can be provided such that both physical and virtual objects and/or physical and virtual presentations of the surgical tool can be superimposed. Thereby, a merged view can be offered to the user”) (Villain, Para 48; “the proposed solution can combine a printed organ model as the physical model of the anatomic construction with a digital biophysics model as the virtual model of the anatomical structure for patient-specific interventional planning. In a first step, the geometry of an organ of interest can be extracted for medical images by processing techniques. The geometry can be turned into a physical model e.g. by 3D printing for allowing a visually tangible manipulation and interaction of the organ and interventional tools. The extracted geometry may also serve to define the domain of a biophysics organ motion or deformation, electric wave action and propagation”).
Regarding claim 2, Villain discloses all of the limitations of claim 1 as discussed above.
Villain further discloses wherein the one or more viewing devices further comprises a screen (Villain, Para 47; “The system 1 can further comprise a display device 50 such as a monitor or glasses comprising a display such as augmented reality glasses that can be worn by a physician.”).
Regarding claim 3, Villain discloses all of the limitations of claim 1 as discussed above.
Villain further discloses wherein a user of the XR device is able to synchronize the visualization and the TDPM as the user interacts with at least the TDPM in real time (Villain, Para 48; “combine a printed organ model as the physical model of the anatomic construction with a digital biophysics model as the virtual model of the anatomical structure for patient-specific interventional planning […] allowing a visually tangible manipulation and interaction of the organ and interventional tools. The extracted geometry may also serve to define the domain of a biophysics organ motion or deformation, electric wave action and propagation.”) (Villain, Para 51; “the proposed mixed-reality approach […] a more meaningful training and patient-specific intervention planning may be achieved. This may further increase the first-time-right surgical success rate”) (Villain, Para 62; “The user can then perform specific gestures to move the interventional tool, more precisely to move the physical representation of the interventional tool with respect to the physical model of the anatomical structure, to virtually deploy the stent inside the digital biophysics model, i.e. the virtual model of the anatomical structure. Optionally, in the virtual model of the anatomical structure, blood flow can be circulating and/or contrast injection can be virtually performed, while manipulating the physical model of the anatomical structure and the physical representation of the interventional tool”).
Regarding claim 4, Villain discloses all of the limitations of claim 2 as discussed above.
Villain further discloses wherein a user of the XR device is able to harmonize the visualization and the TDPM as the user interacts with both the TDPM and the visualization in real time (Villain, Para 48; “combine a printed organ model as the physical model of the anatomic construction with a digital biophysics model as the virtual model of the anatomical structure for patient-specific interventional planning […] allowing a visually tangible manipulation and interaction of the organ and interventional tools. The extracted geometry may also serve to define the domain of a biophysics organ motion or deformation, electric wave action and propagation.”) (Villain, Para 51; “the proposed mixed-reality approach […] a more meaningful training and patient-specific intervention planning may be achieved. This may further increase the first-time-right surgical success rate”) (Villain, Para 62; “The user can then perform specific gestures to move the interventional tool, more precisely to move the physical representation of the interventional tool with respect to the physical model of the anatomical structure, to virtually deploy the stent inside the digital biophysics model, i.e. the virtual model of the anatomical structure. Optionally, in the virtual model of the anatomical structure, blood flow can be circulating and/or contrast injection can be virtually performed, while manipulating the physical model of the anatomical structure and the physical representation of the interventional tool”).
Regarding claim 5, Villain discloses all of the limitations of claim 1 as discussed above.
Villain further discloses an in vivo patient or subject (Villain, Para 53; “Medical image data can be obtained by different modalities. In the example shown in FIG. 2, a computer tomography (CT) scanner is provided. However, it is also possible to use other image acquisition modalities such as magnetic resonance imaging (MRI) or ultrasound. In the example shown in FIG. 2, a CT scanner 120 obtains 3D medical image data of a patient 100”).
Regarding claim 6, Villain discloses all of the limitations of claim 5 as discussed above.
Villain further discloses wherein the image data corresponds to at least a portion of the in vivo patient or subject (Villain, Para 53; “Medical image data can be obtained by different modalities. In the example shown in FIG. 2, a computer tomography (CT) scanner is provided. However, it is also possible to use other image acquisition modalities such as magnetic resonance imaging (MRI) or ultrasound. In the example shown in FIG. 2, a CT scanner 120 obtains 3D medical image data of a patient 100”).
Regarding claim 7, Villain discloses all of the limitations of claim 6 as discussed above.
Villain further discloses wherein the VTDO is configured to provide an OTDO (Villain, Para 47; “The manipulation can be visualized on the display 50 as a virtual manipulation of the virtual model 21 of the anatomical structure 2 with the virtual representation 22 of the interventional tool 3. The virtual model of the anatomical structure can also be referred to as a digital biophysics model”), wherein the OTDO is configured by the XR device to generate a visualization through the XR device that is harmonized with the TDPM (Villain, Para 30; “glasses such as augmented reality glasses to superimpose the virtual and physical models of the anatomical structure and/or of the interventional tool”), wherein the visualization through the XR device is further harmonized with the portion of the in vivo patient or subject that corresponds to the image data (Villain, Para 48; “combine a printed organ model as the physical model of the anatomic construction with a digital biophysics model as the virtual model of the anatomical structure for patient-specific interventional planning […] allowing a visually tangible manipulation and interaction of the organ and interventional tools. The extracted geometry may also serve to define the domain of a biophysics organ motion or deformation, electric wave action and propagation.”) (Villain, Para 51; “the proposed mixed-reality approach […] a more meaningful training and patient-specific intervention planning may be achieved. This may further increase the first-time-right surgical success rate”) (Villain, Para 62; “The user can then perform specific gestures to move the interventional tool, more precisely to move the physical representation of the interventional tool with respect to the physical model of the anatomical structure, to virtually deploy the stent inside the digital biophysics model, i.e. the virtual model of the anatomical structure. Optionally, in the virtual model of the anatomical structure, blood flow can be circulating and/or contrast injection can be virtually performed, while manipulating the physical model of the anatomical structure and the physical representation of the interventional tool”).
Regarding claim 10, Villain discloses all of the limitations of claim 1 as discussed above.
Villain further discloses wherein the XR device is an MR device (Villain, Para 47; “The system 1 can further comprise a display device 50 such as a monitor or glasses comprising a display such as augmented reality glasses that can be worn by a physician.”) (Villain, Para 30; “glasses such as augmented reality glasses to superimpose the virtual and physical models of the anatomical structure and/or of the interventional tool”).
Regarding claim 11, Villain discloses all of the limitations of claim 1 as discussed above.
Villain further discloses wherein the one or more image data are generated by an MID (Villain, Para 53; “Medical image data can be obtained by different modalities. In the example shown in FIG. 2, a computer tomography (CT) scanner is provided. However, it is also possible to use other image acquisition modalities such as magnetic resonance imaging (MRI) or ultrasound. In the example shown in FIG. 2, a CT scanner 120 obtains 3D medical image data of a patient 100”).
Regarding claim 12, Villain discloses all of the limitations of claim 1 as discussed above.
Villain further discloses wherein the one or more image data undergoes at least one of segmentation and registration (Villain, Para 59; “the processor 40 can be adapted to register the physical representation of the anatomical structure, here the printed organ model, and the corresponding virtual model of the anatomical structure extracted from the image data in step 201. As shown in FIG. 2, a virtual or digital representation 22 of the interventional tool can also be registered in the same way of registering the physical model of the anatomical structure”) (Villain, Para 54; “In FIG. 2, the medical image acquisition is denoted by reference numeral 200. From the acquired medical image data, a digital representation of the anatomical structure of interest can be extracted in step 201”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Villain and Rahman et al. (US20160287339, hereafter Rahman).
Regarding claim 8, Villain discloses all of the limitations of claim 1 as discussed above.
Villain does not clearly and explicitly disclose wherein the first tissue or organ is an external tissue or organ that is viewable to the naked eye, and the second tissue or organ is an internal tissue or organ that is obfuscated.
In an analogous 3D modeling of an anatomy field of endeavor Rahman discloses wherein an external tissue or organ that is viewable to the naked eye an internal tissue or organ that is obfuscated are modeled (Rahman, Para 10; "Another object of the present invention is to assess the relationships of soft tissues, airway, skin, bones and joints in a 3D anatomical structure, thus providing a 3D structure having regions similar to the actual tissue, airway, skin, bone, joint or the combination thereof") (Rahman, Para 16; "Another embodiment of the present invention is that the anatomical region of interest is bone, skin, organ, tumour or a combination of any two or more thereof.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Villain wherein the first tissue or organ is an external tissue or organ that is viewable to the naked eye, and the second tissue or organ is an internal tissue or organ that is obfuscated in order to enable physicians, surgeons and radiologists to visualize, rehearse, diagnose or plan for surgery and treatment procedure of a patient that involve internal and externals organs as needed as taught by Rahman (Rahman, Para 2-3).
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 9, Villain discloses all of the limitations of claim 1 as discussed above.
Villain does not clearly and explicitly disclose a third tissue or organ that is different from the first tissue or organ and the second tissue or organ.
In an analogous 3D modeling of an anatomy field of endeavor Rahman discloses wherein at least three different tissues or organs are modeled (Rahman, Para 10; "Another object of the present invention is to assess the relationships of soft tissues, airway, skin, bones and joints in a 3D anatomical structure, thus providing a 3D structure having regions similar to the actual tissue, airway, skin, bone, joint or the combination thereof") (Rahman, Para 16; "Another embodiment of the present invention is that the anatomical region of interest is bone, skin, organ, tumour or a combination of any two or more thereof.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Villain to include a third tissue or organ that is different from the first tissue or organ and the second tissue or organ in order to enable physicians, surgeons and radiologists to visualize, rehearse, diagnose or plan for surgery and treatment procedure of a patient that involve at least three organs as needed as taught by Rahman (Rahman, Para 2-3).
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Villain and Walach (US20200015893).
Regarding claim 13, Villain discloses all of the limitations of claim 1 as discussed above.
Villain does not clearly and explicitly disclose wherein the TDPM includes at least two materials, wherein each of the at least two materials is either a different color and/or has different material or mechanical properties.
In an analogous 3D modeling of an anatomy field of endeavor Walach discloses wherein a TDPM includes at least two materials, wherein each of the at least two materials is either a different color and/or has different material or mechanical properties (Walach, Para 5; "Aspects of the present disclosure are directed toward an apparatus comprising a three-dimensional model. The three-dimensional model can comprise a thermoplastic base material geometrically approximating an organ. The three-dimensional model can further comprise a plurality of fiduciary points integrated in the three-dimensional model, where the plurality of fiduciary points comprises a first contrast material. The three-dimensional model can further comprise a first surgical mark integrated in the three-dimensional model, where the first surgical mark comprises a second contrast material.") (Walach, Para 39-40; "3D model 112 can be fabricated with a base material and at least one contrast material. [...] The base material can comprise a polymer [...] the at least one contrast material can comprise a metal or alloy").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Villain wherein the TDPM includes at least two materials, wherein each of the at least two materials is either a different color and/or has different material or mechanical properties in order to create fiduciary points which allow for improved alignment and scaling as taught by Walach (Walach, Para 35).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
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/JOHN D LI/Primary Examiner, Art Unit 3798