DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The previous objections to the abstract and to claims 1, 6-7, and 12-13 are withdrawn in light of the amendments to the abstract and claims, each filed 03/24/2026. However, a new objection to claim 12 has been raised, as presented in detail below.
The previous rejections to the claims under 35 U.S.C. § 112(b) are withdrawn in light of the amendments to the claims (filed 03/24/2026).
Applicant’s arguments with respect to the rejection of claims 1, 3, 8, 10, and 12 under 35 U.S.C. § 102 (Remarks, filed 03/24/2026, pp. 9-12) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration and as necessitated by amendment, a new ground(s) of rejection of claims 1-3, 8, 10-15, and 17-21 is made as being unpatentable over Galibois in view of Candalh-Touta, as presented in detail below.
However, regarding the citation of Galibois, Applicant asserts that the modules disclosed by Galibois do not constitute the claimed “spacer cassettes” (Remarks, filed 03/24/2026, pp. 10-11). Examiner respectfully disagrees. The modules of Galibois which do not simulate pathologies connect to each other to simulate human limbs and/or limb joints, such as arms and legs (Galibois, fig. 2; par 0033) and can be replaced by like modules which do simulate a pathology (Galibois, par. 0015). Therefore, it is maintained that these non-pathological modules of Galibois can be interpreted as “spacer cassettes” under the broadest reasonable interpretation of the claim. Furthermore, per Applicant’s specification, “cassettes” are merely “the interchangeable parts of the surgical training model,” and “spacer cassettes” are “the cassettes optionally without detailed anatomy and without pathologies” (Specification, p. 3).
Applicant’s arguments with respect to the rejection of claims 2, 4-7, 9, and 11 under 35 U.S.C. § 103 (Remarks, filed 03/24/2026, pp. 12-13) have been considered but they are not persuasive. Specifically, Applicant argues that Galibois in combination with Candalh-Touta, Lowe, and/or Reeh do not render obvious all the elements of independent claim 1 (Remarks, filed 03/24/2026, pp. 12-13). Examiner respectfully disagrees. See in particular figure 2 and paragraph 0025 of Galibois and paragraph 0053 of Candalh-Touta. See also the rejection of claim 1, as presented in detail below.
Applicant's arguments with respect to the rejection of claims 13-15 (Remarks, filed 03/24/2026, pp. 13-14) have been fully considered but they are not persuasive. Applicant requests “the rejection of independent claim 13 be withdrawn for reasons that are similar to those discussed above with respect to claim 1” (Remarks, filed 03/24/2026, p. 13). Examiner reiterates that the newly added limitations are rendered obvious over Galibois in view of Candalh-Touta. See in particular figure 2 and paragraph 0025 of Galibois and paragraph 0053 of Candalh-Touta. See also the rejection of claim 13, as presented in detail below.
Information Disclosure Statement
The information disclosure statement filed 05/18/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 12 is objected to because of the following informality: line 5 should instead read “the spacer cassettes and the anatomy cassette, once assembled, forming the surgical training model according to claim 1.” Appropriate correction is required.
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.
Claims 1-3, 8, 10, 11-15, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Galibois, and further in view of Candalh-Touta.
Regarding Claim 1, Galibois discloses a plurality of cassettes attached together to simulate a limb or limb joint, the cassettes comprising a plurality spacer cassettes (fig. 2: multiple spacer cassettes separately forming arm limb 150 and leg limb 160; par. 0016: “the modules could be sub-divided into smaller modules, i.e. the arm modules could be divided in forearm modules, wrist modules, hand modules;” Examiner notes that the modules being used to simulate a limb/joint that do not simulate a pathology are being interpreted as “spacer cassettes”), each of the spacer cassettes being removable and replaceable with at least one anatomy cassette that simulates an anatomy and/or pathology in the limb or limb joint (fig. 2; par. 0033: “Modularity also provides for the easy introduction of optional elements. With replaceable and interacting modules, a single patient-simulating mannequin 100 can be upgraded to enhance functionalities or expanded to support training in a wider range of specialties;” par. 0015: “the two arm modules 150 [and] the two leg modules 160… are removable and could be replaced by other modules adapted for simulating other physiological functions and/or pathologies;” Examiner notes these replaceable modules simulating pathologies are being viewed as anatomy cassettes),
wherein adjacent ones of the cassettes are attached to each other with a join so that, in use, the attached cassettes do not move relative to each other about the join (fig. 2: modules making up arm limb are flush against each other; par. 0025: “connections between the modules and/or body parts can be made within hollow joints which provide the proper range of motion while protecting tubes and wires from pinching… can be made of any types of components known in the art such as tubes, pipes, clips, cables, latches, joints, screws, etc. or any combination thereof;” Examiner notes the modules are attached via a secure method, such as with screws, and specific connections must be utilized in order to allow realistic range of motion at specified locations).
Galibois does not explicitly disclose the anatomy cassette being operated on with surgical tools. However, Candalh-Touta discloses the at least one anatomy cassette being configured to be operated on with a plurality of surgical tools (par. 0053: “a non-minimally invasive surgical procedure, known as open surgery: this opening may be quite long and adapted to the nature of the said surgical procedure; this opening allows the insertion of an instrument or the simultaneous insertion of several instruments and also direct access to the anatomical part”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the configuration of the anatomy cassettes to be operated on with surgical tools as disclosed by Candalh-Touta with the anatomy cassettes of Galibois in order to allow medical practitioners to practice surgical procedures in a more realistic way (Candalh-Touta, par. 0128).
Regarding Claim 2, Galibois modified by Candalh-Touta further discloses at least each anatomy cassette is 3D printed (abstract: “the manufacture of the anatomical part… carried out by additive manufacturing or 3D printing”).
Regarding Claim 3, Galibois further discloses each spacer cassette is removably attachable to an adjacent spacer cassette or adjacent anatomical cassette to provide a simulated human limb or limb joint with a full range of natural movement (par. 0025: “connections between the modules and/or body parts can be made within hollow joints which provide the proper range of motion;” par. 0033: “replaceable and interacting modules”).
Regarding Claim 8, Galibois further discloses the limb has an upper end that is pivotably connected to a pivot mount (par. 0019: “the torso module 130 is in turn in mechanical and/or electrical connection with the arm module(s) 150… The pelvic module 140 is further in mechanical and/or electrical connection with the leg module(s) 160;” par. 0025: “The mechanical… and/or electrical connections between the modules and/or body parts can be made within hollow joints which provide the proper range of motion;” fig. 2; Examiner notes the top of the arm limb, for example, has full range of motion and is pivotably connected to the shoulder of the torso module).
Regarding Claim 10, Galibois further discloses each anatomy cassette is provided with one or more of a pathology, disease, deformity, dislocation, fracture or injury of any kind including a lodged foreign body, or any alignment that can cause limb/joint pain (par. 0015: “the two arm modules 150 [and] the two leg modules 160… are removable and could be replaced by other modules adapted for simulating… pathologies”).
Regarding Claim 11, Galibois modified by Candalh-Touta further discloses the model is a tailored anatomical model based on patient dimensions (Candalh-Touta, par. 0042: “the anatomical part is manufactured, in additive or subtractive manufacturing, from a file created from medical imaging files, such as radiography, echography, scanner or magnetic resonance imaging;” par. 0017: “An anatomically coherent structure in the sense of the present invention means that the structure in question has realistic dimensions and shapes that are coherent with a biological anatomical model;” Examiner further notes that the pieces of the anatomical model are 3D printed from medical images and are manufactured to be identical in size, shape, etc. to the relevant part of the patient) and each anatomy cassette simulates a specific anatomy, pathology, disease, deformity, dislocation, fracture or injury of any kind including a lodged foreign body, or any alignment that can cause limb/joint pain, that could be subject to surgical intervention (Candalh-Touta, par. 0021: “the scientific or medical object is a patient who is suffering from a pathology or who has suffered a trauma that requires a surgical… procedure;” par. 0020: “the scientific or medical object is a standard test subject, defined as the subject of an image selected because it is representative of a typology of… a pathology and/or of a trauma. This scientific or medical object must enable to give rise to a three-dimensional copy, abbreviated 3D, based on an image thereof;” pars. 0023-0040: some non-exclusive examples of anatomies/pathologies which are simulated by an anatomy cassette include a dislocated shoulder, a fractured limb, and a wounded tendon”).
Regarding Claim 12, Galibois modified by Candalh-Touta further discloses a kit (Galibois, fig. 2), comprising: a plurality of removable spacer cassettes that when arranged together simulate a limb or a limb joint (Galibois, fig. 2: multiple spacer cassettes separately forming arm limb 150 and leg limb 160; par. 0016: “the modules could be sub-divided into smaller modules, i.e. the arm modules could be divided in forearm modules, wrist modules, hand modules;” Examiner notes in the example of the arm, the pieces removable pieces representing the forearm, wrist, and hand can be considered the spacer cassettes; par. 0033: “Modularity also provides for the easy introduction of optional elements. With replaceable and interacting modules, a single patient-simulating mannequin 100 can be upgraded to enhance functionalities or expanded to support training in a wider range of specialties”), an anatomy cassette that simulates an anatomy and/or pathology in the limb or joint (Galibois, par. 0015: “the two arm modules 150 [and] the two leg modules 160… are removable and could be replaced by other modules adapted for simulating other physiological functions and/or pathologies;” Examiner notes these replaceable modules simulating pathologies are being viewed as anatomy cassettes);
the spacer cassettes and the anatomy cassette once assembled forming the surgical training model according to claim 1 (see claim 1 above).
Regarding Claim 18, Galibois modified by Candalh-Touta further discloses each anatomy cassette is manufactured by a combination of manufacturing processes (Candalh-Touta, par. 0049: “the anatomical part and the envelope reproduce the structure of a scientific or medical object… in particular of a human or animal anatomical part; the anatomical part and the envelope are manufactured using additive or subtractive manufacturing technology. In an embodiment, the anatomical part and/or the envelope are manufactured by moulding;” Examiner notes the full anatomical cassette, which includes the anatomical part and envelope/”skin”, can be formed from a combination of additive manufacturing and molding, for example).
Regarding Claim 19, Galibois further discloses the limb or limb joint comprises a leg (fig. 2: multiple spacer cassettes forming leg limb 160; par. 0015: “the two leg modules 160).
Regarding Claim 20, Galibois further discloses the limb or limb joint comprises an arm (fig. 2: multiple spacer cassettes forming arm limb 150; par. 0016: “the modules could be sub-divided into smaller modules, i.e. the arm modules could be divided in forearm modules, wrist modules, hand modules”).
Regarding Claim 21, Galibois modified by Candalh-Touta further discloses providing a surgical training model according to claim 1 (see claim 1 above);
performing an operation on the at least one anatomy cassette in the model, the operation being robotic, endoscopic, or open surgery (Candalh-Touta, par. 0053: “a single opening, for example for a non-minimally invasive surgical procedure, known as open surgery: this opening may be quite long and adapted to the nature of the said surgical procedure; this opening allows the insertion of an instrument or the simultaneous insertion of several instruments and also direct access to the anatomical part;” par. 0023: “the scientific or medical manipulation according to the invention includes all surgical and orthopaedic procedures”); and
providing feedback on the operation to assist in surgical training (Candalh-Touta, par. 0011: “the at least one anatomical part having an outer surface and an inner surface, the at least one anatomical part being made of at least one first material that is capable of generating specific haptic feedback;” par. 0050: “advantage provided by the presence of opening(s) is in particular to allow the user to learn by palpation to choose the location of the trocars, and to learn with haptic feedback;” par. 0112: “the training device can be used in combination with virtual reality software, itself operating in combination with the training device and a display device for this virtual reality: the training device allowing haptic feedback and the software allowing visual and/or sound feedback”).
Regarding Claim 13, Galibois discloses providing a surgical training model (fig. 2; pp. 5-10: training simulations include surgical procedures as well as various other medical procedures) comprising a plurality of cassettes attached together to simulate a limb or limb joint (fig. 2: multiple spacer cassettes separately forming arm limb 150 and leg limb 160; par. 016: “the modules could be sub-divided into smaller modules, i.e. the arm modules could be divided in forearm modules, wrist modules, hand modules;” Examiner notes in the example of the arm, the removable pieces representing the forearm, wrist, and hand can be considered the spacer cassettes”), the cassettes comprising a plurality of spacer cassettes, each of the spacer cassettes being removable and replaceable with at least one anatomy cassette that simulates an anatomy and/or pathology in the limb or limb joint (par. 0033: “Modularity also provides for the easy introduction of optional elements. With replaceable and interacting modules, a single patient simulating mannequin 100 can be upgraded to enhance functionalities or expanded to support training in a wider range of specialties;” par. 0015: “the two arm modules 150 [and] the two leg modules 160… are removable and could be replaced by other modules adapted for simulating other physiological functions and/or pathologies”); and
locating the anatomy cassette into the surgical training model at the location(s) of the one or more anatomies or pathologies by replacing spacer cassette(s) with the anatomy cassette (par. 0015: “the two arm modules 150 [and] the two leg modules 160… could be replaced by other modules adapted for simulating other physiological functions and/or pathologies”).
Galibois does not disclose the anatomy cassette is 3D printed—much less that the anatomy cassette which is located into the surgical training model is a 3D printed anatomy cassette—or that they may be operated on with a plurality of surgical tools. However, Candalh-Touta discloses at least one anatomy cassette that is capable of being operated on with a plurality of surgical tools (par. 0053: “a non-minimally invasive surgical procedure, known as open surgery: this opening may be quite long and adapted to the nature of the said surgical procedure; this opening allows the insertion of an instrument or the simultaneous insertion of several instruments and also direct access to the anatomical part”); and
providing or procuring at least one 3D printed anatomy cassette simulating an anatomy or a pathology (abstract: “the manufacture of the anatomical part… carried out by additive manufacturing or 3D printing”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modular 3D printed anatomical parts of Candalh-Touta with the modular anatomical parts of Galibois (and to specifically locate the 3D printed cassette into the surgical training model) in order to reduce costs (par. 0003) and/or create more anatomically realistic models (pars. 0010-0014).
Regarding Claim 14, Galibois modified by Candalh-Touta further discloses operating or allowing others to perform an operation on the anatomy cassette (Candalh-Touta, par. 0053: “a single opening, for example for a non-minimally invasive surgical procedure, known as open surgery: this opening may be quite long and adapted to the nature of the said surgical procedure; this opening allows the insertion of an instrument or the simultaneous insertion of several instruments and also direct access to the anatomical part”).
Regarding Claim 15, Galibois modified by Candalh-Touta further discloses obtaining details regarding the dimensions of a limb or joint (Candalh-Touta, par. 0042: “the anatomical part is manufactured, in additive or subtractive manufacturing, from a file created from medical imaging files, such as radiography, echography, scanner or magnetic resonance imaging;” par. 0017: “An anatomically coherent structure in the sense of the present invention means that the structure in question has realistic dimensions and shapes that are coherent with a biological anatomical model;” Examiner further notes that the pieces of the anatomical model are 3D printed from medical images and are manufactured to be identical in size, shape, etc. to the relevant part of the patient) and the location(s) of one or more anatomies or pathologies in the limb or joint optionally from a patient (Candalh-Touta, Par. 0021: “the scientific or medical object is a patient who is suffering from a pathology or who has suffered a trauma that requires a surgical… procedure;” par. 0020: “the scientific or medical object is a standard test subject, defined as the subject of an image selected because it is representative of a typology of… a pathology and/or of a trauma. This scientific or medical object must enable to give rise to a three-dimensional copy, abbreviated 3D, based on an image thereof;” 0040: some non- exclusive examples of anatomies/pathologies which are simulated by an anatomy cassette include a dislocated shoulder, a fractured limb, and a wounded tendon;” Examiner notes that because the anatomical part is created from a medical image of a patient, the location(s)—such as a shoulder or particular limb—of the one or more anatomies/pathologies are necessarily obtained from the patient/image).
Regarding Claim 17, Galibois modified by Candalh-Touta further discloses the anatomy cassette is at least partially 3D printed (Candalh-Touta, abstract: “the manufacture of the anatomical part… carried out by additive manufacturing or 3D printing”).
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Galibois in view of Candalh-Touta as applied to claim 1 above, and further in view of Lowe.
Regarding Claim 4, Galibois further discloses each spacer cassette comprises a first end and a second end (fig. 2: each cassette has two ends which form connections with other cassettes or parts), the first end and second end each having an attachment location so that the second end of a first spacer cassette is attachable to a first end of an adjacent second spacer cassette (fig. 2: each of the removable spacer cassettes attach from end to end; par. 0025: “connections can be made of any types of components known in the art such as tubes, pipes, clips, cables, latches, joints, screws, etc. or any combination thereof”).
Galibois does not explicitly disclose grooves. However, Lowe discloses the first end attachment location and the second end attachment location is a groove (par. 0042: “insert 120 may be attached to the patient simulator 110 via fastening means such as… track and rail mechanisms, tongue-and-groove mechanisms, or other releasable attachment devices”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the attachment means of Lowe with the system of Galibois because it is a mere design choice of a known releasable attachment means (Lowe, par. 0042), and Galibois teaches that any releasable attachment means known in the art could be used (Galibois, par. 0025).
Regarding Claim 5, Galibois modified by Lowe further discloses each anatomy cassette comprises a first end and a second end (Galibois, fig. 2: each cassette—whether a spacer or anatomical part—has two ends which form connections with other cassettes or parts), the first end and second end each having an attachment location so that the second end of an anatomy cassette is attachable to a first end of an adjacent spacer cassette (Examiner notes that because the spacer cassettes can attach to each other via attachment means located on their first end and second end and because the anatomy cassettes can replace spacer cassettes, they must also have similar attachment means in the same locations), wherein the first end attachment and the second end attachment location is a tongue (Lowe, par. 0040: “The fasteners 152 and the fasteners 162 are configured to mate with each other to releasably secure the anatomical insert 115 to the patient simulator 110. The fasteners 152, 162 comprise releasable fasteners, such as… tongue-and-groove mechanisms”).
Regarding Claim 6, Galibois modified by Lowe further discloses at least the tongue part of the attachment location is provided on a plate at the first end and/or the second end (Lowe, fig. 3a: fastener 152 extends on one end from base plate 155; par. 0040: “The fasteners 152… comprise releasable fasteners, such as… tongue… mechanisms”).
Regarding Claim 7, Galibois modified by Lowe further discloses there are at least two tongue parts provided along the entire span of the first end and/or the second end (Lowe, fig. 3a: multiple fasteners 152 extending along one end; par. 0040: “The fasteners 152… comprise releasable fasteners, such as… tongue… mechanisms”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Galibois in view of Candalh-Touta as applied to claim 1 above, and further in view of Reeh.
Regarding Claim 9, Galibois does not explicitly disclose the spacer cassettes are hollow. However, Reeh discloses each spacer cassette is hollow (par. 0036: “the anatomical model (1) is hollow. The hand portion (10), forearm portion (12)… may be configured as one piece or as separate pieces which are interconnected to together define a unitary hollow cavity… extending therethrough”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hollow anatomical pieces of Reeh with the anatomical cassettes of Galibois in order to reduce manufacturing costs (Reeh, par. 0071) or to potentially allow for further kinds of training, such as injection training (Reeh, par. 0036).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.G.D./Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715
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