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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "14" and "18" have both been used to designate a generic representation of an actuator in Figure 1 and an air pump in Figure 2. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“make-up” should be spelled “make up” (paragraph 0013, line 2).
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 1-15 and 16-21 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 term “replicate” in claims 1, 15, and 17 is a relative term which renders the claim indefinite. The term “replicate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear as to how closely the movement of a body part model must mimic the movement of the corresponding physical body part for it to be considered as “replicating” physiologically normal movement of the physical body part.
Claims 2-15 depend from claim 1 and are rejected on the same grounds.
The term “substantial anatomical accuracy” in claims 2 and 16 is a relative term which renders the claim indefinite. The term “substantial anatomical accuracy” is not defined by the claim, and although the specification provides a definition for the term, it does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear as to whether all of the anatomical structures in a physical body part must be included in a corresponding body part model for the body part model to be considered as exhibiting “substantial anatomical accuracy.” For example, the lungs model disclosed in the specification is described as having a “hollow interior (paragraph 0013, line 14)”, whereas real human lungs are not hollow, and instead contain a set of bronchial tubes in addition to several walls which divide each lung into separate lobes.
Claims 17-21 depend from claim 16 and are rejected on the same grounds.
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.
Claim(s) 1-4, 6-8, 16-18, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wen et al. (U.S. Patent No 20170169734).
Regarding claim 1, Wen et al. discloses a method of simulating anatomical movements comprising providing at least one additive-manufactured body part model anatomically approximating a corresponding physical body part(s) subject to the modeling (“a movable chest wall” in paragraph 0008, line 4 and “a moveable organ member” in paragraph 0008, line 6; “The organs and other body parts of the phantom 10 can be fabricated or produced using the available, relatively new and advanced three-dimensional printing technologies”, paragraph 0097, lines 1-3) and effecting movement of the at least one additive-manufactured body part model, wherein the effected movement replicates physiologically normal movement of the corresponding physical body part(s) (“the first and second motion mechanisms move the chest wall and the moveable organ member to substantially represent their movement in a human body,” paragraph 0008, lines 10-12).
As the term “substantial anatomical accuracy” has been determined to be indefinite, as discussed in the 112(b) rejection section above, for the purposes of compact prosecution, all physical body part models found in the prior art search will be construed as possessing “substantial anatomical accuracy”, in accordance with the broadest reasonable interpretation of the phrase.
In light of the above, regarding claim 2, Wen et al. discloses the method as set forth in claim 1, wherein the at least one additive-manufacture body part model exhibits substantial anatomical accuracy with respect to the corresponding physical body part(s) (Figure 6a depicts an anatomically accurate heart and Figure 7 depicts an anatomically accurate set of lungs). Furthermore, it can reasonably be inferred from several of the intended uses of the invention disclosed by Wen et al., namely, to allow clinicians to plan and practice procedures such as stereotactic body radiotherapy (SBRT) and fiducial marker insertion (“The phantom 10 could potentially be used for”, paragraph 105, lines 2-3, “[..] commissioning radiotherapy treatment planning systems (RTPS) for DIBH or SBRT”, paragraph 107, lines 1-2, and “training and to be used for practicing fiducial marker insertion procedures by clinicians”, paragraph 115, lines 1-2), that the body part models disclosed by Wen et al. are necessarily required to exhibit a high degree of anatomical accuracy, even if they are not explicitly said to do so in the disclosure (e.g., “precisely determining the position of the cancerous volume surrounded by healthy tissue, and directing the radiation beam towards cancerous tissue, is vital”, paragraph 0003, lines 12-13, and “Due to the complexity at various positions in a breathing lung, the motion locus of the fiducial marker can be an irregular three-dimensional loop during the inhalation and exhalation, known as Hysteresis effect. Therefore, it is important that the fiducial marker indicating the cancer target can be located and tracked accurately.”, paragraph 0132, lines 8-14).
Regarding claim 3, Wen et al. discloses the method as set forth in claim 1, further comprising effecting movement via at least one of a pump actuation, motor actuation, or manual actuation (“It will be understood that the stepper motor 32A and the cam 32C could be replaced with a pneumatic or hydraulic set up”, paragraph 0063, lines 19-21; see also Figure 7 and paragraph 0079).
Regarding claim 4, Wen et al. discloses the method as set forth in claim 1, wherein the at least one additive-manufactured body part model is a three-dimensional-printed body part model (“The organs and other body parts of the phantom 10 can be fabricated or produced using the available, relatively new and advanced three-dimensional printing technologies”, paragraph 0097, lines 1-3).
Regarding claim 6, Wen et al. discloses the method as set forth in claim 1, wherein the at least one additive-manufactured body part model comprises a rib cage model (“the chest wall 20 could be represented by a flat rigid plate, or represented as a human rib cage”, paragraph 0056, lines 3-4), a lungs model (“The moveable organ member may be a pair of lungs”, paragraph 0012, lines 9-10), and a diaphragm model (“The heart 250 may also have a diaphragm 256 attached to the heart 250 to loosely mimic the movement of a human diaphragm”, paragraph 0091, lines 3-5).
Regarding claim 7, Wen et al. discloses the method as set forth in claim 6, wherein the movement effected involves inflation and deflation of the lungs model with respect to the rib cage model (“The inflation of the lungs 60 is designed to mimic the movement and expansion of the human lungs during inspiration, and is synchronised with the pulling of the lungs 60 during an inspiration movement”, paragraph 0082, lines 1-4). Wen et al. also discusses the possibility of actuating the diaphragm model via mechanical means (“It is envisaged that the diaphragm could be controlled by a separate motion mechanism to allow the movement of the diaphragm and the movement of the heart to be different”, paragraph 0091, lines 8-10).
Regarding claim 8, Wen et. al disclose the method as set forth in claim 7, wherein the inflation and deflation of the lungs model is via pump actuation or motor actuation (“FIG. 7 illustrates a pair of lungs 60 that are moved by several motion mechanisms. The lungs 60 are connected to a ventilator 70, which may be made up of an air pump 72 in fluid communication with the lungs 60.”, paragraph 0079, lines 1-4; also “In addition to the ventilator 70, the embodiment shown in FIG. 7 illustrates two further motion mechanisms 62,64 attached to the bottom of each of the pair of lungs 60. The motion mechanisms 62, 64 pull the lungs towards a lower end 19 of the body 12 during inhalation.”, paragraph 0079, lines 12-14).
Regarding claim 16, Wen et al. discloses an anatomical movement simulation assembly (the dynamic phantom 200 depicted in Figures 14-25) comprising a first additive-manufactured body part model exhibiting substantial anatomical accuracy relative to a corresponding first physical body part subject to the modeling (see Figures 14-15 and paragraph 0088, lines 5-7, “The breastbone 226 loosely mimics the sternum and breastbone in the human body, and is shaped similar to a breastbone of a human”; see also Figures 16a-16b and paragraph 0087, lines 1-2, “The phantom has a moveable organ member, shown as heart 250, supported within the internal cavity 218”; “The organs and other body parts of the phantom 10 can be fabricated or produced using the available, relatively new and advanced three-dimensional printing technologies”, paragraph 0097, lines 1-3), a second additive-manufactured body part model exhibiting substantial anatomical accuracy relative to a corresponding second physical body part model subject to the modeling (the spine 217 of phantom 200, seen in Figures 16a-17b), and an actuator interacting with the first body part model, wherein, upon actuation of the actuator, the first body part model moves with respect to the second body part model (see Figures 16a-17b and paragraph 0090, lines 3-7, “when the motor 238 extends the shaft 236 longitudinally the connecting member 234 causes the arm 232 to rotate relative to the spine 217. As the arm 232 rotates the breastbone 226 is moved superior (up) and anterior (forward), causing the chest wall to expand.”; also paragraph 0087, lines 3-4 “The heart 250 is caused to move relative to the body by a second motion mechanism, shown as motor 252. The board 270 provides a convenient surface to mount componentry for the phantom 200.”), which remains static during the movement of the first body part model (see Figures 17a-18 and paragraph 0089, lines 9-10, “The spine 217 and the motor 238 are attached to a board 270.”, which can reasonably be inferred to anchor the spine in place as the breastbone and heart models are moved; the motor 252 which moves the heart 250 is depicted in Figure 18 as also being attached to the board 270 in the same manner as the motor 238).
Regarding claim 17, Wen et al. discloses the anatomical movement simulation assembly as set forth in claim 16, wherein the movement of the first additive-manufactured body part model replicates physiologically normal movement of the corresponding first physical body part subject to the modeling (“The first and second motion mechanisms 230, 252 are designed to substantially represent the movement of inhalation and exhalation in a human body.”, paragraph 0087, lines 6-9).
Regarding claim 18, Wen et al. discloses the anatomical movement simulation assembly as set forth in claim 16, wherein the first additive-manufactured body part model could be a diaphragm model (“The heart 250 may also have a diaphragm 256 attached to the heart 250 to loosely mimic the movement of a human diaphragm”, paragraph 0091, lines 3-5) or a lungs model (“In addition, while the phantom 200 has been described with passive lungs 260, it is envisaged that the phantom 200 could include the lungs 60 described in relation to the phantom 10.”, paragraph 0094, lines 7-10).
Regarding claim 21, Wen et al. discloses the anatomical movement simulation assembly as set forth in claim 16, wherein the actuator is a pump or motor (movement of the breastbone 226 and heart 250 are actuated by motors 238 and 252, respectively).
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as also being anticipated by Mandl (U.S. Patent No 4096645).
Regarding claim 1, Mandl discloses a method of simulating anatomical movements comprising: providing at least one body part model anatomically approximating a corresponding physical body part subject to the modeling (see Figures 1 and 3 and lines 1-4 of the abstract, “a transparent element simulating a human head and movable elements simulating articulating organs such as a lower jaw, front and rear portions of a tongue and an uvula”) and effecting movement of the at least one body part model, wherein the effected movement replicates physiologically normal movement of the corresponding physical body part(s) (see lines 5-8 of the abstract, “[…] such movable elements being connected to control rods which are manually operable to place the movable elements in positions normally used to produce particular sounds”). Although Mandl does not disclose that the body part models are additive-manufactured, this is not necessary for Mandl to be used as grounds for a rejection under 35 U.S.C. 102(a) if claim 1 is regarded as a product-by-process claim, as product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In this case, as the structure of the invention is an anatomical approximation of a corresponding physical human body part, then any body part model may be used as prior art regardless of the method of manufacture so long as the method of manufacture confers the same degree of anatomical accuracy as additive manufacturing.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wen et al. in view of Rubinstein et al. (U.S. Patent No 20130330701).
Regarding claim 5, Wen et al. discloses the method as set forth by claim 1.
However, Wen et al. does not disclose that effecting movement of the at least one additive-manufactured body part model involves activation via wireless user commands.
Rubinstein et al. discloses an analogous physical heart simulator wherein the heart model is capable of reproducing “physiologically normal movement” of a human heart (“A heart beat generator 37, which generates signals, or provides physical output via a mechanical coupling (such as a hydraulic or mechanical connection), for a mechanical vibrator 56 in the mockup patient, causing mockup heart 48 to beat.”, paragraph 0038, lines 1-5), which is governed by an electronic controller (“The functioning of system 20 is managed by a system controller 28, comprising a processing unit 30 communicating with a memory 32, wherein is stored software for operation of system 20.”, paragraph 0034, lines 1-4). Furthermore, Rubinstein teaches that “Communication between system controller 28 and elements of system 20, comprising signals between the controller and the elements, may be by a physical cable such as a conductive or optical cable, and/or by wireless. (paragraph 0034, lines 11-15)” Accordingly, it would have been known in the art at the time of the effective filing date of the claimed invention that wired or wireless connections between a controller and an actuator effecting the movement of a physical body part model are interchangeable, and may be substituted for one another with predictable results.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that communication between an external controller, regardless of whether the controller is an electronic computer or a human user, and an actuator configured for effecting movement of an additive-manufactured body part model, as disclosed by Wen et al., could be established using a wireless connection, as taught by Rubinstein et al., with predictable results.
Claim(s) 9-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mandl (U.S. Patent No 4096645) in view of Wen et al.
Regarding claim 9, Mandl discloses the method as set forth in claim 1, wherein the at least one body part model comprises a tongue model and a jaw and teeth model (see Figures 1 and 3 and column 3, lines 26-30, “The head 2, which is preferably made from transparent material, contains indicating means simulating articulation organs, in the form of movably mounted indicating members, such as a lower jaw member 3, a tongue member 4 […]”, and column 3, lines 34-35, “Upper teeth 11 and lower teeth 12 are also indicated”).
Regarding claim 10, Mandl discloses the method as set forth in claim 9, wherein the movement effected involves upward and downward movement of the tongue model with respect to the jaw and teeth model (“It is therefore possible to move the tip of the tongue, i.e., the part 48 in the direction of the arrows shown in FIG. 3, i.e., inter alia into the position shown by the dotted lines.”, column 3, lines 55-59).
Regarding claim 11, Mandl discloses the method as set forth in claim 10, wherein the movement of the tongue model is via manual actuation (see lines 5-8 of the abstract, “[…] such movable elements being connected to control rods which are manually operable to place the movable elements in positions normally used to produce particular sounds.”).
Regarding claim 12, Mandl discloses the method as set forth in claim 1, wherein the at least one body part model comprises a vocal folds model and a larynx model (see Figure 4 and lines 8-11 of the abstract, “In addition, elements of elastomeric material having spiral springs cast therein are provided and are operable through tensioned wires for simulating the larynx and lips and positions thereof.”).
Regarding claim 13, Mandl discloses the method as set forth in claim 12, wherein the movement effected involves opening and closing movements of the vocal folds model with respect to the larynx model (see Figure 4 and column 5, lines 8-13, “The two parts of the trachea wall can be moved apart by pressing together the tong members 55 and 56 and by means of a corresponding change in the cross-section of the trachea wall 52, it is shown whether a sound must be pronounced in a voiced or voiceless manner.”).
Regarding claim 14, Mandl discloses the method set forth in claim 13. However, Mandl does not disclose that the opening and closing of the vocal folds model is via pump actuation or motor actuation.
Wen et al. discloses effecting movement of a body part model via pump actuation or motor actuation (“In the embodiments shown in FIGS. 6 and 7 the motion mechanisms 52,62,64 comprise a stepper motor connected via a gear and shaft to cam, […] Furthermore, as discussed above, the stepper motor and the cam could be replaced with a pneumatic or hydraulic set up.”, paragraph 0083, lines 1-3 and 7-8). Accordingly, the technique of effecting movement of a body part model via pump or motor actuation would have been known in the art at the time of the effective filing date of the claimed invention.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a technique known in the art (the use of a pump or motor to drive the mechanical movement of a body part model, as taught by Wen et al.) to improve a device known in the art (the larynx/vocal folds model disclosed by Mandl), with predictable results.
Regarding claim 16, Mandl discloses an anatomical movement simulation assembly comprising a first body part model exhibiting substantial anatomical accuracy relative to a corresponding first body part subject to the modeling (“a tongue member 4”), a second body part model exhibiting substantial anatomical accuracy relative to a corresponding second physical body part subject to the modeling (“an upper jaw portion 8”), and an actuator interacting with the first body part model (see lines 1-4 of the abstract, “movable elements simulating articulating organs such as a lower jaw, front and rear portions of a tongue and an uvula”), wherein, upon actuation of the actuator, the first body part model moves with respect to the second body part model which remains static during the movement of the first body part model (“Stationary portions of the head 2, namely an upper jaw portion 8 and gum portion 9 cooperate with the movable indicating members 2-7.”, column 3, lines 32-34).
Regarding claim 17, Mandl discloses the anatomical movement assembly as set forth in claim 16, wherein the movement of the first body part model replicates physiologically normal movement of the corresponding first physical body part subject to the modeling (see lines 5-8 of the abstract, “[…] such movable elements being connected to control rods which are manually operable to place the movable elements in positions normally used to produce particular sounds.”).
Regarding claim 18, Mandl discloses the anatomical movement assembly as set forth in claim 16, wherein the first body part model is at least one of a lungs model, a diaphragm model, a tongue model, or a vocal folds model (“[…] indicating means simulating articulation organs, in the form of movably mounted indicating members, such as […] a tongue member 4”, column 3, lines 27-30).
Regarding claim 19, Mandl discloses the anatomical movement assembly as set forth in claim 18, wherein the second body part model is at least one of a rib cage model, a jaw and teeth model, or a larynx model (“Stationary portions of the head 2, namely an upper jaw portion 8 and gum portion 9 cooperate with the movable indicating members 2-7. Upper teeth 11 and lower teeth 12 are also indicated.”, column 3, lines 32-35).
Regarding claim 20, Mandl discloses the anatomical movement assembly as set forth in claim 19, wherein the movement of the first body part model involves at least one of inflation and deflation, outward and inward movement, forward and rearward movement, upward and downward movement, or opening and closing movement (“It is therefore possible to move the tip of the tongue, i.e., the part 48 in the direction of the arrows shown in FIG. 3, i.e., inter alia into the position shown by the dotted lines”, column 3, lines 55-59). It should be noted that the tongue model disclosed by Mandl is also capable of forward and rearward movement (see Figure 3 and column 4, lines 43-48, “Operating rod 16 is mounted for axial movement in a bushing 46 located in the head 2 and it serves to move the tongue 4 in a longitudinal direction while also pivoting the tongue 4, the movement of the tongue 4 being controlled by the configuration of the slot 44.”).
Although Mandl discloses all other limitations of claims 9-14 and 16-20, Mandl does not disclose that the body part models are additive-manufactured.
However, Wen et al. teaches that body part models may be “fabricated or produced using the available, relatively new and advanced three-dimensional printing technologies,” a type of additive manufacturing, “to achieve their closer similarities to those of human, in terms of shape and size of both outer surface and internal structure, using desirable materials and suitable techniques. (paragraph 0097, lines 1-3)”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have fabricated the tongue, jaw and teeth, and larynx/vocal folds models disclosed by Mandl using the 3D-printing technology suggested by Wen et al., with reasonable expectation of success, and they would have been motivated to do so to achieve more anatomically accurate representations of the corresponding human body parts.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wen et al. in view of Pflug et al. (U.S. Patent No 20240096239).
Regarding claim 15, Wen et al. discloses the method as set forth in claim 1. However, Wen et al. does not that the effected movement is synchronized with a human subject, nor that the effected movement replicates physiological movements of the human subject in real-time.
Pflug et al. discloses a system for simulating a body of a subject, including “a breathing simulator configured to simulate the breathing of the subject. (paragraph 0006, lines 6-7)” Pflug et al. teaches that “the simulated breathing, at the body simulator 100, of the subject may be generated in real-time. (paragraph 0025, lines 1-2)” Although Pflug et al. does not explicitly disclose that the simulated breathing is “synchronized” with that of the subject, it can reasonably be inferred that “real-time simulation” of the subject’s breathing by the breathing simulator nonetheless constitutes “synchronization” of the breathing simulator and the subject. Furthermore, Pflug et al. also note that “[real-time] simulation allows for a more realistic simulation and may allow for various modes of biosynchronization of the user(s) (paragraph 0025, lines 4-6)” and that “it can be possible that the breathing and/or heartrate may naturally synchronize when in the presence of another. It is desirable to enable real-time communication and/or synchronization between a remote user and a local user. (paragraph 0025, lines 6-8)” Thus, it can reasonably be inferred that “biosynchronization” of the breathing of a remote user, whose breathing is being simulated by the breathing simulator, and that of a local user, who is in the presence of the breathing simulator, must necessarily require synchronization of the breathing simulator and the remote user. With that being said, it’s time for the killing blow.
In light of the evidence presented above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wen et al. to incorporate the teachings of Pflug et al. to provide a method of simulating anatomical movements by effecting movement of at least one additive-manufactured body part model anatomically approximating a corresponding physical body part so as to replicate physiologically normal movement of the corresponding physical body part, wherein the effected movement is synchronized with a human subject and replicates physiological movements of the human subject in real-time, with reasonable expectation of success, and they would have been motivated to do so to allow real-time simulation of a living subject’s internal organs, a feature which proves advantageous in the medical and educational use cases set forth by Wen et al., allowing clinicians to plan radiotherapy and fiducial marker insertion procedures in real-time and improving learning outcomes for students using the phantom as an instructional aid.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mandl et al. in view of Pflug et al.
Regarding claim 15, Mandl discloses the method as set forth in claim 1. However, Mandl does not disclose that the effected movement is synchronized with a human subject, nor that the effected movement replicates physiological movements of the human subject in real-time.
Pflug et al. discloses a system for simulating a body of a subject, including “a breathing simulator configured to simulate the breathing of the subject. (paragraph 0006, lines 6-7)” Pflug et al. teaches that “the simulated breathing, at the body simulator 100, of the subject may be generated in real-time. (paragraph 0025, lines 1-2)” Although Pflug et al. does not explicitly disclose that the simulated breathing is “synchronized” with that of the subject, it can reasonably be inferred that “real-time simulation” of the subject’s breathing by the breathing simulator nonetheless constitutes “synchronization” of the breathing simulator and the subject. Furthermore, Pflug et al. also note that “[real-time] simulation allows for a more realistic simulation and may allow for various modes of biosynchronization of the user(s) (paragraph 0025, lines 4-6)” and that “it can be possible that the breathing and/or heartrate may naturally synchronize when in the presence of another. It is desirable to enable real-time communication and/or synchronization between a remote user and a local user. (paragraph 0025, lines 6-8)” Thus, it can reasonably be inferred that “biosynchronization” of the breathing of a remote user, whose breathing is being simulated by the breathing simulator, and that of a local user, who is in the presence of the breathing simulator, must necessarily require synchronization of the breathing simulator and the remote user. With that being said, it’s time for the killing blow.
In light of the evidence presented above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mandl to incorporate the teachings of Pflug et al. to provide a method of simulating anatomical movements by effecting movement of at least one additive-manufactured body part model anatomically approximating a corresponding physical body part so as to replicate physiologically normal movement of the corresponding physical body part, wherein the effected movement is synchronized with a human subject and replicates physiological movements of the human subject in real-time, with reasonable expectation of success, and they would have been motivated to do so to allow real-time simulation of a living subject’s articulators, a feature which proves advantageous in an educational setting, improving learning outcomes for students using the model as an instructional aid.
Conclusion
60. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH HAROLD JOHANSSON whose telephone number is (571)272-5755. The examiner can normally be reached PTA Schedule.
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\K.H.J.\
10/30/2025
/PETER S VASAT/Supervisory Patent Examiner, Art Unit 3715