DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The Amendment filed 4/2/26 has been entered. Claim(s) 1-16 and 69-72 are pending in the application and are under examination.
Claim Rejections - 35 USC § 112(b)
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.
Claim 8 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 8 recites the limitation "a simulation structure". This is an ambiguous term with no plain and ordinary meaning, and under the broadest reasonable interpretation could have an infinite number of meanings. For example, the term “structure” could have an infinite number of meanings, and the word “simulation” which precedes it merely denotes an intended use without further limiting the structure of the term “structure”. Thus, the metes and bounds of the claimed invention are not particularly pointed out and distinctly claimed. Therefore, claim 8 is indefinite.
Claim Rejections - 35 USC § 102/103 (AIA )
Claims 1-9, 11-12, 15-16, and 69-72 are rejected under 35 U.S.C. 102 as being anticipated by WEN US 2017/0169734 A1, or alternatively are rejected under 35 U.S.C. 103 as being obvious over WEN in view of US 2017/0263159 A1 to EICHHORN.
Regarding claim 1, WEN teaches an anatomic simulator (Abstract: dynamic phantom; par. 0070: the phantom 10 is designed to represent the movement of inhalation and exhalation; par. 0080: the inflation of the lungs 60, and the pulling of a lungs 60, will be capable of simulating human lung motions for both free breathing and deep inhalation breathing situations) comprising:
a first constraint panel configured to rotate about a first axis (par. 0058: A first end 22A of the first segment 22 is connected to the spine 40…the first end[] 22a … could be … pivotally connected to the spine 40, or elastically connected to the spine 40);
a second constraint panel configured to rotate about a second axis (par. 0058: a first end 24A of the second segment 24 is connected to the spine 40…the first end[] … 24A could be … pivotally connected to the spine 40, or elastically connected to the spine 40),
wherein the first and second constraint panels at least partially define a variably sized volume configured to receive an organ model (par. 0068: In addition to the movable chest wall 20, the phantom 10 also comprises a movable organ member that is located in the internal cavity 18 (as shown formed in part by the movable first segment 22 and second segment 24; par. 0070: FIGS. 3 to 5 illustrate the phantom 10 comprising two movable organ members, a heart 50 and a pair of lungs 60.); and
at least one elastic member operatively coupling the first and second constraint panels, wherein the at least one elastic member is configured to provide a restorative force when the first and second constraint panels are rotated to increase a size of the volume (par. 0060: third segment 26 may be elastic in order to replicate the human sternum … formed from a material exhibiting elastic qualities. FIG. 2 illustrates a second end 22B of the first segment 22 being connected to the third segment 26, and a second end 24B of the second segment 24 also being connected to the third segment 26. An elastic third segment acts to pull the second end 22B of the first segment 22 and the second end 24B of the second segment 24 together.),
wherein the first and second constraint panels are configured to rotate in response to pressurization or depressurization of the organ model (par. 0059: Splitting the chest wall into two segments allows the chest wall to expand without having to be elastic; par. 0067: phantom 10 is designed to mimic the movement of the human chest wall during respiration; par. 0070: tubing structure may be made of rubber or silicone and be designed to be similarly deformable and expandable as the rest of the lung 60 when it is under the pressure from incoming airflow and the force from the motion mechanism that stretches the lungs 60 inferiorly…pair of lungs 60 will be capable of simulating the motions that occur during free breathing and during deep inhalation breathing; par. 0075: inflation of the human lung and the expansion of the chest cavity; par. 0079: 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. The ventilator 70 may be considered a motion mechanism, as it acts on the lungs 60 to fill the lungs 60 with air, thereby inflating them and moving them relative to the back 16 of the body 12. In order for the lungs 60 to inflate the lungs 60 may be hollow with an opening in fluid communication with the ventilator 70).
Alternatively, EICHHORN teaches a related physiological training system comprising an anatomically correct modular airway simulation manikin developed to provide more realistic training when practicing medical procedures (par. 0002). EICHHORN teaches the simulator includes a chest rise function, including one or more balloons representing a right and left lung, in fluid communication with the airway and configured to at least partially inflate upon the flow of fluid into the one or more balloons (par. 0087). In one embodiment, EICHHORN teaches the simulator including two balloons representing the right and left lung respectively, positioned between a lung shelf and right and left lung plates (par. 0087). EICHHORN discloses that providing the one or more balloons between the lung shelf and lung plates enables the chest of the physiological training system to rise and fall, thereby more accurately simulating the characteristics of an actual patient (par. 0088). EICHHORN discloses that chest rise can serve as an indicator that the medical procedure has been performed successfully, e.g., a chest rise can represent successful intubation of an airway, as opposed to improper intubation of the esophagus, which can carry mortal risks, such as pulmonary aspiration and anoxia, and that by achieving air pressure driven chest rise, the physiological training system can provide a more accurate and lifelike simulation of the physiological responses occurring in a patient, thereby enabling students and medical personnel to observe the physiological training system and determine whether medical procedure has been successfully performed (par. 0089). EICHHORN further teaches the rate at which air pressure increases serves as a tactile indicator of the successful performance of a medical procedure, such as whether only one lung has been intubated, as opposed to both lungs, or otherwise recognizing improper intubation (par. 0090), thus teaching lung plates configured to move in response to pressurization or depressurization of respective balloons sin order to enable chest rise and fall, thereby serving as an indicator of which simulated lung has been intubated, as discussed by EICHHORN above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the motion mechanism of WEN with the balloons representing each lung configured to cause the corresponding chest plates to rise or fall based on the pressurization or depressurization of respective balloons as a result of fluid flow, as taught by EICHHORN, in order to provide a more accurate and lifelike simulation of the physiological responses occurring in a patient, thereby enabling students and medical personnel to observe the physiological training system and determine whether medical procedure has been successfully performed. Providing the capability of balloons that cause chest plates to rise and fall as taught by EICHHORN in the phantom of WEN would also serve as a tactile indicator of the successful performance of a medical procedure, including whether only one lung has been intubated, as opposed to both lungs, or otherwise recognizing improper intubation.
Regarding claim 2, WEN further teaches wherein the organ model expands or collapses within the variably sized volume (par. 0053: The movement of the movable chest wall 20 is designed to represent the movement of the chest as it expands and contracts during respiration; par. 0075: there is movement of the heart due to the inflation of the human lung and the expansion of the chest cavity, there is also movement of the heart due to the pumping action of the heart that supplies blood to the body.).
Regarding claim 3, WEN further teaches wherein when the organ model is pressurized, the first constraint panel rotates about the first axis in a first direction and the second constraint panel rotates about the second axis in a second direction (par. 0061: As the driving member 30 is actuated the connecting members 34, 36 act on the chest wall 20 to expand the chest wall 20 and elongate the third segment 26, thereby moving the first segment 22 and the second segment 24 relative to each other. This movement, wherein the chest wall moves in more than one spatial direction, replicates inhalation, with the chest wall 20 deforming and expanding…By having the chest wall 20 separated into a first segment 22 and a second segment 24, the first segment 22 and the second segment 24 move relative to each other, allowing the chest wall 20 to expand; par. 0070: The pair of lungs 60 could be any inflatable object, for example, the pair of lungs 60 may be represented by sponges wrapped and sealed by silicone coating that is airtight. It is understood that a tubing structure could be built into the pair of lungs 60 that is similar to the human trachea and bronchus system. The tubing structure may be made of rubber or silicone and be designed to be similarly deformable and expandable as the rest of the lung 60 when it is under the pressure from incoming airflow and the force from the motion mechanism that stretches the lungs 60 inferiorly).
Regarding claim 4, WEN further teaches wherein when the organ model is depressurized, the first constraint panel rotates about the first axis in a third direction and the second constraint panel rotates about the second axis in a fourth direction, wherein the third direction is opposite the first direction, and wherein the fourth direction is opposite the second direction (par. 0061: By having the chest wall 20 separated into a first segment 22 and a second segment 24, the first segment 22 and the second segment 24 move relative to each other; par. 0069: If the movement of the movable organ member is designed to represent the movement of an organ in the thorax of a person as the chest … contracts during respiration then the movable organ member will be synchronised with the movement of the chest wall 20; par. 0079: lungs 60 are connected to a ventilator 70; par. 0080: the ventilator could be any device capable of inflating the pair of lungs 60 during inspiration, and allowing the air to exit the pair of lungs 60 during expiration; par. 0086: The movement of the movable chest wall 220 is designed to represent the movement of the chest as it … contracts during respiration).
Regarding claim 5, WEN further teaches wherein the restorative force provided by the at least one elastic member biases the first constraint panel and the second constraint panel towards a retracted configuration (par. 0010: the chest wall may be biased towards an exhalation position; par. 0060: An elastic third segment acts to pull the second end 22B of the first segment 22 and the second end 24B of the second segment 24 together).
Regarding claim 6, WEN further teaches the organ model disposed within the variably sized volume (par. 0068: the phantom 10 also comprises a movable organ member that is located in the internal cavity 18; par. 0070: FIGS. 3 to 5 illustrate the phantom 10 comprising two movable organ members, a heart 50 and a pair of lungs 60.).
Regarding claim 7, WEN further teaches wherein the organ model is a lung model (FIGS. 3 to 5 illustrate the phantom 10 comprising … a pair of lungs 60.).
Regarding claim 8, WEN further teaches a simulation structure disposed within the variably sized volume (par. 0068: the phantom 10 also comprises a movable organ member that is located in the internal cavity 18; FIGS. 3 to 5 illustrate the phantom 10 comprising … a heart 50; also par. 0071: second motion mechanism 52).
Regarding claim 9, WEN further teaches wherein the simulation structure is a heart structure configured to constrain motion of the organ model when the organ model moves within the variably sized volume (par. 0068: the phantom 10 also comprises a movable organ member that is located in the internal cavity 18; FIGS. 3 to 5 illustrate the phantom 10 comprising … a heart 50; FIG. 5, ref. 50, 60, showing heart structure against lung, thus constraining motion of the lung within the internal cavity).
Regarding claim 11, WEN further teaches wherein the simulation structure is an insert configured to shift the organ model within the variably sized volume (par. 0071: The heart 50 may be moved by the second motion mechanism 52. As illustrated in FIG. 6A, the heart 50 may be deformed by the second motion mechanism 52. ).
Regarding claim 12, WEN further teaches a base configured to support the organ model when the organ model is received within the anatomic simulator, wherein the first constraint panel is rotatably coupled to the base, and wherein the second constraint panel is rotatably coupled to the base (par. 0088: left ribs 222 and the right ribs 224 are connected to the back 216 of the phantom 200, specifically at a spine 217. The left ribs 222 and the right ribs 224 are attached to the spine 217 so that they can rotate relative to the spine 217).
Regarding claim 15, WEN further teaches a pressure source configured to flow a fluid to the organ model when the organ model is received within the variably sized volume (FIG. 7; par. 0079: lungs 60 are connected to a ventilator 70…The ventilator 70 may be considered a motion mechanism, as it acts on the lungs 60 to fill the lungs 60 with air, thereby inflating them and moving them relative to the back 16 of the body 12).
Regarding claim 16, WEN further teaches one or more pneumatic controls disposed along a flow path between the pressure source and the organ model when the organ model is received within the variably sized volume (FIG. 7; par. 0079: ventilator 70, which may be made up of an air pump 72 in fluid communication with the lungs 60, as shown along a path between the ventilator 70 and the lungs 60); and a processor operatively coupled to the one or more pneumatic controls, wherein the processor is configured to control the flow of fluid from the pressure source to the organ model with the one or more pneumatic controls (par. 0084: A drive source drives the motion mechanisms 52,62,64. The drive source may be the same as the computer 45 that drives the first motion mechanism 30).
Regarding claim 69, WEN further teaches wherein the first and second constraint panels are configured to rotate (see claim 1) in response to pressurization or depressurization of the organ model without mechanical coupling between the organ model and the first and second constraint panels (par. 0059: Splitting the chest wall into two segments allows the chest wall to expand without having to be elastic; par. 0067: phantom 10 is designed to mimic the movement of the human chest wall during respiration; par. 0070: tubing structure may be made of rubber or silicone and be designed to be similarly deformable and expandable as the rest of the lung 60 when it is under the pressure from incoming airflow and the force from the motion mechanism that stretches the lungs 60 inferiorly…pair of lungs 60 will be capable of simulating the motions that occur during free breathing and during deep inhalation breathing; par. 0075: inflation of the human lung and the expansion of the chest cavity; par. 0079: 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. The ventilator 70 may be considered a motion mechanism, as it acts on the lungs 60 to fill the lungs 60 with air, thereby inflating them and moving them relative to the back 16 of the body 12. In order for the lungs 60 to inflate the lungs 60 may be hollow with an opening in fluid communication with the ventilator 70; FIG. 5 and 8, showing simulated lungs 60 inside cavity of torso, not mechanically coupled to chest panels). Alternatively, EICHHORN teaches the one or more balloons 154 can be positioned between a lung shelf 158 and right and left lung plates 156A/B, which can be positioned proximal to an exterior surface 160 of the torso assembly 104 (par. 0087), as shown in Figure 8 without mechanical coupling between the balloons and the right and left lung plates. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the one or more balloons simulating lungs which cause the chest to move based on pressurization or depressurization, wherein the balloons are not mechanically coupled to the chest plate, as taught by EICHHORN, into the device of WEN, in order to provide a more accurate and lifelike simulation of the physiological responses occurring in a patient, thereby enabling students and medical personnel to observe the physiological training system and determine whether medical procedure has been successfully performed. Providing the capability of balloons that cause chest plates to rise and fall as taught by EICHHORN in the phantom of WEN would also serve as a tactile indicator of the successful performance of a medical procedure, including whether only one lung has been intubated, as opposed to both lungs, or otherwise recognizing improper intubation.
Regarding claim 70, WEN further teaches wherein the organ model comprises an inflatable structure having a shape representative of a biological organ (par. 0075: inflation of the human lung and the expansion of the chest cavity; par. 0079: 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. The ventilator 70 may be considered a motion mechanism, as it acts on the lungs 60 to fill the lungs 60 with air, thereby inflating them and moving them relative to the back 16 of the body 12. In order for the lungs 60 to inflate the lungs 60 may be hollow with an opening in fluid communication with the ventilator 70). Alternatively, EICHHORN teaches the simulator includes a chest rise function, including one or more balloons representing a right and left lung, in fluid communication with the airway and configured to at least partially inflate upon the flow of fluid into the one or more balloons (par. 0087). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the inflatable balloons to represent lungs, as taught by EICHHORN, into the device of WEN, in order to provide a more accurate and lifelike simulation of the physiological responses occurring in a patient, thereby enabling students and medical personnel to observe the physiological training system and determine whether medical procedure has been successfully performed. Providing the capability of balloons that cause chest plates to rise and fall as taught by EICHHORN in the phantom of WEN would also serve as a tactile indicator of the successful performance of a medical procedure, including whether only one lung has been intubated, as opposed to both lungs, or otherwise recognizing improper intubation.
Regarding claim 71, WEN teaches wherein decoupling the portion of the at least one elastic member from the at least one of the first and second constraint panels removes the restorative force and urges the anatomic simulator towards an open configuration in which the first and second constraint panels are configured to receive the organ model (par. 0060: elastic third segment acts to pull the second end 22B of the first segment 22 and the second end 24B of the second segment 24 together.), but does not expressly disclose wherein a portion of the at least one elastic member is removably coupled to at least one of the first and second constraint panels. However, WEN does disclose the phantom 10 is designed to be reusable, and therefore, in general, the components of the phantom 10 will also be reusable and be replaceable should that component be damaged, e.g., lungs (par. 0118). Thus, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the elastic third segment of WEN removable or separable from the ends of the left and right chest plates in order to open the chest cavity to replace damaged components, such as the third segment itself or other components including the lungs, thereby allowing the device to be reuseable by replacing damaged or worn out parts.
Regarding claim 72, WEN further teaches at least one alignment aperture formed in at least one of the first and second constraint panels (par. 0056, 0059: chest wall 20 represented as a human rib cage…the first segment 22 and the second segment 24 could be represented by the left and right set of ribs; As shown in Figure 3, 5, and 12, ribs comprise openings or apertures between each rib through which the internal cavity is viewable, including the lungs).
Claims 10 and 13-14 are rejected under 35 U.S.C. 103 as being obvious over WEN, or alternatively over WEN in view of EICHHORN, as applied to claims 1 and 9, respectively, in view of US 2007/0254273 A1 to LAFRANCE.
Regarding claim 10, WEN further teaches the elements above, and further teaches the phantom 10 can be used to produce useful medical images using x-ray (par. 0064), wherein all of the materials in the internal cavity 18 are anthropomorphic (e.g. the heart 50 and lung 60 have similar densities and electron densities to human organs)(par. 0065), but does not expressly disclose wherein at least a portion of the heart structure is radiopaque.
Regarding claim 13, WEN further teaches the elements above, and further teaches the phantom 10 can be used to produce useful medical images using x-ray (par. 0064), wherein all of the materials in the internal cavity 18 are anthropomorphic (e.g. the heart 50 and lung 60 have similar densities and electron densities to human organs)(par. 0065), but does not expressly disclose wherein at least a first portion of the first constraint panel is radiopaque, and wherein at least a second portion of the second constraint panel is radiopaque.
Regarding claims 10 and 13, LAFRANCE teaches a similar training model including anatomical features, including a heart and rib cage, wherein these anatomical features are desirably made of a radiopaque material such that during training they show up on an X-ray, or another such system for indirectly visualizing the heart valve root that can distinguish between radiopaque and non-radiopaque material (par. 0014; 0051). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of radiopaque material in constructing the simulated anatomical features, including a heart and ribcage, as taught by LAFRANCE, into the same anatomical features in the device of WEN, such that during training they show up on an X-ray, thereby providing a more realistic training experience that allows users to distinguish radiopaque and non-radiopaque material in medical images.
Regarding claim 14, WEN further teaches wherein the first and second portions are representative of anatomic features (par. 0057: a first segment 22 and a second segment 24 define a chest wall).
RESPONSE TO ARGUMENTS
35 USC § 112 – Rejections
Applicant’s amendments have overcome the rejection of claim 2 and 9-11 under 35 USC 112. However, the rejection of claim 8 under 35 USC 112 is maintained. The Applicant’s response filed 4/2/26 does not include arguments regarding claim 8, and therefore, no response to arguments is provided.
35 USC § 102 – Rejections
Applicant’s arguments have been considered, but do not overcome the previous rejection. Applicant is directed to the updated grounds of rejection, as necessitated by claim amendment.
Regarding Applicant's arguments filed 4/2/26 that WEN does not disclose the new limitation of claim 1, Applicant is directed to the revised grounds of rejection above. Applicant’s argument cites to paragraph 0061 and 0063 of WEN, which does disclose the use of driving member 30, such as a stepper motor, to move the chest wall. However, WEN discloses additional motion mechanisms, including a ventilator configured to inflate the lungs, causing them to expand and deform (par. 0079), which would also apply a force to the adjacent chest plates, thus also causing the segments 22 and 24 of WEN to rotate in response to pressurization or depressurization. Alternatively, EICHHORN discloses that providing the one or more balloons between the lung shelf and lung plates enables the chest of the physiological training system to rise and fall, thereby more accurately simulating the characteristics of an actual patient (par. 0088). Therefore, Applicant’s argument is not persuasive.
Applicant further argues that WEN’s driving member 30 is not an organ model and is not pressurized or depressurized. However, WEN teaches the simulated lungs are configured to be inflated by a ventilator, causing them to expand and deform (par. 0079). Further, WEN disclose that when the simulated lungs are inflated, the chest expands (par. 0075). Alternatively, EICHHORN discloses that providing the balloons representing each lung between the lung shelf and lung plates enables the chest of the physiological training system to rise and fall, thereby more accurately simulating the characteristics of an actual patient (par. 0088). Therefore, Applicant’s argument is not persuasive.
35 USC § 103 – Rejections
Applicant’s arguments have been considered, but do not overcome the previous rejection. Applicant is directed to the updated grounds of rejection, as necessitated by claim amendment.
Regarding Applicant's arguments filed 4/2/26 that claims 10 and 13-14 are patentable over the cited prior art at least based on their dependence from an allowable base claim is not persuasive for the reasons provided above, which are incorporated herein by reference. Additionally, in response to Applicant’s argument that new claims 69-72 are also are patentable over the cited prior art at least based on their dependence from an allowable base claim is not persuasive for the reasons provided above, which are incorporated herein by reference.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715
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