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 .
Application Status
Present office action is in response to application filed 05/31/2024. Claims 1-20 are currently pending in the application.
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 11 contains two periods (.): “synthetic muscle. capturing image data of the biomaterial with an imaging device.”. Each claim must begin with a capital letter and end with a period. Periods may not be used elsewhere in the claims except for abbreviations (please see MPEP 60S.01(m)).
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.
Claim 16 is 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. In particular, although the claim was objected to because the claim contains two periods (.), it remains unclear whether the period in the claim was intended to indicate the end of the claim and the additional limitation in the claim after the period (“capturing image data of the biomaterial with an imaging device”) was inadvertently added, or the additional limitation was intended to be included in the claim before the period along with some additional claim language. Furthermore, the additional limitation “capturing image data of the biomaterial with an imaging device” is considered ambiguous in view of the preceding limitation “wherein the biomaterial comprises layers, the layers further comprising at least one of:” and, as such, does not clearly and precisely define the metes and bounds of the claimed invention.
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) 1-7 and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Simhon et al. (US 20070005108 A1) (Simhon) in view of Shelton et al. (US 20220370138 A1) (Shelton).
Re claims 1-6, 10 and 11:
[Claims 1-6, 10 and 11] Simhon teaches or at least suggests a surgical device comprising: a first clamp configured to engage a biomaterial; a second clamp configured to engage the biomaterial; and at least one actuator operably connected to at least one of the first clamp and the second clamp wherein the at least one actuator is configured to impart tension in the biomaterial (at least ¶ 1: holding body tissue and in particular, to a medical device for temporarily holding body tissue sections in alignment during a bonding procedure in which the tissue sections are bonded together; ¶ 8: a medical device for temporarily juxtaposing edges of two regions of tissue, the device comprising: (a) a first suction clamp configured for one-sided clamping of a first region of tissue; (b) a second suction clamp configured for one-sided clamping of a second region of tissue; and (c) a displacement mechanism mechanically associated with both the first and the second suction clamps and configured to define a path of relative displacement between the first and the second suction clamps for bringing together edges of the first and the second regions of tissue; ¶ 31: … additional suction clamps may be attached so as to hold, by non-limiting example, an additional piece of grafting material, as in a grafting procedure. The grafting material may be one of several different materials, such as, but not limited to, natural tissue, tissue cultures and biological or synthetic grafting material; ¶ 72: … The tissue holding device 2 may be used externally to bring two skin surfaces together …), ([Claim 2]) wherein the at least one actuator further comprises: a first actuator operably connected to the first clamp; and a second actuator operably connected to the second clamp (at least ¶ 76: FIGS. 3-6 … the elongated arms 36 and 38 extend beyond the hinge 40 into handles 36a and 38a respectively), ([Claim 3]) an articulating joint configured between the actuator and at least one of the first clamp and the second clamp, the articulating joint being configured to impart the tension in the biomaterial (at least ¶ 31: providing at least one degree of pivotal freedom between the suction clamp and the displacement mechanism by mechanically associating each of the first and the second suction clamps is with the displacement mechanism via at least one pivotal joint, each of the pivotal joints), ([Claim 4) an actuator controller configured to control the tension imparted on the biomaterial by the actuator operably connected to at least one of the first clamp and the second clamp (at least ¶ 33: associating a suction regulator with at least one of the first and the second suction clamps for controlling a suction force applied by at least one of the first and the second suction clamp).
Simhon appears to be silent on but Shelton teaches or at least suggests a surgical trainer, biomaterial and ([Claim 5]) a patient body simulator arranged under the biomaterial, ([Claim 6]) wherein the patient body simulator further comprises at least one of: a synthetic body organ; a synthetic bone; and a synthetic bodily fluid (at least ¶ 40: FIG. 22 … a virtual reality simulation with supplementary medical imaging; ¶ 41: FIG. 23 … a scope-view simulation with supplementary medical imaging; ¶ 73: … visualization system 108 may include one or more imaging sensors, one or more image-processing units; ¶ 118: equipment may include … high fidelity full-size patient units; ¶ 119: The human interface device 30004 may include physical equipment that mimics, physically and/or virtually, surgical instruments …; ¶ 139: managing the simulated appearance and/or behavior of objects within in the simulation. Simulated objects may include objects such as anatomy, instrument, equipment, consumables, fluids …; ¶ 337: An AR-based system may enable projections onto physical models, such as animal training modules, synthetic manual models (e.g., those designed with physical material to simulate dissection, retraction, transection, and the like), synthetic tissue models, vessel models, and the like), ([Claim 10]) an imaging device, the imaging device configured to capture image data of the biomaterial, ([Claim 11]) a computer system, said computer system comprising: at least one processor; and a computer-usable medium embodying computer program code, the computer-usable medium capable of communicating with the at least one processor, the computer program code comprising instructions executable by the at least one processor and configured for: accepting input of the image data from the imaging device; and providing feedback associated with the image data of procedures performed on the biomaterial (at least Figures 7-9 and associated text; ¶ 101: visualization, and imaging; ¶ 114: generation and transmission of visual, audible, and/or haptic information output, the collection of simulation operation and activity information …; ¶ 120: The human interface device 30004 may include a display that communicates visual representations of the simulation to the user; ¶ 164: Feedback from the simulation device 30000 may include any interface with an actuator that provides sensory input to the user … the feedback may include haptic feedback, force feedback, temperature feedback, moisture feedback, audio feedback, olfactory feedback … a force feedback and/or haptic actuator in a user device that mimics the size, shape, and operation of actual surgical stapler may be used to simulate the feedback the user would feel if operating such a device on live tissue, including force feedback when engaging the tissue and firing the stapler for example). Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have utilized the surgical simulator features of Shelton to modify Simhon as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claims 12-15] Simhon discloses a surgical method comprising: configuring a biomaterial; clamping the biomaterial with a first clamp; clamping the biomaterial with a second clamp; and imparting tension on the biomaterial with at least one actuator operably connected to at least one of the first clamp and the second clamp, wherein the biomaterial serves as a medium for surgical procedures (at least ¶ 1: holding body tissue and in particular, to a medical device for temporarily holding body tissue sections in alignment during a bonding procedure in which the tissue sections are bonded together; ¶ 8: a medical device for temporarily juxtaposing edges of two regions of tissue, the device comprising: (a) a first suction clamp configured for one-sided clamping of a first region of tissue; (b) a second suction clamp configured for one-sided clamping of a second region of tissue; and (c) a displacement mechanism mechanically associated with both the first and the second suction clamps and configured to define a path of relative displacement between the first and the second suction clamps for bringing together edges of the first and the second regions of tissue; ¶ 31: … additional suction clamps may be attached so as to hold, by non-limiting example, an additional piece of grafting material, as in a grafting procedure. The grafting material may be one of several different materials, such as, but not limited to, natural tissue, tissue cultures and biological or synthetic grafting material; ¶ 72: … The tissue holding device 2 may be used externally to bring two skin surfaces together …), ([Claim 13]) wherein the at least one actuator further comprises: a first actuator operably connected to the first clamp; and a second actuator operably connected to the second clamp (at least ¶ 76: FIGS. 3-6 … the elongated arms 36 and 38 extend beyond the hinge 40 into handles 36a and 38a respectively), ([Claim 14]) configuring an articulating joint between the actuator and at least one of the first clamp and the second clamp, the articulating joint imparting the tension in the biomaterial (at least ¶ 31: providing at least one degree of pivotal freedom between the suction clamp and the displacement mechanism by mechanically associating each of the first and the second suction clamps is with the displacement mechanism via at least one pivotal joint, each of the pivotal joints), ([Claim 15]) controlling the tension imparted on the biomaterial with an actuator controller for the actuator operably connected to at least one of the first clamp and the second clamp (at least ¶ 33: associating a suction regulator with at least one of the first and the second suction clamps for controlling a suction force applied by at least one of the first and the second suction clamp).
Simhon appears to be silent on but Shelton teaches or at least suggests surgical training, wherein the biomaterial serves as a training medium for surgical procedures (at least ¶ 40: FIG. 22 … a virtual reality simulation with supplementary medical imaging; ¶ 41: FIG. 23 … a scope-view simulation with supplementary medical imaging; ¶ 73: … visualization system 108 may include one or more imaging sensors, one or more image-processing units; ¶ 118: equipment may include … high fidelity full-size patient units; ¶ 119: The human interface device 30004 may include physical equipment that mimics, physically and/or virtually, surgical instruments …; ¶ 139: managing the simulated appearance and/or behavior of objects within in the simulation. Simulated objects may include objects such as anatomy, instrument, equipment, consumables, fluids …; ¶ 337: An AR-based system may enable projections onto physical models, such as animal training modules, synthetic manual models (e.g., those designed with physical material to simulate dissection, retraction, transection, and the like), synthetic tissue models, vessel models, and the like), ([Claim 17]) accepting input of the image data from an imaging device; and providing feedback associated with the image data of procedures performed on the biomaterial (at least Figures 7-9 and associated text; ¶ 101: visualization, and imaging; ¶ 114: generation and transmission of visual, audible, and/or haptic information output, the collection of simulation operation and activity information …; ¶ 120: The human interface device 30004 may include a display that communicates visual representations of the simulation to the user; ¶ 164: Feedback from the simulation device 30000 may include any interface with an actuator that provides sensory input to the user … the feedback may include haptic feedback, force feedback, temperature feedback, moisture feedback, audio feedback, olfactory feedback … a force feedback and/or haptic actuator in a user device that mimics the size, shape, and operation of actual surgical stapler may be used to simulate the feedback the user would feel if operating such a device on live tissue, including force feedback when engaging the tissue and firing the stapler for example). Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have utilized the surgical simulator features of Shelton to modify Simhon as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
Re claims 7 and 16:
[Claim 7] Simhon in view of Shelton teaches or at least suggests synthetic biomaterial (at least Simhon: ¶ 69: grafting material may be one of several different materials, such as, but not limited to, natural tissue, tissue cultures and biological or synthetic grafting material; Shelton: ¶ 37: physical models, such as animal training modules, synthetic manual models (e.g., those designed with physical material to simulate dissection, retraction, transection, and the like), synthetic tissue models, vessel models). However, Simhon in view of Shelton appears to be silent on wherein the biomaterial comprises layers, the layers further comprising at least one of: synthetic skin; synthetic fat; synthetic fascia; and synthetic muscle. The Examiner takes official notice that the concept and advantages of biomaterial layers in anatomical models were old and well known to one of ordinary skill in the art before the effective filing date of the invention. Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified Simhon in view of Shelton as claimed because this would amount to no more than applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 16] As shown above, Simhon in view of Shelton teaches or at least suggests capturing image data of the biomaterial with an imaging device (Shelton: ¶ 40: FIG. 22 … a virtual reality simulation with supplementary medical imaging; ¶ 41: FIG. 23 … a scope-view simulation with supplementary medical imaging; ¶ 73: … visualization system 108 may include one or more imaging sensors, one or more image-processing units; Figures 7-9 and associated text; ¶ 101: visualization, and imaging; ¶ 114: generation and transmission of visual, audible, and/or haptic information output, the collection of simulation operation and activity information …). The claim is further rejected for reasons noted above for claim 7.
Allowable Subject Matter
Claims 18-20 are allowed. The claims are allowable because the references of the Prior Art of record considered pertinent to the applicant's disclosure, either alone or in combination, does not teach or render obvious the instant surgical training system claimed.
Claims 8 and 9 are objected to as being dependent upon rejected base claim 1 but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Simhon in view of Shelton, taken either alone or in combination with the prior art of record fails to disclose or fairly suggest the limitations of claims 8 and 9, in combination with the remaining elements and features of the instant invention.
Conclusion
The prior art made of record and not relied upon is listed in the attached PTO Form 892 and is considered pertinent to applicant's disclosure.
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/EDDY SAINT-VIL/Primary Examiner, Art Unit 3715