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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites generating three-dimensional structure data of a user's body; generating three-dimensional structure data of the spinal thermal device; setting a set value of the spinal thermal device; calculating a stress applied to the user's body and a strain of the user's body in a process of pressurizing the user's body as the spinal thermal device operates as the set value; converting a strain value of a user's body to a degree of traction; and visualizing the degree of traction of the user's body which falls into the abstract idea grouping of mental concepts. The claim recites generating three-dimensional structure data of a user’s body, which reads as an data gathering step. The claimed step of setting a value of the spinal thermal device is considered to a part of the data gathering step, as a user sets an intended value of the device to test the impact of that value on the three-dimensional gathered defining the intended user. The claimed calculating stress and converting it to a strain value of a user’s body to a degree of traction defines a well-known engineering practice involving differential equations and stress-stain calculations. The claimed calculative steps of stress calculations and converting stress to strain are recited at a high level of generality, thereby supporting the conclusion the recited calculations can occur in the human mind, with the aid of pen and paper. Lastly, the step of visualizing the degree of traction is analogous to displaying the results of the claimed calculative and converting steps. Therefore, the claim is considered to be directed towards an abstract idea, amounting to no more than collecting information, analyzing it and displaying the results. Although the claim recites a computer, the generic computer is merely acting as a tool for performing the abstract idea; as the neither the result or operation of the abstract idea improves the computer itself. MPEP 2106.05(a)
This judicial exception is not integrated into a practical application because the additional element of a spinal thermal device, as a user’s body and the device’s degree of traction merely links the identified abstract idea to a field of use, as neither the result or performance of the abstract idea has no impact to the spinal thermal device, the user’s body or the device’s degree of traction. MPEP 2106.05(h)
As stated above, the generically claimed computer is considered to be an additional element merely acting as a tool for performing the abstract idea. The claim recites no improvement to the computer; therefore the claimed additional element fails to integrate the abstract idea into a practical application. MPEP 2106.05(a)
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because none of the additional elements, including the computer are impacted or improved by the result of the abstract idea. These generically claimed elements merely link the abstract idea to a field of use without amounting to significantly more, therefore the claim is not found patent eligible.
Claim 2 further defines the calculative approach commonly practiced during finite element modeling and stress/strain calculations. Therefore, the claim further defines the abstract idea falling into the abstract idea grouping of mental concepts without integrating the abstract idea into a practical application or providing significantly more.
Claims 3 and 4 further define the calculative approach commonly practiced during finite element modeling and stress/strain calculations, as applying a load to examine its effects on the modeled subject is a well-practiced calculative process, that insofar as what is structurally defined, is capable of occurring in the human mind, with the aid of pen and paper. Therefore, the claim fails to integrate the abstract idea into a practical application or provide significantly more, as the claim further defines the abstract idea without any impact or improvement imposed onto the additional elements.
Claim 5 further defines the abstract idea by reciting correcting the strain value by reflecting the spine distance data for each body position of the user. The generically claimed correcting step such that spine distance is reflected in the converted strain value is simple enough to be performed in the human mind, insofar as what is structurally recited. Therefore, the claim fails to integrate the abstract idea into a practical application or provide significantly more, as the claim further defines the abstract idea without providing any impact or improvement imposed onto the additional elements.
Claim 6 further defines the abstract idea falling into the abstract idea grouping of mental concepts, as the claim generically recites calculating the stress and strain through dynamic explicit formulation. Therefore, the claim fails to integrate the abstract idea into a practical application or provide significantly more, as the claim further defines the abstract idea without any impact or improvement imposed onto the additional elements.
Claim 7 further defines the data gathering step of setting the value of the spinal thermal device. The defined ceramic temperature, ceramic height, and a heating element temperature merely link the abstract idea to a field of use, as these defined variables fail to provide signifyingly more or integrate the abstract idea into a practical application.
Claim 8 further defines the abstract idea, as deriving the set value for obtaining an optimal traction effect within a range of the set ceramic temperature, ceramic height, and heating element temperature are limitations that are, insofar as what is structurally recited, simple enough to occur in the human mind. Additionally, observing the results of the visualization to derive an intended optimal effect, within a range of the previously identified additional elements that merely link the abstract idea to a field of use, is simple enough to occur in the human mind. Therefore, the claim further defines the abstract idea without imposing any meaningful limitations or improvement on the additional elements.
Claim 9 further defines the abstract idea, as deriving the set value for obtaining the optimal traction effect for each user’s body type according to a change in structure according to the user’s body are limitations that are, insofar as what is structurally recited, simple enough to occur in the human mind. Further, deriving, insofar as what is structurally claimed, is simple enough to occur in the human mind when observing the visualization. Therefore, the claim further defines the abstract idea without imposing any impact or improvement on the additional elements.
Claim 10 further defines the abstract idea, specifically the portion related to gathering the needed data to perform the generically claimed calculations and conversions. The additional elements of skin, subcutaneous fat, soft tissue, muscles, vertebrae, intervertebral disc, epidural fat, cerebrospinal fluid and spinal cord merely link the abstract idea to a field of use, as these elements are neither improved or bettered by the result of the abstract idea. They merely define the field of use relative to a user’s body.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (CN 105943228A) in view of Wang (CN 107997866A).
With respect to claim 1, Xie et al. teaches a method for predicting safety and effectiveness of a spinal device (i.e. a cervical traction brace; [00035] using a computer (a computer; see para. [00039]), the method comprising: generating three-dimensional structure data of a user's body (as Xie et al. teaches is S1collecting image data of a neck of a patient through a CT scan); generating three-dimensional structure data of the spinal device (as Xie et al. teaches in S3 generating a neck traction brace model containing structure data of the spinal device); setting a set value of the spinal device (as in S3, Xie et al. teaches setting a value related to the structural data of that spinal device such that the structure of the brace matches with next model; [00042]); calculating a stress applied to the user's body and a strain of the user's body in a process of pressurizing the user's body as the spinal thermal device operates as the set value ( Xie et al. teaches in [0047] calculating the size and pressure value for contact areas between the set structural value of the brace and the user’s neck; therefore, the examiner considers this calculation to include both stress and strain calculations, as in engineering practices, both stress and strain are calculated as post-processing quantities after solving for nodal displacements); converting a strain value of a user's body to a degree of traction (as Xie et al. teaches the calculated strain gives meaning to a degree of traction caused by the brace through the calculated pressure values; [00047-00048]); and visualizing the degree of traction of the user's body (as the model will indicate and allow a person to visualize the degree of traction of the user’s body based on the calculated results, for example, if the calculated results show the brace is creating pressure outside a threshold, a person looking at the results can see an indent created into the user’s skin from the brace; [00049]).
Xie et al. remains silent regarding the spinal device is a thermal spinal device.
Wang teaches a similar spinal device that includes thermal characteristics via a heating source [00077].
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the brace taught in Xie et al. to include a heating source as taught by Wang because Wang teaches such a heating source aids in the therapeutic capabilities of a medical device [000131], thereby improving the brace taught by Xie et al.
With respect to claim 2, Xie et al. teaches the method wherein calculating the stress applied to the user's body (via simulations using the FEM analysis as disclosed by Xie et al., stress is calculated as discussed above; [0043]) and the strain of the user's body in the process of pressurizing the user's body (via simulations using the FEM analysis as disclosed by Xie et al., strain is calculated as discussed above; [0043]) comprises visualizing the stress and the strain of the user's body (as the model will visualize the nodal distances causing any stresses or strains outside a predefined threshold; [00050]).
With respect to claim 3, Xie et al. teaches the method wherein calculating the stress applied to the user's body and the strain of the user's body in the process of pressurizing the user's body (via simulations using the FEM analysis as disclosed by Xie et al., stress and strain are calculated as discussed above; [0043]) comprises calculating the stress applied to the user's body and the strain of the user's body while the user's body is strained along a length direction (as the neck brace will create designated strain at a desired location, including a length direction defined by the device).
Xie et al. remains silent regarding the device having a ceramic of the spinal thermal device rises along the height direction.
Wang et al. teaches a similar spinal device having a ceramic of the spinal thermal device that rises along the height direction (as Wang teaches the device being made from ceramic components [000118] and includes structure that allows the device to rise along the height direction; see Fig. 15-17; [000228]).
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the brace taught in Xie et al. to include the ceramic material and height capabilities as taught by Wang because Wang teaches such structure aids in the therapeutic capabilities of a medical device [000131], thereby improving the brace taught by Xie et al.
With respect to claim 4, Xie et al. as modified teaches the method wherein calculating the stress applied to the user's body and the strain of the user's body in a process of pressurizing the user's body (via simulations using the FEM analysis as disclosed by Xie et al., stress and strain are calculated as discussed above; [00043]) comprises calculating the stress and strain of a portion corresponding to the depth of the user's spine (as defined by the scanned data defining the user’s spine) while the user's body is strained along a length direction (i.e. the simulations occurring with the finite element model; [00044] of Xie et al.) as a ceramic of the spinal thermal device rises along the height direction (as modified by Wang).
With respect to claim 5, Xie et al. teaches the method wherein converting the strain value of the user's body to a degree of traction (during the finite element process; [00043]) comprises correcting the strain value of the user's body by reflecting the spine distance data for each body position of the user (as Xie et al. teaches correcting the strain value using the results of the simulation and data collected from the scan of the user’s body to ensure outcome; [00050-00054]; insofar as what is structurally recited the corrective step).
With respect to claim 6, Xie et al. as modified teaches the method wherein calculating the stress and the strain of the user's body (during the finite element process; [00043]) comprises calculating the stress and the strain of the user's body through a dynamic explicit formulation (as FEA uses dynamic formula analysis, specifically for problems involving time-dependent loads, vibrations, or rapid impacts where inertia and damping forces are significant; thereby reading on the claimed invention).
With respect to claim 7, Xie et al. as modified teaches the method wherein setting the set value of the spinal thermal device comprises setting a ceramic temperature, a ceramic height, and a heating element temperature (as the combination as a whole teaches FEA includes settings related to a ceramic temperature of the heating source and itself, and a ceramic height as seen in Fig. 15-17 of Wang).
With respect to claim 8, Xie et al. as modified teaches the method further comprising after visualizing the degree of traction of the user's body (via the FEA and model itself), deriving the set value for obtaining an optimal traction effect within a range of the set ceramic temperature, ceramic height, and heating element temperature (as the combination as a whole, through the iterative simulations, the best optimal settings to provide the best optimal traction are found, see para. [0024] of Xie et al., including the structure related to temperature control and height as taught by Wang).
With respect to claim 9, Xie et al. as modified teaches the method wherein deriving the set value for obtaining the optimal traction effect comprises deriving the set value for obtaining an optimal traction effect (as read in para. [00024] of Xie et al.) for each user's body type (as scanned in S1) according to a change in structure according to the user's body type (as the brace it taught to mimic the structure of each individual user and therefore changes according to a change in structure according to an intended user).
With respect to claim 10, Xie et al. as modified teaches the method wherein the three-dimensional structure data of the user's body is three-dimensional structure data classified into skin, subcutaneous fat, soft tissue, muscles, vertebrae, intervertebral disc, epidural fat, cerebrospinal fluid, and spinal cord (as Xie teaches the scanning of three-dimensional data of the user’s body is classified into using CT data, which would include data regarding skin, subcutaneous fat, soft tissue, muscles, vertebrae, intervertebral disc, epidural fat, cerebrospinal fluid, and spinal cord; [00038] of Xie et al.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
박치순 (KR 101992384B1) teaches bed type massage therapy having heat treatment.
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/MATTHEW G MARINI/ Primary Examiner, Art Unit 2853