Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1-10 and 13-19 are pending. Claims 1 and 13 have been amended. Claim 19 is new. The rejection under 35 USC 112b has been withdrawn. The other rejections are revised in view of the amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10, 13-14, and 17-19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 in part recites, “, the processing comprising extracting one or more surface points from the patient data in the form of a point cloud and embedding the point cloud in a surface network representing a surface structure of the patient and in a bone network representing a simplified bone framework that lies within an interior of the surface network; the simplified bone framework consisting of joints and join connections modeled by one or more vectors; using the patient model to determine one or more patient parameters; generating a virtual representation of the orthopedic device while using the one or more patient parameters and one or more predefined device parameters; receiving at least one input from at least one user; modifying at least one of the patient parameters and/or device parameters on the basis of the input; wherein the modifying creates an amended surface network based on a model of interactions between the simplified bone framework and the surface network; generating a model of the orthopedic device based on the modified patient parameters and/or device parameters.” Claim 13 as recited includes any articulating joint and all of the associated bone framework and data broad range of loosely defined parameters. See below for the breadth of the types of structures which can reasonably be covered based on the breadth of orthosis based on such bone data,
This covers a wide range of braces for the body, including:
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Given the breadth of the types, locations, and materials used for a diverse range of orthoses, and the fact that the claim covers every possible situation, the applicant does not possess an algorithm that is capable of dealing with every possible situation set forth i.e. the breadth of types of bone data and orthopedic medicine involved. The phrase “simplified” does not have any further clarity in Applicant’s disclosure and ambiguously covers the most primitive understanding to a detailed model of the bones and movement thereof. It is more a general concept or way of doing something than an actual invention where a problem is solved and there is a clear way to accomplish it. Given the breadth of the claim, it is preemptive. See MPE 2161(I):
I. DETERMINING WHETHER THERE IS ADEQUATE WRITTEN DESCRIPTION FOR A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION
The 35 U.S.C. 112(a) or first paragraph of pre-AIA 35 U.S.C. 112 contains a written description requirement that is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000) ("The purpose of [the written description requirement] is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification"); LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005) ("Whether the flaw in the specification is regarded as a failure to demonstrate that the applicant possessed the full scope of the invention recited in [the claim] or a failure to enable the full breadth of that claim, the specification provides inadequate support for the claim under [§ 112(a)]"); (Underlining Added)
In this instance, the scope to which the applicant wishes to seek coverage is overreaching. Claims 2-10, 13-14, and 17-19 rejected as depending from claim 1 without meaningfully narrowing the overbreadth. Claims 15-16, by contrast, specify the orthopedic device is [for a] foot, with a particular orientation being corrected.
Claims 1-10, 13-14, and 17-19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Based on the same limitation cited above regarding the written description rejection, claim 1 is also rejected as failing to comply with the enablement requirement. Claim 1 is broad and covers producing an orthosis with bone data for every possible type of orthosis associated with an articulating bone structure. There are no specific working examples, and only broad flow diagrams as to a process of creating the orthosis. Applicant’s discussion of an ankle brace is not representative of every orthosis for every joint in a human body. Claim 1’s recitation of “a bone network representing a bone framework that lies within an interior of the surface network” and modified in view of parameters amounts to modifying the design to practice better orthodontic medicine (alignment correction).
Additionally, the state of the art varies; while it is known to make structures out of metal, “Three-dimensional printing is an exciting technology that is pervasive in every major industry. This rapidly advancing field has created access to almost limitless 3D structures created from a growing variety of materials, including metals, plastics, and even living cells. The benefits of 3D printing include extreme flexibility to customize shapes, increased intricacy/complexity of manufactured products, elimination of assembly steps, and waste and inventory reduction.” See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059996/ “Three-dimensional Printing in Orthopaedic Surgery: Current Applications and Future Developments - PMC (nih.gov).”
Applicant’s method includes the biomedical parameters, modeling, and making predictions for any number of people for any number of joints. That the method is for an individual person does not detract from this. This is not a method directed to a specific named patient with a specific anatomy, this method can be practiced on any person. The complexity and breadth of the range of the quantity of experimentation needed to optimize and validate for every situation would be undue. See MPEP 2161(II):
III. DETERMINING WHETHER THE FULL SCOPE OF A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION IS ENABLED
To satisfy the enablement requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." See, e.g., In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Wands, 858 F.2d 731, 736-37, 8 USPQ2d 1400, 1402 (Fed. Cir. 1988). In In re Wands, the court set forth the following factors to consider when determining whether undue experimentation is needed: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. Wands, 858 F.2d at 737, 8 USPQ2d 1404. The undue experimentation determination is not a single factual determination; rather, it is a conclusion reached by weighing all the factual considerations. Id.
All questions of enablement under 35 U.S.C. 112(a) are evaluated against the claimed subject matter with the focus of the examination inquiry being whether everything within the scope of the claim is enabled. Accordingly, examiners should determine what each claim recites and what subject matter is encompassed by the claim when the claim is considered as a whole and not analyze the claim elements individually.
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, 13-14, and 17-19 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) “[a] computer-implemented method for producing an orthopedic device, in particular, an orthosis or prosthesis, comprising: receiving at least one data set with patient data for a patient; processing the patient data in order to create a patient model, the processing comprising extracting one or more surface points from the patient data in the form of a point cloud and embedding the point cloud in a surface network representing a surface structure of the patient and in a bone network representing a simplified bone framework that lies within an interior of the surface network; the simplified bone framework consisting of joints and joint connections modeled by one or more vectors; using the patient model to determine one or more patient parameters; generating a virtual representation of the orthopedic device while using the one or more patient parameters and one or more predefined device parameters; receiving at least one input from at least one user; modifying at least one of the patient parameters and/or device parameters on the basis of the input; wherein the modifying creates an amended surface network based on a model of interactions between the simplified bone framework and the surface network; generating a model of the orthopedic device based on the modified patient parameters and/or device parameters ; and physically creating the orthopedic device using the model of the orthopedic device, the physically creating comprising generating and transmitting one or more control signals configured to cause a production machine to produce the orthopedic device.”
These limitations amount to mental steps of receiving and processing data. Optimizing and validating is an abstract idea that applies the practice of medicine for understanding the support points. The breadth of “simplified bone framework” includes extreme simplifications that are easy to model in a mental step. This judicial exception is not integrated into a practical application because generically producing an orthosis device making use of the processed data is not a particular application. In other words, physically creating the orthosis making use of the updated orthosis model is the natural next step and is considered insignificant extra-solution activity (i.e. insignificant application, see MPEP 2106.05(g)). Additionally, steps of receiving data (such as a database) or displaying data constitute insignificant extra solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as explained above, the physical process of creating the device based on the mental process of determining parameters is the natural next step and is an insignificant application of the judicial exception. The analysis is not changed for the dependent claims. Claim 1 essentially amounts to practicing medicine (the input from a user, which in claim 6 is a doctor, prosthetist/orthotist) to process patient data, to produce a model, which is then used to create the orthosis.
Claims 2 and 10 recite the technological category of a 3D printer for the production, with no further details.
Claim 3 recites generating a virtual representation of the patient model with a model of the device, which entails further data processing and thereby only adds to the abstract idea.
Claim 4 recites further data processing of aligning virtual representations and thereby only adds to the abstract idea.
Claim 5 recites additional details about the data (patient parameters) and therefore simply adds to the abstract idea.
Claims 6-7 recite additional details about the reception of data and processing it and therefore simply adds to the abstract idea.
Claims 8-9 recite an authentication step for accessing and modifying the data. Such a step is insufficient to amount to significantly more because computer processing that does not technically advance the requisite calculations does not constitute significantly more. Separately, interaction with a computer is not required and the authentication can be a mental step, a person recognizing another person providing data and thereby providing the authentication. Computer processing that does not technically advance the requisite calculations does not constitute significantly more.
Claim 10 recites transmitting a message with a URL (uniform resource locator) to the patient based on contact data. This recitation does not constitute significantly more because electronically transmitting a message with a URL is routine and conventional because it has been a staple of Internet usage for decades. Claim 10 also recites authenticating the patient which can be a mental step. Claim 10 accordingly recites details of network traffic that does not amount to significantly more because it does not technically advance the nature of network traffic.
Claim 14 recites an aspect of orthopedic medicine for the data processing and therefore does not constitute significantly more.
Claim 17 recites displaying through a web server. Web servers are routine and conventional and displaying constitutes insignificant extra solution activity.
Claim 18 recites additional details about the data (the device parameters) and therefore simply adds to the abstract idea.
Claim 19 recites additional details about the processing of data (model with one or more vectors) and therefore simply adds to the abstract idea.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-4, 6-7, 13-15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zachariasen (US 2014/0180185) in view of Parr (US 2021/0205099) and Shin (US 2017/0360578).
Regarding claim 1, Zachariasen discloses [a] computer-implemented method for producing an orthopedic device, in particular, an orthosis or prosthesis (orthosis for a joint, abstract [0003]), comprising: receiving at least one data set with patient data for a patient; processing the patient data in order to create a patient model , (scan of patient’s body part P assembled into a digital model, [0034]); generating a virtual representation of the orthopedic device while using the one or more patient parameters and one or more predefined device parameters (extracting features 17 of digital model 16 relative to predetermined reference features 32 of digital orthosis model 30, [0043]; this information is used to create the orthopedic device, digital orthosis model 30 modified to digital orthosis model 40 based on identified features 17 of scanned model 16 relative to reference features 32, [0043-44]); receiving at least one input from at least one user; modifying at least one of the patient parameters and/or device parameters on the basis of the input (custom orthosis 50 produced based on input from digital orthosis model 40, [0043-44]; prescription by a healthcare professional for modification of the positive physical model, [0012]); modifying at least one of the patient parameters and/or device parameters on the basis of the input (digital orthosis model 30 modified to digital orthosis model 40 based on identified features 17 of scanned model 16 relative to reference features 32; prescription combined with scanning data which entails the recited deformation by the nature of the device and medicine of identified features 17 and producing instructions for custom orthosis 50 which is a virtual representation of the produced orthosis, [0012] [0043-44]); generating a model of the orthopedic device based on the modified patient parameters and/or device parameters (reference features 32 are modified extracting features 17 of digital model 16 relative to predetermined reference features 32, [0043]; digital orthosis model 30 modified to digital orthosis model 40 based on changing identified features 17 based on predetermined reference features and doctor’s prescription and producing instructions for custom orthosis 50 which is a virtual representation of the produced orthosis [0043-44]), and physically creating the orthopedic device using the model of the orthopedic device (custom orthosis 50 produced based on input from digital orthosis model 40, [0043-44]), the physically creating comprising generating and transmitting one or more control signals configured to cause a production machine to produce the orthopedic device (send CAD or STL format data for fabrication, [0044]).
Zachariasen does not disclose the processing comprising extracting one or more surface points from the patient data in the form of a point cloud and embedding the point cloud in a surface network representing a surface structure of the patient and in a bone network representing a simplified bone framework that lies within an interior of the surface network, the simplified bone framework consisting of joints and joint connections modeled by one or more vectors; wherein the modifying creates an amended surface network based on a model of interactions between the simplified bone framework and the surface network.
While Zachariasen teaches generating virtual representations of the data at various stages, this is not “displayed” in the narrow sense of being visible to a human user.
However, in the same field of endeavor of producing an orthosis with additive manufacturing ([0077] [0090-91]; brace [0095]), Shin teaches the processing comprising extracting one or more surface points from the patient data in the form of a point cloud and embedding the point cloud in a surface network representing a surface structure of the patient and in a bone network representing a simplified bone framework that lies within an interior of the surface network (surface mesh of surface information [0073] and CT imaging to develop bone information distinguishing bone and other tissue, [0075] to generate a model for an orthosis [0077]; brace [0095]; modeling movement and resulting force vectors, [0079]), the simplified bone framework consisting of joints and joint connections modeled by one or more vectors (modeling movement and resulting force vectors, [0079]); wherein the modifying creates an amended surface network based on a model of interactions between the simplified bone framework and the surface network (modeling movement and resulting force vectors from CT imaging for surface information, [0073] [0075] [0077] [0079]).
Additionally, in the same field of endeavor of producing an orthosis with additive manufacturing ([0002-03]) Parr teaches the processing comprising extracting one or more surface points from the patient data in the form of a point cloud and embedding the point cloud in a surface network representing a surface structure of the patient and in a bone network representing a simplified bone framework that lies within an interior of the surface network (source to target positions are vectors, various methods of optimizing and validating the vectors, [0125] [0143-44] [0259]); displaying the surface network of mesh data ([0237]), the simplified bone framework consisting of joints and joint connections modeled by one or more vectors ([0144] [0237] [0259]); wherein the modifying creates an amended surface network based on a model of interactions between the simplified bone framework and the surface network ([0144] [0237] [0259]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Zachariasen to representing a surface structure of the patient and in a simplified bone network representing a simplified bone framework that lies within an interior of the surface network because [0120] of Shin teaches “radiography provides the highest spatial resolution of bony anatomy, allowing for accurate identification of acute fractures and allowing for design considerations relevant to the fit, stabilization, and comfort of a brace.” Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zachariasen to track vectors of deformation because [0144] [0259] of Parr teaches modeling the bone movement this way and displaying it [0237] so that users can properly customize the orthosis.
Regarding claim 2, Zachariasen as modified teaches wherein the production machine is a 3D printer (Zachariasen, [0016]).
Regarding claim 3, Zachariasen as modified teaches generating a virtual representation of the patient model (custom orthosis 50 is a virtual representation of the produced orthosis, [0043-44]).
While Zachariasen teaches generating virtual representations of the data at various stages, this is not “displayed” in the narrow sense of being visible to a human user.
However, Parr teaches generating a virtual representation of the patient model, wherein the model of the orthopedic device is represented together with the patient model in the virtual representation (various disclosures of calculating deformation from source to target, [0144] [0259], which is displayed as a virtual representation of the patient model [0237]); displaying a virtual representation of the patient model ([0237]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zachariasen to display the orthosis with the patient model because [0237] of Parr teaches displaying models at various steps to allow users to customize the device.
Regarding claim 4, Zachariasen as modified for claim 3 teaches aligning the virtual representation of the patient model relative to the virtual representation of the orthopedic device (various disclosures of calculating deformation from source to target, Parr [0144] [0259], which is displayed as a virtual representation of the patient model Parr [0237]); displaying a virtual representation of the patient model (Parr [0237]).
Regarding claim 6, Zachariasen as modified teaches receiving at least one first input from a first user (prescription), the first user being a doctor or a certified prosthetist/orthotist, and modifying at least one of the patient model or at least one patient parameter on the basis of the input of the first user (prescription by a healthcare professional for modification of the positive physical model, Zachariasen [0012]; a healthcare professional in this context constitutes a doctor or a prosthetist/orthotist).
Regarding claim 7, Zachariasen as modified teaches receiving at least one second input from a second user, the second user being the patient (Scan P of patient body part constitutes input with information from a patient for scanning, Zachariasen [0034]), and modifying at least one device parameter on the basis of the input of the second user (3D model of the body part processed by a processor to form digital model 16 constitutes representing surface points to outline the 3D model, Zachariasen [0034] [0036] and differences between features 17 and features 32 are incorporated to modify digital orthosis model 30 and produce digital orthosis model 40, Zachariasen [0043]).
In the alternative, assuming the patient’s body part for the scan does not constitute an input with information from the patient regarding claim 21, Zachariasen as modified does not teach receiving at least one second input from a second user, the second user being the patient, and modifying at least one device parameter on the basis of the input of the second user.
However, Shin teaches receiving at least one second input from a second user, the second user being the patient, ([0093]), and modifying at least one device parameter on the basis of the input of the second user 5 ([0093]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zachariasen to receive input with information from a patient and modify the device based on the information associated with the input because [0093] of Shin teaches that modifying at least one parameter of the device (modifying the device) to adjust it and better suit the user.
Regarding claim 13, Zachariasen as modified teaches producing the orthopedic device with the 3D printer (Zachariasen, [0016]).
Regarding claim 14, Zachariasen as modified teaches aligning the bone network, the aligning causing a deformation of the surface network (Parr [0144] [0259]).
Regarding claim 15, Zachariasen as modified teaches wherein the orthopedic device is a foot (Zacharisen [0010]; Shin [0109] treating clubfoot with an orthosis), and further comprising: identifying a foot plane in the patient model; determining a support plane; and modifying the bone network to orient the support plane parallel to a virtual base surface ([0144] [0259] of Parr teaches analyzing and designing an orthotic to deform a bone network and [0109] of Shin teaches treating clubfoot with an orthosis which entails these steps).
Regarding claim 17, Zachariasen as modified teaches displaying a virtual representation of the patient model through a web server (Shin [0177])
It would have been prima facie obviousto one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zachariasen to make use of a web server as taught by [0177] of Shin because [0177] teaches that the apparatus and execution environment can realize a variety of computing infrastructures, such as web services.
Regarding claim 18, Zachariasen as modified teaches wherein the device parameters comprise at least one of a material thickness, a flexibility, or a color of the orthopedic device (material thickness, Zachariasen [0046]).
Regarding claim 19, Zachariasen as modified teaches wherein the model of the interactions comprises one or more vectors representing distances or support sites within the surface network (as modified, modeling movement and resulting force vectors, [0079] of Shin; source to target positions are vectors, various methods of optimizing and validating the vectors, Parr [0125] [0143-44] [0259]).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zachariasen (US 2014/0180185) in view of Parr (US 2021/0205099) and Shin (US 2017/0360578) as applied to claim 1 above, and further in view of Armour (US 2016/0309808).
Regarding claim 5, Zachariasen as modified teaches a method substantially as claimed. Zachariasen does not disclose wherein: the patient parameters comprise parameters which specify a neck circumference, or a shoulder width.
However, in the same field of endeavor of custom sizing an orthosis ([0135]), Armour teaches wherein: the patient parameters comprise parameters which specify a neck circumference, or a shoulder width (measuring neck circumference and shoulder width to custom size a neck support apparatus, [0135]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zachariasen to produce a neck support as the custom orthosis (abstract of Zachariasen) because the abstract of Armour teaches that a neck support reduces head or neck trauma in a living being by mitigating the acceleration experienced by the head, relative to the torso, during a change in motion and [0135] of Armour teaches custom sizing should include measurements including neck circumference and shoulder width.
Claims 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zachariasen (US 2014/0180185) in view of Parr (US 2021/0205099) and Shin (US 2017/0360578) as applied to claim 7 above, and further in view of Smith (US 2014/0134561).
Regarding claim 8, Zachariasen as modified teaches a method substantially as claimed. Zachariasen does not disclose authenticating the first user before receiving the input of the first user and/or authenticating the second user before receiving the second input of the first user.
However, in the same field of endeavor of custom corrective appliances for patients (custom oral appliances, [0028]), Smith teaches authenticating the first user before receiving the input of the first user and/or authenticating the second user before receiving the second input of the first user (username password authentication to configure parameters, [0035]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zachariasen such that input requires authentication because [0035] of Smith teaches that such security helps to comply with regulatory compliance.
Regarding claim 10, Zachariasen as modified teaches wherein the patient data comprises contact data of the patient (medical privacy information, Smith [0035]), further comprising:parameters (configure parameters, Smith [0035]), such that the patient is authorized to provide the input (configure parameters, Smith [0035]).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zachariasen (US 2014/0180185) in view of Parr (US 2021/0205099) and Shin (US 2017/0360578) as applied to claim 8 above, and further in view of Smith (US 2014/0134561) and Russell (US 2001/0000433).
Regarding claim 9, Zachariasen as modified teaches a method substantially as claimed. Zachariasen does not disclose searching an authorization database as to which of the device parameters are amenable by the second user, and displaying only those device parameters for modification which are amendable by the second user according to the authorization database.
However, in the same field of endeavor of custom corrective appliances for patients (custom oral appliances, [0028]), Smith teaches searching an authorization database as to which of the device parameters are amendable by the second user (username password authentication to configure parameters, [0035]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zachariasen such that input requires authentication because [0035] of Smith teaches that such security helps to comply with regulatory compliance.
Zachariasen as modified does not teach displaying only those device parameters for modification which are amendable by the second user according to the authorization database.
However, solving the same problem of access by users to servers (claim 86), Russell teaches displaying only those device parameters for modification which are amendable by the second user according to the authorization database (based on intended access, customizing access and authorization privileges, claim 86).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zachariasen such that access only permits modification of intended parameters because claim 86 of Russell teaches that such limitations improve information security.
Claims 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zachariasen (US 2014/0180185) in view of Parr (US 2021/0205099) and Shin (US 2017/0360578) as applied to claim 1 above, and further in view of LeCursi (US 2018/0318122).
Regarding claim 16, Zacharisen as modified teaches Zacharisen [0010] wherein the orthopedic device is a foot (Zacharisen [0010]). Zachariasen teaches a method substantially as claimed.
Zachariasen does not disclose identifying a foot plane in the patient model; determining a support plane; and modifying the bone network to orient a knee joint to a predetermined value.
However, in the same field of endeavor of ankle-foot orthoses (abstract), LeCursi teaches identifying a foot plane in the patient model; determining a support plane; and modifying the bone network to orient a knee joint to a predetermined value (designing an orthosis with multi-plane direct support to the ankle and indirect support to the knee entails identifying a foot plane as recited, determining a support plane, and modifying the bone network to orient a knee joint, [0203]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Zacharisen to analyze the planes of a foot modify the bone network to orient a knee joint to a predetermined value because [0144] [0259] of Parr teaches analyzing and designing an orthotic to deform a bone network and [0203] of LeCursi teaches doing so to deform a foot to indirectly support a knee which would orient a knee joint to a predetermined value.
Response to Arguments
Applicant's arguments filed February 12, 2026 have been fully considered but they are not persuasive.
Regarding the written description rejection, Applicant argues that a single working example for a foot orthotic is sufficient for every orthotic for any part of the body is sufficient. This is not persuasive for the reasons stated above. Applicant seeks far more than was disclosed, based on essentially the entirety of orthodontic medicine and orthodontic medicine yet to come. Applicant has not provided a written description of different parts of the body to demonstrate this knowledge.
Regarding the enablement rejection, Applicant argues, “The specification further describes how the simplified bone framework is modeled using joints and joint connections represented by vectors, and how vectors can specify distances or support sites within the surface network to model the interaction between the bone network and surface network.” This argument is not persuasive because the specification does not include further detail beyond this, with the narrow exception of a foot orthotic. By this disclosure and related claim recitation, Applicant seeks to claim the application of all of the knowledge of orthotic medicine for every joint, and for any orthotic. Applicant has not provided an adequate written description for this with the singular example of a foot orthotic.
Applicant’s description of the Wands factors is misstated. Applicant’s working example is for an ankle-foot orthosis. There are no examples for different sorts of orthotics such as for a shoulder, wrist, neck, etc. Applicant’s “Direction provided” amounts to a disclosure that vectors should be used to model the bones and the resulting surface. This is exceedingly thin and amounts to the practice of orthodontic medicine with orthotics.
Applicant’s description of the state of the prior art, ordinary skill, and predictability are all at odds with Applicant’s assertion of non-obviousness. Does Applicant believe that there is well developed prior art for the use of vectors and orthodontic medicine to model the movement of bones from orthotics, that there is expertise in doing so, and that this is all predictable for all joints? Applicant’s arguments for non-obviousness run counter to this assertion. Instead, Applicant asserts prior art, ordinary skill, and predictability for something other than the enablement issue. It is not the digital representation, it is modeling the movements of all the bones for all joints that are at issue. Applicant’s presentation of the prior art, ordinary skill, and predictability all ignore this aspect, instead providing a conclusory statement about the broadly defined “simplified bone framework.” A “simplified bone framework” appears to extend from the most primitive digital modeling to the most complicated. It would still be “simplified” in that it is not a physical model, thereby simplified relative to the complications of an actual human’s anatomy.
Turning to the argument for non-obviousness, Applicant argues, “Shin does not teach or suggest the claimed dual-network structure where a point cloud is embedded in both a surface network and a bone network, with the bone network being a simplified bone framework consisting of joints and joint connections modeled by vectors that lies within the interior of the surface network.”
This assertion is belied by the teaching in [0079] of Shin of a “biomimetic virtual model of anatomic motion.” The paragraph details this digital model and how the pressure and movement freedom of the orthotic is based on this modeling, with “A biomimetic cable pulley system, analogous to the modeled myotendinous architecture of the hand and functioning to reproduce anatomic force vectors, can be anchored to a force-generating mechanism associated with the prosthesis, enabling the desired motion.” This constitutes a simplified bone network modeled by vectors that interact with the movement of the surface of the body part.
Applicant asserts that Parr does not teach use of vectors based on an assertion that Parr teaches a warping-based approaching using interpolation functions. This argument is not persuasive because interpolation entails estimating intermediate vectors based on two or more known vectors.
In short, Applicant claims to be the first to have developed an approach to modeling a body part based on force vectors, an assertion belied by [0079] of Shin and Applicant’s misattribution of interpolation as unrelated to vectors. Further, as noted above, Applicant seeks to argue that the prior art knew well all of the orthodontic knowledge needed to perform such modeling was widely known.
Applicant goes on to argue impermissible hindsight, as if Shin does not teach a “biomimetic virtual model of anatomic motion.”
Finally, Applicant’s arguments regarding claim 19 are derivative of the arguments above, and are belied by Shin’s force vector based “biomimetic virtual model of anatomic motion.” The arguments regarding other claims are also derivative of the flawed arguments above.
Regarding the rejection under 101, Applicant argues that the simplified bone framework is a technical improvement because it simplifies. This is true of any model. Given the breadth of “simplified bone framework” this amounts to little more than making a calculation. Accordingly, this cannot be said to make a technical improvement.
Next, Applicant seeks to argue that the claims are limited to a particular technological environment. However, as noted above, this still precludes the entirely of orthotic medicine.
Finally, Applicant argues that physical creation does not constitute significant extra-solution activity. Applicant does not argue that the creation is not generic. Rather, Applicant argues that the modeling step constitutes is why it is not extra-solution activity. This is not persuasive because the modeling is the solution activity, is the mental step of the abstract idea that is at issue.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NICHOLAS J CHIDIAC/ Examiner, Art Unit 1744
/XIAO S ZHAO/ Supervisory Patent Examiner, Art Unit 1744
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