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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE 10 2019 101 370.4, filed on January 21, 2019.
Response to Preliminary Amendment
In the amendment filed on July 29, 2025, the following has occurred: claim(s) 13-32 have been added and claim(s) 1-12 have been cancelled. Now, claim(s) 13-32 are pending.
Notice to Applicant
The Examiner has withdrawn the 35 U.S.C. 101 rejection(s) in light of the newly
Amended claims. The addition of “f) generating instructions and transmitting the instructions to a production plant, the instructions causing the production plant to produce a shape corresponding to the individualized model to create the orthosis or prosthesis from the individualized model” is considered to implement a judicial exception with a particular machine or manufacture that is integral to the claim (MPEP 2106.05(b)), and the judicial exception is integrated into a practical application. The 35 U.S.C. 101 rejection(s) are withdrawn.
Claim Objections
Claim 20 objected to because of the following informalities: “the basis of the selected one or more images;” in p. 4, ll. 14. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “the basis of the at least one of the selected images;”.
Claim 24 objected to because of the following informalities: “The medium of claim 23,” in p. 5, ll. 17. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 23,”.
Claim 25 objected to because of the following informalities: “The medium of claim 24,” in p. 5, ll. 20. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 24,”.
Claim 26 objected to because of the following informalities: “The medium of claim 23,” in p. 5, ll. 22. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 23,”.
Claim 27 objected to because of the following informalities: “The medium of claim 23,” in p. 5, ll. 24. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 23,”.
Claim 28 objected to because of the following informalities: “The medium of claim 23,” in p. 6, ll. 1. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 23,”.
Claim 29 objected to because of the following informalities: “The medium of claim 28,” in p. 6, ll. 3. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 28,”.
Claim 30 objected to because of the following informalities: “The medium of claim 23,” in p. 6, ll. 5, “the basis of the selected one or more images;” in p. 6, ll. 10. These appear to be typographical errors. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 23,”, “the basis of the at least one of the selected images;”.
Claim 31 objected to because of the following informalities: “The medium of claim 30,” in p. 6, ll. 12. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 30,”.
Claim 32 objected to because of the following informalities: “The medium of claim 23,” in p. 6, ll. 15. This appears to be a typographical error. Appropriate correction is required. For examination purpose, the Examiner will interpret the claimed portion as “The non-transitory computer-readable storage medium of claim 23,”.
The claims 28 and 29 are objected to because the lines are crowded too closely together, making reading difficult. Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 13, 15-16, 20-23, 26 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9 of U.S. Patent No. 12,354,737 in view of Deleu et al. (U.S. Patent Pre-Grant Publication No. 2020/0357508). The subject matter of each limitation claims 13, 15-16, 20-23, 26 of the present application is present in the ‘737 application with the exception of the step of “a) generating a raw model of an extremity using a patient-specific input parameter from a user and reference dimensions determined from anatomical data sets associated with example cases of anatomical values of different patients;” in independent claim 13 and 23. The cited prior art of record teaches the missing features of the ‘737 application as described below in the basis of rejection. A person having skill in the art would have been motivated to combine the ‘737 application with the cited prior art in order to provide a development of a method allowing the accurate modelling of the patient anatomy (See Background of Invention of Deleu in Paragraph [0015]).
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.
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.
Claim(s) 13-14, 16-19, 23-24, 26-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deleu et al. (U.S. Patent Pre-Grant Publication No. 2020/0357508) in view of Laster et al. (U.S. Patent Pre-Grant Publication No. 2017/0061375).
As per independent claim 13, Deleu discloses a method comprising:
a) generating a raw model of an extremity using a patient-specific input parameter from a user and reference dimensions determined from anatomical data sets associated with example cases of anatomical values of different patients (See [0130]-[0132], [0136], [0140], [0178]: The processor generates at least one subject-specific model of the foot and ankle in relation with the lower limb, comprising bones and soft tissues using the received information relating to the anatomy of at least a foot and a related ankle of the subject and information relating to subjective parameters evaluated by the subject, which the Examiner is interpreting subject-specific model of the foot and ankle to encompass a raw model of an extremity using a patient-specific input parameter, and the Examiner is interpreting the risk may be a score using as reference a generic healthy lower limb model or the reference model may be selected from a data base as the one being more similar to the actual subject model to encompass reference dimensions determined from anatomical data sets associated with example cases of anatomical values of different patients);
b) ascertaining a measurement parameter of the raw model, the measurement parameter representing a measurement of a distance between two points on the raw model, a volume, an area, or a contour in the raw model (See [0135]-[0137]: The information generated by a quantitative functional analysis of the foot and lower limb comprises biomechanical characteristics, which the Examiner is interpreting a quantitative functional analysis to encompass ascertaining a measurement parameter of the raw model, and interpreting the biomechanical characteristics to encompass a measurement of a distance between two points on the raw model, a volume, an area, or a contour in the raw model as the biomechanical characteristics may further comprise information concerning ground reactions (forces and torques, impulses, peak pressure values, peak pressure ratio, pressure time integral, peak pressure gradient, load rate, pressure contact area, force-time integral and integral ratios, power ratio, center pressure, etc.), body segment kinematics, strain and stress measurements of soft tissues (articular cartilage, ligaments, tendons, muscles, etc.) and hard tissues, geometry and shape of tissues, measures concerning muscle function and physiological cost, spatio-temporal parameters (step length, stride length, foot angle of gait, walking speed, cadence, velocity, step time, stride time, single support, double support, swing time, etc.));
c) receiving an adjustment of the measurement parameter (See [0190]: The processor receives digitalized input data and processes them under the instructions of the computer program to compute the simulation of the foot and ankle model, which the Examiner is interpreting receives digitalized input data to encompass an adjustment of the measurement parameter);
d) modifying the raw model on the basis of the adjustment (See [0190]: The processor receives digitalized input data and processes them under the instructions of the computer program to compute the simulation of the foot and ankle model, which the Examiner is interpreting compute the simulation of the foot and ankle model to encompass modifying the raw model);
e) iteratively performing steps b) through d) to further adjust the measurement parameter and modify the raw model on the basis of the further adjusted measurement parameter to generate an individualized model of the orthosis or prosthesis (See [0162], [0174]-[0175]: Final step 1024 is configured to simulate the after-treatment model in a static and/or dynamic condition using forward dynamics, as described above in the description in order to evaluate the treatment outcome, and step 1024 also comprises an optimization in forward dynamics in order to extract the optimal treatment option, which the Examiner is interpreting the treatment model for the subject-specific foot and ankle model or, if multiple treatment model has been selected, simulate all the treatment models proposed for the subject-specific foot and ankle model to encompass the claimed portion as [0162] describes models of simulating osteosynthesis surgery, simple or complex articular fusion, prosthesis insertion.)
Deleu discloses the method as described above, Deleu may not explicitly teach f) generating instructions and transmitting the instructions to a production plant, the instructions causing the production plant to produce a shape corresponding to the individualized model to create the orthosis or prosthesis from the individualized model.
Laster teaches a method for f) generating instructions and transmitting the instructions to a production plant, the instructions causing the production plant to produce a shape corresponding to the individualized model to create the orthosis or prosthesis from the individualized model (See [0115], [0200], [0283]-[0284]: The manufacturer can use predicted quantities needed for multiple medical facilities or multiple geographical regions to set production levels, the manufacturer can adjust the quantities produced for various sizes of implant components, which the Examiner is interpreting to encompass the claimed portion.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Deleu to include generating instructions and transmitting the instructions to a production plant, the instructions causing the production plant to produce a shape corresponding to the individualized model to create the orthosis or prosthesis from the individualized model as taught by Laster. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Deleu with Laster with the motivation of improving implant determination (See Background of Laster in Paragraph [0007]).
Claim(s) 23 mirrors claim 13 only within (a) different statutory category/categories, and is rejected for the same reason as claim 13.
As per claim 14, Deleu/Laster discloses the method of claim 13 as described above. Deleu further teaches further comprising displaying the raw model and the measurement parameter in an interface, wherein the adjustment of the measurement parameters is received through the interface (See [0079], [0177], [0190]: The processor receives digitalized input data and processes them under the instructions of the computer program to compute the simulation of the foot and ankle model, which the Examiner is interpreting digitalized input data to encompass the adjustment of the measurement parameters is received through the interface, and interpreting the output parameters of the computer implemented method are graphically represented to be visualized on a display to encompass displaying the raw model and the measurement parameter in an interface.)
Claim(s) 24 mirrors claim 14 only within (a) different statutory category/categories, and is rejected for the same reason as claim 14.
As per claim 16, Deleu/Laster discloses the method of claim 13 as described above. Deleu further teaches wherein step e) is performed until a stopping condition is met (See [0162], [0174]-[0175]: Final step 1024 is configured to simulate the after-treatment model in a static and/or dynamic condition using forward dynamics, as described above in the description in order to evaluate the treatment outcome, and step 1024 also comprises an optimization in forward dynamics in order to extract the optimal treatment option, which the Examiner is interpreting the presence of a final step to encompass a stopping condition is met.)
Claim(s) 26 mirrors claim 16 only within (a) different statutory category/categories, and is rejected for the same reason as claim 16.
As per claim 17, Deleu/Laster discloses the method of claim 13 as described above. Deleu further teaches wherein step a) is performed without accessing a three- dimensional scan of the patient or extremity (See [0130]-[0132], [0136], [0140], [0178]: The processor generates at least one subject-specific model of the foot and ankle in relation with the lower limb, comprising bones and soft tissues using the received information relating to the anatomy of at least a foot and a related ankle of the subject and information relating to subjective parameters evaluated by the subject, which the Examiner is interpreting to encompass the claimed portion.)
Claim(s) 27 mirrors claim 17 only within (a) different statutory category/categories, and is rejected for the same reason as claim 17.
As per claim 18, Deleu/Laster discloses the method of claim 13 as described above. Deleu further teaches wherein the patient-specific input parameter comprises pathological information (See [0137]: Wherein the subject presents a pathology, the method according to the present invention comprises a further step consisting in receiving in a processor information concerning a user choice, which the Examiner is interpreting the subject presents a pathology to encompass pathological information.)
Claim(s) 28 mirrors claim 18 only within (a) different statutory category/categories, and is rejected for the same reason as claim 18.
As per claim 19, Deleu/Laster discloses the method of claims 13 and 18 as described above. Deleu further teaches wherein the pathological information comprises a degree of amputation of the extremity (See [0137]: The list of pathologies may comprise different type of trauma such as malleolar fractures, tibial pilon fractures, calcaneus fractures, navicular and midfoot injuries and metatarsal and phalangeal fractures, arthritis of the ankle joint and the joints of the hindfoot (tarsals), midfoot (metatarsals) and forefoot (phalanges), congenital and acquired deformities including adult acquired flatfoot, non-neuromuscular foot deformities, diabetic foot disorders, hallux valgus and several common pediatric foot and ankle conditions such as clubfoot, flat feet, tarsal coalitions, etc., which the Examiner is interpreting the list of pathologies to encompass a degree of amputation of the extremity.)
Claim(s) 29 mirrors claim 19 only within (a) different statutory category/categories, and is rejected for the same reason as claim 19.
Claim(s) 15, 20-22, 25, 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deleu et al. (U.S. Patent Pre-Grant Publication No. 2020/0357508) in view of Laster et al. (U.S. Patent Pre-Grant Publication No. 2017/0061375) in further view of Smith et al. (U.S. Patent Pre-Grant Publication No. 2010/0106475).
As per claim 15, Deleu/Laster discloses the method of claims 13-14 as described above. Deleu/Laster may not explicitly teach wherein displaying the raw model comprises displaying an avatar or a plurality of avatars.
Smith teaches a method wherein displaying the raw model comprises displaying an avatar or a plurality of avatars (See [0005]: In computer graphics, video applications, and other fields, avatars of humans and other animals may be modeled for visual display.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Deleu/Laster to include displaying the raw model comprises displaying an avatar or a plurality of avatars as taught by Smith. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Deleu/Laster with Smith with the motivation of optimize the comfort of the patient (See Detailed Description of Embodiments of the Invention of Smith in Paragraph [0130]).
Claim(s) 25 mirrors claim 15 only within (a) different statutory category/categories, and is rejected for the same reason as claim 15.
As per claim 20, Deleu/Laster discloses the method of claim 13 as described above. Deleu further teaches wherein ascertaining the measurement parameter comprises:
i1) displaying a plurality of images illustrating different examples of a body structure of the patient (See [0047], [0145]: The step of determining at least two segmented volumes corresponding to at least one anatomy portion of said foot and/or ankle extracted from said at least one image, comprises the segmentation of a volume of different types for example bones, tendons, ligaments, articular cartilages and other soft tissues, each type of volume comprising one or more volumes, which the Examiner is interpreting determining at least two segmented volumes corresponding to at least one anatomy portion to encompass displaying a plurality of images illustrating different examples of a body structure of the patient);
i2) receiving a selection from the user of at least one of the images (See [0047]-[0053]: The step of determining a corrective instruction releases on selecting at least one value from a predefined list of set of values, which the Examiner is interpreting selecting at least one value to encompass a selection from the user of at least one of the images as at least one anatomy portion of said foot and/or ankle extracted from said at least one image.)
While Deleu/Laster discloses the method as described above, Deleu/Laster may not explicitly teach i3) determining at least one shape parameter on the basis of the at least one of the selected one or more images;
wherein generating the raw model comprises applying the at least one shape parameter.
Smith teaches a method for i3) determining at least one shape parameter on the basis of the at least one of the selected one or more images (See [0057]-[0058]: Three-dimensional geometry and fibrous structures can be modeled, the parameter fields define a generic virtual model and allows for numeric data entries or the output of numerical measurement devices, the database advantageously provides for storing imaging information, which the Examiner is interpreting to encompass the claimed portion when combined with Deleu and Laster);
wherein generating the raw model comprises applying the at least one shape parameter (See [0064]-[0065]: The generic biophysical model may be customized using a single piece of user physical or functional data, where imagery is available further anatomical modeling may be developed when combined with Deleu/Laster.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Deleu/Laster to include i3) determining at least one shape parameter on the basis of the at least one of the selected one or more images; wherein generating the raw model comprises applying the at least one shape parameter as taught by Smith. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Deleu/Laster with Smith with the motivation of optimize the comfort of the patient (See Detailed Description of Embodiments of the Invention of Smith in Paragraph [0130]).
Claim(s) 30 mirrors claim 20 only within (a) different statutory category/categories, and is rejected for the same reason as claim 20.
As per claim 21, Deleu/Laster discloses the method of claim 13 and Deleu/Laster/Smith discloses the method of claim 20 as described above. Deleu/Laster may not explicitly teach wherein the steps il) to i3) are performed multiple times iteratively to generate or refine the raw model using the patient-specific input parameter and the at least one shape parameter.
Smith teaches a method wherein the steps il) to i3) are performed multiple times iteratively to generate or refine the raw model using the patient-specific input parameter and the at least one shape parameter (See [0162]: The database for one subject or for many subjects conforms to a generic model that includes many parameters, as more and more real data becomes available about an individual, the parameter values and the associated confidence in the accuracy of the database parameters, which the Examiner is interpreting the database for a subject conforms to a generic model that includes many parameters to encompass multiple times in order iteratively to generate the raw model using the at least one input parameter and the at least one shape parameter.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Deleu/Laster to include the steps il) to i3) are performed multiple times iteratively to generate or refine the raw model using the patient-specific input parameter and the at least one shape parameter as taught by Smith. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Deleu/Laster with Smith with the motivation of optimize the comfort of the patient (See Detailed Description of Embodiments of the Invention of Smith in Paragraph [0130]).
Claim(s) 31 mirrors claim 21 only within (a) different statutory category/categories, and is rejected for the same reason as claim 31.
As per claim 22, Deleu/Laster discloses the method of claim 13 as described above. Deleu/Laster may not explicitly teach further comprising modifying the raw model on the basis of the at least one measured parameter to optimize an outer contour.
Smith teaches a method further comprising modifying the raw model on the basis of the at least one measured parameter to optimize an outer contour (See [0133]: The custom design can be based on a generic standardized hip implant to which variances are applied to modify the implant configuration to fit precisely the anatomy of the patient and the fit is optimized according to criteria.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Deleu/Laster to include modifying the raw model on the basis of the at least one measured parameter to optimize an outer contour as taught by Smith. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Deleu/Laster with Smith with the motivation of optimize the comfort of the patient (See Detailed Description of Embodiments of the Invention of Smith in Paragraph [0130]).
Claim(s) 32 mirrors claim 22 only within (a) different statutory category/categories, and is rejected for the same reason as claim 32.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sobinov et al. (U.S. Patent Pre-Grant Publication No. 2020/0253751), describes a system and method for controlling a device, such as a virtual reality (VR) and/or a prosthetic limb are provided. A biomimetic controller of the system comprises a signal processor and a musculoskeletal model.
Strobel et al. (U.S. Patent Pre-Grant Publication No. 2019/0096520), describes a method is for calculating a personalized patient model including an external surface model of a patient and an organ model of the patient.
Misgeld et al. (“Model-Based Estimation of Ankle Joint Stiffness”), describes a novel nonlinear biomechanical model of the lower leg was formulated that is driven by electromyographic signals.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
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