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 .
Response to Arguments
Applicant's arguments filed 2/20/2026 have been fully considered but they are not persuasive. Meyer discloses an external lower leg prosthesis that comprises at least two components that are attached to one another in an adjustable manner. The first component of the external prosthesis is the connection means (3) shown best in Figure 6, having a base (30) to which the lower limb tube (4) shown in Figure 1 connects. The second component of the external prosthesis is a foot part (2) comprising parts (21, 22 and 23) [0038]. Meyer explains that the adjustment device (5) allows for different inclinations of the connection means (3) relative to the foot part (2) to compensate for different heel heights of shoes [0038]. Meyer contemplates having a sensor and signal generating device to either manually or automatically to a control device so that the user can adjust the prosthesis based on the heel height of a shoe [0037].
Since Meyer discloses a prosthesis with two external components adjustably connected to one another using sensors, signals and controller, one of ordinary skill in the art would have recognized this is analogous to the Otto method of aligning two prosthetic components. One of ordinary skill in the art would have found it obvious to apply the Otto method of alignment to the Meyer external prosthesis in order to optimize the wearer’s gait for a particular shoe being worn.
Claim Rejections - 35 USC § 103
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) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2007/106172 (Otto) in view of USPAP 2017/0128236 (Meyer et al.).
Regarding claim 1: Otto discloses a method for carrying out a prosthesis set-up, wherein multiple components are arranged close to each other (see prosthetic components 10, 20, 30, 40 and 50 in Figure 3; [0041]), the method comprising the steps of
a) providing at least one marking (see 70a-c in Figure 3; [0041]) on at least one component;
b) arranging various components close to each other [0057];
c) detecting a position and/or an orientation of the at least one marking of the closely arranged components by means of at least one sensor [0042; 0044; 0046; 0053; 0057;0065];
d) determining the actual position and/or the actual orientation of the closely arranged components relative to one another using the detected position and/or orientation of the at least one marking [0056-0057;0065]; and
e) comparing the determined actual position and/or actual orientation with a target position and/or target orientation [0056-0057;0065].
Otto teaches that the method of alignment may be applied to any type of orthopedic joint implant including ankles [0036], and Otto teaches the method provides adjustment of prosthetic components based on performance characteristics in order to provide a better fit [0087]. Otto fails to disclose an external prosthesis having two components and a method step of determining a target position/orientation based on physical data and/or measurements of a wearer and a heel height of a shoe by reading from a database.
Meyer discloses an external lower leg prosthesis that comprises at least two components that are attached to one another in an adjustable manner. The first component of the external prosthesis is the connection means (3) shown best in Figure 6, having a base (30) to which the lower limb tube (4) shown in Figure 1 connects. The second component of the external prosthesis is a foot part (2) comprising parts (21, 22 and 23) [0038]. Meyer explains that the adjustment device (5) allows for different inclinations of the connection means (3) relative to the foot part (2) to compensate for different heel heights of shoes [0038]. Meyer contemplates having a sensor and signal generating device to either manually or automatically to a control device so that the user can adjust the prosthesis based on the heel height of a shoe [0037]. The optimal angular position (target position/ target orientation) of the foot part (2) is programmed into a database for each heel height of different shoes [0056], and the detected heel height marking (11) can be transmitted to a remote output device [0054]. Therefore by reading the marking (11) on the prosthetic component, a target position/orientation based on physical data and/or measurements of a wearer and a heel height of a shoe are determined.
Since both Otto and Meyer are directed towards proper alignment of components of a prosthesis based on detection of markings, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to apply the Otto method prosthesis set-up method with the external lower leg prosthesis having two components disclosed by Meyer, as the modification merely involves the application of a known method of alignment for a different type of prosthesis that obtains predictable results. One of ordinary skill in the art would have a reasonable expectation of success for aligning a foot and ankle prosthesis (including a shoe) according to Otto’s method, as Otto teaches that the method may be applied to various type of orthopedic and/or musculoskeletal implant [0036]. Since Meyer teaches that the marking (11) on the shoe indicates a pre-programmed, target orientation of the foot and lower limb prosthetic components based on wearer data/measurements, the modification results in a target position/ target orientation determined based on data/measurements of a wearer and a heel height of a shoe.
Regarding claim 2: the prosthesis set-up is a static prosthesis set-up (see Otto [0061-0062; 0065]).
Regarding claim 3: the prosthesis is set up according to a set-up recommendation that designates at least one component as relevant for adjustment (see description of adjusting the implant to achieve the desired relationship at [0057; 0066] of Otto). (Although not necessarily required, the reference discloses at least one marking provided on each of the components designated as relevant for adjustment).
Regarding claim 4: the at least one sensor comprises at least one optical sensor, preferably a camera, especially preferably for visible light or infrared radiation (see infrared camera at [0044 and 0046] of Otto).
Regarding claim 5: the markings can be arranged on the components in the form of stickers (see adhesive at [0043]) or are printed onto the components (see etching, etc. at [0043] of Otto).
Regarding claim 6: the markings (70a-e) are located on separate marking components (See affixed to the component e.g., using adhesive at [0043] of Otto). It would have been further obvious to place marking components on the at least two external components taught by Meyer.
Regarding claim 7: the marking components are detachably arranged on the respective component (See affixed to the component e.g., using adhesive at [0043] of Otto).
Regarding claim 8: the target position and/or target orientation are read from a database [0059].
Regarding claim 9: Meyer teaches that the set-up of the prosthetic components with respect to one another has an effect on the flexion of a joint [0002]. The target orientation of the foot component (2) is determined based at least in part on the flexion contracture of the wearer’s ankle joint (corresponding to the connector 3) to accommodate for different shoe heel heights [0013; 0040].
Regarding claim 10: Otto discloses that based on the comparison of the actual position/ orientation with the target position/orientation, at least one recommendation for action is given via an output device (see description of computer being configured to determine a position and orientation of the components of the prosthesis [0061] and providing feedback for making adjustments [0063] when the actual position and/or the actual orientation deviates from the target position and/or the target orientation by more than a predetermined limit.
Regarding claim 11: the markings contains/ encodes information about each of the components (see [0053] of Otto and [0056] of Meyer).
Regarding claim 12: the markings are a barcode (Otto [0046]) or an RFID (Otto [0053]; Meyer [0021; 0053]).
Regarding claim 13: the position and/or orientation of the markings of the closely arranged components are detected from two different directions (see description of reading the RFID tag after the prosthesis is not exposed and the joint has healed [0053] and/or detecting the position/orientation both before, during and after surgery [0056-0061]).
Regarding claim 14: Otto discloses a device for carrying out the method that comprises a sensor [0044-0046; 0053] and for detecting a position and/or an orientation of the at least one marking and a computer system [0057-0061] that is configured to carry out steps d) and e) of the method.
Regarding claim 15: Otto discloses a method for carrying out a prosthesis set-up comprising the steps of:
a) providing at least two prosthesis components (see prosthetic components 10, 20, 30, 40 and 50 in Figure 3; [0041]);
b) providing at least one marking on at least one prosthesis component (see 70a-c in Figure 3; [0041]) on at least one component;
c) arranging the prosthesis components close to each other (wherein the components are placed in close proximity in the surgical site/joint);
d) detecting a position and/or an orientation of the at least one marking of the closely arranged at least one prosthesis component by means of at least one optical sensor [0042; 0044; 0046; 0053; 0057;0065];
e) determining the actual position and/or the actual orientation of the closely arranged prosthesis components relative to one another using the detected position and/or orientation of the at least one marking [0056-0057;0065], and
f) comparing the determined actual position and/or actual orientation with a target position and/or target orientation [0057], the target position and/or target orientation being obtained from a database [0059].
Otto teaches that the method of alignment may be applied to any type of orthopedic joint implant including ankles [0036], and Otto teaches the method provides adjustment of prosthetic components based on performance characteristics in order to provide a better fit [0087]. Otto fails to disclose an external prosthesis having two components and a method step of determining a target position/orientation based on physical data and/or measurements of a wearer and a heel height of a shoe by reading from a database.
Meyer discloses an external lower leg prosthesis that comprises at least two components that are attached to one another in an adjustable manner. The first component of the external prosthesis is the connection means (3) shown best in Figure 6, having a base (30) to which the lower limb tube (4) shown in Figure 1 connects. The second component of the external prosthesis is a foot part (2) comprising parts (21, 22 and 23) [0038]. Meyer explains that the adjustment device (5) allows for different inclinations of the connection means (3) relative to the foot part (2) to compensate for different heel heights of shoes [0038]. Meyer contemplates having a sensor and signal generating device to either manually or automatically to a control device so that the user can adjust the prosthesis based on the heel height of a shoe [0037]. The optimal angular position (target position/ target orientation) of the foot part (2) is programmed into a database for each heel height of different shoes [0056], and the detected heel height marking (11) can be transmitted to a remote output device [0054]. Therefore by reading the marking (11) on the prosthetic component, a target position/orientation based on physical data and/or measurements of a wearer and a heel height of a shoe are determined.
Since both Otto and Meyer are directed towards proper alignment of components of a prosthesis based on detection of markings, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to apply the Otto method prosthesis set-up method with the external lower leg prosthesis having two components disclosed by Meyer, as the modification merely involves the application of a known method of alignment for a different type of prosthesis that obtains predictable results. One of ordinary skill in the art would have a reasonable expectation of success for aligning a foot and ankle prosthesis (including a shoe) according to Otto’s method, as Otto teaches that the method may be applied to various type of orthopedic and/or musculoskeletal implant [0036]. Since Meyer teaches that the marking (11) on the shoe indicates a pre-programmed, target orientation of the foot and lower limb prosthetic components based on wearer data/measurements, the modification results in a target position/ target orientation determined based on data/measurements of a wearer and a heel height of a shoe.
Regarding claim 16: at least one marking is arranged on the at least one prosthesis component in the form of a sticker (see adhesive at [0043]) or printed onto the component (see etching, etc. at [0043]).
Regarding claim 17: the at least one marking is located on a separate marking component (See affixed to the component e.g., using adhesive at [0043]). The prosthesis taught by Otto comprises various features that meet the requirement of a “rod or plate”, as any flat surface can be considered a plate. For example, the Macomber teaches a transducer (104) having a plate shape [0030].
Regarding claim 18: the markings encodes information about the component [0053].
Regarding claim 19: the position and/or orientation of the markings of the closely arranged components are detected from at least two different directions (see description of reading the RFID tag after the prosthesis is not exposed and the joint has healed [0053] and/or detecting the position/orientation both before, during and after surgery [0056-0061]).
Regarding claim 20: Otto discloses a method for carrying out a prosthesis set-up comprising the steps of:
providing at least two prosthesis components (see prosthetic components 10, 20, 30, 40 and 50 in Figure 3; [0041]);
providing at least one QR code, barcode and/or RFID on at least one of the prosthesis components (See barcode [0046] or an RFID [0053]);
arranging the prosthesis components close to each other (wherein the components 10/20/30/40/50 would be “close” when placed within a joint);
detecting a position and/or an orientation of the at least one marking of the closely arranged at least one prosthesis component by means of at least one optical sensor [0042; 0044; 0046; 0053; 0057;0065];
determining the actual position and/or the actual orientation of the closely arranged prosthesis components relative to one another using the detected position and/or orientation of the at least one marking [0056-0057;0065];
comparing the determined actual position and/or actual orientation with a target position and/or target orientation [0056-0057;0065], the target position and/or target orientation being obtained from a database [0059]; and
providing at least one recommendation for action if the actual position and/or actual orientation deviates from the target position and/or the target orientation by more than a predetermined limit [0057].
Otto teaches that the method of alignment may be applied to any type of orthopedic joint implant including ankles [0036], and Otto teaches the method provides adjustment of prosthetic components based on performance characteristics in order to provide a better fit [0087]. Otto fails to disclose an external prosthesis having two components and a method step of determining a target position/orientation based on physical data and/or measurements of a wearer and a heel height of a shoe by reading from a database.
Meyer discloses an external lower leg prosthesis that comprises at least two components that are attached to one another in an adjustable manner. The first component of the external prosthesis is the connection means (3) shown best in Figure 6, having a base (30) to which the lower limb tube (4) shown in Figure 1 connects. The second component of the external prosthesis is a foot part (2) comprising parts (21, 22 and 23) [0038]. Meyer explains that the adjustment device (5) allows for different inclinations of the connection means (3) relative to the foot part (2) to compensate for different heel heights of shoes [0038]. Meyer contemplates having a sensor and signal generating device to either manually or automatically to a control device so that the user can adjust the prosthesis based on the heel height of a shoe [0037]. The optimal angular position (target position/ target orientation) of the foot part (2) is programmed into a database for each heel height of different shoes [0056], and the detected heel height marking (11) can be transmitted to a remote output device [0054]. Therefore by reading the marking (11) on the prosthetic component, a target position/orientation based on physical data and/or measurements of a wearer and a heel height of a shoe are determined.
Since both Otto and Meyer are directed towards proper alignment of components of a prosthesis based on detection of markings, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to apply the Otto method prosthesis set-up method with the external lower leg prosthesis having two components disclosed by Meyer, as the modification merely involves the application of a known method of alignment for a different type of prosthesis that obtains predictable results. One of ordinary skill in the art would have a reasonable expectation of success for aligning a foot and ankle prosthesis (including a shoe) according to Otto’s method, as Otto teaches that the method may be applied to various type of orthopedic and/or musculoskeletal implant [0036]. Since Meyer teaches that the marking (11) on the shoe indicates a pre-programmed, target orientation of the foot and lower limb prosthetic components based on wearer data/measurements, the modification results in a target position/ target orientation determined based on data/measurements of a wearer and a heel height of a shoe.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights