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 request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Applicant’s arguments, see pages 7-9, filed 12/03/2025, with respect to the rejection(s) of claim(s) 13-32 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Prince (US 2020/0237531 A1) in view of Lincoln (US 2018/0036148 A1).
Claim Objections
Claim 32 objected to because of the following informalities: There is a backslash in line 1, it is unclear if it has an intended purpose or is an error. Appropriate correction is required.
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.
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(s) 13, 17-20, 25-27 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prince (US 2020/0237531 A1) in view of Lincoln (US 2018/0036148 A1).
Regarding claim 13, Prince discloses
an orthopedic device (100, prosthetic knee, fig. 1A) with an energy storage device (500, hydraulic assembly, fig. 5A-5C) that comprises at least one cylinder (520, cylinder, fig. 5A) in which a first cylinder chamber (524, second chamber, fig. 5A), a second cylinder chamber (522, first chamber, fig. 5A), which is fluidically connected to the first cylinder chamber by at least one fluid line (530, fluid circuit, fig. 5A), and a piston (510, piston, fig. 5A), are located,
wherein the piston is arranged relative to the cylinder such that displacing the piston causes an operating medium, which is a fluid (¶ [0064], hydraulic fluid), to be conveyed through the at least one fluid line from one of the first or second cylinder chamber into the other of the first or second cylinder chamber (¶ [0064]), and
the energy storage device has at least one compensation volume (550, fluid sump, fig. 5A), which is fluidically connected to the fluid line via a fluid connection (531, fluid channel, fig. 5A).
Prince fails to teach a controllable valve wherein no exchange of fluid occurs between the compensation volume and the first or second cylinder chambers when the valve is closed. However, Lincoln discloses prosthetic joint with a hydraulic system for energy storage that includes a first controllable valve (108, valve, fig. 1) configured to open and close the fluid connection (¶ [0064), wherein no exchange of fluid occurs between the compensation volume and the first or second cylinder chamber when the first controllable valve is closed (There is only one line leading into the compensation volume, when the valve is closed no fluid exchange can occur in either direction). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the fluid connection of Prince to include a controllable valve as taught by Lincoln in order to allow the energy-harvesting system to have passive impedance control (¶ [0068], Lincoln) and since it is combining prior art element according to known method to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). For clarity the valve of Lincoln is placed between 592 and 556 in fig. 5A of Prince.
Regarding claim 17, Prince further discloses at least one second controllable valve (540, channel valve, fig. 5A) in the fluid line configured to adjust a flow resistance of the fluid connection (¶ [0064]).
Regarding claim 18, Prince fails to teach the fluid connection is between the first and second controllable valves. However, Lincoln further discloses the controllable valve is on a singular fluid line connecting the compensation volume and the cylinder. The controllable valve would be on the fluid line between the fluid circuit (530, Prince) and the sump port (556, Prince) (see annotated fig. 5B, below). The fluid connection (531, Prince) is between the second valve (540, Prince) and the first valve (108, Lincoln). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the energy storage device of Prince to include the fluid connection is between he first and second controllable valves as taught by Lincoln in order to allow the energy-harvesting system to have passive impedance control (¶ [0068], Lincoln) and since it is combining prior art element according to known method to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Regarding claim 19, Prince fails to teach an additional volume fluidically connected to a chamber of the cylinder. However, Lincoln further discloses at least one additional volume that is fluidically connected to at least one of the first cylinder chamber or the second cylinder chamber (114, reservoir, fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the energy storage device of Prince to include an additional volume fluidically connect to a chamber of the cylinder as taught by Lincoln in order to allow the energy-harvesting system to have passive impedance control (¶ [0068], Lincoln) and since it is combining prior art element according to known method to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 20, Prince fails to teach a third controllable valve. However, Lincoln further discloses a third controllable valve (110, valve fig. 1) configured to open and close the connection between the at least one additional volume and the at least one of the first cylinder chamber or the second cylinder chamber (¶ [0064], fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the energy storage device of Prince to include a third controllable valve as taught by Lincoln in order to allow the energy-harvesting system to have passive impedance control (¶ [0068], Lincoln) and since it is combining prior art element according to known method to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 25, Prince fails to teach an electric control unit to control the valves independently. However, Lincoln further discloses an electric control unit that is configured to control the controllable valves independently of each other (¶ [0064], it would be obvious to control the valves independently in order proportionate adjustments to the flow resistance to match the patient’s gait). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the energy storage device of Prince to include an electric control unit to control the valves independently as taught by Lincoln in order to allow the energy-harvesting system to have passive impedance control (¶ [0068], Lincoln) and since it is combining prior art element according to known method to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 26, Prince further discloses the piston is configured to rotate (116, rotation, fig1A-1B, ¶ [0038]).
Regarding claim 27, Prince further discloses the device is a knee prosthesis or a knee orthosis (100, prosthetic knee, fig. 1A).
Regarding claim 32, Price discloses
an energy storage device (500, hydraulic assembly, figs. 5A-5C) \ for an orthopedic device (100, prosthetic knee, fig. 1A), the energy storing device comprising:
at least one cylinder (520, cylinder, fig. 5A),
a first cylinder chamber located in the at least one cylinder (524, second chamber, fig. 5A),
a second cylinder chamber located in the at least one cylinder (522, first chamber, fig. 5A), wherein the second cylinder chamber is fluidically connected to the first cylinder chamber by at least one fluid line (530, fluid circuit, fig. 5A),
a piston located in the at least one cylinder (510, piston, fig. 5A),
at least one compensation volume (550, fluid sump, fig. 5A), which is fluidically connected to the fluid line via a fluid connection (531, fluid channel, fig. 5A), and
wherein the piston is arranged relative to the cylinder such that displacing the piston causes an operating medium, which is a fluid (¶ [0064], hydraulic fluid), to be conveyed through the at least one fluid line from one of the first or second cylinder chamber into the other of the first or second cylinder chamber (¶ [0064]).
Prince fails to teach a controllable valve wherein no exchange of fluid occurs between the compensation volume and the first or second cylinder chambers when the valve is closed. However, Lincoln discloses prosthetic joint with a hydraulic system for energy storage that includes a first controllable valve (108, valve, fig. 1) configured to open and close the fluid connection (¶ [0064), wherein no exchange of fluid occurs between the compensation volume and the first or second cylinder chamber when the first controllable valve is closed (There is only one line leading into the compensation volume, when the valve is closed no fluid exchange can occur in either direction). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the fluid connection of Prince to include a controllable valve as taught by Lincoln in order to allow the energy-harvesting system to have passive impedance control (¶ [0068], Lincoln) and since it is combining prior art element according to known method to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). For clarity the valve of Lincoln is placed between 592 and 556 in fig. 5A of Prince.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prince in view of Lincoln as applied to claim 13 above, and further in view of Schuch (Atlas of Limb Prosthetics: Surgical, Prosthetic, and Rehabilitation Principles).
Regarding claims 14-16, Prince in view of Lincoln fails to teach the operating medium is a compressible fluid. However, Schuch discloses a review of the biomechanics of transfemoral amputation, and teaches that orthopedic devices are known that includes an operating medium that is a compressible fluid, which may be an oil such as silicon oil (page 25, lines 4-7). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Prince and Lincoln to include the operating medium is a compressible fluid as taught by Schuch in order to minimize viscosity changes with temperature, avoid stiffness in cold weather and looseness in hot weather (page 25, lines 4-7, Schuch).
Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prince in view of Lincoln as applied to claim 19 above, and further in view of Dean (US 2002/0099450 A1).
Regarding claim 21, Prince in view of Lincoln fails to teach the energy storage device has multiple additional volumes and multiple third controllable valves configured to open and close the connection of the additional volumes. However, Dean further discloses the energy storage device has multiple additional volumes (14, pressure bladders, fig. 3a) and multiple third controllable valves (32, flow control valves, fig. 3a) configured to open and close the connections of the additional volumes to at least one of the first cylinder chamber or the second cylinder chamber (reasonable to try as the entire circuit is connected to the chambers through fluid lines, it would not make sense for the additional volumes and valves to be unattached to the circuit). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Prince and Lincoln to include the energy storage device has multiple additional volumes and multiple third controllable valves configured to open and close the connection of the additional volumes as taught by Dean in order to manage fluid volume and control pressure (¶ [0050], Dean).
Regarding claim 22, Prince in view of Lincoln fails to teach the multiple third controllable valves are capable of opening and closing independently of each other. However, Dean further discloses the multiple third controllable valves are capable of opening and closing independently of each other (reasonable to try as the valves either function independently or in unison). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Prince and Lincoln to include the multiple third controllable valves are capable of opening and closing independently of each other as taught by Dean in order to manage fluid volume and control pressure (¶ [0050], Dean).
Regarding claim 23, Prince in view of Lincoln fails to teach the multiple additional volumes are fluidically connected to each other in series. However, Dean further discloses the multiple additional volumes are fluidically connected to each other in series (fig. 3a). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Prince and Lincoln to include the multiple additional volumes are fluidically connected to each other in series as taught by Dean in order to manage fluid volume and control pressure (¶ [0050], Dean).
Regarding claim 24, Prince in view of Lincoln fails to teach the multiple additional volumes are fluidically connected to each other in parallel. However, Dean further discloses the multiple additional volumes are fluidically connected to each other in parallel (fig. 3b). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Prince and Lincoln to include the multiple additional volumes are fluidically connected to each other in parallel as taught by Dean in order to manage fluid volume and control pressure (¶ [0050], Dean).
Claim(s) 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prince in view of Lincoln as applied to claim 13 above, and further in view of Brito (Mechanical Analysis of the Prosthetic Knee in Flexion).
Regarding claim 28, Prince in view of Lincoln fails to teach a spring constant of at most 750 N/mm. However, Brito teaches that tendons in the knee have spring constants between 90 and 120 (page 2694, col 2, lines 1-11), therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to tune the mechanics of the prosthesis of Prince and Lincoln to have a spring constant similar to that range in order to achieve motion similar to that of a natural knee.
Regarding claim 29, Prince in view of Lincoln fails to teach a spring constant is less than 600 N/mm. However, Brito teaches that tendons in the knee have spring constants between 90 and 120 (page 2694, col 2, lines 1-11), therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to tune the mechanics of the prosthesis of Prince and Lincoln to have a spring constant similar to that range in order to achieve motion similar to that of a natural knee.
Regarding claim 30, Prince in view of Lincoln fails to teach a spring constant is less than 400 N/mm. However, Brito teaches that tendons in the knee have spring constants between 90 and 120 (page 2694, col 2, lines 1-11), therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to tune the mechanics of the prosthesis of Prince and Lincoln to have a spring constant similar to that range in order to achieve motion similar to that of a natural knee.
Regarding claim 31, Prince in view of Lincoln fails to teach a spring constant is greater than 100 N/mm. However, Brito teaches that tendons in the knee have spring constants between 90 and 120 (page 2694, col 2, lines 1-11), therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to tune the mechanics of the prosthesis of Prince and Lincoln to have a spring constant similar to that range in order to achieve motion similar to that of a natural knee.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774