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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “foot attachment section”, “topmost section”, “bottommost surface” must be shown or the feature(s) canceled from the claim(s). It appears the some of these elements may be present but are not labeled, making it difficult to determine how the invention works. The applicant has asserted that 230 refers to the foot attachment section but 230 refers to the foot component in the instant disclosure.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-4, 6, 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of Jayanti (Bends, Flow and Pressure Drop in).
In regard to claim 1, Gramnaes teaches a prosthesis or orthosis housing (see annotated fig 12), comprising:
a cylinder 16’ configured to receive a piston 9’ of a piston and cylinder assembly 16’ (fig 12);
a pump section (cavity within which pump 6’ fits within, fig 12) configured to receive part of a pump 6’;
and a plurality (defined as two or more) of passages (duct system [72]) connecting the cylinder 16’ to the pump section 6’.
However, Gramnaes does not teach the housing, cylinder, pump section, passages and housing form a unitary piece or the passages are smoothly curved along their lengths.
Jayanti teaches the plurality of passages being smoothly curved along their lengths (fig 1, section 8) and devoid of any right angled bends.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to smooth the passage turns of Gramnaes as taught by Jayanti because smoothing the turns will decrease friction and pressure loss for a more efficient system (paragraph 2: factors depend on the bend angle, curvature ratio)
It has been held that making multiple parts integral, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the housing (see annotated figure), cylinder 16’, pump section (section that contains pump 6’), passages (duct system [72]) one integral piece rather than multiple pieces because it appears either arrangement would work equally well. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04VB
In regard to claim 2, Gramnaes meets the claim limitations as discussed in the rejection of claim 1, and further teaches the prosthesis housing (see annotated figure 12) is an ankle prosthesis housing (fig 12, see joint 10’) and further comprises a foot attachment section (see annotated figure, lip on housing) configured for attaching the housing to a foot component 14 (fig 12).
In regard to claim 3, Gramnaes meets the claim limitations as discussed in the rejection of claim 1, and further teaches one or more apertures (see duct within which 7’ fits, fig 12; [0071]) configured to receive one or more respective valves 7’, 8’ for controlling fluid flow through one or more of the passages. [0071: closes the ducts]
In regard to claim 4, Gramnaes meets the claim limitations as discussed in the rejection of claim 3, and further teaches one or more of the valves 8’, 7’ is an adjustable orifice valve. [0071: dampening can be adjusted by varying the opening degree of the valve]
In regard to claim 6, Gramnaes meets the claim limitations as discussed in the rejection of claim 1, and further teaches an aperture configured to receive a switch 7’, 8’ to be fluidly connected to one of more of the passages (see fig 12, ducts) such that the switch switches the prosthesis housing between first and second modes of operation [0071: free swinging, locked are first and second modes].
In regard to claim 10, Gramnaes meets the claim limitations as discussed in the rejection of claim 1, but does not teach the radius of curvature as claimed.
Jayanti further teaches a plurality (defined as two or more) of the passages (ducts) are devoid of any bends having a radius of curvature of less than a third of the passage width or diameter (this is interpreted as best understood to mean devoid of sharp turns essentially). As shown in formula 1 and figure 3 of Jayanti it is desirable to have gradual turns to prevent pressure loss.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have bends only greater than a third of the passage width or diameter as taught by Jayanti in the invention of Gramnaes to prevent pressure loss. (See figure 3, loss coefficient kb increased with a sharper turn which is indicated by a smaller angle in the figure)
In regard to claims 9 and 11, Gramnaes meets the claim limitations as discussed in the rejection of claim 1 but does not teach the radius of curvature as claimed.
Jayanti further teaches a plurality (defined as two or more) of the passages (ducts) are devoid of any bends having a radius of curvature of less than a quarter of the passage width or diameter (this is interpreted as best understood to mean devoid of sharp turns essentially; also encompasses less than one half). As shown in formula 1 and figure 3 of Jayanti it is desirable to have gradual turns to prevent pressure loss.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have bends only greater than a quarter of the passage width or diameter as taught by Jayanti in the invention of Gramnaes to prevent pressure loss. (See figure 3, loss coefficient kb increased with a sharper turn which is indicated by a smaller angle in the figure)
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of in view of Jayanti (Bends, Flow and Pressure Drop in) and further in view of Jeffrey (2267656).
In regard to claim 5, Gramnaes meets the claim limitations as discussed in the rejection of 1, but remains silent to if the cone valve 7’, 8’ is a check valve.
Jeffrey teaches one or more of the valves is a check valve. (169: tapered cone check valve)
It would have been obvious to one of ordinary skill in the art of hydraulic valves at the time the invention was filed to substitute the valve of Gramnaes for the valve of Jeffrey through functional substitution since both valves are cone valves which control the flow of hydraulic fluid. MPEP 2144.06II
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of in view of Jayanti (Bends, Flow and Pressure Drop in) and further in view of Jeffrey (2267656).
In regard to claim 14, Gramnaes meets the claim limitations as discussed in the rejection of 1, but remains silent to if the cone valve 7’, 8’ is a check valve.
Jeffrey teaches one or more of the valves is a check valve. (169: tapered cone check valve)
It would have been obvious to one of ordinary skill in the art of hydraulic valves at the time the invention was filed to substitute the valve of Gramnaes for the valve of Jeffrey through functional substitution since both valves are cone valves which control the flow of hydraulic fluid. MPEP 2144.06II
Claims 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of in view of Jayanti (Bends, Flow and Pressure Drop in) and further in view of Palmer (2007/0027555A1).
In regard to claim 7, Gramnaes meets the claim limitations as discussed in the rejection of claim 6, but does not teach the switch (valve) is a solenoid.
Palmer teaches the switch to be received in the aperture is a solenoid 52.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to substitute the solenoid valve of Palmer in place of the cone valve of Gramnaes because the valve is able to be controlled by a processor for more advanced programming [0033].
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of in view of Jayanti (Bends, Flow and Pressure Drop in) and further in view of Fairbanks (WO2010/005473A1).
In regard to claim 8, Gramnaes meets the claim limitations as discussed in the rejection of claim 1, and further the pump 6’ connected to the housing (fig 12).
However, Gramnaes remains silent to the type of hydraulic pump used and a mount.
Fairbanks teaches the pump section is configured to receive two gears of a gear pump [0028] (a gear pump must have at least two gears to operate; see 196, 197 parts of pump 201) and a mount for mounting the pump [0085: mounting plate 191].
It would have been obvious to one of ordinary skill in the art at the time the instant invention was filed to substitute the pump and pump mount of Fairbanks in place of the pump of Gramnaes through functional substitution since both pumps are used for a prosthetic hydraulic system and the mount plate is how the pump of Fairbanks is connected. MPEP 2144.06II
Claim 12-14, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of in view of Steinberg (WO9905991A2).
In regard to claim 12, Gramnaes discloses a prosthesis (prosthesis, fig 11) or orthosis, comprising:
a prosthesis or orthosis housing (see annotated figure 11), including:
a cylinder 16;
an accessory interface section (see annotated figure 11) connected and arranged adjacent to the cylinder 16 (see fig 11),
the accessory interface section (see annotated figure) comprising a topmost surface forming a pump interface (interface to 6) and a bottommost surface (distal surface);
a plurality (defined as two or more) of passages (see annotated figure; [0070: duct system]) connecting the cylinder 16 to the pump interface (interface to 6);
and a bridging plate (distal male pyramid plate, see annotated figure, bridges the knee joint to the rest of the prosthesis) connected to the cylinder 16 (indirectly connected to the cylinder 16 via the accessory interface section; see annotated figure) and extending beyond the bottommost surface (interpreted as the bottommost surface of the accessory interface; see annotated figure, extends distally to the accessory interface);
a piston 9 and piston rod housed 10 within the cylinder 16 (fig 11);
and a pump 6 mounted to the pump interface (mounted to cavity within which 6 fits, fig 11.
However, Gramnaes does not teach at least one passage of the plurality of passages opens to an exterior surface of the housing.
Steinberg teaches in a connected state at least one passage of the plurality of passages extends through the pump interface and opens to an exterior surface of the housing (42, extends outside the hydraulic unit and entire prosthesis in figure 1).
It would have been obvious to one of ordinary skill in the art at the time of prosthetic devices at the invention was filed to use the outlet channel of Steinberg in the device of Gramnaes because the outlet allows the amount of fluid in the system to be adjusted without disassembling the prosthesis. (pg 8, lines 2-5) When applied to the device of Gramnaes, one of ordinary skill would place the outlet of Steinberg through the pump interface as this is where there is space to put the outlet. Further, the location of the outlet is no more than design choice.
In regard to claim 13, Gramnaes discloses the prosthesis or orthosis as recited in claim 12, wherein the prosthesis or orthosis housing (see annotated figure) further comprises an actuator interface (see annotated figure) including an aperture (passage within which the valve 8 fits) fluidly connecting the actuator interface to the cylinder 16.
In regard to claim 14, Gramnae discloses the prosthesis or orthosis as recited in claim 13, further comprising a switch 8 (acts as a switch by turning the brake on or off) arranged in the aperture (passage surrounding valve 8, fig 11), the switch operatively arranged to switch the prosthesis or orthosis between first and second modes of operation. [0071: braked or free swinging]
In regard to claim 16, Gramnaes discloses the prosthesis or orthosis as recited in claim 12, further comprising one or more adjustable orifice valves. 7 [0070: cone valve]
In regard to claim 17, Gramnaes discloses the prosthesis or orthosis as recited in claim 12, further comprising one or more apertures (channel within which 8 fits, fig 11; 0070:duct work) configured to receive one or more respective valves 8, 7 for controlling fluid flow through one or more of the passages. [0071]
In regard to claim 18, Gramnaes discloses the prosthesis or orthosis as recited in claim 17, and further discloses one or more of the valves is an adjustable orifice valve. 7 [0070: cone valve]
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Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of in view of Steinberg (WO9905991A2) and further in view of Palmer (2007/0027555A1).
In regard to claim 15, Gramnaes meets the claim limitations as discussed in the rejection of claim 14, but does not teach a solenoid.
Palmer teaches the switch to be received in the aperture is a solenoid 52.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to substitute the solenoid valve of Palmer in place of the valve of Gramnaes because the valve is able to be controlled by a processor for more advanced programming [0033].
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of in view of Steinberg (WO9905991A2) and further in view of in view of Jeffrey (2267656).
In regard to claim 19, Gramnaes meets the claim limitations as discussed in the rejection of claim 17, but does not teach the use of a check valve.
Jeffrey teaches one or more of the valves is a check valve. (169: tapered cone check valve)
It would have been obvious to one of ordinary skill in the art of hydraulic valves at the time the invention was filed to substitute the valve of Gramnaes for the valve of Jeffrey through functional substitution since both valves are cone valves which control the flow of hydraulic fluid. MPEP 2144.06II
Claim 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gramnaes (2015/0320573A1) in view of in view of Steinberg (WO9905991A2).
In regard to claim 20, Gramnaes discloses a prosthesis (ankle prosthesis, fig 12) or orthosis, comprising:
an ankle prosthesis or orthosis housing (see annotated figure 12), including:
a cylinder 16’;
a pump section 6’;
a first passage (see annotated figure 12) fluidly connecting the cylinder 16’ to the pump section 6’;
a second passage (see annotated figure 12) fluidly connecting the cylinder 16’ to the pump section 6’;
a third passage fluidly (see annotated figure 12) connecting the first passage to the second passage (see annotated figure 12);
and an actuator interface section (accessory interface section in annotated figure 12) including a platform (see annotated fig 12) comprising an aperture (see space within the platform where the passages connect; 0070: ducts),
the aperture fluidly connected to the third passage (see annotated figure 12);
and a foot attachment section (see lip on annotated figure) configured for attaching the ankle prosthesis or orthosis housing to a foot component 14 (see fig 12).
However, Gramnaes does not teach the aperture extending through the platform opens to an outer surface of the housing.
Steinberg teaches the aperture extending through the platform opens to an outer surface of the housing (42, extends outside the hydraulic unit and entire prosthesis in figure 1).
It would have been obvious to one of ordinary skill in the art at the time of prosthetic devices at the invention was filed to use the outlet channel of Steinberg in the device of Gramnaes because the outlet allows the amount of fluid in the system to be adjusted without disassembling the prosthesis. (pg 8, lines 2-5) When applied to the device of Gramnaes, one of ordinary skill would place the outlet of Steinberg through the platform and housing in order to be able to connect the hydraulic system to outside the foot. Further, the location of the outlet is no more than design choice.
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Response to Arguments
In regard to the drawing objections, the applicant asserts that figures 12 and 14 shown the pump 244 and figures 11, 12 and 14 show foot attachment section 230. The arguments regarding the pump are found convincing and this objection is withdrawn. If the foot attachment section is 230, then the specification lacks antecedent basis for the terminology used in the claims. The applicant’s arguments do not address the lack of labeling for the topmost section or bottommost surface.
In regard to the 103(a) rejection of claims 1-4, 6 and 9-11 as unpatentable over Gramnaes (2015/0320573A1) in view of Jayanti (Bends, Flow and Pressure Drop in), the applicant’s arguments have been fully considered. The applicant argues that the pump, cylinder and passages and housing of Gramnaes cannot form a unitary piece because the valve cone and springs would not be able to be assembled therein or the brake unit and valve. Unitary has not been specially defined in the instant disclosure. The ordinary definition of unitary is “forming a whole”. Unitary is interpreted as best understood the parts are connected together to form a single product. It is unclear what the applicant intends the terminology “unitary” to mean. The applicant’s own application contains check valves which contain a spring. Therefore they can be made unitary in as much as the components of the instant invention can.
The applicant argues that Jayanti does not teach the use of non-right angle bends over right angle bends and states that figure 1 of Jayanti shows right angle bends. The applicant states that Jayanti shows a 90 degree bend has higher bend loss coefficients than some non right angle bends and not than others. Figure 3 clearly shows that the bend loss coefficient increases with increasing bend angle (radius), though there are some other factors such as friction and pipe diameter that also influence this factor.
The applicant argues that modifying Gramnaes to include non-right angle bends would be impractical, expensive and render the operation inoperable. The applicant argues that if Gramnaes were modified to remove all right angle bends, valve cone 7 would be forced to interact with angled apertures A which would decrease the pump efficiency. It is unclear from the annotated figure what the applicant is trying to argue. It does not appear that chancing the angle of the bends would affect the cone valve 7 as all passages leading into the cone valve are straight at the connection point. The applicant is arguing all orifices would be angled going into the valve but this modification would not require angled orifices off a straight passageway. The applicant further argues that modifying the passages to be devoid of right angles would require a tremendous amount of milling and increased expense. The applicant has not provided any evidence of the claimed issues and these still do not negate the motivation or teach against performing the change in bends for other reasons.
The applicant further argues impermissible hindsight in modifying the primary reference but has not pointed out any particular reasons or evidence. Impermissible hindsight means the motivation would have come from the instant disclosure. All motivations cited case law or came from the secondary references themselves.
In regard to the 103(a) rejection of claims 5 and 14 as unpatentable over Gramnaes (2015/0320573A1) in view of Jayanti (Bends, Flow and Pressure Drop in) and further in view of Jeffrey (2267656),
In regard to the 103(a) rejection of claim 7 as unpatentable over Gramnaes (2015/0320573A1) in view of Jayanti (Bends, Flow and Pressure Drop in) and further in view of Palmer (2007/0027555A1),
In regard to the 103(a) rejection of claim 8 as unpatentable over Gramnaes (2015/0320573A1) in view of Jayanti (Bends, Flow and Pressure Drop in) and further in view of Fairbanks (WO2010/005473A1)
In regard to the 102(a)(1) rejection of claims 12-14 and 16-18 as unpatentable over Gramnaes (2015/0320573A1), the applicant’s arguments have been fully considered but have all been directed toward new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim 15 as unpatentable over Gramnaes (2015/0320573A1) in view of Palmer (2007/0027555A1), no further arguments have been presented.
In regard to the 103(a) rejection of claim 19 as unpatentable over Gramnaes (2015/0320573A1) in view of Jeffrey (2267656), no further arguments have been presented.
In regard to the 102(a)(1) rejection of claim 20 as anticipated by Gramnaes (2015/0320573A1), the applicant’s arguments have been fully considered but have all been directed toward new claim limitations which have been addressed above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774