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 08/06/26 have been fully considered but they are not persuasive.
On page 13-14 regarding prior art rejections Applicant argues amendments overcome the rejections of record since the center of Becker’s membrane is not axially compliant since it has a substantially rigid/unflexible portion 8. Applicant argues their disclosure states that their membrane is compliant.
The Examiner respectfully disagrees, noting that the center portion of the membrane has been defined by the Examiner as element 9 of Becker, which is flexible.
On pages 16-17 Applicant argues Becker’s membrane could not be modified to be compliant because it would be rendered unsatisfactory for its intended purpose, since they describe their inventive concept as having this rigid portion in the center of the membrane to allow a convexly curved spherical surface facing and matching the central concavely curved surface portion of the wall. Applicant argues modification of the membrane would thus eliminate the inventive concept of Becker.
The Examiner respectfully notes Becker’s membrane’s center portion 9 is already compliant, making this argument unpersuasive. Please see the rejection below regarding amended claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 10-12, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caspers et al. (US 20020087215 A1) hereinafter known as Caspers in view of Mosler et al. (US 6099572 A) hereinafter known as Mosler, further in view Caspers et al. (US 20040163278 A1), hereinafter known as Caspers ‘278, and further in view of Becker (US 3947156 A).
Regarding claim 1 Caspers discloses a vacuum suspension system (abstract) for use in combination with a prosthetic socket defining a cavity comprising:
a pump system including a pump mechanism (72),
wherein the system has upper (260) and lower (230) sections such that during gait or when a load is applied, the upper section moves downward relative to the lower section (Figure 24 shows the upper section 260 moved downward relative to lower section 230, as compared to Figure 25 which shows it returning to an original configuration), creating a vacuum ([0157]),
and a tube system in fluid communication with the pump mechanism and the interior cavity of the socket (76),
but is silent with regards to the system including a foot and foot cover, with the pump system disposed in a heel portion of the foot cover so the pump mechanism is separated from the foot by an outer upper surface of the foot cover, with the foot cover having thicknesses and the tube system extending through the upper thickness of the cover,
and the pump system including upper and lower sections within the foot cover so that when a load is applied, the upper section moves downward to cause a pin of the pump to push a center portion of a membrane away from a housing to increase a volume of a fluid chamber and create a vacuum.
However, regarding claim 1 Mosler teaches a system which includes a prosthetic foot (Figure 3) having an upper foot member (9) and a lower foot member disposed below the upper foot member (3), the foot having a heel member (2’) extending rearwardly to a free end and disposed below at least a portion of the lower foot member (Figure 3), wherein the foot is insertable into a foot cover (Figure 1). Caspers and Mosler are involved in the same field of endeavor, namely lower limb prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the vacuum suspension system of Caspers by including a prosthetic foot shaped by Caspers, since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). Further, it would have been obvious to one of ordinary skill to utilize a foot cover as is taught by Mosler in order to provide a barrier between the foot and the outside world, thus insulating the foot against dust, liquids, or other debris that might cause damage or harm to the foot and thus protect. Such a modification would also enable the foot to mimic the appearance of a natural foot or covered foot, thus reducing unwanted attention from strangers and making the wearer more comfortable.
Further, regarding claim 1 Caspers ‘278 teaches vacuum pump system (Figure 1 item 18) which includes a foot cover (Figure 1 item 12) and a pump mechanism disposed in a heel portion of the foot cover (Figure 1; [0009]), such that the pump mechanism is separated from a foot by an outer, upper surface of the cover (Figure 1 shows the pump embedded within the heel of the cover, being separated from the foot by the upper layer of the cover (items 12, 14) with its upper surface), wherein the pump mechanism is embedded in the heel portion of the cover such that an upper portion of the cover has a thickness between the upper half of the pump and an outer, upper surface of the cover, and a lower portion of the cover has a thickness between the lower half of the pump and an external, lower surface of the cover such that first and second side portions flank sides of the upper and lower halves of the pump system (Figure 1), and a tube system in fluid communication with the pump (Figure 1 item 22). Caspers and Caspers ‘278 are involved in the same field of endeavor, namely pump systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Caspers Mosler Combination so that the pump is embedded within the cover as is taught by Caspers ‘278 since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the repositioning of the vacuum pump mechanism of Caspers so that it lies in any weight-bearing location of the prosthesis (e.g. between the stump and socket, socket and pylon, in the pylon, between the pylon and foot, in the foot, etc.) is considered obvious as these all experience weight bearing and would be able to maintain the mode of operation of the pump. The Combination of record is accordingly understood to have the pump mechanism and system being embedded within the foot cover in the position of Caspers ‘278 Figure 1 item 20.
Further, while Caspers ‘278 teaches the tube 22 originating from a side of the pump before extending upward adjacent the thickness between the upper half of the pump and an outer upper surface of the foot cover (Figure 1), the person of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the tube system so that it extends through the thickness between the upper half of the pump and the upper outer surface of the cover since it has been held by the courts that a change in configuration, without any criticality in operation of the device, is nothing more than one of numerous configurations that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well configured as disclosed by Caspers ‘278, with the tube system positioned extending adjacent the thickness, or through the thickness.
Further, regarding claim 1 Becker teaches a pin of a pump to push a center portion of a membrane away from a housing of the system to deform the center portion of the membrane, to increase a volume of a fluid chamber, the increase in the volume creating a vacuum in the pump to draw fluid into the pump, wherein the pin deforms at least the center portion of the membrane to increase the volume of the fluid chamber (Figure 2 item 9 shows the center portion of the membrane 2 as it changes from the zero volume configuration (Figure 1) to an increased volume configuration (Figure 2), via a pin (item 8a), to create the vacuum via fluid (abstract), and also shows the pump being surrounded by a housing. Figures 1-2 also shows how the membrane 2 center deforms at 9, which is considered a central portion of the membrane 2, separated from the periphery 7),
wherein the center portion (9) of the membrane is compliant (Column 3 line 32 annular flexible portion) and axially aligned with a central axis of the pin (Figures 1-2 shows the annular portion 9 axially aligned with the central axis of pin 8a (the pin extends through the middle of the flexible annular portion 9). While Becker’s pump operates based on the operation of the crank drive shaft 12, in order to maintain the principle of operation of Caspers, which is weight-activated, the person of ordinary skill would understand that the movement of the pin 8a of Becker should be weight-activated (and accordingly protruding from an upper portion which moves downward relative to a remaining (e.g. lower) portion of the pump, which moves as a result of the user’s weight/load being applied). Caspers and Becker are involved in the same field of endeavor, namely vacuum pump systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Caspers Caspers ‘278 Mosler Combination so that the pump comprised a diaphragm pump as is taught by Becker since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). Further, the Examiner notes that in the Combination, when the pin/pump/membrane is incorporated into the Caspers Caspers ‘278 Mosler Combination, would have the weight-activated, central-axis of the pin extend through both the upper and lower sections of the Combination.
Regarding claim 2 the Caspers Caspers ‘278 Mosler Becker Combination teaches the system of claim 1 substantially as is claimed,
wherein Caspers further discloses the pump includes a housing (e.g. seen in Figure 19a) containing a valve assembly (74), and a connector (78),
the valve assembly is arranged to only allow fluid to enter the pump ([0115]), and is arranged in fluid communication with the cavity of the socket (socket not positively claimed) ([0074]), the tube system (76) being connected to the valve assembly (the Examiner references any of the embodiments of Caspers (e.g. Fig 4-16)),
and wherein Becker further teaches a vacuum pump that includes a membrane (2), valve assembly (50), housing (3), connector (10/11), and a fluid chamber being defined between the housing and membrane (Figures 1-2),
so that the valve assembly is arranged to allow fluid to enter the pump (Column 4 lines 17-19 only the valve which allows fluid to enter the pump is understood to be part of the valve assembly). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Caspers Mosler Caspers ‘278 Becker Combination so that the pump comprised a diaphragm pump as is taught by Becker since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Regarding claim 3 the Caspers Mosler Caspers ‘278 Becker Combination teaches the system of claim 2 substantially as is claimed,
wherein Becker further teaches the pump is moveable between an original configuration in which a volume of the fluid chamber defined between the membrane and housing is reduced (Figure 1) and an expanded configuration in which the volume of the fluid chamber is increased (Figure 2).
Regarding claim 10 the Caspers Mosler Caspers ‘278 Becker Combination teaches the system of claim 1 substantially as is claimed,
wherein Caspers ‘278 further teaches the pump system is concealed within the foot cover (Figure 1 shows the pump 18 concealed inside the heel of the foot cover 20; [0009]).
Regarding claim 11 the Caspers Mosler Caspers ‘278 Becker Combination teaches the system of claim 1 substantially as is claimed,
wherein Caspers further discloses one or more valve assemblies (74) to control fluid flow into and out of the pump ([0115]), wherein the tube system is connected to the one or more valve assemblies (the Examiner references any of the embodiments of Caspers (e.g. Fig 4-16)).
Regarding claim 12 the Caspers Mosler Caspers ‘278 Becker Combination teaches the system of claim 1 substantially as is claimed,
wherein Caspers further discloses the pump moves toward an original configuration when the foot cover is unloaded (see Figures 24-25 which shows the weight-activated pump with a load, and unloaded, respectfully).
Regarding claim 21 the Caspers Mosler Caspers ‘278 Becker Combination teaches the system of claim 1 substantially as is claimed,
wherein Becker further teaches the membrane is attached to the housing (Figure 2 shows membrane 2 attached to the housing at 7) such that seal is formed between the membrane and the housing (Column 1 lines 9-10; a seal is considered to be inherently present, or the device would be incapable of forming a vacuum as is described throughout).
Claims 15-16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caspers, Mosler, Caspers ‘278, and Becker as is applied above, further in view of Collier (US 20050143838 A1).
Regarding claim 15 the Caspers Mosler Caspers ‘278 Becker Combination teaches the system of claim 1 substantially as is claimed,
wherein Becker further teaches a pin member defined along a vertical moving axis (8a),
the pump including a housing (Figure 1 item K, 3) which is arranged to allow the pin member to slidably pass therethrough (Figures 1-2 shows the sliding movement of pin 8a), a membrane (2) situated on the housing (K, 3) such that a fluid chamber is defined between a side of the membrane and the housing (Figure 2 shows the fluid chamber). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Caspers Mosler Caspers ‘278 Becker Combination so that the pump comprised a diaphragm pump as is taught by Becker since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
While Becker’s pump operates based on the operation of the crank drive shaft 12, in order to maintain the principle of operation of Caspers, which is weight-activated, the person of ordinary skill would understand that the movement of the pin 8a of Becker should be weight-activated (and accordingly located on an upper portion, which moves as a result of the user’s weight/load being applied relative to a lower housing portion, which move along the axial direction shown by the pin 8a movement in Figures 1-2). This would effectively position the pump operatively and positionwise between the upper and lower sections and have the fluid chamber be defined between the upper side of the membrane and housing in order to achieve the desired vacuum.
Further, regarding claim 15 Collier teaches that it is known for mechanical pumps to include a biasing mechanism located between upper and lower sections of a pump mechanism ([0038]-[0039]) which is arranged to bias the pump toward an original configuration such that a vacuum is created in the pump during stance and automatically expels fluid to atmosphere during a swing phase of a user ([0039]). Caspers and Collier are involved in the same field of endeavor, namely vacuum pump systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Caspers Mosler Caspers ‘278 Becker Combination so that there is a biasing mechanism that ensures the pump returns to the original position (e.g. expel the fluid creating the vacuum) when the weight/load of the user is removed as is taught by Collier in order to ensure the pump of Caspers works as described, with the vacuum activating during stance, and ensure the vacuum is able to work during each step, thus maintaining the secure vacuum desired by Caspers.
Regarding claim 16 the Casper Mosler Caspers ‘278 Becker Collier Combination teaches the system of claims 1, 3, 11, and 15 substantially as is claimed,
wherein Casper further discloses the system comprises a prosthetic socket with an interior cavity (Figure 3 item 52),
and the Combination teaches the prosthetic foot is arranged to expand and compress (at least the membrane within the foot is understood to be expanding and compressing during use).
Regarding claim 20 the Casper Mosler Caspers ‘278 Becker Collier Combination teaches the system of claim 16 substantially as is claimed,
wherein Casper further discloses the system has upper (260) and lower (230) sections such that during gait or when a load is applied to the foot cover (Figure 24 shows the upper section 260 moved downward relative to lower section 230, as compared to Figure 25 which shows it returning to an original configuration).
Claim 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caspers, Mosler, Caspers ‘278, and Becker as is applied above, further in view of Halldorsson et al. (US 20130289742 A1) hereinafter known as Halldorsson.
Regarding claim 22 the Caspers Mosler Caspers ‘278 Becker Combination teaches the system of claim 21 substantially as is claimed,
wherein the Combination further teaches the seal is between the housing and an outer radial edge of the membrane (Figure 1 shows the seal connection at 7),
but is silent with regards to whether or not there is an adhesive therebetween.
However, regarding claim 22 Halldorsson teaches an adhesive can be applied between a housing an membrane in order to assist in creating a seal ([0076]). Caspers and Halldorsson are involved in the same field of endeavor, namely vacuum pump prosthetic systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Combination so that there is an adhesive between the outer radial edge of the membrane and the housing as is taught by Halldorsson in order to assist and ensure the seal is maintained, thus ensuring the continued function of the pump.
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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