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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/15/2025 has been entered. Claims 1-37 are currently pending in this application. Claims 2, 3, 15-18, 31-34, and 36 are withdrawn.
Response to Arguments
Applicant's arguments filed 9/15/2025 have been fully considered but they are not persuasive.
With regard to applicant’s argument on page 8 that Lohmann fails to teach shims or compression areas that have a durometer and radial thickness that compress the limb with sufficient force to reduce radial motion of the bone, the examiner disagrees. The shims of Lohmann have a durometer since they are made of a material that inherently has a hardness or stiffness to some degree. The shims also inherently have a radial thickness, regardless of whether or not they are thin, as suggested by applicant. The shims (36 and 38) are laminated onto the inner and outer surfaces of the liner (32) (col. 4, lines 11-15), which means that they are assembled onto the liner in a way that makes the liner thicker at the portions on which the shims are located. The thicker portions of the liner, which include the shims laminated thereon, alternate with the portions of the liner on which shims are not laminated, creating a pattern of alternating areas of thickness. The thicker portions will press into the skin more than their thinner counterparts such that the alternating areas are a pattern of alternating higher compression areas and lower compression areas. The examiner therefore maintains that the shims of Lohmann are fully capable of compressing soft tissue of the body part against the skeletal structure when the interface and liner are worn on the body part.
As stated in the previous office action, the limitation regarding reduction in motion is a contingent limitation. MPEP 2111.04, section II. states that a method claim having contingent limitations, such as lines 11-12 that recite “to compress soft tissue of the body part against the skeletal structure when the interface and liner are worn on the body part with sufficient force to reduce radial motion of the skeletal structure”, requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, since the claim is directed toward a method of fabricating a liner, which does not require a step of subjecting the liner to motion when worn, the limitation of reducing radial motion of the skeletal structure is not required. Lohmann clearly teaches that the shims control the rotational movement (col. 4, lines 54-56; the rotational movement is construed to be the same as radial motion) such that the liner reduces or prevents movement of the residual limb relative to the prosthesis (col. 3, lines 46-49). Therefore, the examiner maintains that the shims of Lohmann are fully capable of compressing soft tissue of the body part against the skeletal structure with sufficient force to reduce radial motion of the skeletal structure when the interface and liner are worn on the body part, as claimed, particularly since the liner encircles the skeletal structure and reduces radial motion, taught by Lohmann.
Claim Objections
Claims 1 and 35 are objected to because of the following informalities: Claims 1 and 35 each recite “the interface” in line 6, which lacks antecedent basis and should be amended to recite – an interface –. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-14, 19-30, 35, and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “sufficient” in each of claims 1, 13, and 35 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The force with which the soft tissue of the body part is compressed against the skeletal structure when the interface and liner are worn on the body part is rendered indefinite by the use of the term “sufficient”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 7, 8, 12, 13, 19-21, 24, 26, 29, 30, and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,728,167 to Lohmann (Lohmann).
Regarding at least claim 1
Lohmann teaches a prosthetic sock (liner) for reducing movement of a residual limb within a prosthetic socket (interface) of a prosthesis (abstract).
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Lohmann meets the limitations of a method of fabricating a liner (sock; 32) for reducing motion of a skeletal structure in a body part, the method comprising: selecting a plurality of shims (movement opposing patch surfaces; 36) each having a durometer, a radial thickness, a width, a longitudinal dimension, and a volume (each shim 36 necessarily has a durometer, a radial thickness, a width, a longitudinal dimension, and a volume); lying the longitudinal dimension of each shim along a longitudinal dimension of the liner prior to or after donning the interface over the liner (col. 3, lines 64-67 through col. 4, lines 1-2 disclose that the shims 36 are integral with the material 34 of the sock 32 and col. 4, lines 44-56 discloses donning the sock/liner with integral shims prior to donning the socket/interface 23), wherein the longitudinal dimension of the liner extends from a distal end to a proximal end of the liner (fig. 2 shows that the longitudinal dimension extends from a distal to a proximal end of the sock/liner); spacing each shim circumferentially around the liner (it can be seen from fig. 2, for example, that the shims are spaced circumferentially around the liner) to create a pattern of alternating higher compression areas and lower compression areas (the shims 36 and 38 are laminated onto the inner and outer surfaces of the liner 32, as disclosed in col. 4, lines 11-15, which means that they are assembled onto the liner in a way that makes the liner thicker at the portions on which the shims are located; the thicker portions of the liner, which include the shims laminated thereon, alternate with the portions of the liner on which shims are not laminated, creating a pattern of alternating areas of thickness; the thicker portions will press into the skin more than their thinner counterparts such that the alternating areas are a pattern of alternating higher compression areas and lower compression areas); and selecting the durometer, radial thickness, width, longitudinal dimension, and volume of the plurality of shims to compress soft tissue of the body part against the skeletal structure when the interface and liner are worn on the body part with sufficient force to reduce radial motion of the skeletal structure (col. 3, lines 46-49 discloses that the present invention provides a sock for reducing or preventing movement of the residual limb relative to the prosthesis and col. 4, lines 51-56 discloses that the movement-opposing patch surfaces, which have a selected durometer, radial thickness, width, longitudinal dimension, and volume, provide a friction component to control the rotational movement).
Regarding at least claim 4
Lohmann teaches the method of claim 1, wherein each shim extends at least approximately 10% the longitudinal dimension of the liner (fig. 2 shows that the shims extend at least approximately 10% of the longitudinal dimension of the sock/liner).
Regarding at least claim 5
Lohmann teaches the method of claim 1, wherein the plurality of shims has an increased thickness relative to the spaces between the shims (col. 4, lines 11-17 discloses that the shims are laminated onto the inner and outer surfaces of the sock/liner and therefore result in an increased thickness relative to the spaces between the shims as claimed).
Regarding at least claim 7
Lohmann teaches the method of claim 1, wherein the liner comprises a sleeve configuration having a proximal open end and a distal open end (col. 3, lines 9-10 discloses the sock/sleeve having an opening at end 18 for protrusions of the locking stud and it can be seen from fig. 1 that the sock also has an open proximal end).
Regarding at least claim 8
Lohmann teaches the method of claim 1, wherein at least one area between the plurality of shims is an open (the space between each shim is construed to be open because it would be lower in compression than the areas of shims, the term “open” is interpreted in light of applicant’s specification which discloses open or low compression areas in paragraph 0006).
Regarding at least claim 12
Lohmann teaches the method of claim 1, further comprising the step of adjusting at least one of durometer, radial thickness, width, longitudinal dimension, or volume of at least one shim (col. 3, lines 22-26 discloses accommodating periodic fluctuations in the size of the limb by adjusting the compression factors needed for a proper fit including prosthetic socks of varying thicknesses and combinations and col. 4, lines 56-63 discloses using several socks with aligned movement-opposing patch surfaces/shims, which would result in an adjustment of volume or durometer of at least one shim).
Regarding at least claim 13
Similar to the explanation above, Lohmann meets the limitations of a method of fabricating a liner (sock; 32) for reducing radial motion of a skeletal structure in a body part, the method comprising: selecting a plurality of attachment areas (36) each having a durometer, a radial thickness, a width, a longitudinal dimension, and a volume (each area necessarily has a durometer, a radial thickness, a width, a longitudinal dimension, and a volume); lying the longitudinal dimension of each attachment area along a longitudinal dimension of the liner (each attachment area lies along a longitudinal dimension of the sock/liner), wherein the longitudinal dimension of the liner extends from a distal end to a proximal end of the liner (fig. 2); spacing each attachment area circumferentially around the liner to create a pattern of alternating higher compression areas and lower compression areas (the attachment areas 36 are laminated onto the liner 32, as disclosed in col. 4, lines 11-15, which means that they are assembled onto the liner in a way that makes the liner thicker at the portions on which the shims are located; the thicker portions of the liner, which include the attachment areas laminated thereon, alternate with the portions of the liner on which attachment areas are not laminated, creating a pattern of alternating areas of thickness; the thicker portions will press into the skin more than their thinner counterparts such that the alternating areas are a pattern of alternating higher compression areas and lower compression areas); selecting a shim for each of the plurality of attachment areas (fig. 4 shows the attachment areas 36 on the outside of the liner and selecting an opposing patch surface/shim 47 to be included on the inside thereof; col. 4, lines 35-39), wherein each shim has a durometer, a radial thickness, a width, a longitudinal dimension, and a volume (each shim necessarily has a durometer, a radial thickness, a width, a longitudinal dimension, and a volume); affixing the shims to the plurality of attachment areas prior to or after donning an interface over the liner (the shims 47 are laminated onto the sock/liner prior to donning the socket 23 as disclosed in col. 4, lines 17-21 and lines 44-56), such that the longitudinal dimension of each shim aligns with the longitudinal dimension of the liner (fig. 2 shows that the longitudinal dimensions align); selecting the durometer, radial thickness, width, longitudinal dimension, and volume of each shim to radially compress soft tissue of the body part against the skeletal structure when the interface and liner are worn on the body part with sufficient force to reduce radial motion of the skeletal structure (col. 3, lines 46-49 discloses reducing or preventing movement of the residual limb relative to the prosthesis and col. 4, lines 51-56 discloses that the attachment areas and shims, which have a selected durometer, radial thickness, width, and longitudinal dimension, provide a friction component to control the rotational movement).
Regarding at least claim 19
Lohmann teaches the method of claim 13, wherein the plurality of attachment areas have an increased thickness relative to the spaces between the attachment areas (col. 4, lines 56-61 discloses combining several such prosthetic socks/liners with patch surfaces/shims being aligned to achieve the proper thickness and compression factors – donning an additional sock/liner to the originally donned sock/liner is construed to meet the limitation of increased thickness where the patch surfaces/shims are aligned relative to the spaces between).
Regarding at least claim 20
Lohmann teaches the method of claim 13, wherein the step of selecting the radial thickness, width, longitudinal dimension, and volume of the shims comprises selecting the shims from a plurality of component parts (col. 4, lines 59-63 discloses that several socks of different thicknesses, which are construed to be a plurality of component parts, may be used).
Regarding at least claim 21
Lohmann teaches the method of claim 13, wherein each of the shims has a durometer adapted to permit a user to don and doff the liner while the shims are attached to the attachment areas (col. 4, lines 44-47 discloses donning the prosthetic sock, which includes the shims 47 attached to the attachment areas).
Regarding at least claim 24
Lohmann teaches the method of claim 13, wherein the liner is integrally formed with the shims (once the shims 47 are in place they are construed to be integrally formed with the sock/liner).
Regarding at least claim 26
Lohmann teaches the method of claim 13, further comprising the step of donning the liner and affixing the shims to the attachment areas after the liner is donned (col. 4, lines 56-61 discloses combining several such prosthetic socks/liners with patch surfaces being aligned to achieve the proper thickness and compression factors – donning an additional sock/liner to the originally donned sock/liner is construed to meet the limitation of affixing shims to the attachment areas after the original sock/liner is donned).
Regarding at least claim 29
Lohmann teaches the method of claim 13, wherein the proximal end and distal end of the liner are both open ends (col. 3, lines 8-10 disclose an open distal end and fig. 1 shows that the proximal end is open for insertion of the stump).
Regarding at least claim 30
Lohmann teaches the method of claim 13, wherein at least one area between the plurality of attachment areas is an open area (the areas between each attachment area/shim would be open/lower in compression than the areas of shims).
Regarding at least claim 35
Similar to the explanation above, Lohmann meets the limitations of a method of fabricating a liner (sock; 32) for reducing radial motion of a skeletal structure in a body part, the method comprising: selecting a plurality of compression areas (areas at which movement-opposing patch surfaces/shims are located) each having a durometer, a radial thickness, a width, a longitudinal dimension, and a volume (each patch area/shim necessarily has a durometer, a radial thickness, a width, a longitudinal dimension, and a volume); lying the longitudinal dimension of each compression area along a longitudinal dimension of the liner prior to or after donning the interface over the liner, wherein the longitudinal dimension of the liner extends from a distal end to a proximal end of the liner (fig. 2, for example, shows that the patch areas lie along the longitudinal dimension); spacing each compression area circumferentially around the liner (fig. 2 shows that the patch areas/shims are spaced circumferentially around the liner) to create a pattern of alternating higher compression areas and lower compression areas (the shims 36 and 38 are laminated onto the inner and outer surfaces of the liner 32, as disclosed in col. 4, lines 11-15, which means that they are assembled onto the liner in a way that makes the liner thicker at the portions on which the shims are located; the thicker portions of the liner, which include the shims laminated thereon, alternate with the portions of the liner on which shims are not laminated, creating a pattern of alternating areas of thickness; the thicker portions will press into the skin more than their thinner counterparts such that the alternating areas are a pattern of alternating higher compression areas and lower compression areas); affixing each compression area to the liner (col. 4, lines 11-25 discloses lamination for fixation of the patch areas); and selecting the durometer, radial thickness, width, longitudinal dimension, and volume of the plurality of compression areas to radially compress soft tissue of the body part against the skeletal structure when the interface and liner are worn on the body part with sufficient force to reduce radial motion of the skeletal structure (col. 3, lines 46-49 discloses that the present invention provides a sock for reducing or preventing movement of the residual limb relative to the prosthesis and col. 4, lines 51-56 discloses that the movement-opposing patch surfaces, which have a selected durometer, radial thickness, width, longitudinal dimension, and volume, provide a friction component to control the rotational movement/radial motion).
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) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lohmann, as applied to claims 1 and 13 above.
Regarding at least claim 6
Lohmann teaches the method of claim 1, including that each shim has a maximum radial thickness greater than a minimum radial thickness of the areas between the shims. However, Lohmann does not explicitly teach wherein the maximum radial thickness of each shim is at least 0.4 mm greater than the minimum radial thickness of the areas between the shims.
There is no evidence of record that establishes that specifying that the maximum radial thickness is at least 0.4 mm greater than the minimum radial thickness would result in a difference in function of the Lohmann device. Further, a person having ordinary skill in the art, being faced with modifying the radial thickness, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed difference in radial thickness. Lastly, applicant has not disclosed that the claimed difference in radial thickness solves any stated problem, indicating that the maximum radial thickness is at least 0.4 mm greater than the minimum radial thickness “in an exemplary method” (specification at para. [0068]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the maximum radial thickness to be at least 0.4 mm greater than the minimum radial thickness, as an obvious matter of design choice within the skill of the art.
Regarding at least claim 14
Lohmann teaches the method of claim 13. Lohmann also teaches that the size, shape, number and/or placement of the movement-opposing patch surfaces may vary (col. 4, lines 67 through col. 5, lines 1-2). However, Lohmann does not explicitly teach wherein at least one of the attachment areas is in a discontinuous configuration.
There is no evidence of record that establishes that changing the configuration of Lohmann to be discontinuous would result in a difference in function of the Lohmann device. Further, a person having ordinary skill in the art, being faced with modifying the configuration, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed discontinuous configuration. Lastly, applicant has not disclosed that the claimed discontinuous configuration solves any stated problem, indicating that the configuration may be discontinuous or uniform (specification at para. [00014]) and therefore there appears to be no criticality placed on the configuration as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the configuration of Lohmann, as an obvious matter of design choice within the skill of the art.
Claim(s) 9, 10, 11, 25, 27, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lohmann, as applied to claims 1 and 13 above, in view of US Patent Application Publication No. 2011/0247321 A1 to Streeter et al. (Streeter).
Regarding at least claim 9
Lohmann teaches the method of claim 1, including achieving the proper compression factors of the prosthetic sock(s)/liner(s) to accommodate periodic fluctuations in the size of the residual limb (col. 3, lines 22-26). However, Lohmann does not explicitly teach further comprising the step of integrating or attaching one or more sensors with one or more shims.
Streeter teaches a support apparatus (10) for upper-limb and lower-limb prosthetic devices or any device with interaction with the body (paragraph 0004). Streeter also teaches attaching actuators, which may be bladders (shims), to the frame of the support (paragraph 0102) and controlling the actuators in response to pressure detected by sensors (paragraph 0006), for the purpose of changing the geometry and volume of the support to secure the support apparatus to the residuum and to account for morphing in the residuum (paragraph 0095). In some embodiments, a load cell may measure an aggregate load that is being transferred from the prosthesis to the residual anatomy through the support (10) and the measurements may be transmitted to a control system (18) through wireless data transmission so that the control system may analyze that data to infer the user’s activity level and determine whether to increase or decrease one or more pressure setpoints (paragraph 0200).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lohmann, which is intended to provide compression factors needed for a proper fit while accommodating periodic fluctuations in the size of the residual limb, to include the step of integrating or attaching one or more sensors with one or more shims, in order to change the geometry and volume of the support to secure the support apparatus to the residuum and to account for morphing in the residuum by controlling the actuators/shims in response to pressure detected by sensors, as taught by Streeter.
Regarding at least claim 10
Lohmann in view of Streeter teaches the method of claim 9. Streeter also teaches that, in some embodiments, a load cell may measure an aggregate load that is being transferred from the prosthesis to the residual anatomy through the support (10) and the measurements may be transmitted to a control system (18) through wireless data transmission so that the control system may analyze that data to infer the user’s activity level and determine whether to increase or decrease one or more pressure setpoints (paragraph 0200), which meets the limitation of the step of sending data from the one or more sensors to a device.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Lohmann in view of Streeter, which accounts for morphing in the residuum by controlling the actuators/shims in response to pressure detected by sensors, to include the step of sending data from the one or more sensors to a device, in order to analyze the sensor data, as taught by Streeter, and determine whether to adjust the compression/pressure, as intended by both Lohmann and Streeter.
Regarding at least claim 11
Lohmann in view of Streeter teaches the method of claim 10. Streeter further teaches wherein the data includes a localized pressure (paragraph 0111 discloses that the control system, which receives the data from the sensors as explained above, makes use of a manifold with pressure selectors for allowing the user to adjust the pressure in the plurality of bladders by different amounts resulting in the capability of pinpoint adjustment based on localized instability or discomfort).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Lohmann in view of Streeter to specify that the data includes a localized pressure, in order to allow the user to adjust the pressure in the plurality of bladders by different amounts resulting in the capability of pinpoint adjustment based on localized instability or discomfort, as taught by Streeter.
Regarding at least claim 25
Lohmann teaches the method of claim 13, wherein at least one of the plurality of attachment areas is movement-opposing patch surface for producing friction and thereby controlling rotational movement (and movement in general) (col. 4, lines 35-39), and therefore meets the limitation that the friction is increased against the socket wall to resist or prevent slippage of the liner with respect to the socket wall. However, Lohmann does not explicitly teach wherein the attachment area or shims have a raised texture.
Streeter teaches a support apparatus for upper-limb and lower-limb prosthetic devices or any device with interaction with the body (paragraph 0004). Streeter also teaches attaching actuators, which may be bladders, to the frame of the support using any fastening mechanism, such as Velcro and/or glue (paragraph 0102), for the purpose of changing the geometry and volume to secure the support apparatus to the residuum and to account for morphing in the residuum (paragraph 0095).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the attachment area or shims have a raised texture, for example Velcro, since this fastening mechanism is known in the art for use in attaching longitudinal components to one another, as taught by Streeter.
Regarding at least claim 27
Lohmann teaches the method of claim 13, wherein at least one of the plurality of attachment areas is movement-opposing patch surface for producing friction and thereby controlling rotational movement (and movement in general) (col. 4, lines 35-39). However, Lohmann does not teach that at least one of the plurality of attachment areas comprises a hook or loop fastener material.
Streeter teaches a support apparatus for upper-limb and lower-limb prosthetic devices or any device with interaction with the body (paragraph 0004). Streeter also teaches attaching actuators, which may be bladders, to the frame of the support using any fastening mechanism, such as Velcro and/or glue (paragraph 0102), for the purpose of changing the geometry and volume to secure the support apparatus to the residuum and to account for morphing in the residuum (paragraph 0095).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify to specify that the attachment area or shims comprises a hook or loop fastener material, since this fastening mechanism is known in the art for use in attaching longitudinal components to one another, as taught by Streeter.
Regarding at least claim 37
Lohmann teaches the method of claim 13, including achieving the proper compression factors of the prosthetic sock(s)/liner(s) to accommodate periodic fluctuations in the size of the residual limb (col. 3, lines 22-26). However, Lohmann does not explicitly teach further comprising the step of integrating or attaching one or more sensors with one or more attachment areas.
Streeter teaches a support apparatus (10) for upper-limb and lower-limb prosthetic devices or any device with interaction with the body (paragraph 0004). Streeter also teaches attaching actuators, which may be bladders (attachment areas), to the frame of the support (paragraph 0102) and controlling the actuators in response to pressure detected by sensors (paragraph 0006), for the purpose of changing the geometry and volume of the support to secure the support apparatus to the residuum and to account for morphing in the residuum (paragraph 0095). In some embodiments, a load cell may measure an aggregate load that is being transferred from the prosthesis to the residual anatomy through the support (10) and the measurements may be transmitted to a control system (18) through wireless data transmission so that the control system may analyze that data to infer the user’s activity level and determine whether to increase or decrease one or more pressure setpoints (paragraph 0200).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lohmann, which is intended to provide compression factors needed for a proper fit while accommodating periodic fluctuations in the size of the residual limb, to include the step of integrating or attaching one or more sensors with one or more attachment areas, in order to change the geometry and volume of the support to secure the support apparatus to the residuum and to account for morphing in the residuum by controlling the actuators/shims in response to pressure detected by sensors, as taught by Streeter.
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lohmann, as applied to claim 13 above, in view of US Patent Application Publication No. 2014/0121783 A1 to Alley (Alley ‘783).
Regarding at least claim 22
Lohmann teaches the method of claim 13, including use of a liner (32). However, Lohmann does not teach the step of applying an alignment indicator to the liner in such a way that a user can align the alignment indicator to an anterior midline of the body part.
Alley ‘783 teaches an adaptable socket system, method, and kit (title). Fig. 14 of Alley ‘783 includes a physical feature alignment marking (1421) on the liner (1416), for the purpose of aligning with bony prominences or other readily locatable physical features of the target in order to ensure proper placement of paddles for optimal tissue compression (paragraph 0135 and claim 18).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the step of applying an alignment indicator to the liner of Lohmann, which includes struts for compression of the soft tissue, in such a way that a user can align the alignment indicator to an anterior midline of the body part, in order to ensure proper placement for optimal tissue compression, as taught by Alley ‘783.
Regarding at least claim 23
Lohmann in view of Alley ‘783 teaches the method of claim 22. Lohmann also teaches four struts (6) designed to partially encompass the residual limb, allowing soft tissue to flow through windows (7) (paragraph 0068).
Alley ‘783 further teaches wherein the alignment indicator (1416) represents zero degrees (paragraph 0135; it is noted that the alignment indicator is construed to represent zero degrees since this term is relative), and the plurality of attachment areas comprise four attachment areas circumferentially located approximately at 45, 135, 225, and 315 degrees relative to the alignment indicator (paragraph 0070 discloses four attachment points of the paddles at distinct intervals, for example, approximately ninety degrees apart, for the purpose of ensuring optimal tissue compression).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include wherein the alignment indicator represents zero degrees and the plurality of attachment areas comprise four attachment areas circumferentially located approximately at 45, 135, 225, and 315 degrees relative to the alignment indicator on the liner of Lohmann, which includes four shims for compression of the soft tissue, in such a way that a user can align the alignment indicator to an anterior midline of the body part, in order to ensure proper placement for optimal tissue compression, as taught by Alley ‘783.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lohmann, as applied to claim 13 above, in view of US Patent Application Publication No. 2013/0053981 A1 to Alley (Alley).
Lohmann teaches the method of claim 13. Lohmann also teaches that the size, shape, number and/or placement of the movement-opposing patch surfaces may vary (col. 4, lines 67 through col. 5, lines 1-2) and that socks of different thicknesses may be used may be used to achieve the proper compression factors (col. 4, lines 56-63). However, Lohmann does not explicitly teach, wherein the shims are selected from a plurality of shims having different durometers.
Alley teaches a compression socket for a patient having an amputated limb and a remaining portion (abstract). Alley also teaches a liner (30) used with an interface/socket to stabilize the prosthesis with respect to the bone (paragraph 0020) through the use of struts (shims) in an open-cage embodiment, as shown in fig. 1, that lie longitudinally and circumferentially spaced on the structure. Alley further discloses selecting the strut material from a plurality of materials having different durometers: a fitted material extending beyond the border of the strut edge, a flexible strut edge, automatically altered strut stiffness, or an inner highly flexible membrane placed between the strut and the limb (paragraph 0029-0030), for the purpose of achieving the desired amount of compression (paragraph 0080 and 0095).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the shims are selected from a plurality of shims having different durometers, in order to achieve the desired amount of compression, as taught by Alley.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774