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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/12/2025 has been entered. The objection to the claims is withdrawn in light of applicant’s amendments. Claims 1-14 are currently pending in this application.
Response to Arguments
Applicant’s arguments with respect to the newly amended claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim 7 is 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.
Claim 7 recites the limitation "the compression of the target area" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, and 4-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 8,323,353 B1 to Alley et al. (Alley) in view of US Patent Application Publication No. 2014/0288670 A1 to Phillips (Phillips).
Regarding at least claim 1
Alley disclose a compression stabilized prosthetic socket for a patient having an amputated limb and a remaining portion including a first socket portion for contacting a patient’s remaining portion of a limb and a second socket portion for attachment of a prosthetic device (abstract).
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Alley meets the limitations of a liner system for reducing motion of a skeletal structure within a limb, the skeletal structure being surrounded by soft tissue (the abstract discloses use of a liner system on a residual limb which includes a bone/skeletal structure surrounded by soft tissue), the system comprising: a liner adapted to be worn over the limb (fig. 6 shows a transfemoral solid-body interface/liner); a plurality of shims comprising at least four shims (col. 8, lines 63-67 discloses four compression areas/shims; 17); wherein the plurality of shims each have a durometer, a radial thickness, a width, and a longitudinal dimension configured to create a plurality of relief areas between each shim (col. 8, lines 63-67 discloses shims 17 that necessarily each having a durometer, a radial thickness, a width and a longitudinal dimension that create a plurality of relief areas 18 between each shim 17 as shown in fig. 6); wherein each of the plurality of shims has a perimeter that is longitudinally shaped (fig. 6 shows that the shims 17 have a longitudinally-shaped perimeter); wherein the longitudinal dimension of the plurality of shims are longitudinally oriented along a length of the liner (fig. 6 shows a longitudinal orientation along a length of the liner); wherein the plurality of shims are circumferentially spaced apart to create a pattern of alternating higher compression areas and lower compression areas (col. 8, lines 63-67 discloses an alternating compression-relief pattern of higher compression areas where the shims 17 are placed and lower compression areas between the shims, and fig. 6 shows that the compression areas/shims 17 are circumferentially spaced apart from relief areas 18); wherein the higher compression areas are completely separated from one another by the lower compression areas (fig. 6 shows that the compression areas 17 are completely separated from one another by the relief/lower compression areas 18); wherein a first compression area and a third compression area are opposed to one another, and a second compression area and a fourth compression area are opposed to one another (two of the four compression areas are shown in fig. 6, it is presumed that the other two compression areas are placed on the other side of the limb, such that a first and third compression area are opposed to one another and a second and fourth are opposed to one another as claimed), and wherein the durometer, radial thickness, width, and longitudinal dimension of each shim define a compressive force that is sufficient to reduce radial motion of the skeletal structure (Alley discloses using the compression areas to minimize lost motion which is the radial motion of the skeletal structures with respect to the prosthetic interface when force is applied between the two; col. 1, lines 60-65 and col. 6, lines 8-13).
However, Alley does not teach that the shims are adapted to be pre-placed along a length of the skeletal structure prior to donning the liner or wherein the liner is adapted to be worn over the plurality of shims when pre-placed on the limb.
Phillips teaches an apparatus to cushion between a prosthetic and an amputee’s residual limb, using a plurality of putty-filled packets (abstract). Phillips further teaches the use of liner sleeves assembled between the patient’s limb and the socket (paragraph 0017), as well as a bladder system that can be adjusted to accommodate volume fluctuations in the residual limb and is made up of a plurality of bladders/shims (paragraphs 0007-0009). Further still, Phillips teaches that the shims preferably can be assembled directly onto the patient’s limb via gluing, for the purpose of providing more certainty to get the correct fit and involving less labor, as an alternative to gluing onto the interior of the prosthetic (paragraphs 0016-0017).
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 liner system of Alley to specify that the shims are adapted to be pre-placed along a length of the skeletal structure prior to donning the liner and that the liner is adapted to be worn over the plurality of shims when pre-placed on the limb, in order to provide more certainty to get the correct fit and/or involve less labor as an alternative to gluing onto the interior of the prosthetic, as taught by Phillips.
Regarding at least claim 2
Alley in view of Phillips teaches the liner system of claim 1. Phillips also teaches wherein the shim is a gel (claim 4 discloses that the liquid within the bladder/shim is a gel).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the compression areas/shims of Alley such that they are a gel, as taught by Phillips, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 4
Alley in view of Phillips teaches the liner system of claim 1. Alley also teaches an interface that includes an inner surface which is construed to include a plurality of attachment areas that are adapted to be worn over the plurality of shims when pre-placed on the limb (any areas of the inner surface of the interface/liner of Alley at which the pre-placed shims/bladders of Alley in view of Phillips would make contact are construed to be attachment areas as claimed).
Regarding at least claim 5
Alley in view of Phillips teaches the liner system of claim 1. Alley also teaches including a configuration of the plurality of shims in which two or more shims are aligned along a length of the skeletal structure (fig. 6). Further, Alley teaches that the fields of compression are located biomechanically, anatomically, and physiologically appropriately by a technician such that there are alternating fields of compression and relief arranged longitudinally along the shaft of the long bone (col. 12, lines 40-45). However, Alley does not teach that the configuration is discontinuous configuration.
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 the plurality of shims of Alley to be discontinuous, depending on the appropriate locations of the fields of compression determined by a technician, as taught by Alley.
Regarding at least claim 6
Alley teaches a method of reducing motion of a skeletal structure within a limb using a liner and a plurality of shims comprising at least four shims (abstract discloses reducing motion of a skeletal structure within a limb using a liner and four shims; col. 8, lines 63-67 discloses four compression areas/shims; 17), the method comprising: orienting a longitudinal dimension of each shim to run along a length of the skeletal structure (fig. 6 shows the shims 17 oriented longitudinally), and circumferentially spacing each shim around the limb to create a pattern of alternating areas of higher compression areas and lower compression areas (col. 8, lines 63-67 discloses that the shims 17 are circumferentially spaced to create a pattern of alternating compression and relief areas); wherein the higher compression areas are completely separated from one another by the lower compression areas (fig. 6 shows complete separation of the higher compression areas 17 and the lower compression areas 18); wherein a first compression area and a third compression area are opposed to one another and a second compression area and a fourth compression area are opposed to one another (two of the four compression areas are shown in fig. 6, it is presumed that the other two compression areas are placed on the other side of the limb, such that a first and third compression area are opposed to one another and a second and fourth are opposed to one another as claimed); wherein each of the shims has a durometer, a radial thickness, a width, and a longitudinal dimension that is longer than the width (col. 8, lines 63-67 discloses shims 17 that necessarily each having a durometer, a radial thickness, a width and a longitudinal dimension that is longer than the width as shown in fig. 6); wherein each of the shims has a perimeter that is longitudinally shaped (fig. 6 shows that the perimeter of the shims 17 is longitudinally shaped); and wherein the durometer, radial thickness, width, and longitudinal dimension of each shim define a compressive force that is sufficient to reduce radial motion of the skeletal structure (Alley discloses using the compression areas to minimize lost motion which is the radial motion of the skeletal structures with respect to the prosthetic interface when force is applied between the two; col. 1, lines 60-65 and col. 6, lines 8-13).
However, Alley does not teach pre-placing the plurality of shims on the limb or donning the liner on the limb and over the plurality of shims.
Phillips teaches an apparatus to cushion between a prosthetic and an amputee’s residual limb, using a plurality of putty-filled packets (abstract). Phillips further teaches the use of liner sleeves assembled between the patient’s limb and the socket (paragraph 0017), as well as a bladder system that can be adjusted to accommodate volume fluctuations in the residual limb and is made up of a plurality of bladders/shims (paragraphs 0007-0009). Further still, Phillips teaches that the shims preferably can be assembled directly onto the patient’s limb via gluing, for the purpose of providing more certainty to get the correct fit and involving less labor, as an alternative to gluing onto the interior of the prosthetic (paragraphs 0016-0017).
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 liner system of Alley to include pre-placing the plurality of shims on the limb and donning the liner on the limb and over the plurality of shims, in order to provide more certainty to get the correct fit and/or involve less labor as an alternative to gluing onto the interior of the prosthetic, as taught by Phillips.
Regarding at least claim 7
Alley in view of Phillips teaches the method of claim 6. Alley also teaches wherein one or more of the durometer, the radial thickness, the width, and the longitudinal dimension of each shim is configured to adjust the compression of the target area to account for change of residual limb volume (col. 5, lines 26-36 disclose altering the stiffness of the strut assembly on demand or automatically such that overall compression is varied appropriately).
Regarding at least claim 8
Alley teaches a liner system for reducing motion of a skeletal structure within a limb, the skeletal structure being surrounded by soft tissue (col. 6, lines 37-43 disclose reducing motion of a skeletal structure as claimed), the system comprising: a liner adapted to be worn over the limb (fig. 6 shows a transfemoral interface/liner); a plurality of compression elements (17) comprising at least four compression elements (col. 8, lines 63-67 discloses four compression areas/elements 17); and wherein the plurality of compression elements each have a durometer, a radial thickness, a width, and a longitudinal dimension that is longer than the width (col. 8, lines 63-67 discloses shims 17 that necessarily each having a durometer, a radial thickness, a width and a longitudinal dimension that have a longitudinal dimension that is longer than the width as shown in fig. 6); wherein each of the plurality of compression elements has a perimeter that is longitudinally shaped and the longitudinal dimension is oriented along a length of the skeletal structure (fig. 6 shows that each of the plurality of compression elements 17 has a longitudinal shaped perimeter and that the longitudinal dimension is oriented along the length of the bone); wherein the plurality of compression elements are circumferentially spaced around the limb to create a pattern of alternating areas of higher compression areas and lower compression areas (col. 8, lines 63-67 discloses an alternating pattern of higher and lower compression areas); wherein the higher compression areas are completely separated from one another by the lower compression areas (fig. 6 shows that the higher compression areas 17 are completely separate from the lower compression areas 18); wherein a first compression area and a third compression area are opposed to one another, and a second compression area and a fourth compression area are opposed to one another (two of the four compression areas are shown in fig. 6, it is presumed that the other two compression areas are placed on the other side of the limb, such that a first and third compression area are opposed to one another and a second and fourth are opposed to one another as claimed); and wherein the durometer, radial thickness, width, and longitudinal dimension of each compression element define a compressive force that is sufficient to reduce radial motion of the skeletal structure (Alley discloses using the compression areas to minimize lost motion which is the radial motion of the skeletal structures with respect to the prosthetic interface when force is applied between the two; col. 1, lines 60-65 and col. 6, lines 8-13).
However, Alley does not teach that the plurality of compression elements is adapted to be pre-placed along a length of the skeletal structure of the limb prior to donning the liner or wherein the liner is adapted to be worn over the plurality of compression elements when pre-placed on the limb.
Phillips teaches an apparatus to cushion between a prosthetic and an amputee’s residual limb, using a plurality of putty-filled packets (abstract). Phillips further teaches the use of liner sleeves assembled between the patient’s limb and the socket (paragraph 0017), as well as a bladder system that can be adjusted to accommodate volume fluctuations in the residual limb and is made up of a plurality of bladders/shims (paragraphs 0007-0009). Further still, Phillips teaches that the shims preferably can be assembled directly onto the patient’s limb via gluing, for the purpose of providing more certainty to get the correct fit and involving less labor, as an alternative to gluing onto the interior of the prosthetic (paragraphs 0016-0017).
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 liner system of Alley to specify that the plurality of compression elements are adapted to be pre-placed along a length of the skeletal structure of the limb prior to donning the liner and wherein the liner is adapted to be worn over the plurality of compression elements when pre-placed on the limb, in order to provide more certainty to get the correct fit and/or involve less labor as an alternative to gluing onto the interior of the prosthetic, as taught by Phillips.
Regarding at least claim 9
Alley teaches a method of reducing motion of a skeletal structure within a limb using a liner (30) and a plurality of shims (6) (col. 6, lines 8-13 discloses minimizing lost motion of a skeletal structure), the method comprising: donning the liner on the limb (fig. 4 shows the liner 30 donned on the limb); wherein the plurality of shims comprises a first shim, a second shim, a third shim, and a fourth shim (col. 8, lines 24-28 discloses four struts/shims), and wherein each shim has a width, a longitudinal dimension that is longer than the width (fig. 4 shows that the longitudinal dimension of each shim 6 is longer than the width); orienting the longitudinal dimension of each shim to run along a length of the skeletal structure (fig. 4 shows that the longitudinal dimension is oriented to run along the length of the bone); circumferentially spacing each shim around the limb to create a pattern of alternating areas of higher compression areas and lower compression areas (col. 8, lines 49-54 discloses struts/higher compression areas; 6 providing compression and windows/lower compression areas; 7 allowing soft tissue flow); wherein the higher compression areas are completely separated from one another by the lower compression areas (fig. 4 shows that the higher compression areas 6 are completely separate from the lower compression areas 7); wherein a first compression area and a third compression area are opposed to one another, and a second compression area and a fourth compression area are opposed to one another (two of the four compression areas are shown in fig. 6, it is presumed that the other two compression areas are placed on the other side of the limb, such that a first and third compression area are opposed to one another and a second and fourth are opposed to one another as claimed); and wherein each of the shims has a durometer, a radial thickness, a width, and a longitudinal dimension that define a compressive force that is sufficient to reduce radial motion of the skeletal structure (Alley discloses using the compression areas/shims, which necessarily have a durometer, a radial thickness, a width, and a longitudinal dimension that define a compressive force to minimize lost motion which is the radial motion of the skeletal structures with respect to the prosthetic interface when force is applied between the two; col. 1, lines 60-65 and col. 6, lines 8-13).
However, Alley does not teach inserting the plurality of shims between the limb and the liner.
Phillips teaches an apparatus to cushion between a prosthetic and an amputee’s residual limb, using a plurality of putty-filled packets (abstract). Phillips further teaches the use of liner sleeves assembled between the patient’s limb and the socket (paragraph 0017), as well as a bladder system that can be adjusted to accommodate volume fluctuations in the residual limb and is made up of a plurality of bladders/shims (paragraphs 0007-0009). Further still, Phillips teaches that the shims preferably can be assembled directly onto the patient’s limb via gluing, for the purpose of providing more certainty to get the correct fit and involving less labor, as an alternative to gluing onto the interior of the prosthetic (paragraphs 0016-0017).
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 liner system of Alley to modify the placement of the shims such that they are assembled directly onto the patient’s limb by inserting the plurality of shims between the limb and the liner, in order to provide more certainty to get the correct fit and/or involve less labor as an alternative to gluing onto the interior of the prosthetic, as taught by Phillips.
Regarding at least claim 10
Alley in view of Phillips teaches the method of claim 9. Alley also teaches further comprising the step of donning a socket over the limb and the liner (col. 5, lines 9-18 discloses that the limb interface device may have any of various prosthetic components attached to it to provide an upper or lower extremity prosthesis extending from the distal end of the interface device and that stabilizers or other devices may be attached to a proximal end of the limb interface device).
Regarding at least claim 11
Alley in view of Phillips teaches the method of claim 10, wherein the step of inserting the plurality of shims between the limb and the liner is performed after donning the socket over the limb (the user is capable of inserting the padding after donning the socket since the padding is selectively removed or inserted depending on the needs of the individual as disclosed in paragraph 0011).
Regarding at least claim 12
Alley in view of Phillips teaches the method of claim 9. Alley also teaches wherein the liner comprises a sleeve configuration having a proximal open end and a distal open end (col. 5, lines 1-8 discloses that the liner may be an open cage configuration having a proximal open end and a distal open end and is therefore construed to be a sleeve configuration).
Regarding at least claim 13
Alley in view of Phillips teaches the liner system of claim 1. Alley also teaches wherein the liner comprises a sleeve configuration having a proximal open end and a distal open end (col. 5, lines 1-8 discloses that the liner may be an open cage configuration having a proximal open end and a distal open end and is therefore construed to be a sleeve configuration).
Regarding at least claim 14
Alley in view of Phillips teaches the liner system of claim 1. Alley also teaches wherein at least one shim has one or more sensors (col. 9, line 54-67 through col. 10, lines 1-12 discloses that the amount of compression for the user can be determined by the use of a sensor and monitor).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alley in view of Phillips, as applied to claim 1 above, in view of US Patent No. 8,409,298 B2 to Perkins et al. (Perkins).
Alley in view of Phillips teaches the liner system of claim 1, including placement of the liner over the plurality of shims when pre-placed on the limb. However, Alley in view of Phillips does not explicitly teach wherein the liner is adapted to be rolled on the limb.
Perkins teaches an attachment system that secures a residual limb to an artificial limb in a comfortable and substantially non-rotational manner (abstract). Perkins clearly teaches that convention liners are rolled on to the limb, for the purpose of suction, slight compression, and/or gripping connection of the inner layer of the liner to the skin of the residual limb (col. 5, lines 28-35).
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 liner of Alley in view of Phillips is adapted to be rolled on the limb, in order to create suction, slight compression, and/or gripping connection of the inner layer of the liner to the skin of the residual limb, as taught by Perkins.
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
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774