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 .
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) 24-25, 29, 32, 40, 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (CN108451676A) in view of Guy (Printed Prosthetics).
In regard to claim 24, Li teaches a prosthetic device, comprising:
a prosthetic liner (1) comprising:
an inner surface of the prosthetic liner arranged to face toward a residual limb (see figure 1), wherein the prosthetic liner (1) comprises at least one first lattice structure (claim 1: crystallinity; pg 2, paragraph 9 of translation: elastic modulus controlled by the crystallinity; pg 3, paragraph 12 of translation: products with different crystallinity can be printed)
and a socket (2) comprising:
an outer surface of the socket arranged to face away from the residual limb and the prosthetic liner (1) (see fig 1);
and an interface (junction between socket 2 and liner 1; see fig 1) where the prosthetic liner and the socket converge such that the prosthetic liner and the socket are integrally formed with each other as a single-piece, unitary structure by additive manufacturing (abstract: integrally formed by 3D printing, see fig 1; pg 2, paragraph 8 of the translation, claim 1)
wherein the socket (2) comprises at least one second lattice structure (page 3, paragraph 12 of translation: products with different crystallinity can be printed).
While Li teaches varying the lattice structure (crystallinity; pg 2, paragraph 11 of translation), and that the socket and liner have different elasticities (pg 3, paragraph 4 of translation: elastic modulus has a gradient change in the axial and radial directions; pg 3, paragraph 11 of the translation: elastic modulus of inner wall is low; remaining area changes from low to high modulus radially to the outer side, and the elasticity is controlled by the crystallinity pg 2, paragraph 9 of translation: elastic modulus controlled by the crystallinity), Li remains silent to if the socket and liner have different lattice structures specifically and does not teach that both the liner and socket are made of the same material.
Guy teaches 3D printing a foot orthotic comprises at least one second lattice structure different than the at least first lattice structure made of the same material (see variable density lattices in the figures of page 16 which show a prosthetic foot with variable density lattice and page 13, figs 6-7 with a foot orthotic made of variable density lattice out of one material).
It would have been obvious to one of ordinary skill in the art of rehabilitation devices and 3D printing at the time the invention was filed to use the 3D printing density changes and single material of Guy to alter the flexibilities of the socket and liner of Li as noted in Li because this allows a high strength to weight ratio (pg 12) and able specific material properties in different zones (page 13) and allows the density to change while maintaining strength, support and stability (pg 16, paragraph 1) and means the same material can be used throughout.
In regard to claim 25, Li meets the claim limitations as discussed in the rejection of claim 24, and further teaches the liner has a first rigidity and the socket has a second rigidity that is greater than the first rigidity. (Pg 2, paragraph 10 of translation: elastic modulus of the inner wall is low and the remaining area changes from low to high; high elastic modulus on outer wall of socket; pg 3, paragraph 11 of translation: elastic modulus of inner wall is low; low to high modulus from the radial inner to outer side]
However, Li does not teach the first and second lattice structures as claimed.
As discussed in the rejection of claim 24, Guy teaches using lattices of different rigidities. (see variable density lattices in the figures of page 16 which show a prosthetic foot with variable density lattice and page 13, figs 6-7 with a foot orthotic made of variable density lattice out of one material).
In regard to claim 29, Li meets the claim limitations as discussed in the rejection of claim 24, and further teaches the outer surface of the socket (2) comprises a solid surface. (see fig 1)
Further, the lattice of Guy has solid surfaces (see pg 16; 4 is solid)
In regard to claim 32, Li meets the claim limitations as discussed in the rejection of claim 24, and further teaches a variable elastic modulus (pg 3, paragraph 11) and a crystallinity that correlates to the elastic modulus (pg 3, paragraph 12).
However, Li does not specifically teach a variable lattice density.
Guy further teaches at least one of the at least one first lattice structure and the at least one second lattice structure comprises a variable lattice density. Guy teaches the first lattice structure comprises a variable lattice density. (see figures 5-7 on page 13)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the variable density design of Guy in the socket and liner of Li because graded material gives you a high strength to weight ratio (pg 12) and allows customization to the individual (pg 13, paragraph 1).
In regard to claim 40, Li teaches a prosthetic device, comprising:
a prosthetic liner (1) comprising:
an inner surface of the prosthetic liner arranged to face toward a residual limb (fig 1), wherein the prosthetic liner is 3D printed (abstract)
prosthetic liner (1) comprises at least one first lattice structure (claim 1: crystallinity; pg 2, paragraph 9 of translation: elastic modulus controlled by the crystallinity; pg 3, paragraph 12 of translation: products with different crystallinity can be printed)
and a socket (2) comprising:
an outer surface of the socket arranged to face away from the residual limb and the prosthetic liner (1) (see fig 1), wherein the socket (2) is 3D printed (abstract) at least one second lattice structure different than the at least one first lattice structure; (page 3, paragraph 12 of translation: products with different crystallinity can be printed).
an interface where the prosthetic liner (1) and the socket (2) converge such that the prosthetic liner and the socket are integrally formed with each other as a single-piece, unitary structure by additive manufacturing (abstract: integrally formed by 3D printing; fig 1; claim 1),
wherein the prosthetic liner (1) further comprises at least one flexible section (pg 2, paragraph 9 of translation: flexible socket; paragraph 11: material can be locally adjusted according to the skin condition of the residual limb; paragraph 9: elastic modulus is variable in the axial and radial directions], wherein the at least one flexible section comprises at least one third lattice structure different than the at least one first lattice structure and the at least one second lattice structure. (pg 2, paragraph 9 of translation: elastic modulus is controlled by the crystallinity)
However, Li does not teach the lattice structures as claimed or that the liner and socket are formed of the same material.
Guy teaches 3D printing a foot orthotic comprises at least one second lattice structure different than the at least first lattice structure made of the same material (see variable density lattices in the figures of page 16 which show a prosthetic foot with variable density lattice and page 13, figs 6-7 with a foot orthotic made of variable density lattice out of one material).
It would have been obvious to one of ordinary skill in the art of 3D printing and rehabilitation devices at the time the invention was filed to use the 3D printing density changes and single material of Guy to alter the flexibilities of the socket and liner of Li as taught by Li because this allows a high strength to weight ratio (pg 12) and able specific material properties in different zones (page 13) and allows the density to change while maintaining strength, support and stability (pg 16, paragraph 1) and means the same material can be used throughout.
In regard to claim 43, Li meets the claim limitations as discussed in the rejection of claim 40, and further teaches the flexible section enables the prosthetic device to bend, compress, extend, expand, and/or deform. (pg 3, paragraph 4 of translation: socket adopts a flexible design; muscles can adapt to the socket; elastic modulus of the material has a gradient change)
Claim(s) 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (CN108451676A) in view of Guy (Printed Prosthetics) and further in view of Silagy (5226918A).
In regard to claims 30-31, Li meets the claim limitations as discussed in the rejection of claim 24, but does not teach the liner and socket define a receiver further comprising a recess in a protruding portion of the distal end of the prosthetic device.
Silagy teaches the prosthetic liner and the socket define a receiver 34 formed in a distal end of the prosthetic device (fig 2); further comprising a recess (64, 66) formed in a protruding portion 30 of the distal end of the prosthetic device (see fig 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the lock assembly of Silagy in the liner and socket of Li because this type of suspension allows for a quick release of the prosthesis (Col 1, lines 30-33).
Response to Arguments
In regard to the 103(a) rejection of claims 24-25, 29, 32, 40 and 43 as unpatentable over Li (CN108451676A) in view of Dudding (2018/0235779A1), the applicant’s arguments have been fully considered.
The applicant argues that a crystalline structure is not a lattice. A secondary reference (Dudding previously and now Guy) was used to teach the lattice structure. However, crystalline is defined as “an ordered structure”. In the context of prior art reference Li it appears crystalline is referring to a lattice structure. Regardless, a secondary reference was used to teach this feature.
The remainder of the arguments are directed towards 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
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