Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1, 3-5, and 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bark (US Pub No.: 5,074,878) in view of Bartolo (US Pub No.: 4,428,364), Forsell (US Pub No.: 2009/0210056) and Raven (US Pub No.: 2011/0196195).
Regarding claim 1, Bark (US Patent No.: 5,074,878) teaches a flexible, fillable prosthesis (shown in figures 6, 8-9), the prosthesis comprising: a shell having an anterior portion and a posterior portion (a shell is depicted in figure 6 with an posterior portion being the bottommost part and the anterior being the topmost part and the bottommost part being the posterior surface), the shell comprising a laminate having a base layer (figure 6 part 70), a top layer (figure 6 part 72), and a soft silicone gel intermediate layer disposed between the base layer and the top layer (figure 6 part 68 which is between parts 70 and 72. Silicone used for the implant is disclosed in column 3 lines 55-60 and claim 16) and of sufficient thickness for self-sealing of a needle hole therethrough (column 6 lines 13-19 as well as claim 16 discloses a self-sealing layer for a needle); and a needle guard (the needle stop member disclosed in the abstract, disclosed as part 22 in column 3 lines 61-68) and comprising a plurality of offset layers of offset (the needle stop member is disclosed to be made up of a mesh that is preferably made of stainless steel in column 3 lines 61-68. A mesh means that a plurality of offset layers are present in part 22. This material is disclosed as being “sufficiently rigid to maintain a degree of compression” in column 3 lines 61-68), Bark does not teach that the needle guard is coupled to the posterior portion of the shell or comprises puncture-resistance structures that, in an expanded state, (i) collectively form a concave shape and (ii) provide a concave exterior surface along the posterior portion of the prosthesis for approximating a human anatomical feature, the needle guard having a shape memory characteristic for urging the prosthesis toward the expanded state.
Bartolo (US Patent No.: 4,428,364) teaches a needle guard that, in an expanded state, (i) collectively form a concave shape (figure 2 parts 12-13 comprise a needle guard that is concave in figure 2) and (ii) form a concave exterior surface along the posterior portion for approximating a human anatomical feature (the needle guard of Bartolo can be placed upon the posterior portion of the prosthesis of Bark), the needle guard having a shape memory characteristic for urging the prosthesis toward the expanded state (the needle guard of Bartolo is shown to have a shape memory in figure 2 and column 2 lines 48-61). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46).
From here, neither Bark nor Bartolo teach that the needle guard is coupled to the posterior surface of the shell. Instead, Forsell does teach a rigid back plate (part 3 in figure 1A, disclosed in [0074]) that is coupled to the posterior surface of the implant part 10. While it isn’t explicitly disclosed as a needle guard, the back plate is disclosed as being relatively stiff in [0090]. It stands to reason that the rigid back plate is able to guard against a needle to an extent as the device is claimed to be sturdy as per [0074]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art at the time of filing to incorporate the rigid back plate of Forsell into the devices of Bark and Bartolo as the back plate of Forsell is depicted as being able to change its geometry as per figures 3A and 3B which allows it to better conform to a user’s body. Additionally, as shown in figures 1A-1C and disclosed in [0073], the back plate part 3 could be used to house a fluid pump part 5 with embedded fluid lines 4 that could then change the shape of the implant as shown visually in figures 1A to 1C. This is beneficial as this allows for post-surgery modification of the implant.
With respect to the needle guard being flexible, Bark in view of Bartolo and Forsell does not teach a flexible needle guard. Instead, Raven (US Pub No.: 2011/0196195) would disclose a flexible needle guard in [0102] and [0104]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible needle guard of Raven into the combination of Bark, Bartolo, and Forsell for the purpose of providing a tactile feedback through the needle during a contact (in [0102]) and provide a means for self-sealing (in [0104]).
Regarding claim 3, Bark in view of Bartolo, Forsell, and Raven teach the prosthesis according to Claim 1, wherein Bark discloses the plurality of offset, rigid, puncture-resistance structures comprise slat members (members of Bark like parts 74 and 76 in figure 6 are depicted as being slats. As these members are to act as a needle guard, parts 74 and 76 are rigid and puncture-resistant to resist a puncturing force by a needle).
Regarding claim 4, Bark in view of Bartolo, Forsell, and Raven teach the prosthesis according to Claim 1, wherein Bartolo further teaches that the plurality of offset rigid, puncture-resistance comprise dome-shaped members (parts 12 and 13 in figure 2 are offset, layers that are curved, forming a dome like appearance. As these members are to act as a needle guard, they are rigid and puncture-resistant to resist a puncturing force by a needle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46).
Regarding claim 5, Bark in view of Bartolo, Forsell, and Raven teach the prosthesis according to Claim 1, wherein Bartolo teaches the plurality of offset layers comprises three layers (column 3 lines 40-49 discloses that the offset layer 12, shown in figure 4, will comprise of layers 18A, 18B, 18C, and 18D). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46). Additionally, while four layers are shown in figure 6 of Bartolo (with eight layers disclosed in the specification), it is obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate three layers as having fewer layers would then reduce the size of the part implanted into the patient while a reasonable expectation of success of part 12 is maintained.
Regarding claim 7, Bark in view of Bartolo, Forsell, and Raven teach the prosthesis according to Claim 1, Bark discloses the soft silicone gel intermediate layer is disposed between an outer surface of the base layer and an interior surface of the top layer (layer 18, shown in figure 3, is made of a silicone gel in column 3 lines 56-60. This layer is between the outer surface of the base layer ant the interior surface of the top layer).
Bark does not disclose that an interior surface of the base layer forms an inflatable cavity. Instead, Bartolo teaches that an interior surface of the base layer forms an inflatable cavity (which is implied in column 2 lines 39-47 wherein the prosthesis is disclosed as being inflatable. This means that the cavity of Bartolo is inflatable). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46).
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bark (US Patent No.: 5,074,878) in view of Bartolo (US Patent No.: 4,428,364), Forsell (US Pub No.: 2009/0210056), Schuessler (US Pub No.: 2010/0228347), and Raven (US Pub No.: 2011/0196195) in further view of “Tacky Gels for Healthcare Applications” by NuSil Silicone Technology.
Regarding claim 2, Bark in view of Bartolo, Forsell Raven, and Schuessler teach the prosthesis according to Claim 1. However, neither Bark nor Bartolo will teach an instance wherein the intermediate layer comprises Nusil ® MED 6350. Instead, the document titled “Tacky Gels for Healthcare Applications” does disclose the Nusil ® Med-6350 silicone gel with details pertaining to biological testing. It should be noted that, as per the first paragraph on page 2, the MED 6350 material is a silicone based gel.
It is obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the MED-6350 silicone gel disclosed in “Tacky Gels for Healthcare Applications” into the combination of Bark, Bartolo, Forsell, Raven, and Schuessler as this will give further details regarding the actual material used here. As per column 3 lines 50-60, silicone is disclosed as a possible material used in the implant. As what “Polymer Systems Technology Limited” discloses is a silicone compound that has been tested for a biological use (i.e. implantation), it stands to reason that this silicone compound can be incorporated within the implant of Bark with known results. From here, benefits for NuSil MED-6350 are disclosed on page 2 of the document as said gels are disclosed to have “a history of biocompatibility, are non-allergenic, and offer superior breathability.” As all of these are beneficial components of MED-6350, it is obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use this silicone based material for the intermediate layer of Bark.
Claims 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bark (US Pub No.: 5,074,878) in view of Bartolo (US Pub No.: 4,428,364), Forsell (US Pub No.: 2009/0210056) and Raven (US Pub No.: 2011/0196195) in further view of Kim (US Pub No.: 2005/0170221).
Regarding claim 6, Bark in view of Bartolo, Forsell, and Raven teach the prosthesis according to claim 1. However, Bark does not teach wherein the plurality of offset layers comprises members having a thickness between 0.1 mm and 1.0 mm and a spacing of between 0.2 mm and 0.5 mm.
Instead, Raven teaches wherein the plurality of offset layers comprises members having a thickness between 0.1 and 1mm (needle resistant material comprising of thermoplastic films between 0.25 and 1 mm in [0101] of Raven. As “thin films” are disclosed, multiple films are present) and a spacing of between 0.2 mm and 0.5 (as multiple films are present, the spacing between alternating films can be between 0.2 mm and 0.5mm). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible needle guard and the material details of Raven into the combination of Bark, Bartolo, and Forsell for the purpose of providing a tactile feedback through the needle during a contact (in [0102]) and provide a means for self-sealing (in [0104]).
With respect to a spacing of between 0.2 mm and 0.5, Kim (US Pub No.: 2005/0170221) teaches a spacing between 0.2 and 0.5 mm (Gap between adjacent plates in [0066], 12 mil spacing in [0074], where 12 mils is about 0.3 mm. 5 to 20 mils in claim 39 of Kim).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the spacing details along with the multiple plates being spaced apart of Kim into the combination involving Bark for the purpose of providing an additional flexibility of the needle guard, as per [0014] while still providing a needle resistance as per [0082].
Claim 8-11 and 13-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bark (US Pub No.: 5,074,878) in view of Bartolo (US Pub No.: 4,428,364), and Forsell (US Pub No.: 2009/0210056).
Regarding claim 8, Bark discloses a flexible, fillable prosthesis, the prosthesis (shown in figures 6 and 8-9) comprising: a shell having an anterior portion and a posterior (a shell is depicted in figure 6 with an posterior portion being the bottommost part and the anterior being the topmost part. The posterior surface is the bottommost surface of Bark); and a needle guard (the needle stop member disclosed in the abstract, disclosed as part 22 in column 3 lines 61-68) comprising a plurality of offset layers of offset, puncture-resistance structures (members of Bark like parts 74 and 76 in figure 6 are depicted as being slats. As these members are to act as a needle guard, parts 74 and 76 are rigid and puncture-resistant to resist a puncturing force by a needle.
However, Bark does not disclose that the needle guard that is concave in shape. Instead, Bartolo (US Pub No.: 4,428,364) would teach a needle guard that, in an expanded state, (i) collectively form a concave shape and (figure 2 parts 12-13 comprise a needle guard that is concave in figure 2) and (ii) provide a concave exterior surface along the posterior portion of the prosthesis for approximating a human anatomical feature (the needle guard of Bartolo can be placed upon the posterior portion of the prosthesis of Bark), the needle guard having a shape memory characteristic for urging the prosthesis toward the expanded state (the needle guard of Bartolo is shown to have a shape memory in figure 2 and column 2 lines 48-61). It is obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46).
From here, neither Bark nor Bartolo teach that the needle guard is coupled to the posterior portion of the shell. Instead, Forsell does teach a rigid back plate (part 3 in figure 1A, disclosed in [0074]) coupled to the posterior portion of the shell (part 10). While it isn’t explicitly disclosed as a needle guard, the back plate is disclosed as being relatively stiff in [0090]. It stands to reason that the rigid back plate is able to guard against a needle to an extent as the device is claimed to be sturdy as per [0074]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art at the time of filing to incorporate the rigid back plate of Forsell into the devices of Bark and Bartolo as the back plate of Forsell is depicted as being able to change its geometry as per figures 3A and 3B which allows it to better conform to a user’s body. Additionally, as shown in figures 1A-1C and disclosed in [0073], the back plate part 3 could be used to house a fluid pump part 5 with embedded fluid lines 4 that could then change the shape of the implant as shown visually in figures 1A to 1C. This is beneficial as this allows for post-surgery modification of the implant.
Regarding claim 9, Bark in view of Bartolo, and Forsell teach the prosthesis according to Claim 8, wherein Bark discloses wherein the plurality of offset layers comprises slat members (members of Bark like parts 74 and 76 in figure 6 are depicted as being slats).
Regarding claim 10, Bark in view of Bartolo, and Forsell teach the prosthesis according to Claim 8, wherein Bartolo further comprises the plurality of offset layers comprises dome-shaped members (parts 12 and 13 in figure 2 are offset, layers that are curved, forming a dome like appearance. As these members are to act as a needle guard, they are rigid and puncture-resistant to resist a puncturing force by a needle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46).
Regarding claim 11, Bark in view of Bartolo, and Forsell teach the prosthesis according to Claim 8, wherein Bartolo teaches the plurality of offset layers comprises three layers (column 3 lines 40-49 discloses that the offset layer 12, shown in figure 4, will comprise of layers 18A, 18B, 18C, and 18D). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46). Additionally, while four layers are shown in figure 6 of Bartolo (with eight layers disclosed in the specification), it is obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate three layers as having fewer layers would then reduce the size of the part implanted into the patient while a reasonable expectation of success of part 12 is maintained.
Regarding claim 13, Bark in view of Bartolo, and Forsell teach the prosthesis according to claim 8, wherein Bark discloses that the shell comprises a laminate having a base layer (figure 6 part 70), a top layer (figure 6 part 72), and a soft silicone gel intermediate layer disposed between the base layer and the top layer (figure 6 part 68 which is between parts 70 and 72. Silicone used for the implant is disclosed in column 3 lines 55-60 and claim 16) and of sufficient thickness for self-sealing of a needle hole therethrough (column 6 lines 13-19 as well as claim 16 discloses a self-sealing layer for a needle).
Regarding claim 14, Bark in view of Bartolo, and Forsell teach the prosthesis according to claim 13, Bark discloses the soft silicone gel intermediate layer is disposed between an outer surface of the base layer and an interior surface of the top layer (layer 18, shown in figure 3, is made of a silicone gel in column 3 lines 56-60. This layer is between the outer surface of the base layer ant the interior surface of the top layer).
Bark does not disclose that an interior surface of the base layer forms an inflatable cavity. Instead, Bartolo teaches that an interior surface of the base layer forms an inflatable cavity (which is implied in column 2 lines 39-47 wherein the prosthesis is disclosed as being inflatable. This means that the cavity of Bartolo is inflatable). It is obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46).
Claim 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bark (US Pub No.: 5,074,878) in view of Bartolo (US Pub No.: 4,428,364), and Forsell (US Pub No.: 2009/0210056) in further view of Raven (US Pub No.: 2011/0196195) and Kim (US Pub No.: 2005/0170221).
Regarding claim 12, Bark in view of Bartolo, and Forsell teach the prosthesis according to claim 8. Bark does not teach Bark discloses that the plurality of offset layers comprises members having a thickness between 0.1 mm and 1.0 mm and a spacing of between 0.2 mm and 0.5 mm.
Instead, Raven teaches wherein the plurality of offset layers comprises members having a thickness between 0.1 and 1mm (needle resistant material comprising of thermoplastic films between 0.25 and 1 mm in [0101] of Raven. As “thin films” are disclosed, multiple films are present) and a spacing of between 0.2 mm and 0.5 (as multiple films are present, the spacing between alternating films can be between 0.2 mm and 0.5mm). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible needle guard and the material details of Raven into the combination of Bark, Bartolo, and Forsell for the purpose of providing a tactile feedback through the needle during a contact (in [0102]) and provide a means for self-sealing (in [0104]).
With respect to a spacing of between 0.2 mm and 0.5, Kim (US Pub No.: 2005/0170221) teaches a spacing between 0.2 and 0.5 mm (Gap between adjacent plates in [0066], 12 mil spacing in [0074], where 12 mils is about 0.3 mm. 5 to 20 mils in claim 39 of Kim).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the spacing details along with the multiple plates being spaced apart of Kim into the combination involving Bark for the purpose of providing an additional flexibility of the needle guard, as per [0014] while still providing a needle resistance as per [0082].
Claims 15-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bark (US Patent No.: 5,074,878) in view of Kim (US Pub No.: 2005/0170221), Bartolo (US Patent No.: 4,428,364), Forsell (US Pub No.: 2009/0210056) and Raven (US Pub No.: 2011/0196195).
Regarding claim 15, Bark teaches a method of making a flexible, fillable prosthesis (constructions and method of making in column 3 lines 21-24, prosthesis shown in figures 6, 8-9)), the prosthesis comprising: providing first and second layers of puncture-resistance structures (the needle stop member is disclosed to be made up of a mesh that is preferably made of stainless steel in column 3 lines 61-68. A mesh means that a plurality of offset layers are present in part 22. This material is disclosed as being “sufficiently rigid to maintain a degree of compression” in column 3 lines 61-68); a needle guard (the needle stop member disclosed in the abstract, disclosed as part 22 in column 3 lines 61-68), such that (i) the structures of the first layer of puncture-resistance structures is offset relative to the structures of the second layer of puncture-resistance structures (the needle stop member is disclosed to be made up of a mesh that is preferably made of stainless steel in column 3 lines 61-68. A mesh means that a plurality of offset layers are present in part 22. This material is disclosed as being “sufficiently rigid to maintain a degree of compression” in column 3 lines 61-68).
However, Bark does not teach bonding the first layer of puncture-resistance structures to the second layer of puncture-resistance structures to form a needle guard, or (ii) in an expanded state, the first layer of puncture-resistance structures collectively form a concave shape; and coupling the needle guard to a posterior portion of shell, wherein the shell further comprises an anterior portion; wherein the a posterior portion of the prosthesis comprises a concave exterior surface configured to approximate a human anatomical feature, and the needle guard comprises a shape memory characteristic for urging the prosthesis toward the expanded state.
Instead, Kim (US Pub No.: 2005/0170221) teaches bonding the first layer of puncture-resistance structures to the second layer of puncture-resistance structures (bonding of puncture resistant fabric with a metal plate in [0086], where said bonding is used to prevent a puncture of a needle in [0086]-[0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the bonding of fabric to puncture resistant metal guard plates for the purpose of providing a high level of resistance for a fabric in [0086]-[0087] without sacrificing a flexibility of a fabric in [0086], allowing the needle guard of Bark to be able to bend while resist needles.
Instead, Bartolo (US Pub No.: 4,428,364) would teach a needle guard that, in an expanded state, (i) collectively form a concave shape (figure 2 parts 12-13 comprise a needle guard that is concave in figure 2) and (ii) form a concave exterior surface along the posterior portion for approximating a human anatomical feature (the needle guard of Bartolo can be placed upon the posterior portion of the prosthesis of Bark), the needle guard having a shape memory characteristic for urging the prosthesis toward the expanded state (the needle guard of Bartolo is shown to have a shape memory in figure 2 and column 2 lines 48-61). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46).
From here, neither Bark nor Bartolo teach that the needle guard is coupled to the posterior surface of the shell. Instead, Forsell does teach a rigid back plate (part 3 in figure 1A, disclosed in [0074]) that is coupled to the posterior surface of the implant part 10. While it isn’t explicitly disclosed as a needle guard, the back plate is disclosed as being relatively stiff in [0090]. It stands to reason that the rigid back plate is able to guard against a needle to an extent as the device is claimed to be sturdy as per [0074]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art at the time of filing to incorporate the rigid back plate of Forsell into the devices of Bark and Bartolo as the back plate of Forsell is depicted as being able to change its geometry as per figures 3A and 3B which allows it to better conform to a user’s body. Additionally, as shown in figures 1A-1C and disclosed in [0073], the back plate part 3 could be used to house a fluid pump part 5 with embedded fluid lines 4 that could then change the shape of the implant as shown visually in figures 1A to 1C. This is beneficial as this allows for post-surgery modification of the implant.
With respect to the needle guard being flexible, Bark in view of Bartolo and Forsell does not teach a flexible needle guard. Instead, Raven (US Pub No.: 2011/0196195) would disclose a flexible needle guard in [0102] and [0104]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible needle guard of Raven into the combination of Bark, Bartolo, and Forsell for the purpose of providing a tactile feedback through the needle during a contact (in [0102]) and provide a means for self-sealing (in [0104]).
Regarding claim 16, Bark in view of Kim, Bartolo, Forsell, and Raven teach the method of Claim 15, with Bark further comprising providing an intermediate layer between the first layer of puncture-resistance structures (figure 6 part 68 which is between parts 70 and 72. Silicone used for the implant is disclosed in column 3 lines 55-60 and claim 16).
Regarding claim 17, Bark in view of Kim, Bartolo, Forsell, and Raven teach the method of Claim 15, with Bark further comprising: providing a third layer of puncture-resistance structures between the first and second layers of puncture-resistance structures (layer 18, shown in figure 3, is made of a silicone gel in column 3 lines 56-60. This layer is between the outer surface of the base layer ant the interior surface of the top layer, which comprise a first and second layer in Bark); and positioning the structures of the third layer of puncture-resistance structures to be offset relative to the structure of at least one of the first and second layers of puncture-resistance structures (layer 68 is offset relative to layers 70 and 72).
Regarding claim 18, Bark in view of Kim, Bartolo, Forsell, and Raven teach the method of Claim 17, with Kim further comprising bonding the third layer of puncture-resistance structures to at least one of the first and second layers of puncture-resistance structures (as multiple metal plates are present in Kim, the bonding of puncture resistant fabric with a metal plate in [0086] includes a bonding of a third layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the bonding of fabric to puncture resistant metal guard plates for the purpose of providing a high level of resistance for a fabric in [0086]-[0087] without sacrificing a flexibility of a fabric in [0086], allowing the needle guard of Bark to be able to bend while resist needles.
Regarding claim 19, Bark in view of Kim, Bartolo, Forsell, and Raven teach the method of Claim 15, wherein Bark discloses the shell comprises a laminate having a base layer (figure 6 part 70), a top layer (figure 6 part 72), and a soft silicone gel intermediate layer disposed between the base layer and the top layer (figure 6 part 68 which is between parts 70 and 72. Silicone used for the implant is disclosed in column 3 lines 55-60 and claim 16) and of sufficient thickness for self-sealing of a needle hole therethrough (column 6 lines 13-19 as well as claim 16 discloses a self-sealing layer for a needle).
Regarding claim 20, Bark in view of Bartolo, Forsell, Raven, and Schuessler teach the prosthesis according to Claim 19, Bark discloses the soft silicone gel intermediate layer is disposed between an outer surface of the base layer and an interior surface of the top layer (layer 18, shown in figure 3, is made of a silicone gel in column 3 lines 56-60. This layer is between the outer surface of the base layer ant the interior surface of the top layer).
However, Bark does not disclose wherein an interior surface of the base layer forms an inflatable cavity. Instead, Bartolo teaches wherein an interior surface of the base layer forms an inflatable cavity (in column 2 lines 39-47 wherein the prosthesis is disclosed as being inflatable. This means that the cavity of Bartolo is inflatable). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the needle guard of Bartolo in place of the needle guard of Bark as the needle guard part 13 has the injection button part 12. This injection button is beneficial to the device of Bark as said button is disclosed as providing a more economical means to seal a prosthesis as disclosed in column 1 lines 41-46).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Powell (US Pub No.: 2009/0118829) discloses a method of making a prosthetic shell. Jones (US Pub No.: 2011/0152913) discloses an implant with a needle stop disclosed in [0142].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
