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 Status
Applicant’s Remarks and Amendments filed 13 February 2026 have been entered. Claims 1-33 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 24 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.
Claims 24-31 and 33 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.
Claim 24 recites the limitation "the biocompatible filler material" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Claims 25-31 and 33 are rejected by dependency.
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 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.
Claims 1-3, 5-6, 8, 13, 22-24, 30, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Manesis et al. (WO 2011/097292 A1), “Manesis” in view of Naficy (US Pat. No. 4298998), “Naficy”.
Regarding claim 1, Manesis teaches an implantable prosthetic device (Fig. 1, device 10) comprising: a shell (Fig. 1, outer shell 22) made of a biocompatible elastomeric material (Fig. 2, outer shell 22 comprises at least one layer of elastomeric material (pg. 16, par. 2)), said shell (Fig. 1, outer shell 22) having a front wall (Fig. 1, inflatable portion 12) and a base (Fig. 1, posterior portion 34) that surround an interior volume of said shell (Fig. 1, inflatable portion 12 and posterior portion 34 surround inflatable cavity 28); a first scaffold (Fig. 1, inner shell 24) disposed within the interior volume of said shell (Fig. 1, inner shell 24 is within outer shell 22), said scaffold (Fig. 1, inner shell 24) having an inner surface (Fig. 1, underside of inner shell 22 facing cavity 28) that faces toward said base of said shell (Fig. 1, underside of inner shell 22 facing cavity 28 is directed toward posterior portion 34) and an outer surface (Fig. 2, topside of inner shell 22 facing intermediate layer 26) that faces toward said front wall of said shell (Fig. 2, topside of inner shell 22 facing intermediate layer 26 is directed towards outer shell 22), the first scaffold having an interior volume (Fig. 1, inner shell 24 defines inflatable cavity 28 filled with saline solution 14) but fails to teach a biocompatible filler material disposed within the interior volume of said shell and the interior volume of the first scaffold, the biocompatible filler material surrounds the inner and outer surfaces of said first scaffold.
Naficy teaches a breast prosthesis comprising a biocompatible filler material disposed within the interior volume of said shell and the interior volume of the first scaffold, the biocompatible filler material surrounds the inner and outer surfaces of said first scaffold (Fig. 5, breast prosthesis 12 comprises core 13 which is filled with substance 15 which is preferably a silicone gel or liquid such as a sterile saline solution and the space inside sac 16 is filled with the same (col. 8, par. 4)). Naficy discloses that other malleable or plastic or semifluid materials may be used to fill the sac as long as they are sterile, nontoxic and of low density (col. 8, par. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prosthesis taught by Manesis with the filler material disposed within both outer and inner scaffolds taught by Naficy in order to provide a nontoxic and shapeable implant.
Regarding claim 2, Manesis teaches wherein said biocompatible elastomeric material of said shell (Fig. 2, outer shell 22 comprises at least one layer of elastomeric material (pg. 16, par. 2)) comprises silicone (Fig. 1, elastomeric material is silicone elastomer (pg. 16, par. 3))
Regarding claim 3, Manesis teaches wherein said biocompatible filler material (Fig. 1, silicone gel (pg. 19, par. 2)) disposed within the interior volume of said shell comprises a cohesive filler material or a silicone gel (Fig. 1, silicone gel between outer and inner shells 22, 24 forms intermediate layer 26 (pg. 19, par. 2)).
Regarding claim 5, Manesis teaches wherein the inner surface of said first scaffold is concave (Fig. 1, underside of inner shell 22 facing cavity 28) and the outer surface of said first scaffold is convexly curved (Fig. 2, topside of inner shell 22 facing intermediate layer 26).
Regarding claim 6, Manesis teaches wherein the convexly curved outer surface of said first scaffold (Fig. 2, topside of inner shell 22 facing intermediate layer 26) mirrors the shape of said front wall of said shell (Fig. 1, topside if inner shell 22 facing intermediate layer 26 comprises similar shape to inflatable portion 12).
Regarding claim 8, Manesis teaches wherein said first scaffold (Fig. 1, inner shell 24) is attached to said base (Fig. 1, posterior portion 34) of said shell (Fig. 1, posterior portion 34 of device is inserted and bonded to inner shell 24 and/or outer shell 22 (pg. 19, par. 2)).
Regarding claim 13, Manesis teaches wherein said front wall (Fig. 1, inflatable portion 12) of said shell (Fig. 1, outer shell 22) includes an apex (Fig. 3, topmost portion of outer shell 22) and a dome that extends between said apex and said base of said shell (Fig. 3, regions of outer shell 22 between topmost portion and posterior portion 34), and wherein said first scaffold (Fig. 1, inner shell 24) has a shape that mirrors the shape of said dome of said shell (Fig. 1, inner shell 24 is within outer shell 22 and comprises a similar shape).
Regarding claim 22, Manesis teaches wherein said shell (Fig. 1, outer shell 22) and said scaffold (Fig. 1, inner shell 24) comprise silicone (Fig. 1, elastomeric material is silicone elastomer (pg. 16, par. 3)).
Regarding claim 23, Manesis teaches wherein said implantable prosthetic device (Fig. 1, device 10) is a breast implant (Fig. 1, device 10 is implanted in human breast 2).
Regarding claim 24, Manesis teaches an implantable prosthetic device (Fig. 1, device 10) comprising: a silicone shell (Fig. 1, outer shell 22) having a front wall portion (Fig. 1, inflatable portion 12) and a base (Fig. 1, posterior portion 34) that surround an interior volume of said silicone shell (Fig. 1, inflatable portion 12 and posterior portion 34 surround inflatable cavity 28); a first silicone scaffold (Fig. 1, inner shell 24) disposed within the interior volume of said silicone shell (Fig. 1, inner shell 24 is within outer shell 22), said first silicone scaffold (Fig. 1, inner shell 24) having a concave inner surface that faces toward said base of said silicone shell (Fig. 1, underside of inner shell 22 facing cavity 28) and a convexly curved outer surface that faces toward said front wall portion of said silicone shell (Fig. 2, topside of inner shell 22 facing intermediate layer 26), the first silicone scaffold having an interior volume (Fig. 1, inner shell 24 defines inflatable cavity 28 filled with saline solution 14) but fails to teach a silicone gel disposed within the interior volume of said silicone shell that fills said silicone shell and the interior volume of the first silicone scaffold, the biocompatible filler material surrounds said first silicone scaffold.
Naficy teaches a breast prosthesis comprising a silicone gel disposed within the interior volume of said silicone shell that fills said silicone shell and the interior volume of the first silicone scaffold, the biocompatible filler material surrounds said first silicone scaffold (Fig. 5, breast prosthesis 12 comprises core 13 which is filled with substance 15 which is preferably a silicone gel or liquid such as a sterile saline solution and the space inside sac 16 is filled with the same (col. 8, par. 4)). Naficy discloses that other malleable or plastic or semifluid materials may be used to fill the sac as long as they are sterile, nontoxic and of low density (col. 8, par. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prosthesis taught by Manesis with the filler material disposed within both outer and inner scaffolds taught by Naficy in order to provide a nontoxic and shapeable implant.
Regarding claim 30, Manesis teaches wherein said front wall (Fig. 1, inflatable portion 12) of said silicone shell (Fig. 1, outer shell 22) comprises an apex (Fig. 3, topmost portion of outer shell 22) and a dome that extends between said apex and said base of said silicone shell (Fig. 3, regions of outer shell 22 between topmost portion and posterior portion 34), and wherein said first silicone scaffold (Fig. 1, inner shell 24) has a geometric shape that mirrors the geometric shape of said dome of said silicone shell (Fig. 1, inner and outer shells 24, 22 comprise similar shapes).
Regarding claim 32, Manesis teaches wherein said first scaffold (Fig. 1, inner shell 24) has a conical shape (Fig. 1, inner shell 24 forms a conical shape when implanted).
Regarding claim 33, Manesis teaches wherein said shell (Fig. 1, outer shell 22) is hemispherical when positioned horizontally (Fig. 3, outer shell 22 is hemispherical in shape when horizontal) and said shell (Fig. 1, outer shell 22) is teardrop shaped when positioned vertically (Fig. 1, outer sell 22 forms teardrop shape with implanted vertically).
Claims 4, 9-12, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Manesis et al. (WO 2011/097292 A1), “Manesis” in view of Naficy (US Pat. No. 4298998), “Naficy” and further in view of Liu et al. (US 2020/0237968 A1), “Liu”.
Regarding claim 4, Manesis teaches wherein said biocompatible filler material (Fig. 1, silicone gel (pg. 19, par. 2)) disposed within the interior volume of said shell (Fig. 1, silicone gel between outer and inner shells 22, 24 forms intermediate layer 26 (pg. 19, par. 2)), but Manesis in view of Naficy fails to explicitly teach that the biocompatible filler material is adhered to at least a portion of the inner surface or the outer surface of said first scaffold.
Liu teaches porogen compositions for biocompatible implantable devices comprising biocompatible filler material is adhered to at least a portion of the inner surface or the outer surface of said first scaffold (silicone is applied as an adhesive onto a surface of a biocompatible implantable device, a porous material sheet, or both [0178]). Liu discloses that this attachment method results in no wrinkles on the surface of the device [0178]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the filler material and it’s positioning as taught by Manesis with the adhering abilities taught by Liu in order to improve cosmetic outcomes of the device when implanted.
Regarding claim 9, Manesis teaches said first scaffold (Fig. 1, inner shell 24), but Manesis in view of Naficy fails to teach it has an open base and a hemispherical, conical, or teardrop shape.
Liu teaches porogen compositions for biocompatible implantable devices having the general shape of a hemisphere having an open base (Fig. 4D, porous material layer 20 comprising hole 16). Liu discloses that this design results in a reduction or prevention of fibrous capsule formation that causes capsular contracture and scarring [0214]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the shape of the scaffold taught by Manesis to reflect the shape taught by Liu in order to prevent capsular contracture.
Regarding claim 10, Manesis teaches wherein said first scaffold (Fig. 1, inner shell 24), but Manesis in view of Naficy fails to teach a lower end including a free edge perimeter that surrounds an opening in said open base of said first scaffold.
Liu teaches porogen compositions for biocompatible implantable devices comprising a lower end including a free edge perimeter (Fig. 4D, ends of porous material layer 20 nearest hole 16) that surrounds an opening in said open base (Fig. 4D, hole 16) of said first scaffold (Fig. 4D, porous material layer 20). Liu discloses that this design results in a reduction or prevention of fibrous capsule formation that causes capsular contracture and scarring [0214]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the shape of the scaffold taught by Manesis to reflect the shape taught by Liu in order to prevent capsular contracture.
Regarding claim 11, Manesis teaches said first scaffold (Fig. 1, inner shell 24) is juxtaposed with said base (Fig. 1, posterior portion 34) of said shell (Fig. 1, outer shell 22), but Manesis in view of Naficy fails to teach a free edge perimeter.
Liu teaches porogen compositions for biocompatible implantable devices comprising a free edge perimeter (Fig. 4D, ends of porous material layer 20 nearest hole 16). Liu discloses that this design results in a reduction or prevention of fibrous capsule formation that causes capsular contracture and scarring [0214]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the shape of the scaffold taught by Manesis to reflect the shape taught by Liu in order to prevent capsular contracture.
Regarding claim 12, Manesis teaches said first scaffold (Fig. 1, inner shell 24) is attached to said base (Fig. 1, posterior portion 34) of said shell (Fig. 1, outer shell 22), but Manesis in view of Naficy fails to teach a free edge perimeter that is attached to said base.
Liu teaches porogen compositions for biocompatible implantable devices comprising a free edge perimeter that is attached to said base (Fig. 4C, ends of porous material layer 20 nearest hole 16 is engaged with bottom of implantable device 10). Liu discloses that this design results in a reduction or prevention of fibrous capsule formation that causes capsular contracture and scarring [0214]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the shape of the scaffold taught by Manesis to reflect the shape taught by Liu in order to prevent capsular contracture.
Regarding claim 26, Manesis teaches said first silicone scaffold (Fig. 1, inner shell 24), but Manesis in view of Naficy fails to teach a hemisphere having an open base and a lower, free edge that surrounds said open base.
Liu teaches porogen compositions for biocompatible implantable devices comprising a hemisphere having an open base (Fig. 4D, hole 16) and a lower, free edge that surrounds said open base (Fig. 4D, porous material layer 20 comprising hole 16). Liu discloses that this design results in a reduction or prevention of fibrous capsule formation that causes capsular contracture and scarring [0214]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the shape of the scaffold taught by Manesis to reflect the shape taught by Liu in order to prevent capsular contracture.
Regarding claim 27, Manesis teaches said first silicone scaffold (Fig. 1, inner shell 24) and said base (Fig. 1, posterior portion 34) of said silicone shell (Fig. 1, outer shell 22), but Manesis in view of Naficy fails to teach said lower, free edge of said first silicone scaffold is juxtaposed with said base.
Liu teaches porogen compositions for biocompatible implantable devices comprising a lower, free edge of said scaffold (Fig. 4D, ends of porous material layer 20 nearest hole 16) is juxtaposed with said base (Fig. 4C, bottom of implantable device 10). Liu discloses that this design results in a reduction or prevention of fibrous capsule formation that causes capsular contracture and scarring [0214]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the shape of the scaffold taught by Manesis to reflect the shape taught by Liu in order to prevent capsular contracture.
Regarding claim 28, Manesis teaches said first silicone scaffold (Fig. 1, inner shell 24) and said base (Fig. 1, posterior portion 34) of said silicone shell (Fig. 1, outer shell 22), but Manesis in view of Naficy fails to teach said lower, free edge of said first silicone scaffold is attached to said base.
Liu teaches porogen compositions for biocompatible implantable devices comprising a lower, free edge of said silicone scaffold (Fig. 4D, ends of porous material layer 20 nearest hole 16) is attached to said base (Fig. 4C, bottom of implantable device 10 is attached to porous material shell [0214]). Liu discloses that this design results in a reduction or prevention of fibrous capsule formation that causes capsular contracture and scarring [0214]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the shape of the scaffold taught by Manesis to reflect the shape taught by Liu in order to prevent capsular contracture.
Claims 7, 14-21, 25, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Manesis et al. (WO 2011/097292 A1), “Manesis” in view of Naficy (US Pat. No. 4298998), “Naficy”, and further in view of Hamas et al. (US 2013/0116784 A1), “Hamas”.
Regarding claim 7, Manesis teaches said first scaffold (Fig. 1, inner shell 24) comprises a wall, but Manesis in view of Naficy fails to teach one or more openings formed therein that extend from the inner surface of said first scaffold wall to the outer surface of said first scaffold wall.
Hamas teaches a breast implant comprising one or more openings (Fig. 1, non-enclosing fitted shell openings 42a-42d) formed therein that extend from the inner surface (Fig. 1, interior surface 40b) of said first scaffold wall (Fig. 1, second non-enclosing fitted shell 16b) to the outer surface (Fig. 1, exterior surface 38b) of said first scaffold wall (Fig. 1, second non-enclosing fitted shell 16b). Hamas discloses that the two or more interacting elastomeric shells provide the implant with a natural tactile feel similar to human breast tissue [0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold taught by Hamas in order to better mimic natural breast tissue to provide better cosmetic outcomes.
Regarding claim 14, Manesis teaches said first scaffold (Fig. 1, inner shell 24), the inner surface of said first scaffold (Fig. 1, underside of inner shell 22 facing cavity 28), said base (Fig. 1, posterior portion 34), and said shell (Fig. 1, outer shell 22), but Manesis in view of Naficy fails to teach a second scaffold that is nested within said first scaffold, wherein said second scaffold is located between the inner surface of said first scaffold and said base of said shell.
Hamas teaches a breast implant comprising a second scaffold (Fig. 1, second non-enclosing fitted shell 16b) that is nested within said first scaffold (Fig. 1, first non-enclosing fitted shell 16a), wherein said second scaffold (Fig. 1, second non-enclosing fitted shell 16b) is located between the inner surface of said first scaffold (Fig. 1, interior surface 40a of first non-enclosing fitted shell 16a (shells are adjacent to each other [0035]) and said base (Fig. 1, exterior (bottom) surface 22) of said shell (Fig. 1, outer shell 22). Hamas discloses that the two or more interacting elastomeric shells provide the implant with a natural tactile feel similar to human breast tissue [0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold taught by Hamas in order to better mimic natural breast tissue to provide better cosmetic outcomes.
Regarding claim 15, Manesis in view of Naficy fails to teach the limitations of claim 15. Hamas teaches a breast implant wherein said second scaffold (Fig. 1, second non-enclosing fitted shell 16b) has a curved wall (Fig. 1, second non-enclosing fitted shell 16b curves) with one or more openings (Fig. 1, non-enclosing fitted shell opening 42b) formed therein that extend from an inner surface (Fig. 1, interior surface 40b) to an outer surface (Fig. 1, exterior surface 38b) of said curved wall of said second scaffold (Fig. 1, second non-enclosing fitted shell 16b).
Hamas discloses that the two or more interacting elastomeric shells provide the implant with a natural tactile feel similar to human breast tissue [0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold taught by Hamas in order to better mimic natural breast tissue to provide better cosmetic outcomes.
Regarding claim 16, Manesis teaches wherein said biocompatible filler material (Fig. 1, silicone gel (pg. 19, par. 2)) is in contact with at least one of said inner and outer surfaces of said curved wall of said scaffold (Fig. 1, silicone gel between outer and inner shells 22, 24 forms intermediate layer 26 (pg. 19, par. 2)), but Manesis in view of Naficy fails to teach a second scaffold.
Hamas teaches a breast implant having a second scaffold (Fig. 1, second non-enclosing fitted shell 16b). Hamas discloses that the two or more interacting elastomeric shells provide the implant with a natural tactile feel similar to human breast tissue [0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold and filler material taught by Manesis with the second scaffold taught by Hamas in order to better mimic natural breast tissue to provide better cosmetic outcomes.
Regarding claim 17, Manesis teaches wherein said front wall (Fig. 1, inflatable portion 12) of said shell (Fig. 1, outer shell 22) has a shell wall thickness, said first scaffold (Fig. 1, inner shell 24) has a first scaffold wall thickness, but Manesis in view of Naficy fails to teach said second scaffold has a second scaffold wall thickness, wherein said second scaffold wall thickness is greater than said first scaffold wall thickness, and wherein said first scaffold wall thickness is greater than said shell wall thickness.
Hamas teaches a breast implant wherein said second scaffold (Fig. 1, second non-enclosing fitted shell 16b) has a second scaffold wall thickness, wherein said second scaffold wall thickness is greater than said first scaffold (Fig. 1, first non-enclosing fitted shell 16a) wall thickness (non-enclosing fitted shells may be of varying thicknesses in different areas [0033]), and wherein said first scaffold wall thickness is greater than said shell wall (Fig. 1, outer shell 22) thickness (non-enclosing fitted shells may be of varying thicknesses in different areas [0033]). Hamas discloses that the thickness of the shells may vary relative to each other and the inner and/or the inner and outer shell [0033]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold and varied thicknesses taught by Hamas in order to minimize bulk of the device.
Regarding claim 18, Manesis teaches said geometric shape of said front wall (Fig. 1, inflatable portion 12) of said shell (Fig. 1, outer shell 22), but Manesis in view of Naficy fails to teach wherein said second scaffold has a geometric shape that is different than the geometric shape of said first scaffold or the geometric shape of said front portion of said shell.
Hamas teaches a breast implant comprising a second scaffold (Fig. 1, non-enclosing fitted shell 16b). Hamas discloses that the two or more interacting elastomeric shells provide the implant with a natural tactile feel similar to human breast tissue [0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold and filler material taught by Manesis with the second scaffold taught by Hamas in order to better mimic natural breast tissue to provide better cosmetic outcomes. However, Manesis in view of Hamas fails to teach the second scaffold having a different geometric shape than said front portion of said shell.
Regarding the geometric shape of the second scaffold as compared to said front wall of said shell, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), the court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” MPEP § 2144.04-IV-B.
Regarding claim 19, Manesis teaches said first scaffold (Fig. 1, inner shell 24) and said front wall (Fig. 1, inflatable portion 12) of said shell (Fig. 1, outer shell 22), but Manesis in view of Naficy fails to teach wherein said first scaffold has a geometric shape that is different than the geometric shape of said second scaffold or the geometric shape of said front portion of said shell.
Regarding the geometric shape of the first scaffold as compared to said front wall of said shell, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), the court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” MPEP § 2144.04-IV-B.
Regarding claim 20, Manesis teaches wherein said shell (Fig. 1, outer shell 22) has a shell wall thickness and said first scaffold (Fig. 1, inner shell 24) has a scaffold wall thickness, but Manesis in view of Naficy fails to teach said first scaffold wall thickness is greater than the shell wall thickness.
Hamas teaches a breast implant wherein said scaffold wall thickness is greater than the shell wall thickness (non-enclosing fitted shells are of varying thicknesses in different areas relative to each other and/or the inner and outer shell [0033]). Hamas discloses that the thickness of the shells may vary relative to each other and the inner and/or the inner and outer shell [0033]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold and varied thicknesses taught by Hamas in order to minimize bulk of the device.
Regarding claim 21, Manesis teaches wherein said scaffold (Fig. 1, inner shell 24) has an apex (Fig. 3, topmost portion of inner shell 24), a radius, and a dome that extends between said apex of said scaffold and said radius of said scaffold (Fig. 3, regions of inner shell 24 between topmost portion and posterior portion 34), and wherein said scaffold (Fig. 1, inner shell 24), but Manesis in view of Naficy fails to explicitly teach a wall that is thicker at said apex of said scaffold and thinner at said radius of said scaffold.
Hamas teaches a breast implant comprising a wall that is thicker at said apex of said scaffold and thinner at said radius of said scaffold (non-enclosing fitted shells are of varying thicknesses in different areas relative to each other and/or the inner and outer shell [0033]). Hamas discloses that the thickness of the shells may vary relative to each other and the inner and/or the inner and outer shell [0033]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold and varied thicknesses taught by Hamas in order to minimize bulk of the device.
Regarding claim 25, Manesis teaches said first silicone scaffold (Fig. 1, inner shell 24), the concave inner surface (Fig. 1, underside of inner shell 22 facing cavity 28), and the convexly curved outer surface (Fig. 2, topside of inner shell 22 facing intermediate layer 26) of said first silicone scaffold (Fig. 1, inner shell 24), but Manesis in view of Naficy fails to teach one or more openings formed therein that extend from the concave inner surface to the convexly curved outer surface.
Hamas teaches a breast implant comprising one or more openings (Fig. 1, non-enclosing fitted shell openings 42a-42d) formed therein that extend from the concave inner surface to the convexly curved outer surface (Fig. 1, openings 42a-42d extend from interior surfaces 40a-40d to exterior surfaces 38a-38d). Hamas discloses that the two or more interacting elastomeric shells provide the implant with a natural tactile feel similar to human breast tissue [0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold taught by Hamas in order to better mimic natural breast tissue to provide better cosmetic outcomes.
Regarding claim 29, Manesis teaches said first silicone scaffold (Fig. 1, inner shell 24) and said base (Fig. 1, posterior portion 34) of said silicone shell (Fig. 1, outer shell 22), but Manesis in view of Naficy fails to teach a second silicone scaffold that is nested within said first silicone scaffold, and that is located between said concave inner surface of said first silicone scaffold of said silicone shell.
Hamas teaches a breast implant comprising a second silicone scaffold (Fig. 1, second non-enclosing fitted shell 16b) that is nested within said first silicone scaffold (Fig. 1, first non-enclosing fitted shell 16a), and that is located between said concave inner surface of said first silicone scaffold of said silicone shell (Fig. 1, non-enclosed fitted shells 16a-16d are contained within each other [0035]). Hamas discloses that the two or more interacting elastomeric shells provide the implant with a natural tactile feel similar to human breast tissue [0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold taught by Hamas in order to better mimic natural breast tissue to provide better cosmetic outcomes.
Regarding claim 31, Manesis teaches wherein said front wall portion (Fig. 1, inflatable portion 12) of said silicone shell (Fig. 1, outer shell 22) has a first wall thickness and said first silicone scaffold (Fig. 1, inner shell 24), but Manesis in view of Naficy fails to explicitly teach said silicone scaffold comprising a second wall thickness that is greater than the first wall thickness.
Hamas teaches a breast implant comprising a second wall thickness (Fig. 1, second non-enclosing fitted shell 16b) that is greater than the first wall thickness (non-enclosing fitted shells are of varying thicknesses in different areas relative to each other and/or the inner and outer shell [0033]). Hamas discloses that the thickness of the shells may vary relative to each other and the inner and/or the inner and outer shell [0033]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first scaffold taught by Manesis with the second scaffold and varied thicknesses taught by Hamas in order to minimize bulk of the device.
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 GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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