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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 2026 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 9 April 2026 have been entered. Claims 7 and 9 are canceled. Claims 32-33 are new. Claims 1-6, 8, 13-25, and 29-33 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 1-6, 8, 13-25, and 29-33 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 1 recites the limitation "the shape" in lines 14 and 16. There is insufficient antecedent basis for this limitation in the claim. Claims 2-6, 8, 13-23, and 32 are rejected by dependency.
Claim 6 recites the limitation "the shape" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "the shape" in lines 9 and 16. There is insufficient antecedent basis for this limitation in the claim. Claims 25, 29-31, 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, 13-25, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Manesis et al. (WO 2011/097292 A1), “Manesis” in view of Hamas et al. (US 2013/0116784 A1), “Hamas” and Aperavich (US Pat. No. 4332634), “Aperavich” and further in view of Glicksman (US 2018/0064530 A1), “Glicksman”.
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 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); and a biocompatible filler material (Fig. 1, silicone gel (pg. 19, par. 2)) disposed within the interior volume of said shell that surrounds the inner and outer surfaces of said scaffold (Fig. 1, silicone gel between outer and inner shells 22, 24 forms intermediate layer 26 (pg. 19, par. 2)), but fails to teach a lower end including a circular, free edge that surrounds an opening in said base of said shell, and that said free edge of said scaffold is adhered to said base of said shell and wherein said biocompatible filler material completely fills the interior volume of said shell and an interior volume of said scaffold, and wherein said free edge of said scaffold is adhered to said base of said shell, said scaffold having the shape of a hemisphere having an open base, said scaffold bonding to the biocompatible filler material, said scaffold being configured to have a sufficient mechanical integrity to reduce the ability of the biocompatible filler material to flow freely within the shell to maintain the shape of the filled implantable prosthetic device, thereby enhancing the form stability of the device.
Hamas teaches a breast implant comprising a lower end including a circular, free edge that surrounds an opening in said base of said shell (Fig. 2, non-enclosing fitted shells 16a-c surround opening for valve 36); and wherein said biocompatible filler material completely fills the interior volume of said shell and an interior volume of said scaffold (Fig. 2, implant may be filled with silicone gel or saline or both [0012]); and wherein said free edge of said scaffold is adhered [0010], said scaffold having the shape of a hemisphere having an open base (Fig. 2, shells 16a-c are sized in a graduated manner to nest within each other and conform to the dome shape [0028] of the implant [0034-0035]), said scaffold bonding to the biocompatible filler material (the implant comprises filler fluid, i.e., silicone gel or saline, that diffuses (i.e., bonds) through the numerous shells of the implant [0012]). 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 scaffold shape and biocompatible filler taught by Hamas with the shell and surfaces taught by Manesis in order to better mimic natural breast tissue and provide better cosmetic outcomes. However, Manesis in view of Hamas fails to teach said free edge of said scaffold is adhered to said base of said shell, and said scaffold being configured to have a sufficient mechanical integrity to reduce the ability of the biocompatible filler material to flow freely within the shell to maintain the shape of the filled implantable prosthetic device, thereby enhancing the form stability of the device.
Aperavich teaches an inflatable valve for a mammary prosthesis comprising a free edge of said scaffold is adhered to said base of said shell (Fig. 6, shell 14 is joined to flat bottom 13 (col. 2, par. 2)). Aperavich discloses that the prosthesis is resealable which provides time and material savings (col. 1, par. 6). 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 positioning taught by Aperavich with the scaffolds taught by Hamas in order to save time and production costs.
Glicksman teaches a breast implant wherein said scaffold being configured to have a sufficient mechanical integrity to reduce the ability of the biocompatible filler material to flow freely within the shell to maintain the shape of the filled implantable prosthetic device, thereby enhancing the form stability of the device (reinforcing structures within the breast implant are configured to stabilize the shape of the implant by reducing movement of the liquid inside the implant [0056]). Glicksman discloses that the reduced movement of the liquid within the implant stabilizes its shape [0056]. 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 characteristics taught by Glicksman with the scaffolds taught by Hamas and the shell taught by Manesis in order to maintain the shape of the implant for cosmetic purposes.
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 scaffold is concave (Fig. 1, underside of inner shell 22 facing cavity 28) and the outer surface of said 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 scaffold (Fig. 2, topside of inner shell 22 facing intermediate layer 26) mirrors the shape of said front portion 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 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 portion (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 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 14, Manesis teaches wherein said scaffold is a first scaffold (Fig. 1, inner shell 24), the implantable prosthetic device further comprising 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 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 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 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 portion (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 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 portion (Fig. 1, inflatable portion 12) of said shell (Fig. 1, outer shell 22), but 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 portion 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 portion (Fig. 1, inflatable portion 12) of said shell (Fig. 1, outer shell 22), but 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 portion 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 scaffold (Fig. 1, inner shell 24) has a scaffold wall thickness, but fails to teach said 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 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 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 (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 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 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 of said silicone shell (Fig. 2, topside of inner shell 22 facing intermediate layer 26); and a silicone gel disposed within the interior volume of said silicone shell that fills said silicone shell and surrounds said silicone scaffold (Fig. 1, silicone gel between outer and inner shells 22, 24 forms intermediate layer 26 (pg. 19, par. 2)), but fails to teach wherein said silicone scaffold having the shape of a hemisphere having an open base and a lower, free edge that surrounds said base of said silicone shell, wherein said silicone gel completely fills the interior volume of said silicone shell and an interior volume of said silicone shell, and wherein said free edge of said silicone scaffold is adhered to said base of said silicone shell, said silicone scaffold bonding to the biocompatible filler material, said silicone scaffold being configured to have a sufficient mechanical integrity to reduce the ability of the biocompatible filler material to flow freely within the shell to maintain the shape of the filled implantable prosthetic device, thereby enhancing the form stability of the device.
Hamas teaches a breast implant comprising a lower end including a circular, free edge that surrounds an opening in said base of said shell (Fig. 2, non-enclosing fitted shells 16a-c surround opening for valve 36); and wherein said biocompatible filler material completely fills the interior volume of said shell and an interior volume of said scaffold (Fig. 2, implant may be filled with silicone gel or saline or both [0012]); and wherein said free edge of said scaffold is adhered [0010], said scaffold having the shape of a hemisphere having an open base (Fig. 2, shells 16a-c are sized in a graduated manner to nest within each other and conform to the dome shape [0028] of the implant [0034-0035]), said scaffold bonding to the biocompatible filler material (the implant comprises filler fluid, i.e., silicone gel or saline, that diffuses (i.e., bonds) through the numerous shells of the implant [0012]). 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 scaffold shape and biocompatible filler taught by Hamas with the shell and surfaces taught by Manesis in order to better mimic natural breast tissue and provide better cosmetic outcomes. However, Manesis in view of Hamas fails to teach said free edge of said scaffold is adhered to said base of said shell, and said scaffold being configured to have a sufficient mechanical integrity to reduce the ability of the biocompatible filler material to flow freely within the shell to maintain the shape of the filled implantable prosthetic device, thereby enhancing the form stability of the device.
Aperavich teaches an inflatable valve for a mammary prosthesis comprising a free edge of said scaffold is adhered to said base of said shell (Fig. 6, shell 14 is joined to flat bottom 13 (col. 2, par. 2)). Aperavich discloses that the prosthesis is resealable which provides time and material savings (col. 1, par. 6). 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 positioning taught by Aperavich with the scaffolds taught by Hamas in order to save time and production costs.
Glicksman teaches a breast implant wherein said scaffold being configured to have a sufficient mechanical integrity to reduce the ability of the biocompatible filler material to flow freely within the shell to maintain the shape of the filled implantable prosthetic device, thereby enhancing the form stability of the device (reinforcing structures within the breast implant are configured to stabilize the shape of the implant by reducing movement of the liquid inside the implant [0056]). Glicksman discloses that the reduced movement of the liquid within the implant stabilizes its shape [0056]. 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 characteristics taught by Glicksman with the scaffolds taught by Hamas and the shell taught by Manesis in order to maintain the shape of the implant for cosmetic purposes.
Regarding claim 25, Manesis teaches said 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 silicone scaffold (Fig. 1, inner shell 24), but 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 wherein said scaffold is a first scaffold (Fig. 1, inner shell 24), the implantable prosthetic device further comprising 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 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 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 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 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 silicone scaffold (Fig. 1, inner shell 24), but 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Manesis et al. (WO 2011/097292 A1), “Manesis” in view of Hamas et al. (US 2013/0116784 A1), “Hamas” and Aperavich (US Pat. No. 4332634), “Aperavich” and Glicksman (US 2018/0064530 A1), “Glicksman” 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 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 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 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.
Claims 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 Hamas et al. (US 2013/0116784 A1), “Hamas” and Aperavich (US Pat. No. 4332634), “Aperavich”, Glicksman (US 2018/0064530 A1), “Glicksman”, and further in view of Spiegel et al. (US 2020/0078165 A1), “Spiegel”.
Regarding claim 32, Manesis teaches said scaffold comprises a wall (Fig. 1, inner shell 24), but fails to teach a plurality of openings formed therein that extend from the inner surface of said scaffold wall to the outer surface of said scaffold wall.
Spiegel teaches soft tissue repair grafts comprising a plurality of openings formed therein that extend from the inner surface of said scaffold wall to the outer surface of said scaffold wall (Fig. 1, openings 42-a-g). Spiegel discloses that the openings allow for expansion of the graft to reshape into a three dimensional structure that conforms to the shape of the breast [0035]. 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 scaffold taught by Manesis with the openings taught by Spiegel in order to provide an implant which better conforms to the natural shape of the breast.
Regarding claim 33, Manesis teaches said scaffold comprises a wall (Fig. 1, inner shell 24), but fails to teach a plurality of openings formed therein that extend from the inner surface of said scaffold wall to the outer surface of said scaffold wall.
Spiegel teaches soft tissue repair grafts comprising a plurality of openings formed therein that extend from the inner surface of said scaffold wall to the outer surface of said scaffold wall (Fig. 1, openings 42-a-g). Spiegel discloses that the openings allow for expansion of the graft to reshape into a three dimensional structure that conforms to the shape of the breast [0035]. 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 scaffold taught by Manesis with the openings taught by Spiegel in order to provide an implant which better conforms to the natural shape of the breast.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA G. B. RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 9:00AM-6:00PM CST.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
