DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Spector (WO 2020/081806) and further in view of Melican et al. (EP 1216717).
Regarding claims 1, 2, and 3, Spector discloses a nipple implant (see [0076]), wherein: the first portion (see [0074] disclosing the cartilage that is encaged within the scaffold, thereby forming the first portion) and the second portion (see [0076] disclosing an external biocompatible scaffold (30A), thereby forming the second portion) are configured to form a cylindrical body portion (see [0076] disclosing how the cylindrical shape is made) and at least a partially dome-shape at an end of the cylindrical body portion (see Fig. 1C illustrating the dome-shaped nipple construct); and a flange base at an end of the cylindrical body portion opposite of the at least partially dome-shape end (see Fig. 1C illustrating the cylindrical body with a partial dome shape and a flange portion surrounding the bottom portion of the cylindrical body).
Furthermore, Spector discloses wherein: one of the first portion and the second portion is a core of the implant (see [0098] disclosing an external scaffold designed with inner dimensions matching a nipple prosthesis, thereby establishing a scaffold surrounding a core body) and the other of the first portion and the second portion surrounds the core (see [0074] disclosing the cartilage encased with the scaffold, thereby requiring a core).
Spector fails to disclose a first portion of a polymeric knitted or woven macroporous textile and a second portion of polymeric microporous non-woven or foam, wherein the first portion and the second portion are configured to form a cylindrical body portion and at least a partially dome-shape at an end of the cylindrical body portion.
Melican et al. also discloses an implant (10) (see [0016]), with a polymeric foam component having pores with an open cell pore structure (see [0010] disclosing the structure). Melican et al. teaches a reinforcing component comprised of biocompatible textiles with woven, knitted, warped knitted, non-woven, and braided structures (see [0028] disclosing the structures); a low-density, open knitted mesh made of 90/10 PGA/PLA copolymer (see [0049] disclosing the mesh); the mesh density is ideally 12% to 80%, thereby making it microporous (see [0050] disclosing the mesh density range); the polymeric foam having an open cell pore structure makes it microporous (see [0014] disclosing the microporous polymer); the webs or walls of the foam component penetrate the mesh of the reinforcement component to interlock it, thereby creating a unified, multi-portion composite structure (see [0010] disclosing the foam reinforcement); the foam/mesh constructs can be optimized to regenerate or repair complex anatomical features (e.g., breast tissues) requiring it to form 3D structures where cylindrical or dome-like configurations are typically utilized (see [0027] disclosing organ repair replacement, and tissue regeneration). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Spector’s nipple reconstruction implant, with the multi-layered, multi-textured polymeric biomaterials, specifically pairing high-strength structural layers (knitted or woven) with soft tissue integration, as taught by Melican et al. Doing so would provide a means to have an implant capable of maintaining its critical 3D cylindrical and dome-like shape under mechanical skin tension, while maximizing soft-tissue integration and tactile realism.
Claims 4-8, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Spector (WO 2020/081806) as applied to claim 2 above, in view of Melican et al. (EP 1216717), and further in view of Felix et al. (US 2015/0112434).
Regarding claims 4-8, Spector/Melican et al. discloses the nipple implant of claim 2, but fails to disclose wherein: the first portion includes at least one sheet of microporous poly-4-hydroxybutyrate or copolymer thereof; wherein the first portion includes at least one sheet of spun poly-4-hydroxybutyrate or copolymer thereof; wherein: the second portion includes at least one sheet of spun poly-4-hydroxybutyrate or copolymer thereof; and wherein: the at least one spun sheet has been manipulated into a cylindrical shape and at least a partially dome-shape.
Felix et al. also discloses an implant with a 3D shape that can be deformed into cylindrical shapes (see [0075] disclosing the shape). Felix et al. teaches the implant, along with the optional addition of a nipple implant, which will inherently require the same material composition of the implant, sits within the nipple-areolar complex (see [0038] disclosing the implant); the implant is made of poly-4-hydroxybutyrate and copolymers (see [0027] disclosing the materials); the poly-4-hydroxybutyrate can be prepared from a thin film (e.g. sheet) (see [0139] disclosing the materials); the materials can be spun (see [0102] disclosing the materials can be nanospun, electrospun, or dry spun); and the materials can be made into a partial dome shape (see [0098] disclosing the shape). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., with the fabrication of soft-tissue surgical scaffolds made of sheets of microporous or spun poly-4-hydroxybutyrate or copolymers, as taught by Felix et al. Doing so would provide a means to fabricate a resilient 3D neo-nipple structural pillar via the rolling, folding, and heat molding of a flat microporous sheet.
Regarding claims 13, and 14, Spector/Melican et al. discloses the nipple implant of claim 1.
Spector/Melican et al. fails to disclose wherein: the first portion and the second portion are respectively formed from an absorbable polymer comprising, or prepared from, one or more monomers selected from the group: glycolide, lactide, glycolic acid, lactic acid, 1,4- dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 3-hydroxybutyrate, 3- hydroxyhexanoate, 4-hydroxybutyric acid, 4-hydroxybutyrate, 3-hydroxyoctanoate, E- caprolactone, 1,4-butanediol, 1,3-propane diol, ethylene glycol, glutaric acid, malic acid, malonic acid, oxalic acid, succinic aid, or adipic acid, or the absorbable polymer comprises poly-4-hydroxybutyrate or copolymer thereof, or poly(butylene succinate) or copolymer thereof; and wherein: the first portion is formed of poly-4- hydroxybutyrate or copolymer thereof, and wherein: the second portion is formed of poly-4- hydroxybutyrate or copolymer thereof.
Felix et al. also discloses that any absorbable biocompatible polymer may be used to make the implant (see [0104]). Felix et al. teaches various polymers can be used for the implant (e.g., glycolides, lactides, P4HB, succinate/adipic acid derivatives) (see [0104] disclosing various polymers). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., with the specific polymers used for high-strength, long-term surgical absorbable implants, as taught by Felix et al. Doing so would provide a means to achieve synchronized absorption kinetics and uniform mechanical reinforcement throughout the entire neo-nipple structure.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Spector (WO 2020/081806) as applied to claim 1 above, in view of Melican et al. (EP 1216717), and further in view of Belleghem et al. (US 2020/0324021).
Spector/Melican et al. discloses the nipple implant of claim 1, but fails to disclose wherein: at least one of the first portion and the second portion is at least partly filled with a hydrogel.
Belleghem et al. also discloses an implantable scaffold device made of biodegradable and non-biodegradable materials (see [0024] disclosing the implantable scaffold device composition), and a support and dermal portion (see [0024] disclosing the portions). Belleghem et al. teaches the support and dermal portions are made of hydrogels (see [0025] disclosing the hydrogels); and the hydrogels support the interior of the implant (see [0024] disclosing the function of the hydrogels). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., with the anatomically shaped nipple-areola complex prosthetic implant using hydrogels for its structural portions, as taught by Belleghem et al. Doing so would provide a means to encapsulate a continuous, hydrated polymeric hydrogel matrix within a defined structural chamber of a 3D nipple reconstruction implant.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Spector (WO 2020/081806) as applied to claim 1 above, in view of Melican et al. (EP 1216717), and further in view of Choi et al. (US 2022/0257365).
Spector/Melican et al. discloses the nipple implant of claim 1, but fails to disclose wherein: the first portion comprises a plurality of macropores, and the macropores have an average diameter or average width of 75 to 2,000 microns.
Choi et al. also discloses a body (100) of an implant (see [0049]), with the implant having a porous structure (see [0048]). Choi et al. teaches the microfibers that make up the body (100) may have an interval of 50 to 1500 µm, thereby encompassing the target range of 75 to 2,000 microns (see [0019] disclosing the intervals). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., with the pore-size optimization parameters, as taught by Choi et al. Doing so would provide a means to size and optimize the structural voids of a nipple implant wall.
Claims 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Spector (WO 2020/081806) as applied to claim 2 above, in view of Melican et al. (EP 1216717), in view of Felix et al. (US 2015/0112434), and further in view of Belleghem et al. (US 2020/0324021).
Regarding claim 11, Spector/Melican et al. discloses the nipple implant of claim 1, but fails to disclose wherein: filaments included in the first portion have one or more of the following properties: an average diameter of 10 pm to 5 mm, a breaking load of 0.1 to 200 N, an elongation at break of 10 to 1,000%, and an elastic modulus of 0.05 to 1,000 MPa.
Felix et al. also discloses mechanical parameters of individual fibers under tension (see [0055]). Felix et al. teaches the processed materials are designed to withstand mechanical loads ranging from 5N to 60 N, thereby falling within the 0.1 N to 200 N range (see [0067] disclosing the mechanical forces); the mechanical loads cannot stretch beyond an elongation limit of 30%, thereby falling within the 10% to 1,000% range (see [0072] disclosing the stretch); the fibers have a diameter distribution of 25 µm and greater than 50 µm (see [0117] disclosing the diameters).
Felix et al. fails to disclose an elastic modulus of 0.05 to 1,000 MPa.
Belleghem et al. also discloses an elastic compressive modulus (see Fig. 3B). Belleghem et al. teaches that by varying the print patterns used to fabricate the scaffolds, the elastic compressive modulus can be dialed in (see [0036] disclosing the mechanical testing; Fig. 3B illustrating the compressive modulus); and a 430 kPa range that falls within the 0.05 to 1,000 MPa range (see [0014] disclosing the mechanical properties of the scaffold patter ratios). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., and Felix et al., with the tuning of the polymer strand elements to hit target physical dimensions and compliance windows, as taught by Belleghem et al. Doing so would provide a means to optimize the physical dimensions, load capacities, elongation thresholds, and elastic modulus of individual structural elements, in order for the implant to withstand physiological load forces without collapsing, tearing or fracturing.
Regarding claim 12, Spector/Melican et al./Felix et al./Belleghem et al., discloses the nipple implant of claim 11.
Spector/Melican et al./Belleghem et al. fails to disclose wherein: the filaments included in the first portion have one or more of the following properties: (i) an elongation at break greater than 100%; (ii) an elongation at break greater than 200%; (iii) a melting temperature of 60 C or higher, (iv) a melting temperature higher than 100 °C, (v) a glass transition temperature of less than 0 °C, (vi) a glass transition temperature between -55 C and 0 "C, (vii) a tensile modulus less than 300 MPa, and (viii) a tensile strength higher than 25 MPa.
Furthermore, Felix et al. also discloses an implant made of poly-4-hydroxybuturate (see [0060]). Felix et al. teaches the use of poly-4-hydroxybuturate which has inherent thermal parameters of a melting temperature of approximately 53°C to 60°C or higher depending on crystallization, and a recognized glass transition temperature of approximately -48°C to 51°C; the implant cannot stretch more than 30% of its original length, thereby possessing an elongation limit greater than 100% and greater than 200% (see [0072] disclosing elongation limits); and the implant can withstand a load of at least 5 N, preferably at 15 N, and more preferably at 60 N (see [0067] disclosing the mechanical forces); poly-4-hydroxybutyrate has an inherent flexibility and a baseline tensile modulus of 70 MPa to 100 MPa, which is less than 300 MPa; and the inherent tensile strength of poly-4-hydroxybutyrate knitted construct (see [0139] disclosing the knitted construct) ranges from 50 MPa to 150 MPa, thereby making it higher than 25 MPa. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., and Belleghem et al., with the intrinsic properties of poly-4-hydroxybutyrate, as taught by Felix et al. Doing so would provide a means to fabricate an external structural nipple implant composed of poly-4-hydroxybutyrate, tuned to specific thermal and mechanical thresholds , in order to have a bio-scaffold that is pliable enough to feel natural, yet strong enough to resist early post-operative vertical flattening.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Spector (WO 2020/081806), in view of Choi et al. (US 2022/0257365), and further in view of Melican et al. (EP 1216717).
Spector discloses a nipple implant (see [0076]), comprising: an exterior body having a base (see Figs. 1B, 1C illustrating a base protrusion at the bottom of the body), a hollow cylindrical portion projecting from the base (see Figs. 1A, 1B, 1C illustrating the hollow cylindrical portion extending from a base), and at least a partially dome-shape at an end of the hollow cylindrical portion opposite the base (see Figs. 1A, 1C illustrating the partial dome shape), the exterior body defining an internal cavity (see Fig. 1A illustrating the exterior body with the hollow internal cavity).
Spector fails to disclose an interior load bearing body located within and at least partially filling the internal cavity; wherein: each of the exterior body and the interior load bearing body are formed of at least one of a knitted, woven or non-woven absorbable textile.
Choi et al. discloses an interior load bearing body located within and at least partially filling the internal cavity (see [0054], [0055] disclosing an empty interior space that can be filled with autologous tissue or an acellular matrix), but fails to disclose wherein: each of the exterior body and the interior load bearing body are formed of at least one of a knitted, woven or non-woven absorbable textile.
Melican et al. also discloses an implant (10) (see [0018]) with bioabsorbable polymers (see [0019]). Melican et al. teaches the bioabsorbable materials can be woven, knitted, non-woven, braided, and warped knitted (see [0028] disclosing the woven structures). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Choi et al., with the knitted, woven, and non-woven absorbable materials, as taught by Melican et al. Doing so would provide a means to have a scaffold that is both load-bearing and conducive to rapid soft-tissue ingrowth via the porosity inherent in the textile structure.
Claims 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Spector (WO 2020/081806) as applied to claim 15 above, in view of Choi et al. (US 2022/0257365), in view of Melican et al. (EP 1216717), and further in view of Felix et al. (US 2015/0112434).
Regarding claim 16, Spector/Choi et al./Melican et al., discloses the nipple implant of claim 15, but fails to disclose wherein: the absorbable textile is formed from an absorbable polymer comprising, or prepared from, one or more monomers selected from the group: glycolide, lactide, glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 3-hydroxybutyrate, 3-hydroxyhexanoate, 4-hydroxybutyric acid, 4-hydroxybutyrate, 3-hydroxyoctanoate, E-caprolactone, 1,4-butanediol, 1,3-propane diol, ethylene glycol, glutaric acid, malic acid, malonic acid, oxalic acid, succinic aid, or adipic acid, or the absorbable polymer comprises poly-4-hydroxybutyrate or copolymer thereof, or poly(butylene succinate) or copolymer thereof.
Felix et al. also discloses that any absorbable biocompatible polymer may be used to make the implant (see [0104]). Felix et al. teaches various polymers can be used for the implant (e.g., glycolides, lactides, P4HB, succinate/adipic acid derivatives) (see [0104] disclosing various polymers). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Choi et al., and Melican et al., with the specific polymers used for high-strength, long-term surgical absorbable implants, as taught by Felix et al. Doing so would provide a means to achieve synchronized absorption kinetics and uniform mechanical reinforcement throughout the entire neo-nipple structure.
Regarding claim 17, Spector/Choi et al./Melican et al., discloses the nipple implant of claim 15.
Spector/Melican et al. fails to disclose wherein: the interior load bearing body includes a base and a resilient structure projecting upwardly from the base, the resilient structure occupying only a portion of the internal cavity when viewed in a radial direction.
Furthermore, Choi et al. also discloses an implant with a cylindrical body (100) with a porous structure (see [0046]), and a disc-shaped support (200) at the lower end of the body (see [0046]). Choi et al. teaches the hollow body (100) has an empty interior space that can be filled with autologous tissues or an acellular matrix to maintain the shape and increase the strength of the hollow body, thereby making it a load bearing structure (see [0054], [0055] disclosing the interior space); and the hollow cylindrical body (100) with the empty interior space, protrudes upward from the disc-shaped support (200) which functions as the base (see Fig. 3 illustrating the body and the base in a radial direction, with a view of the portion of the interior empty space). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., and Felix et al., with the dual body structure of a body (100) and a disc-shaped support (200), and an interior component that acts as a structural foundation, as taught by Choi et al. Doing so would provide a means to have a nipple implant that is structurally stable due to the resilient core, a customizable internal cavity, and a fully absorbable tissue-integrative through the use of textile scaffolds.
Regarding claim 18, Spector/Choi et al./Melican et al., discloses the nipple implant of claim 17.
Spector/Melican et al., fails to disclose wherein: the resilient structure includes at least two adjacent windings, wherein: there is a gap when viewed in the radial direction between the two adjacent windings.
Choi et al. also discloses an implant with a cylindrical body (100) with a porous structure (see [0046]), and a disc-shaped support (200) at the lower end of the body (see [0046]). Choi et al. teaches the body (100) and the support (200) has a porous structure with microfibers stacked at regular intervals, thereby creating the adjacent layers of the structure (see [0047] disclosing the structure and microfiber arrangement); and the stacked microfibers form voids, thereby creating gaps (see [0047] disclosing the voids). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., and Felix et al., with the dual body structure of a body (100) and a disc-shaped support (200) with stacked microfibers that create voids, as taught by Choi et al. Doing so would provide a means to manage mechanical stress, accommodate fluid/tissue integrations, and control the structural compliance of the implant.
Regarding claims 19-23, Spector/Choi et al./Melican et al., discloses the nipple implant of claim 17.
Spector/Melican et al., fails to disclose wherein: the resilient structure has a polygon shape; wherein: the polygon shape is different from a shape of the internal cavity; wherein: the resilient structure of polygon shape is located in the hollow cylindrical portion and the at least partially dome shape of the exterior body; wherein: the resilient structure has a clover- leaf shape; and wherein: the resilient structure has a corrugated surface.
Choi et al. also discloses an implant with a cylindrical body (100) with a porous structure (see [0046]), and a disc-shaped support (200) at the lower end of the body (see [0046]). Choi et al. teaches the acellular matrix body inserted into an interior empty space is a separate structural component, so that any shape (e.g., polygon) placed within the cavity would naturally result in a shape different from the shape of the internal cavity (see [0055] disclosing the acellular matrix); the body (100) which is made of stacked microfibers, is not limited in shape as it is constructed by 3D printing (see [0068] disclosing the 3D printing of the microfibers); the stacked microfibers create a porous network through 3D printing, to which the nozzle of the printer can be programmed to follow any pattern (e.g., polygon, clover leaf, with smooth or corrugated surfaces) which is a standard mechanical method in 3D printed scaffolds to increase the surface area for cell attachment, while providing vertical load-bearing resilience (see [0073], [0074] disclosing the 3D printing process). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstruction implant of Spector, as modified by Melican et al., and Felix et al., with 3D printing capabilities, as taught by Choi et al. Doing so would provide a means to increase structural stiffness, and surface area for tissue integration, while providing anti-rotational stability within a cavity.
Conclusion
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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