82DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 66-82 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method and product, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 13 May 2026.
Applicant's election with traverse of Group I, claims 51-65 in the reply filed on 13 May 2026 is acknowledged. The traversal is on the ground(s) that “the claims share corresponding special technical features that define the technical contribution over the cited prior art” (pg. 1 of remarks) and further that particularly groups I, II, and III, “the product, method of manufacture, and method of use claims are technically interdependent and rely on the same defining structural features” (pg. 2 of remarks). This is not found persuasive because groups II and III in particular, while they may expound upon the invention of group I, claim separate methods and systems which comprise additional steps/features that are not within group I. As disclosed in the restriction, there is an option for rejoinder of the method claims once the application reaches allowance.
The requirement is still deemed proper and is therefore made FINAL.
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 64-65 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 64 recites the limitation "said cells" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends amending to reflect the previously claimed “said cells or adipose tissue”.
Claim 65 recites the limitation "said soft tissue" in line 1. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear if this limitation is regarding soft tissue used for injection into the scaffold, or if it is regarding what bodily region the soft tissue implant may be implanted, or some other limitation. Further clarification is required.
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 51-57 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Hutmacher et al. (US 2017/0258574 A1), “Hutmacher” in view of Shoseyov et al. (WO 2018/225076 A1), “Shoseyov”.
Regarding claim 51, Hutmacher teaches a three-dimensional (3D) biocompatible, degradable soft tissue implant (implant comprising a three-dimensional scaffold structure made of biodegradable material [0073]), comprising a bio-printed composite scaffold (Fig. 21, breast shaped scaffold fabricated using a 3D printer [0274]), said composite scaffold comprising a biocompatible synthetic polymer (Fig. 21, breast shaped scaffold made of poly(D, L)-lactide polymer [0274]) and features: a porous wall (Fig. 21, breast shaped scaffold containing voids and complex channel designs [0274]); an inner cavity at least partially enclosed within the porous wall (Fig. 21, void spaces within scaffold which are later filled with adipose tissue [0276]); and at least one injection port that connects the inner cavity with an outer most surface of the scaffold, wherein said injection port has an opening sized to permit insertion of an injection device through said port (through a single access tunnel all voids are filled with a single injection of transplantation cells [0054]), but fails to teach the scaffold comprises recombinant human collagen (rhCollagen).
Shoseyov teaches compositions containing recombinant human collagen used for additive manufacturing comprising recombinant human collagen (rhCollagen) (Fig. 14, scaffolds comprising rhCollagen-MA). Shoseyov discloses that rhCollagen is more tolerant to temperature and ionic strength conditions than tissue extracted collagen (pg. 11, par. 7). 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 Hutmacher with the rhCollagen taught by Shoseyov in order to simplify the manufacturing process by avoiding cooling of the implant.
Regarding claim 52, Hutmacher teaches wherein said scaffold further comprises at least one printed vascular network path that connects the outer most surface of the scaffold with the inner cavity of the scaffold (implant provides the structure along which the vasculature grows [0074]), wherein said vascular network path is sized to permit entry of vascular cells and tissues (implant provides structures which connective tissue and vasculature grows and further desired cells/tissues are transplanted into the bed of connective tissue and blood vessels [0074]).
Regarding claim 53, Hutmacher teaches wherein said inner cavity comprises from 2 to 30 chambers (Fig. 1, implant comprises 8 voids).
Regarding claim 54, Hutmacher teaches wherein at least two of said chambers are interconnected to one another (Fig. 1, voids are interconnected [0188]).
Regarding claim 55, Hutmacher teaches wherein said bio-printed composite scaffold is formed by bio-printing a curable formulation in a configured pattern which corresponds to a desired shape and dimension of the soft tissue implant (implant scaffolds are formed from conventional laydown patterns (Figs. 7-9) that allow for adaptability of the implant to specific needs [0210]), but fails to teach wherein said curable formulation comprises a recombinant human collagen (rhCollagen) that features a curable moiety.
Shoseyov teaches compositions containing recombinant human collagen used for additive manufacturing wherein said curable formulation comprises a recombinant human collagen (rhCollagen) that features a curable moiety (implant comprises rhCollagen and in addition a curable group or moiety (pg. 33, par. 7)). Shoseyov discloses that rhCollagen is more tolerant to temperature and ionic strength conditions than tissue extracted collagen (pg. 11, par. 7). 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 Hutmacher with the rhCollagen taught by Shoseyov in order to simplify the manufacturing process by avoiding cooling of the implant.
Regarding claim 56, Hutmacher teaches a biocompatible synthetic polymer (Fig. 21, breast shaped scaffold made of poly(D, L)-lactide polymer [0274]), but fails to teach wherein said curable formulation further comprises a curable moiety.
Shoseyov teaches compositions containing recombinant human collagen used for additive manufacturing comprising a curable moiety (implant comprises rhCollagen and in addition a curable group or moiety (pg. 33, par. 7)). Shoseyov discloses that rhCollagen is more tolerant to temperature and ionic strength conditions than tissue extracted collagen (pg. 11, par. 7). 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 Hutmacher with the rhCollagen taught by Shoseyov in order to simplify the manufacturing process by avoiding cooling of the implant.
Regarding claim 57, Hutmacher fails to teach the limitations of claim 57. Shoseyov teaches compositions containing recombinant human collagen used for additive manufacturing teaches wherein said rhCollagen comprises a plant-derived recombinant human collagen (the recombinant human collagen is plant-derived recombinant collagen (pg. 4, par. 7)). Shoseyov discloses that rhCollagen is more tolerant to temperature and ionic strength conditions than tissue extracted collagen (pg. 11, par. 7). 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 Hutmacher with the rhCollagen taught by Shoseyov in order to simplify the manufacturing process by avoiding cooling of the implant.
Regarding claim 65, Hutmacher teaches wherein said soft tissue is selected from a breast tissue, a facial tissue, a neck tissue, a muscle tissue, a joint tissue, a jaw tissue, a buttock tissue, a hand tissue, and a chest tissue (Fig. 3, implant is positioned within breast).
Claims 58-63 are rejected under 35 U.S.C. 103 as being unpatentable over Hutmacher et al. (US 2017/0258574 A1), “Hutmacher” in view of Shoseyov et al. (WO 2018/225076 A1), “Shoseyov” and further in view of Vacanti et al. (US Pat. No. 5716404), “Vacanti”.
Regarding claim 58, Hutmacher teaches said scaffold (Fig. 21, breast shaped scaffold fabricated using a 3D printer [0274]), but fails to teach wherein said scaffold further comprises at least one extracellular matrix (ECM) component and/or an integrin-binding material.
Vacanti teaches methods for reconstruction of breast tissue wherein said scaffold further comprises at least one extracellular matrix (ECM) component and/or an integrin-binding material (Fig. 1, biodegradable polymer scaffold comprises a polymeric matrix (col. 2, par. 3) which further comprises heparin (col. 8, par. 2)). Vacanti discloses that the polymers used for construction of the matrix must meet the mechanical and biochemical parameters needed to provide proper support for the cells and their growth and proliferation (col. 8, 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 scaffold taught by Hutmacher with the ECM component of the matrix taught by Vacanti in order to provide better support for cell growth and infiltration after implantation of the scaffold.
Regarding claim 59, Hutmacher teaches wherein said implant further comprises a matrix at least within the inner cavity of said scaffold (Figs. 7-9, implant scaffolds are formed from conventional laydown patterns [0210] (i.e., comprise matrices within)), and cells or adipose tissue (adipose tissue is injected into void spaces [0276]), but fails to teach said matrix comprising at least one of: at least one extracellular matrix (ECM) component.
Vacanti teaches methods for reconstruction of breast tissue wherein said matrix comprises at least one of: at least one extracellular matrix (ECM) component (Fig. 1, biodegradable polymer scaffold comprises a polymeric matrix (col. 2, par. 3) which further comprises heparin (col. 8, par. 2)). Vacanti discloses that the polymers used for construction of the matrix must meet the mechanical and biochemical parameters needed to provide proper support for the cells and their growth and proliferation (col. 8, 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 scaffold taught by Hutmacher with the ECM component of the matrix taught by Vacanti in order to provide better support for cell growth and infiltration after implantation of the scaffold.
Regarding claim 60, Hutmacher fails to teach the limitations of claim 60. Vacanti teaches methods for reconstruction of breast tissue wherein said at least one ECM component comprises rhCollagen, hyaluronic acid (HA), fibronectin, heparin, elastin, or laminin, or any combination thereof (Fig. 1, biodegradable polymer scaffold comprises a polymeric matrix (col. 2, par. 3) which further comprises heparin (col. 8, par. 2) and also may be coated with fibronectin (col. 8, par. 7)). Vacanti discloses that the polymers used for construction of the matrix must meet the mechanical and biochemical parameters needed to provide proper support for the cells and their growth and proliferation (col. 8, 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 scaffold taught by Hutmacher with the ECM component of the matrix taught by Vacanti in order to provide better support for cell growth and infiltration after implantation of the scaffold.
Regarding claim 61, Hutmacher fails to teach the limitations of claim 61. Shoseyov teaches compositions containing recombinant human collagen used for additive manufacturing teaches wherein said rhCollagen is comprises at least one of a cross-linked fibrillar rhCollagen (Fig. 7, fibrillar rhCollagen (pg. 10, par. 1)) and rhCollagen-derived nanoparticles (curable materials within the rhCollagen are made of nanoparticles (pg. 31, par. 4)). Shoseyov discloses that rhCollagen is more tolerant to temperature and ionic strength conditions than tissue extracted collagen (pg. 11, par. 7). 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 Hutmacher with the rhCollagen taught by Shoseyov in order to simplify the manufacturing process by avoiding cooling of the implant.
Regarding claim 62, Hutmacher teaches said matrix (Figs. 7-9, implant scaffolds are formed from conventional laydown patterns [0210] (i.e., comprise matrices within)), but fails to teach an integrin-binding material.
Shoseyov teaches compositions containing recombinant human collagen used for additive manufacturing comprising an integrin-binding material (cells within comprise suitable proteins such as RGD peptide (i.e., integrin-binding material) (pg. 42, par. 4)). Shoseyov discloses that rhCollagen is more tolerant to temperature and ionic strength conditions than tissue extracted collagen (pg. 11, par. 7). 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 Hutmacher with the rhCollagen taught by Shoseyov in order to simplify the manufacturing process by avoiding cooling of the implant.
Regarding claim 63, Hutmacher teaches cells or adipose tissue (adipose tissue is injected into void spaces [0276]), but fails to teach wherein a weight ratio between said ECM component and said cells or adipose tissue ranges from 1:1 to 1:5.
Shoseyov teaches compositions containing recombinant human collagen used for additive manufacturing wherein a weight ratio between said ECM component and said cells or adipose tissue ranges from 1:1 to 1:5 (weight ratio of the rhCollagen and additional curable material ranges from 10:1 to 1:1 (pg. 5, par. 8)). Shoseyov discloses that rhCollagen is more tolerant to temperature and ionic strength conditions than tissue extracted collagen (pg. 11, par. 7). 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 Hutmacher with the rhCollagen taught by Shoseyov in order to simplify the manufacturing process by avoiding cooling of the implant.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Hutmacher et al. (US 2017/0258574 A1), “Hutmacher” in view of Shoseyov et al. (WO 2018/225076 A1), “Shoseyov” and Vacanti et al. (US Pat. No. 5716404), “Vacanti”, and further in view of Gimble et al. (US 2020/0078411 A1), “Gimble”.
Regarding claim 64, Hutmacher teaches said cells (adipose tissue is injected into void spaces [0276]), but fails to teach a stromal vascular fraction (SVF) isolated from a fat tissue and/or a minimally processed extract from a fat tissue.
Gimble teaches biological scaffolds comprising a stromal vascular fraction (SVF) isolated from a fat tissue and/or a minimally processed extract from a fat tissue (Fig. 10, the biological scaffold comprises human SVF cells derived from adipose tissue [0025, 0040]). Gimble discloses that the biological scaffold contains components such as SVF cells for a specific use [0046]. 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 cells taught by Hutmacher with the SVF cells taught by Gimble in order to tailor the scaffold to the patient and further avoid rejection.
Conclusion
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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