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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement (i.e., J. Koffler, et al., “Biomimetic 3D-printed scaffolds for spinal cord injury repair”, Nature Medicine, 25(2), February 2019; A. Urciulo, et al, “Intravital three-dimensional bioprinting”, Nature Biomed. Eng., 4, 901-915 (2020); and US Patents No. 10,464,307, 9,361,171, and 11,440,225). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Response to Amendment
The amendment filed 07/26/2026 has been entered. Claims 1 and 14-15 have been amended. No claims have been canceled. Claims 22-23 are newly submitted claims. Accordingly, claims 1-23 remain pending and are the claims addressed and examined below.
Applicant’s amendments to claim 14 have overcome the 35 USC 112(b) rejection previously set forth in the Office action mailed 03/26/2026.
In view of the amendments to the claimed subject matter, the following new grounds of rejections are necessitated.
Response to Arguments
Applicant’s arguments, see labeled pages 7-8, filed 07/27/2026, with respect to the rejection(s) of amended claim(s) 1 and 15 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a newly found prior art reference found in an updated search necessitated by the amendments made to the claims (see Evans et al., US 2017/0028623, as applied in the rejections below).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7, 10-12, 15-16 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamayol et al. (US 2022/0212410) in view of Shoham (US 2021/0007778; of record) and further in view of Evans et al. (US 2017/0028623).
As to claim 1: Tamayol discloses the claimed method for in vivo 3D bioprinting to form a structure at a target site within a living body in need thereof (i.e., multi-material printer configured to extrude first and second printable materials for fabricating a scaffold from filaments directly within the body of a human or animal) (Tamayol at Abstract, [0002], [0041], [0042]), the method comprising:
disposing a container (i.e., material storage containers 24, 26) with a liquid polymerizable biomaterial into a cavity (i.e., first printable material 20 and second printable material 22, each of the first and second printable materials being biomaterials comprising cross-linking agents) within a dispensing handle (i.e., multi-material handheld printer 10) in fluid communication with a proximal end of a dispensing tube (i.e., distal end of housing 12 is connected to mixer 34, where the extension of the mixer 34 and nozzle 40 from housing 12 constitute the dispensing tube) (Tamayol at [0042], [0043], [0044], [0047], [0049], FIG. 1, FIG. 2A);
the dispensing tube comprising a hollow tube having a tube interior enclosing a feed tube configured for feeding the liquid polymerizable material from the proximal end to a distal end (i.e., FIG. 2A depicts mixer 34 and nozzle 40 to have a hollow interior enclosing a feed tube configured for feeding the printing filament from the proximal end to a distal end) (Tamayol at [0042], [0043], [0044], [0047], [0049], FIG. 1, FIG. 2A);
inserting the distal end of the dispensing tube into an opening in the living body at the target site (i.e., multi-material printer 10 is used for fabricating a scaffold directly within the body of a human or animal – indicative the distal end of nozzle 40 extending from mixer 34 is necessarily inserted into an opening in the living body at the target site) (Tamayol at Abstract, [0038], [0042], FIG. 1, FIG. 2A);
dispensing the biomaterial by applying pressure within the dispensing handle force the biomaterial into the feed tube and out an extrusion nozzle disposed at the distal end (i.e., the materials within the storage containers 24, 26 can be extruded into the mixer 34 using actuators 30, where actuators 30 can cause extrusion/intrusion through pneumatic pressure), the extrusion nozzle having a nozzle opening through which the biomaterial is extruded at the target site (i.e., the nozzle 40 controls the applied stress to the material and shape of the filament upon deposition) (Tamayol at [0037], [0038], [0039], [0040], [0042], [0043], [0050], FIG. 1, FIG. 2A);
activating a polymerizing light (i.e., radiation source 50), the polymerizing light having an exposure intensity and an exposure duration configured to polymerize the biomaterial extruded through the nozzle opening to form the structure having predetermined mechanical properties at the target site (i.e., radiation source 50 emits an electromagnetic radiation for crosslinking the printed materials) (Tamayol at [0042], [0057], [0069], [0073], [0075], FIG. 1, FIG. 2A); and
withdrawing the distal end after the structure is completed (i.e., the nozzle 40 is inherently removed once done depositing material in order to prevent infection and debris from entering an open wound/access point) (Tamayol at [0042], [0073], FIG. 1, FIG. 2A).
Tamayol discloses the claimed lens configured for transmitting polymerizing light toward the target site (i.e., the radiation source being manipulated by lenses to vary the exposure pattern) though (Tamayol at [0057]). Additionally, Tamayol discloses mixer 34 being connected to the distal end of housing 12 and nozzle 40 being connected to the distal end of mixer 34 for shaping and depositing a filament (Tamayol at [0042], [0043], FIG. 1, FIG. 2A); and the radiation source 50 for emitting an electromagnetic radiation for crosslinking the printed materials being configured in a continuous loop around the nozzle and the radiation source being manipulated by lenses to vary the exposure pattern (Tamayol at [0057], FIG. 1, FIG. 2A).
Though, Tamayol fails to explicitly disclose the claimed (i) the dispensing tube being an elongated dispensing tube, and (ii) an optical channel, being enclosed by the elongated dispensing tube, having an optical path coincident with an axis of the elongated dispensing tube, the optical channel having a lens disposed at a distal end thereof, and a polymerizing light source in optical communication with the optical channel.
However, regarding (i), Shoham teaches a three-dimensional robotic bioprinter (Shoham at Title, [0001]). Shoham further teaches minimally invasive systems and methods of using surgical robots as three-dimensional printers for fabrication of biological tissues in vivo inside the body of a subject, for example, for cartilage repair, the system including a bio-ink ejection assembly comprising a small diameter cannula 11 (i.e., elongated dispensing tube) inserted through an incision into the skin 22 and ejects bio-ink through the cannula 11 and out of the nozzle 2 (Shoham at [0014], [0069], [0070], FIG. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the bio-ink ejection assembly comprising a small diameter cannula to eject bio-ink as such is known in the art of 3D bioprinting in vivo given the discussion of Shoham above presenting a reasonable expectation of success; and doing so is combining prior art elements according to known methods to yield predictable results, with the added benefit of doing so enabling accurately performing minimally invasive surgeries with a small diameter insertable device (as recognized by Shoham at [0012]).
Tamayol and Shoham still fail to disclose the claimed (ii) an optical channel, being enclosed by the elongated dispensing tube, having an optical path coincident with an axis of the elongated dispensing tube, the optical channel having a lens disposed at a distal end thereof, and a polymerizing light source in optical communication with the optical channel.
However, regarding (ii), Evans teaches a method of additively manufacturing a part using system 100 (Evans at [0006], [0051], Fig. 1). Evans further teaches system 100 including delivery guide 112 which is configured to deposit material along a print path, and the delivery guide 112 comprising a curing energy passage 146 (i.e., optical channel being enclosed by the elongated dispensing tube) for delivering the curing energy in the form of a ring 148 from source 116 (i.e., a polymerizing light source in optical communication with the optical channel, illustrated specifically in Fig. 6); and the curing energy passage 146 encircling line passage 154 through which material 106 is conveyed and deposited (i.e., an optical channel having an optical path coincident with an axis of the elongated dispensing tube) (Evans at [0006], [0014], [0051], [0091]-[0092], [0155], Fig. 1, Figs. 6-7). The combination of Evans with Tamayol and Shoham, given the discussion above, would necessarily arrive at the optical channel having a lens disposed a distal end thereof.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the delivery guide having coaxial channels for delivering material encircled by curing energy as such is known in the art 3D printing given the discussion of Evans above presenting a reasonable expectation of success; and doing so is combining prior art elements according to known methods to yield predictable results.
As to claim 2: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol further discloses the claimed method further comprising repeating the steps of dispensing and activating to construct a multi-layer structure (Tamayol at [0038], [0039], [0040], [0075]).
As to claim 3: Tamayol, Shoham, and Evans disclose the method of claim 2. Tamayol further discloses the claimed wherein at least one layer of the multi-layer structure has a different composition than one or more other layer, and further comprising disposing a different container with a different biomaterial in the cavity prior to dispensing (Tamayol at [0038], [0039], [0040], [0075]).
As to claim 4: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol further discloses the claimed wherein the biomaterial is one or more material selected from the group consisting of gelatin methacrylate (GelMA), poly(glycerol sebacate) acrylate (PGSA), hyaluronic acid (HA), glycidyl methacrylate HA (HA-GM), polyacrylamide (PAA), biocompatible hydrogels, and polyethylene glycol diacrylate (PEGDA) (Tamayol at [0049]).
As to claim 7: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol further discloses the claimed wherein applying pressure within the dispensing handle comprises activating a plunger motor configured to drive a plunger against the container (Tamayol at [0042], [0050]).
As to claim 10: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol further discloses the claimed wherein the structure is configured to attach or stabilize tissue to a bone or other tissue at the target site (Tamayol at [0006], [0038], [0040], [0044], [0075]).
As to claim 11: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol further discloses the claimed wherein the structure is configured to replace lost tissue volume at the target site (Tamayol at [0006], [0038], [0040], [0044], [0075]).
As to claim 12: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol further discloses the radiation source 50 for emitting an electromagnetic radiation (e.g., visible light, infrared light, or ultraviolet light) for crosslinking the printed materials being a light source emitting a wavelength of about 420 nm (Tamayol at [0057], [0073], [0155]); though, Tamayol fails to explicitly disclose the claimed wherein the polymerizing light is within a range of ~380nm to ~410nm.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize a wavelength range of ~380nm to ~410nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. One would have been motivated to utilize a wavelength in the range of ~380nm to ~410nm to effectively crosslink the printed materials.
As to claim 15: Tamayol discloses the claimed method for in vivo 3D bioprinting to form a structure at a target site within a living body in need thereof (i.e., multi-material printer configured to extrude first and second printable materials for fabricating a scaffold from filaments directly within the body of a human or animal) (Tamayol at Abstract, [0002], [0041], [0042]), the method comprising:
disposing a container (i.e., material storage containers 24) with a first liquid polymerizable biomaterial into a cavity (i.e., first printable material 20 and second printable material 22, each of the first and second printable materials being biomaterials comprising cross-linking agents) within a dispensing handle (i.e., multi-material handheld printer 10) in fluid communication with a proximal end of a dispensing tube (i.e., conduits 44 connecting the distal end of housing 12 with proximal end of mixer 34 and nozzle 40 constituting the dispensing tube) (Tamayol at [0042], [0043], [0044], [0047], [0049], FIG. 1, FIG. 2A);
the dispensing tube comprising a hollow tube having a tube interior enclosing a feed tube configured for feeding the liquid polymerizable material from the proximal end to a distal end (i.e., FIG. 2A depicts mixer 34 and nozzle 40 to have a hollow interior enclosing a feed tube configured for feeding the printing filament from the proximal end to a distal end) (Tamayol at [0042], [0043], [0044], [0047], [0049], FIG. 1, FIG. 2A);
inserting the distal end of the dispensing tube into an opening in the living body at the target site (i.e., multi-material printer 10 is used for fabricating a scaffold directly within the body of a human or animal – indicative the distal end of nozzle extending from mixer 34 is necessarily inserted into an opening in the living body at a target site) (Tamayol at Abstract, [0038], [0042], FIG. 1, FIG. 2A);
dispensing the first biomaterial by applying pressure within the dispensing handle to force the first biomaterial into the feed tube and out an extrusion nozzle disposed at the distal end (i.e., the material within the storage container 24 can be extruded into the mixer 34 using actuators 30, where actuators 30 can cause extrusion/intrusion through pneumatic pressure), the extrusion nozzle having a nozzle opening through which the first biomaterial is extruded at the target site (i.e., the nozzle 40 controls the applied stress to the material and shape of the filament upon deposition) (Tamayol at [0037], [0038], [0039], [0040], [0042], [0043], [0050], FIG. 1, FIG. 2A);
activating a polymerizing light (i.e., radiation source 50), the polymerizing light having an exposure intensity and an exposure duration configured to polymerize the first biomaterial extruded through the nozzle opening to form at least one first layer of the structure having predetermined mechanical properties at the target site (i.e., radiation source 50 emits an electromagnetic radiation for crosslinking the printed materials) (Tamayol at [0042], [0057], [0069], [0073], [0075], FIG. 1, FIG. 2A);
disposing a second container with a second biomaterial into the cavity (i.e., the material within the storage container 26 can be extruded into the mixer 34 using actuators 30, where actuators 30 can cause extrusion/intrusion through pneumatic pressure) and repeating the steps of dispensing (i.e., the nozzle 40 controls the applied stress to the material and shape of the filament upon deposition) and activating with the second biomaterial (i.e., the materials can be extruded into mixer 34 and mixed to varying levels or in various arrangements to form various architectures; and radiation source 50 emits an electromagnetic radiation for crosslinking the printed materials) to form one or more second layer on top of the at least one first layer to construct a multi-layer structure (i.e., the nozzle 40 controls the applied stress to the material and shape of the filament upon deposition) (Tamayol at [0037], [0038], [0039], [0040], [0042], [0043], [0050], [0075], FIG. 1, FIG. 2A); and
withdrawing the distal end after the structure is completed (i.e., the nozzle 40 is inherently removed once done depositing material in order to prevent infection and debris from entering an open wound/access point) (Tamayol at [0042], [0073], FIG. 1, FIG. 2A).
Tamayol discloses the claimed lens configured for transmitting polymerizing light toward the target site (i.e., the radiation source being manipulated by lenses to vary the exposure pattern) though (Tamayol at [0057]). Additionally, Tamayol discloses mixer 34 being connected to the distal end of housing 12 and nozzle 40 being connected to the distal end of mixer 34 for shaping and depositing a filament (Tamayol at [0042], [0043], FIG. 1, FIG. 2A); and the radiation source 50 for emitting an electromagnetic radiation for crosslinking the printed materials being configured in a continuous loop around the nozzle and the radiation source being manipulated by lenses to vary the exposure pattern (Tamayol at [0057], FIG. 1, FIG. 2A).
Though, Tamayol fails to explicitly disclose the claimed (i) the dispensing tube being an elongated dispensing tube, and (ii) an optical channel, being enclosed by the elongated dispensing tube, having an optical path coincident with an axis of the elongated dispensing tube, the optical channel having a lens disposed at a distal end thereof, and a polymerizing light source in optical communication with the optical channel.
However, regarding (i), Shoham teaches a three-dimensional robotic bioprinter (Shoham at Title, [0001]). Shoham further teaches minimally invasive systems and methods of using surgical robots as three-dimensional printers for fabrication of biological tissues in vivo inside the body of a subject, for example, for cartilage repair, the system including a bio-ink ejection assembly comprising a small diameter cannula 11 (i.e., elongated dispensing tube) inserted through an incision into the skin 22 and ejects bio-ink through the cannula 11 and out of the nozzle 2 (Shoham at [0014], [0069], [0070], FIG. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the bio-ink ejection assembly comprising a small diameter cannula to eject bio-ink as such is known in the art of 3D bioprinting in vivo given the discussion of Shoham above presenting a reasonable expectation of success; and doing so is combining prior art elements according to known methods to yield predictable results, with the added benefit of doing so enabling accurately performing minimally invasive surgeries with a small diameter insertable device (as recognized by Shoham at [0012]).
Tamayol and Shoham still fail to disclose the claimed (ii) an optical channel, being enclosed by the elongated dispensing tube, having an optical path coincident with an axis of the elongated dispensing tube, the optical channel having a lens disposed at a distal end thereof, and a polymerizing light source in optical communication with the optical channel.
However, regarding (ii), Evans teaches a method of additively manufacturing a part using system 100 (Evans at [0006], [0051], Fig. 1). Evans further teaches system 100 including delivery guide 112 which is configured to deposit material along a print path, and the delivery guide 112 comprising a curing energy passage 146 (i.e., optical channel being enclosed by the elongated dispensing tube) for delivering the curing energy in the form of a ring 148 from source 116 (i.e., a polymerizing light source in optical communication with the optical channel, illustrated specifically in Fig. 6); and the curing energy passage 146 encircling line passage 154 through which material 106 is conveyed and deposited (i.e., an optical channel having an optical path coincident with an axis of the elongated dispensing tube) (Evans at [0014], [0051], [0091]-[0092], [0155], Fig. 1, Figs. 6-7). The combination of Evans with Tamayol and Shoham, given the discussion above, would necessarily arrive at the optical channel having a lens disposed a distal end thereof.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the delivery guide having coaxial channels for delivering material encircled by curing energy as such is known in the art 3D printing given the discussion of Evans above presenting a reasonable expectation of success; and doing so is combining prior art elements according to known methods to yield predictable results.
As to claim 16: Tamayol, Shoham, and Evans disclose the method of claim 15. Tamayol further discloses the claimed wherein each of the first and second biomaterial is one or more material selected from the group consisting of gelatin methacrylate (GelMA), poly(glycerol sebacate) acrylate (PGSA), hyaluronic acid (HA), glycidyl methacrylate HA (HA-GM), polyacrylamide (PAA), biocompatible hydrogels, and polyethylene glycol diacrylate (PEGDA) (Tamayol at [0049]).
As to claim 20: Tamayol, Shoham, and Evans disclose the method of claim 15. Tamayol further discloses the claimed wherein the structure is configured to attach or stabilize tissue to a bone or other tissue at the target site (Tamayol at [0006], [0038], [0040], [0044], [0075]).
As to claim 21: Tamayol, Shoham, and Evans disclose the method of claim 15. Tamayol further discloses the claimed wherein the structure is configured to replace lost tissue volume at the target site (Tamayol at [0006], [0038], [0040], [0044], [0075]).
As to claim 22: Tamayol, Shoham, and Evans disclose the method of claim 15. Tamayol, modified by Evans, further reads on the claimed wherein the feed tube is concentrically disposed within the optical channel and the lens has an annular shape to encircle the extrusion nozzle (see Tamayol at [0057], FIG. 1, FIG. 2A; and Evans at [0014], [0051], [0091]-[0092], [0155], Fig. 1, Figs. 6-7), for similar motivation discussed in the rection of claim 15.
As to claim 23: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol, modified by Evans, further reads on the claimed wherein the feed tube is concentrically disposed within the optical channel and the lens has an annular shape to encircle the extrusion nozzle (see Tamayol at [0057], FIG. 1, FIG. 2A; and Evans at [0014], [0051], [0091]-[0092], [0155], Fig. 1, Figs. 6-7), for similar motivation discussed in the rection of claim 1.
Claim(s) 5-6, 8, 13-14, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamayol, Shoham and Evans as applied to claims 1-2 and 15 above, and further in view of Amstad et al. (WO 2022/084499; of record).
As to claim 5: Tamayol, Shoham, and Evans disclose the method of claim 2. Tamayol further discloses using photocrosslinkable hydrogels such as gelatin methacryloyl (GelMA) (Tamayol at [0049]); though, Tamayol fails to explicitly disclose the claimed wherein the multi-layer structure comprises PGSA and PEGDA to define a double network structure having elasticity and strength.
However, Amstad teaches additive manufacturing inks or resins (Amstad at page 1, line 6); specifically, Amstad teaches the additive manufacturing inks or resins including a porous primary material and a crosslinking material precursor within said porous primary material configured to be connectable to form a secondary crosslinked network (Amstad at page 1, line 35 – page 2, line 2), the crosslinking material being poly(ethylene glycol) diacrylate and the porous primary material being poly(glycerol sebacate acrylate) (i.e., wherein the multi-layer structure comprises PGSA and PEGDA to define a double network structure having elasticity and strength) (Amstad at page 2, lines 4-7; page 22, line 32 – page 23, line 10; page 26, lines 1-19).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize poly(ethylene glycol) diacrylate and poly(glycerol sebacate acrylate), since it has been held to be within the ordinary skill of one in the art to select a known material on the basis of its suitability for the intended use. One would have been motivated to utilize poly(ethylene glycol) diacrylate and poly(glycerol sebacate acrylate) for the purpose of forming a structure via additive manufacturing that is formed with high strength and toughness (as recognized by Amstad at page 2, lines 4-7).
As to claim 6: Tamayol, Shoham, Evans and Amstad disclose the method of claim 5. Tamayol, modified by Amstad, further discloses the claimed wherein an amount of PEGDA and the exposure duration are varied to control elasticity and strength of the double network structure (Tamayol at [0130], [0155]; Amstad at page 2, lines 4-7; page 22, line 32 – page 23, line 10; page 26, lines 1-19), for similar motivation discussed in the rejection of claim 5.
As to claim 8: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol further discloses using photocrosslinkable hydrogels such as gelatin methacryloyl (GelMA) and/or proteins (i.e., growth factor) (Tamayol at [0049]); though, Tamayol fails to explicitly disclose the claimed wherein the biomaterial further comprises one or more of thiolated heparin (Hep-SH).
However, Amstad remains as introduced and applied in the rejection of claim 5 and therefore further reads on the claimed biomaterial further comprises one or more of thiolated heparin (Hep-SH) (Amstad at page 26, lines 1-11), for similar motivation discussed in the rejection of claim 5.
As to claim 13: Tamayol, Shoham, and Evans disclose the method of claim 2. Tamayol further discloses using photocrosslinkable hydrogels such as gelatin methacryloyl (GelMA) and/or proteins (i.e., growth factor) (Tamayol at [0049]); though, Tamayol fails to explicitly disclose the claimed wherein the multi-layer structure comprises HA-GM and Hep-SH configured to provide for controlled release of GFs at the target site to promote healing and tissue growth.
However, Amstad remains as introduced and applied in the rejection of claim 5 and therefore further reads on the claimed multi-layer structure comprises HA-GM and Hep-SH configured to provide for controlled release of GFs at the target site to promote healing and tissue growth (Amstad at page 2, lines 4-7; page 26, lines 1-11; page 61, line 10), for similar motivation discussed in the rejection of claim 5.
As to claim 14: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol further discloses using photocrosslinkable hydrogels such as gelatin methacryloyl (GelMA) (Tamayol at [0049]); though, Tamayol fails to explicitly disclose the claimed wherein the biomaterial is PGSA. However, Amstad remains as introduced and applied in the rejection of claim 5 and therefore further reads on the claimed biomaterial being PGSA (Amstad at page 2, lines 4-7; page 22, line 32 – page 23, line 10; page 26, lines 1-19), for similar motivation discussed in the rejection of claim 5.
Accordingly, Tamayol modified by Amstad, further discloses the claimed light exposure intensity is varied to achieve a stiffness within a range of 107 kPa – 225 kPA (Tamayol at [0130], [0155]; and Amstad at page 2, lines 4-7; page 22, line 32 – page 23, line 10; page 26, lines 1-19).
It has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977). See MPEP § 2112.01 (I) and § 2112.01 (II).
As to claim 17: Tamayol, Shoham, and Evans disclose the method of claim 15. Tamayol further discloses using photocrosslinkable hydrogels such as gelatin methacryloyl (GelMA) (Tamayol at [0049]); though, Tamayol fails to explicitly disclose the claimed wherein the multi-layer structure comprises PGSA and PEGDA to define a double network structure having both elasticity and strength.
However, Amstad teaches additive manufacturing inks or resins (Amstad at page 1, line 6); specifically, Amstad teaches the additive manufacturing inks or resins including a porous primary material and a crosslinking material precursor within said porous primary material configured to be connectable to form a secondary crosslinked network (Amstad at page 1, line 35 – page 2, line 2), the crosslinking material being poly(ethylene glycol) diacrylate and the porous primary material being poly(glycerol sebacate acrylate) (i.e., wherein the multi-layer structure comprises PGSA and PEGDA to define a double network structure having elasticity and strength) (Amstad at page 2, lines 4-7; page 22, line 32 – page 23, line 10; page 26, lines 1-19).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize poly(ethylene glycol) diacrylate and poly(glycerol sebacate acrylate), since it has been held to be within the ordinary skill of one in the art to select a known material on the basis of its suitability for the intended use. One would have been motivated to utilize poly(ethylene glycol) diacrylate and poly(glycerol sebacate acrylate) for the purpose of forming a structure via additive manufacturing that is formed with high strength and toughness (as recognized by Amstad at page 2, lines 4-7).
As to claim 18: Tamayol, Shoham, Evans and Amstad disclose the method of claim 17. Tamayol, modified by Amstad, further discloses the claimed wherein an amount of PEGDA and the exposure duration are varied to control elasticity and strength of the double network structure (Tamayol at [0130], [0155]; Amstad at page 2, lines 4-7; page 22, line 32 – page 23, line 10; page 26, lines 1-19), for similar motivation discussed in the rejection of claim 17.
As to claim 19: Tamayol, Shoham, and Evans disclose the method of claim 15. Tamayol further discloses using photocrosslinkable hydrogels such as gelatin methacryloyl (GelMA) and/or proteins (i.e., growth factor) (Tamayol at [0049]); though, Tamayol fails to explicitly disclose the claimed wherein at least one of the first biomaterial and the second biomaterial further comprises one or more of thiolated heparin (Hep-SH).
However, Amstad remains as introduced and applied in the rejection of claim 5 and therefore further reads on the claimed herein at least one of the first biomaterial and the second biomaterial further comprises one or more of thiolated heparin (Hep-SH) (Amstad at page 26, lines 1-11), for similar motivation discussed in the rejection of claim 17.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamayol, Shoham and Evans as applied to claims 1-2 above, and further in view of Dewey et al. (US 2021/0177603; of record).
As to claim 9: Tamayol, Shoham, and Evans disclose the method of claim 1. Tamayol, modified by Shoham and Evans, fails to disclose the claimed wherein inserting further comprises associating the dispensing tube with a viewing scope, so that the dispensing tube and viewing scope are inserted together in conjunction with an arthroscopic procedure.
However, Dewey teaches additive-manufacturing systems and processes for forming parts or devices in-situ, such as in a patient during surgery (Dewey at [0015]). Dewey further teaches the system including one or more cameras, or visual sensing devices, such as an on-dispensing-component, on-robotic arm, camera, or other selectively positioned cameras (Dewey at [0206]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the camera on the dispensing component as such is known in the art of 3D bioprinting in vivo given the discussion of Dewey above presenting a reasonable expectation of success; and doing so is combining prior art elements according to known methods to yield predictable results, with the added benefit of doing so enabling relevant visuals are provided to a surgeon to determine surgeon movements (as recognized by Dewey at [0206]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Secretan et al. (US 5,204,124) discloses a nozzle and curing energy being deposited coincidentally/coaxially and a lens directing the curing energy towards the material dispensed by the nozzle (Fig. 2).
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.
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/BAILEIGH KATE DARNELL/Examiner, Art Unit 1743
/GALEN H HAUTH/Supervisory Patent Examiner, Art Unit 1743
