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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/2/2025, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 102 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 Therefore, the rejection has been withdrawn.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 Hartwell et al. U.S. PGPub 2017/0007462.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-12, 14, 16-18, 20 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartwell et al. U.S. PGPub 2017/0007462 (hereinafter “Hartwell”).
Regarding claims 1 and 23, Hartwell discloses a system for preparing a personalized implantable wound healing scaffold, the system comprising: a 3D data acquisition unit including at least one of a 3D scanner (e.g. 3D scanning device) or camera (e.g. ¶79-81 and 84-87); a 3D model generator operably coupled with the 3D data acquisition unit, wherein the 3D model generator includes one or more processors and one or more non-transitory computer readable media storing instructions that in response to being executed by the one or more processors (e.g. ¶79-81 and 84-87), cause the 3D model generator to perform operations, the operations comprising: obtaining 3D data of a wound from the 3D data acquisition unit (e.g. ¶79-81 and 84-87); and generating a 3D model (e.g. 3D wound model) from the 3D data (e.g. ¶79-81 and 84-87); and a physical printer (e.g. 3D printing device) operably coupled with the 3D model generator (e.g. ¶87, 97, 110-111, 114 and 118).
Regarding claim 2, Hartwell discloses the system of claim 1, wherein the physical printer is selected from a 3D, 4D, 5D, or 6D printer (e.g. ¶87, 97, 110-111, 114 and 118).
Regarding claim 4, Hartwell discloses the system of claim 1, further comprising: a sensor for real-time monitoring of the wound, optionally a personalized implantable wound healing scaffold having the sensor (e.g. ¶79-81 and 84-87); and a monitor operably coupled with the sensor for acquiring sensor data, saving the sensor data, and analyzing the sensor data (e.g. ¶79-81 and 84-87).
Regarding claim 5, Hartwell discloses the system of claim 1, wherein the 3D model generator is configured to generate 3D models of the wound, and the 3D model is a model of the wound to receive the wound healing scaffold (e.g. ¶79-81 and 84-87).
Regarding claim 6, Hartwell discloses the system of claim 1, wherein the 3D model generator is configured to generate 3D models of the wound and/or personalized implantable wound healing scaffold to fit into the wound, and wherein the 3D model is a model of the wound and/or wound healing scaffold adapted to fit into the wound (e.g. ¶79-81 and 84-87).
Regarding claim 7, Hartwell discloses a method of preparing an implantable wound healing scaffold, the method comprising: acquiring 3D data of a wound with a 3D acquisition unit that includes at least one of a 3D scanner or camera (e.g. ¶79-81 and 84-87); generating a 3D model of the wound (e.g. ¶79-81 and 84-87); and forming the implantable wound healing scaffold in accordance with the 3D model of the wound (e.g. ¶87, 97, 110-111, 114 and 118).
Regarding claim 8, Hartwell discloses the method of claim 7, wherein the forming of the implantable wound healing scaffold in accordance with the 3D model of the wound includes physically printing, with a 3D, 4D, 5D, or 6D printer, a mold of the wound and/or an implantable wound healing scaffold in accordance with the wound (e.g. ¶87, 97, 110-111, 114 and 118).
Regarding claim 9, Hartwell discloses the method of claim 8, wherein the forming of the implantable wound healing scaffold in accordance with the 3D model of the wound includes casting an implantable wound healing scaffold in the mold of the wound (e.g. ¶79-81 and 84-87).
Regarding claim 10, Hartwell discloses the method of claim 1, further comprising: generating at least one wound data structure of a point cloud or mesh of the wound (e.g. ¶79-81 and 84-87); importing the at least one wound data structure of the wound to a CAD software (e.g. ¶79-81 and 84-87); extracting desired parts of wounds from the imported mesh (e.g. ¶79-81 and 84-87); and generating a CAD model of the wound (e.g. ¶79-81 and 84-87).
Regarding claim 11, Hartwell discloses the method of claim 10, further comprising at least one of: creating of wound mold, which includes a mold of the wound; using the wound mold to develop exact replica of the wound in the form of a wound healing scaffold; integrating at least one agent into the wound healing scaffold (e.g. ¶69, 114 and 149); or integrating the wound healing scaffold with sensors for wound environment monitoring.
Regarding claim 12, Hartwell discloses the method of claim 7, further comprising implanting the implantable wound healing scaffold in accordance into the wound (e.g. ¶79-81 and 84-87).
Regarding claim 14, Hartwell discloses the method of claim 7, further comprising: resolving the 3D data to mimic the layers of the wound, skin, and the vasculature (e.g. ¶79-81 and 84-87); integrating cells of different layers of the wound healing scaffold (e.g. ¶79-81 and 84-87); and forming a wound healing implant with an epidermis layer with keratinocytes, a dermis layer with fibroblasts, a base layer with adipocytes and/or stem cells and a vasculature structure with endothelial cells in the wound healing scaffold, wherein the cells can be natural or synthetically modified cells (e.g. ¶87, 97, 110-111, 114 and 118).
Regarding claim 16, Hartwell discloses the method of claim 7, further comprising forming the wound healing scaffold with a material with components (e.g. ¶79-81 and 84-87) selected from natural polymers selected from: collagen (e.g. ¶150), gelatin, chitosan, alginate (e.g. ¶81), silk, elastin, laminin (e.g. ¶145), fibronectin, hyaluronic acid, or combinations thereof; or synthetic polymers (e.g. ¶68-70 and 102) selected from polyethylene glycol (PEG), polyethylene glycol diacrylate (PEGDA), polycaprolactone (PCL), polyvinyl alcohol (PVA), poly(d,l-lactide-co- glycolide) (PLGA), or combinations thereof; ornative, synthetic (e.g. ¶70, 102 and 121), modified collagen methacrylate (ColMA) or gelatin methacrylate, or a combination of those in varying ratio.
Regarding claim 17, Hartwell discloses the method of claim 12, further comprising: detecting changes in a local wound environment adjacent the wound healing scaffold (e.g. ¶79-81 and 84-87);
transmitting data regarding the changes in the local wound environment actively or passively to a device and/or server and/or app and/or cloud capable of receiving the transmission (e.g. ¶79-81 and 84-87); and using the data to decide the next course of wound treatment (e.g. pg. 4-5, ¶53-54).
Regarding claim 18, Hartwell discloses the method of claim 7, further comprising performing at least one of: Laser triangulation, Structured light 3D scanning technology, Photogrammetry, Contact-based 3D scanning technology, or Laser pulse-based 3D scanning technology (e.g. ¶79-81 and 84-87).
Regarding claim 20, Hartwell discloses a method comprising preparing the wound healing scaffold to include at least one of: natural or synthetic DNA, RNA, exosomes, proteins, antibacterial therapeutics, antifungal therapeutics, antiviral, bacteriophages, growth factors, cytokines, chemokines and signaling molecules for cell and tissue growth, selected from the group consisting of: EGF, FGF, KGF, TGF-β, PDGF, VEGF, GM-CSF, CTGF, IL-1, IL-6, TNF, CXCL1, CXCL12, CCL2, or combinations thereof; oxygen generation components selected from the group consisting of calcium peroxide, magnesium peroxide, sodium percarbonate, hydrogen peroxide, perfluorodecalin, perflubron, and combinations thereof; oxygen generation components from natural sources; inorganic metal or non-metal particles; or
organic polymeric or non-polymeric particles (e.g. ¶68-70 and 102).
Regarding claim 22, Hartwell discloses the method of claim 7, further comprising: determining one or more layers for the wound healing scaffold (e.g. ¶79-81 and 84-87); preparing the one or more layers (e.g. ¶79-81 and 84-87); and assembling the one or more layers to form the wound healing scaffold (e.g. ¶87, 97, 110-111, 114 and 118).
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.
Claim(s) 3, 19, 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell as applied to the claims above, and further in view of Tran U.S. PGPub 2016/0367358 (hereinafter “Tran”).
Regarding claims 3, 19 and 23, Hartwell does not explicitly disclose the system further comprising a mold caster that can develop a wound mold for casting or printing scaffolds.
Tran discloses a system for manufacturing a scaffold comprising a mold caster that can develop a wound mold for casting or printing scaffolds (e.g. abstract; ¶33). Tran discloses using 3D, 4D, 5D, or 6D printing methods based on inkjet, extrusion, and laser-based technologies, selected from Stereolithography (SLA), Fused Deposition Modeling (FDM), Selective Laser Sintering (SLS), Digital Light Process (DLP), Multi Jet Fusion (MJF), PolyJet, Direct Metal Laser Sintering (DMLS), Electron Beam Melting (EBM), Solvent-based extrusion free forming (SEF), solvent-based extrusion (SBE), Laser-induced forward transfer (LIFT) bioprinting, or a combination of the above (e.g. ¶33 and 38).
At the time the invention was filed, it would have been obvious to a person of ordinary skill in the art to create a scaffold mold to create a scaffold. One of ordinary skill in the art would have been motivated to do this since producing products with molds can be more efficient.
Therefore, it would have been obvious to modify Hartwell with Tran to obtain the invention as specified in claims 3, 19, 23 and 24.
Regarding claim 23, Hartwell discloses a method for customizing an external wound healing scaffold, comprising: locating an external wound in a subject (e.g. ¶79-81 and 84-87); measuring one or more dimensions of the external wound or providing a scale reference marker at the external wound for imaging (e.g. ¶79-81 and 84-87); acquiring 3D data of the external wound from at least one of a 3D scanner or camera (e.g. ¶79-81 and 84-87); and creating a 3D model of the external wound from the 3D data (e.g. pg. 3, ¶41; pg. 4, ¶48).
Regarding claim 24, Hartwell discloses the method of claim 23, further comprising implanting the implantable wound healing scaffold in accordance into the external wound (e.g. pg. 1-2, ¶17-20 and 23; pg. 4, ¶49 and 52; pg. 5, ¶55; pg. 6, ¶73; pg. 7, ¶85-90).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell as applied to the claims above, and further in view of Gaudette et al. U.S. PGPub 2011/0142804 (hereinafter “Gaudette”).
Hartwell discloses the method of claim 12, further comprising: acquiring 3D data of the wound by scanning or imaging of the wound to develop a wound healing scaffold corresponding to the morphology of the healing wound (e.g. ¶79-81 and 84-87); forming the wound healing scaffold (e.g. ¶87, 97, 110-111, 114 and 118); and implanting the second healing scaffold into the wound (e.g. ¶87, 97, 110-111, 114 and 118). Hartwell does not disclose removing a scaffold based on observed changes.
Gaudette discloses removing a scaffold based on observing a complication with the scaffold (e.g. pg. 4, ¶70).
At the time the invention was filed, it would have been obvious to a person of ordinary skill in the art to produce and implant a second scaffold when the current scaffold experiences complications. One of ordinary skill in the art would have been motivated to do this in order to provide optimal treatment to a patient.
Therefore, it would have been obvious to modify Hartwell with Gaudette to obtain the invention as specified in claim 13.
Claim(s) 15 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell as applied to the claims above, and further in view of Boughton WO 2020/168394 (hereinafter “Boughton”).
Regarding claim 15, Hartwell discloses integrating a therapeutic composition with the wound healing scaffold to treat/prevent infection (e.g. ¶67, 88-89, 91, 93 and 114), but does not explicitly disclose releasing an active agent from the therapeutic composition before, during or after implantation of the scaffold in the wound. Regarding claim 21, Hartwell does not explicitly disclose a scaffold that includes magnetic or electrically conductive particles mixed or as a layer on top.
Regarding claim 15, Boughton discloses the method of claim 12, further comprising: integrating a therapeutic composition with the wound healing scaffold to treat/prevent infection (e.g. pg. 8, ¶52); and releasing an active agent from the therapeutic composition before, during or after implantation of the scaffold in the wound (e.g. pg. 8, ¶52).
Regarding claim 21, Boughton discloses a method wherein the wound healing scaffold includes magnetic or electrically conductive particles mixed or as a layer on top to provide pulse based therapy (e.g. pg. 9, ¶64 and 68; pg. 11, ¶85; pg. 12, ¶92-93; pg. 15, ¶114; pg. 42, ¶358).
At the time the invention was filed, it would have been obvious to a person of ordinary skill in the art to implement a therapeutic composition for a scaffold, make the scaffold with natural polymers, prepare the scaffold with proteins and antibacterial therapeutics and include magnetic or electrically conductive particles mixed or as a layer on top to provide pulse based therapy. One of ordinary skill in the art would have been motivated to do this in order to prevent infections via therapeutic compositions, stimulate tissue growth via proteins and pulse based therapy and provide biocompatibility via natural polymers.
Therefore, it would have been obvious to modify Hartwell with Boughton to obtain the invention as specified in claims 15 and 21.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES R KASENGE whose telephone number is (571)272-3743. The examiner can normally be reached Monday - Friday 7:30am to 4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kamini Shah can be reached at (571) 272-2279. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CK
December 30, 2025
/CHARLES R KASENGE/Primary Examiner, Art Unit 2116