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 .
Status of Claims
The preliminary amendment of 10/02/2024 is acknowledged. Claims 9-10 and 12-13 are amended and claims 25-57 are canceled. Claims 58-60 are new. Claims 1-24 and 58-60 are currently pending and are examined on the merits herein.
Priority
The instant application filed 10/02/2024, is a 371 filing of PCT/US2023/017288, filed 04/03/2023, which claims priority to U.S. Provisional Application No. 63/326,982, filed 04/04/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/02/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 24 is objected to because of the following informalities: The second line of claim 24 recites “ration” which is believed to be a typographical error for ratio. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
1. Claims 58-60 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. Claims 58-60 recited “GelMA”, “PEGDA”, and “ECM” without defining these abbreviations in the claims. As such, the claims are indefinite. Please define the abbreviations in the claims prior to their recitation.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 6-9, 12, 17, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kapnisi M, et al. (2018). Auxetic Cardiac Patches with Tunable Mechanical and Conductive Properties toward Treating Myocardial Infarction. Adv Funct Mater. 28(21):1800618 (PTO-892), hereinafter Kapnisi.
Regarding claim 1: Kapnisi discloses an auxetic conductive cardiac patch (AuxCP) for the treatment of myocardial infarction (MI) (abstract), which reads on a patch for organ or tissue application. The auxetic design gives the patch a negative Poisson’s ratio, providing it with the ability to conform to the demanding mechanics of the heart (abstract), which reads on having an auxetic architecture matching a Poisson’s ratio of an organ or tissue to which the patch is applied. Further, the auxetic patches are conductive and cytocompatible in vitro. Ex vivo studies demonstrate that the auxetic patches have no detrimental effect on electrophysiology of rat hearts. Finally, the AuxCP applied in a rat MI model results in no detrimental effect on cardiac function and negligible fibrotic response after two weeks in vivo (abstract), thereby reading on a biocompatible material. The material is made up of a chitosan-polyaniline composite (abstract), which further reads on a polymeric material. The cardiac patch is tuned to have an anisotropic ratio of effective stiffness matching the reported ratio for native heart tissue (Section 2.2, para. 3-4), which reads on matching a stiffness ratio of an organ or tissue to which the patch is applied.
Regarding claim 2: The patch has a bowtie geometry that is anisotropic (abstract; section 2.1, para. 1).
Regarding claim 6: Kapnisi teaches that auxetic behavior is independent of scale. Larger AuxCPs will maintain similar mechanical properties. In addition, the excimer laser microablation process used by Kapnisi lends itself well to scale-up; with the ability for high-throughput production (section 2.5.2; para. 3).
Regarding claim 7-9 and 12: Excimer laser microablation is used to micropattern a re-entrant honeycomb (bow-tie) design into the composite (abstract). Figure 1C and 1D show the following structure:
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which reads on apertures of repeating shape, patterned apertures, and a lattice structure.
Regarding claim 17: The dimension of A, which represents the highlighted region above, is optimized from 320 to 480 μm to impact the stiffness ratio (Figure 2A; section 2.2 para. 3), which reads on a structural feature within the instantly claimed size range.
Regarding claim 24: Table S1 of the supporting information discloses several patches having an anisotropic ratio of effective stiffness (E1/E2 as defined in section 2.2, para. 1) of 1 to 5, as instantly claimed (Ex. 1-5 and 8-9). The Poisson’s ratio of several of these patches (v as defined in section 1, para. 3) also falls within the claimed ratio of -1.2 to -0.05 (Ex. 1-5, 7, and 9).
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.
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.
1. Claims 1-10, 12-15, 17-20, 22-24, and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Soman, P, et al. (US 20130344601 A1, 12/26/2023, IDS dated 10/02/2024), hereinafter Soman.
Soman discloses devices, techniques and material related to micro-structured biomaterials, more particularly auxetic micro-structured biomaterials ([0003]).
Regarding claim 1: The auxetic biomaterials are used in the field of tissue engineering, non-limiting examples of tissue engineering include auxetic cardiac patches ([0015]; [0089]) as well as wound healing patches ([0087]-[0088]). The microstructured biomaterial of Soman is specifically used to produce a scaffold patch ([0045]; claim 18). The auxetic materials are fabricated using digital micromirror device projection printing from photocurable biocompatible materials ([0014]), specifically a photo-curable polymer (Example 2; claim 13). Soman teaches that a scaffold's elastic properties must be matched with the elastic properties of native tissue. The elastic behavior of a porous scaffold can be described by its elastic modulus and Poisson's ratio, wherein elastic modulus represents stiffness ([0006]-[0007]). In tissue engineering, one must have the capability to precisely tune the magnitude and polarity (positive or negative) of Poisson's ratio in three-dimensional constructs to match the properties of the specific tissue being regenerated ([0010]), as such, the auxetic construct has a tunable negative Poisson’s ratio ([0012]). This technical teaching reads on an auxetic architecture matching a Poisson’s ratio of a tissue to which the patch is applied.
Regarding claim 2: Strain dependent Poisson’s ratio can be tuned in exemplary constructs by simply changing the direction of loading (anisotropic) relative to the orientation of the unit-cell shape ([0043]). Additionally, the biomaterial’s Poisson's ratio is directional (anisotropic) if it varies in magnitude or polarity with the direction of loading ([0057]).
Regarding claim 3: Unit-cell geometries and spatial-arrangements were designed from an acrylated-PEG hydrogel ([0040]; Example 2).
Regarding claim 4: Multilayer constructs were fabricated by staking the single-layer constructs with alternating layers of vertical connecting posts ([0017]; [0023]; Fig. 5A; [0042]; claim 12). FIGS. 2D, 2E and 2F show double-layer PEG constructs; and FIGS. 2G, 2H, and 2I show triple-layer reentrant PEG constructs ([0020]).
Regarding claim 6: Using the technique described by Soman, one can impart a hybrid negative-positive Poisson ratio (NPR-PPR) to any photocurable biomaterial, without changing the intrinsic elastic modulus property of the biomaterial. These hybrid scaffolds are scale independent, since deformations observed in these scaffolds only depend on the geometry or architecture of the struts, which implies similar strain-dependent elastic response at various resolutions, from nano-to-macro scale ([0089]). Such a technical teaching indicates that the stiffness ratio and Poisson’s ratio remain unchanged regardless of scaling factor, as claimed.
Regarding claims 7-9: Single-layer constructs are composed of a lattice of specially-arranged unit-cells (i.e., apertures) having well-defined geometries (i.e., patterns) resembling the reentrant honeycomb (shown in FIGS. 2A, 2D, 2G, 2H and 2I) and missing rib (shown in FIGS. 2B and 2D). Constructs having the reentrant and missing rib unit-cells exhibit a negative Poisson's ratio (i.e., auxetic architecture) ([0061]).
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It can be seen in the figures that the constructs comprise apertures of repeating shape, patterned apertures, and lattice structures ([0061]).
Regarding claim 10: Results illustrate that bovine aortic smooth muscle cells not only adhere and proliferate on the struts of the reentrant scaffolds, but also fill up the spaces between the struts ([0038]), which reads on the apertures being filled with a material blocking the passage of liquid or gas, as claimed.
Regarding claim 12: A reentrant honeycomb design is used to form unit cells with negative Poisson’s ratio (NPR) [0043]; [0061]; claim 14). Furthermore, the missing rib geometry in Fig. 2B above resembles the chiral truss structure of the instant invention (See FIG. 2A of instant invention).
Regarding claim 17: Figures 1A and 1B illustrate unit cell geometry and undeformed dimensions. L1 and L2 of the reentrant honeycomb geometry are 360 μm and 480 μm, respectively (Fig. 1B). As such the material comprises various structural features within the instantly claimed size range (i.e., 100-500 μm).
Regarding claim 18: Photoinitiator Irgacure 2959 and TINUVIN 234 UV-dye were obtained from Ciba Chemistry and used to produce the PEGDA scaffolds. TINUVIN 234 is a UV-absorbing agent, which was used to reduce the curing depth of the monomers and adjust the thickness of the microstructures in the DMD-based layer-by-layer fabrication process ([0094]).
Regarding claims 58 and 59: Poly(ethylene glycol)diacrylate (PEGDA) was used for the preparation of photocurable monomers and in the fabrication of three-dimensional multi-layer scaffolds (Examples 1-2).
Soman further teaches that the elastic behavior of a porous scaffold can be described by its elastic modulus and Poisson's ratio, which depend on its porosity, the properties of the biomaterial making up the rib structures, and any anisotropic behavior due to the presence of pores. Optimizing these attributes requires control over pore size and geometry with the restriction of arranging the pores so they are open to the environment and completely interconnected ([0006]). Soman further teaches that yield strength and stiffness (elastic modulus) are of vital importance in providing the scaffold with satisfactory mechanical integrity, and show power-law behavior with regards to porosity ([0007]). A method for fabricating a nerve mimicking complex designer scaffold uses a biopolymer which is a native ECM component and a photocrosslinkable salt that imparts mechanical stiffness to the scaffold ([0116]).
Soman also teaches that the techniques disclosed can spatially impart hybrid regions in a variety of hydrogels (PEG, Hyaluronic acid, Gelatin-methyacrylate) ([0088]). Growth factors and ECM components can be spatially localized in different layers or regions of the scaffold resulting in spatial patterning of biochemical microenvironments ([0117]), which suggests that multiple layers may have differing hydrogel materials as recited in claim 5. The gelatin methacrylate reads on the gelatin methacroyl (i.e., GelMA) of claims 23 and 58-60.
Acrylated-PEG hydrogel was used in the examples, in part because of its use in porous tissue scaffolds seeded with bone marrow-derived progenitor cells and its ability to encapsulate timed-release biomolecules that stimulate tissue growth ([0040]). Using the technique of Soman, a variety of hydrogels (PEG, Hyaluronic acid, Gelatin-methyacrylate) can be loaded with drugs and growth factors for controlled release during different wound-healing stages according to wound severity ([0088]). These cells, biomolecules, drugs, and growth factors all read on the therapeutic agents of claims 13-15.
Each molecule of the polymerizable material contains at least one active group, selected from a list including acrylate, methacrylate, epoxy, carboxylic group, and amino group ([0130]), which read on moieties operable to form hydrogen bonds with tissue surfaces, as recited in claim 19, specifically carboxyl groups, as recited in claim 20. The presence of these active groups on the polymerizable material further read on side chains of the biocompatible polymeric material, as defined in claim 22.
The design of multi-material scaffolds of native ECM components is also taught, wherein multi-material systems are used to fabricate scaffolds. An aqueous solution of uncrosslinked natural biopolymer with acrylated salt is prepared containing a photocrosslinker. Addition of acrylated salt to the biopolymer solution aids the fabrication process of long guidance conduits by reinforcement of the conduit during the fabrication. The photocrosslinkable moiety present in the salt gets incorporated into the scaffold during photopolymerization and adds to the stiffness of the scaffold while maintaining the submicron scale resolution ([0112]). Poly(ethylene glycol)-co-acrylic acid scaffolds were also produced and cells were found to attach to said scaffolds ([0086]; Example 1).
The teachings of Soman differ from that of the instant invention in that Soman does not explicitly teach wherein the material has a stiffness ratio matching that of an organ or tissue to which it is applied, as defined in claims 1 and 24, nor wherein multiple layers have differing hydrogel materials, as recited in claims 5 and 60, nor a specific embodiment wherein the apertures are filled with a therapeutic agent, as defined in claims 13-15, nor a specific embodiment wherein the surface of the patches are populated with the moieties of claims 19-20 and 22, nor a specific embodiment wherein the hydrogel includes the materials of claim 23.
Regarding the stiffness ratio of claim 1, while Soman does not explicitly teach matching a stiffness ratio to an organ or tissue to which the patch is applied, such a modification would have been obvious in view of the broader teachings of Soman. It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to optimize the stiffness ratio of the auxetic architecture in the patch of Soman, since stiffness is a known and routine parameter to optimize in the art as taught by Soman. In fact, the entirety of Soman centers around optimizing the elastic behavior of a porous scaffold, such as its elastic modulus and Poisson’s ratio, to match native tissue. Soman teaches that in addition to the Poisson’s ratio, stiffness (elastic modulus) is of vital importance in providing the scaffold with satisfactory mechanical integrity. As such, the stiffness ratio of the scaffold is a results effective parameter that one of ordinary skill in the art would have been motivated to optimize to match that of the tissue to which the patch is applied. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
Regarding claim 5, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide a multi-layer scaffold having different hydrogel materials in each layer, since various hydrogel materials are known and routine in the art and Soman teaches spatially localizing different ECM components in different layers of the scaffold. As discussed above, Soman teaches a multi-layer scaffold as well as various hydrogel materials which may be utilized for the scaffolds. It is also taught that the scaffolds can be fabricated using a biopolymer which is a native ECM component and that ECM components can be spatially localized in different layers of the scaffold to result in spatial patterning of biochemical microenvironments. As such, one of ordinary skill in the art would have been motivated to generate a multilayer scaffold containing hydrogels made of different ECM biopolymers or non ECM biopolymers in each layer, in order to provide a scaffold with spatial patterning. One of ordinary skill in the art could have combined these elements (i.e., layers of different hydrogel materials) according to known methods to predictably yield the instant invention.
Regarding claims 13-15, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to load the patch scaffolds taught by Soman with cells, biomolecules, drugs, or growth factors since loading scaffolds with such therapeutic agents is known and routine in the art. One of ordinary skill in the art would have been motivated to add any of the therapeutic agents taught by Soman into the disclosed patches in order to stimulate tissue growth and wound healing, as is the intended use of these patches. One of ordinary skill in the art could have combined the specific patches of Soman with any of the disclosed therapeutic agents according to known methods to predictably yield the instant invention of claims 13-15.
Regarding claims 19-20 and 22, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to generate the patch of Soman with a polymerizable material comprising an active group such as a carboxylic acid, since such active groups are known and routine in the art as taught by Soman. One of ordinary skill in the art could have selected a polymerizable material containing a carboxylic group to generate the hydrogel scaffolds simply by combining prior art elements according their established functions via known methods to yield predictable results. Alternatively, it would have been prima facie obvious to one of ordinary skill in the art to use any of the known and routine hydrogel materials specifically taught by Soman, such as hyaluronic acid or gelatin-methyacrylate to generate the patch of Soman. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Such a selection would also yield a patch wherein the surface is populated with hydrogen bond forming moieties since hyaluronic acid and gelatin-methacrylate are known to contain carboxyl and hydroxyl side chains.
Regarding claim 23, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use a hydrogel including gelatin methyacrylate modified with acrylic acid, since both are known and routine hydrogel components in the art as taught by Soman. Soman independently teaches that gelatin-methyacrylate and acrylic acid may be used to form hydrogel scaffolds of the invention. Soman also teaches that the addition of acrylated salt to a biopolymer solution aids in the fabrication process and adds to the stiffness of the scaffold while maintaining the submicron scale. As such, one of ordinary skill in the art could have selected gelatin methacrylate as the hydrogel material and combined it with an acrylic acid or a salt thereof, according to their established functions via known methods to yield predictable results. One of ordinary skill in the art would have been motivated to modify the gelatin methacrylate with acrylic acid in order to optimize stiffness of the final product.
Regarding claim 24, it is discussed above that the entirety of Soman centers around optimizing the elastic behavior of a porous scaffold, such as its elastic modulus and Poisson’s ratio, to match native tissue. Soman teaches that the Poisson’s ratio and stiffness (elastic modulus) is of vital importance in providing the scaffold with satisfactory mechanical integrity. Experimental Poisson’s ratios are -1.1 to -0.5 in the NPR regions of single-layer scaffolds ([0051]), which falls within the claimed Poisson’s ratio range (i.e., -1.2 to -0.05). Regardless, it would have been prima facie obvious to one of ordinary skill in the art to optimize both the stiffness ratio and the Poisson’s ratio of the patches to arrive at the instantly claimed ranges together. Both parameters are results effective as suggested by Soman and the optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
Regarding claim 60, as discussed above it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide a multi-layer scaffold having different hydrogel materials in each layer, since various hydrogel materials are known and routine in the art and Soman teaches spatially localizing different ECM components in different layers of the scaffold. It would have been further prima facie obvious that these differing hydrogel materials are selected from GelMA and PEGDA, since both are taught as known and routine hydrogel materials in the art by Soman. One of ordinary skill in the art could have selected and combined these known hydrogel materials according to their established functions via known methods to yield predictable results. Additionally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
There would have been a reasonable expectation of success in making the above modifications since each of these modifications are suggested within the broader disclosure of Soman. One of ordinary skill in the art would have recognize that the teachings from various embodiments could be combined according to known methods while maintaining the function of the broadly disclosed product.
Claims 1-15, 17-20, 22-24, and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Soman as applied to claims 1-10, 12-15, 17-20, 22-24, and 58-60 above, and further in view of Kapnisi M, et al. (2018). Auxetic Cardiac Patches with Tunable Mechanical and Conductive Properties toward Treating Myocardial Infarction. Adv Funct Mater. 28(21):1800618 (PTO-892), hereinafter Kapnisi.
The teachings of Soman are discussed above.
The teachings of Soman differ from that of the instantly claimed invention in that Soman does not explicitly teach wherein the Yong’s modulus of the filler material is less than the biocompatible polymeric material, as recited in claim 11.
Kapnisi discloses an auxetic conductive cardiac patch (AuxCP) for the treatment of myocardial infarction (MI) (abstract). Typically, it is believed that the mechanical properties of a cardiac patch should match those of healthy native heart tissue. However, the Young's modulus of the native human heart varies from 0.02 to 0.50 MPa depending on whether the heart is in systole or diastole, with infarct tissue being even stiffer (Intro, para. 2). Previously, a conductive cardiac patch with exceptional electrical stability, was developed, however, the Young's modulus of this biomaterial is significantly greater (6.73 ± 1.1 MPa) than that reported for native human heart tissues (0.02–0.50 MPa). As such, Kapnisi introduces the ability to control and tune the effective stiffness and anisotropy of auxetic, conductive cardiac patches (Intro, para. 6). Theoretical models based on the 2D bow-tie pattern, were used to predict the mechanical properties of micropatterned patches. The equations use the Young's modulus of the bulk material and the various bow-tie dimensions to calculate the resultant effective stiffness (E) values and the anisotropic ratio of effective stiffness (E1/E2) (Section 2.2, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to optimize the Young’s modulus of the bulk material used in the hydrogel patch in relation to any filler material present, since Young’s modulus is a results effective parameter that impacts the stiffness ratio of the overall product, as taught by Kapnisi. As discussed above, the entirety of Soman centers around optimizing the elastic behavior of a porous scaffold, such as its elastic modulus and Poisson’s ratio, to match native tissue. As such, one of ordinary skill in the art would have been motivated to optimize a parameter having such a large effect on these properties, such as the Young’s modulus of the materials used. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Soman and Kapnisi both teach auxetic patches with tunable properties related to stiffness.
Claims 1-10, 12-20, 22-24, and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Soman as applied to claims 1-10, 12-15, 17-20, 22-24, and 58-60 above, and further in view of Ferreira, L, et al. (US 20200289583 A1, 06/17/2020, IDS dated 10/02/2024), hereinafter Ferreira.
The teachings of Soman are discussed above.
The teachings of Soman differ from that of the instantly claimed invention in that Soman does not explicitly teach the therapeutic agents contained in exosomes, as recited in claim 16.
Ferreira discloses a method of promoting wound healing in a patient in need thereof comprising contacting a wound of the patient with exosomes secreted by umbilical cord blood mononuclear cells (UCBMNCs) so as to thereby promote wound healing in the patient (abstract). Wound care products comprising the described compositions are also taught, for example the wound care product is a dressing such as a patch ([0163]-[0171]; claim 64).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the exosomes of Ferreira into the patches of Soman since these exosomes are known and routine wound healing agents in the art, as taught by Ferreria. One of ordinary skill in the art could have combined the exosomes of Ferreira with the patches of Soman according to known methods to predictably yield the instant invention. One of ordinary skill in the art would have been specifically motivated to incorporate said exosomes into the wound healing patches of Soman since the exosomes of Ferreira comprise agents that help promote wound healing. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Soman welcomes the incorporation of therapeutic agents and Ferreira teaches that exosomes can be incorporated into a wound care product such as a patch.
Claims 1-10, 12-15, 17-24, and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Soman as applied to claims 1-10, 12-15, 17-20, 22-24, and 58-60 above, and further in view of Guo et al. (Feb. 2022, First Published 17 Nov. 2021). One-Step Synthesis of Multifunctional Chitosan Hydrogel for Full-Thickness Wound Closure and Healing. Adv. Healthcare Mater. 11, 2101808 (PTO-892).
The teachings of Soman are discussed above.
The teachings of Soman differ from that of the instantly claimed invention in that Soman does not explicitly teach the patch to further comprise cationic metals as recited in claim 21.
Guo teaches a multifunctional hydrogel as a sealant or wound dressing with high adhesiveness and excellent antibacterial activity. One-step synthetic hydrogel based on quaternized chitosan (QCS), tannic acid (TA), and ferric iron (Fe(III)) was developed (abstract). QCS/TA forms the backbone of the hydrogel. The introduction of Fe(III) heightens the adhesiveness, self-healing, electroconductivity, and rapid sterilization by photothermal capacity (Intro, para. 5). The QCS/TA/Fe hydrogel has good adhesiveness to both biological tissues (heart, liver, spleen, lung, kidney, skin) and non-biological materials (wood, iron, plastic, glass, rubber). The incorporation of Fe(III) could clearly enhance the adhesion (Section 2.2, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the Fe(III) (i.e., metal cation) of Guo into the patch of Soman since the use of Fe(III) is known and effective for increasing adhesion of wound dressings as taught by Soman. One of ordinary skill in the art would have been specifically motivated to incorporate Fe(III) into the wound healing patches of Soman since incorporation of Fe(III) enhances adhesion of hydrogels to biological tissues, as taught by Guo. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Soman welcomes the incorporation of additional agents to the hydrogel patches and Guo teaches incorporating Fe(III) into biocompatible hydrogels.
Conclusion
No claims allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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