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 .
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 reli1ed 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Nguyen et al. (hereinafter ‘Nguyen’, U.S. PGPub No. 2020/0276018).
In regards to claim 1, Nguyen discloses an implantable scaffold comprising a plurality of piezoelectric films; and at least one compressible intervening layer, wherein a first of the plurality of piezoelectric films is on a first side of the compressible intervening layer and a second of the plurality of piezoelectric films is on a second side of the compressible intervening layer opposite the first piezoelectric film, and wherein upon applying a mechanical force to the first piezoelectric film, the first piezoelectric film deforms towards the second piezoelectric film (Fig. 1, [0020]: "FIG. 7 is testing of ultrasound response from the implanted PLLA scaffold inside calvarial defect of a euthanized mouse.", [0025]: "The PLLA layers 14 are separated by a plurality of hydrogel layers 18...This construction provides that each of the PLLA layers 14 is about 25 μm thick and each of the hydrogel layers 18 is about 10-25 μm thick. The scaffold 10 may comprise about 2-10 PLLA layers 14. The PLLA layers 14 comprise a nanofiber mesh, which is made by different collector rotation speeds (1,000-4,000 rpm) of an electrospin process to exhibit different piezoelectric constants (i.e., efficiency to convert mechanical loading to output charge).").
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In regards to claim 2, Nguyen discloses that the plurality of piezoelectric films are biodegradable and wherein the implantable scaffold does not comprise a battery (Fig. 1, [0007]: "This disclosure provides a novel biodegradable piezoelectric polymer of PLLA that provides a solution to construct an ideal biodegradable piezoelectric tissue scaffold.").
In regards to claim 3, Nguyen discloses that each of the plurality of piezoelectric films comprise at least one of poly (L-lactic acid) (PLLA), silk, polyglycine, or collagen, and wherein each of the plurality of piezoelectric films are manufactured by electrospinning ([0024]: "The biodegradable piezoelectric scaffold disclosed herein may be constructed from processed biocompatible polymers, such as poly-lactic acid (PLA), poly-lactic glycolic acid (PLGA), and the like.", [0025]: "The PLLA layers 14 comprise a nanofiber mesh, which is made by different collector rotation speeds (1,000-4,000 rpm) of an electrospin process to exhibit different piezoelectric constants (i.e., efficiency to convert mechanical loading to output charge).").
In regards to claim 4, Nguyen discloses that the plurality of piezoelectric films are manufactured by dispensing a solvent from a needle in an electric field to deposit nanofibers onto a drum rotating at a speed sufficient so as to mechanically stretch and align the nanofibers ([0026]: "The electrospin system utilizes a drum that is rotated at a very high speed (1,000-4,000 rpm) to mechanically stretch and align the nanofibers (Eli Curry et al., Biodegradable Piezoelectric Nanofiber Based Transducer, PNAS Jan. 7, 2020 117 (1) 214-220). Additionally, the PLLA layer is post-treated by thermal annealing at sequential temperatures of 130° C. and 160° C. before slowly cooling down the samples to room temperature.").
In regards to claim 5, Nguyen discloses that each of the plurality of piezoelectric films comprises nanofibers substantially aligned with each other ([0031]: " Fabrication of the PLLA piezoelectric nanofiber mesh: highly-aligned PLLA nanofibers were achieved, using the aforementioned electrospinning system (see FIG. 3 (at a)). The PLLA nanofibers were obtained with a high degree of crystallinity (˜70-80%), crystal-alignment (Herman factor of ˜0.9) and a stable crystal phase (β-phase).").
In regards to claim 6, Nguyen discloses that the plurality of piezoelectric films is three piezoelectric films arranged as substantially parallel planes with the third piezoelectric film being between the first and second piezoelectric films, and wherein the at least one compressible intervening layer is a first compressible intervening layer between the first piezoelectric film and the third piezoelectric film and a second compressible intervening layer between the second piezoelectric film and the third piezoelectric film ([0025]: "FIG. 1 illustrates a scaffold 10 comprised of a plurality of PLLA layers 14. The PLLA layers 14 may include stem cells as shown. The PLLA layers 14 are separated by a plurality of hydrogel layers 18. In one construction, the scaffold 10 comprises a disc-like shape of ˜4 mm in diameter, and 0.5 mm in depth and is configured to match with the critical-size calvarial defect for mice in an in vivo experiment. This construction provides that each of the PLLA layers 14 is about 25 μm thick and each of the hydrogel layers 18 is about 10-25 μm thick. The scaffold 10 may comprise about 2-10 PLLA layers 14. The PLLA layers 14 comprise a nanofiber mesh, which is made by different collector rotation speeds (1,000-4,000 rpm) of an electrospin process to exhibit different piezoelectric constants (i.e., efficiency to convert mechanical loading to output charge).").
In regards to claim 7, Nguyen discloses that the substantially aligned nanofibers of the first piezoelectric film are substantially parallel with the substantially aligned nanofibers of the second piezoelectric film, and are substantially perpendicular with the substantially aligned nanofibers of the third piezoelectric film ([0025]: "FIG. 1 illustrates a scaffold 10 comprised of a plurality of PLLA layers 14. The PLLA layers 14 may include stem cells as shown. The PLLA layers 14 are separated by a plurality of hydrogel layers 18. In one construction, the scaffold 10 comprises a disc-like shape of ˜4 mm in diameter, and 0.5 mm in depth and is configured to match with the critical-size calvarial defect for mice in an in vivo experiment. This construction provides that each of the PLLA layers 14 is about 25 μm thick and each of the hydrogel layers 18 is about 10-25 μm thick. The scaffold 10 may comprise about 2-10 PLLA layers 14. The PLLA layers 14 comprise a nanofiber mesh, which is made by different collector rotation speeds (1,000-4,000 rpm) of an electrospin process to exhibit different piezoelectric constants (i.e., efficiency to convert mechanical loading to output charge).").
In regards to claim 8, Nguyen discloses that each of the piezoelectric films has a first side manufactured on a surface of the drum and a second side manufactured facing away from the drum, and wherein the first side of each of the piezoelectric films faces the compressible intervening layer ([0030]: " The ultrasound generated different surface charges from different 3D piezoelectric PLLA scaffolds, made of different numbers of PLLA layers (i.e., 2, 4, 6, 8 and 10 layers) and from PLLA layers, made by different spin-speeds of the drum-collectors (i.e., 1,000, 2,000, 3,000 and 4,000 rpm). While changing the number of PLLA layers, the thickness of the hydrogel layers was tailored to keep the entire thickness of the scaffold constant (˜500 μm). For each scaffold, different ultrasound intensities (10-400 mW/cm.sup.2, 40 kHz) were applied for 30 minutes/day and 5 days/week over a period of 20 days.").
In regards to claim 9, Nguyen discloses that each of the piezoelectric films has a first side for generating a positive electrical charge and a second side for generating a negative electrical charge, and wherein the first side of each of the piezoelectric films faces the compressible intervening layer (Fig. 2, [0029]: "To quantify surface charge, generated from the scaffold under applied ultrasound, electrodes were deposited on each PLLA layer. The electrodes were encapsulated by PMMA (Polymethylmethacrylate), and the electrode/PLLA layers were assembled into the 3D scaffold. All positively-charged surfaces of the PLLA layers were electrically connected together and all negatively-charged surfaces were wired together as shown in FIG. 2.").
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In regards to claim 10, Nguyen discloses that the compressible intervening layer is a hydrogel ([0025]: "FIG. 1 illustrates a scaffold 10 comprised of a plurality of PLLA layers 14. The PLLA layers 14 may include stem cells as shown. The PLLA layers 14 are separated by a plurality of hydrogel layers 18.").
In regards to claim 11, Nguyen discloses a method of treatment for osteoarthritis comprising identifying a cartilage or bone defect to be treated ([0014]: "FIG. 1 illustrates 3D biodegradable piezoelectric PLLA-nanofiber scaffold, seeded with stem cells, to treat, for example, calvarial/skull bone defect."), providing an implantable scaffold comprising a plurality of piezoelectric films and at least one compressible intervening layer between at least two of the plurality of piezoelectric films ([0020]: "FIG. 7 is testing of ultrasound response from the implanted PLLA scaffold inside calvarial defect of a euthanized mouse.", [0025]: "The PLLA layers 14 are separated by a plurality of hydrogel layers 18...This construction provides that each of the PLLA layers 14 is about 25 μm thick and each of the hydrogel layers 18 is about 10-25 μm thick. The scaffold 10 may comprise about 2-10 PLLA layers 14. The PLLA layers 14 comprise a nanofiber mesh, which is made by different collector rotation speeds (1,000-4,000 rpm) of an electrospin process to exhibit different piezoelectric constants (i.e., efficiency to convert mechanical loading to output charge)."), implanting the implantable scaffold adjacent the cartilage or bone defect to be treated and within a pinch point of a joint ([0046]: " BALB/c mice (˜2 months old and immune-deficient for using ASCs from different mice) was used to create the calvarial defect model. This is a common bone defect model, used to assess regenerative capability of biomaterial scaffolds, stem cells and bone growth factors. Both male and female (50:50) were used for each experimental group as there had not been any report on sex-related difference in healing rate of calvarial defects. A ˜2 cm long sagittal incision on the animal head was created. To create the bone defect, a trephine bur was used to remove skull bone and create a full-thickness critical-sized defect (i.e., the smallest defect that would not heal spontaneously) of ˜4 mm for mice. Different PLLA scaffolds (piezo or non-piezo layers) with the same sizes were then implanted into the defects."), providing an exercise protocol for generating periodic impact at the pinch point, such that the periodic impact applies a mechanical force to a first piezoelectric film of the plurality of piezoelectric films such that the first piezoelectric film compresses the compressible intervening layer and deforms towards the second piezoelectric film ([0023]: "Since piezoelectric materials can generate electricity from mechanical impact, they can serve as appealing sensing materials, alternative to the described passive semiconductors and capacitive polymers, for self-powered force sensors.").
In regards to claim 12, Nguyen discloses that each of the piezoelectric films has a first side for generating a positive electrical charge and a second side for generating a negative electrical charge, and wherein after implanting the implantable scaffold, the second side of the first piezoelectric film faces the cartilage or bone defect to be treated ([0030]: " The ultrasound generated different surface charges from different 3D piezoelectric PLLA scaffolds, made of different numbers of PLLA layers (i.e., 2, 4, 6, 8 and 10 layers) and from PLLA layers, made by different spin-speeds of the drum-collectors (i.e., 1,000, 2,000, 3,000 and 4,000 rpm). While changing the number of PLLA layers, the thickness of the hydrogel layers was tailored to keep the entire thickness of the scaffold constant (˜500 μm). For each scaffold, different ultrasound intensities (10-400 mW/cm.sup.2, 40 kHz) were applied for 30 minutes/day and 5 days/week over a period of 20 days.").
In regards to claim 13, Nguyen discloses that the plurality of piezoelectric films are biodegradable and wherein no battery is implanted with the implantable scaffold (Fig. 1, [0007]: "This disclosure provides a novel biodegradable piezoelectric polymer of PLLA that provides a solution to construct an ideal biodegradable piezoelectric tissue scaffold.").
In regards to claim 14, Nguyen discloses that each of the plurality of piezoelectric films comprise at least one of poly (L-lactic acid) (PLLA), silk, polyglycine, or collagen, and wherein each of the plurality of piezoelectric films are manufactured by dispensing a solvent from a needle in an electric field to deposit nanofibers on a surface, and wherein the nanofibers of each of the plurality of piezoelectric films are substantially aligned ([0024]: "The biodegradable piezoelectric scaffold disclosed herein may be constructed from processed biocompatible polymers, such as poly-lactic acid (PLA), poly-lactic glycolic acid (PLGA), and the like.", [0025]: "The PLLA layers 14 comprise a nanofiber mesh, which is made by different collector rotation speeds (1,000-4,000 rpm) of an electrospin process to exhibit different piezoelectric constants (i.e., efficiency to convert mechanical loading to output charge).").
In regards to claim 15, Nguyen discloses that the plurality of piezoelectric films is three piezoelectric films arranged as substantially parallel planes with the third piezoelectric film being between the first and second piezoelectric films, and wherein the at least one compressible intervening layer is a first compressible intervening layer between the first piezoelectric film and the third piezoelectric film and a second compressible intervening layer between the second piezoelectric film and the third piezoelectric film ([0025]: "FIG. 1 illustrates a scaffold 10 comprised of a plurality of PLLA layers 14. The PLLA layers 14 may include stem cells as shown. The PLLA layers 14 are separated by a plurality of hydrogel layers 18. In one construction, the scaffold 10 comprises a disc-like shape of ˜4 mm in diameter, and 0.5 mm in depth and is configured to match with the critical-size calvarial defect for mice in an in vivo experiment. This construction provides that each of the PLLA layers 14 is about 25 μm thick and each of the hydrogel layers 18 is about 10-25 μm thick. The scaffold 10 may comprise about 2-10 PLLA layers 14. The PLLA layers 14 comprise a nanofiber mesh, which is made by different collector rotation speeds (1,000-4,000 rpm) of an electrospin process to exhibit different piezoelectric constants (i.e., efficiency to convert mechanical loading to output charge).").
In regards to claim 16, Nguyen discloses that the substantially aligned nanofibers of the first piezoelectric film are substantially parallel with the substantially aligned nanofibers of the second piezoelectric film, and are substantially perpendicular with the substantially aligned nanofibers of the third piezoelectric film ([0025]: "FIG. 1 illustrates a scaffold 10 comprised of a plurality of PLLA layers 14. The PLLA layers 14 may include stem cells as shown. The PLLA layers 14 are separated by a plurality of hydrogel layers 18. In one construction, the scaffold 10 comprises a disc-like shape of ˜4 mm in diameter, and 0.5 mm in depth and is configured to match with the critical-size calvarial defect for mice in an in vivo experiment. This construction provides that each of the PLLA layers 14 is about 25 μm thick and each of the hydrogel layers 18 is about 10-25 μm thick. The scaffold 10 may comprise about 2-10 PLLA layers 14. The PLLA layers 14 comprise a nanofiber mesh, which is made by different collector rotation speeds (1,000-4,000 rpm) of an electrospin process to exhibit different piezoelectric constants (i.e., efficiency to convert mechanical loading to output charge).").
In regards to claim 17, Nguyen discloses that the compressible intervening layer is a hydrogel ([0025]: "FIG. 1 illustrates a scaffold 10 comprised of a plurality of PLLA layers 14. The PLLA layers 14 may include stem cells as shown. The PLLA layers 14 are separated by a plurality of hydrogel layers 18.").
In regards to claim 19, Nguyen discloses that upon identifying the cartilage or bone defect to be treated and prior to providing the implantable scaffold, at least one characteristic of the implantable scaffold is selected based on a characteristic of a patient in which the cartilage or bone defect was identified ([0046]: "BALB/c mice (˜2 months old and immune-deficient for using ASCs from different mice) was used to create the calvarial defect model. This is a common bone defect model, used to assess regenerative capability of biomaterial scaffolds, stem cells and bone growth factors.").
Allowable Subject Matter
Claims 18 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claim 18, no applicable prior art found discloses or teaches establishing an exercise protocol for the express purpose of generating periodic impacts at the knee joint within the context of an implantable piezoelectric device.
In regards to claim 20, no applicable prior art found discloses or teaches tuning the piezoelectric film’s at least one of a porosity of nanofibers of the plurality of piezoelectric films, a number of compressible intervening layers, or a thickness of at least one of the compressible intervening layers based on the weight of a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796