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 § 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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-6, 8, 9, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2007/0293912 A1 to Cowan et al. (Cowan) in view of US Patent Application Publication No. 2012/0226295 A1 to Jabbari (Jabbari).
Regarding at least claim 1
Cowan teaches systems and methods to enhance bone growth by stimulating bone sites for bone regrowth, fusion, or grafts (abstract). Cowan meets the limitations of a method of regenerating bone or tissue (paragraph 0017 discloses accelerating bone healing by stimulating the bone), the method comprising: applying a scaffold to a wound (paragraph 0017 discloses surgical attachment of devices such as pins, cages, plates, or bone grafts for bone healing including bone fractures, fusions, or joint replacement), the scaffold comprising a plurality of layers (paragraph 0032 discloses an implanted device/scaffold; 2, which contains an ultrasound transducer, an electrical circuit, and electrodes and that the transducer is made of piezoelectric polymer or copolymer films); applying ultrasound energy to the scaffold (paragraph 0030 discloses a controller-transmitter; 1, for transmitting an ultrasound signal through intervening tissue to the device/scaffold; 2); generating an electrical surface charge on the scaffold (paragraph 0030 discloses that the device/scaffold contains means to receive the acoustic energy and convert it into an electrical current which may be applied to the attached electrodes); and delivering an electrical output to the bone or tissue from the scaffold to regenerate the bone or tissue (paragraph 0030 discloses that the ultrasound transmission is configured such that the targeted bone site receives sufficient ultrasonic energy to promote bone healing).
However, Cowan does not teach that the layers of the scaffold are PLLA layers, each layer separated by a hydrogel layer, wherein the PLLA layers comprise a biodegradable nanofiber mesh created by an electrospinning process.
Jabbari teaches a method for forming a laminated nanocomposite as a scaffold in a variety of applications in regenerative medicine to provide structural support and pore volume for integration with the surrounding tissue (abstract and paragraph 0045). More specifically, Jabbari teaches applying a hydrogel precursor solution to a first layer of poly(L-lactide) nanofiber mesh and stacking a second layer of poly(L-lactide) nanofiber mesh on the first layer with at least a portion of the hydrogel precursor solution being situated between the first layer and the second layer (abstract). The lamination process taught by Jabbari includes fiber layers coated with hydrogel precursor solution and then stacked together and compressed, and then crosslinking the multi-layer assembly to form a laminated nanocomposite (paragraph 0028), for the purpose of mimicking the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling (paragraph 0019). Jabbari further teaches wherein the nanofiber mesh is created by an electrospinning process (paragraph 0019 discloses that random and aligned poly(L-lactide) nanofiber mesh was fabricated by electrospinning).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold of Cowan, which accelerates the healing of bone, to specify that the piezoelectric polymer or copolymer films that make up the transducer are a plurality of PLLA layers, each layer being separated by a hydrogel layer, wherein the PLLA layers comprise a biodegradable nanofiber mesh, in order to mimic the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling, as taught by Jabbari, particularly since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 3
Cowan in view of Jabbari teaches the method of claim 1. Cowan also teaches wherein the ultrasound energy includes a frequency in the kHz range (paragraph 0026 discloses an ultrasound frequency range of 20 kHz-10 MHz).
Regarding at least claim 4
Cowan in view of Jabbari teaches the method of claim 3. Cowan also teaches wherein the ultrasound energy includes an ultrasound frequency range of 20 kHz-10 MHz (paragraph 0026).
However, Cowan does not explicitly disclose the frequency is at 40 KHz.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the frequency of Cowan from between 20 KHz to 10 MHz to 40kHz since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding at least claim 5
Cowan in view of Jabbari teaches the method of claim 1. Cowan also teaches wherein at least one of the PLLA layers includes stem cells (paragraph 0042 discloses that the implanted bone stimulation electrodes could be used to deliver therapeutic agents, such as stem cells that promote bone healing and growth and the like).
Regarding at least claim 6
Cowan in view of Jabbari teaches the method of claim 1. Cowan also teaches wherein at least one of the PLLA layers includes growth factors (paragraph 0042 discloses that the implanted bone stimulation electrodes could be used to deliver therapeutic agents, such as bone growth factor).
Regarding at least claim 8
Cowan in view of Jabbari teaches the method of claim 1, wherein the PLLA layers comprise a biodegradable nanofiber mesh (the abstract of Jabbari teaches applying a hydrogel precursor solution to a first layer of poly(L-lactide) nanofiber mesh and stacking a second layer of poly(L-lactide) nanofiber mesh on the first layer with at least a portion of the hydrogel precursor solution being situated between the first layer and the second layer, for the purpose of mimicking the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling as disclosed in paragraph 0019).
Regarding at least claim 9
Cowan in view of Jabbari teaches the method of claim 8. Cowan also teaches that the ultrasound transducer (20) of the device/scaffold (2) is made of polymer or copolymer films that exhibit piezoelectricity (paragraph 0032). However, Cowan does not teach wherein the nanofiber mesh is created by an electrospinning process to exhibit piezoelectricity.
Jabbari further teaches wherein the nanofiber mesh is created by an electrospinning process (paragraph 0019 discloses that random and aligned poly(L-lactide) nanofiber mesh was fabricated by electrospinning.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the nanofiber mesh of Cowan is created by an electrospinning process, in order to produce random and aligned fibers, as taught by Jabbari.
Regarding at least claim 11
Cowan in view of Jabbari teaches the method of claim 1. Jabbari also teaches that the lamination process is used to produce a four-layer laminated composite having a final thickness of 85 +/- 15 µm (paragraph 0028 discloses a four-layer laminated composite, for the purpose of mimicking the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling as disclosed in paragraph 0019). Therefore, it can be calculated that each layer of the composite has a thickness of about 21.25 µm, which is about 25 µm, as claimed. The examiner notes that the term “about” is broad (see MPEP 2173.05b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold of Cowan, which accelerates the healing of bone, to specify that the plurality of PLLA layers includes 2-10 PLLA layers, in order to mimic the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling, as taught by Jabbari.
Regarding at least claim 12
Cowan in view of Jabbari teaches the method of claim 1. Jabbari further teaches wherein the scaffold includes about 2-10 PLLA layers (paragraph 0028 discloses a four-layer laminated composite, for the purpose of mimicking the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling as disclosed in paragraph 0019). The examiner notes that the term “about” is broad (see MPEP 2173.05b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold of Cowan, which accelerates the healing of bone, to specify that the scaffold includes about 2-10 PLLA layers, in order to mimic the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling, as taught by Jabbari.
Claim 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowan in view of Jabbari, as applied to claim 1, and further in view of US Patent No. 6,627,421 B1 to Unger et al. (Unger).
Cowan in view of Jabbari teaches the method of claim 1. Cowan also teaches that ultrasonic bone growth stimulation generally refers to the treatment of bone fusion and repair using low-intensity ultrasound as an energy source and the ultrasound energy is externally applied (paragraph 0006). However, Cowan does not teach wherein the ultrasound energy includes an intensity that is less than 0.5 W/cm2.
Unger teaches a system for applying ultrasonic energy to cells to provide a synergistic effect in enhancing transfection and cell transformation (col. 3, lines 58-60). The ultrasonic energy may be applied in a variety of ways such that the duration, frequency, mode, intensity, etc. of the energy may be varied as necessary for a given application (col. 4, lines 20-27). The ultrasound intensity is preferably applied over a range of 0.1 to 5 watts/cm2 (col. 4, lines 59-61).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the ultrasound energy, which is used by Cowan to stimulate bone healing, includes an intensity that is in a range of 0.1 to 5 watts/cm2, since this intensity is preferably applied to produce a desired effect, depending on what is deemed necessary for a given application, as taught by Unger, particularly in view of paragraph 0036 of applicant’s specification, which discloses that the intensity range of less than 0.5 W/cm2 is commonly used in ultrasound therapy for bone healing.
Claim 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowan in view of Jabbari, as applied to claim 6, and further evidenced by US Patent Application Publication No. 2009/0163965 A1 to Boyden et al. (Boyden).
Cowan in view of Jabbari teaches the method of claim 6. Cowan also teaches that the implanted bone stimulation electrodes could be used to deliver therapeutic agents, such as bone growth factor, bone cement, stem cells that promote bone healing and growth and the like (paragraph 0042). However, Cowan does not specify wherein the growth factors includes BMP-2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the growth factors include BMP-2, since BMP-2 is a well-known example of bone growth promoting materials, as evidenced by Boyden (paragraph 0130), in order to promote bone healing and growth, as taught by Cowan.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowan in view of Jabbari, as applied to claim 9, and further in view of US Patent Application Publication No. 2017/0179370 A1 to Kim et al (Kim).
Cowan in view of Jabbari teaches the method of claim 9. Jabbari also teaches an electrospinning process. However, Jabbari does not teach the electrospinning process rotates a collector drum at rotation speeds of between 1,000 - 4,000 rpm.
Kim teaches a piezoelectric material including poly(L-lactic acid) (PLLA) that can be produced at very low cost and can manifest high thermal stability and piezoelectric properties (abstract). Kim also teaches electrospinning of the PLLA at a collector’s rotational rate of 60 rpm (paragraph 0064), for the purpose of producing the desired piezoelectric material. The examiner notes that higher speeds, particularly over 1,000 rpm, produce aligned fibers, which is contemplated by Jabbari (paragraph 0019)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify the rotation speed of the collector’s drum during the electrospinning process taught by Cowan in view of Jabbari to be at a rate of 60 rpm, in order to produce the desired piezoelectric material, as taught by Kim. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the speed of the collector’s drum to include speeds between 1,000 - 4,000 rpm, in order to obtain aligned fibers, particularly since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowan in view of Jabbari, as applied to claim 1, and further in view of 2007/0255422 A1 to Wei et al. (Wei).
Regarding at least claim 13
Cowan in view of Jabbari teaches the method of claim 1. Cowan also teaches that the implanted bone stimulation electrodes could be used to deliver therapeutic agents, such as bone growth factor, bone cement, stem cells that promote bone healing and growth and the like (paragraph 0042). However, Cowan does not teach wherein at least one of the PLLA layers is bonded with a layer of collagen, loaded with calcium phosphate.
Wei teaches a bone-repair composite including a core and a sheath and having a bending modulus comparable to that of a mammalian bone such that the ratio of the core to the sheath is provided to maximize the mechanical strength of the bone-repair composite to mimic the mammalian bone (abstract). The core of the bone-repair composite taught by Wei is coated with a low temperature polymer selected from a group consisting of collagen, hyaluronans, fibrin, chitosan, alginate, silk, polyesters, polyethers, polycarbonates, polyamines, polyamides, co-polymers, poly(L-lactic) acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide-co-glycolide) (PLGA), and poly(.epsilon.-caprolactone) (PCL), and other polymers (paragraph 0015). Wei further teaches a calcium phosphate compound layer that is anchored to the polymer surface (paragraph 0015).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that at least one of the PLLA layers is bonded with a layer of collagen, loaded with calcium phosphate, in order to maximize the mechanical strength of the bone-repair composite to mimic the mammalian bone, as taught by Wei, and therefore also promote bone healing and growth, as desired by Cowan, particularly since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding at least claim 14
Cowan in view of Jabbari and further in view of Wei teaches the method of claim 13. Wei also teaches wherein the calcium phosphate is tri-calcium phosphate.
Wei further teaches that the calcium phosphate compound layer is selected from a group consisting of ion-substituted apatite, calcium phosphate, carbonate hydroxyapatite, fluorinated hydroxyapatite, chlorinated hydroxyapatite, silicon-containing hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, monotite, dicalcium phosphate, dicalcium phosphate dihydrate, octocalcium phosphate, calcium phosphate monohydrate, alpha-tricalcium phosphate, beta-tricalcium phosphate, amorphous calcium phosphate, biphasic calcium phosphate, tetracalcium phosphate, calcium deficient hydroxyapatite, precipitated hydroxyapatite, oxyapatite, calcium sulfate, and calcium containing phosphate minerals.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the calcium phosphate is tri-calcium phosphate, in order to maximize the mechanical strength of the bone-repair composite to mimic the mammalian bone, as taught by Wei, and therefore also promote bone healing and growth, as desired by Cowan, particularly since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 15-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowan in view of Jabbari, and further in view of US Patent Application Publication No. 2011/0109204 A1 to Tajitsu et al. (Tajitsu).
Regarding at least claim 15
Cowan teaches systems and methods to enhance bone growth by stimulating bone sites for bone regrowth, fusion, or grafts (abstract). Cowan meets the limitations of a scaffold for regenerating bone or tissue (paragraph 0017 discloses surgical attachment of devices such as pins, cages, plates, or bone grafts for bone healing including bone fractures, fusions, or joint replacement, as well as accelerating bone healing by stimulating the bone), the scaffold comprising: a plurality of layers (paragraph 0032 discloses an implanted device/scaffold; 2, which contains an ultrasound transducer, an electrical circuit, and electrodes and that the transducer is made of a piezoelectric polymer or copolymer films); wherein the plurality of layers deliver an electric charge to the bone or tissue after ultrasound energy is applied to the plurality of layers to induce growth of the bone or tissue applying ultrasound energy to the scaffold (paragraph 0030 discloses a controller-transmitter; 1, for transmitting an ultrasound signal through intervening tissue to the device/scaffold which contains means to receive the acoustic energy and convert it into an electrical current which may be applied to the attached electrodes such that the targeted bone site receives sufficient ultrasonic energy to promote bone healing).
However, Cowan does not teach that the layers are a plurality of PLLA layers comprising a nanofiber mesh, or a plurality of hydrogel layers, each hydrogel layer positioned between two PLLA layers.
Jabbari teaches a method for forming a laminated nanocomposite as a scaffold in a variety of applications in regenerative medicine to provide structural support and pore volume for integration with the surrounding tissue (abstract and paragraph 0045). More specifically, Jabbari teaches applying a hydrogel precursor solution to a first layer of poly(L-lactide) nanofiber mesh and stacking a second layer of poly(L-lactide) nanofiber mesh on the first layer with at least a portion of the hydrogel precursor solution being situated between the first layer and the second layer (abstract). The lamination process taught by Jabbari includes fiber layers coated with hydrogel precursor solution and then stacked together and compressed, and then crosslinking the multi-layer assembly to form a laminated nanocomposite (paragraph 0028), for the purpose of mimicking the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling (paragraph 0019).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold of Cowan, which accelerates the healing of bone, to specify that the piezoelectric polymer or copolymer films that make up the transducer are a plurality of PLLA layers comprising a nanofiber mesh, and wherein the PLLA layers; and a plurality of hydrogel layers, each hydrogel layer positioned between two PLLA layers, in order to mimic the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling, as taught by Jabbari, particularly since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
However, Cowan in view of Jabbari does not teach that the PLLA layers having a piezo constant of 15-20 pC/N.
Tajitsu teaches a piezoelectric element including a plurality of piezoelectric sheets (abstract) of PLLA (paragraph 0060) having a constant of 20 pC/N (paragraph 0081). The examiner notes that the piezoelectric constant appears to be a result of the electrospinning process and is capable of being adjusted depending on the desired properties of the material best suited for the intended purpose of the device.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the PLLA layers have a piezo constant of 20 pC/N, in order to exhibit the desired properties of the material best suited for the intended purpose of the device, particularly depending on the electrospinning process used. It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify a range of 15-20 pC/N, 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. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding at least claim 16
Cowan in view of Jabbari and further in view of Tajitsu teaches the scaffold of claim 15. Jabbari also teaches wherein the plurality of PLLA layers includes 2-10 PLLA layers (paragraph 0028 discloses a four-layer laminated composite, for the purpose of mimicking the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling as disclosed in paragraph 0019). The examiner notes that the term “about” is broad (see MPEP 2173.05b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold of Cowan, which accelerates the healing of bone, to specify that the plurality of PLLA layers includes 2-10 PLLA layers, in order to mimic the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling, as taught by Jabbari.
Regarding at least claim 17
Cowan in view of Jabbari and further in view of Tajitsu teaches the scaffold of claim 15. Cowan also teaches wherein at least one of the PLLA layers includes stem cells (paragraph 0042 discloses that the implanted bone stimulation electrodes could be used to deliver therapeutic agents, such as stem cells that promote bone healing and growth and the like).
Regarding at least claim 18
Cowan in view of Jabbari and further in view of Tajitsu teaches the scaffold of claim 15. Cowan also teaches wherein at least one of the PLLA layers includes growth factors (paragraph 0042 discloses that the implanted bone stimulation electrodes could be used to deliver therapeutic agents, such as bone growth factor).
Regarding at least claim 20
Cowan in view of Jabbari and further in view of Tajitsu teaches the scaffold of claim 15. Jabbari also teaches that the lamination process is used to produce a four-layer laminated composite having a final thickness of 85 +/- 15 µm (paragraph 0028 discloses a four-layer laminated composite, for the purpose of mimicking the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling as disclosed in paragraph 0019). Therefore, it can be calculated that each layer of the composite has a thickness of about 21.25 µm, which is about 25 µm, as claimed. The examiner notes that the term “about” is broad (see MPEP 2173.05b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold of Cowan, which accelerates the healing of bone, to specify that the plurality of PLLA layers includes 2-10 PLLA layers, in order to mimic the laminated structure of osteons in bone to accelerate bone formation and facilitate bone remodeling, as taught by Jabbari.
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowan in view of Jabbari and Tajitsu as applied to claim 18 above and further in view of Boyden.
Cowan in view of Jabbari and further in view of Tajitsu teaches the scaffold of claim 18. Cowan also teaches that the implanted bone stimulation electrodes could be used to deliver therapeutic agents, such as bone growth factor, bone cement, stem cells that promote bone healing and growth and the like (paragraph 0042). However, Cowan does not specify wherein the growth factors includes BMP-2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the growth factors include BMP-2, since BMP-2 is a well-known example of bone growth promoting materials, as evidenced by Boyden (paragraph 0130), in order to promote bone healing and growth, as taught by Cowan.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,678,989 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, the patent claims also recite a method of regenerating bone or tissue, the method comprising: applying a scaffold to a wound, the scaffold comprising a plurality of PLLA layers, each layer separated by a hydrogel layer; applying ultrasound energy to the scaffold; generating an electrical surface charge on the scaffold; and delivering an electrical output to the bone or tissue from the scaffold to regenerate the bone or tissue (see patent claim 1).
Regarding claim 2, the patent claims also recite the method of claim 1, wherein the ultrasound energy includes an intensity that is less than 0.5 W/cm2 (see patent claim 2) .
Regarding claim 3, the patent claims also recite the method of claim 1, wherein the ultrasound energy includes a frequency in the kHz range (see patent claim 3).
Regarding claim 4, the patent claims also recite the method of claim 3, wherein the ultrasound energy includes a frequency at 40 kHz (see patent claim 4).
Regarding claim 5, the patent claims also recite the method of claim 1, wherein at least one of the PLLA layers includes stem cells (see patent claim 5).
Regarding claim 6, the patent claims also recite the method of claim 1, wherein at least one of the PLLA layers includes growth factors (see patent claim 6).
Regarding claim 7, the patent claims also recite the method of claim 6, wherein the growth factors includes BMP-2 (see patent claim 7).
Regarding claim 8, the patent claims also recite the method of claim 1, wherein the PLLA layers comprise a biodegradable nanofiber mesh (see patent claim 1).
Regarding claim 9, the patent claims also recite the method of claim 8, wherein the nanofiber mesh is created by an electrospinning process to exhibit piezoelectricity (see patent claim 1).
Regarding claim 10, the patent claims also recite the method of claim 9, wherein the electrospinning process rotates a collector drum at rotation speeds of between 1,000 - 4,000 rpm (see patent claim 1).
Regarding claim 11, the patent claims also recite the method of claim 1, wherein each PLLA layer includes a thickness of about 25 µm (see patent claim 8).
Regarding claim 12, the patent claims also recite the method of claim 1, wherein the scaffold includes about 2-10 PLLA layers (see patent claim 9).
Regarding claim 13, the patent claims also recite the method of claim 1, wherein at least one of the PLLA layers is bonded with a layer of collagen, loaded with calcium phosphate (see patent claim 10).
Regarding claim 14, the patent claims also recite the method of claim 13, wherein the calcium phosphate is tri-calcium phosphate (see patent claim 11).
Regarding claim 15, the patent claims also recite a scaffold for regenerating bone or tissue, the scaffold comprising: a plurality of PLLA layers comprising a nanofiber mesh, the PLLA layers having a piezo constant of 15-20 pC/N; and a plurality of hydrogel layers, each hydrogel layer positioned between two PLLA layers; wherein the plurality of PLLA layers deliver an electric charge to the bone or tissue after ultrasound energy is applied to the plurality of PLLA layers to induce growth of the bone or tissue (see patent claim 12).
Regarding claim 16, the patent claims also recite the scaffold of claim 15, wherein the plurality of PLLA layers includes 2-10 PLLA layers (see patent claim 13).
Regarding claim 17, the patent claims also recite the scaffold of claim 15, wherein at least one of the PLLA layers includes stem cells (see patent claim 14).
Regarding claim 18, the patent claims also recite the scaffold of claim 15, wherein at least one of the PLLA layers includes growth factors (see patent claim 15).
Regarding claim 19, the patent claims also recite the scaffold of claim 18, wherein the growth factors includes BMP-2 (see patent claim 16).
Regarding claim 20, the patent claims also recite the scaffold of claim 15, wherein each PLLA layer includes a thickness of about 25 µm (see patent claim 17).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The reference to Omnetto et al. (US Patent Application Publication No. 2014/0145365 A1) discloses silk-based piezoelectric materials (biodegradeable PLLA nanofibers) that may be used in biomedical applications, as well as the application of ultrasound to generate electrical surface charge. Paragraphs 0058-0059 disclose different material formats such as electrospun mats, scaffolds, and films, including multiple layers of silk films that may be casted on a substrate, and paragraph 0055 teaches silk hydrogels. The examiner notes that Omnetto meets the claim limitations but does not appear to disclose a relationship between high electrospinning speed to increased piezoelectricity of the PLLA layers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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