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 Objections
Claims 3 and 7 are objected to because of the following informalities: Claim 3 recites “the biodegradable polymer/extracellular matrix” in line 2, which appears to be referring to – the polymer/extracellular matrix –, as recited in claim 1. Claim 7 recites “the biodegradable composite” in both line 2 and line 3, which appears to be referring to – the biomimetic, biodegradable composite –. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2015/0105854 A1 to Shanov et al. (Shanov) in view of "Influence of electrospinning and dip-coating techniques on the degradation and cytocompatibility of Mg-based alloy” to Abdal-hay et al. (Abdal-hay), and further in view of WO 2015/138970 A1 to Scripps Health (Scripps).
Regarding claim 1
Shanov teaches method for making a magnesium biodegradeable stent for medical implant applications, using magnesium foil or pure magnesium or magnesium alloys (abstract). Shanov meets the limitations of method of fabricating a biomimetic, biodegradable composite comprising: creating a magnesium alloy mesh (specific embodiments of Shanov are directed to the manufacturing of biodegradeable magnesium based stents for medical applications including but not limited to scaffolding of any blood vessels (cardiovascular, etc.). that are produced by chemical etching of magnesium foil through a mask created by using any lithographic approach; abstract and paragraph 0037).
Shanov also teaches that the thin magnesium foil can be covered on both sides with a thin layer of a positive photoresist by a spin coating technique followed by backing the resin (paragraph 0040). However, Shanov does not teach electrospinning polymer onto the magnesium alloy mesh.
Abdal-hay discloses an investigation of the influence of coating technique on the biological and corrosive properties of Mg alloy (abstract). Abdal-hay teaches a biomimetic, biodegradable scaffold (abstract: "Mg-based implant materials... coat the Mg substrate with a biodegradable polymer"; page 38 col 1 para 2: "The biodegradability of magnesium alloys is another advantage..."), comprising: a magnesium alloy substrate (abstract: “coating technique on the biological and corrosive properties of Mg alloy... coat the Mg substrate..."); and a composite applied to the substrate, the composite comprising: electro-spun polymer fibers (abstract: “Electrospinning... employed to coat the Mg substrate with a biodegradable polymer... the electrospin nanofiber layer was stable...”), for the purpose of promoting bioactivity and/or osseointegration and providing high stability to provide acceptable corrosion resistance (page 38 col 1 para 1-2 and col 2 para 1-2). Abdal-hay also teaches that the procedures can produce a porous film that may promote bioactivity and/or osseointegration such that the electrospun biodegradeable polymer layer coating is a promising method for increasing the use of Mg-based materials in orthopedic and cardiovascular applications (page 38 col 2 para 1-2).
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 Mg alloy mesh substrate of Shanov, which is intended for placement in animals to increase the size of the vessels, as well as optimize configuration and hemodynamics, such that it is embedded in or encapsulated by a composite comprising electro-spun polymer fibers, wherein the composite is a porous structure and wherein the scaffold is structured to regenerate bone tissue for calvarial critical sized defects, as taught by Abdal-hay, in order to promote bioactivity and provide acceptable corrosion resistance resulting in an implant material that is promising for increased use in cardiovascular applications, such as those taught by Shanov and Abdal-hay.
However, Shanov in view of Abdal-hay does not disclose concurrently electrospinning polymer and electrospraying extracellular matrix onto the magnesium alloy mesh.
Scripps teaches a scaffold composition produced by electrospinning a polymer solution onto a collector and adding a plurality of cells to the scaffold composition (abstract). More specifically, Scripps discloses a biomimetic, biodegradable scaffold (para [002]: “...a polymer scaffold composition...") and a composite, the composite comprising: electro-spun polymer fibers, (para [002]: ”...electrospinning a first polymer solution... to form polymer fibers..."); and electro-sprayed extracellular matrix (para [002]: "...methods further comprise contacting the polymer fibers with a plurality of cells... electrospraying the plurality of cells on to the polymer fibers... electrospinning the polymer solution and electrospraying the plurality of cells occurs simultaneously... the plurality of cells is suspended in a biomimetic gel... the biomimetic gel comprises one or more growth factors” para [0166]: "...the plurality of cells are selected from…extracellular matrix (ECM) cells”), for the purpose of resulting in a three-dimensional construct comprising polymer fibers and a plurality of cells through the scaffold to treat a tissue defect in a subject, and particularly for increasing repair and growth of the body part to which the scaffold is applied, as taught by Scripps.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composite of Shanov in view of Abdal-hay, which is made up of electro-spun polymer fibers and is applied to a biomimetic, biodegradable scaffold comprising a created magnesium alloy mesh substrate, to further include concurrently electrospinning polymer and electrospraying extracellular matrix, as disclosed by Scripps, onto the magnesium alloy mesh substrate to form a magnesium alloy mesh scaffold that includes an applied composite of electro-spun polymer fibers combined with electro-sprayed extracellular demineralized bone matrix, in order to increase repair and growth of the body part to which the scaffold is applied, as taught by Scripps.
Regarding claim 2
Shanov in view of Abdal-Hay, and further in view of Scripps teaches the method of claim 1. Shanov also teaches wherein the magnesium alloy mesh creating step comprises photochemical etching (paragraph 0039 discloses processing the foil made of magnesium alloy by photochemical etching).
Regarding claim 3
Shanov in view of Abdal-Hay, and further in view of Scripps teaches the method of claim 1. As explained above, Abdal-Hay teaches that the process of electrospinning is employed for coating the Mg substrate with a biodegradeable polymer/ECM, which includes embedding the magnesium substrate into the coating of biodegradeable polymer/ECM, for the purpose of promoting bioactivity and/or osseointegration and providing high stability to provide acceptable corrosion resistance (page 38 col 1 para 1-2 and col 2 para 1-2).
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 Mg alloy mesh substrate of Shanov, which is intended for placement in animals to increase the size of the vessels, as well as optimize configuration and hemodynamics, such that it is embedded in or encapsulated by a composite comprising electro-spun polymer fibers, wherein the composite is a porous structure and wherein the scaffold is structured to regenerate bone tissue for calvarial critical sized defects, as taught by Abdal-hay, in order to promote bioactivity and provide acceptable corrosion resistance resulting in an implant material that is promising for increased use in cardiovascular applications, such as those taught by Shanov and Abdal-hay.
Regarding claim 4
Shanov in view of Abdal-Hay, and further in view of Scripps teaches the method of claim 1. Scripps also teaches wherein electrospraying of the extracellular matrix comprises suspending the extracellular matrix into a hyaluronic acid solution (paragraph 002 on page 3, lines 2-7 discloses that the plurality of cells is suspending in a biomimetic gel that comprises hyaluronan), for the purpose of producing a plurality of polymer compositions between the layers of biomimetic gel (paragraph 088).
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 electrospraying of the extracellular matrix taught by Scripps comprises suspending the extracellular matrix into a hyaluronic acid solution, in order to produce a plurality of polymer compositions between the layers of biomimetic gel, as taught by Scripps.
Regarding claim 7
Shanov in view of Abdal-Hay, and further in view of Scripps teaches the method of claim 1. Scripps also teaches further comprising: seeding bone marrow stem cells on the surface of the biodegradable composite; and implanting the seeded, biodegradable composite into a patient body (paragraph 0228 discloses cell seeding into electrospun collagen and paragraph 012 discloses implanting the cell-seeded polymer scaffold composition), in order to replace a tissue or a portion thereof while being remodeled when placed in a subject by the subject’s endogenous enzymes (paragraphs 0124-0126).
It would have been obvious to include seeding bone marrow stem cells on the surface of the biodegradable composite; and implanting the seeded, biodegradable composite into a patient body, in order to replace a tissue or a portion thereof while being remodeled when placed in a subject by the subject’s endogenous enzymes, as taught by Scripps.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanov in view of Abdal-Hay and Scripps, and further in view of US Patent Application Publication No. 2004/0037813 A1 to Simpson et al. (Simpson).
Regarding claim 5
Shanov in view of Abdal-Hay, and further in view of Scripps teaches the method of claim 1, including the step of electrospinning and electrospraying the magnesium alloy mesh. However, Shanov in view of Abdal-Hay, and further in view of Scripps does not teach wherein the magnesium alloy mesh is rotating on a mandrel during the electrospinning and electrospraying step.
Simpson teaches a method of electroprocessing materials via electrospinning and electrospraying comprising rotating a mandrel (paragraph 0182), for the purpose of obtaining an even distribution of the coating (paragraph 0344).
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 magnesium alloy mesh of Shanov in view of Abdal-Hay, and further in view of Scripps is rotating on a mandrel during the electrospinning and electrospraying step, in order to obtain an even distribution of the coating, as taught by Simpson.
Regarding claim 6
Shanov in view of Abdal-Hay, and further in view of Scripps and Simpson teaches the method of claim 5. As explained above, Abdal-Hay in view of Scripps an electrospun and electrosprayed coating of a biodegradeable polymer/ECM on an Mg substrate, as taught by Abdal-hay in view of Scripps, which includes encapsulating the magnesium substrate with the coating of biodegradeable polymer/ECM, for the purpose of promoting bioactivity and providing acceptable corrosion resistance and also to increase repair and growth of the body part to which the scaffold is applied.
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 Mg alloy mesh substrate of Shanov, such that it is encapsulated by a composite comprising electro-spun polymer fibers combined with electrosprayed ECM, in order to promote bioactivity and provide acceptable corrosion resistance and also to increase repair and growth of the body part to which the scaffold is applied, as taught by Abdal-hay in view of Scripps.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights