-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 .
Priority
This application is a CIP of 16/137,771 filed on 09/21/2018 (ABN), which is a CIP of 15/834,699 filed on 12/07/2017 (ABN), claims benefit in provisional application 62/431,076 filed on 12/07/2016.
This application is a CIP of 15/834,699 filed on 12/07/2017 (ABN), which is a CIP of 15/624,425 filed on 06/15/2017 (PAT 10,238,496).
Claims Status
Claims 1-31 are pending and examined.
Warning
Applicant is advised that should claims 26 and 27 be found allowable, claims 30 and 31, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections – 35 USC § 112
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.
Claims 1-31 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.
Claim 1 requires a structure comprising a scaffold by treating a 3D structure. The claim is indefinite because it is not clear what is meant by “a scaffold by a treating a 3D structure”. For the purpose of applying prior art, the claim is interpreted as requiring a scaffold obtained by treating a 3D structure.
Claim 1 lines 9-10, recites “the third medium comprises solid particulates alone or in polymeric structures that are dissolvable”. The phrase is indefinite because “that are dissolvable” could be interpreted to modify solid particulates, polymeric structures, or both.
Claim 1 lines 12-14, recites treating the 3D structure with “the second solvent to dissolve the solid particulates of the second medium therefrom so as to remove the solid particulates from the 3D structure”. The phrase is indefinite because “the solid particulates” of the second medium lacks antecedent basis. The phrase is further indefinite because it requires dissolving the solid particulates of the second medium using a second solvent. The second medium is described in lines 8-9 as comprising a polymer that is dissolvable or removable in a first solvent. The second solvent is intended for dissolving particulate in the third medium. For the purpose of applying prior art the claim is interpreted to require the 3D structure treated with the second solvent to dissolve the solid particulates or solid particulates in polymer structures of the third medium. This interpretation is logical in view of the description of the 3D structure in lines 2-11 of the claim.
Claim 13 requires “wherein the third medium comprises solid particulates that dissolve…”. The claim is indefinite because it is not clear if the description of the solid particulates in claim 13 is intended to further limit the solid particulates of the third medium recited in claim 1, or if applicant intended to require the third medium to further comprise the solid particulates described in claim 13.
Claim 13 requires the third medium to comprise solid particulates that do not immediately interact with the first medium and the second medium. The claim is indefinite because it is not clear what structural relationship between the solid particulates of the third medium and the first medium and the second medium is implied by “do not immediately interact”.
The term rapidly in claims 14 and 15 is a relative term that renders the claims indefinite. The term “rapidly” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary sill in the art would not be reasonably apprised of the scope of the invention.
Claim 14 recites “a solvent that immediately interacts with the first medium and the second medium”. The claim is indefinite because it is not clear how this description structurally defines the solvent.
Claim 15 recites “a solvent that does not immediately interact with the first medium and the second medium”. The claim is indefinite because it is not clear how this description structurally defines the solvent.
Claim 16 recites the limitation "the at least fourth medium material" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the at least fourth medium materials" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites “loaded with a variety of solid particulates similar to the second medium or the third medium in weight ratios varying from 0.01 to 99.99 wt. %”. The phrase is indefinite because the scope of “a variety of solid particulates” is unknown. The particles are described as similar to the second medium or the third medium, however it is unknown what degree of structural difference is allowed in order for the variety of solid particulates to be considered similar to the second medium or to the third medium. The term “similar” extends the scope of the second medium or the third medium, but it is unknown to what extent and how much structural variation the solid particulates are allowed to have and still be considered similar to the second medium or the third medium. The claim is further indefinite because it is unknown what is present in the claimed range of weight ratios. A weight ratio requires at least two components and in the instant case it is not clear what at least two components are present in said range of ratios.
Claim 19 recites “wherein the at least fourth medium is independent”. The claim is indefinite because it is unknown what structure is implied by independent. It is unknown from what the at least fourth medium is independent.
Claim 19 requires the at least fourth medium to be deposited in equal or variable ratios compared to the second medium. The claim is indefinite because it does not state units of the ratios. The ratio of the two could be based on weight, volume, moles, or some other unit of measurement.
Claim 20 recites the limitation "the at least one fourth medium" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites “the pores is between 0.1 nm to 3 mm”. The phrase is indefinite because it is unknown what dimension is required to be between the recited range.
Claim 24 is indefinite because it mixes statutory classes. The claim is drawn to a scaffold, but it recites that is scaffold is exposed, which implies a method step.
Claims 2-8, 11, 18, 21, 23, and 25-31 are indefinite because the claims depend from an indefinite base claim.
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.
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.
Claims 1-31 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2007/0061015 A1 Published March 15, 2007).
The claims encompass a biocompatible structure useable for tissue regeneration comprising a scaffold as described by the claims.
The teachings of Jensen are related to a layered porous structure for the repair of damaged tissue (Abstract). Jensen teaches a biocompatible implement for bone and tissue regeneration comprising a layered structure with alternating layers formed of a bioresorbable polymer carrier and of a bone or tissue forming material applied to a major surface of the polymer carrier (paragraph 0014).
Regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed a porous implant having interconnected channels and pores comprising a layered structure of polymeric materials and substances for promoting tissue growth, with a reasonable expectation of success because Jensen teaches a biocompatible implant having interconnected channels and pores wherein the implant is a layered structure comprising alternating layers of biocompatible polymer and bone forming materials (paragraphs 0008 and 0038). It would have been obvious to have selected polylactide as the polymer because Jensen teaches polylactide as a suitable polymer for making the implant (paragraphs 0043 and 0044). It would have been obvious to have selected bone nanoparticles as the bone forming material because Jensen teaches bone nanoparticles having a particle size from several nanometers to 10 micrometers as a suitable bone forming material that may be included in the implant as a layer placed between polymer layers to form an implant having alternating layers of bone particles and polymer (paragraph 0053).
The scaffold described by Jensen is a 3D structure having a tunable porosity with interconnected pores and channels along with adjustable dimensions and it is formed from alternating layers of polylactide (relevant to the second medium comprising a polymer that is dissolvable or removable in a first solvent in claim 1, and the polymer is a synthetic biodegradable and biocompatible polymer in claim 12) and layers of bone nanoparticles having a particle size from several nanometers to 10 micrometers (relevant to the first medium comprising bone particles in claim 1, where the bone particles have sizes in a range between 1 nm to 100 mm). The claimed particle size range is obvious because it overlaps with the Jensen’s range.
The third medium is not required to be in the scaffold because the claim has been interpreted to require the third medium (solid particulates alone or in polymeric structures) to be dissolved or removed by the second solvent. The “wherein” clause is product by process limitation that describes how the adjustable porosity in the scaffold is formed. It would have been obvious to have arranged the bone particles of the first medium and the polylactide of the second medium in layers, with a reasonable expectation of success because Jensen teaches a layered structure in Figure 4A. Jensen teaches that the implant is formed by forming a stack 20 of layers 14 and 16 of biocompatible polymer and bone particles 18, and stacking successive stacks on top of one another as indicated in Figure 2 (paragraph 0056). Figures 4A and 4B show the implant structure of FIG. 2 in a perspective view 40, clearly illustrating the four-sided open structure which enables rapid neo-vascularization (paragraph 0060). It is apparent from Figure 4A that the structure comprises multiple alternating polymer layers and bone layers. A layer of bone particles reads on the second layer formed from the first medium (bone particles). Two polymer layers, one above and one below the bone particle layer, read on the first layer comprising the second medium and surrounding the second layer.
Figure 4A
PNG
media_image1.png
528
884
media_image1.png
Greyscale
According to Jensen, porosity is introduced into the implant through layers of bone particles. The porous bone particle layer could have been obtained by combining bone particles and solid particulates alone or in polymeric structures that are dissolvable or removable in a second solvent, followed by dissolving or removing said solid particulates by treating the layer with the second solvent thereby creating pores and forming a scaffold having a porosity that is adjustable by sizes of the solid particulates and concentration of the solid particulates, absent evidence to the contrary.
Regarding claims 2 and 3, Jensen’s implant comprising layers of polylactide and layers of bone particles arranged in alternating manner could have been formed by alternating layers of the first layer comprises the second medium (polylactide), and the second layer comprises the first medium (bone particles) and the third medium (solid particulates alone or in polymeric structures that are dissolvable or removable in a second solvent), followed by exposing the second layer to the second solvent to dissolve or remove the third medium thereby forming pores and a porous second layer.
Regarding claim 4, it would have been obvious to have arranged the layers to comprises a first polylactide layer, a first bioactive agent layer, a first bone particle layer, a second bone particle layer, a second bioactive agent layer, and a second polylactide layer, with a reasonable expectation of success because Jensen teaches an embodiment intended to further increase the porosity of the implant where one of the layers may be inverted based on the specific needs of the surgeon and tissue to be generated. In the exemplary embodiment shown in FIG. 10, two (or more) bone particle layers 18a, 18b may be laid on top of each other and supported by respective top 14b and bottom 14a polymeric layers. On the bottom layer 20a, only the underside of the bone particle layer 18a contacting the polymer layer 14a, shown here with
an interposed bioactive layer 16a, would adhere to the bottom layer 14a and 16a, respectively. Conversely, on the top layer 20b, only the topside of the bone particle layer 18b contacting the top polymer/bioactive layer 14b, 16b would adhere to the top polymer/bioactive layer. When these two layers 20a and 20b are placed one on top of each other, with the bone particles of the respective layers facing each other, a considerably thicker bone particle layer is formed from the
combination of layers 18a and 18b, which greatly increases the porosity of the implant system.
In this embodiment, two polymer layers 14a and 14b read on the first layer comprising the second medium, either 18a or 18 reads on the second layer, and the remaining 18a or 18b reads on the third layer comprising the first medium deposited on the first layer. It is noted that the third medium comprised in the second layer would have been dissolved and removed as a result of exposure to the second solvent and the formation of pores in the second layer.
Figure 10
PNG
media_image2.png
339
946
media_image2.png
Greyscale
.
Regarding claim 5, it is apparent from Figure 4A that the implant comprises a plurality of base layered structures attached to each other vertically.
Regarding claim 6, it is apparent from Figure 4A that the implant does not comprise polymer columns attached vertically or horizontally.
Regarding claim 7, the implant in Jensen comprises alternating polylactide layers (first medium) and bone particle layers (second medium) horizontally arranged on top of each other.
Regarding claim 8, it would have been obvious to have applied columns made from polylactide to the layered structure, with a reasonable expectation of success because Jensen teaches an embodiment where the layered structure comprises a layer 46 of a polymer applied in a columnar pattern on the outside surface of the implant stacked in the direction perpendicular to the layers 20n as shown in Figure 4B (paragraph 0061)
PNG
media_image3.png
592
932
media_image3.png
Greyscale
.
Jensen does not limit the polymer used for making the layer 46, thus it would have been obvious to have selected polylactide because Jensen teaches that polylactide is suitable for making the implant.
The polylactide reads on the second medium and it is apparent from the structure that polylactide is present in horizontal geometries (layers) and vertical geometries (columns 46). Layers of bone particles separate polylactide layers horizontally, and layer of bone particles separate polylactide columns vertically.
Claim 9 describes how the second medium is deposited. Jensen’s polylactide layer could have been formed by depositing the polylactide in any one of the claimed patterns to obtain polylactide layers. The claim does not limit the structure of the second medium that is obtained after the claimed deposition patters, therefore Jensen’s polylactide layer reads on the claimed layer formed by depositing the second medium in claimed patterns.
Regarding claim 10, it would have been obvious to have utilized bovine bone particles, with a reasonable expectation of success because Jensen teaches that bovine bone particles are suitable for making the layered implant (paragraph 0082).
Regarding claim 11, Jensen teaches bone nanoparticles having a particle size from several nanometers to 10 micrometers, which renders the claimed range obvious because the ranges overlap.
Regarding claim 12, Jensen teaches polylactide which is a synthetic biocompatible and biodegradable polymer.
Claims 13-15 describe the third medium. As explained above, the third medium is not required to be in the scaffold because it is dissolved or removed with the second solvent. The claims describe the scaffold as a product by process where the product is formed from the first medium, second medium, and third medium and wherein the third medium is dissolved or removed. The pores in Jensen’s layered implant could have been formed by removing or dissolving a material that corresponds to the third medium by dissolving the material with a solvent that corresponds to the second solvent as claimed.
Regarding claim 16, it would have been obvious to have formed the scaffold comprising a layer of a biostable polymer and layers of biodegradable polymer, with a reasonable expectation of success because Jensen teaches that the mechanical properties of the bioresorbable
polymer layer 14 may be altered by incorporating into one, into several or into all polymer layers of the implant structure a sheet 33 made of a more rigid bioresorbable polymer. Particularly desirable is to form a scaffold having a biostable polymer portion of the scaffold sandwiched inside two biodegradable polymer portions. The combination of the layers 32 and 34 can
then take the place of any of the polymer layers in the implant structure depicted in FIG. 2. The second polymer layer may be made of a more rapidly dissolving polymer that will release bioactive substances, such as proteins, drugs, collagen, bone morphogenic proteins, peptides, and antibiotics for bone/tissue regeneration (paragraph 0059). The biostable polymer reads on a fourth medium that has a longer biodegradation time in a biological system compared to the polylactide.
Regarding claim 17, it would have been obvious to have formed the implant comprising stacked layers of bioresorbable polymer and layers of bone particles and comprising a fine layer of a polymer applied in a columnar pattern on the outside surface of the implant stack to add rigidity to the scaffold wherein the fine layer comprises nanoparticles of hydroxyapatite, with a reasonable expectation of success because Jensen teaches such structure in paragraph 0060. The fine layer applied in columnar pattern meets the limitation of at least fourth material loaded with solid particulates. The claimed range of weight ratios is indefinite because the claim does not state which components are in a ratio with each other. The claim is included in the rejection for the purpose of compact prosecution. The purpose of the fine layer applied in columnar pattern is to add rigidity to the layered scaffold, therefore it would have been obvious to have utilized a polymer that is different from polylactide (the polymer used to make the layers). A polymer that is structurally different from polylactide would have had a degradation time in a biological system that is faster or longer compared to polylactide. Paragraph 0043 teaches synthetic biodegradable polymers that are suitable for making Jensen’s implant.
Regarding claim 18, Jensen’s implant comprises bioresorbable polylactide layer (the second medium) and biostable polymer layer (the at least fourth medium), which would have had degradation rates that range from 1 second to 100 months when placed under conditions that cause degradation of these materials from 1 second to 100 months. The claim does not limit conditions under which degradation occurs for the specified time period. The third medium is not required to be present in the claimed product because the claimed product is a product by process where the third medium is removed and its degradation rage is irrelevant.
Regarding claim 19, the limitation regarding ratio is met because the at least fourth medium is necessarily present in an equal or variable ratio compared to the second medium. The limitation related to the at least fourth medium being independent or along with the second medium is indefinite to the extent that prior art cannot be applied to the limitation. The claim is included in the obviousness rejection for the purpose of compact prosecution.
Regarding claim 20, the limitation is met because the at least fourth medium is necessarily present in an equal or variable ratio compared to the second medium.
Regarding claim 21, the claim is a product by process claim. The second medium, the third medium, and the at least fourth medium could have been deposited by the claimed methods to obtain Jensen’s implant, absent evidence to the contrary.
Regarding claim 22, it would have been obvious to have formed the implant having a pore size in the range from 10 microns to 300 microns, with a reasonable expectation of success because Jensen teaches about 10 microns to about 300 microns as a suitable range of pore sizes in the implant (paragraph 0053). The claim is included in the rejection for the purpose of compact prosecution and the range is interpreted as a pore size range, which is obvious because it overlaps with Jensen’s range. Jensen does not teach the porosity of the implant. However, the claimed porosity range of 1-99% is obvious over Jensen because Jensen’s implant has a porosity that is at least close enough to the claimed range or overlaps with the claimed range. Considering the broad range of claimed porosity and the fact that the purpose of Jensen is to form a porous implant, it would have been obvious to conclude that Jensen’s implant has a porosity that renders the claimed porosity obvious. The limitation “wherein the porosity of the scaffold is controlled by the deposition parameters, density of component materials and packing” is a product by process limitation and Jensen’s pores in the range of 10-300 microns could have been obtained by the claimed method.
Regarding claim 23, it would have been obvious to have added growth factors TGF and EGF to the scaffold, with a reasonable expectation of success because Jensen teaches that the scaffold comprises therapeutic agents such as TGF and EGF (paragraph 0063).
Regarding claim 24, it would have been obvious to have treated the scaffold with plasma in order to enhance tissue growth, with a reasonable expectation of success because Jensen teaches treating the scaffold with plasma for the purpose of enhancing tissue growth (paragraphs 0050 and 0061). Jensen additionally teaches that the surface of the polymer layer 14, 16 may be
negatively charged by exposure to a plasma, electrostatic corona discharge, ions or electron bombardment and bone particles may be applied to the top surface, optionally also the bottom surface, with the substrate 12 removed, of the polymer layer 14, 16 with an electro-sprayer having a friction charger to positively charge the bone particles. The bone layer can hold a surprisingly large charge of approximately 0.1-10 μC/g. This electrostatic process is also useful
in improving the adhesion of proteins and amino acids to the surface of the implant (paragraph 0055).
Regarding claim 25, Jensen’s implant is comprised to layers formed from different materials having different densities, therefore the implant is designed to have a non-uniform density and packing density.
Regarding claims 26-31, the claims describe how the scaffold is formed. Jensen’s implant is a layered structure that meets all of the claimed limitations and it could have been formed by methods described by the claims, absent evidence to the contrary.
Combining prior art elements according to known method to obtain predictable results supports obviousness.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alma - Pipic whose telephone number is (571)270-7459. The examiner can normally be reached M-F 9:00am-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, Michael Hartley can be reached on 571-272-0616. 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.
/ALMA PIPIC/Primary Examiner, Art Unit 1617