DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-19 are pending and represent all claims currently under consideration.
Priority
This application claims priority to CON/16/332,574 filed on 03/12/2019, which is a 371 of PCT/US2018/059563, which claims priority to PRO 62/699,991 and PRO 62/582,505.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/582,505, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Regarding claim 1, the prior application does not teach an implant body having a convex upper surface or a plurality of sheets of bacterial cellulose nanofibers.
Claims 2-11 are dependent on claim 1 and therefore are deficient for the same reasons as above.
Regarding claim 2, the prior application does not teach a convex upper surface having the claimed shape.
Regarding claim 3, the prior application does not teach a body having a mushroom shape.
Regarding claim 4, the prior application does not teach a sheet having the claimed height.
Regarding claim 5, the prior application does not teach a coefficient of friction.
Regarding claim 6, the prior application does not teach a convex upper surface which is porous.
Regarding claim 7, the prior application does not teach an outer region having the claimed porosity.
Regarding claim 8, the prior application does not teach an outer region.
Regarding claim 9, the prior application does not teach a coating of hydroxyapatite or IGF.
Regarding claim 11, the prior application does not teach sheets which are adhesively secured to a surface.
Regarding claim 12, the prior application does not teach an implant body having a convex upper surface, a plurality of sheets of bacterial cellulose nanofibers, or a fixation portion.
Claims 13-18 are dependent on claim 12 and therefore are deficient for the same reasons as above.
Regarding claim 13, the prior application does not teach a sheet having the claimed height.
Regarding claim 14, the prior application does not teach a coefficient of friction.
Regarding claim 15, the prior application does not teach a convex upper surface which is porous.
Regarding claim 16, the prior application does not teach an outer region having the claimed porosity.
Regarding claim 17, the prior application does not teach an outer region.
Regarding claim 19, the prior application does not teach an implant body having a convex upper surface or a plurality of sheets of bacterial cellulose nanofibers.
The disclosure of the prior-filed application, Application No. 62/699,991, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Regarding claim 1, the prior application does not teach an implant body having a convex upper surface or a plurality of sheets of bacterial cellulose nanofibers.
Claims 2-11 are dependent on claim 1 and therefore are deficient for the same reasons as above.
Regarding claim 2, the prior application does not teach a convex upper surface having the claimed shape.
Regarding claim 3, the prior application does not teach a body having a mushroom shape.
Regarding claim 4, the prior application does not teach a sheet having the claimed height.
Regarding claim 6, the prior application does not teach a convex upper surface which is porous.
Regarding claim 7, the prior application does not teach an outer region having the claimed porosity.
Regarding claim 8, the prior application does not teach an outer region.
Regarding claim 11, the prior application does not teach sheets which are adhesively secured to a surface.
Regarding claim 12, the prior application does not teach an implant body having a convex upper surface, a plurality of sheets of bacterial cellulose nanofibers, or a fixation portion.
Claims 13-18 are dependent on claim 12 and therefore are deficient for the same reasons as above.
Regarding claim 13, the prior application does not teach a sheet having the claimed height.
Regarding claim 15, the prior application does not teach a convex upper surface which is porous.
Regarding claim 16, the prior application does not teach an outer region having the claimed porosity.
Regarding claim 17, the prior application does not teach an outer region.
Regarding claim 19, the prior application does not teach an implant body having a convex upper surface or a plurality of sheets of bacterial cellulose nanofibers.
Claims 1-19 are considered to have an effective filing date of 11/07/2018.
Information Disclosure Statement
The information disclosure statements filed 12/11/2024, 03/10/2025, and 08/07/2025 have been considered.
Claim Objections
Claims 1, 9, 12, and 19 are objected to because of the following informalities. Appropriate correction is required.
Regarding claims 1, 9, 12, and 19, “one or more of:” should read “one or more of”.
Regarding claims 1 and 19, “surface;” should read “surface; and”.
Specification
The use of the terms Instron, Anton Paar, and Arthrex OATS, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to because the tables in Figures 1, 6A, 6B, 7B are missing labels for the values listed. Further, the drawings should be numbered in consecutive order. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3-4, 7-8, 13, and 16-17 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.
Regarding claim 3, the claim recites the limitation "the upper head potion". There is insufficient antecedent basis for this limitation in the claim. This limitation should read “an upper head portion”.
Regarding claims 4 and 13, the claim recites the limitation "the sheet". There is insufficient antecedent basis for this limitation in the claim. This limitation should read “the plurality of sheets”.
Regarding claims 7 and 16, the recitation of “having a porosity of between 0.1-300 micrometers diameter” is unclear. It is the Examiner’s interpretation that the claimed values are referring to a diameter of the hydrogel pores.
Claim 8 is dependent on the rejected claim 7 and does not cure its deficiencies, and therefore is deficient for the same reason as above.
Claim 17 is dependent on the rejected claim 16 and does not cure its deficiencies, and therefore is deficient for the same reason as above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Osada (US 8025696 B2; IDS reference, 12/11/2024), further in view of Gatenholm (US 20100297239 A1) and Myung (US 8679190 B2; IDS reference, 12/11/2024).
Regarding claim 1, Osada teaches an artificial meniscus (i.e., an implant for treating a joint; Osada, abstract) comprising a network structure of bacterial cellulose wherein a monomer component is added to the bacterial cellulose and polymerized (Osada, column 3, lines 22-35), and teaches an example wherein a gel (i.e., hydrogel) comprising PAMPS and PAAm is formed after crosslinking (i.e., bacterial cellulose is impregnated with PAMPS and PAAm; Osada, column 15, example 1). Osada further teaches examples which are compressed (Osada, column 22, test example 6). Osada teaches a compression stress at rupture (i.e., compression strength) of most preferably 4 to 40 MPa (Osada, column 12, lines 5-6), and a tensile stress at rupture (i.e., tensile strength) of preferably 0.1 to 50 MPa (Osada, column 12, lines 7-8), which each overlap the claimed ranges, and teaches an example having a tensile modulus of 11 MPa (Osada, column 23, table 11, example 16), which lies within the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Osada teaches a degree of crosslinking as a mol % (Osada, column 14, lines 63-68), but does not measure a concentration of cross-linked bacterial cellulose in as a weight percent as claimed. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. Osada further teaches the amount of crosslinker used is adjusted as appropriate in relation to the starting monomers in order to produce a preferred degree of crosslinking for each network structure (Osada, columns 9-10). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to optimize the degree of crosslinking, and it would be reasonable to expect the concentration of crosslinked bacterial cellulose would be dependent on the optimized degree of crosslinking.
Osada teaches a hydrogel formed from a network structure of bacterial cellulose (Osada, column 3, lines 22-35), but does not specify bacterial cellulose nanofibers as sheets. Gatenholm teaches a composite material for treatment of injured or degenerated menisci having a cellulose layer produced by Acetobacter xylinum (i.e., a bacterial cellulose; Gatenholm, abstract), wherein a cellulose fibril component is provided in a sheet-like configuration having three or more layers (Gatenholm, page 3, paragraph 0034).
Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), but does not specify an implant body having a convex upper surface as claimed. Myung teaches an arthroplasty device (i.e., an implant; Myung, abstract), which is for the removal and replacement of a diseased joint (i.e., for treating a joint; Myung, column 1, lines 57-59). Myung teaches a device comprising a material that conforms to the convexity of a joint surface (i.e., an implant body having a convex upper surface; Myung, column 5, lines 41-44), and specifically teaches the device can serve as a meniscus replacement (Myung, column 12, line 1).
Osada, Gatenholm, and Myung are considered to be analogous to the claimed invention, because Osada, Gatenholm, Myung, and the instant invention are in the same field of biomaterials for joint repairs. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the bacterial cellulose of Osada would result in a layered sheet-like configuration as taught by Gatenholm, because both Osada and Gatenholm teach the same bacteria for the production of cellulose for the same purpose (Osada, column 8, line 44; Gatenholm, abstract). Further, it would have been prima facie obvious to one of ordinary skill in the art to have used the hydrogel composition of Osada in the shape as taught by Myung, because Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), while Myung specifies a material that conforms to the convexity of a joint surface is known (Myung, column 5, lines 41-44).
Regarding claim 2, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. As above, Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), but does not specify an implant body having a convex upper surface as claimed. Myung teaches a device comprising a material that conforms to the convexity of a joint surface (i.e., an implant body having a convex upper surface; Myung, column 5, lines 41-44), and specifically teaches the device can serve as a meniscus replacement (Myung, column 12, line 1) which can resemble a shallow circular dish (Myung, column 11, line 55). As above, it would have been prima facie obvious to one of ordinary skill in the art to have used the hydrogel composition of Osada in the shape as taught by Myung, because Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), while Myung specifies a known shape.
Regarding claim 3, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. Myung teaches a patient specific geometry, which can be placed on a bone such as the femur like a sock (Myung, column 16, lines 1-3), and teaches the femoral side is shaped as a ball and stem (Myung, column 2, lines 6-8), suggesting the device would adapt the ball and stem shape (i.e., a mushroom shape comprising a stem portion extending from an upper head portion). As above, it would have been prima facie obvious to one of ordinary skill in the art to have used the hydrogel composition of Osada in the shape as taught by Myung, because Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), while Myung specifies a known shape.
Regarding claim 4, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. As above, Gatenholm teaches a cellulose fibril component is provided in a sheet-like configuration having three or more layers (Gatenholm, page 3, paragraph 0034), and teaches the bacteria produces layers of about 1-2 mm (Gatenholm, page 5, paragraph 0050), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the bacterial cellulose of Osada would result in a layered sheet-like configuration as taught by Gatenholm, because both Osada and Gatenholm teach the same bacteria for the production of cellulose for the same purpose (Osada, column 8, line 44; Gatenholm, abstract).
Regarding claim 5, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. Osada does not measure a coefficient of friction. Myung, however, teaches a coefficient of friction of 0.05 (Myung, column 14, table 1), which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Osada to have a coefficient of friction as taught by Myung to be known in the field for the same purpose.
Regarding claim 6, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. Osada does not teach a porous surface. Myung, however, teaches the bone interfacing region of the hydrogel device is made to be porous (Myung, column 14, lines 7-9). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Osada to have a porous surface as taught by Myung to help achieve physical anchoring to the bone (Myung, column 14, lines 7-9).
Regarding claim 7, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. As above, Osada does not teach a porous surface. Myung, however, teaches the bone interfacing region of the hydrogel device is made to be porous (Myung, column 14, lines 7-9), and teaches a pore size in the range of 10-1000 microns (Myung, column 15, lines 24-25), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Osada to have a porous surface as taught by Myung to help achieve physical anchoring to the bone (Myung, column 14, lines 7-9).
Regarding claim 8, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 7. Osada teaches a meniscus (i.e., outer region) with a thickness of 1 mm (Osada, column 29, lines 27-29).
Regarding claim 9, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. Osada does not teach a further coating of HA or IGF as claimed. Gatenholm, however, teaches cellulose nanofibrils decorated with hydroxyapatite (i.e., a coating of HA; Gatenholm, page 3, paragraph 0031). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Osada to comprise hydroxyapatite, because both references teach meniscus replacements, and Gatenholm teaches inducing the crystallization of hydroxyapatite results in simulated migration, attachment, and differentiation of cells, integrating the composite material upon implantation (Gatenholm, page 3, paragraph 0031).
Regarding claim 10, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. As above, Osada teaches a compression stress at rupture (i.e., compression strength) of most preferably 4 to 40 MPa (Osada, column 12, lines 5-6), which overlaps the claimed range; a tensile stress at rupture (i.e., tensile strength) of preferably 0.1 to 50 MPa (Osada, column 12, lines 7-8), which encompasses the claimed range; a tensile modulus of 11 MPa (Osada, column 23, table 11, example 16), which lies within the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Osada does not teach a compression modulus within the claimed range of 8-22 MPa. Osada does, however, teach that the hydrogel’s mechanical strength is optimized for stress dispersibility (Osada, column 19, lines 39-41). Therefore, a person of ordinary skill in the art would understand to optimize the physical properties of the hydrogel, and it would be reasonable to expect that the optimization of a hydrogel with overlapping ranges of tensile strength, tensile modulus, and compression strength would likely result in a similar compression modulus.
Regarding claim 11, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 1. Osada does not teach an adhesive. Myung, however, teaches the use of an adhesive to bond the hydrogel (i.e., the bacterial cellulose) and the bone (i.e., the convex surface; Myung, column 13, lines 61-67). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Osada to use an adhesive as taught by Myung to help achieve robust anchoring to the bone (Myung, column 13, lines 61-67).
Regarding claim 12, Osada teaches an artificial meniscus (i.e., an implant for treating a joint; Osada, abstract) comprising a network structure of bacterial cellulose wherein a monomer component is added to the bacterial cellulose and polymerized (Osada, column 3, lines 22-35), and teaches an example wherein a gel (i.e., hydrogel) comprising PAMPS and PAAm is formed after crosslinking (i.e., bacterial cellulose is impregnated with PAMPS and PAAm; Osada, column 15, example 1). Osada further teaches the hydrogel contains a metal ion (i.e., the implant is metallic; Osada, claim 2), and a protrusion (i.e., a fixation portion) to securely fix the meniscus to the bone (Osada, column 14, lines 20-25), and teaches examples which are compressed (Osada, column 22, test example 6). Osada teaches a compression stress at rupture (i.e., compression strength) of most preferably 4 to 40 MPa (Osada, column 12, lines 5-6), and a tensile stress at rupture (i.e., tensile strength) of preferably 0.1 to 50 MPa (Osada, column 12, lines 7-8), which each overlap the claimed ranges, and teaches an example having a tensile modulus of 11 MPa (Osada, column 23, table 11, example 16), which lies within the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Osada teaches a degree of crosslinking as a mol % (Osada, column 14, lines 63-68), but does not measure a concentration of cross-linked bacterial cellulose in as a weight percent as claimed. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Osada teaches a hydrogel formed from a network structure of bacterial cellulose (Osada, column 3, lines 22-35), but does not specify bacterial cellulose nanofibers as sheets. Gatenholm teaches a composite material for treatment of injured or degenerated menisci having a cellulose layer produced by Acetobacter xylinum (i.e., a bacterial cellulose; Gatenholm, abstract), wherein a cellulose fibril component is provided in a sheet-like configuration having three or more layers (Gatenholm, page 3, paragraph 0034). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the bacterial cellulose of Osada would result in a layered sheet-like configuration as taught by Gatenholm, because both Osada and Gatenholm teach the same bacteria for the production of cellulose for the same purpose (Osada, column 8, line 44; Gatenholm, abstract).
Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), but does not specify an implant body having a convex upper surface as claimed. Myung teaches an arthroplasty device (i.e., an implant; Myung, abstract), which is for the removal and replacement of a diseased joint (i.e., for treating a joint; Myung, column 1, lines 57-59). Myung teaches a device comprising a material that conforms to the convexity of a joint surface (i.e., an implant body having a convex upper surface; Myung, column 5, lines 41-44), and specifically teaches the device can serve as a meniscus replacement (Myung, column 12, line 1). It would have been prima facie obvious to one of ordinary skill in the art to have used the hydrogel composition of Osada in the shape as taught by Myung, because Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), while Myung specifies a material that conforms to the convexity of a joint surface is known (Myung, column 5, lines 41-44).
Regarding claim 13, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 12. As above, Gatenholm teaches a cellulose fibril component is provided in a sheet-like configuration having three or more layers (Gatenholm, page 3, paragraph 0034), and teaches the bacteria produces layers of about 1-2 mm (Gatenholm, page 5, paragraph 0050), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the bacterial cellulose of Osada would result in a layered sheet-like configuration as taught by Gatenholm, because both Osada and Gatenholm teach the same bacteria for the production of cellulose for the same purpose (Osada, column 8, line 44; Gatenholm, abstract).
Regarding claim 14, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 12. Osada does not measure a coefficient of friction. Myung, however, teaches a coefficient of friction of 0.05 (Myung, column 14, table 1), which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Osada to have a coefficient of friction as taught by Myung to be known in the field for the same purpose.
Regarding claim 15, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 12. Osada does not teach a porous surface. Myung, however, teaches the bone interfacing region of the hydrogel device is made to be porous (Myung, column 14, lines 7-9). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Osada to have a porous surface as taught by Myung to help achieve physical anchoring to the bone (Myung, column 14, lines 7-9).
Regarding claim 16, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 12. As above, Osada does not teach a porous surface. Myung, however, teaches the bone interfacing region of the hydrogel device is made to be porous (Myung, column 14, lines 7-9), and teaches a pore size in the range of 10-1000 microns (Myung, column 15, lines 24-25), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Osada to have a porous surface as taught by Myung to help achieve physical anchoring to the bone (Myung, column 14, lines 7-9).
Regarding claim 17, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 16. Osada teaches a meniscus (i.e., outer region) with a thickness of 1 mm (Osada, column 29, lines 27-29).
Regarding claim 18, Osada, Gatenholm, and Myung teach all the elements of the current invention as applied to claim 12. As above, Osada teaches a compression stress at rupture (i.e., compression strength) of most preferably 4 to 40 MPa (Osada, column 12, lines 5-6), which overlaps the claimed range; a tensile stress at rupture (i.e., tensile strength) of preferably 0.1 to 50 MPa (Osada, column 12, lines 7-8), which encompasses the claimed range; a tensile modulus of 11 MPa (Osada, column 23, table 11, example 16), which lies within the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Osada does not teach a compression modulus within the claimed range of 8-22 MPa. Osada does, however, teach that the hydrogel’s mechanical strength is optimized for stress dispersibility (Osada, column 19, lines 39-41). Therefore, a person of ordinary skill in the art would understand to optimize the physical properties of the hydrogel, and it would be reasonable to expect that the optimization of a hydrogel with overlapping ranges of tensile strength, tensile modulus, and compression strength would likely result in a similar compression modulus.
Regarding claim 19, Osada teaches an artificial meniscus (i.e., an implant for treating a joint; Osada, abstract) comprising a network structure of bacterial cellulose wherein a monomer component is added to the bacterial cellulose and polymerized (Osada, column 3, lines 22-35), and teaches an example wherein a gel (i.e., hydrogel) comprising PAMPS and PAAm is formed after crosslinking (i.e., bacterial cellulose is impregnated with PAMPS and PAAm; Osada, column 15, example 1). Osada further teaches the hydrogel contains a metal ion (i.e., the implant is metallic; Osada, claim 2), and a protrusion (i.e., a fixation portion) to securely fix the meniscus to the bone (Osada, column 14, lines 20-25), and teaches examples which are compressed (Osada, column 22, test example 6). Osada teaches a compression stress at rupture (i.e., compression strength) of most preferably 4 to 40 MPa (Osada, column 12, lines 5-6), and a tensile stress at rupture (i.e., tensile strength) of preferably 0.1 to 50 MPa (Osada, column 12, lines 7-8), which each overlap the claimed ranges, and teaches an example having a tensile modulus of 11 MPa (Osada, column 23, table 11, example 16), which lies within the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Osada teaches a degree of crosslinking as a mol % (Osada, column 14, lines 63-68), but does not measure a concentration of cross-linked bacterial cellulose in as a weight percent as claimed. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Osada does not teach a compression modulus within the claimed range of 8-22 MPa. Osada does, however, teach that the hydrogel’s mechanical strength is optimized for stress dispersibility (Osada, column 19, lines 39-41). Therefore, a person of ordinary skill in the art would understand to optimize the physical properties of the hydrogel, and it would be reasonable to expect that the optimization of a hydrogel with overlapping ranges of tensile strength, tensile modulus, and compression strength would likely result in a similar compression modulus.
Osada teaches a hydrogel formed from a network structure of bacterial cellulose (Osada, column 3, lines 22-35), but does not specify bacterial cellulose nanofibers as sheets. Gatenholm teaches a composite material for treatment of injured or degenerated menisci having a cellulose layer produced by Acetobacter xylinum (i.e., a bacterial cellulose; Gatenholm, abstract), wherein a cellulose fibril component is provided in a sheet-like configuration having three or more layers (Gatenholm, page 3, paragraph 0034) and teaches the bacteria produces layers of about 1-2 mm (Gatenholm, page 5, paragraph 0050), which overlaps the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the bacterial cellulose of Osada would result in a layered sheet-like configuration as taught by Gatenholm, because both Osada and Gatenholm teach the same bacteria for the production of cellulose for the same purpose (Osada, column 8, line 44; Gatenholm, abstract).
Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), but does not specify an implant body having a convex upper surface as claimed. Myung teaches an arthroplasty device (i.e., an implant; Myung, abstract), which is for the removal and replacement of a diseased joint (i.e., for treating a joint; Myung, column 1, lines 57-59). Myung teaches a device comprising a material that conforms to the convexity of a joint surface (i.e., an implant body having a convex upper surface; Myung, column 5, lines 41-44), and specifically teaches the device can serve as a meniscus replacement (Myung, column 12, line 1). It would have been prima facie obvious to one of ordinary skill in the art to have used the hydrogel composition of Osada in the shape as taught by Myung, because Osada teaches a shape which is the same as a natural meniscus and which differs between patients to find the most suitable shape (Osada, column 14, lines 9-32), while Myung specifies a material that conforms to the convexity of a joint surface is known (Myung, column 5, lines 41-44).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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