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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2021-141332, filed on 08/26/2022.
Claim Objections
Claim 5 objected to because of the following informalities: Units for the following limitation,” the partition surface density is 0.8/mm or greater”. Examiner suggests adding a unit of density or clarifying if applicant is referring to surface charge density and also adding appropriate units.
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.
Claim(s) 1, 2, 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardwick et al. US 6328765 B1, herein referred to as Hardwick, in view of Komur, B. et al. Fabrication of naturel pumice/hydroxyapatite composite for biomedical engineering. BioMed Eng OnLine 15, 81 (2016). https://doi.org/10.1186/s12938-016-0203-0, herein referred to as Komur,, and further in view of Maidaniuc et al. Induced wettability and surface-volume correlation of composition for bovine bone derived hydroxyapatite particles, Applied Surface Science, Volume 438, 2018,Pages 158-166, ISSN 0169-4332,https://doi.org/10.1016/j.apsusc.2017.07.074., herein referred to as Maidaniuc.
Regarding claim 1, Hardwick discloses a tissue body formation device (Fig 1A, 1) for forming a connective tissue body in an environment in which a living tissue material is present (Col 2, lines 57-67), the tissue body formation device comprising: a partition wall (Fig 1A, 6) that defines a hollow space (Fig 1B, 10) for forming the connective tissue body from the living tissue material (Fig 6, cells 68; Col 7, 48-53; Col 8, lines 63- Col 9, lines 17), wherein an exterior portion (Fig 6, outer potion of 61) of the partition wall that separates the environment from the hollow space includes through-holes (Fig 1A, holes 4) that extend between the environment and the hollow space (Fig 1A), the through-holes have an opening size of 0.02 mm or greater and 2.5 mm or less (Col 4, lines 57-67; Col 17, lines 65- Col 18, lines19; While Hardwick does not teach the specific range, the claimed range is taught by Hardwick), a section of the connective tissue body that includes dense connective tissue is a dense section (Col 19, lines 7-47), a surface (Fig 6, inner portion of 61) of the partition wall that is in contact with the dense section includes non- degradable resin (Col 25. 55-67, polyethylene imine is a known non-degradable resin) (Fig 6).
But does not explicitly disclose a non-degradable resin has a compressive strength of 10 MPa or greater and 60 MPa or less.
But, in the same field of endeavor Komur teaches a non-degradable resin has a compressive strength of 10 MPa or greater and 60 MPa or less (Komur pg 2, para 4; Komur teaches using pure hydroxyapatite resin; “range from 12 MPA … to 64”; While Komur does not teach the specific range, the claimed ranges are within the ranges taught by Komur.),
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hardwick to incorporate wherein the non-degradable resin has a compressive strength of 10 MPa or greater and 60 MPa or less, as suggested and taught by Komur in order to produce resin with ideal hardness and biocompatibility (Komur pg 3, para 1).
But Hardwick/Komur do not explicitly teaches wherein the non-degradable resin has a contact angle with water of 90 degrees or greater.
In addition, Maidaniuc teaches non-degradable resin (Maidaniuc teaches a hydroxyapatite bone based resin, such as those used by Komur, that is irritated to provide a contact angle with water greater than 90 degrees, see pg 159 para 1) has a contact angle with water of 90 degrees or greater.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hardwick/Komur to incorporate wherein the non-degradable resin has a contact angle with water of 90 degrees or greater, as taught and suggested by Maidaniuc in order to tune material permeability (Maidaniuc pg 159 para 2).
Regarding claim 2, Hardwick/Komur/Maidaniuc discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein a section of the connective tissue body that includes loose connective tissue is a loose section (Applicant defines loose connective tissue in the instant application ([0007]): “Loose connective tissue with low fiber density” ; Hardwick Col 10, lines 14-27 teaches using low density tissue such as fatty bone tissue which meets applicants defined limitation), and a surface (Hardwick Col 12, lines 1-12 teaches different coating) of the partition wall that is in contact with the loose section has a contact angle with water that is less than a contact angle with water of the surface of the partition wall that is in contact with the dense section (Capable of claimed configuration).
Regarding claim 7, Hardwick/Komur/Maidaniuc discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein a shape of openings of the through-holes represents visually perceivable information (Hardwick Fig 1A).
Regarding claim 8, Hardwick/Komur/Maidaniuc discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches a tissue body formation method for forming a connective tissue body in a tissue body formation device (Hardwick Col 2, lines 57-67; Col 3, lines 25-41) by implanting the tissue body formation device in an environment that is other than a human body and in which a living tissue material is present (Hardwick Col 13, lines 27-41, teaches in vitro uses), wherein the tissue body formation device is the tissue body formation device according to claim 1 (Hardwick Col 2, lines 57-67).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardwick, in view of Komur/Maidaniuc, and further in view of Nakayama et al. 20190083225 A1, herein referred to as Nakayama.
Regarding claim 3. Hardwick/Komur/Maidaniuc discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the exterior portion includes: a first metal plate (Hardwick Col 39, lines 27-34) including a first inner surface and the through-holes Hardwick Col 39, lines 27-34; teaches holes for screw, meeting definition of through-holes); and a second metal plate including a second inner surface and the through-holes (Hardwick Col 39, lines 27-34 teaches using multiple steel plates), the first metal plate is joined to the second metal plate in a separable manner such that the first inner surface and the second inner surface face each other (Hardwick Col 39, lines 27-34; capable of claimed limitation); and the through-holes are located in and around the first inner surface in the first metal plate and also located in and around the second inner surface in the second metal plate (capable of claimed configuration).
But does not teach wherein the first inner surface is a curved recess surface that is recessed away from the second inner surface in the first metal plate, and has a shape that winds in a spiral in the first metal plate, the second inner surface is a curved recess surface that is recessed away from the first inner surface in the second metal plate, and has a shape that winds in a spiral in the second metal plate, the first inner surface and the second inner surface separate the single hollow space that winds in a spiral from the environment.
But Nakayama teaches wherein the first inner surface (Fig 5a, inner surface 20) is a curved recess surface (Fig 5a, inner surface 20) that is recessed away from the second inner surface (Fig 7b, 20s) in the first metal plate (Fig 7b), and has a shape that winds in a spiral in the first metal plate (Fig 11), the second inner surface is a curved recess surface that is recessed away from the first inner surface in the second metal plate (Fig 11, capable of claimed configuration), and has a shape that winds in a spiral in the second metal plate (Fig 11), the first inner surface and the second inner surface separate the single hollow space that winds in a spiral from the environment ([0006]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hardwick/Komur/ Maidaniuc to incorporate wherein the first inner surface is a curved recess surface that is recessed away from the second inner surface in the first metal plate, and has a shape that winds in a spiral in the first metal plate, the second inner surface is a curved recess surface that is recessed away from the first inner surface in the second metal plate, and has a shape that winds in a spiral in the second metal plate, the first inner surface and the second inner surface separate the single hollow space that winds in a spiral from the environment, as taught and suggested by Nakayama in order to improve structural precision in the connective tissue bodies (Nakayama [0011-0014]).
Regarding claim 4, Hardwick/Komur/Maidaniuc/Nakayama discloses the invention substantially as claimed and as discussed above with respect to claim 3 teaches wherein the partition wall has a spiral shape that conforms to the hollow space bodies (Nakayama [0011-0014]; Fig 11), and includes an interior portion that defines the hollow space in a space surrounded by the first inner surface and the second inner surface ([0013] constructed as shown using components in claim 3, Nakayama includes a hollow as claimed), and the surface in contact with the dense section includes a surface of the interior portion (capable of claimed configuration).
Regarding claim 5, Hardwick/Komur/Maidaniuc discloses the invention substantially as claimed and as discussed above with respect to claim 3 teaches wherein a length between opening edges of the through-holes that are mutually adjacent is 0.2 mm or greater (Hardwick Col 17, lines 65- Col 18, lines19; While Hardwick does not teach the specific range, the claimed range is taught by Hardwick), a ratio of an opening area of all of the through-holes that are disposed in a unit area of an outer surface of the partition wall to the unit area of the outer surface of the partition wall is an opening occupancy rate (Hardwick Col 17, lines 65- Col 18, lines19; Teaches claimed surface coverage), a ratio of a length of the opening edges of all of the through-holes that are disposed in a unit area of an outer surface of the exterior portion to the unit area of the outer surface of the exterior portion is a partition surface density (As taught, Hardwick meets claimed limitation), the opening occupancy rate is 4% or greater and 70% or less (Nakayama [0009], While Nakayama does not teach the specific range, the claimed range is taught by Nakayama) and the partition surface density is 0.8/mm or greater.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardwick, in view of Komur/Maidaniuc, and further in view of Engstrand et al. US 10076416 B2A1, herein referred to as Engstrand.
Regarding claim 6, Hardwick/Komur/Maidaniuc discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein a shape of openings of the through-holes includes a shape of two or more line segments intersecting at one point.
But Engstrand teaches disclose wherein a shape of openings of the through-holes includes a shape of two or more line segments intersecting at one point (Fig 1).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hardwick/Komur/ Maidaniuc to incorporate wherein a shape of openings of the through-holes includes a shape of two or more line segments intersecting at one point, as taught and suggested by Engstrand in order to better fit placement (Engstrand Col 1, lines 33-40).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./ Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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