DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
3. Figures 7A, 7B, 8A, and 8B of the instant application are not present in the Certified Copy of the Foreign Priority Application.
Election/Restrictions
4. Applicant’s election without traverse of Group/Invention I (claims 14-19) in the reply filed on 23 December 2025 is acknowledged.
5. Applicant’s election without traverse of MEDICAL TISSUE RECONSTRUCTION BAG – Species A (Figure 11A) in the reply filed on 23 December 2025 is acknowledged.
6. Applicant’s election without traverse of UNDERCUT OF GROOVE SIDE WALL 22 – Species B (Figure 6B) in the reply filed on 23 December 2025 is acknowledged.
7. Applicant’s election without traverse of THROUGH-HOLE DIRECTION – Species B (Figure 7B) in the reply filed on 23 December 2025 is acknowledged.
8. Applicant’s election without traverse of DIRECTION PERPENDICULAR to THROUGH-HOLE and PARALLEL to GROOVE BOTTOM SURFACE – Species A (Figure 8A) in the reply filed on 23 December 2025 is acknowledged.
9. Claims 20-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 December 2025.
Drawings
10. Figures 1A and 1B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Specification
11. The disclosure is objected to because of the following informalities:
a. Regarding the Brief Description of the Drawings section, EACH of Figures 1, 2, 4, 5, 7-14 lacks a brief description for each of the “a)”, “b)”, “c)”, etc. portions of the respective figure. Appropriate correction is required.
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 14-19 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.
a. Regarding independent claim 14, the recitation “and a value obtained by dividing a total opening area of the mesh by an area of the mesh section is 0.2 or more” (lines 2-3) is vague and unclear, since the preamble of independent claim 1 recites “a mesh section”. This is construed as the total porosity area (total opening area of the mesh) is at least 20 percent of the total area of the mesh. Claims 16, 18, and 19 depend from claim 14.
b. Regarding independent claim 15, the recitation “and a value obtained by dividing a total opening area of the mesh by an area of the mesh section is 0.2 or more” (lines 2-3) is vague and unclear, since the preamble of independent claim 1 recites “a mesh section”. This is construed as the total porosity area (total opening area of the mesh) is at least 20 percent of the total area of the mesh. Claim 17 depends from claim 15.
Claim Rejections - 35 USC § 102
14. 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
15. Claims 14, 16, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Wei (US PG Pub No. 2018/0296343 A1; cited in Applicant’s IDS).
Regarding independent claim 14, and referring to Figures 4, 5A, and 5B, Wei ‘343 discloses a medical tissue reconstruction bag (70) comprising a mesh section ([0072]-[0074]) in at least one portion, wherein a mesh opening area is 2 x10-9 m2 or larger (paragraph [0108] - “The shape, mesh size, thickness, and other structural characteristics, of mesh implants or bags 70, for example, architecture, may be customized for the desired application. For example, to optimize cell or fluid migration through the mesh, the pore size may be optimized for the viscosity and surface tension of the fluid or the size of the cells. For example, pore sizes between threads 72 on the order of approximately 100-200 μm may be used if cells are to migrate through the mesh” – if the pore is considered to be circular in shape with a diameter of at least 100 µm, then each mesh/pore would have an area of 7.9x10-9 m2; further, see paragraphs [0137] and [0180]), and a value obtained by dividing a total opening area of the mesh by an area of the mesh section is 0.2 or more (Figure 5B - the entire section of the mesh bag 70 comprises mesh openings, therefore a total opening area of the mesh divided by an area of the mesh section would be at least 0.2, or in other words at least 20% of the entire mesh bag has a mesh openings; further, see paragraph [0181]),
comprising an introduction port (Figure 5B – port 71) for incorporation of a medical tissue reconstruction material (83), or incorporating a medical tissue reconstruction material without an introduction port ([0116]), and
satisfying at least one requirement selected from the group of (D) to (F):
(D) having a mesh opening area of 2 x 10-5 m2 or smaller ([0108], [0137], [0180]), and comprising a structure that reduces enlargement of the bag associated with the incorporation of a material ([0107]);
(E) having a mesh opening area of 2 x 10-5 m2 or smaller, and exhibiting a strain of 0.2 or more under a load of 10 N in an arbitrary direction; and
(F) having a mesh opening area of 1.0 x10-7 m2 or smaller (paragraph [0108] - diameter of “approximately 100-200 µm” would equate to a mesh opening area between 7.9x10-9 m2 to 1.25x 10⁻⁷ m²; further, see paragraphs [0137] and [0180]).
Regarding claim 16, Wei ‘343 discloses wherein the medical tissue reconstruction bag comprises a hole and/or a thread for fixing the medical tissue reconstruction bag to a tissue ([0118]).
Regarding claim 18, Wei ‘343 discloses wherein the medical tissue reconstruction material comprises at least one selected from the group consisting of carbonate apatite, apatite, tricalcium phosphate, octacalcium phosphate, calcium phosphate, calcium carbonate, calcium sulfate, calcium-containing glass, collagen, chitosan, polyglycolic acid, polylactic acid, poly(lactic-co-glycolic acid), and poly(lactide-co-caprolactone) in composition ([0125], [0126], [0215]).
Regarding claim 19, Wei ‘343 discloses wherein the medical tissue reconstruction material comprises at least one selected from the group consisting of carbonate apatite, apatite, tricalcium phosphate, octacalcium phosphate, calcium phosphate, calcium carbonate, calcium sulfate, calcium-containing glass, collagen, chitosan, polyglycolic acid, polylactic acid, poly(lactic-co-glycolic acid), and poly(lactide-co-caprolactone) in composition ([0125], [0126], [0215]).
Claim Rejections - 35 USC § 103
16. 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.
17. Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (US PG Pub No. 2018/0296343 A1; cited in Applicant’s IDS), or Wei (US PG Pub No. 2018/0296343 A1; cited in Applicant’s IDS) in view of Ishikawa et al. (WO 2018/074429 A1; cited in Applicant’s IDS).
Regarding independent claim 15, and referring to Figures 4, 5A, and 5B, Wei ‘343 discloses a medical tissue reconstruction bag (70) comprising a mesh section ([0072]-[0074]) in at least one portion, wherein a mesh opening area is 2 x 10-9 m2 or larger and 2 x 10-5 m2 or smaller (paragraph [0108] - “The shape, mesh size, thickness, and other structural characteristics, of mesh implants or bags 70, for example, architecture, may be customized for the desired application. For example, to optimize cell or fluid migration through the mesh, the pore size may be optimized for the viscosity and surface tension of the fluid or the size of the cells. For example, pore sizes between threads 72 on the order of approximately 100-200 μm may be used if cells are to migrate through the mesh” – if the pore is considered to be circular in shape with a diameter of at least 100 µm, then each mesh/pore would have an area of 7.9x10-9 m2; further, see paragraphs [0137] and [0180]), and a value obtained by dividing a total opening area of the mesh by an area of the mesh section is 0.2 or more (Figure 5B - the entire section of the mesh bag 70 comprises mesh openings, therefore a total opening area of the mesh divided by an area of the mesh section would be at least 0.2, or in other words at least 20% of the entire mesh bag has a mesh openings; further, see paragraph [0181]).
Wei ‘343 discloses the invention as claimed, including incorporating a hydroxyapatite medical tissue reconstruction material ([0125], [0126], [0215]), except for particularly disclosing the medical tissue reconstruction material as being a carbonate apatite. Notice, carbonate apatite is a well-known bone substitute material and it would be obvious to a person skilled in the art that one could be substituted with the other without changing the way the invention works.
Further, this is already known in the art. For example, Ishikawa et al. ‘429 teaches a medical tissue reconstruction implant (Figures 1, 2, 6, and 7) incorporating a carbonate apatite in order to replace the carbonate apatite material with tissue (“When carbonate apatite is contained in the composition of the honeycomb structure, the carbonate apatite is absorbed by osteoclasts and the like”; and “Depending on the composition of the medical material, the material is replaced with tissue. From this viewpoint, carbonated apatite, tricalcium phosphate, calcium sulfate, and calcium carbonate are excellent materials. Among them, apatite carbonate and tricalcium phosphate are more excellent materials, and carbonate apatite is an even better material. Material is replaced by tissue by the cells. For example, in the case of carbonate apatite, the material is replaced with tissue by a mechanism similar to bone remodeling in which osteoclasts absorb the material and osteoblasts form bone”).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of incorporating a carbonate apatite medical tissue reconstruction material, as taught by Ishikawa et al. ‘429, with the invention of Wei ‘343, in order to replace the carbonate apatite material with tissue.
Regarding claim 17, Wei ‘343 discloses wherein the medical tissue reconstruction bag comprises a hole and/or a thread for fixing the medical tissue reconstruction bag to a tissue ([0118]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774