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.
Response to Amendment
4. Applicant’s amendment of claim 14 in the reply filed on 15 June 2026 is acknowledged.
5. Applicant’s cancellation of claims 15 and 17 in the reply filed on 15 June 2026 is acknowledged.
6. Applicant’s Replacement Drawing Sheet (indicating Figure 1 as “PRIOR ART”) in the reply filed on 15 June 2026 is acknowledged.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 14, 16, 18, and 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.
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 14, 16, 18, and 19 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 Bouten et al. (US 2008/0145920 A1)
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 the requirement (E):
(E) having a mesh opening area of 2 x 10-5 m2 or smaller (see above, wherein 7.9x10-9 m2 is smaller than 2 x 10-5 m2).
Wei ‘343 discloses the invention as claimed, except for particularly disclosing exhibiting “a strain of 0.2 or more under a load of 10 N in an arbitrary direction”. Notice:
(i) Paragraph [0108] of Wei ‘343 teaches – “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”.
(ii) Paragraph [0303] of Wei ‘343 teaches – “a 3-D printed customized porous implant is provided which can meet dimensional, structural, mechanical and biological requirements for a variety of tissue repair sites, including bone defects, osteochondral defects and or cartilage defects”.
(iii) No particular material composition is recited for either of the “bag” or “mesh section” in the claim language of claim 14. No particular structure and/or architecture is recited for either of the “bag” or “mesh section” in the claim language of claim 14. No intended implantation site is recited for either of the “bag” or “mesh section” in the claim language of claim 14.
Therefore, since the medical tissue reconstruction bag of Wei ‘343 appears to be identical or substantially identical to the claimed medical tissue reconstruction bag, it would be expected to have a strain of 0.2 or more under a load of 10 N in an arbitrary direction. Further, this mechanic property is something a person having ordinary skill in the art would choose based on the particular structure/architecture of the device (bag and/or mesh), particular material composition, and particular implantation site, in order to obtain desired and expected results.
WHEN THE STRUCTURE RECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE PRESUMED TO BE INHERENT.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
(iv) Further, this is already known in the art. For example, Bouten et al. ‘5920 teaches (Figures 1A, 1B, and 3) a mesh section ([0015], [0043], [0054]) exhibiting a strain of 0.2 or more under a load of 10 N in an arbitrary direction ([0052]) in order to approximate the mechanical properties of the mesh section to that of the intended implantation site ([0007], [0013], [0052]-[0054]). 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 a strain of 0.2 or more under a load of 10 N in an arbitrary direction, as taught by Bouten et al. ‘5920, with the invention of Wei ‘343, in order to approximate the mechanical properties of the mesh section to that of the intended implantation site.
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]).
Response to Arguments
11. Applicant's arguments filed 15 June 2026 have been fully considered but they are not persuasive.
The Applicant presented the following as their main argument – “In this regard, Applicant respectfully notes that claim 14 is amended such that requirement (D) and requirement (F) have been deleted. Applicant respectfully submits that no rejection has been raised regarding requirement (E).”.
The Examiner respectfully disagrees. Previous version of independent claim 14 recited -- satisfying AT LEAST ONE requirement selected from the group of (D) to (F): -- in line 7. In other words, ONLY ONE requirement was needed to be presented (i.e., rejected), not ALL of the requirements D, E, and F. The previous Office Action presented (i.e., rejected) at least one requirement (e.g., “D”). No rejection was needed for requirement “E”.
Applicant's amendment (i.e., removal/deletion of requirements “D” and “F”) necessitated the new ground(s) of rejection presented in this Office action.
Conclusion
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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