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 .
The examiner acknowledges receipt of response to restriction requirement filed 03/24/2026, preliminary amendment filed 04/27/2023, and IDS filed 06/05/2026, 04/23/2025 and 04/27/2023.
Claims 1-14 were amended in the preliminary amendment of 04/27/2023.
Claim 15 was canceled in the preliminary amendment of 04/27/2023.
New claims 16-22 sere added in the preliminary amendment of 04/27/2023.
Claim 1 was further amended on 03/24/2026.
Claims 1-14 and 16-22 are pending.
Election/Restrictions
In response to the restriction requirement and based on the amendment, applicant has elected claims 1-12 and 16-22. Applicant elected pericardial tissue and cross-linkable groups of claim 3. Applicant has also requested that claim 14 should also be examined with claim 12 because claim 14 can include pericardial tissue. Therefore applicant traverses the restriction of claim 14 in that claim 14 reads on pericardial tissue. Thus, claim 14 which recites “wherein the shaped molded body shapes the tissue or tissues component into shape of or …” is examined as pericardial tissue. The scope of claim 3 is the same as that of claim 13 except that claim 3 depends on claim 1 and claim 13 depends on claim 12. Because claim 1 now depends on claim 12, claim 13 is examined with claims 1-12. Further also, applicant’s statement that claim 14 can include pericardial tissue, claim 14 is also examined with claims 1-12.
Because the amendment filed 03/24/2026 made claim 1 to depend from claim 12 and because of applicant’s statement that claim 14 includes pericardial tissue, and because claim 13 is the same as claim 3, all pending claims are now related to claims 1-11. Therefore, the restriction requirement as set forth in the Office action mailed on 01/28/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1-14 and 16-22 are under consideration.
Priority
This application is a 371 of PCT/EP2021/080038 filed 10/28/2021 and which claims benefit of EPO applications 20205070.4 and 202005067.0, both filed 10/30/2020.
Information Disclosure Statement
The IDS filed 06/05/2026, 04/23/2025 and 04/27/2023 have been considered.
Claim Objections
Claim 14 uses the abbreviations TAVI for Transcatheter Aortic Valve Implantation and TAVR for Transcatheter Aortic Valve Replacement without an initial designation of what the abbreviations are. It is suggested that the full names of the abbreviations be written out and the abbreviations placed within parenthesis.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rzany et al. (US 20170100239 A1).
For claims 12-14, Rzany discloses method for impressing a 3D shape onto a biological tissue by placing the tissue, such as pericardial tissue, into a mold that includes arranging the tissue to be cross-linked against two 3D contact faces of the mold and the tissues to be cross-linked is cross-linked by a cross-linking agent resulting in a 3D cross-linked tissue/pericardial tissue (See the whole document with emphasis on the abstract, paragraphs [0007]-[0008], [0012]-[0016]). Heart valve prostheses namely TAVI heart valve prostheses is 3D shaped for implant (paragraph [0009]). The cross-linking agent is glutaraldehyde (paragraphs [0024], [0034], [0035], [0041], [0046], [0047], [0049], [0051], claim 5) and other solutions containing glutaraldehyde, carbodiimide, formaldehyde, glutaraldehyde acetals, acyl azide, cyanamide, genepin, tannin, pentagalloyl glucose, phytate, proanthocyanidin, reuterin, epoxy compounds (paragraph [0019], claim 6) can be used. The mold regions permeable such that the cross-linking agent would pass the mold regions during cross-linking to contact the tissue (paragraphs [0011], [0012]). The mold has porous regions or supports that have the 3D contact faces and the porous mold region include supports materials of borosilicate glass, ceramics, or porous metals (paragraphs [0014], [0033]) with these materials helping to fix and providing support for the 3D shaped tissue (paragraph [0003]). The borosilicate glass, ceramics, or porous metals meet the limitation of granulate of claim 12. The glutaraldehyde, carbodiimide, formaldehyde, glutaraldehyde acetals, acyl azide, cyanamide, genepin, tannin, pentagalloyl glucose, phytate, proanthocyanidin, reuterin, epoxy compounds cross linking agent meet the cross-linking agent of claims 12 and 13. Pericardial tissue and TAVI heart valve meet the limitation of tissue of claims 12 and 14 and the TAVI heart valve of claim 14.
Rzany teaches claims 12-14.
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.
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.
Claim(s) 12, 1-11 and 16-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rzany et al. (US 20170100239 A1).
Claim 1 depends on claim 12. Rzany has been described above to teach claim 12.
Claim 1 is a further description of the method of claim 12 and prepares 3D shaped tissues of claim 12 by providing a container or receptacle, placing the molded body with the tissue or tissue component in the container or receptacle, filling the container or receptacle with the granulate to at least partially cover the tissue or penetrate the granulate, filling the container or receptacle with the suitable cross-linking agent, chemically cross-linking the tissue or tissue component and removing the cross-linked tissue or tissue component from the container to release the 3D shaped. The granulates are defined in applicant’s specification as filed as glass spheres, metal spheres, plastic spheres (see at least lines 16-18 of page 61).
Scope and content of the prior art: Rzany discloses method for impressing a 3D shape onto a biological tissue by placing the tissue, such as pericardial tissue, into a mold that includes arranging the tissue to be cross-linked against two 3D contact faces of the mold and the tissues to be cross-linked is cross-linked by a cross-linking agent resulting in a 3D cross-linked tissue/pericardial tissue (See the whole document with emphasis on the abstract, paragraphs [0007]-[0008], [0012]-[0016]). Heart valve prostheses namely TAVI heart valve prostheses is 3D shaped for implant (paragraph [0009]). The cross-linking agent is glutaraldehyde (paragraphs [0024], [0034], [0035], [0041], [0046], [0047], [0049], [0051], claim 5) and other solutions containing glutaraldehyde, carbodiimide, formaldehyde, glutaraldehyde acetals, acyl azide, cyanamide, genepin, tannin, pentagalloyl glucose, phytate, proanthocyanidin, reuterin, epoxy compounds (paragraph [0019], claim 6) can be used. The mold regions are permeable such that the cross-linking agent would pass the mold regions during cross-linking to contact the tissue (paragraphs [0011], [0012]). The mold has porous regions or supports that have the 3D contact faces and the porous mold region include supports materials of borosilicate glass, ceramics, or porous metals (paragraphs [0014], [0033]) with these materials helping to fix and providing support for the 3D shaped tissue (paragraph [0003]).
Difference between claim 1 and the prior art: While Rzany teaches cross-linking tissue such as pericardial tissue with cross-linking agent and granulate such as borosilicate glass or ceramic, Rzany does not say that the mold, the ceramic or borosilicate glass which is the granulate and the cross-linking agent are in a container or receptacle or vessel. Rzany teaches cross-linking tissue in a mold in the presence of cross-linking agent and granulate (borosilicate glass or ceramic).
The ordinary skilled artisan understands that reactions are carried out it containers or receptacle or vessels because the tissue, cross-linking agent, granulate and the mold should be held by a container. Therefore, before the effective date of the invention, the ordinary skilled artisan would reasonably place the mold, tissue, cross-linking agent and granulate (borosilicate glass or ceramic) in a container to hold the components/reactants for the crosslinking reaction and shaping of the 3D shaped tissue. The 3D shaped tissue article is used as implant (abstract, paragraphs [0002], [0004], [0006], [0009], [0016], [0022], [0023], [0026], claims 9 and 10). For the 3D shaped tissue to be used as an implant it must be removed from the container or receptacle; also Rzany teaches removing the cross-linked pericardial tissue from the 3D porous mold (paragraphs [0048], [0051]). Cross-linking is performed with 0.6% glutaraldehyde and the process can take up to 14 days, which is at least 1 minute, at room temperature (20 oC to 25 oC) (paragraph [0047]). Therefore, Rzany renders claim 1 prima facie obvious.
For claims 2, 4, 5, the glutaraldehyde, carbodiimide, formaldehyde, glutaraldehyde acetals, acyl azide, cyanamide, genepin, tannin, pentagalloyl glucose, phytate, proanthocyanidin, reuterin, epoxy compounds cross linking agent teach the limitations of these claims.
For claim 3, the pericardial tissue (see at least the abstract, paragraphs [0002], [0007], [0017], [0024], [0033], [0041], claim 1) of Rzany meets the claim.
For claim 6, 0.6% glutaraldehyde (paragraphs [0046], [0047]) teaches the requirement of the claim as 0.6 is a species of the claimed range of 0.5-0.65%.
For claims 7 and 8, the cross linking takes 1-3 days at 2 oC to 2 oC, and preferably at 4 oC (paragraph [0020], claim 7) or for 10-18 days at 20 oC to 25 oC (paragraph [0021]) or 14 days at 20 oC to 25 oC (paragraph [0047], claim 8).
For claims 9 and 10, the borosilicate glass renders the claims prima facies obvious.
For claim 11, the pore size of the porous mold regions or supports is 16-40 mm (paragraph [0034]). The granulate is present as a support for the tissue and the cross-linking agent within the mold. Sine the support id not expected to be part of the cross-linked tissue, it will be reasonable to expect that the size/diameter of the granulate be larger than the pores of the mold with the expectation that support would predictably not be present with the 3D shaped tissue.
For claims 16-18, the tissue is stabilized (paragraph [0014]) is cut in a laser cutter for 3D objects (paragraphs [0027], [0040], [0043], [0049]).
For claim 19, the tissue is placed in glutaraldehyde solution after an initial crosslinking (paragraph [0046], [0047]).
For claims 20 and 21 and 22, the tissue is arranged against two 3D contact faces and the granulate would be expected to cover the tissue in order for the cross-linking agent to make contact with the tissue.
Therefore, Rzany renders claims 1-11 and 16-22 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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