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.
Election/Restrictions
3. Applicant’s election without traverse of Group/Invention II – claims 16-23, 25, and 26 (drawn to a seamless connected tissue comprising a piece of tissue having at least two tissue parts overlapping each other and the at least two tissue parts overlapping each other are materially bonded to each other via crosslinked groups of the tissue) in the reply filed on 19 January 2026 is acknowledged.
Response to Amendment
4. Applicant’s cancellation of claims 1-10, 15, and 24 (claims from non-elected group/invention) in the reply filed on 19 January 2026 is acknowledged.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 25 and 26 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. Claim 25 recites the limitation "the crosslinked amino groups of collagen fibers" in line 2. There is insufficient antecedent basis for this limitation in the claim.
b. Claim 26 recites the limitation "the crosslinked amino groups of collagen fibers" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
7. 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.
8. Claims 16-23, 25, and 26 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Rzany et al. (US PG Pub No. 2019/0224369 A1; cited in Applicant’s IDS).
Regarding independent claim 16, Rzany et al. ‘369 teaches (Figure 4B) a seamless connected ([0173]; [0175]; [0185]) tissue comprising a piece of tissue ([0085]; [0175]) having at least two tissue parts overlapping each other and the at least two tissue parts overlapping each other are materially bonded to each other via crosslinked groups of the tissue ([0085] – “and wherein the two members are arranged with respect to one another such that the suspension forms an intermediary suspension layer that contacts both members and is arranged between the two members, and wherein the two members are bonded to one another by contacting the intermediary suspension layer and the members with a crosslinking agent”; [0092] - “at least two members formed out of a biological tissue (e.g. pericardial tissue, particularly native pericardial tissue, particularly porcine or bovine pericardial tissue) which at least to members are bonded together by applying a layer of the suspension described herein between adjacent regions of the members and by contacting the suspension and the members with a crosslinking agent to crosslink the suspension and to therewith bond the members together”; [0175] – “Here, the solution can be used to bond e.g. porcine pericardial tissue (e.g. of a TAVI heart valve prosthesis). Particularly, the homogenate/suspension is applied between two members, each formed by a native pericardial tissue patch. By adding a crosslinking agent/solution, e.g. 0.5% glutaraldehyde in DPBS, a permanent covalent bond is achieved between the pericardial tissue patches and the suspension. Optionally, a mechanical stabilization of the connection region can be achieved by e.g. pressing the connection region. The resulting bond between the patches is seamless and load-bearing”).
Regarding claim 17, Rzany et al. ‘369 teaches wherein the tissue is selected from biological tissue, autologous, xenogeneic, allogeneic tissue or collagen containing tissue ([0175] – “Here, the solution can be used to bond e.g. porcine pericardial tissue”).
Regarding claim 18, Rzany et al. ‘369 teaches wherein the tissue is selected from pericardial tissue ([0092]; [0175]), connective tissue, peritoneal tissue, dura mater, tela submucosa, skin, ligament, tendons.
Regarding claim 19, Rzany et al. ‘369 teaches wherein the at least two tissue parts overlapping each other are materially bonded to each other via crosslinked amino groups of collagen fibers of the tissue ([0054] – “further main preparation step of the method includes crosslinking the solubilized biological tissue as already indicated above, in particular and to a high extent the collagen fibers. Without being bound to theory, it is believed that crosslinking appears between the aldehyde groups of the crosslinking agent (e.g. glutaraldehyde) and amino groups naturally existing in the biological material to be crosslinked. After the material has been contacted with the crosslinking agent heat treatment results in the formation of many very stable chemical bonds between these groups of neighboring tissue fibers.”).
Regarding claim 25, Rzany et al. ‘369 teaches wherein the crosslinked amino groups of collagen fibers are crosslinked by an aldehyde ([0066]; [0175]).
Regarding independent claim 20, Rzany et al. ‘369 teaches (Figure 4B) a seamless connected ([0173]; [0175]; [0185]) tissue comprising at least one first piece of tissue ([0085]; [0175]) and least one second piece of tissue ([0085]; [0175]), wherein at least one part of the at least one first piece of tissue overlaps with at least one part of the at least one second piece of tissue and the at least one part of the at least one first piece of tissue overlapping with the at least one part of the at least one second piece of tissue are materially bonded to each other via crosslinked groups of the at least one part of the at least one first piece of tissue and the at least one part of the at least one second piece of tissue ([0085] – “and wherein the two members are arranged with respect to one another such that the suspension forms an intermediary suspension layer that contacts both members and is arranged between the two members, and wherein the two members are bonded to one another by contacting the intermediary suspension layer and the members with a crosslinking agent”; [0092] - “at least two members formed out of a biological tissue (e.g. pericardial tissue, particularly native pericardial tissue, particularly porcine or bovine pericardial tissue) which at least to members are bonded together by applying a layer of the suspension described herein between adjacent regions of the members and by contacting the suspension and the members with a crosslinking agent to crosslink the suspension and to therewith bond the members together”; [0175] – “Here, the solution can be used to bond e.g. porcine pericardial tissue (e.g. of a TAVI heart valve prosthesis). Particularly, the homogenate/suspension is applied between two members, each formed by a native pericardial tissue patch. By adding a crosslinking agent/solution, e.g. 0.5% glutaraldehyde in DPBS, a permanent covalent bond is achieved between the pericardial tissue patches and the suspension. Optionally, a mechanical stabilization of the connection region can be achieved by e.g. pressing the connection region. The resulting bond between the patches is seamless and load-bearing”).
Regarding claim 21, Rzany et al. ‘369 teaches wherein the at least one first piece of tissue and/or the at least one second piece of tissue is selected from biological tissue, autologous, xenogeneic, allogeneic tissue or collagen containing tissue ([0175] – “Here, the solution can be used to bond e.g. porcine pericardial tissue”).
Regarding claim 22, Rzany et al. ‘369 teaches wherein the at least one first piece of tissue and/or the at least one second piece of tissue is selected from pericardial tissue ([0092]; [0175]), connective tissue, peritoneal tissue, dura mater, tela submucosa, skin, ligament, tendons.
Regarding claim 23, Rzany et al. ‘369 teaches wherein the at least one part of the at least one first piece of tissue overlapping with the at least one part of the at least one second piece of tissue are materially bonded to each other via crosslinked amino groups of collagen fibers of the at least one part of the at least one first piece of tissue and amino groups of collagen fibers of the at least one part of the at least one second piece of tissue ([0054] – “further main preparation step of the method includes crosslinking the solubilized biological tissue as already indicated above, in particular and to a high extent the collagen fibers. Without being bound to theory, it is believed that crosslinking appears between the aldehyde groups of the crosslinking agent (e.g. glutaraldehyde) and amino groups naturally existing in the biological material to be crosslinked. After the material has been contacted with the crosslinking agent heat treatment results in the formation of many very stable chemical bonds between these groups of neighboring tissue fibers.”).
Regarding claim 26, Rzany et al. ‘369 teaches wherein the crosslinked amino groups of collagen fibers are crosslinked by an aldehyde ([0066]; [0175]).
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