DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5 February 2026 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 .
Claim Objections
Claims 10 are objected to because of the following informalities:
-Claim 10 recites “the collagen including fibrous collagen forms” in line 13. Examiner recommends amending to –the collagen, including fibrous collagen, forms—
-Claim 10 recites “the non-surface layer portion,” in line 15. Examiner recommends amending to –the non-surface layer portion, and—
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 9, 10, 11, 12, 16, 17, 18, 19 and 20 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.
-Claim 9 recites “to obtain…which has not been in contact with the tissue formation surface of the connective tissue body formation substrate” in lines 24-27. It’s unclear whether this is intending to recite that the surface layer and the non-surface layer portion were previously in contact before the step of peeling off the connective tissue body from the connective tissue body formation substrate. Further clarification should be provided.
-Claim 10 recites “a thickness direction” in line 17. It is unclear whether this is the same or different from “an entire thickness direction” in claim 10, line 14.
-Claim 11 recites “to obtain…which has not been in contact with the tissue formation surface of the connective tissue body formation substrate” in lines 26-27. It’s unclear whether this is intending to recite that the surface layer and the non-surface layer portion were previously in contact before the step of peeling off the connective tissue body from the connective tissue body formation substrate. Further clarification should be provided.
-Claim 19 recites “and living cells” in line 3. It is unclear whether the living cells are the same or different from the living cells originally referenced in claim 9, line 13.
-Claim 20 recites “and living cells” in line 3. It is unclear whether the living cells are the same or different from the living cells originally referenced in claim 11, line 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.
Claim(s) 9, 11, 12, 16, 18, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (U.S. 20070154515) in view of Tavakol (WO 202110908), in further view of Owens et al. (U.S. 20130121970) and in even further view of Ruszczak (U.S. 20030133967).
Regarding Claim 9, Johnson teaches a method for producing a connective tissue body including a surface layer [Fig. 10, element 153], a non-surface-layer portion [Fig. 10, element 151], which is other than the surface layer [0039], and biological origin tissue including collagen [0012] and [0043], the method comprising:
placing, in a living body [Fig. 1, reference to “insert…body cavity”], a connective tissue body formation substrate including a tissue formation surface that is at least partially made of a polymer material [0047]—reference to “polymers…formed into a substrate”], wherein the step of placing the connective tissue body formation substrate in the living body forms an internal space that accommodates the connective tissue body formation substrate in the living body [Fig. 6B, element 71];
leaving the connective tissue body formation substrate in the internal space of the living body to allow the connective tissue body [Fig. 4, reference to “allow a residence time…to occur”], including the surface layer, the non-surface-layer portion, and the biological origin tissue containing the collagen produced by the living cells, to form on the tissue formation surface [0122]—reference to the covering materials, inner and outer and tissue material including the collage inserted in body cavity;
removing, from the living body, the connective tissue body formation substrate on which the connective tissue body is formed [Fig. 4, reference to “Remove…cavity”]; and
peeling off the connective tissue body from the connective tissue body formation substrate to obtain the connective tissue body that includes the surface layer [Fig. 4, reference to “Manipulate…separate material…to form an implantable prothesis”], which has been in contact with the tissue formation surface of the connective tissue body formation substrate, and the non-surface- layer portion, which has not been in contact with the tissue formation surface of the connective tissue body formation substrate [0039; “wherein an outer, remodelable covering material and/or an inner, remodelable covering material contour to and/or embed elements of the stent.”],
Johnson is silent on removing air percutaneously and transluminally from the internal space that accommodates the connective tissue body formation substrate to an outside of the living body by applying a negative pressure to the internal space, wherein the step of removing air is configured to facilitate contact between the tissue formation surface of the connective tissue body formation substrate and living cells in the living body, thereby promoting production of collagen by the living cells contacting the tissue formation surface of the connective tissue body formation substrate and formation of the connective tissue body, which includes the biological origin tissue containing the collagen produced by the living cells, on the tissue formation surface of the connective tissue body formation substrate in the internal space of the living body;
Takavol teaches removing air percutaneously and transluminally from the internal space that accommodates the connective tissue body formation substrate to an outside of the living body [Pg. 4, lines 40-43]—includes reference to air venting via syringe (interpreted to be percutaneous removal) and catheter (transluminal), wherein the step of removing air is configured to facilitate contact between the tissue formation surface of the connective tissue body formation substrate and living cells in the living body [Pg. 4, lines 34-37]-discusses contact between transfer device (interpreted to be the connective tissue body formation substrate, and microcarrier-culture (living cells), thereby promoting production of collagen by the living cells contacting the tissue formation surface of the connective tissue body formation substrate and formation of the connective tissue body, which includes the biological origin tissue containing the collagen produced by the living cells, on the tissue formation surface of the connective tissue body formation substrate in the internal space of the living body [Pg. 8, lines 19-21] and [Pg. 8, lines 35-38]—include reference to promoting growth of the tissue on the scaffold by means of delivering growth factor agents to the site, [Pg. 9, lines 5-11]—describes enhancing cell seeding process through compression and aspiration and other various techniques linked to air venting and perfusion;
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include air removal mechanisms and methods as taught by Tavakol to promote collagen and tissue production and growth in the connective tissue body formation substrate as suggested by Johnson, as Johnson discusses applying different techniques to enhance dehydration and compression of the overall matrix structure [0090] with Tavakol because Tavakol teaches the adherence and colonization of the microcarrier by dehydration and compression [Pg. 9, lines 5-6].
Johnson and Takavol are silent on by applying a negative pressure to the internal space. Owens teaches by applying a negative pressure to the internal space [0065]—reference to applying negative pressure to an internal space within an acellular tissue matrix.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include negative pressure/vacuum pressure as taught by Owens to increase and enhance cellular growth in the connective tissue body and tissue matrix as suggested by Johnson and Takavol, as Johnson discusses considerations for tissue ingrowth [0048] and Takavol which discloses use of therapeutic agents to enhance growth factors [Pg. 8, lines 19-22] with Owens because Owens teaches maintaining an intact collagen framework over time and the use of negative pressure to draw cells from surrounding tissue into the tissue matrix [0065 and 0029].
Johnson, Takavol and Owens are silent on wherein the surface layer of the connective tissue body is a dense surface layer in which the biological origin tissue is denser than in the non-surface-layer portion. Ruszczak teaches wherein the surface layer of the connective tissue body is a dense surface layer in which the biological origin tissue is denser than in the non-surface-layer portion [0065; “where said first and second layers have substantially different dry thicknesses and densities.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate certain design properties such as density and thickness as taught by Ruszczak to allow for removal and separation of the dual-layers as suggested by Johnson, Owens, and Tavakol as Johnson discusses separating the remodeled material from the form [0067] and Owens which discloses using drape material of a sufficient thickness for reduced pressure therapy [0011] and Tavakol which teaches layering the structure of the microcarrier to achieve certain adhesion with differing cell types [Pg. 49, lines 4-6] with Ruszczak because Ruszczak teaches the limitations of preparing thick layers of material with relatively low density [0017].
Regarding Claim 11, Johnson teaches a method for producing a connective tissue body that includes a surface layer [Fig. 10, element 153], a non-surface-layer portion [Fig. 10, element 151], which is other than the surface layer [0039], and biological origin tissue including collagen and is used for tissue transplantation [0012] [0043], and [0072]—reference to inserting material into non-human animal and recovered and implanted into a human, the method comprising:
placing, in a living body other than a human body [Fig. 1, reference to “insert…body cavity”] and [0072]—reference to inserted into a non-human animal, a connective tissue body formation substrate including a tissue formation surface that is at least partially made of a polymer material [0047]—reference to “polymers…formed into a substrate”], wherein the step of placing the connective tissue body formation substrate in the living body forms an internal space that accommodates the connective tissue body formation substrate in the living body [Fig. 6B, element 71];
leaving the connective tissue body formation substrate in the internal space of the living body to allow the connective tissue body [Fig. 4, reference to “allow a residence time…to occur”], including the surface layer, the non-surface-layer portion, and the biological origin tissue containing the collagen produced by the living cells, to form on the tissue formation surface [0122]—reference to the covering materials, inner and outer and tissue material including the collage inserted in body cavity;
removing, from the living body, the connective tissue body formation substrate on which the connective tissue body is formed [Fig. 4, reference to “Remove…cavity”];
and peeling off the connective tissue body from the connective tissue body formation substrate to obtain the connective tissue body that includes the surface layer [Fig. 4, reference to “Manipulate…separate material…to form an implantable prothesis”], which has been in contact with the tissue formation surface of the connective tissue body formation substrate, and the non-surface- layer portion, which has not been in contact with the tissue formation surface of the connective tissue body formation substrate [0039; “wherein an outer, remodelable covering material and/or an inner, remodelable covering material contour to and/or embed elements of the stent.”],
Johnson is silent on removing air percutaneously and transluminally from the internal space that accommodates the connective tissue body formation substrate to an outside of the living body, wherein the step of removing air is configured to facilitate contact between the tissue formation surface of the connective tissue body formation substrate and living cells in the living body, thereby promoting production of collagen by the living cells contacting the tissue formation surface of the connective tissue body formation substrate and formation of the connective tissue body, which includes the biological origin tissue containing the collagen produced by the living cells, on the tissue formation surface of the connective tissue body formation substrate in the internal space of the living body. Takavol teaches removing air percutaneously and transluminally from the internal space that accommodates the connective tissue body formation substrate to an outside of the living body [Pg. 4, lines 40-43]—includes reference to air venting via syringe (interpreted to be percutaneous removal) and catheter (transluminal), wherein the step of removing air is configured to facilitate contact between the tissue formation surface of the connective tissue body formation substrate and living cells in the living body [Pg. 4, lines 34-37]-discusses contact between transfer device (interpreted to be the connective tissue body formation substrate, and microcarrier-culture (living cells), thereby promoting production of collagen by the living cells contacting the tissue formation surface of the connective tissue body formation substrate and formation of the connective tissue body, which includes the biological origin tissue containing the collagen produced by the living cells, on the tissue formation surface of the connective tissue body formation substrate in the internal space of the living body [Pg. 8, lines 19-21] and [Pg. 8, lines 35-38]—include reference to promoting growth of the tissue on the scaffold by means of delivering growth factor agents to the site, [Pg. 9, lines 5-11]—describes enhancing cell seeding process through compression and aspiration and other various techniques linked to air venting and perfusion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include air removal mechanisms and methods as taught by Tavakol to promote collagen and tissue production and growth in the connective tissue body formation substrate as suggested by Johnson, as Johnson discusses applying different techniques to enhance dehydration and compression of the overall matrix structure [0090] with Tavakol because Tavakol teaches the adherence and colonization of the microcarrier by dehydration and compression [Pg. 9, lines 5-6].
Johnson and Takavol are silent on by applying a negative pressure to the internal space. Owens teaches by applying a negative pressure to the internal space [0065]—reference to applying negative pressure to an internal space within an acellular tissue matrix.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include negative pressure/vacuum pressure as taught by Owens to increase and enhance cellular growth in the connective tissue body and tissue matrix as suggested by Johnson and Takavol, as Johnson discusses considerations for tissue ingrowth [0048] and Takavol which discloses use of therapeutic agents to enhance growth factors [Pg. 8, lines 19-22] with Owens because Owens teaches maintaining an intact collagen framework over time and the use of negative pressure to draw cells from surrounding tissue into the tissue matrix [0065 and 0029].
Johnson, Takavol and Owens are silent on wherein the surface layer of the connective tissue body is a dense surface layer in which the biological origin tissue is denser than in the non-surface-layer portion. Ruszczak teaches wherein the surface layer of the connective tissue body is a dense surface layer in which the biological origin tissue is denser than in the non-surface-layer portion [0065; “where said first and second layers have substantially different dry thicknesses and densities.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate certain design properties such as density and thickness as taught by Ruszczak to allow for removal and separation of the dual-layers as suggested by Johnson, Owens, and Tavakol as Johnson discusses separating the remodeled material from the form [0067] and Owens which discloses using drape material of a sufficient thickness for reduced pressure therapy [0011] and Tavakol which teaches layering the structure of the microcarrier to achieve certain adhesion with differing cell types [Pg. 49, lines 4-6] with Ruszczak because Ruszczak teaches the limitations of preparing thick layers of material with relatively low density [0017].
Regarding Claim 12, Johnson further teaches wherein the connective tissue body is formed by an encapsulation reaction [0063]—describes the prosthetic forming device maintained in the body for a period of time, with the capacity to induce host tissue proliferation, resulting in infiltration of the inserted material by cells within the body, this includes the description of encapsulation reaction as provided in the disclosure.
Regarding Claim 16, Johnson further teaches wherein:
the surface layer and the non-surface-layer portion form a biological peelable boundary therebetween where the surface layer is peelable off from the non-surface-layer portion [0067]—discloses manipulating the prothesis forming device in any manner, including physical alteration, manual separation and separation of portions of the material.
Regarding Claim 18, Johnson further teaches wherein:
the surface layer and the non-surface-layer portion form a biological peelable boundary therebetween where the surface layer is peelable off from the non-surface-layer portion [0067].
Regarding Claim 19, Johnson, Tavakol, and Ruszczak are silent on wherein the step of removing air is configured to facilitate contact between the tissue formation surface of the connective tissue body formation substrate and living cells in the living body by drawing some of the living cells into the substrate.
Owens teaches wherein the step of removing air is configured to facilitate contact between the tissue formation surface of the connective tissue body formation substrate and living cells in the living body by drawing some of the living cells into the substrate [0065]—reference to drawing cells from surrounding tissue into the matrix which includes the supporting substrate material according to [0069].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate properties that attract and draw cells to the desired area as taught by Owens to control tissue growth and approximation as suggested by Johnson, Tavakol and Ruszczak as Johnson discusses remodeling material to promote tissue ingrowth in a seam [0087] and Tavakol which discloses tissue transplantation by fragmented pieces [Pg. 9, lines 27-31] and Ruszczak which discusses influencing amount direction, speed and degree of cell ingrowth [0062] with Owens because Owens teaches enhancing speed and or overall effectiveness of tissue approximation to secure the implant to surrounding tissue planes [0065].
Regarding Claim 20, Johnson, Tavakol, and Ruszczak are silent on wherein the step of removing air is configured to facilitate contact between the tissue formation surface of the connective tissue body formation substrate and living cells in the living body by drawing some of the living cells into the substrate.
Owens teaches wherein the step of removing air is configured to facilitate contact between the tissue formation surface of the connective tissue body formation substrate and living cells in the living body by drawing some of the living cells into the substrate [0065]—reference to drawing cells from surrounding tissue into the matrix which includes the supporting substrate material according to [0069].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate properties that attract and draw cells to the desired area as taught by Owens to control tissue growth and approximation as suggested by Johnson, Tavakol and Ruszczak as Johnson discusses remodeling material to promote tissue ingrowth in a seam [0087] and Tavakol which discloses tissue transplantation by fragmented pieces [Pg. 9, lines 27-31] and Ruszczak which discusses influencing amount direction, speed and degree of cell ingrowth [0062] with Owens because Owens teaches enhancing speed and or overall effectiveness of tissue approximation to secure the implant to surrounding tissue planes [0065].
Allowable Subject Matter
Claims 10 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 5 February 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive. New rejections are presented for newly added claims 19 and 20.
Applicant’s arguments filed 5 February 2026 with respect to the rejection of
claims 9, 11, 12, 16, and 18 under 35 U.S.C.103 have been fully considered and are persuasive, however, new rejections are presented above in light of the amendments for claims 9, 11, 16 and 18 and newly added claims 19 and 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Alt (U.S. 20120195863)-discusses removal of air via suction from syringe into lumen of container
-Nikalson (U.S. 6537567)-teaches growing bovine and porcine vascular tissue constructs via negative pressure
-Zamierowski (U.S. 9408956)-discloses applying negative pressure to a therapy zone
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791