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 .
Response to Arguments
Arguments with regard to drawing reference characters, specification, claim objections, and 112b rejections has been considered persuasive, objection/rejections of record have been withdrawn.
In response to applicant's argument that Dardik fail to show certain features of the invention, (i.e., polyampholyte cryoprotectant). The examiner agrees, however Dardik is not relied upon to teach that limitation. Kazuaki teaches this feature, see rejection below.
In response to applicant's argument that Dardik and the combination of references fails to show certain features of the invention, (i.e., 30-minute time frame, softening and drying process). The examiner disagrees, note it has been held that when the prior art teaches all of the structural elements of an apparatus how the device is intended to be used does not differentiate the claimed apparatus from the prior art if the device is capable of being used in that way (MPEP 2114 (II)). See rejection below, the structural elements are taught from the combination of art, the structure is substantially the same and can function in the same way.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). See motivation in rejection below.
Drawings
The drawings are objected to because figures 10 on the replacement sheet filed 10/13/25 does not comply with 37 CFR 1.84.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 103
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) 1-2, 4-5, 7-8, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dardik (US 5131908 A) in view of Bhattacharya (“Cryoprotectants and their usage in cryopreservation process) and Kazuaki (“Polyampholytes as Cryoprotective Agents for Mammalian Cell Cryopreservation”).
Regarding claim 1, Dardik teaches a biologic stent or conduit (abstract) made from a mammalian umbilical cord (col 2, lines 50-52), comprising: a tissue body structure (the umbilical cord vessel is the tissue body structure) having a fluid passageway (fig 4) configured to be open (col 4, lines 12-13) to pass fluids through from a first end to a second end (body fluid would pass through the prosthesis, col 4, lines 30-36 or see col 4 lines 54-56), the tissue body structure having an internal surface defining a boundary interior wall of the fluid passageway (the conduit inherently has an inner surface) and an external surface defining an exterior wall of the tissue body structure (the conduit inherently has an outer surface), wherein the external surface is configured to connect or reinforce an inner wall of a cut vessel, duct, or bowel of a patient (col 4, lines 30-36); and wherein the tissue body structure forms a semi-rigid or rigid condition of the biological stent or conduit to maintain the fluid passageway open for at least 30 minutes during implantation and securing of the tissue body structure into the cut vessel, duct, or bowel (structure is capable of this, col 4, lines 12-13, the structure of a umbilical cord vessel is at least semi rigid and would stay open to make implantation possible, (MPEP 2114 (II)), an wherein after the 30 minutes, the biological conduit or stent softens to a conformable stent or conduit inside the vessel, duct, or bowel being repaired or reinforced (structure is capable of this, col 7, lines 45-52, overtime the stent would be softened and is supported naturally, (MPEP 2114 (II)).
Dardik fails to specifics regarding a freeze-drying process. Bhattacharya teaches known methods of using a cryoprotectant during biological freeze-drying process (page 8, lines 17-18) wherein the tissue structure is coated with a cryoprotectant and dried (page 8, lines 17-18) and wherein the use of a cryoprotectant is vital in reducing damage (page 8, lines 14-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention apply the freeze-drying teachings of Bhattacharya, to the device of Dardik, because Dardik teaches wherein the umbilical cord can be freeze dried or preserved in known ways (col 2, lines 41-52).
Dardik in view of Bhattacharya does not exactly teach wherein the cryopreservation process utilizes a polyampholyte cryoprotectant. Kazuaki teaches the use of non-toxic polyampholyte cryoprotectant in mammalian tissue treatment (pg. 696, Discussion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention apply the cryoprotectant teachings of Kazuaki, to the process of Dardik in view of Bhattacharya, in order to choose a cryoprotectant that has successfully accomplished a high preservation in mammalian tissue without introducing toxic compounds (pg. 696, Discussion).
The modified device taught by Dardik in view of Bhattacharya would by substantially the same structure as the instant application, the structure is capable of maintaining the fluid passageway open for at least 30 minutes and after about 30 minutes softening to a conformable material inside the vessel, duct, or bowel being repaired or reinforced ((MPEP 2114 (II)).
Regarding claim 2, Dardik further teaches wherein the fluid passageway has an inner diameter or size formed on one or more mandrels or dilators to achieve a desired size (col 8, lines 26-34).
Regarding claim 4, Dardik further teaches wherein the external surface of the tissue body structure is pressed into or otherwise formed in a mold (col 8, lines 40-41).
Regarding claim 5, Dardik further teaches wherein the tissue body structure is formed by stretching (col 8, lines 35-46) the mammalian umbilical cord forming a seamless stent (col 8, lines 46-48, impurities are removed, and stent would be seamless).
Regarding claim 7, Dardik further teaches wherein the biologic stent or conduit has a diameter of 0.1 cm to 5.0 cm (col 8, lines 40-45, 0.1cm<1cm<5cm).
Regarding claim 8, Dardik further teaches wherein the biologic stent or conduit has a length of 1 cm to 6 cm (col 2, lines 63-65, length is selected as desired, can be between 1cm and 6cm).
Regarding claim 13, Dardik further teaches wherein the biologic stent or conduit is multi-layered or single-layered (the stent inherently has a layer or multiple layers).
Regarding claim 14, Dardik further teaches wherein the biologic stent or conduit is sized to be implanted in a bowel or intestine to repair or reinforce the bowel or intestine (intended use, structure is capable of being used in this way).
Regarding claim 15, Dardik further teaches wherein the biologic stent or conduit is sized to repair or reinforce an esophagus of a patient (intended use, structure is capable of being used in this way).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dardik (US 5131908 A) in view of Bhattacharya (“Cryoprotectants and their usage in cryopreservation process) and Kazuaki (“Polyampholytes as Cryoprotective Agents for Mammalian Cell Cryopreservation”) and in further view of Ganey (US 20170049553 A1).
Regarding claim 6, Dardik in view of Bhattacharya and Kazuaki fails to teach wherein the tissue body structure is formed by spirally winding strips. Ganey teaches an umbilical transplant product (abstract) wherein the tissue body structure is formed by spirally winding strips ([0035]) of umbilical cord ([0037]) onto a sizing mandrel ([0050]) and applying heat and pressure to seal the edges of the spirally winding strips together ([0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Dardik in view of Bhattacharya and Kazuaki by including the winding strips, as taught by Ganey, in order to control wall thickness and shape memory ([0052], [0049])
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dardik (US 5131908 A) in view of Bhattacharya (“Cryoprotectants and their usage in cryopreservation process) and Kazuaki (“Polyampholytes as Cryoprotective Agents for Mammalian Cell Cryopreservation”) and in further view of Marcos (JP 2014525760 A).
Regarding claim 9, Dardik in view of Bhattacharya and Kazuaki fails to teach wherein the conduit has a center with a visual indicator. Marcos teaches an implantable stent (stent support 102, fig 5) wherein the stent or conduit has a center with a visual indicator on the external surface located halfway between the ends of the stent or conduit (marker 116, fig 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Dardik in view of Bhattacharya and Kazuaki by including the marker, as taught by Marcos, in order to aid in positioning and orienting (pg. 6., paragraph 8).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dardik (US 5131908 A) in view of Bhattacharya (“Cryoprotectants and their usage in cryopreservation process) and Kazuaki (“Polyampholytes as Cryoprotective Agents for Mammalian Cell Cryopreservation”) and in further view of Palmaz (US 20120282391 A1) and Clerc (US 20090187240 A1).
Regarding claim 10, Dardik in view of Bhattacharya and Kazuaki fails to teach specific patterns and markings. Palmaz teaches an implantable stent (abstract) wherein the internal surface of the fluid passageway ([0084]) has an embossed ([0084]) or otherwise formed flow enhancing directional pattern ([0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Dardik in view of Bhattacharya and Kazuaki by including the internal pattern, as taught by Palmaz, in order to enhance the flow rate ([0009]].
Dardik in view of Bhattacharya and Kazuaki and in further view of Palmaz fails to teach specific external markings and patterns. Clerc teaches an implantable stent (abstract) wherein the external surface has a marking indication (fig 8, external pattern arches) showing the direction of flow for proper placement upon implantation (intended use, the marking can be viewed in this way, the pattern is one directional and the surgeon can choose which way to implant it based on desired flow).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Dardik in view of Bhattacharya and Kazuaki and in further view of Palmaz by including the external markings/pattern, as taught by Clerc, in order to provide friction ([0041]].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dardik (US 5131908 A) in view of Bhattacharya (“Cryoprotectants and their usage in cryopreservation process) and Kazuaki (“Polyampholytes as Cryoprotective Agents for Mammalian Cell Cryopreservation”) and in further view of Clerc (US 20090187240 A1).
Regarding claim 11, Dardik in view of Bhattacharya and Kazuaki fails to teach specific external markings and patterns. Clerc teaches an implantable stent (abstract) wherein the external surface is affixed with surface patterns (fig 8, external pattern) to reduce slippage, enhance anchorage, and facilitate placement during suturing ([0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Dardik in view of Bhattacharya and Kazuaki by including the external markings/pattern, as taught by Clerc, in order to provide friction ([0041]].
Conclusion
THIS ACTION IS MADE FINAL. 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 HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 7:30PM-5:00PM EST M-F (occasionally off Fridays).
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/HANNA L PASQUALINI/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799