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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 13 have been considered but are moot because the new ground of rejection addresses the new functional limitation in claims 1 and 13 of which no combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument was argued. The new teaching to Giasolli ‘375 suggests an implant system can be half the length or less than the site of treatment and can be said to suggest the length modification as it must be noted claims 1 and 13 are product or apparatus claims with just intended use recitations. Size modifications only involve routine skill in the art.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,2 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (2020/0054867) alternatively in view of Greenberg et al. (2007/0055365) and in view of Giasolli et al. (2013/0144375). Schwartz et al. disclose (paragraph 45) a lymph conduction system implant, comprising: a stent graft (paragraph 50) having a non- porous tubular side wall (paragraphs 57,76), the non-porous tubular side wall having a proximal end and a distal end, the non-porous tubular side wall configured to define a lumen having an inflow port at the proximal end and an outflow port at the distal end (paragraph 30), and wherein all exposed surfaces of the stent graft are made of a first biocompatible material. Fig. 26 shows what could be construed as a porous "membrane" since the structure spans the inflow port. Schwartz et al. disclose (paragraph 75) the porous membrane being made of a second biocompatible material, such as cellulose and the porous membrane is configured as an active flow device generating a pressure gradient and/or a concentration gradient of lymph fluid. However, in the alternative, Schwartz et al. did not disclose a "membrane" but it is noted Schwartz et al. disclose (paragraph 47) that a control apparatus is connected to the proximal end of the non-porous tubular side wall of the stent graft, the control structure also spanning an entirety of a transverse area of the inflow port of the lumen of the stent graft. Greenberg et al. teach (Fig. 12) a stent device 4 with a porous membrane 94 spanning an entirety of a transverse area of the inflow port of the lumen 92 of the stent. It would have been obvious to one of ordinary skill in the art to alternative provide a membrane as the porous structure as taught by Greenberg et al. with the stent device of Schwartz et al. in order to provide an easy means to remove if wanting to establish full flow therethrough at a later time, see Greenberg. However, Schwartz et al. did not disclose a length of the lymph conduction system implant is no more than one-half of an overall length of a lymphangion targeted by the lymph conduction system implant. Please note the recitation of length of a targeted lymphangion is an intended use and is arbitrary especially since it can vary based on recipients. Giasolli et al. teach (paragraph 196) that an endoluminal implant can be provided with a length no more than half the targeted site or lumen location placed therein. It would have been obvious to one of ordinary skill in the art to provide the implant with a length no more than half the targeted site as taught by Giasolli et al. with the stent implant device of Schwartz et al. and alternatively Greenberg such that it reduces the risk of stiffness, a cause of restenosis, see paragraphs 9,187,190 of Giasolli. Regarding claim 2, see Greenberg et al. which states the porous membrane is a resorbable material.
Claim(s) 3,5 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (2020/0054867) and alternatively modified with Greenberg et al. (2007/0055365) and in view of Giasolli et al. (2013/0144375) as applied to claim 1 above, and further in view of Itkin et al. (2017/0197066). Schwartz is explained supra along with the alternative modification with Greenberg and with Giasolli. Regarding claim 3, Schwartz and Greenberg did not disclose the second biocompatible material for the porous membrane is PGA or PLGA. Itkin et al. teach (paragraph 8) that a stent graft and components for lymphatic vessels can be made with materials such as PGA or PLGA, paragraph 64. It would have been obvious to one of ordinary skill in the art to utilize PGA or PLGA as biocompatible material used with lymphatic stent grafts as taught by Itkin et al. and form the porous membrane of the stent graft of Schwartz as alternatively modified with Greenberg and Giasolli et al. using PGA or PLGA since such a modification only involves routine skill in the art and a substitution of materials is a result expected variable. Regarding claim 5, Schwartz and Greenberg and Giasolli did not disclose the non-porous tubular side wall is ePTFE. Itkin et al. teach (paragraph 8) that a stent graft and components for lymphatic vessels can be made with materials such as ePTFE, paragraph 64. It would have been obvious to one of ordinary skill in the art to utilize ePTFE as a tubular wall biocompatible material used with lymphatic stent grafts as taught by Itkin et al. and provide the non-porous side wall of the stent graft of Schwartz as alternatively modified with Greenberg and with Giasolli using a known material such as ePTFE since such a modification only involves routine skill in the art and a substitution of materials is a result expected variable.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (2020/0054867) and alternatively modified with Greenberg et al. (2007/0055365) and in view of Giasolli et al. (2013/0144375) as applied to claim 1 above, and further in view of Anderson et al. (2003/0109824). Schwartz is explained supra along with the alternative modification with Greenberg and with Giasolli. However, Schwartz and Greenberg did not disclose the porous membrane is a mesh of electrospun fibers. Anderson et al. teach (paragraph 5) that mesh implantable structures for fluid control within vessels can be formed of electrospun fibers. It would have been obvious to one of ordinary skill in the art to utilize an electrospun mesh as taught by Anderson et al. and form the porous membrane of the stent graft of Schwartz as alternatively modified with Greenberg and in view of Giasolli et al. using this construction process since such a modification only involves routine skill in the art and a substitute manufacture of forming a membrane material is a result expected variable.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (2020/0054867) and alternatively modified with Greenberg et al. (2007/0055365) and in view of Giasolli et al. (2013/0144375) as applied to claim 1 above, and further in view of Aye (WO 2017/079691). Schwartz is explained supra along with the alternative modification with Greenberg and with Giasolli. However, Schwartz and Greenberg did not disclose the non-porous tubular side wall includes a coating of ePTFE. Aye teaches (paragraphs 26,27) that an implantable structure for a body vessel include a coating of ePTFE. It would have been obvious to one of ordinary skill in the art to incorporate a coating of ePTFE as taught by Aye on the stent graft of Schwartz et al. and alternatively modified with Greenberg et al. and in view of Giasolli et al. such that it prevents adhesion to the structure, see Aye.
Claim(s) 7,8,13,16 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (2020/0054867) and alternatively modified with Greenberg et al. (2007/0055365) and in view of Giasolli et al. (2013/0144375) as applied to claim 1 above, and further in view of VanTassel et al. (6689150). Schwartz is explained supra along with the alternative modification with Greenberg and with Giasolli. It is noted that Schwartz did disclose (paragraphs 7,28) the stent graft can be used with a drug, in addition to Giasolli suggesting a drug could be delivered with the implant but Schwartz and Greenberg nor Giasolli disclose the porous membrane is carrying the drug. VanTassel et al. teach (col. 8, lines 40-45) that a filtering membrane is porous. VanTassel et al. also teach (col. 2, lines 58-60, col. 3, lines 1-5) that a filtering membrane carry a drug. It would have been obvious to one of ordinary skill in the art to utilize a drug on the porous membrane as taught by VanTassel et al. with the stent graft of Schwartz as alternatively modified with Greenberg and Giasolli et al. since using an alternative drug carrier location is an obvious expedient because such a modification only involves routine skill in the art and provides a site specific location that can be desirable along with the ability to carry a specific quantity for controlling a specific response. Regarding claim 8, it is noted that Schwartz discloses (paragraph 28) a chemotherapeutic drug can be used with the stent graft. Regarding claim 13, it is the same scope as claim 7, which includes the combined features of claim 1. Therefore the same obviousness rejection is made disclosing the features as recited and would have been obvious over Schwartz as modified alternatively with Greenberg and in view of Giasolli. As mentioned above Schwartz disclosed a drug to be used with the implant device, but did not explicitly state the drug is carried by the membrane. Thus, it would have been obvious to one of ordinary skill in the art in view of VanTassel to provide the drug on the membrane in the implant of Schwartz alternatively modified with Greenberg to have the drug exposed with the fluid of the lumen. It is also noted in claim 13 (similar to claim 1), Schwartz et al. did not disclose a length of the lymph conduction system implant is no more than one-half of an overall length of a lymphangion targeted by the lymph conduction system implant. Please note the recitation of length of a targeted lymphangion is an intended use and is arbitrary especially since it can vary based on recipients. Giasolli et al. teach (paragraph 196) that an endoluminal implant can be provided with a length no more than half the targeted site or lumen location placed therein. It would have been obvious to one of ordinary skill in the art to provide the implant with a length no more than half the targeted site as taught by Giasolli et al. with the stent implant device of Schwartz et al. and alternatively Greenberg such that it reduces the risk of stiffness, a cause of restenosis, see paragraphs 9,187,190 of Giasolli. Regarding claim 16, it is noted that Schwartz discloses (paragraph 28) a chemotherapeutic drug can be used with the stent graft.
Claim(s) 14,17 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (2020/0054867) and alternatively modified with Greenberg et al. (2007/0055365) and in view of Giasolli et al. (2013/0144375) and VanTassel et al. (6689150) as applied to claim 13 above, and further in view of Itkin et al. (2017/0197066). Schwartz is explained supra along with the alternative modification with Greenberg and with Giasolli and VanTassel. Regarding claim 14, Schwartz and Greenberg did not disclose the second biocompatible material for the porous membrane is PGA or PLGA. Itkin et al. teach (paragraph 8) that a stent graft and components for lymphatic vessels can be made with materials such as PGA or PLGA, paragraph 64. It would have been obvious to one of ordinary skill in the art to utilize PGA or PLGA as biocompatible material used with lymphatic stent grafts as taught by Itkin et al. and form the porous membrane of the stent graft of Schwartz as alternatively modified with Greenberg and Giasolli et al. and VanTassel using PGA or PLGA since such a modification only involves routine skill in the art and a substitution of materials is a result expected variable. Regarding claim 17, Schwartz and Greenberg and Giasolli did not disclose the non-porous tubular side wall is ePTFE. Itkin et al. teach (paragraph 8) that a stent graft and components for lymphatic vessels can be made with materials such as ePTFE, paragraph 64. It would have been obvious to one of ordinary skill in the art to utilize ePTFE as a tubular wall biocompatible material used with lymphatic stent grafts as taught by Itkin et al. and provide the non-porous side wall of the stent graft of Schwartz as alternatively modified with Greenberg and with Giasolli and in view of Van Tassel using a known material such as ePTFE since such a modification only involves routine skill in the art and a substitution of materials is a result expected variable.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (2020/0054867) and alternatively modified with Greenberg et al. (2007/0055365) and in view of Giasolli et al. (2013/0144375) and in view of VanTassel et al. (6689150) as applied to claim 13 above, and further in view of Anderson et al. (2003/0109824). Schwartz is explained supra along with the alternative modification with Greenberg and with Giasolli and also in view of VanTassel. However, Schwartz and Greenberg did not disclose the porous membrane is a mesh of electrospun fibers. Anderson et al. teach (paragraph 5) that mesh implantable structures for fluid control within vessels can be formed of electrospun fibers. It would have been obvious to one of ordinary skill in the art to utilize an electrospun mesh as taught by Anderson et al. and form the porous membrane of the stent graft of Schwartz as alternatively modified with Greenberg and in view of Giasolli et al. and in view of VanTassel using this construction process since such a modification only involves routine skill in the art and a substitute manufacture of forming a membrane material is a result expected variable.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (2020/0054867) and alternatively modified with Greenberg et al. (2007/0055365) and in view of Giasolli et al. (2013/0144375) and also in view of Van Tassel et al. (6689150) as applied to claim 13 above, and further in view of Aye (WO 2017/079691). Schwartz is explained supra along with the alternative modification with Greenberg and with Giasolli and also in view of VanTassel. However, Schwartz and Greenberg did not disclose the non-porous tubular side wall includes a coating of ePTFE. Aye teaches (paragraphs 26,27) that an implantable structure for a body vessel include a coating of ePTFE. It would have been obvious to one of ordinary skill in the art to incorporate a coating of ePTFE as taught by Aye on the stent graft of Schwartz et al. and alternatively modified with Greenberg et al. and in view of Giasolli et al. and in view of VanTassel such that it prevents adhesion to the structure, see Aye.
Allowable Subject Matter
Claims 9, 11, 12 are allowed.
Conclusion
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.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799