DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1,4,8-10,13,15,16,18,24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878). Duran shows (Fig. 9) a product 28, comprising: a frame configured to retain a mammalian tissue thereon. Fig. 1e of Duran shows the frame 20 comprising a first end, a second end, a longitudinal axis, one or more lower arms 22, and at least one connection portion 26 extending along the longitudinal axis, the one or more lower arms disposed at the second end and connected to the at least one connection portion, the at least one connection portion comprising connection bars (3 about the circumference). Fig. 8 of Duran shows the mammalian tissue being coupled to the frame. Duran discloses (col. 5, lines 13-16) implanting the product and thus it is capable of being positioned within a mammalian luminal organ fluid native to the mammalian luminal organ may pass through a lumen defined within the product. Duran also discloses (col. 3, lines 16,17) the product is configured as a stent valve. Duran also discloses (col. 6, lines 39-41) the mammalian tissue comprises pleura. Fig. 9 of Duran shows the at least one connection portion is used to connect the pleura to the frame via suture 46. Duran also discloses (col. 3, lines 39-41) the mammalian tissue chemically is fixed (col. 7, lines 33-36). However, Duran did not explicitly state the pleura is visceral pleura. Tanaka teaches (paragraph 76,82) that visceral pleura is thin and easy to be manipulated to place around implantable structure. It would have been obvious to one of ordinary skill in the art to alternatively try visceral pleura for the pleura of the vascular stent valve of Duran since such biological material would provide a pliable material for the leaflet structure of the implantable structure. Thus, selecting a known material from a finite number of optional selections of the pleura available only involves routine skill in the art. Thus it would have been obvious to one of ordinary skill in the art to alternatively use visceral pleura as one of the types known. Regarding claims 4,13 Duran discloses (col. 7, lines 28-30) the mammalian tissue is fixed with a fixative agent such as glutaraldehyde. Regarding claims 8, 15, Duran discloses (col. 3, lines 4-7) the stent valve is used for the sigmoid valve which is known to be a venous channel, thus it is capable of being a venous valve. Regarding claims 9,16 Duran discloses (col. 4, lines 66,67, col. 5, lines 1,2) the frame can be constructed of nitinol, a titanium alloy. Regarding claim 18, please note if the same material is used it inherently has the same construction or properties. Thus, the prior art tissue being visceral pleura per the modification of Duran with Tanaka has a non-mesothelial side and a mesothelial side. It is also noted that, Duran does disclose (col. 7, lines 22-25 )the non-mesothelial side positioned such that it contacts fluid native to the mammalian luminal organ passing through the lumen defined within the product, the mesothelial side opposably facing the non-mesothelial side since the tissue is said to face the inner wall of the conduit with the frame. With respect to claim 24, Duran discloses (see claim 9 of patent) the product can be configured as a tricuspid valve.
Claims 2,11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878) as applied to claims 1,10 respectively above, and further in view of Hiles (2006/0210597). Duran in view of Tanaka is explained supra. However, Duran as modified by Tanaka failed to disclose the tissue material is decellularized. Hiles teaches (paragraphs 16,65) to decellularize (purify) the tissue implant material such that it is non-antigenic. It would have been obvious to one of ordinary skill in the art to provide decellularized tissue material as taught by Hiles with the stent valve of Duran as modified with Tanaka such that it provides a biocompatible and non-antigenic implant to not cause a negative response in the patient.
Claims 3,12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878) as applied to claims 1,10 respectively above, and further in view of Atala et al. (WO 2006/099372). Duran in view of Tanaka is explained supra. However, Duran as modified by Tanaka failed to disclose the visceral pleura is harvested from a middle-anterior portion of a lung. Atala et al. teach (page 14, lines 6,7,16-19) that lung tissue is advantageously used since it provides strength, elasticity and flexibility. It would have been obvious to one of ordinary skill in the art to select a portion of lung tissue, such as the middle- anterior portion of the lung to provide advantageous properties as taught by Atala et al. for the tissue material in the stent valve of Duran as modified by Tanaka such that it is pliable but flexible to suitably function within the patient vessel.
Claims 5,6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878) as applied to claim 1 above, and further in view of Ketharanathan (WO 02/49687). Duran in view of Tanaka is explained supra. However, Duran as modified by Tanaka failed to disclose the mammalian tissue is fixed using a fixative within a HEPES or phosphate buffer. Ketharanathan teaches that pleura tissue used for implant material (page 4, lines 13,14,18-20, page 10, lines 10-14) is fixed using a buffer that can be one such as a phosphate buffer. It would have been obvious to one of ordinary skill in the art to select a known buffering agent such as phosphate to fix tissue for implantation as taught by Ketharanathan and treat the tissue of the stent valve of Duran as modified by Tanaka to suitably fix the tissue material and provide a non-antigenic material.
Claims 7,14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878) as applied to claims 1,10 respectively above, and further in view of Paniagua et al. (2012/0310041). Duran in view of Tanaka is explained supra. However, Duran as modified by Tanaka failed to disclose the mammalian tissue is sterilized. Paniagua et al. teach (paragraph 48) the tissue implant material is sterilized such that is suitable for implantation in a patient. It would have been obvious to one of ordinary skill in the art to sterilize the implant material as taught by Paniagua et al. with the implant material for the stent valve of Duran as modified by Tanaka such that it prevents any infection in the patient by being sterile.
Claims 17,23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878) and (further in view of for claim 23) Nitzan et al. (2012/0165928). Regarding claim 17, Duran as modified with Tanaka is explained above as detailed for claim 10, since the same limitations are present for claim 17. However, Duran and Tanaka did not explicitly disclose the product is configured as a bi-leaflet stent valve. Nitzan et al. teach (paragraph 69) that vascular implants for different valve locations are capable of selecting the design by one of ordinary skill in the art. Nitzan et al. also teach that a bi-leaflet stent valve is known in the art, paragraph 13. It would have been obvious to one of ordinary skill in the art to select a bi-leaflet stent valve as taught by Nitzan et al. for the stent valve of Duran as modified with Tanaka since such a modification only involves routine skill in the art and would provide expected results when designing for the specific location where a bi-leaflet would be suitable.
Claims 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878) as applied to claim 1 respectively above, and further in view of Ogle et al. (2003/0229394). Duran in view of Tanaka is explained supra. It is inherent the product of Duran has a first axial axis, see Fig. 9. However, Duran as modified by Tanaka failed to disclose the visceral pleura has a circumferential axis and a second axial axis, the visceral pleura being stiffer along the second axial axis relative to the circumferential axis; and wherein the visceral pleura is coupled to the frame such that the circumferential axis is aligned with the first axial axis. Ogle et al. teach (paragraph 56) the importance of stiffness and variation in properties based upon arrangement of the tissue. It would have been obvious to one of ordinary skill in the art to provide the visceral pleura having a defined circumferential axis and a second axial axis, such that the visceral pleura being stiffer along the second axial axis relative to the circumferential axis and coupling to the frame the tissue such that the circumferential axis is aligned with the first axial axis as taught by Ogle et al. in the stent valve of Duran as modified with Tanaka such that it provides the desired mechanical properties and use such arrangement for appropriate accommodation of blood flow pressures, see paragraphs 44,45 of Ogle.
Claims 20,21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878) as applied to claim 1 above, and further in view of Case et al. (WO 2006/062976). Duran in view of Tanaka is explained supra. However, Duran as modified by Tanaka failed to disclose the tissue has a thickness between about 40 microns and about 300 microns or between the range of about 40 microns and about 80 microns. Case et al. teach (page 13 lines 1-3) the tissue implant material is provided with a thickness between about 40 microns and about 300 microns or even between about 40 microns and about 80 microns. It would have been obvious to one of ordinary skill in the art to provide a thickness for the tissue material to be between about 40 microns and about 300 microns or even between about 40 microns and about 80 microns as taught by Case et al. with the pleura material for the stent valve of Duran as modified by Tanaka such that it provides the desired flexibility or stability due to the thickness resulting properties.
Claims 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duran (5545215) in view of Tanaka (2008/0287878) as applied to claim 1 respectively above, and further in view of Quijano et al. (5500014). Duran in view of Tanaka is explained supra. However, Duran as modified by Tanaka failed to disclose the product is configured as a monocusp valve. Quijano et al. teach (col. 13, lines 46-50) a monocusp valve could be used in a frame where only a single leaflet needs to be replaced. It would have been obvious to one of ordinary skill in the art to provide a monocusp valve as taught by Quijano et al. with the stent valve of Duran as modified with Tanaka such that it provides ability to utilize the native leaflet and only replace a diseased leaflet, thus the use of a monocusp type valve.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 10, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,406,495 in view of Duran (7160320). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim recites or covers the same scope of a frame with mammalian tissue coupled thereto and being visceral pleura. It is noted the patented claims are narrower in scope, which anticipate broader claims. See In re Goodman. Regarding the tissue being chemically fixed, it is noted claim 20 discloses fixing tissue and it is well known in the art to use chemical fixation solutions to fix tissue. Duran teaches (col., 11, lines 50-58) to chemically fix the tissue material. It would have been obvious to one of ordinary skill in the art to select a fixing agent such as chemical solutions to fix the tissue as taught by Duran with the prosthetic valve of US '495 to stabilize the tissue and provide a non- antigenic implant.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9,10 of U.S. Patent No. 10,940,167 in view of Tekulve et al. (2009/0062844). US '167 discloses/claims the same invention except for explicitly stating the pleura tissue is visceral type. Tekulve et al. teach (paragraph 72) that vascular implants can use a variety tissue materials or ECM which contain collagen and alternatively substitute one for the other such as ligament and pleura. Please note the term "pleura" as recited in Tekulve is a genus and can be considered to encompass a plurality of subsets or species of the main type. Thus it would have been obvious to one of ordinary skill in the art to alternatively use visceral pleura as one of the types known and encompassed by the teaching of Tekulve et al. with the stent valve of US '167 since such a substitution of known materials only involves routine skill in the art and would be an obvious expedient to the surgeon desiring to select the optimal tissue material and provide the suitable properties needed. It is noted the recited "chemically fixed" is disclosed/claimed by claim 10 of US '167 having the same treatment which is essentially its own independent claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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