DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments, see pgs 1-3 of remarks (pgs 6-8 of response), filed 10/24/24, with respect to indefinite issues have been fully considered and are persuasive. The 112 2nd paragraph rejections of claims 1,2,4-12,15,16,40 has been withdrawn.
Applicant's arguments filed 10/24/24 have been fully considered but they are not persuasive. Applicant argues the prior art reference of Butterwick suggests the endoluminal seal is positioned on the outer wall of a prosthesis and the amended claim recites “the first membrane being formed into a ring-like configuration that is configured to be positioned within a tubular support member…of the …..prosthesis”. However, Applicant is reminded MPEP 2141.02 states a prior art reference must be considered in its entirety. Thus, it is noted that Butterwick also disclosed (paragraph 15) that the membrane structure that can be ring-like was also potentially provided within the prosthesis and this was an alternative embodiment. Therefore it is the examiner’s position that the Butterwick reference still applies here.
Applicant did not submit any arguments against dependent claim rejections pointing out disagreements with the examiner’s contentions of the teaching references for the features of those claims other than stating the new limitation of claim 1 was not met. The examiner does not agree as Butterwick did teach the new limitation that a seal can be within the prosthesis, paragraph 15. Thus the rejections are maintained.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the “foam is configured to expand between a mesh or struts of the tubular support member of the cardiac valve implant or prosthesis” was not found in the written disclosure.
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 41,42,45 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.
The term “complete” in claim 41 is a relative term which renders the claim indefinite. The term “complete” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not evident as to what features are required to have a “complete” cardiac valve replacement prosthesis. Dependent claim 42 is indefinite for depending from claim 41.
In claim 45, the recitation of “the foam is configured to expand radially outwards from the membrane towards …” is contradicting the claim it depends from, claim 43. It is not understood how the foam expands away, if the expandable material remains coupled to the first membrane?
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 1,2,4-6,10,11,15,16,41-43,47 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Butterwick et al. (2007/0060998). Fig. 3b shows an endoluminal seal 104 for sealing a prosthesis 106 to a wall of a lumen of a subject. Butterwick et al. disclose the endoluminal seal comprises (paragraph 36) a first membrane comprising a plurality of pores (semipermeable has pores); and additionally an expandable material selected from the group consisting of hydrogels (paragraph 17), the expandable material being coupled to the first membrane, since it is within the membrane (paragraph 37). Butterwick et al. also disclose the endoluminal seal is configured to seal (paragraph 33) the prosthesis to the wall of the lumen (paragraph 36) by the first membrane being formed into a ring-like configuration (Fig. 3b) that is configured to be positioned within (paragraph 15) a tubular support member of the prosthesis. Butterwick et al. also disclose (paragraph 43) the first membrane, when formed in the ring-like configuration, has a circumference complementary to the tubular support member.
Regarding claim 2, Butterwick further teaches that there is an impermeable shell or membrane which inherently prevents embolization of the expandable material by stopping too much release of an agent, paragraph 49. With respect to claim 4, it can be construed the seal including a containment band which is positioned within or is in close abutment to the exterior of the implant or prosthesis (paragraph 43), doesn’t change its profile from that of the implant or prothesis during implantation. With respect to claim 5, Butterwick et al. disclose (paragraph 33) the seal provides a complete seal against the wall and thus does not push away the implant or prosthesis. As best understood since a balloon expansion can be provided to expand the seal against the wall it can be controlled under low pressure as known in the art to prevent rupture. Regarding claim 6,
the seal is able to actively conform to a leak site (paragraph 33) between the lumen wall (paragraph 11) and the implant or prosthesis, without altering the rest of the device configuration (as best understood). With respect to claim 10, Butterwick discloses (paragraph 36) the prosthesis can be a stent or support member which interfaces between the first membrane and the endoluminal prosthesis and can transition from an unexpanded or crimped state to an expanded state, see Abstract. Regarding claim 11, Figs. 1,8,9 show the support member is a mesh and Butterwick discloses the membrane circumscribes the prosthesis mesh such that is sized about it and defines a tubular configuration at its location. Regarding claim 15, Butterwick discloses (paragraphs 34,37,41) a drug can be included with the seal. With respect to claim 16, Butterwick et al. disclose (paragraph 34) that there can be an adhesive used with the support member. With respect to claim 41, the prosthesis can be a “complete” cardiac valve replacement prosthesis, see paragraph 60 of Butterwick. Regarding claim 42, it can be construed that the seal is “substantially” the same or less than the diameter of the complete cardiac valve replacement prosthesis prior to expansion of the seal, as Butterwick discloses the cardiac valve is to be expanded, paragraph 60. Regarding claim 43, Butterwick discloses there can be an impermeable material about the expandable material and thus it would be coupled to the first membrane after the expandable material swells since it cannot leave or escape. Regarding claim 47, Butterwick discloses (paragraph 16) the prosthesis and endoluminal seal can be used within a cardiac valve and thus it is fully capable of being configured to be positioned within and against a native cardiac valve annulus and support one or more prosthetic cardiac valve leaflets.
Claim 7 is rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Butterwick et al (2007/0060998) in view of Flanagan et al. (WO 2008/134493). Butterwick et al. is explained supra. However, Butterwick et al. did not explicitly disclose the porosity specifics of a permeable membrane. Flanagan teaches (paragraph 93) pores in a membrane can be 1 micron. However, Butterwick as modified with Flanagan did not explicitly disclose pores in a membrane are 5 microns. Flanagan also teaches that pores in a membrane can be any size, paragraph 87. It would have been obvious to one of ordinary skill in the art to optimize the pore size to be 5 microns or up to 70 microns per the suggestion of Flanagan with the membrane of Butterwick since such a modification only involves routine skill in the art and has predictable results in that a variation in size materially affects a release rate or influx rate of fluids imbibed and thus can be selected to meet the desired release rate or expansion rate resulting from inflow rates.
Claim 8 is rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Butterwick et al (2007/0060998) in view of Lee (WO 02/098324). Butterwick et al. is explained supra. However, Butterwick et al. did not explicitly disclose the expandable hydrogel material expands two to one hundred fold upon contact with a fluid and the first membrane is permeable to a fluid. Lee teaches (Fig. 2B) the expandable material which is a hydrogel expands within the range of two to one hundred fold upon contact with a fluid, page 9, lines 27,28. It would have been obvious to one of ordinary skill in the art to optimize the expansion capability to be two to one hundred fold per the suggestion of Lee with the membrane of Butterwick since such a modification only involves routine skill in the art and has predictable results in that a variation in expansion capability materially affects the sealing dimension size needed by fluids imbibed and thus can be selected to meet the desired release leak site needed to be addressed.
Claim 9 is rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Butterwick et al (2007/0060998) in view of Lee (WO 02/098324) as applied to claim 8 above, and further in view of Birdsall et al. (2007/0244544). Butterwick as modified by Lee is explained supra. However, Butterwick in view of Lee did not disclose the hydrogel is selected from polyacrylic acids and polyalkylene oxides. Birdsall et al. teach (paragraph 41) polyacrylic acid is a swellable hydrogel. It would have been obvious to one of ordinary skill in the art to substitute known hydrogel materials and use polyacrylic acid as taught by Birdsall et al. with the seal device of Butterwick as modified with Lee such that it provides a predictable result of expansion by swelling to form a seal., KSA International Co. v. Teleflex Inc. 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claims 12,40,44-46 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Butterwick et al (2007/0060998) in view of Rhodes (WO 97/19653). Butterwick et al. is explained supra. However, Butterwick et al. did not explicitly disclose the seal is crimped distal or proximal to the prosthesis, aligned with the prosthesis prior to or at the time of placement. Also the expandable material comprises a sponge or a foam and wherein the second membrane is sized to fit the expandable material. Rhodes teaches (page 15) that a prosthesis can utilize an endoluminal seal which is crimped distal or proximal to the prosthesis, and aligned with the prosthesis prior to or at the time of placement and also there is a support member which interfaces between the first membrane and the endoluminal implant or prosthesis and can transition from an unexpanded or crimped state to an expanded state, wherein the support member is a mesh or struts (page 15) wherein the second membrane (page 18) is sized to couple with the mesh or struts. It would have been obvious to one of ordinary skill in the art to use the teaching of Rhodes to provide the support member in the form of a mesh or struts and have it capable of crimping to be deployed with the prosthesis and expanded using the endoluminal seal of Butterwick et al. such that it effectively prevents leaks and emboli, see Rhodes. Regarding claims 40,44 Rhodes teaches (page 15, 1st paragraph) a seal or expandable material can be a foam. With respect to claim 45, per the combined teachings and note that Butterwick discloses the membrane can be permeable, it can be construed that the foam as suggested by Rhodes would allow the foam to expand radially outward from the first membrane. With respect to claim 46, it is inherent that an expandable material that swells and extends radially outward would extend through openings, thus since Butterwick discloses a mesh support the foam per the teaching of Rhodes goes out by having the expandable material within the prosthesis.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,5 of U.S. Patent No. 9216076 in view of Butterwick et al. (2007/0060998). Claim 1 of US ‘076 recites an endoluminal seal for sealing a prosthesis to a wall of a lumen of a subject, the endoluminal seal comprising; a first membrane comprising a plurality of pores and an expandable material selected from the group consisting of hydrogels and foams. It must be noted that US ‘076 describes first membrane as a semipermeable membrane which encompasses having pores and coupled to expandable material since it is recited to encapsulate the expandable material. US ‘076 also defines/claims the expandable material swells (expands) when exposure to a fluid or foaming agent. Claim 5 of US ‘076 recites the endoluminal seal is within the prosthesis. However, US ‘076 did not explicitly recite/claim the first membrane being formed into a ring-like configuration that is configured to be positioned within a tubular support member of the prothesis. Butterwick et al. show (Fig. 3) a ring-like configuration for the first membrane. Additionally Butterwick et al. teach (paragraph 15) the membrane can be positioned within a prosthesis. It would have been obvious to one of ordinary skill in the art to select the appropriate location for the membrane and provide it within the prosthesis as taught by Butterwick et al. with the endoluminal seal of US ‘076 in order to provide the appropriate seal location and profile for the patient being treated and their needs.
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 extension fee 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 date of this final action.
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
