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 Amendment
This Office Action is a response to applicant’s arguments and amendment filed 06/03/2026. Claims 1, 4-5, 8, 11, 13 and 17 are amended. Claims 6-7, 9 and 15 are cancelled. Claims 18-24 are new. Claims 1-5, 8, 10-14 and 16-24 are currently pending, with claims 16-17 withdrawn from consideration.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/03/2026, with respect to the rejection(s) of claim(s) 1-5, 8 and 10-14 under 35 U.S.C. 102(a)(1) as being anticipated by Khairkhahan, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendments to the claims.
Applicant argues Khairkhahan fails to teach any structure that can be considered to be the claimed conformable material that is different from a material forming the occlusive member (Remarks, pg. 6).
In response to applicant’s argument, it is respectfully submitted Khairkhahan teaches swellable bodies 70 formed of a different material than membrane 11 (paras. [0057] and [0060]). Further, the claim language does not preclude the swellable bodies 70 from being a component of the sealing member. This is also consistent with the instant spec., which describes the sealing member 228 and conformable material 230 as two distinct structures, such that the claim language is interpreted to be consistent with the disclosed sealing member and conformable material (e.g. the sealing member as claimed includes the conformable material in addition to a separate structure of the sealing member).
Applicant’s arguments with respect to claims 18-24 have been fully considered, and new claims 18-24 have been rejected as discussed below.
Applicant’s arguments with respect to the double patenting rejection have been fully considered; the double patenting rejection has been modified necessitated by applicant’s amendments to the claims as discussed below.
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.
Claim 23 is 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.
Regarding claim 23, the claim recites “the occlusive member” in line 2. There is insufficient antecedent basis for this limitation in the claim, since an occlusive member has not been previously introduced. Therefore, the scope of the claim is indefinite.
Further, the claim recites “wherein the conformable material is disposed directly on the expandable framework and under the occlusive member”. Applicant appears to be referring to para. [0081] and fig. 5a of the instant spec. depicting the conformable material 230 disposed under occlusion member 214, however, claim 11 previously recites the protrusion portion including the conformable material extending outward from the covering. Therefore, it is unclear how the conformable material can extend outward from the covering and also extend under the covering as recited in claim 23. For examination purposes, claim 23 is interpreted to recite the conformable material disposed directly on the framework and under the covering, and the phrase “extending outward from the covering” in claim 11 is interpreted as extending outward of the covering (e.g. protruding outward relative to the covering, as opposed to protruding within the covering).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 10-14, 18-19, 21-22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khairkhahan (US 2006/0281965 A1) (previously of record).
Regarding claim 1, Khairkhahan discloses (see abstract; paras. [0040]-[0063]; figs. 1-18) an occlusive implant (10, fig. 1), comprising:
an expandable framework (13, para. [0040]; fig. 1) configured to shift between a collapsed configuration and an expanded configuration (para. [0040]; figs. 11a-e), the expandable framework includes a plurality of anchor members (27, para. [0045]; figs. 2 and 7) extending radially outward from the expandable framework (figs. 2-3);
an occlusive member (inner layer of membrane 11, para. [0041]; figs. 7 and 18) disposed along at least a portion of the expandable framework (figs. 1-2 and 17); and
a sealing member (includes outer layer of membrane 11 and swellable bodies 70, para. [0060]; fig. 18) disposed along the occlusive member (figs. 7 and 17-18), the sealing member including a conformable material (70) different from a material forming the occlusive member (includes swellable bodies 70 formed of foam, considered to be formed of a different material than membrane 11, para. [0057]).
Regarding claim 2, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the sealing member extends radially outward from the occlusive member (figs. 7 and 18).
Regarding claim 3, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric (at least outer layer of membrane 11 and inner layer of membrane 11 formed from fabric, para. [0015]).
Regarding claim 4, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the sealing member and the conformable material both extend around only a portion of an outer surface of the occlusive member (considered to extend only around portions of inner layer of membrane 11 due to presence of ribs 14 and swellable bodies 70 located in between layers, figs. 2-3, 7 and 18).
Regarding claim 5, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the sealing member and the conformable material both extend circumferentially around an outer surface of the occlusive member (figs. 1-3 and 17-18).
Regarding claim 8, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the conformable material includes an expandable material (swellable bodies 70 are expandable, para. [0060]; figs. 17-18).
Regarding claim 10, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the expandable framework and the plurality of anchor members are formed from a unitary tubular member (considered to be consisting of a single base unit/element formed in a tubular shape similar to figs. 5-6 of the instant spec., note the limitation “formed from a unitary tubular member” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Khairkhahan discloses frame 13 and ribs 14 formed of a unitary structure, the limitation is considered to be met, see MPEP 2113).
Regarding claim 18, Khairkhahan discloses the occlusive implant of claim 8. Khairkhahan further discloses wherein the expandable material is a hydrogel (swellable material includes collagen, a known hydrogel, paras. [0012]-[0013] and [0037]).
Regarding claim 19, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the conformable material is disposed inside a pocket formed between the occlusive member and the sealing member (see fig. 18 depicting swellable bodies 70 formed between the inner and outer layer of membrane 11, such that swellable bodies 70 are considered to be disposed inside a pocket formed between the occlusive member and a portion of the sealing member, which is consistent with fig. 5 of the instant spec.).
Regarding claim 21, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the conformable material is disposed axially between a proximal end of the expandable framework and the plurality of anchor members (see figs. 17-18, swellable bodies 70 are disposed between a proximal end of the frame and a distal end of tip elements 27 of ribs 14, such that the limitation is considered to be met).
Regarding claim 11, Khairkhahan discloses (see abstract; paras. [0040]-[0063]; figs. 1-18) a medical implant (10, fig. 1) for occluding a left atrial appendage (considered to be capable of occluding a left atrial appendage, since the device of Khairkhahan divides portions of the heart, para. [0054]), comprising:
an expandable framework (13, para. [0040]; fig. 1) configured to shift between a collapsed configuration and an expanded configuration (para. [0040]; figs. 11a-e);
a plurality of anchor members (27, para. [0045]; figs. 2 and 7) disposed along the expandable framework (figs. 2-3);
a covering (inner layer of membrane 11, para. [0041]; figs. 7 and 18) disposed along an outer surface of the expandable framework (figs. 1-2 and 17); and
a protrusion portion (includes outer layer of membrane 11 and swellable bodies 70, para. [0060]; fig. 18) extending outward from the covering (figs. 7 and 17-18), the protrusion portion including a conformable material (70) different from a material forming the covering (includes swellable bodies 70 formed of foam, considered to be formed of a different material than membrane 11, para. [0057]).
Regarding claim 12, Khairkhahan discloses the medical implant of claim 11. Khairkhahan further discloses wherein the covering is formed from a fabric (para. [0015]).
Regarding claim 13, Khairkhahan discloses the medical implant of claim 11. Khairkhahan further discloses wherein the covering and the conformable material both extend along only a portion of the expandable framework (see figs. 5 and 7 depicting proximal and distal ends of ribs 14 not covered by membrane, see also swellable bodies 70 located only along portions of the frame, figs. 2-3, 7 and 18).
Regarding claim 14, Khairkhahan discloses the medical implant of claim 11. Khairkhahan further discloses wherein the protrusion portion extends circumferentially around an outer surface of the covering (figs. 1-3).
Regarding claim 22, Khairkhahan discloses the medical implant of claim 11. Khairkhahan further discloses wherein the conformable material is a hydrogel (swellable material includes collagen, a known hydrogel, paras. [0012]-[0013] and [0037]).
Regarding claim 24, Khairkhahan discloses the medical implant of claim 11. Khairkhahan further discloses wherein the conformable material is disposed inside a pocket formed from the covering (see fig. 18 depicting swellable bodies 70 formed between the inner and outer layer of membrane 11, pocket considered to be formed from inner layer of membrane 11).
Claim(s) 1, 11, 20 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edmiston (US 2017/0156840 A1).
Regarding claim 1, Edmiston discloses (see abstract; paras. [0072]-[0075]; figs. 1-1b) an occlusive implant (20, fig. 1), comprising:
an expandable framework (frame of occluder portion 24 and anchor portion 26, para. [0072]; fig. 1) configured to shift between a collapsed configuration and an expanded configuration (para. [0089]), the expandable framework includes a plurality of anchor members (26) extending radially outward from the expandable framework (depicted in figs. 1-1a);
an occlusive member (second material layer 32, para. [0074]) disposed along at least a portion of the expandable framework (fig. 1a-b); and
a sealing member (first material layer 30) disposed along the occlusive member (figs. 1a-b), the sealing member including a conformable material (foam, para. [0074]) different from a material forming the occlusive member (para. [0074]).
Regarding claim 20, Edmiston discloses the occlusive implant of claim 1. Edmiston further discloses wherein the conformable material is disposed directly on the expandable framework and under the occlusive member (depicted in figs. 1a-b).
Regarding claim 11, Edmiston discloses (see abstract; paras. [0072]-[0075]; figs. 1-1b) a medical implant (20, fig. 1) for occluding a left atrial appendage (abstract), comprising:
an expandable framework (frame of occluder portion 24, para. [0072]; fig. 1) configured to shift between a collapsed configuration and an expanded configuration (para. [0089]);
a plurality of anchor members (anchor portion 26) disposed along the expandable framework (figs. 1-1a);
a covering (second material layer 32, para. [0074]) disposed along an outer surface of the expandable framework (figs. 1a-b); and
a protrusion portion (first material layer 30) extending outward from the covering (considered to extend outward of second material layer 32, e.g. extends outside of second material layer 32, fig. 1b), the protrusion portion including a conformable material (foam, para. [0074]) different from a material forming the covering (para. [0074]).
Regarding claim 23, Edmiston discloses the medical implant of claim 11. Edmiston further discloses wherein the conformable material is disposed directly on the expandable framework and under the covering (figs. 1a-b, see 112(b) rejection above).
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 1-5, 8, 10-14, 18-19, 21-22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-9 of U.S. Patent No. 12,082,794 B2 to Onushko in view of Khairkhahan.
Regarding claim 1, Onushko claims the implant of claim 1 (claim 8), but fails to claim wherein the sealing member includes a conformable material different from a material forming the occlusive member.
Khairkhahan teaches wherein the sealing member includes a conformable material (70) different from a material forming the occlusive member (includes swellable bodies 70 formed of foam, considered to be formed of a different material than membrane 11, para. [0057]), for the purpose of sealing the peripheral portion of the membrane against the patient’s heart wall via an expandable material (paras. [0012]-[0013] and [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the sealing member includes a conformable material different from a material forming the occlusive member, in order to seal the peripheral portion of the sealing member against the patient’s tissue via an expandable material, based on the teachings of Khairkhahan (paras. [0012]-[0013] and [0060]).
Regarding claim 2, Onushko (as modified) claims the implant of claim 2 (claim 8).
Regarding claim 3, Onushko (as modified) claims the implant of claim 3 (claim 8), but fails to claim wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric.
Khairkhahan teaches wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric (para. [0015]), for the purpose of forming the membrane of an appropriate flexible material (para. [0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric, in order to form the membrane of an appropriate flexible material, based on the teachings of Khairkhahan (para. [0015]).
Regarding claim 4, Onushko (as modified) claims the implant of claim 4 (claim 8), but fails to claim wherein the sealing member and the conformable material both extend around only a portion of an outer surface of the occlusive member.
Khairkhahan teaches wherein the sealing member and the conformable material both extend around only a portion of an outer surface of the occlusive member (outer membrane of layer 11 and swellable bodies 70 considered to extend only around portions of inner layer of membrane 11 due to presence of ribs 14 and swellable bodies 70 located in between layers, figs. 2-3, 7 and 18), for the purpose of providing swellable bodies to seal the peripheral portion of the membrane against the patient’s heart wall at specific parts of the device (para. [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the sealing member and the conformable material both extend around only a portion of an outer surface of the occlusive member, in order to provide swellable bodies to seal the peripheral portion of the membrane against the patient’s tissue at specific parts of the device, based on the teachings of Khairkhahan (para. [0060]).
Regarding claim 5, Onushko (as modified) claims the implant of claim 5 (claim 8), but fails to claim wherein the sealing member and the conformable material both extend circumferentially around an outer surface of the occlusive member.
Khairkhahan teaches wherein the sealing member and the conformable material both extend circumferentially around an outer surface of the occlusive member (figs. 1-3 and 17-18), for the purpose of sealing the peripheral portion of the membrane against a patient’s heart circumferentially around the implant (para. [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the sealing member and the conformable material both extend circumferentially around an outer surface of the occlusive member, in order to seal the peripheral portion of the membrane against a patient’s tissue circumferentially around the implant, based on the teachings of Khairkhahan (para. [0060]).
Regarding claim 8, Onushko (as modified) claims the implant of claim 8 (claim 8), and further claims wherein the conformable material includes an expandable material (swellable bodies 70 are formed of expandable material, para. [0060] of Khairkhahan).
Regarding claim 10, Onushko (as modified) claims the implant of claim 10 (claim 9).
Regarding claim 18, Onushko (as modified) claims the implant of claim 10 (claim 8), and further claims wherein the expandable material is a hydrogel (swellable material includes collagen, a known hydrogel, paras. [0012]-[0013] and [0037] of Khairkhahan).
Regarding claim 19, Onushko (as modified) claims the implant of claim 19 (claim 8), but fails to claim wherein the conformable material is disposed inside a pocket formed between the occlusive member and the sealing member.
Khairkhahan teaches wherein the conformable material is disposed inside a pocket formed between the occlusive member and the sealing member (see fig. 18 depicting swellable bodies 70 formed between the inner and outer layer of membrane 11, such that swellable bodies 70 are considered to be disposed inside a pocket formed between the occlusive member and a portion of the sealing member, which is consistent with fig. 5 of the instant spec.), for the purpose of forming a barrier around the swellable bodies 70 for proper sealing (paras. [0012]-[0013] and [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the conformable material is disposed inside a pocket formed between the occlusive member and the sealing member, in order to form a barrier around the conformable material for proper sealing, based on the teachings of Khairkhahan (paras. [0012]-[0013] and [0060]).
Regarding claim 21, Onushko (as modified) claims the implant of claim 21 (claim 8), but fails to claim wherein the conformable material is disposed axially between a proximal end of the expandable framework and the plurality of anchor members.
Khairkhahan teaches wherein the conformable material is disposed axially between a proximal end of the expandable framework and the plurality of anchor members (see figs. 17-18, swellable bodies 70 are disposed between a proximal end of the frame and a distal end of tip elements 27 of ribs 14), for the purpose of proper sealing of the device to the patient’s tissue (para. [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the conformable material is disposed axially between a proximal end of the expandable framework and the plurality of anchor members, in order to provide proper sealing of the device to the patient’s tissue along an appropriate location of the device, based on the teachings of Khairkhahan (para. [0060]).
Regarding claim 11, Onushko claims the implant of claim 11 (claim 11), but fails to claim the protrusion portion including a conformable material different from a material forming the covering.
Khairkhahan teaches the protrusion portion including a conformable material different from a material forming the covering (includes swellable bodies 70 formed of foam, considered to be formed of a different material than membrane 11, para. [0057]), for the purpose of sealing the peripheral portion of the membrane against the patient’s heart wall via an expandable material (paras. [0012]-[0013] and [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the protrusion portion includes a conformable material different from a material forming the covering, in order to seal the peripheral portion of the protrusion portion against the patient’s tissue via an expandable material, based on the teachings of Khairkhahan (paras. [0012]-[0013] and [0060]).
Regarding claim 12, Onushko (as modified) claims the implant of claim 12 (claim 12).
Regarding claim 13, Onushko (as modified) claims the implant of claim 13 (claim 11), but fails to claim wherein the covering and the conformable material both extend along only a portion of the expandable framework.
Khairkhahan teaches wherein the covering and the conformable material both extend along only a portion of the expandable framework (see figs. 5 and 7 depicting proximal and distal ends of ribs 14 not covered by membrane, see also swellable bodies 70 located only along portions of the frame, figs. 2-3, 7 and 18), for the purpose of providing specific locations for the swellable bodies to seal against the patient’s tissue (para. [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the covering and the conformable material both extend along only a portion of the expandable framework, in order to provide specific locations for the swellable bodies to seal against the patient’s tissue, based on the teachings of Khairkhahan (para. [0060]).
Regarding claim 14, Onushko (as modified) claims the implant of claim 14 (claim 13).
Regarding claim 22, Onushko (as modified) claims the implant of claim 22 (claim 11), and further claims wherein the conformable material is a hydrogel (swellable material includes collagen, a known hydrogel, paras. [0012]-[0013] and [0037] of Khairkhahan).
Regarding claim 24, Onushko (as modified) claims the implant of claim 24 (claim 11), but fails to claim wherein the conformable material is disposed inside a pocket formed from the covering.
Khairkhahan teaches wherein the conformable material is disposed inside a pocket formed from the covering (see fig. 18 depicting swellable bodies 70 formed between the inner and outer layer of membrane 11, pocket considered to be formed from inner layer of membrane 11), for the purpose of forming a barrier around the swellable bodies 70 for proper sealing (paras. [0012]-[0013] and [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the conformable material is disposed inside a pocket formed from the covering, in order to form a barrier around the conformable material for proper sealing, based on the teachings of Khairkhahan (paras. [0012]-[0013] and [0060]).
Claims 1, 11, 20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,082,794 B2 to Onushko in view of Edmiston.
Regarding claim 1, Onushko claims the implant of claim 1 (claim 8), but fails to claim wherein the sealing member includes a conformable material different from a material forming the occlusive member.
Edmiston teaches wherein the sealing member includes a conformable material (30) different from a material forming the occlusive member (different from second material layer 32, para. [0074]), for the purpose of promoting tissue growth (para. [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the sealing member includes a conformable material different from a material forming the occlusive member, in order to promote tissue in-growth and endothelization to occur, based on the teachings of Edmiston (para. [0075]).
Regarding claim 20, Onushko (as modified) claims the implant of claim 20 (claim 8), but fails to claim wherein the conformable material is disposed directly on the expandable framework and under the occlusive member.
Edmiston teaches wherein the conformable material is disposed directly on the expandable framework and under the occlusive member (depicted in figs. 1a-b), for the purpose of providing an additional layer to effectively prevent the passage of blood, enabling tissue in-growth at the inside of the medical device (para. [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the conformable material is disposed directly on the expandable framework and under the occlusive member, in order to provide an additional layer to effectively prevent the passage of blood, enabling tissue in-growth at the inside of the medical device, based on the teachings of Edmiston (para. [0075]).
Regarding claim 11, Onushko claims the implant of claim 11 (claim 11), but fails to claim the protrusion portion including a conformable material different from a material forming the covering.
Edmiston teaches the protrusion portion including a conformable material (foam, para. [0074]) different from a material forming the covering (different from second material layer 32, para. [0074]), for the purpose of promoting tissue growth (para. [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the protrusion portion includes a conformable material different from a material forming the covering, in order to promote tissue in-growth and endothelization to occur, based on the teachings of Edmiston (para. [0075]).
Regarding claim 23, Onushko (as modified) claims the implant of claim 23 (claim 11), but fails to claim wherein the conformable material is disposed directly on the expandable framework and under the occlusive member.
Edmiston teaches wherein the conformable material is disposed directly on the expandable framework and under the occlusive member (figs. 1a-b, see 112(b) rejection above), for the purpose of providing an additional layer to effectively prevent the passage of blood, enabling tissue in-growth at the inside of the medical device (para. [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the conformable material is disposed directly on the expandable framework and under the occlusive member, in order to provide an additional layer to effectively prevent the passage of blood, enabling tissue in-growth at the inside of the medical device, based on the teachings of Edmiston (para. [0075]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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