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 responsive to the amendment filed on 02/25/2026. As directed by the amendment: claims 1, 13, 22, and 24-25 have been amended, claims 5, 8, 10-11, and 16 have been cancelled and claim 26 have been added. Thus, claims 1-4, 6-7, 9, 12-15, and 17-26 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 7, filed 02/25/2026, with respect to the USC 112(d) rejection have been fully considered and are persuasive. The applicant’s amendment to claim 22 to correct dependency overcomes the rejection. The USC 112d rejections have been withdrawn.
Applicant’s arguments, see page 8, filed 02/25/2026, with respect to the rejection(s) of claim(s) 13 under 35 U.S.C. 102(a)(1) as being anticipated by Peh et al (US 20080033241 A1), herein referenced to as “Peh” been fully considered and are persuasive.
The applicant has amended claim 13 to further recite “wherein said distal section of said isolator comprises a fastener loop in contact with a surface of said distal section; expanding said distal section of said isolator in said LA following said extending, wherein expansion of said isolator expands said fastener loop, wherein following said expanding said distal section surface and said fastener loop surround a lumen of said isolator”.
The applicant asserts that Peh does not disclose the amended limitations. The examiner agrees that Peh does not disclose wherein said distal section of said isolator comprises a fastener loop in contact with a surface of said distal section.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fleischman et al (US 20110077672 A1) in view of Peh and Kiser et al (US 20190262003 A1).
Applicant’s arguments, see pages 9-10, filed 02/25/2026, with respect to the rejection(s) of claim(s) 1, 24, and 25 under 35 U.S.C. 103 as being unpatentable over Peh et al (US 20080033241 A1), herein referenced to as “Peh” in view of Kassab (US 20160022273 A1), herein referenced to as “Kassab” have been fully considered and are persuasive.
The applicant amended claim 1 to further recite “a fastener coupled to and contact a surface of said isolator body” and “wherein expansion of said isolator in said LA expands said fastener”.
Claims 24-25 have been amended similarly.
The examiner agrees that the amendments overcome the prior art of record.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fleischman et al (US 20110077672 A1) in view of Peh and Kiser et al (US 20190262003 A1).
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 25 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.
Claim 25 recites the limitation "said body" in ll 6. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art examination limitation “said body” will be interpreted as “a body of said isolator”. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2-4, 6-7, 9, 12-15, and 17-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleischman et al (US 20110077672 A1), herein referenced to as “Fleischman” in view of Peh et al (US 20080033241 A1), herein referenced to as “Peh” and Kiser et al (US 20190262003 A1), herein referenced as “Kiser”.
Claim 1
Fleischman discloses: A left atrial appendage (LAA) isolator system (see Figs. 18-19B, [0036] and [0079]-[0080, methods & devices for affixing the inverted appendages), comprising: a catheter 74a (see Figs. 18-19B, [0079]) having a lumen the lumen of 74a (see Fig. 18), wherein said catheter 74a is insertable via blood vessels into a left atrium (LA) of a subject (see Figs. 19A-19B, [0089], the catheter is introduced in to the LA adjacent to the left atrial appendage 17, see also Figs. 5-6, [0064], catheter advanced through the aorta); an isolator 77 (see Figs. 18-19B, [0079]) comprising a body 78 (see Figs. 18-19B, [0079]), wherein said body 78 is configured to extend from said catheter 74A into the LA the LA is tissue in which the LAA 17 is inverted into (see Figs. 19A-19B, see also Figs. 5-6), and has a lumen the lumen of 78 which accepts 17 (see Figs. 19A-19B, [0079]), a proximal opening 75 (see Fig. 18, [0079], the proximal opening is in the lumen of 74A) in said catheter lumen the lumen of 74A and a distal opening the opening defined by 79 (see Figs. 19A-19B, [0079]) large enough to at least match an opening of said LAA (see annotated Fig. 19A below); a fastener 79 (see Figs. 18-19B, [0079], 79 is a fastener as it is a loop as further defined in the claim) coupled to and contact a surface the surface of 78 of said isolator body 78 (see Figs. 18-19B, 78 is connected to 79, hence contacting a surface of 78), wherein said fastener 79 is shaped as a loop 79 (see Figs. 19A-19B, [0079], 79 is a loop that defines the lumen of 78, hence surrounding said lumen) surrounding said lumen the lumen of 78 that accepts 17 of said isolator 77, and is configured to surround around a portion of said LAA inverted (see Figs. 19A-19B, 70 surrounds the portion of 17 inverted into 78) into said lumen the lumen of 78 that accepts 17 of said isolator 77 via said distal opening the distal opening defined by 79, wherein said isolator 77 and said fastener 79 are configured to expand in said LA (see Figs. 18-19B, [0079] 77 and 79 expand in the LA when released from 74A) when extended out from said catheter 74A into said LA, to a width larger (see annotated Fig. 19A below, the opening defined by 79 is larger than the opening of the LAA) than said LAA opening, and wherein when expanded (see Figs. 19A-19B), said isolator 77 is configured to be positioned over said LAA opening in said LA (see Figs. 19A-19B), wherein expansion of said isolator 77 in said LA expands said fastener 79 (see Figs. 18-19B, [0079], the expansion of 77 also expands 79).
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Fleischman does not explicitly disclose: wherein said isolator is configured to prevent LAA content from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening; the fastener is configured to fasten around the portion of said LAA.
However, Peh in a similar field of invention teaches a left atrial appendage (LAA) isolator system 10 (see Figs. 1A – 1B, [0042]) with an isolator 12 (see Figs. 1A – 1B, 11 and 15A – 15C, [0043]) comprising a body the body of 12 (see Figs. 15A-15C) with a distal opening distal opening of 12 that is larger than the opening of the LAA (see Fig. 15B, [0044], 1 to 5 times greater than diameter of a catheter, 5 times greater than a catheter would at least match, if not exceed the opening of the LAA, as shown in Figs. 15A-15C) large enough to at least match an opening of said LAA LAA (see Figs. 15A-15C, 12 matches the opening of the LAA and surrounds it). Peh further teaches: wherein said isolator is configured to prevent LAA content (see [0070], 12 is configured to enable capture and/or removable of blood clots and prevents release of blood clots) from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening (see [0070]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a left atrial appendage isolator system with the isolator is configured to prevent LAA content from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening. Motivation for such can be found in Peh as this can allow for the capture and/or removal of blood clots which may be found in the LAA by inhibiting or preventing the release of blood clots or debris which may be dislodged from within the LAA (see [0070]).
The combination of Fleischman and Peh does not explicitly teach: the fastener is configured to fasten around the portion of said LAA.
However, Kiser in a similar field of invention teaches a left atrial appendage isolator system (see Figs. 4A-4E) with an isolator 2 (see Figs. 4A-4E) with a fastener 44 (see Figs. 4A-4E) shaped as a loop 44 (see Figs. 4A-4E) configured to surround a portion of an LAA 24 (see Figs. 4B-4D). Kiser further teaches: configured to fasten around the portion of said LAA 24 (see Figs. 4A-4E, 44 surrounds and fastens around 24, [0114]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Kiser and teach a left atrial appendage isolator system with the fastener is configured to fasten around the portion of said LAA. Motivation for such can be found in Kiser as this loop is a cushion that can reduce the trauma to the atrial surface and increase sealing between the opening of the AA portion and the atrial surface (see [0059]), thus preventing LAA content from escaping or entering into the segregated LAA.
Claim 2
The combination of Fleischman, Peh, and Kiser teaches: A system according to claim 1, see 103 rejection above. Fleischman does not explicitly disclose: comprising a negative pressure source configured to apply vacuum via said catheter lumen and said isolator distal opening on said LAA which is sufficient to direct said LAA content into said catheter lumen.
However, Peh further teaches: comprising a negative pressure source 132 suction pump (see [0064]) configured to apply vacuum suction via said catheter lumen deployment catheter (see [0064]) and said isolator 12 distal opening (see annotated Fig. 1B below claim 1) on said LAA which is sufficient to direct said LAA content (see [0064]) fluid or debris may be sucked) into said catheter lumen (see [0064]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a left atrial appendage isolator system with a negative pressure source configured to apply vacuum via said catheter lumen and said isolator distal opening on said LAA which is sufficient to direct said LAA content into said catheter lumen. Motivation for such can be found in Peh as this allows the user to suck fluid or debris for evacuation from the patient body (see [0064]).
Claim 3
The combination of Fleischman, Peh, and Kiser teaches: A system according to claim 1, see 103 rejection above. Fleischman does not explicitly disclose: comprising: an extendible LAA manipulation tool located within said catheter lumen and within said isolator, wherein said extendible LAA manipulation tool comprises a vacuum catheter having a vacuum channel with at least one distal vacuum head, wherein said at least one distal vacuum head is configured to extend from said catheter lumen into said LAA, and to apply negative pressure which is sufficient to remove said LAA content from said LAA into said vacuum channel.
However, Peh further teaches: comprising: an extendible LAA manipulation tool 260 (see Fig. 17A, [0076] and [0077]) located within said catheter lumen the catheter lumen and within said isolator 12 (the manipulation tool is within the isolator, see Fig. 17A), wherein said extendible LAA manipulation tool 260 comprises a vacuum catheter suction catheter (see [0079]) having a vacuum channel suction catheter is a catheter, which has a lumen for suction with at least one distal vacuum head 264 (see Fig. 17A, [0079]), wherein said at least one distal vacuum head 264 is configured to extend from said catheter lumen from the catheter lumen distally into said LAA (see Fig. 17A), and to apply negative pressure which is sufficient to remove said LAA content from said LAA into said vacuum channel (see [0064] and [0079]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a left atrial appendage isolator system with an extendible LAA manipulation tool located within said catheter lumen and within said isolator, wherein said extendible LAA manipulation tool comprises a vacuum catheter having a vacuum channel with at least one distal vacuum head, wherein said at least one distal vacuum head is configured to extend from said catheter lumen into said LAA, and to apply negative pressure which is sufficient to remove said LAA content from said LAA into said vacuum channel. Motivation for such can be found in Peh as this allows the user to suck fluid or debris for evacuation from the patient body (see [0064]).
Claim 4
The combination of Fleischman, Peh, and Kiser teaches: A system according to claim 1, see 103 rejection above. Peh further teaches: wherein at least a portion of said at least one distal vacuum head 264 (catheters as known in the art are made from flexible materials to bend through vasculature to reach their targets, and flexible materials are disclosed in Peh) is elastic soft elastomeric material (see [0048], silicone or polyurethane) and/or foldable polymeric plastic (see [0043], see also applicant’s PGPUB [0249], an example of material used for the vacuum head is plastic or silicon).
Claim 6
The combination of Fleischman, Peh, and Kiser teaches: A system according to claim 1, see 103 rejection above. Fleischman does not explicitly disclose: wherein a width of said isolator distal opening is in a range between 7 mm to 70 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Fleischman to have wherein a width of said isolator distal opening is in a range between 7 mm to 70 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Fleischman would not operate differently with wherein a width of said isolator distal opening is in a range between 7 mm to 70 mm. Further, applicant places no criticality on the range claimed, as the applicant states within their specification that the width of the cover can be any value “of up to 15 mm, for example 5 mm, 10 mm, 12 mm or any intermediate, smaller or larger value” as the width can be any value larger or smaller, thus it is not critical.
Claim 7
The combination of Fleischman, Peh, and Kiser teaches: A system according to claim 1, see 103 rejection above. Fleischman does not explicitly disclose: wherein said isolator is porous, having openings with a maximal dimension of up to 0.5 mm.
However, Peh further teaches: wherein said isolator 12 is porous woven material (see [0043], a woven material is a porous one as the threads that are woven together have gaps in between the threads).
Peh does not explicitly teach: having openings with a maximal dimension of up to 0.5 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Fleischman as modified by Peh to have openings with a maximal dimension of up to 0.5 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Fleischman as modified by Peh would not operate differently with having openings with a maximal dimension of up to 0.5 mm. Further, applicant places no criticality on the range claimed, as the applicant states within their specification that the dimensions of the openings of a mesh cover can be any value “for example 0.5 mm, 1 mm, 5 mm, 10 mm, 15 mm or any intermediate, smaller or larger value” as the opening can be any dimension value larger or smaller, thus it is not critical.
Claim 9
The combination of Fleischman, Peh, and Kiser teaches: a system according to claim 1, see 103 rejection above. Peh further teaches: wherein said isolator 12 comprises an elastic cover soft elastomeric material (see [0048]) configured to be positioned over said LAA opening (see [0070]).
Claim 12
The combination of Fleischman, Peh, and Kiser teaches: a system according to claim 1, see 103 rejection above. Peh further teaches: wherein said LAA content comprises blood clots, tissue debris and/or cell debris (see [0070], 12 is configured to enable capture and/or removable of blood clots and prevents release of blood clots).
Claim 13
Fleischman discloses: A method for isolating a left atrial appendage (LAA) (see Figs. 18-19B, [0036] and [0079]-[0080, methods & devices for affixing the inverted appendages), comprising: inserting a catheter 74a (see Figs. 18-19B, [0079]) having a lumen the lumen of 74a (see Fig. 18) into a left atrium (LA) of a subject (see Figs. 19A-19B, [0089], the catheter is introduced in to the LA adjacent to the left atrial appendage 17, see also Figs. 5-6, [0064], catheter advanced through the aorta); extending a distal section the distal portion of 77 including 79 (see Figs. 18-19B, [0079]) of an isolator 77 (see Figs. 18-19B, [0079]) from said catheter lumen the lumen of 74A into said LA (see Figs. 18-19A, [0079]) while keeping a proximal section the proximal end of 52 within 74A (see [0079], only the distal end of 52 exits from 74A) of said isolator 77 within said catheter lumen the lumen 74A, wherein said distal section the distal portion of 77 including 79 of said isolator 77 comprises a fastener loop 79 (see Figs. 18-19B, [0079]) in contact with a surface the surface of 78 where it contacts 79 of said distal section the distal portion of 77 including 79; expanding (see Figs. 18-19A, [0079], 77 + 79 expanding) said distal section the distal portion of 77 including 79 of said isolator 77 in said LA following said extending (see Figs. 18-19A, [0079], 76A, is used to extend 77 and 79, thus expanding after it enters into the LA), wherein expansion (see Figs. 18-19B, [0079], the expansion of 77 also expands 79) of said distal section the distal portion of 77 including 79 of said isolator 77 expands said fastener loop 79, wherein following said expanding said distal section surface the surface of 78 where it contacts 79 (see Figs. 18-19A, the surface 78 expands) and said fastener loop 79 surround a lumen the lumen of 78 which accepts 17 (see Figs. 19A-19B, [0079]) of said isolator 77; coupling said distal section the distal portion of 77 including 79 of said isolator 77 to a wall of said LA (see annotated Figs. 19A-19B below) over an opening (see annotated Figs. 19A-19B below) of said LAA; surrounding (see Figs. 19A-19B, 70 surrounds the portion of 17 inverted into 78) following said expanding (see above) and said coupling (see above) said fastener loop 79 around a portion of said LAA 17 (see Figs. 19B) inverted into said LA (see Figs. 19A-19B, 70 surrounds the portion of 17 inverted into 78 and the LA) and into said isolator lumen the lumen of 78 that accepts 17.
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Fleischman does not explicitly disclose: isolating said LAA by coupling said distal section of said isolator to a wall of said LA over an opening of said LAA to prevent the release of LAA content from said LAA into said LA; fastening following said expanding and said isolating said fastener loop around a portion of said LAA, while said LAA remains isolated.
However, Peh in a similar field of invention teaches a method for isolating a left atrial appendage (LAA) (see Figs. 1A – 1B, [0042]) with an isolator 12 (see Figs. 1A – 1B, 11 and 15A – 15C, [0043]) comprising a body the body of 12 (see Figs. 15A-15C) with a distal opening distal opening of 12 that is larger than the opening of the LAA (see Fig. 15B, [0044], 1 to 5 times greater than diameter of a catheter, 5 times greater than a catheter would at least match, if not exceed the opening of the LAA, as shown in Figs. 15A-15C) large enough to at least match an opening of said LAA LAA (see Figs. 15A-15C, 12 matches the opening of the LAA and surrounds it). Peh further teaches: isolating said LAA by distal section the distal section of 12 of said isolator 12 to a wall of said LA over an opening of said LAA (see [0070]) to prevent the release of LAA content from said LAA into said LA (see [0070], 12 is configured to enable capture and/or removable of blood clots and prevents release of blood clots).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a method for isolating a left atrial appendage (LAA) with isolating said LAA by coupling said distal section of said isolator to a wall of said LA over an opening of said LAA to prevent the release of LAA content from said LAA into said LA. Motivation for such can be found in Peh as this can allow for the capture and/or removal of blood clots which may be found in the LAA by inhibiting or preventing the release of blood clots or debris which may be dislodged from within the LAA (see [0070]).
The combination of Fleischman and Peh further teaches: surrounding (Fleischman, see Figs. 19A-19B, 70 surrounds the portion of 17 inverted into 78) following said expanding (Fleischman, see above) and said coupling (Fleischman, see above) said fastener loop 79 around a portion of said LAA 17 (Fleischman, see Figs. 19B) inverted into said LA (Fleischman, see Figs. 19A-19B, 70 surrounds the portion of 17 inverted into 78 and the LA) and into said isolator lumen the lumen of 78 that accepts 17, while said LAA (78 of Fleischman is modified by 12 of Peh to isolate, so the configuration as shown from Figs 19A-19B of Fleischman remains, with now isolating 17 as well, hence the loop 79 with 17 placed within 78 is also isolating while surrounding) remains isolated.
The combination of Fleischman and Peh does not explicitly teach: fastening following said expanding and said isolating said fastener loop around a portion of said LAA.
However, Kiser in a similar field of invention teaches a method for isolating a left atrial appendage (LAA) (see Figs. 4A-4E) with an isolator 2 (see Figs. 4A-4E) with a fastener 44 (see Figs. 4A-4E) shaped as a loop 44 (see Figs. 4A-4E) configured to surround a portion of an LAA 24 (see Figs. 4B-4D). Kiser further teaches: fastening following expanding (see Fig. 4B, 44 is expanded) and said isolating (see Fig. 4B, 24 is isolated via 2 surrounding it) said fastener loop 44 around the portion of said LAA 24 (see Figs. 4A-4E, 44 surrounds and fastens around 24, [0114]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Kiser and teach a method for isolating a left atrial appendage (LAA) with fastening following said expanding and said isolating said fastener loop around a portion of said LAA. Motivation for such can be found in Kiser as this loop is a cushion that can reduce the trauma to the atrial surface and increase sealing between the opening of the AA portion and the atrial surface (see [0059]), thus preventing LAA content from escaping or entering into the segregated LAA.
Claim 14
The combination of Fleischman, Peh, and Kiser teaches: A method according to claim 13, see 103 rejection above. Fleischman does not explicitly disclose: applying vacuum through said isolator distal section on said LAA to direct said LAA content from said LAA into said catheter lumen.
However, Peh further teaches: applying vacuum (see [0064] and [0079]) through said isolator distal section distal portion of 12 on said LAA to direct said LAA content from said LAA into said catheter lumen LAA (see Figs. 15A-15C, 12 matches the opening of the LAA and surrounds it).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a method of isolating the LAA with applying vacuum through said isolator distal section on said LAA to direct said LAA content from said LAA into said catheter lumen. Motivation for such can be found in Peh as this allows the user to suck fluid or debris for evacuation from the patient body (see [0064]).
Claim 15
The combination of Fleischman, Peh, and Kiser teaches: A method according to claim 13, see 103 rejection above. Peh further teaches: wherein said isolator distal section 12 comprises a porous cover woven material (see [0043], a woven material is a porous one as the threads that are woven together have gaps in between the threads), and wherein said method comprises positioning following said extending said porous cover 12 over said opening of said LAA, and wherein said coupling comprises coupling said porous cover of said isolator to said LA wall (see [0070]).
Claim 17
The combination of Fleischman, Peh, and Kiser teaches: A method according to claim 13, see 103 rejection above. Fleischman does not explicitly disclose: inserting a vacuum catheter having at least one vacuum head into said LAA via a distal opening of said isolator, and applying vacuum by said at least one vacuum head from within the LAA to remove said LAA content out from the body of the subject.
However, Peh further teaches: inserting a vacuum catheter 260 suction catheter (see [0079]) having at least one vacuum head 264 (see Fig. 17A, [0079]) into said LAA via a distal opening of said isolator distal opening of 12 (see Fig. 17A), and applying vacuum by said at least one vacuum head from within the LAA to remove said LAA content out from the body of the subject (see [0064] and [0079]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a method of isolating the LAA with inserting a vacuum catheter having at least one vacuum head into said LAA via a distal opening of said isolator, and applying vacuum by said at least one vacuum head from within the LAA to remove said LAA content out from the body of the subject. Motivation for such can be found in Peh as this allows the user to suck fluid or debris for evacuation from the patient body (see [0064]).
Claim 18
The combination of Fleischman, Peh, and Kiser teaches: A method according to claim 13, see 103 rejection above. Peh further teaches: wherein said LAA content comprises blood clots, tissue debris and/or cell debris (see [0070], 12 is configured to enable capture and/or removable of blood clots and prevents release of blood clots).
Claim 19
The combination of Fleischman, Peh, and Kiser teaches: A method according to claim 13, see 103 rejection above. Fleischman does not explicitly disclose: anchoring following said coupling, a plug within the LAA, wherein said plug is configured to block said LAA opening; and removing said distal section of said isolator from the LA after said anchoring.
However, Peh in a similar field of invention teaches a method of isolating the LAA (see Fig. 10A) with an isolator 12 (see Fig. 10A). Peh further teaches: anchoring (see [0069], remain within the LAA) following said coupling, a plug 156 (see Fig. 10A, [0069]) within the LAA, wherein said plug 156 is configured to block said LAA opening (see [0056], seal the LAA off from the atrial chamber); and removing said distal section of said isolator from the LA after said anchoring (see [0059] and [0069], disengaging the hood 12 after 156 has been deployed).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a method of isolating the LAA with anchoring following said coupling, a plug within the LAA, wherein said plug is configured to block said LAA opening; and removing said distal section of said isolator from the LA after said anchoring. Motivation for such can be found in Peh as this device can remain within the LAA to seal the LAA from within off form the atrial chamber (see [0069]).
Claim 20
The combination of Fleischman, Peh, and Kiser teaches: A method according to claim 13, see 103 rejection above. Fleischman further discloses: comprising: diagnosing said subject with atrial fibrillation prior to said inserting (see [0001]-[0004], patients with atrial fibrillation).
Claim 21
The combination of Fleischman, Peh, and Kiser teaches: A method according to claim 13, see 103 rejection above. Fleischman further discloses: comprising inverting said portion of said LAA 17 into said LA (see annotated Figs. 19A-19B below claim 13, 70 grasps and inverts the LAA into the LA and into the isolator 77) and into said isolator 77 by introducing a tissue inverting element 70 (see Figs. 18-19B, [0079], introduced through 75 and in the LAA, see Fig. 19A) into said LAA and applying a pulling force on a wall of said LAA (see Figs. 19A-19B, [0079], a portion of the wall of 17 is pulled by 70) by said tissue inverting element 70 while retracting said tissue inverting element 70 into said LA (see annotated Fig. 19B below claim 13, as 70 is pulled into the LA, the LAA is also pulled into the LA).
Fleischman does not explicitly disclose: the pulling force is applying vacuum.
However, Peh in a similar field of invention teaches a tissue inverting element 260 (see Figs. 17A-17B) with a pulling force (see Figs. 17A-17B, the tissue of LAA is inverted via a pulling force, inverting meaning “to turn inward” as defined by the Merriam-Webster online dictionary, the LAA is turning inward on itself). Peh further teaches: the pulling force is applying vacuum suction (see [0064 and [0079]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a method of isolating the LAA with the pulling force is applying vacuum. Motivation for such can be found in Peh as this allows the user to suck fluid or debris for evacuation from the patient body (see [0064]).
Claim 22
The combination of Fleischman, Peh, and Kiser teaches: A method according to claim 21, see 103 rejection above. Fleischman further discloses: wherein said inverting (see annotated Figs. 19A-19B below claim 13) further comprises grasping (see Figs. 19A-19B, the wall of 17 is grasped with an anchor at the end of 70) said wall of said LAA 17 during said inverting.
Claim 23
The combination of Fleischman, Peh, and Kiser teaches: A system according to claim 1, see 103 rejection above. Fleischman further discloses: wherein said fastener 79 is attached to a circumference the inner circumference of 77 (see Figs. 19A-19B, the circumference being a periphery of 77 defined by 79) of an inner surface the inner surface of 77 (see Figs. 19A-19B, 79 is attached the inner circumference by being the distal circumference of 77, hence contacting both an outer and inner circumference of the 77) of said isolator body 77 surrounding said lumen the lumen of 78 that accepts 17 of said isolator 77.
Claim 24
Fleischman discloses: A left atrial appendage (LAA) isolator system (see Figs. 18-19B, [0036] and [0079]-[0080, methods & devices for affixing the inverted appendages), comprising: a catheter 74a (see Figs. 18-19B, [0079]) having a lumen the lumen of 74a (see Fig. 18), wherein said catheter 74a is insertable via blood vessels into a left atrium (LA) of a subject (see Figs. 19A-19B, [0089], the catheter is introduced in to the LA adjacent to the left atrial appendage 17, see also Figs. 5-6, [0064], catheter advanced through the aorta); an isolator 77 (see Figs. 18-19B, [0079]) comprising a body 78 (see Figs. 18-19B, [0079]), wherein said body 78 is configured to extend from said catheter 74A into the LA the LA is tissue in which the LAA 17 is inverted into (see Figs. 19A-19B, see also Figs. 5-6) and to expand in said LA (see Fig. 18 and annotated Fig. 19A below, 77 expands in the LA), wherein said body 78 has a lumen the lumen of 78 which accepts 17 (see Figs. 19A-19B, [0079]), a proximal opening 75 (see Fig. 18, [0079], the proximal opening is in the lumen of 74A) in said catheter lumen the lumen of 74A and a distal opening the opening defined by 79 (see Figs. 19A-19B, [0079]) large enough to at least match an opening of said LAA (see annotated Fig. 19A below) when said body 78 is expanded (see annotated Fig. 19A below); a fastener 79 (see Figs. 18-19B, [0079], 79 is a fastener as it is a loop as further defined in the claim) shaped as a loop 79 (see Figs. 19A-19B, [0079], 79 is a loop that defines the lumen of 78, hence surrounding said lumen) attached to a circumference the inner circumference of 78 (see Figs. 19A-19B, the circumference being a periphery of 78 defined by 79) of an inner surface the inner surface of 78 (see Figs. 19A-19B, 79 is attached the inner circumference by being the distal circumference of 77, hence contacting both an outer and inner circumference of the 77) of said isolator body 78 surrounding said lumen the lumen of 78 which accepts 17 of said isolator 77, configured to be surrounded around a portion of said LAA inverted (see Figs. 19A-19B, 70 surrounds the portion of 17 inverted into 78) into said LA (see annotated Fig. 19B below), and into said lumen the lumen of 78 that accepts 17 of said isolator 77 via said distal opening the opening defined by 79; wherein expansion of said isolator 77 in said LA expands said fastener 79 (see Figs. 18-19B, [0079], the expansion of 77 also expands 79).
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Fleischman does not explicitly disclose: wherein said isolator is configured to prevent LAA content from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening; the fastener is configured to fasten around the portion of said LAA.
However, Peh in a similar field of invention teaches a left atrial appendage (LAA) isolator system 10 (see Figs. 1A – 1B, [0042]) with an isolator 12 (see Figs. 1A – 1B, 11 and 15A – 15C, [0043]) comprising a body the body of 12 (see Figs. 15A-15C) with a distal opening distal opening of 12 that is larger than the opening of the LAA (see Fig. 15B, [0044], 1 to 5 times greater than diameter of a catheter, 5 times greater than a catheter would at least match, if not exceed the opening of the LAA, as shown in Figs. 15A-15C) large enough to at least match an opening of said LAA LAA (see Figs. 15A-15C, 12 matches the opening of the LAA and surrounds it). Peh further teaches: wherein said isolator is configured to prevent LAA content (see [0070], 12 is configured to enable capture and/or removable of blood clots and prevents release of blood clots) from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening (see [0070]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a left atrial appendage isolator system with the isolator is configured to prevent LAA content from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening. Motivation for such can be found in Peh as this can allow for the capture and/or removal of blood clots which may be found in the LAA by inhibiting or preventing the release of blood clots or debris which may be dislodged from within the LAA (see [0070]).
The combination of Fleischman and Peh does not explicitly teach: the fastener is configured to fasten around the portion of said LAA.
However, Kiser in a similar field of invention teaches a left atrial appendage isolator system (see Figs. 4A-4E) with an isolator 2 (see Figs. 4A-4E) with a fastener 44 (see Figs. 4A-4E) shaped as a loop 44 (see Figs. 4A-4E) configured to surround a portion of an LAA 24 (see Figs. 4B-4D). Kiser further teaches: configured to fasten around the portion of said LAA 24 (see Figs. 4A-4E, 44 surrounds and fastens around 24, [0114]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Kiser and teach a left atrial appendage isolator system with the fastener is configured to fasten around the portion of said LAA. Motivation for such can be found in Kiser as this loop is a cushion that can reduce the trauma to the atrial surface and increase sealing between the opening of the AA portion and the atrial surface (see [0059]), thus preventing LAA content from escaping or entering into the segregated LAA.
Claim 25
Fleischman discloses: A left atrial appendage (LAA) isolator system (see Figs. 18-19B, [0036] and [0079]-[0080, methods & devices for affixing the inverted appendages), comprising: a catheter 74a (see Figs. 18-19B, [0079]) having a lumen the lumen of 74a (see Fig. 18), wherein said catheter 74a is insertable via blood vessels into a left atrium (LA) of a subject (see Figs. 19A-19B, [0089], the catheter is introduced in to the LA adjacent to the left atrial appendage 17, see also Figs. 5-6, [0064], catheter advanced through the aorta); an isolator 77 (see Figs. 18-19B, [0079]) configured to extend from said catheter 74A into the LA the LA is tissue in which the LAA 17 is inverted into (see Figs. 19A-19B, see also Figs. 5-6) and to expand in said LA (see Fig. 18 and annotated Fig. 19A below, 77 expands in the LA), wherein said body 78 (see Figs. 18-19B, [0079], see 112b rejection above, interpreted as “a body of said isolator) has a proximal opening 75 (see Fig. 18, [0079], the proximal opening is in the lumen of 74A) in said catheter lumen the lumen of 74A and a distal opening the opening defined by 79 (see Figs. 19A-19B, [0079]) large enough to at least match an opening of said LAA (see annotated Fig. 19A below) when said body 78 is expanded (see annotated Fig. 19A below); a fastener 79 (see Figs. 18-19B, [0079], 79 is a fastener as it is a loop as further defined in the claim) coupled to said isolator 77 and surrounds the distal opening the distal opening defined by 79 of the isolator 77, wherein said fastener 79 is configured to be surrounding around a portion of said LAA inverted (see Figs. 19A-19B, 70 surrounds the portion of 17 inverted into 78) into said isolator 77; wherein expansion of said isolator 77 in said LA expands said fastener 79 (see Figs. 18-19B, [0079], the expansion of 77 also expands 79).
Fleischman does not explicitly disclose: wherein said isolator is configured to prevent LAA content from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening; the fastener is configured to fasten around the portion of said LAA.
However, Peh in a similar field of invention teaches a left atrial appendage (LAA) isolator system 10 (see Figs. 1A – 1B, [0042]) with an isolator 12 (see Figs. 1A – 1B, 11 and 15A – 15C, [0043]) comprising a body the body of 12 (see Figs. 15A-15C) with a distal opening distal opening of 12 that is larger than the opening of the LAA (see Fig. 15B, [0044], 1 to 5 times greater than diameter of a catheter, 5 times greater than a catheter would at least match, if not exceed the opening of the LAA, as shown in Figs. 15A-15C) large enough to at least match an opening of said LAA LAA (see Figs. 15A-15C, 12 matches the opening of the LAA and surrounds it). Peh further teaches: wherein said isolator is configured to prevent LAA content (see [0070], 12 is configured to enable capture and/or removable of blood clots and prevents release of blood clots) from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening (see [0070]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Peh and teach a left atrial appendage isolator system with the isolator is configured to prevent LAA content from exiting said LAA into a general circulation when said isolator is positioned over said LAA opening. Motivation for such can be found in Peh as this can allow for the capture and/or removal of blood clots which may be found in the LAA by inhibiting or preventing the release of blood clots or debris which may be dislodged from within the LAA (see [0070]).
The combination of Fleischman and Peh does not explicitly teach: the fastener is configured to fasten around the portion of said LAA.
However, Kiser in a similar field of invention teaches a left atrial appendage isolator system (see Figs. 4A-4E) with an isolator 2 (see Figs. 4A-4E) with a fastener 44 (see Figs. 4A-4E) shaped as a loop 44 (see Figs. 4A-4E) configured to surround a portion of an LAA 24 (see Figs. 4B-4D). Kiser further teaches: configured to fasten around the portion of said LAA 24 (see Figs. 4A-4E, 44 surrounds and fastens around 24, [0114]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman to incorporate the teachings of Kiser and teach a left atrial appendage isolator system with the fastener is configured to fasten around the portion of said LAA. Motivation for such can be found in Kiser as this loop is a cushion that can reduce the trauma to the atrial surface and increase sealing between the opening of the AA portion and the atrial surface (see [0059]), thus preventing LAA content from escaping or entering into the segregated LAA.
Claim 26
The combination of Fleischman, Peh, and Kiser teaches: A system according to claim 1, see 103 rejection above. Fleischman further discloses: wherein said isolator is configured to self- expand when extended out from said catheter into said LA.
The language, " wherein said isolator is configured to self- expand when extended out from said catheter into said LA," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Fleischman meets the structural limitations of the claim, and is capable of the isolator self-expand when extended out of the catheter, as the extension of 76a, hence pushing 79 and 78 out of the sheath 74A causes the expansion of 77 (see [0079], hence a self-expansion occurs when 79 and 78 are no longer constrained by 74A).
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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