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 03/20/2026. As directed by the amendment: claims 22, 24, 26-28, 34-38, and 40-41 have been amended and claims 1-21, 23, 29-33, and 39 have been cancelled. Thus, claims 22, 24-28, 34-38, and 40-41 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 1-2, filed 03/20/2026, with respect to the drawing objections have been fully considered and are partly persuasive. The applicant’s amendments to the claims overcome the drawing objections for not showing claimed language specifically for “a tissue treatment element” and “in which at least one of the anchoring arms comprises a fluid delivery lumen with an outlet adjacent a tip of the anchoring arm, and in which the delivery catheter comprises a lumen configured to fluidically connect with the lumen of the anchoring arm”. The drawing objections have been withdrawn.
Applicant’s arguments, see pages 1-2, filed 03/20/2026, with respect to the drawing objections have been fully considered but they are not persuasive. The applicant argues that Fig. 8 and Figs. 2A and 2B, show “the intermediate part of the mesh cage comprises one or more struts that project radially outwardly of the sidewall of the mesh cage”. The examiner respectfully disagrees, struts projecting radially outwardly of the sidewall of the mesh cage in Fig. 8 are the anchor struts not additional struts that are part of the intermediate part of the mesh cage which is separate from the anchoring module.
The drawing objection will be maintained.
Applicant’s arguments, see page 2, filed 03/20/206, with respect to the USC 112(f) interpretation of “tissue treatment element” have been fully considered and are persuasive. The applicant’s removal of the claim limitation renders the interpretation moot.
Applicant’s arguments, see pages 2-4, filed 03/20/2026 with respect to the rejection of claim 22 under 35 U.S.C. 102(a)(2) as being anticipated by Zhou et al (US 20220031333 A1), herein referenced to as “Zhou” have been fully considered and are persuasive.
The applicant has amended claim 22 to further recite: “an anchoring module hub and a circumferential array of anchoring arms attached to and extend distally from the anchoring module hub… the anchoring module is axially movable relative to the implantable occlusion apparatus through the central lumen of the elongated deployment catheter, and wherein a distal end of each anchoring arm is not attached to the radially expansible body”.
The applicant argues that the anchoring arms (traction structures 112) of Zhou have a distal end that is attached to the radially expansible body. The examiner agrees that the traction structures have a distal end that is attached to the radially expansible body.
The applicant additionally argues that Zhou fails to disclose that the anchoring module being “axially movable relative to the implantable occlusion apparatus through the central lumen of the elongated deployment catheter”. The examiner respectfully disagrees.
As seen in Figs. 3-4A, 112 the anchoring arms and the anchoring hub 130 can move relatively to 111, the implantable apparatus through the central lumen of 200 + 150.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Zhou in view of Ayres et al (US 20150005809 A1), herein referenced to as “Ayres”.
Applicant's arguments see pages 5-6, filed 03/20/2026 with respect to the rejection of claim 40 and 41 under 35 U.S.C. 102(a)(2) as being anticipated by Zhou et al (US 20220031333 A1), herein referenced to as “Zhou” have been fully considered but they are not persuasive.
The applicant amended claim 40 to further recite “anchoring module can be axially withdrawn independently of the occlusion apparatus and recaptured in the central lumen of the elongated deployment catheter”.
The applicant argues that Zhou does not explicitly disclose this as the traction structure 112 is secured together with the occlusion structure 111.
The examiner respectfully disagrees as seen in Figs. 3-4A, 112 the anchoring arms and the anchoring hub 130 can move relatively to 111, the implantable apparatus through the central lumen of 200 + 150.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the intermediate part of the mesh cage comprises one or more struts that project radially outwardly of the sidewall of the mesh cage” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 40 and 41 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhou et al (US 20220031333 A1), herein referenced to as “Zhou”.
Claim 40
Zhou discloses: A device 100 + 200 (see Figs. 1-4B, [0051] and [0059]) to occlude a body lumen (see [0059], LAA occluder) of a subject, comprising: an implantable occlusion apparatus 100 (see Figs. 1-4B, [0059]) comprising a proximal connecting hub 120 (see Figs. 1-4B, [0059]) and a radially expansible body 110 (see Figs. 1-4B, [0059] and [0079], self-expanding) configured for radial expansion upon deployment from a contracted configuration to a radially expanded configuration (see [0079], self-expanding) to fluidically occlude the body lumen (see [0079], closure of the LAA, and prevention of the passage of blood clots); an elongated deployment catheter delivery sheath + 200 + 150 (see Figs 1-4B, [0078]) having a central lumen the lumen of the delivery sheath (see [0078], the device is contained into the delivery sheath, and can be pushed out of the distal end of the sheath to be released); an elongated delivery catheter 210 disposed in the central lumen (see [0078], 210 is within the delivery sheath) of the elongated deployment catheter delivery sheath and having a distal connecting hub 211 (see Fig. 3, [0063], complementary in form to 120, which is a hub) detachably attachable (see [0063], detachably coupled) to the proximal connecting hub 120 of the implantable occlusion apparatus 100 for transluminal delivery of the implantable occlusion apparatus 100 to the body lumen (see [0078], LAA), wherein the elongated deployment catheter 210 is axially movable proximally relative to the elongated delivery catheter delivery sheath to deploy the implantable occlusion apparatus (see [0078], 210 can be used to push out 100, see [0063], is detachable from 110 to release/deploy the device by proximally retrieving 210 from 110); and an anchoring module 112 (see Figs. 1-4B, [0060]) comprising a circumferential array of anchoring arms 1121 (see Figs. 1-4B, [0061]) in which each anchoring arm 1121 has a proximal end first end connected to 130 (see Fig. 2, [0061]) and is configured for pivotable self- adjustment about it's proximal end first end connected to 130 from (a) a delivery configuration (see Fig. 4B, the axial arms are bunched together) in which the array of anchoring arms 1121 are arranged in an axial bunched configuration (b) a deployed configuration (see Fig. 3) in which the anchoring arms 1121 are pivoted outwardly about their proximal ends first end connected to 130 to engage a wall of the body lumen the wall of the LAA through an open section (see [0060], 112 is partially overlapped, such that a part of 112 extends outside of 111, at 111b, through the opening of 11b) of the occlusion apparatus 100, wherein device 100 + 200 is configured such that the anchoring module 112 is can be axially withdrawn independently (see Figs. 3-4A, 130 + 112 can be withdrawn without moving the proximal portion of 111) of the occlusion apparatus 100 and recaptured in the central lumen the lumen of 200 + 150 (see Fig. 4A, 130 is recaptured within the lumen of 150 which is an extension of the lumen of 200) of the elongated deployment catheter delivery sheath + 200 + 150.
Claim 41
Zhou discloses: A device 100 + 200 (see Figs. 1-4B, [0051] and [0059]) to occlude a body lumen (see [0059], LAA occluder) of a subject, comprising: an implantable occlusion apparatus 100 (see Figs. 1-4B, [0059]) comprising a proximal connecting hub 120 (see Figs. 1-4B, [0059]) and a radially expansible body 110 (see Figs. 1-4B, [0059] and [0079], self-expanding) configured for radial expansion upon deployment from a contracted configuration to a radially expanded configuration (see [0079], self-expanding) to fluidically occlude the body lumen (see [0079], closure of the LAA, and prevention of the passage of blood clots); an elongated deployment catheter delivery sheath (see [0078]) having a central lumen the lumen of the delivery sheath (see [0078], the device is contained into the delivery sheath, and can be pushed out of the distal end of the sheath to be released); an elongated delivery catheter 210 disposed in the central lumen (see [0078], 210 is within the delivery sheath) of the elongated deployment catheter delivery sheath and having a distal connecting hub 211 (see Fig. 3, [0063], complementary in form to 120, which is a hub) detachably attachable (see [0063], detachably coupled) to the proximal connecting hub 120 of the implantable occlusion apparatus 100 for transluminal delivery of the implantable occlusion apparatus 100 to the body lumen (see [0078], LAA), wherein the elongated deployment catheter 210 is axially movable proximally relative to the elongated delivery catheter delivery sheath to deploy the implantable occlusion apparatus (see [0078], 210 can be used to push out 100, see [0063], is detachable from 110 to release/deploy the device by proximally retrieving 210 from 110); and an anchoring module 112 (see Figs. 1-4B, [0060]) comprising a circumferential array of anchoring arms 1121 (see Figs. 1-4B, [0061]) in which each anchoring arm 1121 has a proximal end first end connected to 130 (see Fig. 2, [0061]) and is configured for pivotable self- adjustment about it's proximal end first end connected to 130 from (a) a delivery configuration (see Fig. 4B, the axial arms are bunched together) in which the array of anchoring arms 1121 are arranged in an axial bunched configuration (b) a deployed configuration (see Fig. 3) in which the anchoring arms 1121 are pivoted outwardly about their proximal ends first end connected to 130 to engage a wall of the body lumen the wall of the LAA through an open section (see [0060], 112 is partially overlapped, such that a part of 112 extends outside of 111, at 111b, through the opening of 11b) of the occlusion apparatus 100, wherein the anchoring arms 1121 are attached to and extend distally from an anchoring module hub 130 (see Figs. 1-4B, [0059]), in which the anchoring module 130 is axially movable relative (see Figs. 2-4B, 130 can move axially in relation to 100) to the implantable occlusion apparatus 100 and wherein the proximal connecting hub 120 comprises a central lumen the lumen of 120 (see Figs. 3-4B), in which the anchoring module is configured for axial movement through the central lumen.
The language, " in which the anchoring module is configured for axial movement through the central lumen," 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 Zhou meets the structural limitations of the claim, and is capable of the anchoring module 112 to be able to pass through the central lumen of 120, as 130 is narrower in a diameter than the central lumen of 120 and hence can pass through its lumen.
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) 22, 24-28, 34-35, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Ayres et al (US 20150005809 A1), herein referenced to as “Ayres”.
Claim 22
Zhou discloses: A device 100 + 200 (see Figs. 1-4B, [0051] and [0059]) to occlude a body lumen (see [0059], LAA occluder) of a subject, comprising: an implantable occlusion apparatus 100 (see Figs. 1-4B, [0059]) comprising a proximal connecting hub 120 (see Figs. 1-4B, [0059]) and a radially expansible body 110 (see Figs. 1-4B, [0059] and [0079], self-expanding) configured for radial expansion upon deployment from a contracted configuration to a radially expanded configuration (see [0079], self-expanding) to fluidically occlude the body lumen (see [0079], closure of the LAA, and prevention of the passage of blood clots); an elongated deployment catheter delivery sheath + 200 + 150 (see Figs. 1-4A, [0078]) having a central lumen the lumen of the delivery sheath (see [0078], the device is contained into the delivery sheath, and can be pushed out of the distal end of the sheath to be released); an elongated delivery catheter 210 disposed in the central lumen (see [0078], 210 is within the delivery sheath) of the elongated deployment catheter delivery sheath and having a distal connecting hub 211 (see Fig. 3, [0063], complementary in form to 120, which is a hub) detachably attachable (see [0063], detachably coupled) to the proximal connecting hub 120 of the implantable occlusion apparatus 100 for transluminal delivery of the implantable occlusion apparatus 100 to the body lumen (see [0078], LAA); and an anchoring module 112 (see Figs. 1-4B, [0060]) comprising an anchoring module hub 130 (see Figs. 1-4A, [0059]) and a circumferential array of anchoring arms 1121 (see Figs. 1-4B, [0061]) extending distally (see Figs. 3-4A) from the anchoring module hub 130 in which each anchoring arm 1121 has a proximal end first end connected to 130 (see Fig. 2, [0061]) and is configured for pivotable self- adjustment about the proximal end first end connected to 130 from (a) a delivery configuration (see Fig. 4B, the axial arms are bunched together) in which the array of anchoring arms 1121 are arranged in an axial bunched configuration (b) a deployed configuration (see Fig. 3) in which the anchoring arms 1121 are pivoted radially outwardly about their proximal ends first end connected to 130 to engage a wall of the body lumen the wall of the LAA through an open section (see [0060], 112 is partially overlapped, such that a part of 112 extends outside of 111, at 111b, through the opening of 11b) of the occlusion apparatus 100, wherein the anchoring module 130 is axially movable relative (see Figs. 2-4B, 130 can move axially in relation to 100) to the implantable occlusion apparatus 100 through the central lumen the lumen of 200 + 150 (see Figs. 3-4A, 130 is axially movable within the lumen of 150 which is an extension of the lumen of 200) of the elongated deployment catheter delivery sheath + 200 + 150.
Zhou does not explicitly disclose: and wherein a distal end of each anchoring arm is not attached to the radially expansible body.
However, Ayres in a similar field of invention teaches a device 930 (see Fig. 44) to occlude a body lumen comprising a radially expansible body 932 (see Fig. 44, [0078], devices can expand) and an anchoring module hub 937 (see Fig. 44) with a circumferential array of anchoring arms 934 (see Fig. 44) extending distally from the anchoring module hub 937 (see Fig. 44). Ayres further teaches: and wherein a distal end the distal portions of 934 (see Fig. 44) of each anchoring arm 934 is not attached (see [0195], free ends of the anchor frame 934 protrude from the distal area of the occlusive device frame, see also claim 39, “plurality of elongate anchor portion frame members that are separately distinct from the plurality of elongate occlusive portion frame members, at least some of the elongate anchor portion frame members including a first end and a second end, wherein the second ends of the elongate anchor portion frame members are free ends that are configured to contact tissue when the medical device is implanted in a patient”) to the radially expansible body 932.
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 Zhou to incorporate the teachings of Ayres and teach a device to occlude a body lumen with a distal end of each anchoring arm is not attached to the radially expansible body. Motivation for such can be found in Ayres as these additional anchor arm ends can provide additional migration resistance for the occlusive device (see [0195]).
Claim 24
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: in which the proximal connecting hub 120 comprises a central lumen the lumen of 120 (see Figs. 3-4B), in which the anchoring module is configured for axial movement through the central lumen.
The language, " in which the anchoring module is configured for axial movement through the central lumen," 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 Zhou meets the structural limitations of the claim, and is capable of the anchoring module 112 to be able to pass through the central lumen of 120, as 130 is narrower in a diameter than the central lumen of 120 and hence can pass through its lumen.
Claim 25
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: in which anchoring module hub 130 and proximal connecting hub 120 are configured to engage (see Figs. 3-4B, 120 and 130 are engaged through 150).
Claim 26
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: including an anchoring catheter 220 (see Figs. 1-4B, [0063]), in which the anchoring module 112 (112 via 130 is connected to 220, see Figs. 3-4B) is attached to the anchoring catheter 220 and movable axially through a central lumen the lumen of 210 + 150 (see Figs. 3-4B, 150 is a continuation of the lumen of 210) of the elongated delivery catheter 210 and a central lumen the central lumen of 120 in the proximal connecting hub 120.
Claim 27
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: to fluidically occlude a left atrial appendage of a heart of a subject (see [0059], LAA occluder), in which the radially expansible body 110 is configured for radial expansion (see [0079], self-expanding) to a radially expanded configuration to fluidically occlude the left atrial appendage of the heart (see [0079], self-expanding, closure of the LAA, and prevention of the passage of blood clots).
Claim 28
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: in which the radially expansible body 110 comprises a mesh cage (see Figs. 1-4B, 110 is a mesh cage with interwoven wires to form pores and openings).
Claim 34
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: in which each anchoring arm 1121 in a deployed configuration (see Fig. 2) is splayed radially outwardly (see Fig. 2, each arm is directed radially outward from the central axis of 100) at an angle (see Fig. 2, the angle of 1121) of to a central axis the central longitudinal axis of 100 (see Fig. 2) of the implantable occlusion apparatus 100.
The combination of Zhou and Ayres does not explicitly teach: the angle is 60-80°.
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 Zhou and Ayres to have the angle is 60-80° 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 Zhou would not operate differently with the angle is 60-80°. Further, applicant places no criticality on the range claimed, (see [0036] of applicant’s patent application publication) that the angle can be 30-80 degrees, which is not included in the claimed range of 60-80 degrees, hence a wider range is also acceptable and that 60-80 is not critical.
Claim 35
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: in which the radially expansible body 110 comprises a mesh cage (see Figs. 1-4B, 110 is a mesh cage with interwoven wires to form pores and openings) comprising a sidewall 111 (see Figs. 1-4B, [0060]) comprising a proximal part 111a (see Fig. 2, [0060]), a distal part 111d (see Fig. 2, [0066]), and an intermediate part 111c (see Fig. 2, [0066]) having a mesh size (see Fig. 2, the region of 111c, hence the mesh size is greater than that of 111d and 111a) greater than a mesh size of the distal 111d or proximal parts 111a.
Claim 38
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: in which a distal end distal end of 1121 (see Fig. 2) of one or more of the anchoring arms 1121 comprises an anchoring barb 113 (see Fig. 2, [0084]) configured to engage tissue (see [0084], piercing into the tissue of the inner wall of the LAA), and optionally at least partially proximally (see Fig. 2, 113 is directed proximally).
Zhou does not explicitly disclose: in which the one or more anchoring barbs are curved radially outwardly.
However, Ayres in a similar field of invention teaches a device 930 (see Fig. 44) to occlude a body lumen comprising a radially expansible body 932 (see Fig. 44, [0078], devices can expand) and an anchoring module hub 937 (see Fig. 44) with a circumferential array of anchoring arms 934 (see Fig. 44) extending distally from the anchoring module hub 937 (see Fig. 44) with one or more anchoring barbs the distal barbs/hooks of 934 (see Fig. 44). Ayres further teaches: : in which the one or more anchoring barbs the distal barbs/hooks of 934 are curved radially outwardly (see Fig. 44, the barbs of 934 curve outwardly in order to provide additional migration resistance).
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 Zhou to incorporate the teachings of Ayres and teach a device to occlude a body lumen with the one or more anchoring barbs are curved radially outwardly. Motivation for such can be found in Ayres as these curved anchor arm ends can provide additional migration resistance for the occlusive device (see [0195]).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Ayres as applied to claim 22 above, and further in view of Gabay et al (US 20220079667 A1), herein referenced to as “Gabay”.
Claim 36
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. Zhou further discloses: in which the radially expansible body 110 comprises a mesh cage (see Figs. 1-4B, 110 is a mesh cage with interwoven wires to form pores and openings) comprising a sidewall 111 (see Figs. 1-4B, [0060]) comprising a proximal part 111a (see Fig. 2, [0060]), a distal part 111d (see Fig. 2, [0066]), and an intermediate part 111c (see Fig. 2, [0066]) having a mesh size (see Fig. 2, the region of 111c, hence the mesh size is greater than that of 111d and 111a) greater than a mesh size of the distal 111d or proximal parts 111a.
The combination of Zhou and Ayres does not explicitly teach: in which the intermediate part of the mesh cage comprises one or more struts that project radially outwardly of the sidewall of the mesh cage.
However, Gabay in a similar field of invention teaches a device 320 to occlude a body lumen of a subject (see Fig. 3, [0036], LAA) with a mesh cage 372 (see Fig. 3) with an intermediate part the intermediate part of 372 between 375 and 312 (see Fig. 3) of the mesh cage with a sidewall the lateral walls of 372 which 310 is on (see Fig. 3). Gabay further teaches: in which the intermediate part the intermediate part of 372 between 375 and 312 of the mesh cage 372 comprises one or more struts 310 (see Fig. 3, [0037], are strut-like projections that are radially outward of the sidewall of 372) that project radially outwardly of the sidewall the lateral walls of 372 which 310 is on of the mesh cage 372.
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 Zhou to incorporate the teachings of Gabay and teach a device with the intermediate part of the mesh cage comprises one or more struts that project radially outwardly of the sidewall of the mesh cage. Motivation for such can be found in Gabay as these elements can measure if the application of ablation energy to the LAA has electrically isolated the LAA From the left atrium (see [0038]).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Ayres as applied to claim 22 above, and further in view of Kreidler (US 20070066993 A1), herein referenced to as “Kreidler”.
Claim 37
The combination of Zhou and Ayres teaches: A device according to Claim 22, see 103 rejection above. The combination of Zhou and Ayres does not explicitly teach: which the proximal end of the occlusion apparatus has a recessed base and the proximal connecting hub is disposed in the recessed base.
However, Kreidler in a similar field of invention teaches a device 300 (see Fig. 3E) to occlude a body lumen of a subject (see Figs. 2-3E, [0060]) with a proximal end proximal end of 300 (see Fig. 3E) and a proximal connecting hub 308 (see Fig. 3, [0065], proximal hub). Kreidler further teaches: which the proximal end proximal end of 300 of the occlusion apparatus 300 has a recessed base recessed (see Fig. 3E, [0068]) and the proximal connecting hub 308 is disposed in the recessed base (see Fig. 3E, [0068], 308 is recessed relative to the surface).
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 Zhou to incorporate the teachings of Kreidler and teach a device with the proximal end of the occlusion apparatus has a recessed base and the proximal connecting hub is disposed in the recessed base. Motivation for such can be found in Kreidler as when the hub is deployed it does not cause irritation or tissue damage to the heart (see [0068]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Miles et al (US 20100324588 A1) teaches an occlusive device with separate occlusive and anchoring hubs, with the anchoring hub moving independently from the occlusive hub
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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
Prosecution Insights