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 02/23/2026. As directed by the amendment: claims 1, 3, 5-9, 12, 18, and 19 have been amended, claims 4 and 13-15 have been cancelled and claims 21-24 have been added. Thus, claims 1-3, 5-12, and 16-24 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 8, filed 02/23/2026, with respect to the U.S.C. 112(b) rejections have been fully considered and are persuasive. The applicant’s amendments to the claim to clarify the language of “biogel” to fluid overcomes the issues of clarity within the claims. The 112b rejections have been withdrawn.
Applicant’s arguments, see pages 8-10, filed 02/23/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Inouye et al (US 20190357916 A1), herein referenced to as “Inouye” have been fully considered and are persuasive.
The applicant amended claim 1 to further recite “and a plurality of reinforcing struts coupled to only the central portion of the expandable hollow body, wherein the reinforcing struts extend generally longitudinally and are disposed circumferentially around the central portion”.
The examiner agrees that Inouye does not explicitly disclose that a plurality of reinforcing struts coupled to only the central portion of the expandable hollow body.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Inouye in view of Anderson et al (US 20190183509 A1).
Applicant’s arguments, see pages 8-10, filed 02/23/2026, with respect to the rejection(s) of claim(s) 12 under 35 U.S.C. 102(a)(1) as being anticipated by Inouye et al (US 20190357916 A1), herein referenced to as “Inouye” have been fully considered and are persuasive.
The applicant amended claim 12 into an independent claim. The applicant additionally added limitations including “wherein the central portion further comprises a first circumferential band that at least partially extends around the proximal end of the central portion and a second circumferential band that at least partially extends around the distal end of the proximal portion, wherein the first circumferential band and the second circumferential band are radiopaque”.
The examiner agrees that Inouye does not explicitly disclose a second circumferential band, with the second circumferential band at least partially extends around the distal end of the proximal portion, and that both first and second circumferential bands are radiopaque.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Inouye in view of Anderson et al (US 20190374230 A1) and Halden et al (US 20130211495 A1).
Claim Objections
Claim 21 is objected to because of the following informalities:
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the proximal the proximal portion
the proximal portion
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being form of a second
being formed of a second
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13
being form of a third
being formed of a third
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-6, 9-11, and 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “a plurality of reinforcing struts coupled to only the central portion of the expandable hollow body”. The limitation “coupled to only the central portion” is a negative limitation excluding the struts from being located anywhere else on the expandable hollow body. The applicant does not have supporting for this exclusion in their original disclosure as the disclosure only notes that the struts may extend around the central portion (see [0105] of applicant’s patent application publication). There is no disclosure that the struts cannot be coupled to or are excluded from the rest of the expandable hollow body.
It is noted that any negative limitation or exclusionary provisions must have basis in the original disclosure. The mere absence of a positive recitation is not basis for an exclusion. See MPEP 2173.05(i).
Claims 2-3, 5-6, 9-11, and 16-20 are rejected as being dependent on claim 1.
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) 1-3, 5, 9-11, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al (US 20190357916 A1), herein referenced to as “Inouye” in view of Anderson et al (US 20190183509 A1), herein referenced to as “Anderson 509”.
Claim 1
Inouye discloses: An occlusion device 500 (see Fig. 13, [0147]) for occluding a left atrial appendage 600 (see Fig. 13, [0147]), the device 500 comprising: an expandable hollow body 504 + 506 (see Fig. 13, [0147]) with an internal volume the internal volumes of 504 + 506 (see [0147], inflatable via inflation media), wherein the expandable hollow body 504 + 506 is expandable by the introduction of a fluid (see [0147], inflation media, [0104]) into the internal volume the internal volume of 504 + 506 of the hollow body 504 + 506, wherein the expandable hollow body 504 + 506 comprises: a proximal portion (see annotated Fig. 13 below) having a first diameter (see annotated Fig. 13 below), wherein the proximal portion (see annotated Fig. 13 below) is arranged to sealingly engage (see Fig. 13, [0150], a proximal portion of the device fits against and seals the ostium of the LAA) against an opening of the left atrial appendage 600; a distal portion (see annotated Fig. 13 below) having a second diameter (see annotated Fig. 13 below), wherein the distal portion (see annotated Fig. 13 below) is arranged to be positioned inside (see Fig. 13) and at least partially fill (see Fig. 13, the distal portion of 500 partially fills the LAA) the left atrial appendage 600; and a central portion (see annotated Fig. 13 below) extending between the proximal (see annotated Fig. 13 below) and distal portion (see annotated Fig. 13 below), wherein the central portion (see annotated Fig. 13 below) comprises a waist region (see annotated Fig. 13 below) with a third diameter (see annotated Fig. 13 below), wherein the third diameter (see annotated Fig. 13 below) of the waist region (see annotated Fig. 13 below) is smaller than the first diameter (see annotated Fig. 13 below) of the proximal portion (see annotated Fig. 13 below) and the second diameter (see annotated Fig. 13 below) of the distal portion (see annotated Fig. 13 below).
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Inouye does not explicitly disclose: and a plurality of reinforcing struts coupled to only the central portion of the expandable hollow body, wherein the reinforcing struts extend generally longitudinally and are disposed circumferentially around the central portion.
However, Anderson 509 in a similar field of invention teaches an occlusion device 210 (see Fig. 11) with an expandable hollow body 216 (see [0092], similar to form and function of other occlusion devices, see Fig. 1, 10, expandable) with a distal portion 212 (see Fig. 11), a proximal portion 214 (see Fig. 11), and a central portion the portion which 218 extends (see Fig. 11). Anderson 509 further teaches: and a plurality of reinforcing struts 218 (see Fig. 11, [0093]) coupled to only the central portion the portion which 218 extends is the central portion (see Fig. 11, [0093]) of the expandable hollow body 216, wherein the reinforcing struts 218 extend generally longitudinally (see Fig. 11, the struts extend generally longitudinally are circumferentially disposed) and are disposed circumferentially around the central portion the portion which 218 extends is the central portion (see Fig. 11).
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 Inouye to incorporate the teachings of Anderson 509 and teach an occlusion device with a plurality of reinforcing struts coupled to only the central portion of the expandable hollow body, wherein the reinforcing struts extend generally longitudinally and are disposed circumferentially around the central portion. Motivation for such can be found in Anderson 509 as the struts can provide additional radial support for the occlusion device (see [0093]).
Claim 2
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 1, see 103 rejection above. Inouye further discloses: wherein the central portion (see annotated Fig. 13 below claim 1) is formed from a woven material (see [0149], the coating which comprises the central portion is made of a woven material).
Claim 3
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 2, see 103 rejection above. Inouye further discloses: wherein the woven material (see [0149], woven) comprises a synthetic polymeric material (see [0185], polymers).
Claim 5
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 2, see 102 rejection above. Inouye further discloses: wherein the fluid (see [0104]) has sufficient viscosity and surface tension to prevent leakage through the woven material.
The language, " wherein the fluid has sufficient viscosity and surface tension to prevent leakage through the woven material," 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 “INSERT REFERENCE NAME” meets the structural limitations of the claim, and is capable of the fluid not leaking through the woven material as the fluid can transition at gel at physiological temperatures, such as when introduced to the expandable hollow body to create a custom mold fit in the LAA, which when a gel it will not leak (see [0104]).
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.
Claim 9
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 1, see 103 rejection above. The combination of Inouye and Anderson 509 does not explicitly teach: wherein the reinforcement struts further comprise least one barb, wherein the at least one barb is arranged to engage with the left atrial appendage to secure the central portion to the left atrial appendage.
However, a variant embodiment (Fig. 12) of Anderson 509 further teaches an occlusion device 310 (see Fig. 12) with reinforcement struts 318 (see Fig. 12). The variant embodiment (Fig. 12) of Anderson 509 further teaches: wherein the reinforcement struts 318 further comprise least one barb 364 (see Fig. 12, [0096], the base 368 of the anchor members 364 may be bonded directly to a portion of the spine members 318), wherein the at least one barb 364 is arranged to engage (see [0095], contact the tissue of the left atrial appendage and anchoring) with the left atrial appendage to secure the central portion the central portion of 310 (see Fig. 12) to the left atrial appendage.
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 the combined reinforcement struts of Inouye and Anderson 509 to incorporate the teachings of a variant embodiment (Fig. 12) of Anderson 509 and teach an occlusion device with the reinforcement struts further comprise least one barb, wherein the at least one barb is arranged to engage with the left atrial appendage to secure the central portion to the left atrial appendage. Motivation for such can be found in Anderson 509 as this allows for anchor member that contacts the tissue of the left atrial appendage and anchoring the occlusion implant (see [0095]).
Claim 10
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 1, see 103 rejection above. Inouye further discloses: wherein the distal portion (see annotated Fig. 13 below claim 1) is formed from a woven material (see [0149], the coating which comprises the distal portion is made of a woven material).
Claim 11
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 1, see 103 rejection above. Inouye further discloses: wherein the proximal portion (see annotated Fig. 13 below claim 1) is formed from a woven material (see [0149], the coating which comprises the proximal portion is made of a woven material).
Claim 16
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 1, see 103 rejection above. Inouye further discloses: wherein the distal portion (see annotated Fig. 13 below claim 1) is substantially domed (see annotated Fig. 13 below claim 1, the distal portion is domed).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inouye in view of Anderson 509 as applied to claim 1 above, and in further view of Knudson et al (US 20030199917 A1), herein referenced to as “Knudson”.
Claim 6
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 5, see 103 rejection above. Inouye does not explicitly disclose: wherein the fluid comprises radiopaque markers.
However, Knudson in a similar field of invention teaches an occlusion device (see Fig. 8) with a fluid (see [0056], hydrogel). Knudson further teaches: wherein the fluid hydrogel (see [0056]) comprises radiopaque markers (see [0056], radiopaque).
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 Inouye to incorporate the teachings of Knudson and teach an occlusion device with the fluid comprises radiopaque markers. Motivation for such can be found in Knudson as this can be used to identify the location of the occluder (see [0056], that can also be laden with therapeutic agents, see [0057]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inouye in view of Anderson 509 as applied to claim 1 above, and in further view of Gray et al (US 20210330333 A1), herein referenced to as “Gray”.
Claim 17
The combination of Inouye and Anderson 509 teaches: The occlusion device of claim 1, see 103 rejection above. The combination of Inouye and Anderson 509 does not explicitly teach: wherein the occlusion device further comprises a central lumen extending from a proximal opening in the proximal portion to a distal opening at a distal end of the distal portion, and at least one aperture extending from the central lumen, wherein the at least one aperture is in fluid communication with the internal volume of the expandable hollow body of the occlusion device.
However, Gray in a similar field of invention teaches an occlusive device 100 (see Fig. 5) with an expandable hollow body 103, proximal portion 104 (see Fig. 5), a distal portion 108 (see Fig. 5), a central portion central portion of 103 between 104 and 108 (see Fig. 5) and an internal volume internal volume of 103 (see Fig. 5). Gray further teaches: wherein the occlusion device 100 further comprises a central lumen the lumen of 140 + 120 (see Figs. 5-6, [0089]) extending from a proximal opening 110 (see Fig. 5, [0089]) in the proximal portion 104 to a distal opening 112 (see Fig. 5, [0070]) at a distal end distal end of 108 (see Fig. 5) of the distal portion 108, and at least one aperture 144 (see Fig. 5, [0074]) extending from the central lumen the lumen of 140 + 120, wherein the at least one aperture 144 is in fluid communication (see [0074]) with the internal volume internal volume of 103 of the expandable hollow body 103 of the occlusion device 100.
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 Inouye to incorporate the teachings of Gray and teach an occlusion device with the occlusion device further comprises a central lumen extending from a proximal opening in the proximal portion to a distal opening at a distal end of the distal portion, and at least one aperture extending from the central lumen, wherein the at least one aperture is in fluid communication with the internal volume of the expandable hollow body of the occlusion device. Motivation for such can be found in Gray as the distal port can be used to deliver a glue or adhesive to help keep the form of the inflated balloon occlusive device and assist it in adhering to the tissue wall of the left atrial appendage (see [0006], [0012], [0052], and [0070]).
Claim 18
The combination of Inouye, Anderson 509, and Gray teaches: The occlusion device according to claim 17, see 103 rejection above. Inouye further discloses: wherein the occlusion device 500 comprises a closure first valve (see Fig. 13, [0151) that is moveable between a first position and a second position (see [0023], the valve is configured to selectively seal the inflation cavities); wherein in the first position, the closure prevents flow of fluid in and out of the central lumen through the proximal opening the first valve is on the proximal opening of the device (see Fig. 13, [0151], and in a state is able to seal the inflation cavity/inflation lumen of the device, [0023]); and wherein in the second position, the closure permits flow of fluid in and out of the central lumen through the proximal opening (see Fig. 13, [0023] and [0151], when the valve is open it is able to permit the flow of the inflation media).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inouye in view of Anderson 509 and Grey as applied to claim 18 above, and further in view of O’Halloran et al (US 20210369283 A1), herein referenced to as “O’Halloran”.
Claim 19
The combination of Inouye, Anderson 509, and Gray teaches: The occlusion device according to claim 18, see 103 rejection above. The combination of Inouye, Anderson 509, and Gray does not explicitly teach: wherein the closure device comprises a plurality of leaflets, and wherein the leaflets are moveable between the first position and the second position.
However, O’Halloran in a similar field of invention teaches an occlusion device (see Figs. 2A-2B) with a closure device 8 (see Figs. 2A-2B) with a first position (see Fig. 2A) and a second position (see Fig. 2B). O’Halloran further teaches: wherein the closure device 8 comprises a plurality of leaflets 11 (see Figs. 2A-2B, [0121]), and wherein the leaflets 11 are moveable between the first position (see Fig. 2A, [0121]) and the second position (see Fig. 2B, [0121]).
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 Inouye to incorporate the teachings of O’Halloran and teach an occlusion device with the closure device comprises a plurality of leaflets, and wherein the leaflets are moveable between the first and second position. Motivation for such can be found in O’Halloran as the valve leaflets are able to conform closely to a catheter that is used to introduce elements through the closure device, enabling minimal flow of fluid not from the catheter when switching the first and second position (see [0121]-[0122]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inouye in view of Anderson 509, Grey, and O’Halloran as applied to claim 19 above, and further in view of Watson et al (US 20230363898 A1), herein referenced to as “Watson”.
Claim 20
The combination of Inouye, Anderson 509, Gray, and O’Halloran teaches: The occlusion device according to claim 19, see 103 rejection above. The combination of Inouye, Anderson 509, Gray, and O’Halloran does not explicitly teach: wherein the plurality of leaflets comprise nitinol.
However, Watson in a similar field of invention teaches an occlusion/valve device (see Fig. 3A) with a plurality of leaflets 230 (see Fig. 3A, [0100], arranged with multiple leaflets). Watson further teaches: wherein the plurality of leaflets 230 comprise nitinol (see [0100], leaflet prothesis 230 may be a nitinol frame).
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 the combination of Inouye and O’Halloran to incorporate the teachings of Watson and have a valve leaflet with a nitinol material. This is due to nitinol being used for leaflets (see [0100] of Watson) is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim(s) 12 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inouye in view of Anderson et al (US 20190374230 A1), herein referenced to as “Anderson 230” and Halden et al (US 20130211495 A1), herein referenced to as “Halden”.
Claim 12
Inouye discloses: An occlusion device 500 (see Fig. 13, [0147]) for occluding a left atrial appendage 600 (see Fig. 13, [0147]), the device 500 comprising: an expandable hollow body 504 + 506 (see Fig. 13, [0147]) with an internal volume the internal volumes of 504 + 506 (see [0147], inflatable via inflation media), wherein the expandable hollow body 504 + 506 is expandable by the introduction of a fluid (see [0147], inflation media, [0104]) into the internal volume the internal volume of 504 + 506, wherein the expandable hollow body 504 + 506 comprises: a proximal portion (see annotated Fig. 13 below) having a first diameter (see annotated Fig. 13 below), wherein the proximal portion (see annotated Fig. 13 below) is arranged to sealingly engage (see Fig. 13, [0150], a proximal portion of the device fits against and seals the ostium of the LAA) against an opening of the left atrial appendage 600; a distal portion (see annotated Fig. 13 below) having a second diameter (see annotated Fig. 13 below), wherein the distal portion (see annotated Fig. 13 below) is arranged to be positioned inside (see Fig. 13) and at least partially fill (see Fig. 13, the distal portion of 500 partially fills the LAA) the left atrial appendage 600; and a central portion (see annotated Fig. 13 below) extending between the proximal (see annotated Fig. 13 below) and distal portion (see annotated Fig. 13 below), wherein the central portion (see annotated Fig. 13 below) comprises a waist region (see annotated Fig. 13 below) with a third diameter (see annotated Fig. 13 below), wherein the third diameter (see annotated Fig. 13 below) of the waist region (see annotated Fig. 13 below) is smaller than the first diameter (see annotated Fig. 13 below) of the proximal portion (see annotated Fig. 13 below) and the second diameter (see annotated Fig. 13 below) of the distal portion (see annotated Fig. 13 below), wherein the central portion (see second annotated Fig. 13 below) comprises a proximal end (see second annotated Fig. 13 below) and a distal end (see second annotated Fig. 13 below), and wherein the central portion (see second annotated Fig. 13 below) further comprises a first circumferential band proximal bands that form 510 (see Fig. 13, [0161]) that at least partially extends around the proximal end (see second annotated Fig. 13 below) of the central portion (see second annotated Fig. 13 below).
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Inouye does not explicitly disclose: and a second circumferential band that at least partially extends around the distal end of the proximal portion, wherein the first circumferential band and the second circumferential band are radiopaque.
However, Anderson 230 in a similar field of invention teaches an occlusion device 250 (see Fig. 7B) with a proximal portion (see annotated Fig. 7B below), a distal portion (see annotated Fig. 7B below), and a central portion (see annotated Fig. 7B below), and circumferential bands 266 (see Fig. 7B). Anderson 230 further teaches: a second circumferential band 266 (see annotated Fig. 7B below, [0112], entire circumference) that at least partially extends around the distal end (see annotated Fig. 7B below) of the proximal portion (see annotated Fig. 7B below).
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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 Inouye to incorporate the teachings of Anderson 230 and teach an occlusive device with a second circumferential band that at least partially extends around the distal end of the proximal portion. Motivation for such can be found in Anderson 230 as this can provide a raised region for securing the implant to the LAA (see [0109]-[0112]).
The combination of Inouye and Anderson 230 does not explicitly teach: wherein the first circumferential band and the second circumferential band are radiopaque.
However, Halden in a similar field of invention teaches an occlusion device 60 (see Fig. 5) with a circumferential band 32 (see Figs. 5-8) which extends at least partially around the device (see Figs. 5-8). Halden further teaches: wherein the circumferential band 32 is radiopaque (see [0089], proximal marking band, outer Pt band 32, [0010], radiopaque material such as Pt).
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 the combined circumferential bands of Inouye and Anderson 230 to incorporate the teachings of Halden and teach an occlusive device with the first circumferential band and the second circumferential band are radiopaque. Motivation for such can be found in Halden as making the circumferential radiopaque allows as this allows for visualization of specific portions of the device depending on the type of device during occlusive implantation (see [0003], [0010], and [0092]).
Claim 24
The combination of Inouye, Anderson 230, and Halden teaches: The occlusion device according to claim 12, see 103 rejection above. Halden further teaches: wherein the expandable hollow body 60 (see Figs. 5-8, [0089], further includes a third circumferential band 32 (see Figs. 5-8, [0089]) that extends at least partially around a proximal end the proximal end of 60 (see Figs. 5-8) of the proximal portion the proximal portion of 60 (see Figs. 5-8) of the expandable hollow body 60.
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 Inouye to incorporate the teachings of Halden and teach an occlusive device with a third circumferential band that extends at least partially around a proximal end of the proximal portion of the expandable hollow body. Motivation for such can be found in Halden as this can assist in stabilizing the structure of the braid of the expandable hollow body (see [0089]).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inouye in view of Anderson 230, and Halden as applied to claim 12 above, and further in view of Anderson 509.
Claim 7
The combination of Inouye, Anderson 230, and Halden teaches: The occlusion device according to claim 12, see 103 rejection above. The combination of Inouye, Anderson 230, and Halden does not explicitly teach: wherein the central portion comprises a plurality of reinforcement struts that are arranged to strengthen the central portion.
However, Anderson 509 in a similar field of invention teaches an occlusion device 210 (see Fig. 11) with an expandable hollow body 216 (see [0092], similar to form and function of other occlusion devices, see Fig. 1, 10, expandable) with a distal portion 212 (see Fig. 11), a proximal portion 214 (see Fig. 11), and a central portion the portion which 218 extends (see Fig. 11). Anderson 509 further teaches: wherein the central portion the portion which 218 extends (see Fig. 11) comprises a plurality of reinforcing struts 218 (see Fig. 11, [0093]) that are arranged to strengthen (see [0093], additional radial support) the central portion the portion which 218 extends.
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 Inouye to incorporate the teachings of Anderson 509 and teach an occlusion device with a plurality of reinforcing struts coupled to only the central portion of the expandable hollow body, wherein the reinforcing struts extend generally longitudinally and are disposed circumferentially around the central portion. Motivation for such can be found in Anderson 509 as the struts can provide additional radial support for the occlusion device (see [0093]).
Claim 8
The combination of Inouye, Anderson 230, Halden, and Anderson 509 teaches: The occlusion device according to claim 7, see 103 rejection above. Anderson 509 further teaches: wherein plurality of reinforcement struts 218 extend generally longitudinally (see Fig. 11, the struts extend generally longitudinally are circumferentially disposed) and are disposed circumferentially around the central portion the portion which 218 extends is the central portion (see Fig. 11).
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inouye in view of Wolfe et al (US 20200367897 A1), herein referenced to as “Wolfe”.
Claim 21
Inouye discloses: An occlusion device 500 (see Fig. 13, [0147]) for occluding a left atrial appendage 600 (see Fig. 13, [0147]), the device 500 comprising: an expandable hollow body 504 + 506 (see Fig. 13, [0147]) with an internal volume the internal volumes of 504 + 506 (see [0147], inflatable via inflation media), wherein the expandable hollow body 504 + 506 is expandable by the introduction of a fluid (see [0147], inflation media, [0104]) into the internal volume the internal volume of 504 + 506 of the hollow body 504 + 506, wherein the expandable hollow body 504 + 506 comprises: a proximal portion (see annotated Fig. 13 below) having a first diameter (see annotated Fig. 13 below), wherein the proximal portion (see annotated Fig. 13 below) is arranged to sealingly engage (see Fig. 13, [0150], a proximal portion of the device fits against and seals the ostium of the LAA) against an opening of the left atrial appendage 600, the proximal portion (see annotated Fig. 13 below) being formed of a first compliant woven material (see [0149], the coating which comprises the proximal portion is made of a woven material, [0147], compliant material); a distal portion (see annotated Fig. 13 below) having a second diameter (see annotated Fig. 13 below), wherein the distal portion (see annotated Fig. 13 below) is arranged to be positioned inside (see Fig. 13) and at least partially fill (see Fig. 13, the distal portion of 500 partially fills the LAA) the left atrial appendage 600, the distal portion (see annotated Fig. 13 below) being form of a second compliant woven material (see [0149], the coating which comprises the distal portion is made of a woven material, [0147], compliant material); and a central portion (see annotated Fig. 13 below) extending between the proximal (see annotated Fig. 13 below) and distal portion (see annotated Fig. 13 below), wherein the central portion (see annotated Fig. 13 below) comprises a waist region (see annotated Fig. 13 below) with a third diameter (see annotated Fig. 13 below), the central portion (see annotated Fig. 13 below) being form of a third compliant woven material (see [0149], the coating which comprises the central portion is made of a woven material, [0147], compliant material), wherein the third diameter (see annotated Fig. 13 below) of the waist region (see annotated Fig. 13 below) is smaller than the first diameter (see annotated Fig. 13 below) of the proximal portion (see annotated Fig. 13 below) and the second diameter (see annotated Fig. 13 below) of the distal portion (see annotated Fig. 13 below).
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Inouye does not explicitly disclose: wherein the first compliant woven material and the second compliant woven material are less compliant than the third compliant woven material.
However, Wolfe in a similar field of invention teaches an occlusion device (see Fig. 14) with an expandable hollow body 400 (see Fig. 14) with a proximal portion 402 (see Fig. 14) with a first compliant woven material (see [0062], nitinol, is a compliant woven material, braided, nitinol is superelastic, hence compliant), a distal portion 404 (see Fig. 14) with a second compliant woven material (see [0062], nitinol, is a compliant woven material, braided, nitinol is superelastic, hence compliant), and a central portion 406 (see Fig. 14) with a third compliant woven material (see [0062], nitinol, is a compliant woven material, braided, nitinol is superelastic, hence compliant). Wolfe further teaches: wherein the first compliant woven material and the second compliant woven material are less compliant than the third compliant woven material the material of 406 (see 0047], the longer, more flexible extension 406, hence the third compliant woven material that makes up 406 is more flexible than 404 and 402, allowing 404 to angulate in respect to 402).
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 Inouye to incorporate the teachings of Wolfe and teach an occlusion device with the first compliant woven material and the second compliant woven material are less compliant than the third compliant woven material. Motivation for such can be found in Wolfe as this allows the distal section to angulate with respect to the proximal section of the device, allowing the device to conform to a large number of different aneurysm shapes or aneurysm angular takeoff angles or general angulations (see [0047]).
Claim 22
The combination of Inouye and Wolfe teaches: The occlusion device according to claim 21, see 103 rejection above. Inouye further discloses: wherein the first compliant woven material (see [0149], the coating which comprises the proximal portion is made of a woven material, [0147], compliant material) and the second compliant woven material (see [0149], the coating which comprises the proximal portion is made of a woven material, [0147], compliant material) are the same material (see [0149] and [0147], the same woven complaint material makes up these two portions of the device).
Claim 23
The combination of Inouye and Wolfe teaches: The occlusion device according to claim 21, see 103 rejection above. The combination of Inouye and Wolfe does not explicitly teach: wherein the first compliant woven material and the second compliant woven material stretch less than approximately 20% of its unloaded length.
As noted in Inouye it is necessary for the compliant material that makes up the proximal and distal portions of the expandable hollow body to expand from a first unexpanded (deflated/delivery) configuration to a second expanded (inflated/delivered) configuration with an inflation material (see [0147]). This correlates to the stretching of the first compliant woven material and the second compliant woven material and as such wherein the first compliant woven material and the second compliant woven material stretch less than approximately 20% of its unloaded length is considered to be a result effective variable since that compliance of the first and second compliant woven materials effects how much the device can expand. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Inouye by causing the first compliant woven material and the second compliant woven material to stretch less than approximately 20% of its unloaded length as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
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.
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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