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 04/21/2026. As directed by the amendment: claims 1-20 have been amended and claims 5, 7, 9-10, and 16-20 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 6, filed 04/21/2026, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see page 6, filed 04/21/2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The applicant’s amendment to claims to recite “a delivery system” rather than “a delivery device for an occlusive implant” overcome the lack of clarity in regards to the positive recitation of “an occlusive implant releasably coupled to the core member”. The USC 112b rejections have been withdrawn.
Applicant’s arguments, see pages 7-8, filed 04/21/2026, with respect to the rejection(s) of claim(s) 1 and 14 under 35 U.S.C. 102(a)(1) as being anticipated by Kelly (US 20170014252 A1), herein referenced to as “Kelly” have been fully considered and are persuasive.
The applicant amended claim 1 to further recite “wherein in the expanded configuration the distal arm segments form a funnel shape that tapers radially outward in a distal direction”.
The applicant amended claim 14 to further recite “wherein in the funnel configuration the distal arm extends form a funnel shape that tapers radially outward in a distal direction; wherein a distal opening of the funnel shape has a diameter greater than an outer diameter of the delivery sheath”.
The examiner agrees that Kelly does not explicitly disclose that the funnel shape tapers radially outward in a distal direction and that a distal opening of the funnel shape has a diameter greater than an outer diameter of the delivery sheath. While Kelly does disclose a funnel shape by noting that the arms pivot outwardly flexed position (see Fig. 2A, [0048], as all the arms pivot into a wider distal end diameter, they collectively create a funnel like shape as they pivot outward on the pivot point 114), Kelly does not explicitly disclose the diameter will be greater or that the funnel tapers radially outwardly in a distal direction.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kelly in view of Puckett et al (US 20160106562 A1).
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim #
Line #
Current
Suggested change
14
1
A system
A delivery system
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites “wherein the plurality of distal arm segments have a funnel-like shape when in the expanded configuration. Claim 1, which claim 11 is dependent on recites “wherein in the expanded configuration the distal arm segments form a funnel shape”. As such, claim 11 fails to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 6, and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 20170014252 A1), herein referenced to as “Kelly” in view of Puckett et al (US 20160106562 A1), herein referenced to as “Puckett”.
Claim 1
Kelly discloses: A delivery system 118 (see Figs. 1-2B, [0042] and [0047]), the delivery system 118 comprising: a delivery sheath 118 (see Fig. 1, [0047], catheter) having a sheath body the catheter body 118 (see [0047]) and a distal tip region 100 (see Figs. 1-2B, [0047]); a tip reinforcing member 112 (see Figs. 1-2B, [0043]) coupled to the distal tip region 100, the tip reinforcing member 112 defining a plurality of distal arm segments 112 (see Figs. 1-2B, [0043], plurality of pivotable arms); wherein the distal arm segments 112 are configured to shift between a first configuration (see Fig. 1, [0048], unflexed position) and an expanded configuration (see Fig. 2A, [0048], flexed position), wherein in the expanded configuration the distal arm segments 112 form a funnel shape (see Fig. 2A, [0048], flexed position, as all the arms pivot into a wider distal end diameter, they collectively create a funnel like shape as they pivot outward on the pivot point 114); a core member guidewire (see [0038], guidewire, [0043] and [0047]) slidably disposed (see [0038], delivering an implantable device and [0052], slide back and forth) within the delivery sheath 118; and an occlusive implant occluder (see [0047]) releasably coupled (see [0047] and [0038], over-the-wire guidance, which in the field of art is known advance an implant over the wire to a target lumen and then retrieving the wire while leaving the implant in place) to the core member guidewire.
Kelly does not explicitly disclose: the funnel shape that tapers radially outward in a distal direction.
However, Puckett in a similar field of invention teaches a delivery system 10 + 26 (see Figs. 1A-1B and 6A-6B) with a delivery sheath 26 (see Figs. 6A-6B) and a tip reinforcing member 10 (see Figs. 1A-1B and 6A-6B) defining a plurality of distal arm segments 12 (see Figs. 1A-1B) configured to shift between a first configuration (see Fig. 6A) and an expanded configuration (see Fig. 6B), wherein in the expanded configuration the distal arm segments 12 of 10 (see Fig. 6B) form a funnel shape (see Fig. 6B, [0046], 10 expands into a funnel). Puckett further teaches: the funnel shape the funnel shape of 10 (see Fig. 6B, [0046]) that tapers radially outward in a distal direction (see Fig. 6B, 10 tapers radially outward in the distal direction away from the sheath 26).
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 funnel shape of Kelly to incorporate the teachings of Puckett and teach a delivery system with the funnel shape that tapers radially outward in a distal direction. Motivation for such can be found in Puckett as this allows for an expandable device to easily pass through the distal tip of the sheath, which initially can be small and tapered to track well on a wire guide through tortuous curvature (see [0004]) and allow for gradual stretching of the expandable device as it leaves the tip (see [0046]).
Claim 2
The combination of Kelly and Puckett teaches: The delivery system of claim 1, see 103 rejection above. Kelly further discloses: wherein the sheath body 118 includes a reinforcing braid braided strands (see [0038], braided strands within the catheter wall).
Claim 3
The combination of Kelly and Puckett teaches: The delivery system of claim 2, see 103 rejection above. Kelly further discloses: wherein the reinforcing braid braided strands (see [0038]) extends at least partially along the distal tip region 100 (see [0038], the braided strands are bonded to the structural elements 112 of the catheter tip 100, hence they extend via connecting to 112).
Claim 6
The combination of Kelly and Puckett teaches: The delivery system of claim 1, see 103 rejection above. Kelly further discloses: wherein at least some of the distal arm segments 112 include a plurality of discrete segments (see Fig. 1, [0043] and [0044], the arm segments are discrete as being separately counted arms with their own pivot points 114).
Claim 11
The combination of Kelly and Puckett teaches: The delivery system of claim 1, see 103 rejection above. Kelly further discloses: wherein the plurality of distal arm segments 112 have a funnel-like shape (see Fig. 2A, [0048], as all the arms pivot into a wider distal end diameter, they collectively create a funnel like shape as they pivot outward on the pivot point 114) when in the expanded configuration (see Fig. 2A, [0048]).
Claim 12
The combination of Kelly and Puckett teaches: The delivery system of claim 1, see 103 rejection above. Kelly further discloses: wherein the plurality of distal arm segments 112 are defined by slits the expandable opening 106 comprise a discontinuous ring defined by the plurality of pivotable arms 112 (see [0045], the areas in which 112 does not exist is a slit, which form a discontinuous ring via the gaps where 112 is not there) formed along the distal tip region 100, and wherein the plurality of distal arm segments 112 have a reinforcing member 112 (see [0043], suitable rigid material, compared to flexible housing 102, see [0042]) coupled thereto.
Claim 13
The combination of Kelly and Puckett teaches: The delivery system of claim 1, see 103 rejection above. Kelly further discloses: wherein the occlusive implant is configured to be implanted into a left atrial appendage.
The language, " wherein the occlusive implant is configured to be implanted into a left atrial appendage," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of meets the structural limitations of the claim, and is capable of the delivery device delivery an occluder which has the function of being implanted into an left atrial appendage, which is a bodily lumen which is a target lumen in the field of art (see [0038]).
Claim 14
Kelly discloses: A system 118 (see Figs. 1-2B, [0042] and [0047]), the delivery system 118 comprising: a delivery sheath 118 (see Fig. 1, [0047], catheter) having a reinforced sheath body the catheter body 118 (see [0047] and [0038], braided strands within the catheter wall to increase structural integrity) and a distal tip region 100 (see Figs. 1-2B, [0047]); a tip reinforcing member 112 (see Figs. 1-2B, [0043]) coupled to the distal tip region 100, the tip reinforcing member 112 having a base 114 (see Figs. 1-2B, [0044]) a plurality of distal arm extensions 112 (see Figs. 1-2B, [0043], plurality of pivotable arms) extending distally from the base 114; wherein the distal arm extensions 112 are configured to shift between a delivery configuration (see Fig. 1, [0048], unflexed position) and a funnel configuration (see Fig. 2A, [0048], flexed position, as all the arms pivot into a wider distal end diameter, they collectively create a funnel like shape as they pivot outward on the pivot point 114), wherein in the funnel configuration (see Fig. 2A) the distal arm extensions 112 form a funnel shape (see Fig. 2A, as all the arms pivot into a wider distal end diameter, they collectively create a funnel like shape as they pivot outward on the pivot point 114); a core member guidewire (see [0038], guidewire, [0043] and [0047]) slidably disposed (see [0038], delivering an implantable device and [0052], slide back and forth) within the delivery sheath 118; and a left atrial appendage occlusive implant occluder (see [0047]) releasably coupled (see [0047] and [0038], over-the-wire guidance, which in the field of art is known advance an implant over the wire to a target lumen and then retrieving the wire while leaving the implant in place) to the core member guidewire.
The language, " left atrial appendage occluder," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of meets the structural limitations of the claim, and is capable of the delivery device delivery an occluder which has the function of being implanted into an left atrial appendage, which is a bodily lumen which is a target lumen in the field of art (see [0038]).
Kelly does not explicitly teach: the funnel shape that tapers radially outward in a distal direction; wherein a distal opening of the funnel shape has a diameter greater than an outer diameter of the delivery sheath.
However, Puckett in a similar field of invention teaches a delivery system 10 + 26 (see Figs. 1A-1B and 6A-6B) with a delivery sheath 26 (see Figs. 6A-6B) and a tip reinforcing member 10 (see Figs. 1A-1B and 6A-6B) defining a plurality of distal arm segments 12 (see Figs. 1A-1B) configured to shift between a first configuration (see Fig. 6A) and an expanded configuration (see Fig. 6B), wherein in the expanded configuration the distal arm segments 12 of 10 (see Fig. 6B) form a funnel shape (see Fig. 6B, [0046], 10 expands into a funnel). Puckett further teaches: the funnel shape the funnel shape of 10 (see Fig. 6B, [0046]) that tapers radially outward in a distal direction (see Fig. 6B, 10 tapers radially outward in the distal direction away from the sheath 26); wherein a distal opening distal opening of 10 (see Fig. 6B and 1B, [0019], “In this second position, the distal opening 18 of the expandable tip 10 has a diameter which may be larger than the diameter of the distal opening 18 in the first tapered position. Depending on the configuration and purpose of the device it may be desirable that, in the second position, the distal opening 18 has a diameter which may be equal to or greater than the diameter of the proximal opening 20 of the expandable tip 10”… and [0046], the proximal opening 20 is the diameter of the delivery sheath) of the funnel shape (see Fig. 1B and 6B) has a diameter greater than an outer diameter (see Fig. 6B, the distal end diameter of 10 is greater than the outer diameter of 26) of the delivery sheath 26.
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 funnel shape of Kelly to incorporate the teachings of Puckett and teach a delivery system with the funnel shape that tapers radially outward in a distal direction; wherein a distal opening of the funnel shape has a diameter greater than an outer diameter of the delivery sheath. Motivation for such can be found in Puckett as this allows for an expandable device to easily pass through the distal tip of the sheath, which initially can be small and tapered to track well on a wire guide through tortuous curvature (see [0004]) and allow for gradual stretching of the expandable device as it leaves the tip (see [0046]).
Claim 15
The combination of Kelly and Puckett teaches: The delivery device of claim 14, see 103 rejection above. Kelly further discloses: wherein the reinforced sheath body the catheter body 118 includes a reinforcing braid braided strands (see [0038], braided strands within the catheter wall)and wherein the reinforcing braid braided strands extends at least partially along the distal tip region 100 (see [0038], the braided strands are bonded to the structural elements 112 of the catheter tip 100, hence they extend via connecting to 112).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Puckett as applied to claim 2 above, and further in view of Gray et al (US 20150216533 A1), herein referenced to as “Gray”.
Claim 4
The combination of Kelly and Puckett teaches: The delivery device of claim 2, see 103 rejection above. The combination of Kelly and Puckett does not explicitly teach: wherein at least a portion of the reinforcing braid includes a polymer.
However, Gray in a similar field of invention teaches a delivery device 10 (see Figs. 8A-8B, [0042]) for an occlusive implant 32 (see Figs. 8A-8B, [0042]) with a delivery sheath 10 (see Figs. 8A-8B) with a sheath body 28 (see Figs. 8A-8B) with a reinforcing braid inner reinforcement layer braid (see [0033]). Gray further teaches: wherein at least a portion of the reinforcing braid inner reinforcement layer braid includes a polymer PTFE (see [0033], PTFE is a polymer).
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 Kelly to incorporate the teachings of Gray and have a reinforcing braid for a sheath with a polymer material. This is due to using a polymer such as PTFE for a reinforcing braid (see [0033] of Gray) 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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Puckett as applied to claim 1 above, and further in view of Zhou et al (US 20160296332 A1), herein referenced to as “Zhou”.
Claim 8
The combination of Kelly and Puckett teaches: The delivery device of claim 1, see 103 rejection above. The combination of Kelly and Puckett does not explicitly teach: wherein the plurality of distal arm segments include arm segments of differing lengths.
However, Zhou in a similar field of invention teaches a delivery device 3 (see Figs. 8A-8D, [0009] and [0076]) for an implant (see [0009]) with a tip reinforcing member 74 (see Figs. 8A-8D) with a plurality of distal arm segments 74 (see Figs. 8A-8D, [0077], discrete fingers). Zhou further teaches: wherein the plurality of distal arm segments 74 include arm segments 74 of differing lengths (see Figs. 8A-8D, [0077], the fingers 74 are defined by the gaps 70, with some of the gaps being longer than the others, hence some finger segments are longer while some are shorter, in Fig. 8D shows both the shorter and longer segments of 68 which comprise 74, in Fig. 8C only the longer segments 68 exist as the shorter one terminated via the gaps 70).
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 Kelly to incorporate the teachings of Zhou and teach a delivery device with the plurality of distal arm segments include arm segments of differing lengths. Motivation for such can be found in Zhou as this allows for a tapering expansion stiffness of the catheter from proximally to the distal end while distributing expansion such that risk of fracture is reduced (see [0077]-[0078]). Additionally, with the drop of compression exerted on the implant as it moves in the distal direction causes the friction or resistance to advancement to increase with distance of travel, which offsets the drop in expansion resistance with the somewhat increased push resistance, which prevents a user from experiencing a sudden drop of resistance when pushing the implant and preventing inadvertent deployment of the implant (see [0076]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Haasl et al (US 11278720 B2) teaches a delivery device for cardiac implants with a reinforced distal tip, reinforced with a braid
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 8:00 AM - 5:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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