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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-18, Group 1: Species B (Figs. 5-6), Group 2: Species A (Fig. 13), and Group 3: Species A (Fig. 17) in the reply filed on 01/12/2026 is acknowledged.
Claims 5, 7, 9-10, and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/12/2026.
Claim Objections
Claim 14 is objected to because of the following informalities:
In claim 14, line 5, “having a base a plurality of distal” should be “having a base and a plurality of distal”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6, 8, and 11-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In Claim 1, the Applicant is required to clarify to what the claim is intended to be drawn to, i.e., either the delivery device alone or the combination of the delivery device and occlusive implant. The Applicant sets forth the combination of the delivery device and the occlusive implant when describing “and an occlusive implant releasably coupled to the core member”, which is inconsistent with the preamble, that sets forth the subcombination of the delivery device alone. Applicant is required to make the language of the claims consistent with the intent of the claims. It should also be noted that in considering the claims on the merits, the Examiner will consider the claims as drawn to the combination.
Claims 2-4, 6, 8, and 11-13 are rejected as being dependent on claim 1.
In Claim 14, the Applicant is required to clarify to what the claim is intended to be drawn to, i.e., either the delivery device alone or the combination of the delivery device and occlusive implant. The Applicant sets forth the combination of the delivery device and the occlusive implant when describing “and a left atrial appendage occlusive implant releasably coupled to the core member”, which is inconsistent with the preamble, that sets forth the subcombination of the delivery device alone. Applicant is required to make the language of the claims consistent with the intent of the claims. It should also be noted that in considering the claims on the merits, the Examiner will consider the claims as drawn to the combination.
Claim 15 is rejected as being dependent claim 14.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6, and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelly (US 20170014252 A1), herein referenced to as “Kelly”.
Claim 1
Kelly discloses: A delivery device 118 (see Figs. 1-2B, [0042] and [0047]) for an occlusive implant occluder (see [0047]), the delivery device 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); 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.
Claim 2
Kelly discloses: The delivery device of claim 1, see 102 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
Kelly discloses: The delivery device of claim 2, see 102 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
Kelly discloses: The delivery device of claim 1, see 102 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
Kelly discloses: The delivery device of claim 1, see 102 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
Kelly discloses: The delivery device of claim 1, see 102 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
Kelly discloses: The delivery device of claim 1, see 102 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 delivery device 118 (see Figs. 1-2B, [0042] and [0047]) for an occlusive implant occluder (see [0047]), the delivery device 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); 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]).
Claim 15
Kelly discloses: The delivery device of claim 14, see 102 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 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Gray et al (US 20150216533 A1), herein referenced to as “Gray”.
Claim 4
Kelly discloses: The delivery device of claim 2, see 102 rejection above. Kelly does not explicitly disclose: 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 Zhou et al (US 20160296332 A1), herein referenced to as “Zhou”.
Claim 8
Kelly discloses: The delivery device of claim 1, see 102 rejection above. Kelly does not explicitly disclose: 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
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