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 07/31/2026. As directed by the amendment: claims 31 and 41-43 have been amended and claims 1-30 and 37-40 have been cancelled. Thus, claims 31-36 and 41-49 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 4-6, filed 07/31/2026, with respect to the rejection of claim 37 incorporated into claim 31 with further limitations under 35 U.S.C. 103 as being unpatentable over van der Burg et al (US 20040034366 A1), herein referenced to as “van der Burg" in view of Bates et al (US 20060052816 A1), herein referenced to as “Bates” have been fully considered but they are not persuasive.
Claim 31 has been amended to further recite “and a sealing member disposed about a perimeter of the defect spanning structure, wherein the sealing member comprises a swellable polymer”. The claim language “disposed about a perimeter of the defect spanning structure” is a new limitation.
The applicant argues that the combination of van der Burg and Bates does not teach the amended claim language. Specifically, they argue that Bates does not teach the amended limitations, as element 1022 is not a swellable polymer as the sealing lip forms part of anchor member to which 1030 is attached as does not comprise the swellable polymer. The examiner respectfully disagrees.
Bates notes that the patch 1030/105 (see [0092]) overlaps with the neck region 1021 (see [0092]) which additionally overlaps with 1022, hence the sealing lip contains the material of the swellable polymer (see [0145]-[0146]) of the patch as admitted by the applicant (see applicant’s arguments, page 5, paragraph 4).
The applicant additionally argues that one of ordinary skill in the art would not be motivated to modify van der Burg with Bates to have a sealing member comprising a swellable polymer as van der Burg already has structure addressing sealing, citing [0060] of van der Burg. The examiner respectfully disagrees.
The paragraph [0060] of Van der Brug refers to a separate embodiment not relied upon in the non-final office action, referring to Figures. 1-3, while the office action relied on the embodiment of Fig. 34A. This is further noted as [0060] refers to 17 as “a soft polymer material” while Fig. 34A, [0095], refers to 17 as “one or more spokes”. As such the embodiment of van der Burg relied upon does not have the sealing architecture and would benefit from a seal, especially one that induces tissue growth, which van der Burg does not disclose ([0060] merely discusses sealing).
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) 31-36, 41-46, and 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over van der Burg et al (US 20040034366 A1), herein referenced to as “van der Burg” in view of Bates et al (US 20060052816 A1), herein referenced to as “Bates”.
Claim 31
van der Burg discloses: An intrasaccular device 10 (see Fig. 34A, [0112]), comprising: an expandable body 14 (see Fig. 34A, [0095]) comprising a plurality of elongate filamentary elements 17 (see Fig. 34A, [0095]) each having a first the first end at 190 (see Fig. 34A) and a second end the second end at 192 (see Fig. 34A), wherein each of the plurality of elongate filamentary elements 17 extend from a first end 190 (see Fig. 34A) of the device 10 to a second end 192 (see Fig. 34A) of the device 10; a first hub 191 (see Fig. 34A, [0106], the distal hub at 190), wherein the first ends the first end at 190 of each of the plurality of elongate members 17 are coupled at the first end 190 of the device 10; and a second hub 222 (see Fig. 34A, [0106]), wherein the second ends the second end at 192 of each of the plurality of elongate members 17 are coupled at the second end 192 (see Fig. 34A) of the device 10; and a defect spanning structure 15 (see Fig. 34A, [0112]) comprising a mesh (see [0112], mesh), wherein the defect spanning structure 15 is located around a proximal portion 216 (see Fig. 34A, [0112]) of the expandable body 14, wherein the defect spanning portion 15 is disposed exteriorly (see Fig. 34A, [0112], 15 is on the external surface of 14) to an outer surface of the expandable body 14.
The preamble, "intrasaccular device," merely recites intended uses 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 van der Burg meets the structural limitations of the claim, and is capable of being inserted into an intrasaccular space to occlude the sac.
van der Burg does not explicitly disclose: a sealing member disposed about a perimeter of the defect spanning structure, wherein the sealing member comprises a swellable polymer.
However, Bates in a similar field of invention teaches an intrasaccular device 1010 (see Figs. 8-10) with an expandable body 1020 (see Figs. 8-10) and a defect spanning structure 1030 (see Figs. 8-10). Bates further teaches: further comprising a sealing member 1022 (see Figs. 8-10, [0162]) disposed about a perimeter (see Figs. 8-10, [0092] and [0162], 1022 is disposed about the perimeter of 1030 as it extends up to 1021) of the defect spanning structure 1030, wherein the sealing member 1022 comprises a swellable polymer dry foam SIS (see [0144]-[0146], polymeric material coated with SIS, when wetted expands, gelatinous, and [0165], 1030 overlaps with 1022, a hydrogel is a material that expands when put into contact with water, Bates notes that the patch 1030/105 (see [0092]) overlaps with the neck region 1021 (see [0092]) which additionally overlaps with 1022, hence the sealing lip contains the material of the swellable polymer (see [0145]-[0146]) of the patch as admitted by the applicant (see applicant’s arguments, page 5, paragraph 4).
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 van der Burg to incorporate the teachings of Bates and teach an intrasaccular device with a sealing member disposed about a perimeter of the defect spanning structure, wherein the sealing member comprises a swellable polymer. Motivation for such can be found in Bates as the sealing lip assists in closing the neck of the aneurysm (see [0019]) and to induce tissue growth (see [0164]-[0167]).
Claim 32
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. van der Burg further discloses: wherein the mesh (see [0112]) is a braid of wires or filaments (see Figs. 36-39, [0088]-[0092]. 15 is a braid of filaments with cross-hatch pattern).
Claim 33
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. van der Burg further discloses: wherein the defect spanning structure 15 comprises multiple layers (see Figs. 36-39, [0088], at least two layers, hence multiple layers).
Claim 34
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. van der Burg further discloses: wherein the defect spanning structure 15 has an open second end the open distal end of 15 towards 190 (see Fig. 34A) and a first end the end of 15 towards 192 (see Fig. 34A).
van der Burg does not explicitly disclose: first end is substantially flattened
However, Bates in a similar field of invention teaches an intrasaccular device 1010 (see Figs. 8-10) with an expandable body 1020 (see Figs. 8-10) and a defect spanning structure 1030 (see Figs. 8-10) with a first end the end of 1030 pointing towards the parent vessel (see Figs. 8-10). Bates further teaches: a substantially flattened first end (see Figs. 8-10, [0164]-[0166] 1030 is flattened).
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 van der Burg to incorporate the teachings of Bates and teach an intrasaccular device with the first end is substantially flattened. Motivation for such can be found in Bates as this end disposed to seal the aneurysm and induce tissue growth (see [0165]-[0167]).
Claim 35
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. van der Burg further discloses: wherein the plurality of elongate filamentary elements 17 comprise a plurality of wires (see Fig. 34A, [0107], spokes, hence a plurality of wires).
Claim 36
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. van der Burg further discloses: wherein the plurality of elongate filamentary elements 17 comprise nickel titanium alloys (see [0061], 14 which comprises 17, is made of NiTi, a nickel titanium alloy).
Claim 41
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. Bates further teaches: wherein the sealing member 1022 is located near the proximal portion (see Figs. 8-10, 1022 is near the proximal portion of 1020) of the expandable body 1020.
Claim 42
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. Bates further teaches: wherein the sealing member 1022 comprises an annular configuration (see Figs. 8-10, 1022 is an annular member, as it is a “lip”).
Claim 43
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. Bates further teaches: wherein the sealing member 1022 is secured to the proximal portion (see Figs. 8-10, 1022 is near the proximal portion of 1020) of the expandable body 1020.
Claim 44
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. van der Burg further discloses: wherein the intrasaccular device 10 (see Fig. 34A) has an expanded state (see Fig. 34A, is the expanded state), wherein the defect spanning structure 15 has a height the height of 15 (see Fig. 34A, extending along 10) in the expanded state and the expandable body 10 has a height the height of the device 10 (see Fig. 34A) in the expanded state, and wherein the height of the defect spanning structure 15 extends to a longitudinal position (see Fig. 34A, 15 extends halfway distally of 10) of the expandable body 10 of about 10 percent to about 60 percent (see Fig. 34A, halfway is about 50% which is between 10 percent and 60 percent) of the total height of the expandable body 10.
Claim 45
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. van der Burg further discloses: wherein the device 10 has a low profile radially constrained state (see [0110], low profile orientation) and a relaxed expanded state (see Fig. 34A, [0110]-[0111], shows the device in its expanded state).
Claim 46
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 31, see 103 rejection above. van der Burg further discloses: further comprising one or more fixation elements 195 (see Fig. 34A, [0095], a plurality of barbs or other anchors, meets the 112(f) interpretation, see above, of “barbs”).
Claim 48
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 46, see 103 rejection above. van der Burg further discloses: wherein the one or more fixation elements 195 comprises a hook, barb (see Fig. 34A, [0095], barb), protrusion (see Fig. 34A, [0095], a barb is a protrusion), pore, texturing, bioadhesives (the alternatives to “barb” and “protrusion” will not be examined here due to being optional claim limitations), or combinations thereof.
Claim 49
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 46, see 103 rejection above. van der Burg further discloses: wherein the one or more fixation elements 195 are located near the proximal portion 216 (see Fig. 34A, 195 is near in proximity to 216) of the expandable body 10.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over van der Burg in view of Bates as applied to claim 46 above, and further in view of Greenhalgh et al (US 20080119886 A1), herein referenced to as “Greenhalgh”.
Claim 47
The combination of van der Burg and Bates teaches: The intrasaccular device of claim 46, see 103 rejection above. The combination of van der Burg and Bates does not explicitly teach: wherein the one or more fixation elements comprises a bioadhesive.
However, Greenhalgh in a similar field of invention teaches an occlusive device 10 (see Fig. 2A) with an expandable body 12 (see Fig. 2A) and defect spanning structure 14 (see Fig. 2A) with one or more fixation elements (see [0065], bioadhesive, which meets the 112(f) interpretation, see above). Greenhalgh further teaches: wherein the one or more fixation elements bioadhesive (see [0065]) comprises a bioadhesive bioadhesive (see [0065]).
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 van der Burg to incorporate the teachings of Greenhalgh and teach an intrasaccular device with the one or more fixation elements comprises a bioadhesive. Motivation for such can be found in Greenhalgh as this can allow the device to attach to tissue without piercing it (see [0065]-[0066]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Meng (US 20080033478 A1) teaches an occlusive device with a flat proximal end
THIS ACTION IS MADE FINAL. 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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