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 11/05/2025. As directed by the amendment: claims 11 have been amended, claims 1-10 have been cancelled, claim 17 remains withdrawn and claims 23-25 have been added. Thus, claims 11-25 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of
Group 1: Species B (Fig. 4) Lead out sections without branch sections,
Group 2: Species A (Fig. 3) Convergence section that are folded linear rods,
Group 3: Species C (Fig. 8) The supporting sections incline circumferentially to be arranged in mirror symmetry; and
Group 4: Species B (Fig. 9) Supporting section with folded linear shape that is wider than the other sections
in the reply filed on 07/11/2025 is acknowledged.
Claims 17 and 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/11/2025.
Claim 23, which is a new claim, is directed to Group 2: Species C (Fig. 6) Convergence section that are connected by a third connecting rod, which was not elected by the applicant in the reply filed 07/11/2025, hence, is also withdrawn.
Specifically, in [0042] of applicant’s patent application publication states that “ In other embodiments, as shown in FIG. 6, for three adjacent supporting bodies 122, their distal ends bend and extend from tail ends of the corresponding three adjacent supporting sections 124 towards the interior of the fixing portion 120 to form a convergence section 125, by which the tail ends of the three adjacent supporting sections 124 are connected”. Thus, the claim “wherein the number of the at least two adjacent supporting sections is three, tail ends of three adjacent supporting sections form the convergence section” is directed to a non-elected species.
Claims 24-25 depend from claim 23 and also further refer to non-elected species Group 2: Species C (Fig. 6) Convergence section that are connected by a third connecting rod.
Response to Arguments
Applicant's arguments filed 11/05/2025, with respect to the rejection of claim 11 under 35 U.S.C. 102(a)(2) as being anticipated by Li et al (US 20190223882 A1), herein referenced to as “Li” have been fully considered but they are not persuasive.
The applicant has amended in claim 11 that “for all of the plurality of supporting sections… all sets of suspended sections are spaced apparat and suspended along the circumferential direction of the fixing portion and being independent from each other”.
The applicant argues that these limitations require that two adjacent suspended sections are spaced apart circumferentially and independent from each other, that the two sections are separated by a distance while remaining unconnected.
The applicant additionally argues that the tail ends of the at least two adjacent supporting sections do not bend and extend towards the interior of the fixing portion but rather they bend to the “exterior”.
The examiner respectfully disagrees.
Firstly, two adjacent suspended sections being 141 + two adjacent supporting sections (see annotated Fig. 8 below, form a suspended section, as the segments suspend proximally towards an interior) as it can be seen the 141 is separated from a distance away from an adjacent 141 (see Fig. 8) hence they are independent from each other and not directly connected.
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Secondly, the tail ends of the two adjacent supporting sections extend towards an interior of the fixing portion by extending proximally. According to the online Merriam-Webster dictionary the definition of interior is “the internal or inner part of a thing”, in this case the interior of the fixing portion of the device of Li, is the portion between the distal and proximal ends of the device (see annotated Fig. 6 below).
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As such the rejection of claim 11 will be maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-13 and 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Li et al (US 20190223882 A1), herein referenced to as “Li”.
Claim 11
Li discloses: An occlusion device 100 (see Figs. 5-8, [0067]), comprising: a fixing portion 111 (see Figs. 5-8, [0067]), the fixing portion 111 comprising a plurality of supporting bodies portion of 121 (see annotated Fig. 8 below, [0067]), the plurality of supporting bodies portions of 121 (see annotated Fig. 8 below) comprising a plurality of supporting sections portions of 121 (see annotated Fig. 8 below, these portions are distributed circumferentially around the fixing portion 111) spaced apart along a circumferential direction of the fixing portion; wherein for all of the plurality of supporting sections portions of 121 (see annotated Fig. 8 below) tail ends (see annotated Fig. 8 below) of at least two adjacent supporting sections bend (see annotated Fig. 8 below) and extend towards the interior (see annotated Figs. 6 and 8 below, the interior is portion away from the distal end of the device, towards a center or interior of a device) of the fixing portion 111 to form a convergence section 141 (see Figs. 5-8, [0067]), by which the tail ends (see annotated Fig. 8 below, they join to connect at 141) of the at least two adjacent supporting sections (see annotated Fig. 8 below) are connected; and wherein the at least two adjacent supporting sections (see annotated Fig. 8 below) and the corresponding convergence section 141 form a set of suspended sections 141 + two adjacent supporting sections (see annotated Fig. 8 below, form a suspended section, as the segments suspend proximally towards an interior), all sets of suspended sections 141 + two adjacent supporting sections (see annotated Fig. 8 below) of which are spaced apart and suspended (see Figs. 5-8, the suspended sections are spaced apart and suspended) along the circumferential direction of the fixing portion 111 and being independent from (141 is separated from a distance away from an adjacent 141 (see Fig. 8) hence they are independent from each other and not directly connected) each other.
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Claim 12
Li discloses: The occlusion device according to claim 11, see 102 rejection above. Li further discloses: wherein the plurality of supporting sections (see annotated Fig. 8 below) inclines circumferentially around a central axis (see annotated Fig. 8 below) of the fixing portion 111.
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Claim 13
Li discloses: The occlusion device according to claim 12, see 102 rejection above. Li further discloses: wherein at least two of the supporting sections (see annotated Fig. 8 below claim 12) within at least one set of the suspended sections (see annotated Fig. 8 below claim 12) incline in different directions (see annotated Fig. 8 below claim 12) along the circumferential direction of the fixing portion 111.
Claim 18
Li discloses: The occlusion device according to claim 11, see 102 rejection above. Li further discloses: wherein the occlusion device 100 further comprises a sealing portion 11 (see Figs. 5-8, [0067]) connected to the fixing portion 111, wherein one end the proximal ends of 121 connect to 11 via 16 (see Figs. 5-8) of each of the plurality of supporting bodies portion of 121 (see annotated Fig. 8 below claim 11) is connected to the sealing portion 11 and the other end the other end of the supporting bodies towards the supporting sections (see annotated Fig. 8 below claim 11, extends away from 11) extends away from the sealing portion 11.
Claim 19
Li discloses: The occlusion device according to claim 11, see 102 rejection above. Li further discloses: wherein the fixing portion 111 further comprises a central end portion 16 (see Figs. 5-8, [0067]), and the occlusion device 100 further comprises a sealing portion 11 (see Figs. 5-8, [0067], 11 is connected to 16, and on an proximal side of 111) connected to the central end portion 16 and disposed at one side of the fixing portion 111; wherein one end the proximal ends of 121 connect to 11 via 16 (see Figs. 5-8) of each of the plurality of supporting bodies portion of 121 (see annotated Fig. 8 below claim 11) is connected to the central end portion 16, and the other end the other end of the supporting bodies towards the supporting sections (see annotated Fig. 8 below claim 11, extends away from 16) extends radially outward from the central end portion and flipping towards (see Figs. 6 and annotated Fig. 8 below claim 11, as the supporting bodies transition to the supporting sections, they begin to flip proximally to allow the supporting sections and the suspending sections to “hang” proximally) the sealing portion 11 to form a flipping section the distal portions of the supporting bodies; and wherein each of the plurality of supporting bodies (see annotated Fig. 8 below claim 11) continues to extend from a tail end of the flipping section towards the sealing portion to form the supporting section (see annotated Fig. 8 below claim 11, the tail end of the flipping sections split into the branching supporting sections).
Claim 20
Li discloses: The occlusion device according to claim 19, see 102 rejection above. Li further discloses: wherein the sealing portion 11 comprises a distal disc surface the distal disc surface of 11 facing 111 (see Figs. 5-8) facing the fixing portion 111, at least a part of the distal disc surface the distal disc surface of 11 being coated with at least one thin-film body flow blocking membrane (see [0067], the flow blocking membrane is placed inside 11, and hence covering part of the distal disc surface from the inside).
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Wessman et al (US 6231589 B1), herein referenced to as “Wessman”.
Claim 14
Li discloses: The occlusion device according to claim 12, see 102 rejection above. Li does not explicitly disclose: wherein at least two adjacent sets of the suspended sections incline in different directions along the circumferential direction of the fixing portion.
However, Wessman in a similar field of invention teaches a filtering and clot capturing/aggerating device 10 (see Figs. 1-3) with a fixing portion 6 (see Figs. 1-3) and suspended sections 6.3 + 6.6 (see Figs. 1-3, these are suspended sections as they are “hanging” from a section, 6.2 in this case they branch from). Wessman further teaches: at least two adjacent sets (see annotated Fig. 2 below) of the suspended sections 6.2 + 6.3 incline in different directions (see annotated Fig. 2 below, col. 7, lines 41-59) along the circumferential direction of the fixing portion 6 (see Fig. 2).
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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 the occlusion device of Li to incorporate the teachings of Wessman and teach an occlusion device with wherein at least two adjacent sets of the suspended sections incline in different directions along the circumferential direction of the fixing portion. Motivation for such can be found in Wessman as the slight rotation allow the suspended sections to nest neatly when the wires are elastically compressed such as when the device is in a delivery catheter.
Claim(s) 15-16 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Miles et al (US 20130178889 A1), herein referenced to as “Miles”.
Claim 15
Li discloses: The occlusion device according to claim 11, see 102 rejection above. Li does not explicitly disclose: wherein each of the supporting sections comprises a first supporting area and a second supporting area connected to each other; wherein the first supporting area deforms along the circumferential direction of the fixing portion upon release and spreading of the fixing portion; and wherein a maximum width of the first supporting area along the circumferential direction of the fixing portion after deformation is greater than a maximum width of the second supporting area along the circumferential direction of the fixing portion.
However, Miles in a similar field of invention teaches an occlusion device 20 (see Figs. 1-3b) with a fixing portion 24 + 26 (see Figs. 1-3b), supporting bodies 24 (see Figs. 1-3b) and supporting sections 26 (see Figs. 1-3b). Miles further teaches: wherein each of the supporting sections 26 comprises a first supporting area 70 (see Fig. 3, [0057]) and a second supporting area 76 + 82 (see Fig. 3, [0057]) connected to each other (see Fig. 3, 70 and 76 + 82 are connected to each other); wherein the first supporting area deforms along the circumferential direction of the fixing portion upon release and spreading of the fixing portion; and wherein a maximum width of the first supporting area 70 along the circumferential direction of the fixing portion 24 + 26 after deformation (see Figs. 2-3, see also annotated Fig. 2 below shows the final state of the device, and 70 is wider than 76, since it has a barbed portion and 82 which is the second supporting area, is a tapered portion from 70) is greater than a maximum width the maximum width of 76 + 82 (see Figs. 2-3 and annotated Fig. 2 below) of the second supporting area 76 + 82 along the circumferential direction of the fixing portion 24 + 26.
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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 the occlusion device of Li to incorporate the teachings of Miles and teach an occlusion device with wherein each of the supporting sections comprises a first supporting area and a second supporting area connected to each other and wherein a maximum width of the first supporting area along the circumferential direction of the fixing portion after deformation is greater than a maximum width of the second supporting area along the circumferential direction of the fixing portion. Motivation for such can be found in Miles as the widened areas can be hooks that can assist in engaging with the tissue wall of the LAA (see [0059]) and the thinner section of the second support area, or flexure portion can facilitate repetitious movement of the device from a deployed position and the non-deployed position while maintaining structural integrity during deployment of the device (see [0057]).
The language, "wherein the first supporting area deforms along the circumferential direction of the fixing portion upon release and spreading of the fixing portion," 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 combination device of Li and Miles meets the structural limitations of the claim, and is capable of deforming along the circumferential direction of the fixing portion upon release and spreading of the fixing portion as both devices are elastically flexible materials that are capable of deformation in order to transition from delivery to implanted states (see [0017] of Li and [0060] of Miles).
Claim 16
The combination of Li and Miles teaches: The occlusion device according to claim 15, see 103 rejection above. The combination of Li and Miles further teaches: wherein the second supporting area deforms along the circumferential direction of the fixing portion upon a release of the fixing portion.
The language, " wherein the second supporting area deforms along the circumferential direction of the fixing portion upon a release of the fixing portion," 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 combination device of Li and Miles meets the structural limitations of the claim, and is capable of deforming along the circumferential direction of the fixing portion upon release and spreading of the fixing portion as both devices are elastically flexible materials that are capable of deformation in order to transition from delivery to implanted states (see [0017] of Li and [0060] of Miles).
Claim 21
The combination of Li and Miles teaches: The occlusion device according to claim 15, see 103 rejection above. Miles further teaches: wherein the deformation of the first supporting area 70 is a folded linear shape 86 (see Figs. 2-3, [0059], 86 is folded linear shape of 70, per the definition of folded according to the online Merriam-Webster dictionary as “to lay one part over another part of” wherein 86 is laid over the strut of 70 that it originates from to provide an overall greater width, and as seen in Fig. 2, the section 70 is still overall linear) or a wave shape (will not be examined here due to being an optional claim limitation because it is an “or”/alternative clause).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Campbell et al (US 20120172927 A1), herein referenced to as “Campbell”.
Claim 22
Li discloses: The occlusion device according to claim 11, see 102 rejection above. Li does not explicitly disclose: wherein the convergence section comprises folded linear rods.
However, Campbell in a similar field of invention teaches an occlusion device 100 (see Figs. 1-5A) with supporting sections wires of 101 that lead to 106 (see Figs. 1-5A) with convergence section 106 + 107 (see Figs. 1-5a, [0056], 106 + 107 are convergence sections as they are two segments that form a loop/connect with one another). Campbell further teaches: wherein the convergence section 106 + 107 (see Figs. 1 and 5A) comprise folded linear rods (see Fig. 5A, [0095], 106 in Fig. 5A are folded linear rods because they meet the definition of folded according to online Merriam-Webster dictionary as “to lay one part over another part of” in this case bends of 106 overlap each other in the length direction, and the parts of 106 still extend in the overall length, hence linear, direction).
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 occlusion device of Li to incorporate the teachings of Campbell and teach an occlusion device with the convergence section comprises folded linear rods. Motivation for such can be found in Campbell as these folds can facilitate anchor disengagement when a sheath is passed over it for recapture (see [0095]).
Conclusion
Applicant's amendment necessitated the ground of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771