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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/19/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 05/19/2026. As directed by the amendment: claims 11 have been amended, claims 1-10 and 23-25 have been cancelled and claim 17 remains withdrawn. Thus, claims 11-22 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 05/19/2026, with respect to the rejection(s) of claim(s) 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 and are persuasive.
The applicant has amended claim 11 to further recite “tails end of at least two adjacent supporting sections bend and extend towards a central axis…; and wherein the convergence section is disposed closer to the central axis of the fixing portion than the corresponding at least two adjacent supporting sections”. The applicant asserts that Li does not disclose the amended claim language.
The examiner agrees as the convergence section 141 extends inwardly but not towards the central axis of the fixing portion 111.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Li et al (US 20190223882 A1) in view of Obradovic (US 20170156898 A1).
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) 11-13 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US 20190223882 A1), herein referenced to as “Li” in view of Obradovic (US 20170156898 A1), herein referenced to as “Obradovic”.
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 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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Li does not explicitly disclose: the tails ends of the at least two adjacent supporting sections bend and extend towards a central axis; and wherein the convergence section is disposed closer to the central axis of the fixing portion than the corresponding at least two adjacent supporting sections.
However, Obradovic in a similar field of invention teaches an occlusion device 7 (see Figs. 1-8) with a fixing portion 14 (see Figs. 7-8) with tails end the ends of 7b (see Figs. 7-8) at least two adjacent supporting sections 7b (see Figs. 7-8) bend and extend towards the fixing portion to form a convergence section 15 (see Figs. 7-8). Obradovic further teaches: the tails ends the ends of 7b (see Figs. 7-8) at least two adjacent supporting sections 7b (see Figs. 7-8) bend and extend towards a central axis the longitudinal axis of 14 (see annotated Fig. 8 below) of the fixing portion 14; and wherein the convergence section 15 is disposed closer to the central axis (see annotated Fig. 8 below) of the fixing portion 14 than the corresponding at least two adjacent supporting sections 7b (see annotated Fig. 8 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 Li to incorporate the teachings of Obradovic and teach an occlusion device with the tails ends of the at least two adjacent supporting sections bend and extend towards a central axis; and wherein the convergence section is disposed closer to the central axis of the fixing portion than the corresponding at least two adjacent supporting sections. Motivation for such can be found in Obradovic as the inwardly curved tip of the loop/convergence formed by two elements 7b prevents the tissue from suffering injuries and on the other causes anchor elements 7b to be tensioned which is conducive to and enhances the anchoring of the implant (see [0056]).
Claim 12
The combination of Li and Obradovic teaches: The occlusion device according to claim 11, see 103 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
The combination of Li and Obradovic teaches: The occlusion device according to claim 12, see 103 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
The combination of Li and Obradovic teaches: The occlusion device according to claim 11, see 103 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
The combination of Li and Obradovic teaches: The occlusion device according to claim 11, see 103 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
The combination of Li and Obradovic teaches: The occlusion device according to claim 19, see 103 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(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Obradovic as applied to claim 12 above, and further in view Wessman et al (US 6231589 B1), herein referenced to as “Wessman”.
Claim 14
The combination of Li and Obradovic teaches: The occlusion device according to claim 12, see 103 rejection above. The combination of Li and Obradovic does not explicitly teach: 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 Obradovic as applied to claim 11 above, and further in view of Miles et al (US 20130178889 A1), herein referenced to as “Miles”.
Claim 15
The combination of Li and Obradovic teaches: The occlusion device according to claim 11, see 103 rejection above. The combination of Li and Obradovic does not explicitly teach: 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.
Claim 16
The combination of Li, Obradovic, 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, Obradovic, 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 Obradovic as applied to claim 11 above, and further in view of Campbell et al (US 20120172927 A1), herein referenced to as “Campbell”.
Claim 22
The combination of Li and Obradovic teaches: The occlusion device according to claim 11, see 103 rejection above. The combination of Li and Obradovic does not explicitly teach: 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]).
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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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al (US 20190021741 A1) teaches an occlusion device with a fixing portion with suspended sections pointing towards the central axis
Li et al (US 20160287261 A1) teaches an occlusion device with a fixing portion with suspended sections with a convergence section pointing towards the central axis
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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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
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