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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 has been entered.
Response to Amendment
The amendments filed on 04/28/2026 has been entered. Claims 1 and 16 have been amended; claim 6 has been cancelled; claims 10-16 have been withdrawn. Accordingly, claims 1-5, and 7-16 are pending and under consideration.
Response to Arguments
Applicant’s arguments filed on 04/28/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Ginn et al. US 2010/0256670 A1 (newly cited). See rejection of claims below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ginn et al. US 2010/0256670 A1 (newly cited, hereinafter Ginn).
Regarding claim 1, Ginn discloses a device 100 (Fig. 1A – delivery system 100) for closing a perforation 506 (Fig. 5C – aperture 506) in a wall 503/504 (Fig. 5C – tissue flap 503, 504) of a cavity 508/509 (Fig. 5A-5C – side 508, 509) in a human or animal body (Par. 46 – “patient's vasculature”), said wall 503/504 (Fig. 5C) having an internal part 508/509 (Fig. 5C – side 508 and 509 correspond to wall 503 and 504 respectively) and an external part 505 (Fig. 5C – opening 505), wherein the closing device 100 (Fig. 1A) has closing means 800 (Fig. 8A-8B; Examiner notes that the embodiment of Fig. 8A-8B can be used in place of clip 104 of Fig. 5C, as described in Par. 62 – “FIG. 8A depicts a perspective view of another exemplary embodiment of clip 800, for use with the systems and methods described herein as an alternative to clip 104”) comprising:
- a central portion 806 (Fig. 8A-8B – coiled body 806) comprising a loop (see annotated Fig. 8A-8B below), the loop (see annotated Fig. 8A-8B below) being formed by crossing two strands 820, 820 (Fig. 8B – first coiled segment 820 and second coiled segment 822) of a single wire (Fig. 8A-8B),
- a first end 802 (Fig. 8B – end 802) having a first hooking means 802 (Fig. 8B) and a second end 804 (Fig. 8B – end 804) having a second hooking means 804 (Fig. 8B), the two ends 802, 804 (Fig. 8B) being arranged on either side of the central portion 806 (Fig. 8A), each hooking means 802, 804 (Fig. 8B) being configured to be anchored on a border of the perforation 506 (Fig. 5C) at the internal part 508/509 (Fig. 5C) of the wall 503/504 (Fig. 5C, Fig. 5E and Fig. 5F for exemplary demonstration – each end is disposed to anchor the border of aperture 506 at the internal side 508, 509) of the cavity 508/509 (Fig. 5C),
the closing means 800 (Fig. 8A-8B) having a structure allowing a variation in the relative position of the hooking means 802, 804 (Fig. 8A-8B) with respect to one another according to the state of compression of the loop (see annotated Fig. 8A and Fig. 8B below) of the central portion 806 (Fig. 8A-8B each shows a relaxed state and a stressed state) such that lateral compression of the loop (see annotated Fig. 8B below – loop being compressed in a direction perpendicular to the central axis 811) decreases the width of the loop (see annotated Fig. 8B below – loop decreases in width) and increases the distance between the hooking means 802, 804 (Fig. 8B) and that when the loop (see annotated Fig. 8B below) of the central portion 806 (Fig. 8A-8B) passes from a compressed state (Fig. 8B shows a stressed state of clip 800, including the compression of the annotated loop) to a relaxed state (Fig. 8A shows a relaxed state), the distance between the ends of the hooking means 802, 804 (Fig. 8A) decreases (Fig. 8A, and Par. 62 – “When clip 800 is deformed from the relaxed state to the stressed state, second coiled segment 822 is preferably passed within first coiled segment 820”), which leads to the alignment of the borders of the perforation 506 (Fig. 5E) and therefore the closing of the perforation 506 (Fig. 5Em and Par. 63 – “Clip 800 can be used to close a PFO in a method similar to that depicted with regard to clip 104 in FIGS. 5A-E. FIG. 8C depicts a perspective view of clip 800 deployed over two tissue flaps of a PFO”).
However, Ginn does not currently disclose the closing means being made of a shape memory material.
Examiner notes that clip 800 is taught to be biased towards the relaxed state.
Ginn, in another embodiment, teaches that the closing means being made of a shape memory material (Par. 53 – “Clip 104 can be formed from an elastic material, such as stainless steel, and preferably a superelastic material having shape memory and superelastic characteristics, such as nitinol, various nitinol alloy combinations and the like”).
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 material of Ginn’s closing means to be made of a shape memory material, as such material is well-known to one of ordinary skill in the art as discussed by Ginn (Par. 53 of Ginn). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the closing means of Ginn out of a shape memory material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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Annotated Fig. 8A and Fig. 8B of Ginn
Regarding claim 2, Ginn suggests the invention of claim 1. Ginn further discloses wherein the device 100 (Fig. 1A) has a guide channel 119 (Fig. 1A – inner lumen 119) having an end 118 (Fig. 1A – open distal end 118) adapted to be positioned in the cavity 508/509 (Fig. 5C) through the perforation 506 (Fig. 5C), the guide channel 119 (Fig. 1A) being configured to receive the closing means 800 (Fig. 5C – clip 800 in place of clip 104) and to ensure the compression of said closing means 800 (Fig. 5C).
Regarding claim 3, Ginn suggests the invention of claim 2. Ginn further discloses wherein the closing means 800 (Fig. 8A-8B) are configured to adopt:
- a compression position (Fig. 8B) in which the loop (see annotated Fig. 8A and Fig. 8B above) of the central portion 806 (Fig. 8B) and the hooking means 802, 804 (Fig. 8B) are in a compressed state (Fig. 8B) in the guide channel 119 (Fig. 1A and Fig. 5C – the clip is compressed within the inner lumen 119),
- a rest position (Fig. 8A) in which the central portion 806 (Fig. 8A) and the hooking means 802, 804 (Fig. 8B) are outside of the guide channel 119 (Fig. 1A and Fig. 5E) and in a relaxed state (Fig. 1A and Fig. 5E – the clip is released and decompressed outside the inner lumen 119),
- an intermediate position (Fig. 5D) in which the loop (see annotated Fig. 8A and Fig. 8B above) of the central portion 806 (Fig. 8A-8B) is in a compressed state in the guide channel 119 (Fig. 5D – the middle portion of the clip is still compressed within the inner lumen 119) while the hooking means 804 (Fig. 8B) are outside of the guide channel 119 (Fig. 1A and Fig. 5D) in a relaxed state (Fig. 5D – one end is relaxed outside the inner lumen), the distance between the hooking means 802, 804 (Fig. 8B and Fig. 5D) in the intermediate position (Fig. 5D) being greater than the distance between the hooking means 802, 804 (Fig. 8A and Fig. 5E) in the rest position (Fig. 8A and Fig. 5E – when the clip is decompressed, two ends 802, 804 come closer together).
Regarding claim 4, Ginn suggests the invention of claim 2. Ginn further discloses wherein the device 100 (Fig. 1) has movement means 116 (Fig. 1 – pusher 116) configured to ensure the movement of the closing means 800 (Fig. 8A-8B, Fig. 1, and Par. 49) inside the guide channel 119 (Fig. 5D, and Par. 49 – “pusher 116 can be advanced distally within inner lumen 119 of needle 114 until one end of clip 104”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn as applied to claim 4 above, and further in view of Phillips et al. US 7,326,231 B2 (newly cited, hereinafter Phillips).
Regarding claim 5, Ginn suggests the invention of claim 4. However, Ginn does not disclose wherein the movement means are removably fixed to the central portion of the closing means.
Phillips, in the same field of endeavor of device for surgically joining living tissue (Col.1 , line 8-10), teaches wherein the movement means 50 (Fig. 8 – positioning tube 50) are removably fixed to the central portion 42 (Fig. 7-8 – looped portion 42) of the closing means 40 (Fig. 7-8 – surgical fixator means 40, and Col. 5, line 25-26 – “A length of flexible suture 70 is threaded through loop 42 and positioning tube 50”).
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 movement means of Ginn to be removably fixed to the central portion as taught by Phillips, so that the position of the implant can be adjusted by a combination of pushing on the positioning tube and by pulling handle of suture (Col. 5, line 27-30 of Phillips).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn as applied to claim 1 above, and further in view of McGuckin et al. US 2005/0055049 A1 (previously cited, hereinafter McGuckin).
Regarding claim 7, Ginn suggests the invention of claim 1. However, Ginn does not disclose wherein the first hooking means and the second hooking means each have the form of a hook.
McGuckin, in the same field of endeavor of apparatus for closing an aperture (Abstract), teaches wherein the first hooking means 18 (Fig. 2 – right-side tip 18) and the second hooking means 18 (Fig. 2 – left-side tip 18) each have the form of a hook 28 (Fig. 2 – curved transition portion 28, and Par. 97 – “curved loop transition portion 28”).
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 hooking means of Ginn to have the form of a hook as taught by McGuckin, in order to form a sharp point functioning to easily penetrate tissue (Par. 97 of McGuckin).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn as applied to claim 1 above, and further in view of Freier et al. WO 2007006140 A1 (previously cited, hereinafter Freier), as cited in the IDS.
Regarding claim 8, Ginn suggests the invention of claim 1. However, Ginn does not disclose wherein the closing means are made of a resorbable material.
Freier, in the same field of endeavor of clips (Abstract), teaches wherein the closing means (Page 4, line 17 – “The clip body comprises at least one contact surface which has a bioactive element... The resilient material may itself be a bioactive material”) are made of a resorbable material (Page 4, line 20 – “In one possible embodiment, the resilient material may be a bioresorbable… material”).
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 device of Ginn to be made of a bioresorbable material as taught by Freier, in order to promote disappearance of the implant as soon as the closure takes place (Page 3, line 13-14 of Freier), thereby avoiding unwanted compression of the tissue (Page 3, line 14 of Freier). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the closing means of McGuckin out of a resorbable material as taught by Freier, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn as applied to claim 1 above, and evidenced by Chemistry Learner, “Nitinol” (previously cited, hereinafter Chemistry Learner).
Regarding claim 9, Ginn suggests the invention of claim 1. Ginn further discloses wherein the closing means are made from a nickel-titanium alloy wire (Par. 53 – “Clip 104 can be formed from an elastic material, such as stainless steel, and preferably a superelastic material having shape memory and superelastic characteristics, such as nitinol, various nitinol alloy combinations and the like”).
Examiner notes Chemistry Learner supports that nitinol is a nickel-titanium metal alloy (Page 1, section “What is Nitinol?”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sampson et al. US 10,667,914 B2 teaches a ribbon-shaped anchor with a central loop.
Starksen et al. US 9,949,829 B2 teaches a looped anchor.
Bolduc et al. US 5,976,159 A teaches a surgical clip with double hooks and each end and a central loop.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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