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
The amendments filed on 11/11/2025 has been entered. Claims 1 and 3 have been amended; claim 6 has been cancelled; claims 10-16 have been withdrawn.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 11/11/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “Simply put, McGuckin does not disclose a central portion comprising a loop in which the state of compression of the loop actuates the hooking means. By contrast, McGuckin describes a central portion (element 200, see Fig. 2, 3) that includes a straight, vertical stem and upper arms 30 that form a figure-eight shape ([0089], [0095], [0094]) with two loops. In McGuckin, the upper arms 30 are axially straightened and brought closer together inside the cannula tube (see [0101], [0132]). When the device is released, the upper arms reposition themselves laterally, with a release of axial tension. However, in McGuckin, it is not the "loops" of the arms 30 that are compressed to actuate the device. They are simply brought together and straightened. Compression and relaxation of the loops is not what actuates the devices.” on page 7-8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. The limitation “a central portion comprising a loop”, specifically the transitional term “comprising”, is interpreted to be open-ended and does not exclude additional, unrecited elements (See MPEP 2111.03.I). Therefore, one of the loops/arms 30 of McGuckin still reads on the limitation, and each loop/arm 30 is compressed/squeezed towards one another. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “it is not the "loops" of the arms 30 that are compressed to actuate the device”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Currently, claim 1 does not recite any limitation regarding a direct causation between the loop and the device’s actuation. Examiner currently interprets the limitation of claim 1, i.e. the majority of the last paragraph, to be a particular point in time instead of an actuation event. For example, McGuckin discloses that when one of the loops 30 is compressed, at that point in time, the hooks 18 are spaced apart some distance (Fig. 7-8, and see rejection of claims below); a similar interpretation is applied for the point in time when the loop 30 is relaxed. Therefore, McGuckin reads on the limitations of claim 1, and the rejection is maintained.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin Jr. et al. US 2006/0052802 A1 (previously cited, hereinafter McGuckin), as cited in the IDS.
Regarding claim 1, McGuckin discloses a device 10-1 (Fig. 1-2 – clip 10-1) for closing a perforation (Fig. 7-9 – the opening of surface 13, and Par. 81 – “an aperture in a vessel”) in a wall 13 (Fig. 7-9 – exterior surface 13) of a cavity 11 (Fig. 7-9 – vessel 11) in a human or animal body (Par. 3 – “apertures in human and animal tissue”), said wall 13 (Fig. 7-9) having an internal part 155 (Fig. 7-9) and an external part 13 (Fig. 7-9), wherein the closing device 10-1 (Fig. 1-9) has closing means 10-1 (Fig. 2) comprising:
- a central portion 200 (Fig. 7 – first portion 200) comprising a loop 30 (Fig. 1 – extending side arms 30 are curved, each creating a loop),
- a first end 12 (Fig. 2 and Fig. 7 – right-side elongated strand 12) having a first hooking means 18 (Fig. 2 and Fig. 7 – right-side tip 18) and a second end 12 (Fig. 2 and Fig. 7 – left-side elongated strand 12) having a second hooking means 18 (Fig. 2 and Fig. 7 – left-side tip 18), the two ends 12, 12 (Fig. 2 and Fig. 7 – right and left side tip elongated strand 12) being arranged on either side of the central portion 200 (Fig. 2 and Fig. 7), each hooking means 18, 18 (Fig. 2 and Fig. 7) being configured to be anchored on a border of the perforation at the internal part 155 (Fig. 8) of the wall 13 (Fig. 8, and Par. 48 – “in FIG. 8 whereby tip members of the clip have penetrated the vessel wall”) of the cavity 11 (Fig. 8),
the closing means 10-1 (Fig. 2-9) being made of a shape memory material (Par. 87 – “Clip 10-1 is preferably memory metal”) and having a structure allowing a variation in the relative position of the hooking means 18, 18 with respect to one another according to the state of compression of the loop 30 (Fig. 1) of central portion 200 (Fig. 8-9 – position of tips 18 changes when portion 200 is released and unconstrained) such that when the loop 30 (Fig. 6-7) of the central portion 200 (Fig. 6-7 – portion 200) is in a compressed state (Fig. 7-8 depicts a compressed state of portion 200), the distance between the hooking means 18, 18 (Fig. 7-8) increases (Fig. 7-8 – the horizontal distance between the left-side tip 18 and right-side tip 18 is greatest when the portion 200 is still being compressed and constrained within delivery member 20) and that when the loop 30 (Fig. 8-9) of the central portion 200 (Fig. 8-9) passes from a compressed state (Fig. 8 depicts a compressed/constrained state) to a relaxed state (Fig. 9 depicts a relaxed/unconstrained state), the distance between the ends of the hooking means 18, 18 (Fig. 9) decreases (Fig. 2 and Fig. 9 depict an unconstrained state, thus the horizontal distance between the left-side tip 18 and the right-side tip is lowest), which leads to the alignment of the borders of the perforation and therefore the closing of the perforation (Par. 51 – “the clip within a vessel wall in an unconstrained configuration at least substantially closing an aperture in the vessel wall”, and Par. 91 – “clip 10-1 has deployed and closed an aperture in a vessel 11, upper half 64 preferably extends externally to now closed vessel 11”).
Regarding claim 2, McGuckin discloses the invention of claim 1. McGuckin further discloses wherein the device 10-1 (Fig. 7) has a guide channel 20 (Fig. 7 – delivery member 20) having an end 52 (Fig. 7 – front end 52) adapted to be positioned in the cavity 11 (Fig. 7) through the perforation (Par. 103 – “insertion of front end 52 of clip delivery member 20 with clip 10-1 therein into an aperture within a vessel 11”), the guide channel 20 (Fig. 7) being configured to receive the closing means 10-1 (Fig. 7) and to ensure the compression of said closing means (Fig. 6, and Par. 101 – “FIG. 6 when clip 10-1 is loaded into a device for deployment of clip 10-1 to close a vessel aperture, clip 10-1 is in a strained extended configuration”).
Regarding claim 3, McGuckin suggests the invention of claim 2. McGuckin further discloses wherein the closing means 10-1 (Fig. 2) are configured to adopt:
- a compression position (Fig. 6) in which the loop 30 (Fig. 6) of the central portion 200 (Fig. 6) and the hooking means 18, 18 (Fig. 6) are in a compressed state in the guide channel 20 (Fig. 6 shows a compressed state of the clip 10-1 within the member 20),
- a rest position (Fig. 9) in which the central portion 200 (Fig. 9) and the hooking means 18, 18 (Fig. 9) are outside of the guide channel 20 (Fig. 9) and in a relaxed state (Fig. 9, and Par. 104 – “Continued curvature of third portions 206 as tube 55 is removed from vessel 11 permits third portions 206 to reach their configuration whereby they are at least substantially free of internal stresses”),
- an intermediate position (Fig. 7) in which the loop 30 (Fig. 7) of the central portion 200 (Fig. 7) is in a compressed state in the guide channel 20 (Fig. 7 – central portion 200 still remains compressed in the member 20) while the hooking means 18, 18 (Fig. 7) are outside of the guide channel 20 (Fig. 7) in a relaxed state (Fig. 7, and Par. 104 – “As clip 10-1 is further ejected from ejection chamber 56 in the direction indicated by arrow A in FIG. 7 third portions 206 continue to curve”), the distance between the hooking means 18, 18 (Fig. 7) in the intermediate position (Fig. 7) being greater than the distance between the hooking means in the rest position (Fig. 9 – the horizontal distance between the left-side tip 18 and right-side tip 18 in Fig. 7 is greater than that in Fig. 9).
Regarding claim 4, McGuckin suggests the invention of claim 2. McGuckin further discloses wherein the device 10-1 (Fig. 2) has movement means 54 (Fig. 2 – wire 54) configured to ensure the movement of the closing means 10-1 (Fig. 2) inside the guide channel 20 (Fig. 2, Fig. 7, and Par. 105 – “the physician or other attending health professional may draw clip 10-1 back into tube 55 in the direction indicated by arrow B in FIG. 7 by pulling on pull ring 46 having wire 54 connected thereto”).
Regarding claim 5, McGuckin suggests the invention of claim 4. McGuckin further discloses wherein the movement means 54 (Fig. 2) are removably fixed (Par. 105 – “in the event the physician or other health professional has disconnected wire 54 from pull ring 46”; thus wire 54 is removable from clip 10-1) to the central portion 200 (Fig. 2) of the closing means 10-1 (Fig. 2 – wire 54 loops through first portion 200).
Regarding claim 7, McGuckin suggests the invention of claim 1. McGuckin further discloses 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”).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McGuckin in view of Freier et al. WO 2007006140 A1 (previously cited, hereinafter Freier), as cited in the IDS.
Regarding claim 8, McGuckin suggests the invention of claim 1. However, McGuckin 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 McGuckin 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 McGuckin in view of Eskridge US 8,876,863 B2 (previously cited, hereinafter Eskridge), as cited in the IDS, and evidenced by Chemistry Learner, “Nitinol” (previously cited, hereinafter Chemistry Learner).
Regarding claim 9, McGuckin suggests the invention of claim 1. However, McGuckin does not disclose wherein the closing means are made from a nickel-titanium alloy wire.
Eskridge, in the same field of endeavor of closure device (Title), teaches wherein the closing means 10 (Fig. 2A – closure device 10) are made from a nickel-titanium alloy wire 22 (Fig. 3 – wire frame 22, and Col. 7, line 13-14 – “Closure device 10 includes a wire frame 22, which is made of nitinol”).
Examiner notes Chemistry Learner supports that nitinol is a nickel-titanium metal alloy (Page 1, section “What is Nitinol?”).
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 McGuckin to be made from a nickel-titanium alloy wire as taught by Eskridge, in order to secure clipping to the tissue given its shape-memory property (Col. 7, line 13-21 of Eskridge, and Page 1, section “What is Nitinol” of Chemistry Learner). 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 from nitinol as taught by Eskridge, 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Roorda et al. US 9,314,230 B2
Goetz et al. US 2022/0296223 A1
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 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
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781