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 amendment filed 09/22/2025 has been entered. Claims 1-20 remain pending in the application and claims 12-20 are withdrawn. Applicant’s amendments to the claims have overcome each objection, 112(b) rejection, and prior art rejection with respect to claim 1 previously set forth in the Non-Final Office Action mailed 05/20/2025, however has not overcome the rejection to claim 6 and the drawing objection. In light of the amended language, claim 1 is now rejected under Arnesen.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive with respect to claim 6. Foshee discloses the first and second legs each curved outwardly in a convex fashion, as depicted by annotated figure 1 below. Therefore, the rejection is maintained.
The Drawings from U.S. Patent Publication No. 2022/0401180 are the same as included in the present drawings, and are still objected to for the same reason listed below. The Drawings objections are maintained.
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Drawings
The drawings are objected to because the color drawings must be of sufficient quality such that all details in the drawings are reproducible in black and white in the printed patent (MPEP 608.02 and 37 CFR 1.84). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-2 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnesen (WO 2012/126477).
With regards to claim 1, Arnesen discloses (Figures 1.1-1.3) a clip 1 adapted to selectively interconnect to tissue 8 (page 25 line 35 – page 26 line 23), comprising:
a first leg having a proximal end with a first plurality of inwardly-extending teeth and a distal end (see annotated figure 1.1 below);
a second leg being substantially a mirror image of the first leg, the second leg having a proximal end with a second plurality of inwardly-extending teeth and a distal end (see annotated figure 1.1 below);
wherein the first leg and the second leg are each curved outwardly in a convex fashion (see annotated figure 1.1 below), and wherein the proximal end of the first leg and the proximal end of the second leg define an apex (see annotated figure 1.1 below), wherein the first and second legs extend away from the apex in the same direction (figure 1.2); and
a tapered portion on the first leg or the second leg, wherein the tapered portion is spaced from the apex configured to facilitate selective leg deformation (see annotated figure 1.1 below – functional limitation – compressing the clip via the tapered portion from figure 1.1 to figure 1.2 allows for leg deformation).
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With regards to claim 2, Arnesen discloses further comprising a suture 2 interconnected to at least one of the first leg or the second leg (figure 1.1-1.2; page 26 lines 6-11).
With regards to claim 5, Arnesen discloses wherein the distal ends of the first leg and the second leg are spaced such that a distance between the distal ends is less than a length of the first leg or the second leg (figure 1.2 – in the closed configuration, the distance between the distal ends is minimal, which is less than a length of either the first leg or the second leg).
Claims 6-7 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foshee et al. (US PGPub 2018/0368852), hereinafter known as “Foshee.”
With regards to claim 6, Foshee discloses (Figures 1-6) a clip 100 adapted to selectively interconnect to tissue (paragraphs 2 and 39), comprising:
a first leg 102 having a proximal end 102A and a distal end 102B (paragraph 39);
a second leg 104 having a proximal end 104A and a distal end 104B (paragraph 39);
wherein the first leg 102 and the second leg 104 are each curved outwardly in a convex fashion (paragraph 41; see annotated figure 1 below), and wherein the proximal end 102A of the first leg 102 and the proximal end 104A of the second leg 104 define an apex 106 (paragraphs 39 and 47), wherein the first 104 and second 104 legs extend away from the apex 106 in a same direction (figure 6 – legs 102 and 104 extend in the same direction in the closed configuration); and
a tapered portion 174 on the second leg 104, wherein the tapered portion 174 is configured to facilitate selective leg deformation (figure 1; paragraphs 38 and 44-45 – functional limitation – “the surgical clip is compressed, while maintaining flexibility and accommodating the complex deformation that the surgical clip goes through to close and/or lock”).
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With regards to claim 7, Foshee discloses further comprising a suture interconnected to at least the second leg 104 (paragraphs 46 and 53 – interconnected via channel 178 on the second leg 104 that enables a suture to pass through to tissue).
With regards to claim 11, Foshee discloses wherein the distal ends 102B/104B of the first leg 102 and the second leg 104 are spaced such that a distance between the distal ends is less than a length of the first leg 102 or the second leg 104 (paragraph 52; figure 6 – in the closed configuration, the distance between the distal ends 102B/104B is minimal, which is less than a length of either the first leg 102 or the second leg 104).
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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Arnesen in view of Opperman et al. (US PGPub 2016/0331485), hereinafter known as “Opperman.”
With regards to claims 3-4, Arnesen discloses the clip as claimed in claim 1. Arnesen is silent wherein at least one of the suture or the clip includes identifying indicia (claim 3); and wherein the identifying indicia comprises at least one of a surface texture, a micro-engraving, x-ray markings, microchip technology, nanotech technology, RFID chips, and a coating (claim 4).
However, in a similar field of endeavor of endoscopic clip/sutures, Opperman teaches (Figure 2) wherein at least the suture 214a-e includes identifying indicia (paragraphs 15 and 17); and wherein the identifying indicia comprises at least a coating (paragraphs 14-18 – sutures are coated with a color coded scheme to indicate a location for specimen marking as paragraphs 51-52 of Applicant’s specification also discloses coating in the form of color coding).
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 clip of Arnesen to include wherein at least the suture includes identifying indicia as taught by Opperman for the purpose of indicating a location for specimen marking, enabling accurate communication between a pathologist and a surgeon (paragraphs 15-16 and 19 of Opperman).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Foshee in view of Opperman.
With regards to claims 8-10, Foshee discloses the clip as claimed in claim 6. Foshee is silent wherein the clip and the suture are of a same color (claim 8); wherein at least one of the suture or the clip includes identifying indicia (claim 9); and wherein the identifying indicia comprises at least one of a surface texture, a micro-engraving, x-ray markings, microchip technology, nanotech technology, RFID chips, and a coating (claim 10).
However, in a similar field of endeavor of endoscopic clip/sutures, Opperman teaches (Figure 2) wherein the clip 210 and the suture 214a-e are of a same color (paragraph 15 – “ the color-coded sutures 214(a)-214(e) are implemented to indicated a location. In such an embodiment, 214(a) includes a red suture indicating an anterior location. Similarly, 214(b), 214(c), 214(d) and 214(e) include green, blue, purple and yellow sutures, respectively, that represent inferior, superior, posterior and deep locations, respectively”; paragraph 17 – “Color coded sutures 214 are attached to the clips having colors designating the anterior, inferior, superior, posterior, and deep margins, as discussed above”; therefore clips 210 and sutures 214a-e have the same color respective of the location); wherein at least the suture 214a-e includes identifying indicia (paragraphs 15 and 17); and wherein the identifying indicia comprises at least a coating (paragraphs 14-18 – sutures are coated with a color coded scheme to indicate a location for specimen marking as paragraphs 51-52 of Applicant’s specification also discloses coating in the form of color coding).
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 clip of Foshee to include wherein the clip and suture are of the same color; and wherein at least the suture includes identifying indicia as taught by Opperman for the purpose of indicating a location for specimen marking, enabling accurate communication between a pathologist and a surgeon (paragraphs 15-16 and 19 of Opperman).
Conclusion
Applicant's amendment necessitated the new ground(s) 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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 10/24/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771