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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 29, 2025 has been entered. Claims 1-23 are pending in the application with claim 20 being withdrawn from further consideration. Response to applicant's arguments can be found at the end of this office action.
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.
Claims 1, 3, 5, 6, 11, 12, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shave (U.S. Patent No. 5358498).
Regarding claim 1, Shave discloses a suturing device (10’’; Figs. 9-13) comprising:
a suturing needle (12; annotated Fig. 1 below)), comprising
a needle tip portion having a needle tip at a distal end for piercing tissue;
a needle body having a distal end connected to a proximal end of the needle tip portion; and
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a thread attachment component (30; annotated Fig. 9 below), wherein the thread attachment component includes a first end that is connected to a proximal end of the needle body, and a second end opposed to the first end that faces away from the proximal end of the needle body;
a suture thread (14; Fig. 9),
a tapered transition portion (22; annotated Fig. 12 below) extending from the proximal end of the needle body and overlapping and surrounding the thread attachment component and at least a portion of the suture thread, wherein the tapered transition component extends away from the proximal end of the needle body past the second end of the thread attachment component and over the at least the portion of the suture thread, wherein the tapered transition portion is separate and distinct from the thread attachment component and tapers from the proximal end of the needle body to the at least the portion of the suture thread (annotated Fig. 12 below).
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The device of Shave discloses the invention substantially as claimed, except for the suture thread being swaged to the second end of the thread attachment component.
However, Shave teaches that it was known to mechanically swage a needle channel onto a suture to firmly hold the suture to the needle (col. 1, ll. 13-19).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the suturing device such that the suture thread is swaged to the second end of the thread attachment component, in view of Shave, in order to further firmly hold the suture to the needle during use. Additionally or alternatively, such modification would have been obvious in order to prevent suture (14) from shifting within groove (32) while sleeve (22) is positioned over hub (30) to shrink and secure the suture to the needle.
Regarding claim 3, Shave discloses wherein the tapered transition portion is flexible (e.g., being made from a flexible polymer (col. 4, ll. 59-63).
Regarding claim 5, Shave discloses, wherein the needle tip portion is formed to become gradually thicker from the needle tip to the proximal end thereof (Fig. 1).
Regarding claim 6, Shave discloses wherein the suture thread is mono-filamentary or multi-filamentary (Figs. 9-12 show suture (14) as a single thread filament).
Regarding claim 11, Shave discloses wherein the needle body is straight (Figs. 9-12).
Regarding claim 12, Shave discloses wherein the needle body is curved (Fig. 1).
Regarding claim 21, Shave discloses wherein a first end of the tapered transition portion overlaps the proximal end of the needle body (Figs. 11 and 12; e.g., sleeve (22) overlaps needle (12) where the two make contact, when viewed along a median plane of the suturing device).
Regarding claim 22, shave discloses wherein the tapered transition portion is conically shaped (Figs. 9-13).
Regarding claim 23, Shave discloses wherein the tapered transition portion is formed by a shrink-wrapped procedure (col. 6, ll. 45-61), wherein a preform is positioned over the suture thread and extends over the thread attachment component to the proximal end of the needle (Figs. 10-11), and heat is applied to form the preform on the suture and the thread attachment component up to the proximal end of the needle, thus forming the tapered transition portion (col. 6, ll. 45-61).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Shave, as applied to claim 1 above, and further in view of Flagg et al. (U.S. Patent No. 2240330; hereinafter “Flagg”) and Miller (U.S. Patent No. 5865836).
Regarding claim 2, Shave further discloses wherein the tapered transition portion provides a smooth transition from the first end to the second end thereof (Fig. 12). The modified device discloses the invention substantially as claimed, except for the first end having a diameter equal to a needle body diameter and the second end having a diameter substantially qual to a suture thread diameter.
Miller, a reference in the suture needle field of endeavor, teaches that the dimensions of shrink tubing may be selected to have larger or smaller diameter along the length of the tubing (Fig. 6; col. 4, ll. 1-7)
Flagg, a reference in the suture needle field of endeavor, teaches selecting diameters of a tapered transition portion (10; Fig. 3) such that that a first end of the tapered transition portion has a diameter equal to a needle body diameter (e.g., at needle shoulder (6); col. 3, ll. 41-45), and a second end of the tapered transition portion opposite the first end has a diameter substantially equal to a suture thread (1) diameter (Fig. 3; col. 5, ll. 28-34), and wherein the tapered transition portion provides a smooth transition from the first end to the second end thereof (Fig. 3) to prevent the formation of sharp corners that may injure tissues through which the needle passes (col. 5, ll. 41-45).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the tapered transition portion such that a first end of the tapered transition portion proximal to the needle body has a diameter equal to a needle body diameter, and a second end of the tapered transition portion opposite the first end has a diameter substantially equal to a suture thread diameter, and wherein the tapered transition portion provides a smooth transition from the first end to the second end thereof, in view of Miller and Flagg, in order to mitigate harm to tissue through which the needle passes during a procedure.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shave, as applied to claim 1 above, and further in view of Korthoff et al. (U.S. Patent No. 5156615; hereinafter “Korthoff”).
Regarding claim 4, the modified device discloses the invention substantially as claimed, except for the tapered transition portion being formed of cyanoacrylate.
Korthoff, a reference in the suture needle field of endeavor, teaches a needle coupling formed of a cyanoacrylate (the bonding agent material includes epoxies and monomers or polymers of cyanoacrylate, col. 9, ll. 1-60) to allow a needle-suture combinations to be atraumatic and advantageously exhibit flexibility in the attachment region (using a bonding agent introduces flexibility in the for needle-suture combinations, col. 3, ll. 31-41; col. 5, ll. 65-68; and col. 13, ln. 6 – col. 14, ln. 9).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the joint formed by the tapered transition portion to incorporate the use of cyanoacrylate bonding agent such that the tapered transition portion is formed of a cyanoacrylate, in view of Korthoff, to facilitate atraumatic threading of the needle and suture through tissue during a procedure.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shave, as applied to claim 1 above, and further in view of Sander (U.S. Patent No. 5269783).
Regarding claim 7, the modified device discloses the invention substantially as claimed, except for the suture thread being bioabsorbable.
Sander teaches forming a suture thread to be bioabsorbable (col. 3, ll. 51-54) to facilitate tissue healing (col. 4, ll. 53-56).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the suture thread of bioabsorbable material so that the suture thread is bioabsorbable, in view of Sander, to promote tissue healing and to allow treatment of a patient without requiring invasive removal of the suture after healing.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shave, as applied to claim 1 above, and further in view of D’Agostino et al. (U.S. Patent Application Publication No. 20130226233; hereinafter “D’Agostino”).
Regarding claim 8, the modified device discloses the invention substantially as claimed, except for the suture thread including tissue retaining structures.
D’Agostino, a reference in the suture needle field of endeavor, teaches providing a needle with at least one region of tissue retaining structures (retainer or barb; Figs. 3-6) to resist movement of the suture in a direction other than a deployment direction of the suture (para. [0095]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the suture thread with at least one region of tissue retaining structures, in view of D’Agostino, in order to prevent undesired reverse movement of the suture through tissue.
Regarding claim 9, the modified device discloses wherein the tissue retaining structures are barbs (D'Agostino Fig. 3-6; col. 12, ll. 35-67).
Regarding claim 10, the modified device discloses wherein the at least one region of tissue retaining structures are distal from the tapered transition portion (e.g., as D’Agostino teaches the barbs are on the suture (D’Agostino Fig. 3) and Shave teaches the suture being distal of the transition portion (Shave Figs. 9-12).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shave, as applied to claim 1 above, and further in view of Fukuda et al. (U.S. Patent No. 6322581; hereinafter “Fukuda”).
Regarding claim 13, the modified device discloses the invention substantially as claimed, except for the needle body being formed to have a substantially circular cross-section having a non-smooth profile.
Fukuda, a reference in the suture needle field of endeavor, teaches providing a needle body being formed to have a substantially circular cross-section having a non-smooth profile (i.e., circumferential indentations (63) forming ridges (62) having a convex shape (Fig. 5b)) to facilitate grasping the needle for manipulation (col. 2, ll. 1-22).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the needle body to have a substantially circular cross-section having a non-smooth profile, in view of Fukuda, to facilitate manipulation of the needle during a procedure.
Regarding claim 14, Fukuda discloses wherein the non-smooth profile comprises a plurality of substantially equally spaced circumferential indentations (63) extending longitudinally on the curved needle body (Fig. 5b).
Regarding claim 15, Fukuda discloses wherein the non-smooth profile comprises from 4 to 16 equally spaced circumferential indentations (63) forming ridges (62) having a convex shape (Fig. 5b).
Regarding claim 16, Fukuda discloses wherein the circumferential indentations (63) extend along a full length of the curved needle body (Figs. 1 and 5a).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Shave in view of Fukuda, as applied to claim 16 above, and further in view of Cabezas (U.S. Patent Application Publication No. 20100036415).
Regarding claim 17, the modified device discloses the invention substantially as claimed, except for the circumferential indentations being angled on the curved needle body to form a spiral thereon.
Cabezas, a reference in the suture needle field of endeavor, teaches forming on or more circumferential indentations (416’) on a curved needle body to form a spiral thereon (Fig. 15; para. [0035]) to reduce force necessary to advance the needle and facilitate atraumatic insertion and removal of the needle (para. [0029]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the circumferential indentations to be angled on the curved needle body to form a spiral thereon, in view of Cabezas, to reduce trauma to a patient while the needle is inserted and removed from tissue.
Regarding claim 18, Cabezas discloses wherein the spiral is right-handed or left-handed (Fig 15 shows the spiral is left handed).
Regarding claim 19, Cabezas discloses the needle comprising at least two regions of circumferential indentations having different angles on the curved needle body (para. [0009] teaches the at least one indentation may include a plurality of indentations that are spaced about a periphery of the shaft and the plurality of protrusions may be positioned uniformly, or randomly, about the outer surface of the shaft; Fig. 15 of Cabezas depicts circumferential indentions on opposed sides of the needle (i.e., solid-line indentations vs. phantom-line indentations) having different angles on the curved needle body).
Response to Arguments
Applicant's arguments filed September 29, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the combination of Ferragamo, Sander, and Miller, as previously applied to claim 1 (Response pp. 7-9), have been considered but are moot because the new ground of rejection over Shave does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in those arguments.
Applicant’s argument concerning Korthoff, as applied to claim 4 (Response pg. 10), is not persuasive. On page 10 of the Response, Applicant argues that Korthoff does not disclose a tapered transition portion being formed of cyanoacrylate.
This argument is not persuasive because Korthoff teaches that cyanoacrylate may be included as a layer or coating of a bonding tube (col. 8, ll. 62-68). Thus, as the layer bonding tube includes a layer or coating of cyanoacrylate, Korthoff teaches the bonding tube being formed of a cyanoacrylate. Therefore, the combination of Shave and Korthoff meets the limitation of “the tapered transition portion is formed of a cyanoacrylate,” as claimed.
Applicant’s arguments concerning D’Agostino, as applied to claims 8-10 (Response pp. 10-11); Fukuda, as applied to claims 15-16 (Response pg. 11); and Cabezas, as applied to claims 17-18 (Response pp. 11-12) are not persuasive because Applicant merely argues that each of D’Agostino, Fukuda, and Cabezas does not cure the deficiencies of Ferragamo, Sander, and Miller as applied to claim 1. As explained above, Applicant’s arguments concerning the combination Ferragamo, Sander, and Miller are moot in light of the new grounds of rejections.
Applicant’s argument concerning Cabezas, as applied to claim 19 (Response pg. 12) is not persuasive. On page 12 of the Response, Applicant argues that Cabezas does not disclose at least two regions of circumferential indentations having different angles.
This argument is not persuasive because Fig. 15 of Cabezas depicts circumferentially-extending indentations on opposite sides of the needle having different angles. Specifically, the solid-line indentations have first angle and are present on a first side/region of the needle body while the phantom-line indentations have a second, different angle and are present no a second side/region of the needle body. Thus, the combination of Shave, Fukuda, and Cabezas meets the limitation of the device comprising “at least two regions of circumferential indentations having different angles on the curved needle body,” as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Logan (U.S. Patent No. 1981651) disclosing a surgical needle and suture connected by a holding element (Figs. 1 and 4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771