DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 8/19/2026 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 8/6/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 9, with respect to Applicant’s amendments to the drawings made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant’s arguments, see page 9, with respect to Applicant’s amendments to the claims made in view of the previous 112 rejections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn.
Applicant’s arguments, see pages 9-10, with respect to the deficiencies of the Meade prior art reference in view of the present claim amendments have been fully considered and are persuasive. Therefore, the previous prior art rejections made under Meade have been withdrawn. However, upon further consideration, new ground(s) of rejection are made in view of Shelton, IV et al. (US 2007/0239206), as set forth below.
Applicant’s arguments, see page 10, with respect to Applicant’s amendments to the claims made in view of the previous double patenting rejections have been fully considered and are persuasive. The previous double patenting rejections have been withdrawn.
Claim Rejections - 35 USC § 102
Claim(s) 1, 7 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV et al. (US 2007/0239206).
Shelton discloses (see Figs. 1-10) a suturing device comprising the following claim limitations:
(claim 1) A suturing device comprising: a housing (24, Fig. 1) defining an arced needle track (26, Fig. 3) having a first end and a second end (i.e., at both respective sides of central opening 44 in Fig. 3), the housing (24) defining a gap (44, Fig. 3) between the first end of the arced needle track (26) and the second end of the arced needle track (26) that extends inwardly into the housing (24) to receive a tissue sample therein for suturing (as shown in Fig. 3), the arced needle track (26) being configured to (i.e., capable of) receive an arced needle (28, Fig. 3) therein, the housing (24) further defining an arcuate guide track (32, Fig. 3) to receive at least a portion of a needle drive (36/38/40/42, Fig. 3) of the suturing device; and a needle drive (36/38/40/42, Fig. 3) configured to (i.e., capable of) advance the arced needle (28) along the arced needle track (26) along a first direction (as expressly shown in Figs. 5-10), the needle drive comprising a drive filament (42, Fig. 3) and a needle engagement surface (62, Fig. 3), the drive filament (42) being configured to be bent from a straight configuration into a curved configuration while the drive filament is directed around and at least partially surrounding the gap (44) of the housing (24) (as shown in Figs. 3-10; [0085]), the drive filament (42) being coupled to the needle engagement surface (62) for engaging the arced needle (28) (as shown in Figs. 3-10; [0085]), wherein actuation of the needle drive causes the drive filament (42) to reciprocate the needle engagement surface (62) along an arcuate pathway defined by the arcuate guide track (26) of the housing (24) (as shown in Figs. 5-10; [0085]-[0090]; reciprocating motion to drive needle around arcuate path expressly disclosed);
(claim 7) wherein the needle drive is configured to (i.e., capable of) place the drive filament (42) under tension to advance the arced needle (28) along the arced needle track (26) (as shown in Figs. 5-6; [0089]; as needle 28 is begun to be driven along its arcuate path, drive filament 42 in proximally tensioned to provide the needle driving force);
(claim 16) wherein the drive filament (42) traverses an arcuate pathway that is parallel to the arcuate needle guide (26) (as shown in Figs. 3-7; [0066]; [0098]-[0099]; [0101]; flexible drive filament 42 expressly attached to pin 40 and follows pin 40 along the arcuate path during reciprocation);
(claim 17) further comprising a brake (i.e., anti-backup structure; [0097]) configured to (i.e., capable of) engage a braking surface (56, Fig. 3) of the arced needle (28) to prevent the arced needle (28) from moving along a second direction opposite the first direction after the drive filament (42) decouples from the needle engagement surface (62) ([009; anti-backup structure expressly prevents the needle 28 from backing-up during recycling/reciprocation of the needle drive); and
(claim 18) wherein the needle drive is configured to (i.e., capable of) advance the arced needle (28) fully around the needle track (26) in a plurality of reciprocations of the needle drive (as shown in Figs. 3-10; [0085]-[0090]; drive filament 42 expressly undergoes reciprocal motion to drive the needle 28 through 360 degrees of travel).
Claim Rejections - 35 USC § 103
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shelton, as applied to claims 1 above.
Shelton discloses the claimed invention except for the drive filament comprising a flat band having a rectangular cross-section. It would have been an obvious to one skilled in the art at the time the invention was made to construct the drive filament of Shelton as a flat band having a rectangular cross-section, since applicant has not disclosed that such a feature solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a driving force to a needle driver at the end of a medical instrument shaft. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claims 5-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shelton, as applied to claims 1 above.
Shelton discloses the claimed invention except for the drive filament being formed from a polymeric or metallic material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the drive filament from polymeric or metallic 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.
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton as applied to claim 1 above, and further in view of Meade et al. (US 2006/0096396).
Shelton, as applied above, discloses a suturing device comprising all the limitations of the claim except for the housing being pivotally coupled to a flexible proximal section of the suturing device, and the flexible proximal section being steerable.
However, Meade teaches a similar suturing device comprising a housing (56, Fig. 2A) being pivotally coupled to a flexible proximal section (54) of the suturing device (as shown in Figs. 1-2B; [0054]; [0066]; [0073]-[0074]; [0080]; spherical portion 58 expressly provides for rotation/pivoting between the distal housing 56 and the proximal device handle portion 54), and the flexible proximal section being steerable (as shown in Figs. 1-2B; [0054]; [0066]; [0073]-[0074]; [0080]; spherical portion 58 expressly provides for rotation/pivoting between the distal housing 56 and the proximal device handle portion 54) in order to beneficially enhance and assist in articulation of a suture head assembly during delivery and positioning of the instrument adjacent to the tissue desired to be sutured ([0054]; [0066]; [0073]-[0074]; [0080]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Shelton to have the housing being pivotally coupled to a flexible proximal section of the suturing device, and the flexible proximal section being steerable in order to beneficially enhance and assist in articulation of a suture head assembly during delivery and positioning of the instrument adjacent to the tissue desired to be sutured, as taught by Meade.
Allowable Subject Matter
Claims 2-3 and 10-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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