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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 52 and 67 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 52 recites the limitation "the elongate shaft" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the claim will presume to depend from claim 51 instead of claim 49 because claim 51 provides proper antecedent basis.
Claim 67 recites the limitation "the second actuator" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 49-57, 60, 61-65, and 66-67 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0044410 A1 to Argentine et al. (hereinafter “Argentine”) (cited in an IDS dated 08/16/2024).
Regarding claim 49, Argentine discloses (see abstract; Figs. 12-20H; and [0056]-[0081]) a suture delivery system (300), comprising: a housing (350) configured to contain a suture (304) in a flattened configuration (see Figs. [0060]-[0062] and Figs. 12/20A), the housing defining an opening (380) for releasing the suture from an interior of the housing such that the suture can automatically transition from the flattened configuration into a curved configuration (see Fig. 20D and [0062]/[0076]); a deployment element (352) having a ribbon-shaped distal portion disposed in the housing (see Fig. 15 and [0060]), the ribbon-shaped distal portion of the deployment element having a surface with a set of formations (406/408) configured to interface with the suture (see Fig.15 and [0063]-[0067]), the housing and the set of formations of the deployment element configured to collectively constrain the suture in the flattened configuration until the suture is released through the opening of the housing (see Figs. 12 and 20A-E and [0073]-[0078]); and a control mechanism ("actuator or handle", see [0074]) configured to move the deployment element relative to the housing to release the suture from the opening of the housing (see [0073]-[0078] and Figs. 20A-H).
Argentine further discloses (claim 50) wherein the housing has a distal end that is coupled to an introducer tip (312, see Fig. 12 and [0068]) and a proximal end that is disposed around the deployment element (see Fig. 20A-E and [0060]); (claim 51) wherein the deployment element has a distal end (400) that is free-floating within the housing and a proximal end (proximal portion of 352 having trailing region 434 in Fig. 15) that is coupled to the control mechanism via an elongate shaft (tubular portion indicated by 402 in Fig. 15) (see [0063]-[0067] and [0074] and Fig. 15); (claim 52) wherein the elongate shaft includes a first elongate shaft (104), the suture delivery system further comprising: a catheter (310) defining a lumen; and a second elongate shaft (306) coupled to the introducer tip (see Fig. 12), the first and second elongate shafts disposed concentrically within the lumen of the catheter (see Fig. 12); (claim 53) a third elongate shaft ([0070], "additional body" connected to fifth link 470), and biasing mechanism (460) configured to expand to press the opening of the housing against a suture site (see [0033]/[0059]/[0060]), the biasing mechanism having a distal end (462) coupled to the introducer tip (312, Fig. 12 and [0072]) and a proximal end (470) coupled to the third elongate shaft (see [0070]), the third elongate shaft disposed concentrically with the first and second elongate shafts within the lumen of the catheter (see [0070]); (claim 54) wherein the third elongate shaft can be moved relative to the introducer tip to expand the biasing mechanism (see Fig. 12 and [0069]-[0070]); (claim 55) wherein, when the biasing mechanism is expanded (see [0050]/[0056]), the control mechanism is configured to move the deployment element to release the suture from the opening of the housing such that the suture is directed through the suture site (see [0041]-[0042] and [0074]-[0080]); (claim 56) wherein the suture includes a set of two legs (322/324) having penetrating tips (330) that are configured to exit the opening of the housing and penetrate through the suture site (see Figs. 13A-B, 20C, and [0058]/[0073]/[0075]); (claim 57) wherein the set of two legs of the suture has proximal ends that are joined together such that the set of legs form a U-shaped structure (at #320, Figs. 13A-B); and (claim 60) wherein the housing includes a bearing material disposed inside the housing near the opening such that suture can slide along the bearing without damaging the housing when being released from the housing (see Fig. 14A and [0061]-[0062]).
Regarding claim 61, Argentine discloses (see abstract; Figs. 12-20H; and [0056]-[0081]) a suture delivery system (300), comprising: a housing (350) configured to contain a suture (304) in a flattened configuration (see [0060]-[0062]), the housing defining an opening (380) for releasing the suture from an interior of the housing such that the suture can automatically transition from the flattened configuration into a curved configuration (see Fig. 20D and [0062]/[0076]), the housing at least partially constraining the suture in the flattened configuration until the suture is released through the opening of the housing (see Figs. 20A-E and [0074]-[0078]); a deployment element (352) having a distal portion disposed in the housing (see [0060]), the distal portion of the deployment element having one or more formations (notch 406 and/or shuttle surface 408) configured to interface with the suture (see [0063]-[0067]); a biasing mechanism (314, Fig. 12) formed of a plurality of braided wires disposed about a shaft (see [0069] and Fig. 12), the biasing mechanism configured to transition between an undeployed configuration in which the biasing mechanism extends generally parallel to the housing and the distal portion of the deployment element (see Fig. 20A and [0070]) and an expanded configuration in which a portion of the biasing mechanism bows outward in a direction away from the housing to form an asymmetrical shape (Figs. 12/20D, asymmetric with respect to long. axis of device) that presses the housing against a suture site (see Figs. 12, 20A, 20D, [0070], [0051], [0056]) and a control mechanism ("actuator or handle", see [0074]) configured to move the deployment element relative to the housing when the biasing mechanism is in the deployed configuration to release the suture from the housing to deploy the suture in the suture site (see [0073]-[0078] and Figs. 20A-H).
Argentine further discloses (claim 62) wherein the shaft includes a first shaft (350), and a distal end (462) of the biasing mechanism is coupled to an introducer (312, as shown in Fig. 12) disposed at a distal end of the first shaft (see Fig. 12), the suture delivery system further comprising: a second shaft (additional body connected to fifth link 470 for manipulation by treating clinician, see [0070]) coupled to a proximal end (470) of the biasing mechanism and concentrically disposed around a portion of the first shaft (see [0070]), the first and second shafts configured to move relative to one another to transition the biasing mechanism into the deployed state (see [0070]); (claim 63) wherein the control mechanism is a first control mechanism, the suture delivery system further comprising a second control mechanism (see [0070]) configured to advance the second shaft relative to the first shaft to transition the biasing mechanism into the expanded configuration (see [0070]); (claim 64) further comprising a locking mechanism configured to lock movement of the control mechanism until the biasing mechanism has transitioned into the expanded configuration (see [0056], [0069]-[0070], and [0076]-[0080]); and (claim 65) wherein the portion of the biasing mechanism is configured to bow out radially away from the housing up to about 270 degrees relative to a longitudinal axis of the shaft (see Fig. 12, [0056] and [0069]-[0070])
Regarding claim 66, Argentine discloses (see abstract; Figs. 12-20H; and [0056]-[0081]) a suture delivery method (see Figs. 20A-H and [0074]-[0080]), comprising: expanding a biasing mechanism (314, Fig. 12) of the suture delivery system, the biasing mechanism when expanded configured to press a housing of the suture delivery system against a portion of a graft disposed in a vessel (see [0033]/[0056]/[0059]/[0060]/[0080]), the housing configured to constrain a suture (304) in a flattened configuration (see Figs. 20A-E and [0074]-[0078]) and including an opening (380) through which the suture can be deployed from the housing such that the suture can transition to a natural curved configuration (see Fig. 20D and [0062]/[0076]); manipulating a control mechanism ("actuator or handle", see [0074]) of the suture delivery system one or more times to cause a deployment element (352) disposed within the housing (see [0060]) to move proximally to partially deploy the suture from the housing such that a set of legs of the suture exit the opening of the housing and curve to penetrate through the portion of the graft and the vessel (see Figs. 20C-D and [0075]-[0080]); and manipulating the control mechanism one or more additional times to cause the deployment element to continue to move proximally to fully deploy the suture from the housing (see Figs. 20D-E and [0077]-[0080]) such that a tail (320, Figs. 13A-B & 20C-D) of the suture that extends opposite to the legs (322/324) exit the opening of the housing and curve to press against material disposed between the set of legs of the suture to hold the graft and the vessel relative to one another (see Figs. 13A, 20D-E, and [0078]-[0080]).
Argentine further discloses (claim 67) using a mode selector of the suture delivery system in a first position such that the control mechanism of the suture delivery system is engaged with a drive system of the suture delivery system to cause the manipulating of the control mechanism (see [0041]/[0056]/[0074], under BRI, actuating the actuator in a first direction moves the deployment rod 352 distally, thus, the position of the actuator which causes the distal movement of deployment rod 352 is a mode that can be selected by the user, where the interface with the proximal portion of the deployment rod is considered a drive system); in response to the mode selector being set to a second position, disengaging the second actuator from the drive system; and moving the deployment element distally to retract the suture back into the housing (see [0041]/[0056]/[0074]/[0076]-[0078]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 49 and 51-56 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-12 and 28 of U.S. Patent No. 11,717,288 B2.
Regarding current claim 49, ‘288 patent claim 8 discloses a suture delivery system (C32L1), comprising: a housing configured to contain a suture in a flattened configuration (C32L2-3), the housing defining an opening for releasing the suture from an interior of the housing such that the suture can automatically transition from the flattened configuration into a curved configuration (C32L3-7); a deployment element having a distal portion disposed in the housing (C32L8-9), the distal portion of the deployment element having a surface with a set of formations configured to interface with the suture (C32L9-18), the housing and the set of formations of the deployment element configured to collectively constrain the suture in the flattened configuration until the suture is released through the opening of the housing (C32L19-24); and a control mechanism configured to move the deployment element relative to the housing to release the suture from the opening of the housing (C32L54-57).
Regarding current claim 49, ‘288 patent claim 28 discloses a suture delivery system (C34L3), comprising: a housing configured to contain a suture in a flattened configuration (C34L4-5), the housing defining an opening for releasing the suture from an interior of the housing such that the suture can automatically transition from the flattened configuration into a curved configuration (C34L5-9); a deployment element having a distal portion disposed in the housing (C34L10-11), the distal portion of the deployment element having a surface with a set of formations configured to interface with the suture (C34L11-19), the housing and the set of formations of the deployment element configured to collectively constrain the suture in the flattened configuration until the suture is released through the opening of the housing (C34L20-25); and a control mechanism configured to move the deployment element relative to the housing to release the suture from the opening of the housing (C34L51-54).
‘288 patent claims 8/28 fails to recite wherein the deployment element distal portion is ribbon-shaped. The current specification defines “ribbon-shaped” as merely being an elongate flat shape (see [0103]), and does not discuss any criticality or unexpected benefit attributable to the ribbon-shape. Therefore, it would have been obvious to one having ordinary skill in the art to have made the ‘288 patent’s deployment element to have an elongate flat shape, since a mere recitation of a shape of a structure without providing any criticality or unexpected benefit attributable to the shape is an obvious matter of choice to a person of ordinary skill in the art. See MPEP 2144.04(IV)(B).
Further, there is correspondence between ‘288 patent claims and the current claims as follows:
Current claim #
51
52
53
54
55
56
‘288 patent claim #
8
9/28
10
11
12
8
Allowable Subject Matter
Claims 58-59 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.
The following is a statement of reasons for the indication of allowable subject matter: with respect to claim 58, Argentine does not teach or disclose that the suture has a tail that extends opposite to the set of two legs of the U-shaped structure. There is no apparent reason or motivation to modify Argentine to have a tail on the suture (this would require redesign of the internal components to accommodate the tail and its interface with the deployment rod).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771