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 1-10 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. In regards to claims 1, 7, and 10, these claims recite the limitation “the needle insertion tooth engages with the suture needle, and the return component drives the needle insertion tooth and the suture needle to insert.” However, the claim is indefinite because it is unclear where the suture needle inserts into as the needle, as understood from the specification, inserts into the patient’s tissue but also into the needle insertion assembly and other structures of the device.
Claims 2-6 and 8-9 are rejected as being dependent upon claims 1 and 7.
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) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WIPO Publication WO2021/217373 to Wan (hereinafter “Wan”). (Please note: The citations provided are from the US filed version of this WIPO document – US Patent Application Publication 2023/0165581.)
Regarding Claim 1, Wan discloses a suturing device comprising: a main housing (Element 11); a suture needle (Element 13) slidingly disposed within the main housing, wherein one end of the suture needle connects to a suture thread and the other end of the suture needle is a tip ([0082] [0097]); a needle insertion assembly (Element 12) disposed within the main housing, the needle insertion assembly including a drive component (Elements 121 and 122), a return component (Elements 1251 and 124), and a needle insertion tooth (Element 125), the needle insertion tooth being in a separable engagement relationship with the suture needle ([0088] [0087] [0098]), wherein when the drive component acts on the needle insertion tooth and the suture needle that are in an engagement state, the suture needle is controlled to be inserted, and the return component undergoes deformation when the suture needle is inserted; when the drive component is released, the engagement state of the needle insertion tooth and the suture needle is released, and the return component drives the needle insertion tooth to return ([0086] [0088] [0090]; or when the drive component acts on the needle insertion tooth that is in a released engagement state, the needle insertion tooth moves relative to the suture needle, and the return component undergoes deformation when the needle insertion tooth moves relative to the suture needle; when the drive component is released, the needle insertion tooth engages with the suture needle, and the return component drives the needle insertion tooth and the suture needle to insert ([0090]); and an anti-retraction component disposed within the main housing, the anti-retraction component forming a separable engagement relationship with the suture needle to prevent the suture needle from retracting (Element 14, [0092] [0093])
Regarding Claim 2, Wan discloses that the drive component includes a manipulating rope that acts on the needle insertion tooth, and the return component includes at least one of a return spring or a metallic spring plate that acts on the needle insertion tooth ([0086] [0088] [0097])
Regarding claim 3, Wan discloses that the main housing has a sliding groove (Element 1122), the suture needle is disposed in the sliding groove ([0088]), the needle insertion assembly further includes a slider (Element 126) disposed in the sliding groove and located above the suture needle, the needle insertion tooth is retractably assembled in the slider, and the drive component and the return component are both connected to the slider ([0087] [0088])
Regarding Claim 4, Wan discloses that the needle insertion assembly further includes an upper housing (Element 123) that covers the main housing and an upper cover (Element 112) that covers the upper housing, a holding cavity is formed between the upper housing and the upper cover, the slider includes a slider body and a slider connecting portion, the slider connecting portion sequentially passes through the upper housing and the upper cover, the return component is disposed within the holding cavity, one end of the return component is connected to the slider connecting portion, the other end of the return component is connected to the upper housing or the upper cover, and the drive component is connected to an upper end of the slider connecting portion ([0079]-[0085], Figs 2A-3C and 26)
Regarding Claim 5, Wan discloses that a bottom of the slider has a holding groove, the return component is disposed in the holding groove and is confined between the slider and the suture needle (Fig. 3A shows 1251 going through slider 126), one end of the return component is connected to a side wall of the holding groove (Element 1251 is connected to the side wall see Fig. 3A), and the other end of the return component is connected to an inner wall of the sliding groove of the main housing (spring 124 makes this connection in Fig. 3A)
Regarding Claim 6, Wan further comprises an external clamp catheter, wherein the main housing includes a first housing, a second housing, and a third housing, the first housing is connected to the second housing, the third housing and the second housing are rotated relative to the first housing, and the external clamp catheter is drivably connected to the first housing to drive relative rotation among the first housing, the second housing, and the third housing, so as to arbitrarily convert an orientation and a position of a C-shaped opening of the suturing device ([0077] [0129] [0134] [0135], Figs. 16A-17B)
Regarding Claim 7, Wan discloses a therapeutic apparatus comprising: a suturing device (Element 1) fixed at an apex of the endoscope ([0129]), and the suturing device including: a main housing (Element 11); a suture needle (Element 13) slidingly disposed within the main housing, wherein one end of the suture needle connects to a suture thread and the other end of the suture needle is a tip ([0082] [0097]); a needle insertion assembly (Element 12) disposed within the main housing, the needle insertion assembly including a drive component (Elements 121 and 122), a return component (Elements 1251 and 124), and a needle insertion tooth (Element 125), the needle insertion tooth being in a separable engagement relationship with the suture needle ([0088] [0087] [0098]), wherein when the drive component acts on the needle insertion tooth and the suture needle that are in an engagement state, the suture needle is controlled to be inserted, and the return component undergoes deformation when the suture needle is inserted; when the drive component is released, the engagement state of the needle insertion tooth and the suture needle is released, and the return component drives the needle insertion tooth to return ([0086] [0088] [0090]; or when the drive component acts on the needle insertion tooth that is in a released engagement state, the needle insertion tooth moves relative to the suture needle, and the return component undergoes deformation when the needle insertion tooth moves relative to the suture needle; when the drive component is released, the needle insertion tooth engages with the suture needle, and the return component drives the needle insertion tooth and the suture needle to insert ([0090]); and an anti-retraction component disposed within the main housing, the anti-retraction component forming a separable engagement relationship with the suture needle to prevent the suture needle from retracting (Element 14, [0092] [0093]); and a control handle fixed at an operating end of the endoscope, wherein the drive component of the suturing device is connected to the control handle, and the control handle controls the drive component to control the insertion of the suture needle ([0122] [0123] [0134] [0144]. Fig 13A)
Regarding Claim 8, Wan discloses that the control handle includes: a handle housing; a manipulating rope pulley disposed within the handle housing, wherein the drive component of the suturing device is a manipulating rope, and the manipulating rope is connected to the manipulating rope pulley; a clutch plate separability disposed on one side of the manipulating rope pulley, wherein the clutch plate has a snap ring engaged with the manipulating rope pulley on a side near the manipulating rope pulley; and a pull rod connected to the clutch plate and resettably connected to the handle housing ([0122]-[0124])
Regarding Claim 9, Wan further comprises a connecting ring (Element 4), a loop ring (Element 7), a hook clamp (Element 9), and a push catheter (Element 5), wherein the connecting ring is fitted onto the endoscope, the loop ring performs a cutting action on a target suturing tissue at the apex of the endoscope ([0129]), and the hook clamp performs a grabbing action on the target suturing tissue or a hooking and pulling action on the suture thread at the apex of the endoscope ([0130] [0131])
Regarding Claim 10, Wan discloses a therapeutic device comprising: an endoscope (Element 2); a therapeutic apparatus used in conjunction with the endoscope, wherein the therapeutic apparatus includes a suturing device and a control handle, the suturing device is fixed to an apex of the endoscope ([0122] [0123] [0129]), and the suturing device includes: a main housing (Element 11); a suture needle (Element 13) slidingly disposed within the main housing, wherein one end of the suture needle connects to a suture thread and the other end of the suture needle is a tip ([0082] [0097]); a needle insertion assembly (Element 12) disposed within the main housing, the needle insertion assembly including a drive component (Elements 121 and 122), a return component (Elements 1251 and 124), and a needle insertion tooth (Element 125), the needle insertion tooth being in a separable engagement relationship with the suture needle ([0088] [0087] [0098]), wherein when the drive component acts on the needle insertion tooth and the suture needle that are in an engagement state, the suture needle is controlled to be inserted, and the return component undergoes deformation when the suture needle is inserted; when the drive component is released, the engagement state of the needle insertion tooth and the suture needle is released, and the return component drives the needle insertion tooth to return ([0086] [0088] [0090]; or when the drive component acts on the needle insertion tooth that is in a released engagement state, the needle insertion tooth moves relative to the suture needle, and the return component undergoes deformation when the needle insertion tooth moves relative to the suture needle; when the drive component is released, the needle insertion tooth engages with the suture needle, and the return component drives the needle insertion tooth and the suture needle to insert ([0090]); and an anti-retraction component disposed within the main housing, the anti-retraction component forming a separable engagement relationship with the suture needle to prevent the suture needle from retracting (Element 14, [0092] [0093]); and the control handle fixed at an operating end of the endoscope, the drive component of the suturing device is connected to the control handle, the control handle controls the drive component to control the insertion of the suture needle (Fig. 13A, [0122] [0123] [0134] [0144])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL JAMES CAREY whose telephone number is (571)270-7235. The examiner can normally be reached Monday-Friday (8am-5pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 571-270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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