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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-16 in the reply filed on 8/19/2026 is acknowledged.
Claim Objections
Claims 1, 3-5, 7 and 9-16 are objected to because of the following informalities:
Claim 1, line 8: “at least two rocker arms, wherein one end of the rocker arm is hinged on the moving member” should be amended to pluralize “the rocker arm”. This line should be amended to recite “at least two rocker arms, wherein one end of each of the rocker arms is hinged on the moving member” or an equivalent thereof.
The claim also refers to “the rocker arms” in lines 10-11 and 12, it is recommended that recitation of the at least two rocker arms be standardized such that every reference to these components recites “the at least two rocker arms” to match the previously established antecedent basis.
Claim 1, lines 12-13: “the rocker arms pull the clamping arm to close” is grammatically incorrect. The clamping arms should be referenced in the plural form since there are two of them, and “to close” should be amended to recite “the rocker arms pull the at least two clamping arms closed” or “the rocker arms pull the at least two clamping arms to a closed state” or an equivalent thereof.
It is recommended that recitation of the clamping arms be standardized such that each recitation state “the at least two clamping arms” to match the previously established antecedent basis.
Claim 3, line 3: “the two rocker arms” should be amended to recite “the at least two rocker arms” instead.
Claim 3, lines 4-5 and 6: “at least one rocker arm” should be amended to recite “at least one rocker arm of the at least two rocker arms” instead. Please note that there are two recitations in these lines which require correction.
Claim 4, lines 2 and 4: “the rocker arm” in each line should be pluralized to read “each of the at least two rocker arms” instead.
Claim 4, lines 1-2: “the clamping arms” should be amended to recite “the at least two clamping arms” instead.
Claim 5, lines 2 and 3: “the two rocker arms” in each line should be amended to recite “the at least two rocker arms” instead.
Claim 5, lines 2, 4, and 5: “the clamping arms” in each line should be amended to recite “the at least two clamping arms” instead.
Claim 7, lines 2 and 5: “the two rocker arms” and “the rocker arms” in each line should be amended to recite “the at least two rocker arms” instead.
Claim 7, lines 2 and 6: “the clamping arms” in each line should be amended to recite “the at least two clamping arms” instead.
Claim 9, lines 2-3 and 4: “the rocker arms” in each line should be amended to recite “the at least two rocker arms” instead.
Claim 9, line 3: “the clamping arms” should be amended to recite “the at least two clamping arms” instead.
Claim 10, line 3: “the clamping arms” should be amended to recite “the at least two clamping arms” instead.
Claim 10, line 4: “one of the support arms” should be amended to recite “one of the support arms of the pair of support arms” instead.
Claim 11, lines 1-2: “the support arm” and “the clamping arm” should each be pluralized and amended to recite “wherein each support arm of the pair of support arms is integrally formed with or fixedly connected to each of the at least two clamping arms” instead.
Claim 12, line 2: “the clamping arm” should be pluralized and amended to recite “the at least two clamping arms each comprise” instead.
Claim 12, lines 2-3: “the clamping head and the bendable portion” should be amended to be pluralized and recite “each of the clamping heads and the bendable portions remain relatively fixed to each other” instead.
Claim 12, line 3: “the clamping head is configured” should be amended to recite “each clamping head” instead.
Claim 12, line 4: “the bendable portion” should be amended to recite “each bendable portion” instead.
Claim 12, lines 4-5: “the clamping arms” should be amended to recite “the at least two clamping arms” instead.
Claim 13, lines 2-3: “an end of the clamping arm” should be pluralized and recite “an end of each of the at least two clamping arms” instead.
Claim 14, lines 2, 5, and 6: “the rocker arm” in each line should be pluralized to read “each of the at least two rocker arms” instead.
Claim 15, line 2: “the rocker arm” should be pluralized to read “each of the at least two rocker arms” instead.
Claim 15, lines 2-3: “a corresponding clamp arm” should be amended to recite “a corresponding clamping arm of the at least two clamping arms” instead.
Claim 15, line 4: “the clamp heads” lacks antecedent basis and should be amended to recite “the clamping head” to match the antecedent basis established in claim 12.
Claim 16, line 2: “the rocker arm” should be amended to recite “each of the at least two rocker arms” instead.
Claim 16, lines 2-3: “the protrusion connecting portion” should be pluralized to recite “each of the protrusion connecting portions” instead.
Claim 16, line 3: “a corresponding clamping arm” should be amended to recite “a corresponding clamping arm of the at least two clamping arms” instead.
Claim 16, line 4: “the clamping arm” should be pluralized and amended to recite “the at least two clamping arms each comprise” instead.
Please note that the claims should generally be amended to ensure that each recited component is properly pluralized and the language used to describe it matches the established antecedent basis of the original limitation in which it is introduced.
Appropriate correction is required.
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.
Claim 4 is 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 4 recites the limitation "the clamping head" in line 4. There is insufficient antecedent basis for this limitation in the claim since no clamping head is mentioned in any of the preceding claims, rendering the claim unclear and indefinite. Examination will continue under the assumption that this structure is meant to be the clamping arms.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sigmon et al. (US PGPub 2012/0089176 A1).
With respect to claim 1, Sigmon et al. discloses an insertion-type (PP [0023]: “The medical system 20 and device 40 are generally sized and structured for operation through the working channel of an endoscope (not shown) or other scope”, the device is an insertion-type device intended for use through a scope) tissue clamping device (see Figs. 1-4), comprising:
a clamping structure having at least two clamping arms (44 and 46 in Fig. 9), wherein the clamping arms (44 and 46) are configured to clamp a target tissue (PP [0023]: “a first jaw 44 and a second jaw 46 pivotally connected thereto for engaging the tissue T”);
a moving member (22 and 48), wherein the clamping structure (44 and 46) defines a moving space provided along an axial direction thereof (44 and 46 define a moving space between them where 48 and 22 are centered), the moving member (22 and 48) is provided in the moving space (44 and 46 define a moving space between them where 48 and 22 are centered), and the moving member (22 and 48) is configured to move in association with a control handle to reciprocate in the moving space (PP [0040]: “Control handles (not shown) for controlling relative translation of the drive wire 22 and catheter 24 are well known in the art, and may be employed at the proximal end of the system 20”); and
at least two rocker arms (68 and 70), wherein one end of the rocker arm (68 and 70) is hinged on the moving member (68 and 70 are connected to 48 via pins 80 which are hinges), and another end thereof is connected to a corresponding clamping arm (68 and 70 connect to arms 44 and 46 by pins 81);
wherein when the moving member (22 and 48) moves towards a front end of the clamping structure, the rocker arms (68 and 70) spread the clamping arms (44 and 46) to enable the clamping arms (44 and 46) to be in an opening state (PP [0035]: “further distal advancement of drive wire 22, and hence the driver 48, causes the proximal ends 64, 66 of jaws 44, 46 to continue moving distally (to the left on the page), while the links 68, 70 induce rotation of the jaws 44, 46 away from each other, as shown in FIG. 9. Eventually, the pin 49 reaches the end of jaw slot 86, at which point the jaws 44, 46 are fully open”); [and]
when the moving member (22 and 48) moves towards a back end of the clamping structure, the rocker arms (68 and 70) pull the clamping arms (44 and 46) to close to enable the clamping arms (44 and 46) to be in a clamping state (PP [0036]: “proximal retraction of the drive wire 22 and the driver 48 causes the flanges 56, 58 of the driver 48 to engage the pins 80 at the proximal ends of the links 68, 70. In particular, as also clear from FIGS. 5 and 6, the flange 56 will engage pin 80 of the first link 68, and flange 58 will engage pin 80 of second link 70. As the links 68, 70 are pulled proximally (to the right on the page) the housing 42 presses on the links 68, 70 (and/or the jaws 44, 46) and causes them to rotate towards each other to grasp the tissue T therebetween”).
Regarding claim 2, Sigmon et al. further discloses wherein the two rocker arms (68 and 70 in Fig. 9) are arranged in an intersection-shape (68 and 70 intersect with clamping arms 44 and 46 on opposite respective sides of arms 44 and 46, see Figs. 5-6).
Regarding claim 3, Sigmon et al. further discloses wherein the clamping structure is provided with a limiting member (49 in Fig. 9), the limiting member (49) is located in an intersection region formed by the two rocker arms (68 and 70, 49 is located where the rocker arms intersect with clamping jaws 44 and 46) and adjacent to the moving member (22 and 48, 49 is adjacent 48), such that when the moving member (22 and 48) moves to the back end, the limiting member (49) is capable of being in contact with at least one rocker arm (49 is in contact with 68 and 70 via clamping jaws 44 and 46), and forms a fulcrum of a lever structure for the at least one rocker arm (49 is a hinge which controls the rotation of clamping jaws 44 and 46, and additionally acts as a fulcrum to rocker arms 68 and 70 which are connected to clamping jaws 44 and 46).
Regarding claim 4, Sigmon et al. further discloses wherein when the clamping arms (44 and 46 in Fig. 9) move to the clamping state (see Fig. 10), a lever arm of a rotational center of the rocker arm (68 and 70) relative to the moving member (22 and 48) from a center of the limiting member (49) is longer than a lever arm of a connection center between the rocker arm (68 and 70) and the clamping head (44 and 46) from the center of the limiting member (49, see annotated Fig. 10, the lever arm defined between 81 of the rocker arms and 80 which connects them to the moving member 48 is longer than a lever arm defined between the overlapping region between the rocker arms 68/70 and clamping arms 44/46 bounded by 81 to limiting member 49).
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Regarding claim 5, Sigmon et al. further discloses wherein the two rocker arms (68 and 70 in Fig. 9) having locking fitting surfaces (inner surfaces of 68 and 70), when the clamping arms (44 and 46) are in the clamping state, the locking fitting surfaces (inner surfaces of 68 and 70) of the two rocker arms enclose a locking groove (86, the inner surfaces of 68 and 70 enclose the locking groove 86 when clamped and when the rocker arms 68 and 70 are axially aligned with the longitudinal axis of the device, see Figs. 9-10), and the limiting member (49) is located in the locking groove (86, 49 translates within 86) to prevent the two clamping arms (44 and 46) from cross moving transversely, so as to maintain the clamping arms (44 and 46) in the clamping state (see Fig. 10, 86 controls the movement of limiting member 49 to maintain the clamping arms in the clamping state without the clamping arms moving out of alignment).
Regarding claim 6, Sigmon et al. further discloses wherein a transverse size of the locking groove (86 in Fig. 10) is slightly greater than or equal to a transverse size of the limiting member (49, since pin 49 translates within groove 86, locking groove 86 is slightly greater than or equal to limiting member 49 in transverse size).
Regarding claim 7, Sigmon et al. further discloses wherein the two rocker arms (68 and 70 in Fig. 9) have guide surfaces (ends of 68 and 70 near pins 80), when the clamping arms (44 and 46) move from the opening state to the clamping state (see Figs. 9-10), the guide surfaces (ends of 68 and 70 near pins 80) enclose a guide space (43, the ends of 68 and 70 near pins 80 traverse through the guide space defined by 43 and enclose that space in Fig. 10), the limiting member (49) is provided in the guide space (43, the limiting member 49 extends through slot 86 to be provided within guide space 43), and the guide space (43) is in communication with the locking groove (86), so as to guide the locking groove (86) to be engaged with the limiting member (49) when the rocker arms (68 and 70) drive the clamping arms (44 and 46) to move to the clamping state (86 extends through the sidewall of the device into guide space 43 to allow engagement and translation of the limiting member 49).
Regarding claim 8, Sigmon et al. further discloses wherein the locking groove (86 in Fig. 10) is in communication with a front side of the guide space (43), and a transverse size of the guide space (43) gradually decreases from back to front (the guide space 43 gets narrower at the distal end as more components such as 68 and 70 take up space within the guide space 43, see Fig. 10).
Regarding claim 9, Sigmon et al. further discloses wherein the rocker arms (68 and 70 in Fig. 9) have the guide surfaces (ends of 68 and 70 near pins 80) that are inclined (the ends of 68 and 70 near pins 80 are inclined when in the open position, see Fig. 9) and the locking fitting surface (inner surfaces of 68 and 70) in an arc-shape (see arc-shape cutout in annotated Fig. 9), the locking fitting surface (see arc-shaped cutout in annotation) is located on a front side of the guide surface (inner surfaces of 68 and 70, the cut-out is located towards a front distal side of this surface), when the clamping arms (44 and 46) are in the clamping state, the locking fitting surfaces (see arc-shaped cutout in annotation) of the two rocker arms (68 and 70) enclose an arc-shaped locking groove (see Fig. 10, when clamped the arc-shaped cutouts in 68 and 70 are adjacent and enclose an arc-shaped groove).
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Regarding claim 10, Sigmon et al. further discloses wherein the clamping structure (44 and 46 in Fig. 9) comprises a pair of support arms (radially inner portions of 44 and 46 extending between 81 and 49 in annotated Fig. 9 above), the pair of support arms (radially inner portions of 44 and 46 extending between 81 and 49 in annotated Fig. 9) are oppositely disposed at a notch (see notch that pins 81 extend through which define the support arms) between the two clamping arms (44 and 46), and both ends of the limiting member (49) are fixedly connected to one of the support arms (44 and 46, 49 connects to 44 and 46 in Fig. 9), respectively.
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Regarding claim 11, Sigmon et al. further discloses wherein the support arm (radially inner portions of 44 and 46 extending between 81 and 49 in annotated Fig. 9 above) is integrally formed with or fixedly connected to the clamping arm (44 and 46, the support arms are proximal extensions of the clamping arms).
Regarding claim 12, Sigmon et al. further discloses wherein the clamping arm (44 and 46 in Fig. 9) comprises a clamping head (60 and 62) and a bendable portion (52 in Figs. 5-6), the clamping head (60 and 62) and the bendable portion (52) remain relatively fixed to each other (see Figs. 5-6, 52 is fixed to 60 and 62), the clamping head (60 and 62) is configured to clamp the target tissue (PP [0027]: “distal ends 60, 62 that are structured to grasp and engage tissue”), and the bendable portion (52) has a structure capable of bending towards a closing direction of the clamping arms (44 and 46) and/or bending towards an opening direction of the clamping arms (44 and 46, PP [0028]: “two deflectable locking tabs 52 are formed which rotate relative to the remainder of the driver 48 to increase or decrease the size of the socket 50. The locking tabs 52 may be separately formed and pivotally attached to the driver 48, or may be integrally formed with the driver 48 and formed of a resilient material which flexes to permit rotation of the locking tabs 52 radially inwardly and radially outwardly”).
Regarding claim 13, Sigmon et al. further discloses wherein the clamping structure further comprises a sleeve (42 in Fig. 10), an end of the clamping arm (44 and 46) is provided in the sleeve (42, the proximal ends of the clamping arm are within the sleeve 42 in Fig. 10), another end thereof extends out of the sleeve (42, the clamping arms 44 and 46 extend out of the sleeve in Fig. 9), the moving member (22 and 48) is at least partially located in the sleeve (42) and is capable of reciprocating along an axial direction of the sleeve (42, PP [0024]: “the drive wire 22 slidably extends through the catheter 24”), and the limiting member (49) is fixedly provided on the sleeve (PP [0030]: “jaws 44, 46 are pivotally attached to the housing 42 directly via a pin 49”).
Regarding claim 14, Sigmon et al. further discloses wherein one of the moving member (22 and 48 in Fig. 9) and the rocker arm (68 and 70) has a rotating shaft (PP [0024]: “The drive wire 22 should also be capable of properly transmitting a rotational/torsional force from the proximal end to the distal end to rotate the medical device 40 and jaws 44, 46”), and another one thereof has a self-adjusting groove (see grooves between 68/70 and 48 in Figs. 5-6, the groove is self-adjusting since 68 and 70 can rotate and adjust the size/shape of the groove by rotating relative to pins 80 and 81), the rotating shaft (22 and 48, see PP [0024] as cited above) is provided in the self-adjusting groove (see 54 of shaft 48 in Figs. 5-6 extending in the self-adjusting groove formed between 68 and 70), and the rotating shaft (22 and 48, see PP [0024] as cited above) and the self-adjusting groove (see grooves between 68/70 and 48 in Figs. 5-6) are capable of adaptively adjusting relative positions of the moving member (22 and 48) and the rocker arm (68 and 70) in a transverse direction during movement of the rocker arm (68 and 70, see Figs. 9-10).
Regarding claim 15, Sigmon et al. further discloses wherein a front end of the rocker arm (68 and 70 in Fig. 9) away from a corresponding clamp arm (44 and 46) has a concave portion (see concave cutout portion along 68 and 70 in Fig. 9), and the concave portion (see concave cutout portion along 68 and 70) is configured to avoid a tissue clamped by the clamp heads (60 and 62, see Figs. 10-11, this portion avoids tissue T).
Regarding claim 16, Sigmon et al. further discloses wherein a front end of the rocker arm (68 and 70 in Fig. 9) has a protrusion connecting portion (81), the protrusion connecting portion (81) is inserted into a corresponding clamping arm (44 and 46) and is fixedly connected to the clamping arm (pins 81 fixedly connect clamping arms 44 and 46 to rocker arms 68 and 70).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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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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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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