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 Objections
Claim 8 is objected to because of the following informalities: in line 8 of claim 8, “two opposite sidewalls are provided with the protrusion” should be amended to “two opposite sidewalls are each provided with one of the protrusions” for clarity. 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.
Claims 7, 13-14, and 16-20 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 7 recites the limitation "a first implant" in line 2 and “the first implant” in line 3. Previously in claim 1, “one or more implants” were introduced, and the claims are unclear on whether the first implant is one of the one or more implants, or a separate implant from the one or more implants. For the purposes of examination, the first implant will be considered one of the one or more implants.
Claim 13 recites the limitation “a front end” in lines 3-4. Previously in claim 12, a front end was introduced in line 5, and the claims are unclear on if this is the same front end or a different front end. For the purposes of examination, the front ends will be considered the same. Claim 14 is rejected for their dependency on claim 13.
Claim 16 recites the limitation “the fixing portion” in line 7. There is insufficient antecedent basis for this limitation in the claim. Claim 12 introduced a fixing portion, but claim 16 is not dependent on claim 12. Claim 17 is rejected for their dependency on claim 16.
Claim 18 recites the limitation “the notch” in line 7. There is insufficient antecedent basis for this limitation in the claim. Claims 19-20 are rejected for their dependency on claim 18.
Claim 20 recites the limitations “the first slot unit and the second slot unit” in lines 2-3, “the rear end” in lines 6-7, “the front end” in line 7, “the first retreat slot” in line 10, “the first limiting end” in line 11, “the second retreat slot” in line 14, and “the second limiting end” in line 16. There is insufficient antecedent basis for these limitations in the claim. While these limitations were introduced in claim 19, claim 20 is dependent on claim 18, and none of the claims that claim 20 is dependent on introduce these limitations.
Claim Rejections - 35 USC § 102
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) 1-2, 4-9, and 11-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Santangelo et al. (Pub. No. 2018/0116654).
Regarding claim 1, Santangelo et al. discloses an implant (400; FIG. 4A; [0031]), wherein a first chamfer is provided between a front end surface of the implant and a circumferential sidewall of the implant (Annotated FIG. 4A below); and a second chamfer is provided between a rear end surface of the implant and the circumferential sidewall of the implant (Annotated FIG. 4A).
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Regarding claim 2, Santangelo et al. further discloses a bottom surface of the implant is a plane (Annotated FIG. 4A above: the bottom surface of 400 in the left-most image is planar).
Regarding claim 4, Santangelo et al. discloses a suturing device (100; FIGs. 1-2; [0029]), comprising a puncture needle (104) and one or more implants (302’ and 304’), wherein a first chamfer is provided between a front end surface of each of the one or more implants and a circumferential sidewall of each of the one or more implants (Annotated FIG. 4A above; [0031] states that 400 are example shapes for 302 and 304), and a second chamfer is provided between a rear end surface of each of the one or more implants and the circumferential sidewall of each of the one or more implants (Annotated FIG. 4A); the one or more implants are disposed on the puncture needle (FIG. 3: 302 and 304 are placed on 104); the puncture needle is provided with a channel (308) extending in an axial direction ([0031] 308 extends in the axial direction 116), and the one or more implants are capable of being triggered from the suturing device through the channel ([0034] and FIGs. 5A-5C: the implants are deployed by pusher 508 to go through the axial bore); and at least two limiting structures (604; FIGs. 6A-6B) are disposed on an inner wall of the channel and arranged along a circumferential direction (FIG. 6B); the at least two limiting structures are capable of at least blocking a second implant to be triggered ([0035] 604 resist mechanical force applied by the implants to prevent inadvertent axial movement), such that an applied force is increased when the second implant to be triggered is triggered from the suturing device ([0035] since 604 are resisting mechanical force from both implants, the force to deploy the proximal implant will be greater than the force to only deploy distal implant).
Regarding claim 5, Santangelo et al. further discloses each of the at least two limiting structures includes a guide slope obliquely arranged relative to the inner wall of the channel (FIG. 6B: the slope of each 604), the one or more implants are in sliding contact with the guide slope (FIGs. 6A-6B: the implants contact 604 while exiting the needle), and the guide slope is configured to guide the one or more implants to cross over the at least two limiting structures (FIG. 6B: the slope of 604 center and align the implants with the distal end of the needle as the implants cross over 604).
Regarding claim 6, Santangelo et al. further discloses the at least two limiting structures are capable of blocking the one or more implants ([0035] 604 can prevent the implants from leaving the needle).
Regarding claim 7, Santangelo et al. further discloses an avoidance structure ([0036] the body of the implant 608) for avoiding the at least two limiting structures is provided on a first implant to be triggered ([0036] and FIG. 6B: the body of 608 cooperates with 604 when properly positioned to avoid friction force from 604), such that a friction force applied to the first implant to be triggered when the first implant to be triggered passes through the at least two limiting structures is less than a friction force applied to the second implant to be triggered when the second implant to be triggered passes through the at least two limiting structures ([0036] the force necessary to push distal implant 606 to leave 600 is less than the force to also push proximal implant 608 out of 600, especially with the retention features in 608).
Regarding claim 8, Santangelo et al. further discloses the puncture needle includes a hollow hole (FIG. 6C: the distal end of female receiving slot 630), and a notch (630; FIG. 6C) communicated with the hollow hole is provided on a circumferential sidewall of the puncture needle (FIG. 6C: 630 connects with the distal end of 634 and is formed in the sidewall of 634); in the axial direction, a front end of the notch is communicated with a tip end surface of the puncture needle (FIG. 6C: the distal end of 630 connects with the distal end of 634), the notch and the hollow hole enclose to form a slot structure (FIG. 6C), and the slot structure forms the channel (FIG. 6C: 630 forms the channel of 634); each of the at least two limiting structures includes a protrusion (604; FIG. 6B) located on an inner surface of the slot structure (FIG. 6B: 604 are on inner surface 632); and two opposite sidewalls of the slot structure are provided with the protrusion, respectively, and the two protrusions are arranged opposite to each other (FIG. 6B: 604 are on opposite sides from each other).
Regarding claim 9, Santangelo et al. further discloses at least a portion of the one or more implants is located in the hollow hole (FIG. 6A: 606 is located partially within the distal opening of 600), and when the portion of the one or more implants located in the hollow hole abuts against the notch of the slot structure, a deformation clearance is formed between a bottom surface of the one or more implants and a bottom surface of the slot structure (FIG. 6B: space exists between the bottom surface of 606/608 and the inner surface of 600 while the implants are in the needle).
Regarding claim 11, Santangelo et al. further discloses each of the one or more implants includes a first portion (402) and a second portion (404) which are connected from top to bottom along a depth direction of the slot structure (FIG. 4A: 402 and 505 are connected along the proximal-distal depth of channel 308); a sidewall of the first portion is provided with a suspension structure (FIG. 4A: the slot in 402), and the first portion is suspended on the notch through the suspension structure (FIG. 6B: the slot of 402 is placed on the notches 630), such that a clearance is formed between a bottom of the second portion and an inner sidewall of the hollow hole (FIG. 6B: space exists between the bottom surface of 606/608 and the inner surface of 600); and the second portion is located in the hollow hole (FIG. 6C: the top of the implant is in the hollow hole), and a width at a widest position of the second portion is greater than a width of the notch (FIG. 6B: the top portion of the implant above the suspension structure is wider than the hole that the top portion travels through).
Regarding claim 12, Santangelo et al. further discloses a fixing portion (604) and a triggering mechanism (638), wherein the puncture needle is connected with the fixing portion (FIG. 6B: 604 connects with 600), the triggering mechanism is capable of moving along an axial direction relative to the fixing portion (FIG. 6C: 638 pushes the implants along 636), and the triggering mechanism is configured to trigger the one or more implants toward a front end (FIG. 6C: 638 pushes the implants distally).
Regarding claim 13, Santangelo et al. further discloses the triggering mechanism includes a push pin (736), a push button (130), a connection arm (108), and a linkage portion (Annotated FIG. 1 below); the push button, the connection arm, and the linkage portion are arranged in sequence in a direction from a front end to a rear end of the suturing device (Annotated FIG. 1: 130 is proximal to 108, which is proximal to the linkage portion identified in the illustration); a front end of the push pin is located in the hollow hole of the puncture needle (FIG. 2: 736 is located within 104); and the push button is slidably connected with the fixing portion (FIG. 2: 130 slides axially relative to where 604 are formed on the needle); a front end of the connection arm is connected with the push button (FIG. 1: 130 is connected to the proximal end of 108), and a rear end of the connection arm is connected with the linkage portion (FIG. 1: the distal end of 108 is connected with the linkage portion); the linkage portion is connected with a rear end of the push pin (FIG. 2: the linkage portion is connected to 130, which is connected to the distal end of 736, which means the linkage portion is connected to the distal end of 736).
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Regarding claim 14, Santangelo et al. further discloses a spring (710) is provided between the fixing portion and the linkage portion (FIGs. 1 and 7B: 710 is between where 604 are formed on the needle and the linkage portion).
Regarding claim 15, Santangelo et al. further discloses a depth limiting tube (508) and a locking mechanism (650 and 652), wherein the depth limiting tube sleeves an outer side of the puncture needle (FIG. 5A: 508 surrounds needle 504), a front end of the depth limiting tube is a depth limiting end (FIG. 5A: the distal end of 508 is narrower than 502, which limits how far back 502 can go); a position of the depth limiting tube in the axial direction is adjustable ([0034] 508 is a pusher member that can be moved along the axial direction); and the locking mechanism is configured to lock the depth limiting tube such that the position of the depth limiting tube is fixed relative to the puncture needle (FIGs. 6D-6F and [0038] 646 is the equivalent of 508 for an embodiment where 650 and 652 lock 646 relative to the needle tube).
Regarding claim 16, Santangelo et al. further discloses the locking mechanism includes a control arm (108; FIG. 2), the control arm includes a first connection arm (Annotated FIG. 2 below), a pressing arm (Annotated FIG. 2), and a second connection arm (Annotated FIG. 2) which are connected in sequence along the axial direction (Annotated FIG. 2), one end of the first connection arm is connected with the depth limiting tube (Annotated FIG. 2: the end of 108 comprising the first connection arm is connected with 104, which connects with 508), and the other end of the first connection arm is connected with one end of the pressing arm (Annotated FIG. 2); one end of the second connection arm is connected with the other end of the pressing arm (Annotated FIG. 2), and the other end of the second connection arm is slidably connected with a fixing portion (Annotated FIG. 2: the end of 108 which is the second connection arm is slidably connected to 104); a clearance is provided between the pressing arm and the fixing portion (Annotated FIG. 2: the middle portion of 108 is separated from 104) such that the pressing arm is capable of moving relative to the fixing portion (Annotated FIG. 2: when 108 is not connected to 104, 108 can move axially relative to 104); a gear pin is provided on the pressing arm (Annotated FIG. 2: the distal end of the first connection arm is the gear pin); the locking mechanism further includes a plurality of limiting slots located on a housing (Annotated FIG. 2: 104 has a series of slots which the distal end of 108 can fit within), and the plurality of limiting slots are arranged in sequence along the axial direction (Annotated FIG. 2: the slots in 104 go in the 116 direction); and the pressing arm has a locked state (Annotated FIG. 2) and an unlocked state ([0029] 108 can be lifted out of contact with 104 to allow 104 to move freely), in the locked state, the gear pin is located in one of the plurality of limiting slots, and the limiting slot is configured to prevent the pressing arm from moving along the axial direction (Annotated FIG. 2: when 108 is within the slots in 104, 104 is locked axially), and in the unlocked state, the gear pin is pressed out of the limiting slot, and the pressing arm is capable of moving along the axial direction (Annotated FIG. 2: when 108 is out of the slots in 104, 104 is able to move axially).
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Regarding claim 17, Santangelo et al. further discloses a first guide slot extending along the axial direction is provided on the fixing portion (Annotated FIG. 2: the inside of the protrusion that the first connection arm is shown within), a sliding abutting portion is provided on the first connection arm (Annotated FIG. 2: the end of the first connection arm raises upward), the sliding abutting portion abuts against the first guide slot (Annotated FIG. 2: when the end of the first connection arm moves distally, the raised upward portion comes into contact with the protrusion), and the first guide slot is configured to guide the first connection arm to slide along the axial direction of the puncture needle (Annotated FIG. 2: the first connection arm is stabilized in their axial movement by the contact between the raised upward portion and the protrusion).
Regarding claim 18, Santangelo et al. further discloses a housing (102) and a triggering mechanism (130), wherein the triggering mechanism is configured to trigger the one or more implants toward a front end (FIG. 2: as 130 moves in direction 134, 108 is moved forward to move 114 forward and trigger the implants to move distally); and a gear slot is disposed on an inner wall of the housing (FIG. 2: the opening near 122); an elastic swing rod (124) is disposed on the triggering mechanism (FIG. 2: 124 is disposed on 130), a fixed end of the elastic swing rod is fixedly connected with the triggering mechanism (FIG. 2: the fixed end of 124 is attached to 130), and a free end of the elastic swing rod extends into the gear slot from the notch of the gear slot (FIG. 2: the free end of 124 extends into the gear slot near 122).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Santangelo et al. in view of Chao et al. (Pub. No. 2024/0164770).
Regarding claim 3, Santangelo et al. discloses the invention as claimed in claim 1, as discussed above. Santangelo et al. is silent regarding the size of the angles of the first chamfer and the second chamfer, including the angles being within a range of eight degrees to ten degrees.
Chao et al. teaches in the same field of endeavor of soft tissue implants ([0555]), and discloses an implant (202; FIG. 2C) with a chamfer (222), where the chamfer angle is between 7.5 and 17.5 degrees ([0555]) for the purpose of further facilitating insertion into soft tissue ([0555]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the angle of the first and second chamfers of Santangelo et al. to be within 7.5 and 17.5 degrees, as taught by Chao et al., for the purpose of further facilitating insertion into soft tissue.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Santangelo et al. in view of Boyes et al. (Pub. No. 2025/0195106).
Regarding claim 10, Santangelo et al. discloses the invention as claimed in claim 9, as discussed above. Santangelo et al. is silent regarding the size of the deformation clearance, including being within a range of 0.05 mm to 0.4 mm.
Boyes et al. discloses a system (100; FIG. 1) comprising a medical instrument (12) and a cannula shaft (14), where the clearance between the instrument and the shaft is less than 0.5 mm ([0095]) for the purpose of positioning the instrument based on the position of the shaft and allowing for the instrument to be deployed axially from the shaft while guiding the instrument in the direction of the shaft ([0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the deformation clearance of Santangelo et al. to be less than 0.5 mm, as taught by Boyes et al., for the purpose of positioning the instrument based on the position of the shaft and allowing for the instrument to be deployed axially from the shaft while guiding the instrument in the direction of the shaft.
Allowable Subject Matter
Claims 19-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
Regarding claim 19, the prior art does not disclose, alone or in combination, the gear slot includes a first slot unit, a second slot unit, a first retreat slot, and a second retreat slot, where one end of the first retreat slot extends from a first limiting end of the first slot unit toward a rear end and passes through a sidewall of the first slot unit to communicate with the second slot unit, and one end of the second retreat slot extends from a second limiting end of the second slot unit towards the rear end to communicate with a starting end of the first slot unit.
As discussed above, Santangelo et al. discloses the limitations of claim 18, and further discloses the gear slot includes a first slot unit (FIG. 2: the opening near 122 can be considered a slot). However, Santangelo et al. does not disclose a second slot unit or either retreat slot.
Another close prior art reference, Bourque et al. (U.S. Patent No. 8,888,798), discloses a gear slot (FIGs. 8A-8B) including a free end (14c’), a slot unit (13a), and a retreat slot (13b), where one end of the retreat slot extends from a first limiting end of the slot unit toward a rear end and passes through a sidewall of the slot unit. However, Bourque et al. does not disclose another slot unit in communication with the initial slot unit or retreat slot, and also does not disclose another retreat slot.
Regarding claim 20, the prior art does not disclose, alone or in combination, the gear slot includes a first slot unit, a second slot unit, a first retreat slot, and a second retreat slot, where a front end of the first retreat slot is connected to a first limiting end of the first slot unit through a first transverse slot and a rear end of the first retreat slot is connected with a second starting end of the second slot unit through a second transverse slot, and a front end of the second retreat slot is connected with a second limiting end of the second slot unit through a third transverse slot and a rear end of the second retreat slot is connected with a second slot wall of the first slot unit.
As discussed above, Santangelo et al. discloses the limitations of claim 18, and further discloses the gear slot includes a first slot unit (FIG. 2: the opening near 122 can be considered a slot). However, Santangelo et al. does not disclose a second slot unit or either retreat slot.
Another close prior art reference, Bourque et al., discloses a gear slot (FIGs. 8A-8B) including a free end (14c’), a slot unit (13a), and a retreat slot (13b), where a front end of the retreat slot extends from a first limiting end of the slot unit through a first transverse slot (FIG. 8A). However, Bourque et al. does not disclose another slot unit in communication with the initial slot unit or retreat slot, and also does not disclose another retreat slot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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