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 .
Response to Arguments
Applicant argues in the response filed 10/14/2025 that claim amendments would overcome the claim objections, 112 rejections and 112 paragraph 6 interpretations. The objections, 112 rejections, and means plus function interpretations have been withdrawn. It is noted, the claim objection to claim 1 with respect to “the suture thread” is maintained below since there was no applicable amendment.
The applicant argues prior art Stone, Martin, and Harrison do not disclose the amended claims with respect to the limitation “one locking member blocking simultaneously release of the anchor and release of the suture thread (interacting with the reel)”. However it is to be noted that claim 1 does not recite “one locking member blocking simultaneously release of the anchor and suture thread”. The limitation recites “in the activated state the one locking member simultaneously interacts with the housing for preventing the anchor from coming out of the casing and with the reel for prevent the suture thread from being released”. Claim 1 does not recite the specific structure of the locking member or how the locking member “interacts” with the housing. If there is a general interaction where the suture anchor and suture thread simultaneously are not released, then the locking member can be able to read on the claim limitation.
With respect to Stone, the applicant states how the device works and then states “Stone does not disclose one locking member which has an activated state and a deactivated state, where in the activated state the one locking member simultaneously interacts with the housing for preventing the anchor from coming out of the casing and with the reel for preventing the suture thread from being released while the deactivated state allows the anchor to come of the casing and the release of the suture thread as claimed in claim 1”. However, the applicant does not specifically argue why the structure and teachings of Stone would not be able to read on the limitation. The examiner maintains that based on the rotation of the carousel, the device can read on the activated and deactivated state. There will need to be a rotation to allow alignment for the reel/needle/anchor with the delivery device. When the elements are not aligned, the device can be in the activated state, which is based on the locking member interacting with the housing. In this configuration, the “anchor” and “suture thread” are simultaneously prevented from being released. The examiner maintains the rejection with respect to Stone below.
With respect to Martin, the applicant states how the device works and then states “Martin does not disclose one locking member which has an activated state and a deactivated state, where in the activated state the one locking member simultaneously interacts with the housing for preventing the anchor from coming out of the casing and with the reel for preventing the suture thread from being released while the deactivated state allows the anchor to come of the casing and the release of the suture thread as claimed in claim 1”. However, the applicant does not specifically argue why the structure and teachings of Martin would not be able to read on the limitation. The examiner maintains the locking member 22 general engagement with the housing will be able to read on the activated and deactivated state. The locking member prevents the needle to be connected to the anchor. The suture will be released when the anchor is released. Therefore the locking member will simultaneously interact with the housing to prevent the anchor and the suture thread from being released. The examiner maintains the rejection with respect to Harrison below.
The applicant argues Harrison does not teach a device for loading an anchor associated with a suture thread. The applicant then describes embodiments of Harrison, where none of the describe “a locking member simultaneously blocking the reel and the anchor as recited in claim 1”. However, the applicant does not specifically argue how the embodiments do not read on the specific claim limitations. Claim 1 is directed to an anchor holder for at least one suture thread, where the anchor holder has the anchor, a casing including a housing where the anchor is stowed, and a reel which is in communication with the housing. However, the structure of the casing/housing is not defined nor how the reel “communicates” with the housing. Harrison does disclose element 421’ which can read on the locking member since it has the activated state which can simultaneously interact with the housing for preventing the anchor from coming out of the casing since the anchor is not aligned with the attachment guide and prevents the suture from being released since. The element 421’ can be moved to the activated state which aligns the attachment guide with the anchor/suture in order to deliver/release the anchor. Further the Harrison has a suture storage element which can read on the reel and communicate with the housing since the suture will extend through/into the housing. The elements and embodiments of Harrison can be combined in order to read on the claim limitations of record. The rejection has been maintained below.
The examiner suggests amending claim 1 lines 14-16 with respect to “…preventing the anchor from coming out of the casing from a second opening in the casing coaxial and opposite the first opening” and “…engaging with the reel to prevent rotation of the reel and for preventing the suture thread from being released” and line 17 “allows the anchor to come out of the second opening of the casing” which can overcome the prior art of record.
Claim Objections
Claim 1 is objected to because of the following informalities: Lines 3-4 states “the suture thread”. Claim 1 does state “at least one suture thread” in the preamble, however, to avoid any antecedent issues, “the suture thread” should state “a suture thread”. The limitation could also state “the at least one suture thread”. 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 8, 11-14 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 8 recites the limitation "a closed position" in line 4. However, claim 8 already recites “a closed position” in line 3. It is unclear if “a closed position” of line 4 is the same or different closed position than line 3. For examination purposes, the limitation will be interpreted to be “[[a]] the closed position”.
Claim 11 recites the limitation "an attachment guide " in line 3. However, claim 11 is dependent off of claim 1 which already recites “an attachment guide” in line 8. It is unclear if “an attachment guide” of claim 8 is the same or different attachment guide of claim 1. For examination purposes, the limitation will be interpreted to be “[[an]] the attachment guide”.
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.
Claims 1, 4, 8-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 5,478,345 to Stone.
As to claim 1, Stone discloses an anchor holder (10) for at least one suture thread in a biological tissue, the anchor holder comprising: an anchor (80, the needle can read on an anchor without further limitations on the anchor) equipped with an assembly head (the tip of the needle), the anchor being connected to the suture thread (82), a casing (12) including a housing (14) in which the anchor is stowed in a predetermined position (figure 3), the housing comprising a first opening (28), the assembly head of the anchor being positioned coaxial with the first opening (figure 3, 5, the tip of the needle is on the same axis with the opening defined by recess 28) for allowing an insertion of an assembly end (90) of an attachment guide (88) into the housing, the assembly end of the attachment guide being complementary to the assembly head of the anchor (col. 6 ll. 53-61, the recess 94 is a recess which is complementary to the tip of the needle 80), a reel (50) which is configured to stow and release the suture thread, the reel being in communication with the housing so as to allow the passage of the suture thread (figure 3, 3a, 5), and one locking member (46, 48, 30, col. 4 ll. 49-col. 5, the indexing mechanism can read on the locking mechanism since it will “temporarily locking” a supply station to the receiving structure 21) which has, an activated state (col. 4 ll. 49-col. 5, the supply station 16 is not aligned with the receiving structure 21), an a deactivated state (figure 3, when the supply station is aligned with the receiving structure 21, col. 4 ll. 49-col. 5), in the activated state the one locking member simultaneously interacts with the housing preventing the anchor from coming out of the casing and with the reel for preventing the suture thread from being released (col. 4 ll. 49-col. 5, the mechanism that allows the carousel locks in the configuration which has the supply station not aligned with the receiving structure, this mechanism does interact with the housing and reel and can simultaneously prevent the anchor from coming out suture from coming out/being released since they are not aligned with the opening), while the deactivated state allows the anchor to come out of the casing and the release of the suture thread (figure 3, col. 4 ll. 49-col. 5).
As to claim 4, Stone discloses the reel comprising at least one circular groove around which the suture thread is wound (figure 3a).
As to claim 8, Stone discloses the housing is mounted rotatably relative to the casing, the housing is movable, between an open position and a closed position, wherein in the open position the housing is radially at a distance from the reel, and on the other hand, a closed position in which the housing is connected to the reel, and when the housing is in the closed position, the locking members are in their activated state and when the housing is in the open position, the locking members are in their deactivated state (col. 4 ll. 49-col. 5). The carousel rotates and is mounted within the body 12. Further, as the carousel rotates, the carousel can be in the open and closed positions which can align with the active and deactivated states.
As to claim 9, Stone discloses includes a poka-yoke (18, 30, the abutment and support members can read on a “poka-yoke”) arranged in the housing at least in the first opening so as to insert the assembly end of the attachment guide with a predetermined orientation to allow assembly with the head of the anchor (figure 5). The members 18,30, can read on the poka-yoke, since they are structures that help align the attachment guide. Further limitations with respect to the “poka-yoke” would be needed.
As to claim 10, Stone discloses the poka-yoke is formed of a ridge which extends longitudinally along the axis of the housing (figure 3, 5).
As to claim 11, Stone discloses an attachment kit for attaching at least one suture thread to a biological tissue, the attachment kit comprising an anchor holder as claimed in claim 1 (10, figure 3, 5) and an attachment guide which is sterilizable and reusable (86, the suturing device is capable of being sterilized and reused), wherein the attachment guide includes a sleeve (88) extended by a rod (89) ending in the assembly end (90,90) that is configured to be assembled with the assembly head of the anchor which is stowed in the housing of the anchor holder (figure 5).
As to claim 12, Stone discloses the anchor holder is translatably movable along the rod of the attachment guide when the housing slides on the rod (col. 7 ll. 15-25). The attachment guide is pulled out and away from the loading unit 10. Further the loading unit 10 does contact the rod. Therefore, the anchor holder is capable of movable translation on the rod, when the housing slides on the rod.
As to claim 13, Stone discloses a suture thread holder (60) which is configured to hold the suture thread against the rod (figure 3,3a,5).
Claims 1-7, 11, 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2008/0275474 to Martin.
As to claim 1, Martin discloses an anchor holder (10) for at least one suture thread in a biological tissue, the anchor holder comprising: an anchor (42) equipped with an assembly head (end of the anchor 42), the anchor being connected to the suture thread (40), a casing (12) including a housing (top portion of the housing, figure 2) in which the anchor is stowed in a predetermined position (figure 2), the housing comprising a first opening (14), the assembly head of the anchor being positioned coaxial with the first opening (figure 2) for allowing an insertion of an assembly end (32) of an attachment guide (30) into the housing, the assembly end of the attachment guide being complementary to the assembly head of the anchor (paragraph 13, the needle is hollow which is complementary to the end of the anchor, and/or the friction fit), a reel (50) which is configured to stow and release the suture thread, the reel being in communication with the housing so as to allow the passage of the suture thread (figure 2, paragraph 14,16), and one locking member (22) which has, an activated state (figure 2, paragraph 15) and a deactivated state (figure 4), in the activated state the one locking member simultaneously interacts with the housing for preventing the anchor from coming out of the casing and with the reel for preventing the suture thread from being released (safety 22 prevents the anchor from loading into the needle, since loading of the anchor is blocked, the lock can interact with the housing to simultaneously prevent the anchor and suture thread from being released/removed), while the deactivated state (figure 4) allows the anchor to come out of the casing and the release of the suture thread.
As to claim 2, Martin discloses the reel is mounted rotatably about an axis and includes at least one toothed wheel (52,54, figure 5, paragraph 17).
As to claim 3, Martin discloses the locking member includes a stop (“tang”, paragraph 17) which interacts with the toothed wheel so as to block the rotation of the reel (paragraph 17). The spring and tang can be included in the given “locking mechanism” since they also help to control movement of the device.
As to claim 4, Martin discloses the reel comprising at least one circular groove around which the suture thread is wound (figure 5).
As to claim 5, Martin discloses wherein the housing passes through the casing between the first opening and a second opening (opposite end of channel 16) opposite and coaxial with the first opening, the anchor being stowed in a position proximal to the second opening (figure 1, 2).
As to claim 6, Martin discloses wherein the locking member obstructs the second opening (figure 1, paragraph 15). The locking mechanism is at the opposite end of the channel 16, preventing the actuator to be depressed, which blocks to the second opening.
As to claim 7, Martin discloses the locking member is detachable from the casing, the locking member going into its deactivated state when it is detached from the casing (paragraph 15).
As to claim 11, Martin discloses an attachment kit for attaching at least one suture thread to a biological tissue, the attachment kit comprising an anchor holder as claimed in claim 1 (10, figure 1) an attachment guide (30) which sterilizable and reusable, wherein the attachment guide includes a sleeve (38) extended by a rod (32) ending in the assembly end (lumen of needle, 34) that is configured to be assembled with the assembly head of the anchor which is stowed in the housing of the anchor holder (paragraph 15).
As to claim 12, Martin discloses the anchor holder is translatably movable along on the rod of the attachment guide when the housing slides on the rod (paragraph 15).
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.
Claims 1, 5, 6, 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2016/0000422 to Harrison.
As to claim 1, Harrison discloses an anchor holder (paragraph 101) for at least one suture thread in a biological tissue, the anchor holder comprising: an anchor (the end of the anchor knot 504 in figure 4a-c, 5a,b) equipped with an assembly head (the proximal end of the knot), the anchor being connected to the suture thread (50), a casing (400/500) including a housing (420/520) in which the anchor is stowed in a predetermined position (figure 4a-c, 5a,b), the housing comprising a first opening (proximal opening of seat channel 424, as seen in figure 4a-c, 5a,b), the assembly head of the anchor being positioned coaxial with the first opening (figure 4a-c, 5a,b) for allowing insertion of an assembly end (931) of an attachment guide (900) into the housing, the assembly end of the attachment guide being complementary to the assembly head of the anchor (figure 6d-f, paragraph 141, alternatively, the knot is a solid sphere which can be complimentary to the open lumen of the assembly guide), a reel (160, figure 1b) which is configured to stow and release the suture thread, the reel being in communication with the housing so as to allow passage of the suture thread (paragraph 113), and one locking member (421’, figure 4a-c, paragraph 131-136) which has, on the one hand, an activated state (figure 4a) and an deactivated state (figure 4c), in the activated state the one locking member simultaneously interacts with the housing for preventing the anchor from coming out of the casing and with the reel for preventing the suture thread from being released (figure 4a, the interlock blocks the opening for the attachment guide while pinching the suture, since the interlocks prevents the anchor and suture from engaging the attachment guide, the interlock simultaneously interacts with the housing to prevent release of the suture thread and anchor), while the deactivated state allows the anchor to come out of the casing and the release of the suture thread (figure 4c,5b).
If however, it would not be known that the end of the suture knot can be an assembly head complimentary to the assembly end of the attachment guide, Harrison discloses another embodiment using a ferrule which has a complimentary assembly head to the assembly end (paragraph 140, 145, figure 6b-f) for the purpose of helping to align and secure the delivery instrument with the anchor. Further Harrison discloses that separate features can be combined in a single embodiment (paragraph 365). It would have been obvious to one of ordinary skill in the art before the effective filing date to use a complimentary assembly end of the attachment guide and assembly head of the anchor in order for helping to align and secure the delivery instrument with the anchor.
Harrison does not necessarily disclose that the interlock ‘421 can be used in the embodiment with the suture reels 160. Harrison does disclose that separate features can be combined in a single embodiment (paragraph 365) and that the reel can help to prevent entanglement (paragraph 113). Using the reel of 160 with the housing with the locking members ‘421 can allow for the device to control when the anchor is released while prevent the suture from tangling. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a reel with the locking member in a single embodiment in order for storing the suture during delivery while preventing entanglement.
As to claim 5, Harrison discloses wherein the housing passes through the casing between the first opening and a second opening (distal opening of the seat channel 424, figure 4b) opposite and coaxial with the first opening (figure 4a), the anchor being stowed in a position proximal to the second opening (figure 4a).
As to claim 6, Harrison discloses wherein the locking member obstructs the second opening (figure 4a).
As to claim 9, Harrison discloses includes a poka-yoke (205a, 2040, 2042, figure 14ei,fi, paragraph 192-195) arranged in the housing at least in the first opening so as to insert the assembly end of the attachment guide with a predetermined orientation to allow assembly with the head of the anchor. The grooves/arms/channel can read on a poka-yoke since they do allow for the orientation with the head of the anchor. The poka-yokes of Harrison helps to track and guide the instrument. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the poka-yoke in the single embodiment in order to help track and guide the instrument.
As to claim 10, Harrison discloses the poka-yoke is formed of a ridge which extends longitudinally along the axis of the housing (205a, 2040, 2042, figure 14ei,fi, paragraph 192-195).
As to claim 11, Harrison discloses an attachment kit for attaching at least one suture thread to a biological tissue, the attachment kit comprising an anchor holder as claimed in claim 1 and an attachment guide (900) which is sterilizable and reusable, wherein the attachment guide includes a sleeve (910) extended by a rod (931) ending in the assembly end (figure 6b, the top end of the needle) that is configured to be assembled with the assembly head of the anchor which is stowed in the housing of the anchor holder (figure 7b).
As to claim 12, Harrison discloses the anchor holder is translatably movable along the rod of the attachment guide when the housing slides on the rod (figure 6d-f).
As to claim 13, Harrison discloses a suture thread holder (slots that define groove 16, where the suture 500 extends, figure 1a; 1064, figure 31a-b, paragraph 181; 2064, figure 31e,f, paragraph 263) which is configured to hold the suture thread against the rod. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the holding means in the single embodiment in order to help hold the suture thread close to the rod or against the rod.
As to claim 14, Harrison discloses the suture thread holder includes a slot (slots that define groove 16, where the suture 500 extends, figure 1a; 1064, figure 31a-b, paragraph 181; 2064, figure 31e,f, paragraph 263) which extends longitudinally on an attachment guide, the slot being configured to receive a suture thread when an anchor holder is moved in the direction of the sleeve on the rod of the attachment guide.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,478,345 to Stone in view of U.S. Patent 5,755,729 to de la Torre.
As to claim 14, Stone discloses the kit above but is silent about the suture thread holder include a slot which extends longitudinally on the attachment guide, the slot being configured to receive the suture thread when the anchor holder is moved in the direction of the sleeve on the rod of the attachment guide.
De la Torre disclose a similar device (magazine, abstract) having a suture thread holder which includes a slot (either 72 in figure 4, or 164, figure 10a) which extends longitudinally on an attachment guide, the slot being configured to receive a suture thread when an anchor holder is moved in the direction of the sleeve on the rod of the attachment guide (figure 4, 10a, col. 7 ll. 21-25, col. 11 l. 40-51) for the purpose of being able to releasable secure the suture. It would have been obvious to one ordinary skill in the art before the effective filing date to have the holding means include a slot which extends longitudinally on an attachment guide, the slot being configured to receive a suture thread when an anchor holder is moved in the direction of the sleeve on the rod of the attachment guide in order for being able to releasable secure the suture.
Allowable Subject Matter
Claim 16 is allowed.
Of note: A call was made to the applicant to discuss the allowable subject matter for an Examiner’s Amendment to place the application in condition for allowance. However an interview was not able to be scheduled.
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached 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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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771