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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Application 19/191127 on 04/28/2025. It is noted, however, that applicant has not filed a certified copy of the CN202410548931 application as required by 37 CFR 1.55. (Priority documents failed to be delivered).
Drawings
The drawings are objected to because reference characters “10”, “100”, “200”, and “400” in Fig. 1 do not point to anything. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 9, 11, and 20 are objected to because of the following informalities:
Claim 9 recites “the traction line is passed through”, although the line is understood by the Examiner to be a functional limitation and not a method step, the Examiner suggests the line be amended to read “the traction line is configured to be passed through” for the purpose of maintaining consistent language throughout the claims;
Claim 11 recites “selectively fixed to or released from the proximal connecting member” in line 3, although the line is understood by the Examiner to be a functional limitation and not a method step, the Examiner suggests the line be amended to read “configured to be selectively fixed to or released from the proximal connecting member” for the purpose of maintaining consistent language throughout the claims;
Claim 20 recites “wherein the anchoring body of the anchor moves along” in line 5, although the line is understood by the Examiner to be a functional limitation and not a method step, the Examiner suggests the line be amended to read “wherein the anchoring body of the anchor is configured to move along” for the purpose of maintaining consistent language throughout the claims;
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 3 – 18 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.
Regarding claim 9, the phrase "a second receiving channel" renders the claim indefinite because the term “second” implies the existence of a “first receiving channel”, however within the claim branch of claim 9 no “first receiving channel” was previously defined; therefore, it is unclear if Applicant is intending the term “second” to mean that the “second receiving channel” is one of two “receiving channels” or if Applicant is intending the term “second” to be purely nomenclature, such that the claim does not require two, distinct, receiving channels. For the purpose of examination, the Examiner is interpreting the claim to mean the latter.
Regarding claims 3 and 15, the phrase “the first receiving channel communicates with a channel of the puncture needle” and "the stopper selectively arranged between the stopper and the puncture needle", respectively renders the claim indefinite because it is unclear whether Applicant is intending to positively recite a previously functionally recited structure (i.e., the puncture needle) or if Applicant is intending for the limitations to only functionally require the puncture needle. For the purpose of Examination, the Examiner will read the claims as positively requiring the puncture needle.
Claims 4 – 8, 10 – 14, and 16 – 18 are rejected for being dependent on an indefinite 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.
Claims 1, 2, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayhurst et al (US 5,041,129).
Regarding claim 1, Hayhurst discloses an anchor (system shown in Figs. 1 – 5 comprising anchor 10) (abstract, col. 3 line 36 – col. 4 line 14, and Figs. 1 – 5), comprising:
a traction line (suture 20), wherein the traction line is a flexible member (suture) (col. 5 line 50 – 55);
an anchoring body (anchor 10), connected to a distal end of the traction line and capable of being pulled by the traction line (col. 3 lines 7 – 17, col. 4 lines 18 – 36, and Figs. 1 – 4); and
a driving tube (pusher tube 32), at least sleeved on at least a portion of the traction line (col. 4 lines 18 – 36 and Fig. 2), wherein the anchoring body (anchor 10) is configured to move along a puncture needle (outer needle 30) under drive of the driving tube (col. 3 lines 7 – 17, col. 4 lines 18 – 36, and Figs. 1 – 4), and can be flipped when extending out of a distal end of the puncture needle to form an angle with the traction line so that the anchoring body stops at an inner wall of a target tissue (col. 3 lines 7 – 17, col. 4 lines 18 – 36, and Figs. 1 – 4).
Regarding claim 2, Hayhurst discloses wherein the driving tube (pusher tube 32) is sleeved on the traction line (col. 4 lines 18 – 36, and Fig. 2), and the anchoring body (anchor 10) is located at a distal end of the driving tube (pusher tube 32) (Fig. 2); and when the anchoring body (anchor 10) is located in the puncture needle (outer needle 30), a proximal end (trailing end 16) of the anchoring body abuts the distal end of the driving tube, so that when the anchoring body extends out of the puncture needle, the anchoring body can be flipped under pushing of the driving tube and pulling of the traction line (Examiner’s note: there is a point, prior to the anchor 10 extending the outer needle 30, wherein the trailing end 16 of the anchor abuts the distal end of the pusher tube 32; and as stated in col. 3 lines 46 – 60 the trailing end 16 helps the anchor to flip when pushed).
Regarding claim 19, Hayhurst discloses wherein a limiting groove (hole / channel through the anchor body 10) and a side notch (slot 18) communicated with the limiting groove are formed on the anchoring body (anchor 10) (col. 3 line 37 – col. 4 line 4, and Fig. 1 – 3), the limiting groove and the side notch both extend along a length direction of the anchoring body (Fig. 1), and one ends of the limiting groove and the side notch both run through a proximal end (trailing end 16) of the anchoring body (anchor 10) (Examiner’s note: as shown in Fig. 1, both of the channel through the anchor body and the slot 18 extend through the trailing end 16), wherein when the proximal end (trailing end 16) of the anchoring body is located at the puncture needle (outer needle 30), at least part of the traction line (suture 20) is located in the limiting groove (hole / channel through the anchor body 10), and during a process of the traction line pulling the anchoring body to flip, a part of the traction line (suture 20) detaches from the anchoring body through the side notch (Examiner’s note: as shown in Figs. 2 – 5 the suture at the proximal end (trailing end 16) detaches from the anchoring body through the side notch 18).
Regarding claim 20, Hayhurst discloses an anchoring device (anchoring system shown in Figs. 1 – 5) (abstract, col. 3 line 36 – col. 4 line 14, and Figs. 1 – 5), comprising:
a puncture needle (outer needle 30), wherein a distal end of the puncture needle is configured to extend into a target tissue (col. 4 lines 56 – 68); and
the anchor (anchoring system shown in Figs. 1 – 5) according to claim 1 (see rejection of claim 1);
wherein the anchoring body (anchor 10) of the anchor moves along the puncture needle under the drive of the driving tube (pusher tube 32) to enter the target tissue (col. 4 lines 18 – 36 and Figs. 2 – 5).
Claim Rejections - 35 USC § 103
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 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.
Claims 3 and 4 rejected under 35 U.S.C. 103 as being unpatentable over Hayhurst et al (US 5,041,129) as applied to claim 1 above, and further in view of Koike et al (US 6,056,760) and Igaki et al (US 2013/0345787 A1).
Regarding claim 3, as discussed above, Hayhurst discloses the anchor, driver, and the needle of claim 1.
However, Hayhurst is silent regarding (i) a distal locking structure, configured to be fixed to a proximal end of the puncture needle, wherein a first receiving channel is formed in the distal locking structure, the first receiving channel communicates with a needle channel of the puncture needle, a part of the driving tube and the anchoring body are located in the first receiving channel, and the anchoring body is configured to enter the needle channel of the puncture needle through the first receiving channel under the drive of the driving tube, and the distal locking structure is configured to selectively cooperate with the driving tube to lock the driving tube and the anchoring body in the first receiving channel.
As to the above, Koike teaches, in the same field of endeavor an anchor comprising a traction line (suture thread ‘T’), an anchoring body (engaging member 4; which is equated to the anchor 10 of Hayhurst), a driving tube (rod 3; which is equated to the pusher tube 32 of Hayhurst) configured to move along a puncture needle (piercing catheter 2; which is equated to the shaft of the outer needle 30 of Hayhurst) (abstract, col. 3 line 25 – col. 4 line 33, and Figs. 1 – 4), a distal locking structure (connector 23 and hemostatic valve 24; and designated in annotated Fig. 4), configured to be fixed to a proximal end of the puncture needle (sleeve 22 of piercing catheter 2; which is equated to the shaft of the outer needle 30 of Hayhurst), wherein a first receiving channel (lumen through connector; designated in annotated Fig. 4) is formed in the distal locking structure communicating with a needle channel of the puncture needle (see annotated Fig. 4), a part of the driving tube (rod 3) and the anchoring body (engaging member 4) are located in the first receiving channel (Figs. 1 – 2), and the anchoring body is configured to enter the needle channel of the puncture needle through the first receiving channel under the drive of the driving tube (Examiner’s note: the preceding limitation is intended use which requires only that the structure of the prior art be capable of functioning as claimed. With that said, the engaging member 4 is capable of entering through the needle channel of the needle via the first receiving channel via the rod 3), and the distal locking structure is configured to selectively cooperate with the driving tube to lock the driving tube and the anchoring body in the first receiving channel (Examiner’s note: the distal locking structure as designated in annotated Fig. 4, comprises hemostatic valve 24; and as stated in col. 3 lines 55 – 66 the inner diameter of the central through hole 142 (i.e., the first receiving channel), which receives the piercing catheter 2, is adjusted by the bolt-like member 143 being driven distally into the screw-hole 144 such that the packing 141 is pressed into the through-hole 142 (i.e., the first receiving channel). The packing 141 is therefore configured to frictionally engage the rod 3 (i.e., the drive tube) and is capable of frictionally restricting the longitudinal movement, selectively, by driving the bolt-like member 143 into the screw-hole 144. In addition to the teachings above, Igaki teaches a catheter system comprising an outer tubular member (sheath 1; which equates to the needle), an inner member (catheter 2; which is equated to the drive rod), and a distal locking structure (connecting member 21 and fixing tool 28) comprising a compressing member holder 27 (which equates to the screw hole 144 of Koike), a fitting portion 31 (which equates to the bolt-like member 143 of Koike), and a compressing member 26 (which equates to the hemostatic valve / packing 141) as the compressing member 26 is disclosed as fluidly sealing the channel and frictionally restricting the movement of the inner member (catheter 2) relative to the outer member (sheath 1) by decreasing the inner diameter of the channel therethrough (paragraphs [0076 – 0078] of Igaki). In summary, Koike teaches a compressible packing 141 that reduces the inner diameter of the channel to frictionally engage the inner member and fluidly seals the channel, and Igaki teaches a compressible member 26 that reduces the inner diameter of the channel to frictionally engage and restrict the movement of the inner member and fluidly seal the channel, the Examiner contends that the compressible packing 141 of Koike is capable, and thus configured to, frictionally restrict / lock the rod 3 (i.e., the driving tube) and engaging member 4 (i.e., the anchoring body) in the first receiving channel).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the needle and driving tube of Hayhurst to incorporate the distal locking structure, based on the teachings of Koike and Igaki, for the purpose of allowing the user to maneuver the system more easily, for the purpose of fluidly sealing the system in order to prevent leakage of blood during the surgical operation (col. 4 lines 18 – 34 of Koike), and for the purpose of being able to restrict movement of the driving tube relative to the needle in order to prevent inadvertent longitudinal movement and deployment of the anchor (paragraphs [0029 – 0031] of Igaki).
Annotated Figure 4 of Koike
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Regarding claim 4, as discussed above, it would have been obvious to modify the needle and driving tube of Hayhurst to incorporate a distal locking structure based on the teachings of Koike and Igaki. Additionally, the Koike further teaches wherein the distal locking structure comprises:
a distal connecting member (connector 23; and designated in annotated Fig. 4), configured to be fixed to the proximal end of the puncture needle (outer needle 30 of Hayhurst) and to form at least a portion of the first receiving channel (see annotated Fig. 4) for the driving tube and the anchoring body to pass through; and
a distal locking member (bolt-like member 143; and designated in annotated Fig. 4), disposed on the distal connecting member (see annotated Fig. 4) and configured to selectively cooperate with the driving tube to lock or release the driving tube and the anchoring body on the distal connecting member (Examiner’s note: the preceding limitation is intended use and only requires the structure of the prior art to be capable of functioning as claimed. With that said, because the bolt-like member 143 (i.e., distal locking member) detachably couples to the connector 23 (i.e., the distal connecting member), bolt-like member 143 (i.e., distal locking member) is capable of selectively cooperating with the drive tube and to lock / release the drive tube with the anchoring body as claimed). Therefore, the combination encompasses the limitations above.
Claims 5 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hayhurst et al (US 5,041,129) in view of Koike et al (US 6,056,760) and Igaki et al (US 2013/0345787 A1), as applied to claim 4 above, and further in view of Zhu et al (US 2005/0107826 A1).
Regarding claim 5, as discussed above, it would have been obvious to modify the needle and driving tube of Hayhurst to incorporate a distal locking structure based on the teachings of Koike and Igaki. Additionally, the Koike further teaches wherein the distal locking member comprises:
a distal fixing portion (external threads of the bolt-like member 143; and designated in annotate Fig. 4), wherein the distal fixing portion is provided with the first receiving channel (see annotated Fig. 4), and is selectively fixed to or released from the distal connecting member (Examiner’s note: the bolt-like member can be fixed or released from the connector 23 (i.e., the distal connecting member); and
a distal locking portion (packing 141), within the distal connecting member (connector 23) (see annotated Fig. 4);
wherein when the distal fixing portion is fixed to the distal connecting member (see annotated Fig. 4), the distal locking portion (packing 141) is configured to cooperate with the distal connecting member and act on the driving tube to lock the driving tube and the anchoring body (Examiner’s note: the preceding limitation is intended use and only requires the structure of the prior art to be capable of functioning as claimed. With that said, as stated in the rejection of claim 3, and in col. 3 lines 50 – 65 of Koike, the packing 141 is compressed into the channel, through which the drive tube extends, therefore, the packing 141 (i.e., the distal locking portion) is capable of functioning as claimed); and
wherein when the distal fixing portion (external threads of the bolt-like member 143) is released from the distal connecting member (connector 23), the distal locking portion is configured to detach from the distal connecting member (connector 23) to release the driving tube and the anchoring body (Examiner’s note: Koike teaches that the bolt-like member 143 only frictionally fixes the packing 141 (i.e., the distal locking portion) to the connector 23 (i.e., the distal connecting member), therefore, the packing 141 (i.e., the distal locking portion) is capable of and configured to detach from the connector 23 (i.e., the distal connecting member) when no longer pressed into/ against the connector 23).
Annotated Figure 4 of Koike
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However, the combination is silent regarding (i) wherein the distal locking portion is located inside the distal fixing portion.
As to the above, Zhu teaches in a similar field of endeavor reasonably pertinent to a problem with which Applicant is attempting to solve, namely a distal locking structure (handle 514, threaded proximal end 504, threaded locking cap 546, and locking members 544) on the proximal end of insertable medical device (delivery tube 490; which is equated to the outer needle 30 of Hayhurst) in order to restrict movement between an inner moveable member (pusher member 500; which equates to the pusher tube 32 of Hayhurst) and the insertable medical device (delivery tube 490), wherein the distal locking structure (handle 514, threaded proximal end 504, threaded locking cap 546, and locking members 544) comprises a distal locking portion (locking members 544; which equate to the packing 141 of Koike) within a distal fixing portion (threaded locking cap 546).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the distal locking structure of Hayhurst in view of Koike and Igaki, such that the distal locking member has internal threads with the distal locking portion therein, as shown in the teachings of Zhu, because the modification is merely the reversal of parts known to be reversable such that one of ordinary skill in the art would have a reasonable expectation of success in making such a modification.
Regarding claim 6, as discussed above, it would have been obvious to modify the needle and driving tube of Hayhurst to incorporate a distal locking structure based on the teachings of Koike, Igaki, and Zhu. The combination further teaches:
wherein the distal locking portion (packing 141 of Koike) is a distal elastic member (packing 141 of Koike) (col. 4 lines 12 – 17 of Koike) embedded in the distal fixing portion (bolt-like member 143 modified to house / be embedded with the packing 141 therein – see rejection of claim 5), and
the distal elastic member (packing 141 of Koike) is elastic at least along a first direction intersecting with an extension direction (i.e., the longitudinal direction) of the driving tube (Examiner’s note: as stated in col. 3 lines 50 – 65 of Koike the packing compresses into the channel, thereby intersecting the longitudinal direction of the drive tube);
wherein when the distal fixing portion (threads of bolt-like member 143 of Koike) is fixed to the distal connecting member (connector 23 of Koike), the distal elastic member (packing 141 of Koike) is pressed by the distal connecting member (connector 23) and abuts the driving tube along the first direction to lock the driving tube and the anchoring body (Examiner’s note: as stated in the rejection for claim 3, and in col. 3 lines 50 – 65 of Koike, the packing 141 is pressed into the connector 3, thereby forcing the packing 141 into channel; and because the packing 141 is forced in to the channel, the packing 141 is configured to lock the driving tube); and
wherein when the distal fixing portion (threads of bolt-like member 143 of Koike) is released from the distal connecting member (connector 23 of Koike), the distal elastic member (packing 141 of Koike) detaches from the distal connecting member (connector 23 of Koike) to release the driving tube and the anchoring body during a rebound process (Examiner’s note: Koike teaches only that the bolt-like member 143 fixes the packing 141 (i.e., the distal locking portion) to the connector 23 (i.e., the distal connecting member), therefore, the packing 141 (i.e., the distal locking portion) is capable of and configured to detach from the connector 23 (i.e., the distal connecting member) as claimed).
Regarding claim 7, as discussed above, it would have been obvious to modify the needle and driving tube of Hayhurst to incorporate a distal locking structure based on the teachings of Koike, Igaki, and Zhu. The combination further teaches:
wherein the distal elastic member (packing 141 of Koike) is a distal elastic sleeve (Examiner’s note: the packing 141 forms a sleeve as it radially surrounds the channel);
the distal elastic sleeve is provided with a penetration hole (through-hole) for the driving tube to pass through (Fig. 4 and annotated Fig. 4 of Koike); and
when the distal elastic sleeve (packing 141 of Koike) is pressed by the distal connecting member (connector 23 of Koike), a hole wall (inner diameter wall) of the penetration hole abuts the driving tube to lock the driving tube and the anchoring body (col. 3 lines 50 – 65 of Koike), and after the distal elastic sleeve (packing 141 of Koike) is detached from the distal connecting member (connector 23 of Koike), the hole wall of the penetration hole rebounds to release the driving tube and the anchoring body (Examiner’s note: as stated in col. 3 line 50 – col. 4 line 17 of Koike the packing 141 is made out of an elastic compressible material that when compressed extends into the channel, and when uncompressed would return to its un-restricted state, thereby ‘rebounding’ to release any structures that were previously frictionally engaged).
Regarding claim 8, as discussed above, it would have been obvious to modify the needle and driving tube of Hayhurst to incorporate a distal locking structure based on the teachings of Koike, Igaki, and Zhu. The combination further teaches wherein the distal fixing portion (bolt-like member 143 with internal threads) is a distal locking nut (bolt-like member 143 with internal threads), and the distal locking nut is threadedly connected to the distal connecting member (connector 23 of Koike) (col. 3 lines 50 – 65, Fig. 4, and annotated Fig. 4 of Koike).
Claims 3 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hayhurst et al (US 5,041,129) as applied to claim 1 above, and further in view of Zhu et al (US 2005/0107826 A1).
Regarding claim 3, as discussed above, Hayhurst discloses the anchor, driver, and the needle of claim 1.
However, Hayhurst is silent regarding (i) a distal locking structure, configured to be fixed to a proximal end of the puncture needle, wherein a first receiving channel is formed in the distal locking structure, the first receiving channel communicates with a needle channel of the puncture needle, and the distal locking structure is configured to selectively cooperate with the driving tube to lock the driving tube and the anchoring body in the first receiving channel.
As to the above, Zhu teaches, in a similar field of endeavor reasonably pertinent to a problem with which Applicant is attempting to solve, namely, a distal locking structure (handle 514, threaded proximal end 504, threaded locking cap 546, and locking members 544; and designated in annotated Fig. 42A) fixed on the proximal end of an outer insertable medical device (delivery tube 490; which is equated to the outer needle 30 of Hayhurst) in order to restrict movement between a driving tube (pusher member 500; which equates to the pusher tube 32 of Hayhurst) and the outer, insertable, outer medical device (delivery tube 490) (paragraphs [0185], [0189], [0195 – 0198], and Figs. 42 – 46), wherein the distal locking structure is configured to selectively cooperate with the driving tube (pusher member 500) to lock the driving tube (pusher member 500) in the first receiving channel (paragraphs [0195 – 0197]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the outer needle 30 and pusher tube 32 of Hayhurst to incorporate a distal locking structure, based on the teachings of Zhu, for the purpose of giving the operator something to hold onto while using the needle and for the purpose of allowing the operator to selectively lock the pusher tube relative to the outer needle so that the any unintended relative movement is prevented, thereby decreasing the chances that the anchor will be prematurely delivered.
It should be understood that with the modification above, the system encompasses wherein a part of the driving tube (proximal portion of the pusher tube 32 of Hayhurst) and the anchoring body (anchor 10 of Hayhurst) are located in the first receiving channel (channel shown in annotated Fig. 42A of Zhu) when pushed therethrough, and the anchoring body (anchor 10 of Hayhurst) is configured to enter the needle channel of the puncture needle through the first receiving channel under the drive of the driving tube (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the anchor 10 is capable of entering the channel of the outer needle 30 of Hayhurst via the ‘first receiving channel’ via the drive of the pusher tube 32 of Hayhurst). Therefore, the combination encompasses or makes obvious the limitations above.
Annotated Figure 42A of Zhu
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Regarding claim 4, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a distal locking structure as taught by Zhu. Additionally, Zhu further teaches wherein the distal locking structure comprises:
a distal connecting member (handle 514; designated in annotated Fig. 42A of Zhu), configured to be fixed to the proximal end of the puncture needle and to form at least a portion of the first receiving channel for the driving tube and the anchoring body to pass through (Fig. 42A of Zhu); and
a distal locking member (locking cap 546; designated in annotated Fig. 42A of Zhu), disposed on the distal connecting member (Fig. 42A of Zhu) and configured to selectively cooperate with the driving tube (pusher member 500; which equates to the pusher tube 32 of Hayhurst) to lock or release the driving tube and the anchoring body on the distal connecting member (paragraphs [0195 – 0197] of Zhu).
Regarding claim 5, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a distal locking structure as taught by Zhu. Additionally, Zhu further teaches wherein the distal locking member (locking cap 546; designated in annotated Fig. 42A of Zhu) comprises:
a distal fixing portion (internal threaded portion of locking cap 546 of Zhu; designated in annotated Fig. 42A of Zhu), wherein the distal fixing portion is provided with the first receiving channel (see annotated Fig. 42A of Zhu), and is selectively fixed to or released from the distal connecting member (paragraphs [0195 – 0197] of Zhu); and
a distal locking portion (locking members 544 of Zhu; designated in annotated Fig. 42A of Zhu), wherein the distal locking portion is located inside the distal fixing portion (see annotated Fig. 42A of Zhu),
wherein when the distal fixing portion (internal threaded portion of locking cap 546 of Zhu) is fixed to the distal connecting member (handle 514 of Zhu) (Fig. 42A of Zhu), the distal locking portion (locking members 544 of Zhu) is configured to cooperate with the distal connecting member (handle 514 of Zhu) and act on the driving tube to lock the driving tube (pusher member 500; which equates to the pusher tube 32 of Hayhurst) and the anchoring body (paragraphs [0195 – 0197] of Zhu); and
wherein when the distal fixing portion (internal threaded portion of locking cap 546 of Zhu) is released from the distal connecting member (handle 514 of Zhu), the distal locking portion is configured to detach from the distal connecting member to release the driving tube and the anchoring body (Examiner’s note: Zhu teaches that the locking cap 546 is only frictionally fixes the locking members 544 (i.e., the distal locking portion) to the handle 514 (i.e., the distal connecting member), therefore, the locking members 544 (i.e., the distal locking portion) are capable of and configured to detach from the handle 514 (i.e., the distal connecting member) when no longer pressed against the handle 514 via the locking cap 546).
Regarding claim 6, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a distal locking structure as taught by Zhu. Additionally, Zhu further teaches wherein:
the distal locking portion (locking members 544 of Zhu) is a distal elastic member (paragraph [0200] of Zhu) embedded in the distal fixing portion (see Fig. 42A and annotated Fig. 42A of Zhu), and the distal elastic member is elastic at least along a first direction (laterally – perpendicular to the longitudinal axis) and intersecting with an extension direction of the driving tube (pusher member 530 of Zhu; which equates to the pusher tube 32 of Hayhurst) (paragraph [0196] of Zhu);
wherein when the distal fixing portion (internal threaded portion of locking cap 546 of Zhu) is fixed to the distal connecting member (handle 514 of Zhu) (fixed via threaded connection – see Fig. 42A of Zhu), the distal elastic member (locking members 544 of Zhu) is pressed by the distal connecting member (handle 514 of Zhu) and abuts the driving tube (pusher member 530 of Zhu; which equates to the pusher tube 32 of Hayhurst) along the first direction to lock the driving tube and the anchoring body (paragraphs [0195 – 0197] of Zhu); and
wherein when the distal fixing portion (internal threaded portion of locking cap 546 of Zhu) is released from the distal connecting member (handle 514 of Zhu), the distal elastic member (locking members 544 of Zhu) detaches from the distal connecting member to release the driving tube and the anchoring body during a rebound process (paragraphs [0195 – 0197] of Zhu).
Annotated Figure 42A of Zhu
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Regarding claim 7, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a distal locking structure as taught by Zhu. Additionally, Zhu further teaches wherein:
the distal elastic member (locking members 544 of Zhu) is a distal elastic sleeve (paragraph [0200] of Zhu) (Examiner’s note: locking members 544 of Zhu are elastic, and form sleeves as they radially extend around pusher member 500);
the distal elastic sleeve is provided with a penetration hole (through-hole) for the driving tube to pass through (Fig. 42A of Zhu); and
when the distal elastic sleeve (locking members 544 of Zhu) is pressed by the distal connecting member (handle 514 of Zhu), a hole wall (interior wall of the through-hole) of the penetration hole abuts the driving tube (pusher tube 500 of Zhu; which equates to the pusher tube 32 of Hayhurst) to lock the driving tube and the anchoring body (paragraphs [0195 – 0197]), and after the distal elastic sleeve (locking members 544 of Zhu) is detached from the distal connecting member (handle 514 of Zhu), the hole wall of the penetration hole rebounds to release the driving tube and the anchoring body (Examiner’s note: as stated in paragraphs [0195 – 0197] and [0200] the locking members 544 of Zhu is made out of an elastic compressible material that when compressed extends into the channel, and when uncompressed would return to its un-restricted state, thereby ‘rebounding’ to release any structures that were previously frictionally engaged).
Regarding claim 8, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a distal locking structure as taught by Zhu. Additionally, Zhu further teaches wherein the distal fixing portion (internal threaded portion of locking cap 546 of Zhu) is a distal locking nut (internal threaded portion of locking cap 546 of Zhu), and the distal locking nut is threadedly connected to the distal connecting member (handle 514 of Zhu) (Fig. 42A and annotated Fig. 42A of Zhu).
Regarding claim 9, as discussed above, Hayhurst discloses the anchor, driver, and the needle of claim 1.
However, Hayhurst is silent regarding (i) a proximal locking structure, wherein the proximal locking structure is arranged at a proximal end of the driving tube and is fixedly connected to the driving tube, a second receiving channel is formed in the proximal locking structure, and the proximal locking structure is configured to selectively cooperate with the traction line to lock the traction line on the driving tube.
As to the above, Zhu teaches, in a similar field of endeavor reasonably pertinent to a problem with which Applicant is attempting to solve, namely, a proximal locking structure (coupling member 552, threaded proximal end 532, and locking member 550; and designated in annotated Fig. 42B) fixed on the proximal end of an intermediate tubular, driving tube (pusher member 500 and designated in annotated Fig. 42B; which equates to the pusher tube 32 of Hayhurst) in order to restrict movement between the driving tube (pusher member 500; which equates to the pusher tube 32 of Hayhurst) and an inner member (catheter 432; which equates to the traction line, suture 20 of Hayhurst) (paragraphs [0185], [0189], [0195 – 0198], and Figs. 42 – 46), a second receiving channel is formed in the proximal locking structure (see annotated Fig. 42B), the proximal locking structure (coupling member 552, threaded proximal end 532, and locking member 550) is configured to selectively cooperate with the traction line (catheter 432; which equates to the traction line, suture 20 of Hayhurst) to lock the traction line on the driving tube (pusher member 500; which equates to the pusher tube 32 of Hayhurst) (paragraphs [0201 – 0204] and Fig. 42B).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the pusher tube 32 and the suture 20 of Hayhurst to incorporate a proximal locking structure, based on the teachings of Zhu, for the purpose of giving the operator something to hold onto while using the operating the pusher tube and suture to deploy the anchor and for the purpose of allowing the operator to selectively lock the suture 20 relative to the pusher tube 32 so that the any unintended relative movement is prevented, thereby decreasing the chances that the anchor will be prematurely delivered.
It should be understood that with the modification above, the system encompasses wherein the traction line (suture 20 of Hayhurst) is passed through the second receiving channel (channel shown in annotated Fig. 42A of Zhu). Therefore, the combination encompasses or makes obvious the limitations above.
Annotated Figure 42B of Zhu
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Regarding claim 10, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a proximal locking structure as taught by Zhu. Additionally, Zhu further teaches wherein the proximal locking structure comprises:
a proximal connecting member (external threaded portion of the pusher tube 500 of Zhu; designated in annotated Fig. 42B), fixed to the proximal end of the driving tube, and forming at least a portion of the second receiving channel for the traction line to pass through (Fig. 42B and annotated Fig. 42B of Zhu); and
a proximal locking member (coupling member 552 of Zhu; designated in annotated Fig. 42B), arranged on the proximal connecting member (Fig. 42B of Zhu), and configured to selectively cooperate with the traction line (catheter 432 of Zhu; which equates to the suture 20 of Hayhurst) to lock or release the traction line on the proximal connecting member (paragraph [0201]).
Regarding claim 11, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a proximal locking structure as taught by Zhu. Additionally, Zhu further teaches wherein the proximal locking member comprises:
a proximal fixing portion (internal portion of the coupling member 552 of Zhu; designated in annotated Fig. 42B), wherein the proximal fixing portion is provided with the second receiving channel and selectively fixed to or released from the proximal connecting member (paragraph [0201] and annotated Fig. 42B); and
a proximal locking portion (stop member 550 of Zhu; and designated in annotated Fig. 42B), wherein the proximal locking portion is located inside the proximal fixing portion (Fig. 42B and annotated Fig. 42B of Zhu),
wherein when the proximal fixing portion (internal portion of the coupling member 552 of Zhu) is fixed to the proximal connecting member (fixed via threaded connection), the proximal locking portion is configured to cooperate with the proximal connecting member and act on the traction line to lock the traction line (paragraph [0201] and annotated Fig. 42B of Zhu); and
wherein when the proximal fixing portion (internal portion of the coupling member 552 of Zhu) is detached from the proximal connecting member (external threads of pusher member 500), the proximal locking portion is configured to detach from the proximal connecting member to release the traction line (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior be capable of functioning in the manner claimed. With that said, the stop member 550 is capable of being detached from the external threads of the pusher in order to release the catheter 432).
Regarding claim 12, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a proximal locking structure as taught by Zhu. Additionally, Zhu further teaches or, at least, makes obvious wherein:
the proximal locking portion (stop member 550 of Zhu) is embedded in the proximal fixing portion (see annotated Fig. 42B), and the proximal elastic member is an elastic member and elastic at least along a first direction (laterally – perpendicular to the longitudinal axis) which intersects with an extension direction of the traction line (Examiner’s note: although Zhu is silent regarding the stop member 550 being an elastic member that is elastic along the first direction; Zhu, teaches, in paragraph [0196], a similar locking portion (locking members 544) for restricting movement between two coaxial members, wherein the locking members 544 are elastic and compress along the first direction, and it would have been obvious to one of ordinary skill in the art to have substituted one locking annular portion for another, and the results of the substitution would have been predictable and resulted in the modified proximal locking portion being able to restrict movement between the pusher tube 500 (i.e., the driving tube) and the catheter 432 (i.e., the traction line) as intended);
wherein when the proximal fixing portion is fixed to the proximal connecting member (see annotated Fig. 42B) (Examiner’s note: the elements are fixed via the threaded connection) the proximal elastic member (the locking members 544 of Zhu) is pressed by the proximal connecting member (external threaded portion of pusher member 500 of Zhu which equates to the pusher tube 32 of Hayhurst) and abuts the traction line (catheter 432 of Zhu which equates to the suture 20 of Hayhurst) along the first direction to lock the traction line (paragraph [0196] and [0201] of Zhu); and
wherein when the proximal fixing portion is released from the proximal connecting member, the proximal elastic member detaches from the proximal connecting member to release the traction line during a rebound process (Examiner’s note: as stated in paragraphs [0195 – 0197] and [0200] the locking members 544 of Zhu is made out of an elastic compressible material that when compressed extends into the channel, and when uncompressed would return to its un-restricted state, thereby ‘rebounding’ to release any structures that were previously frictionally engaged).
Annotated Figure 42B of Zhu
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Regarding claim 13, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a proximal locking structure as taught by Zhu. Additionally, Zhu further teaches:
the proximal elastic member (locking members 544 of Zhu) is a proximal elastic sleeve (paragraph [0200] of Zhu) (Examiner’s note: locking members 544 of Zhu are elastic, and form sleeves as they radially extend around pusher member 500);
the proximal elastic sleeve is provided with a penetration hole (through-hole) for the driving tube to pass through (Fig. 42A of Zhu); and
when the proximal elastic sleeve (locking members 544 of Zhu) is pressed by the proximal connecting member (external threaded portion of pusher member 500 of Zhu), a hole wall (interior wall of the through-hole) of the penetration hole abuts the traction line (catheter 432 of Zhu; which equates to the suture 20 of Hayhurst) to lock the driving tube (paragraphs [0196] and [0201]), and after the proximal elastic sleeve (locking members 544 of Zhu) is detached from the proximal connecting member (external threaded portion of pusher member 500 of Zhu), the hole wall of the penetration hole rebounds to release the driving tube and the anchoring body (Examiner’s note: as stated in paragraphs [0195 – 0197] and [0200] the locking members 544 of Zhu is made out of an elastic compressible material that when compressed extends into the channel, and when uncompressed would return to its un-restricted state, thereby ‘rebounding’ to release any structures that were previously frictionally engaged).
Regarding claim 14, as discussed above, it would have been obvious to modify the device of Hayhurst to incorporate a proximal locking structure as taught by Zhu. Additionally, Zhu further teaches wherein the proximal fixing portion (internal portion of the coupling member 552 of Zhu) is a proximal locking nut, and the proximal locking nut is threadedly connected to the proximal connecting member (Fig. 42B and annotated Fig. 42B of Zhu).
Claims 15 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hayhurst et al (US 5,041,129) as applied to claim 1 above, and further in view of Zhu et al (US 2005/0107826 A1) and Griffin et al (US 2008/0262506 A1).
Regarding claim 15, as discussed above, Hayhurst discloses the anchor, driver, and the needle of claim 1.
However, Hayhurst is silent regarding (i) a handle for the needle and the driving tube.
As to (i), Zhu teaches, in a similar field of endeavor reasonably pertinent to a problem with which Applicant is attempting to solve, namely, needle handle / a distal (handle 514, threaded proximal end 504, threaded locking cap 546, and locking members 544; and designated in annotated Fig. 42A) fixed on the proximal end of an outer insertable medical device (delivery tube 490; which is equated to the outer needle 30 of Hayhurst) in order to restrict movement between a driving tube (pusher member 500; which equates to the pusher tube 32 of Hayhurst) and the outer, insertable, outer medical device (delivery tube 490) (paragraphs [0185], [0189], [0195 – 0198], and Figs. 42 – 46), wherein the distal locking structure is configured to selectively cooperate with the driving tube (pusher member 500) to lock the driving tube (pusher member 500) in the first receiving channel (paragraphs [0195 – 0197]). Additionally, Zhu teaches a handle for the driving tube / a proximal locking structure (coupling member 552, threaded proximal end 532, and locking member 550; and designated in annotated Fig. 42B) fixed on the proximal end of the driving tube (pusher member 500 and designated in annotated Fig. 42B; which equates to the pusher tube 32 of Hayhurst) in order to restrict movement between the driving tube (pusher member 500; which equates to the pusher tube 32 of Hayhurst) and an inner member (catheter 432; which equates to the traction line, suture 20 of Hayhurst) (paragraphs [0185], [0189], [0195 – 0198], and Figs. 42 – 46), a second receiving channel is formed in the proximal locking structure (see annotated Fig. 42B), the proximal locking structure (coupling member 552, threaded proximal end 532, and locking member 550) is configured to selectively cooperate with the traction line (catheter 432; which equates to the traction line, suture 20 of Hayhurst) to lock the traction line on the driving tube (pusher member 500; which equates to the pusher tube 32 of Hayhurst) (paragraphs [0201 – 0204] and Fig. 42B).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the outer needle 30 and pusher tube 32 of Hayhurst to incorporate a distal locking structure and a proximal locking structure, respectively, based on the teachings of Zhu, for the purpose of giving the operator something to hold onto while operating each of the outer and inner members, for the purpose of allowing the operator to selectively lock the pusher tube relative to the outer needle, and for the purpose allowing the operator to selectively lock the suture 20 relative to the pusher tube 32 so that the any unintended relative movement is prevented, thereby decreasing the chances that the anchor will be prematurely delivered so that the any unintended relative movement between any of the outer needle, pusher tube, and the suture is prevented, thereby decreasing the chances that the anchor will be prematurely delivered.
Annotated Figures 42A and 42B of Zhu
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However, the combination of Hayhurst and Zhu is silent regarding (ii) a stopper, selectively arranged between the driving tube and the puncture needle, and (iii) wherein when the anchoring body is located in the puncture needle and has a preset distance from the distal end of the puncture needle, the stopper cooperates with the driving tube and the puncture needle respectively to limit a movement of the driving tube in the puncture needle, and wherein during a movement of the anchoring body from a first position to the distal end of the puncture needle, the stopper is detached from a position between the driving tube and the puncture needle, wherein the first position is a position of the anchoring body when having the preset distance from the distal end of the puncture needle.
As to (ii), Griffin teaches a medical implant delivery system / catheter comprising a stopper (releasable clamping clip 24) disposed between a proximal and distal handle for the purpose of holding the proximal and distal handles in a fixed relative position during the introduction of the catheter (which equates to the outer needle of Hayhurst) (abstract, paragraphs [0171] and [0184], and Fig. 2a).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Hayhurst in view of Zhu to incorporate a stopper arranged between the distal locking structure (i.e., the needle) and the proximal locking structure (i.e., the driving tube), based on the teachings of Griffin for purpose of holding the two distal and proximal locking structures fixed relative to each other during the introduction of the needle (paragraph [0171] – Griffin). With respect to (iii) the combination encompasses or, in the alternative, makes obvious wherein when the anchoring body is located in the puncture needle and has a preset distance from the distal end of the puncture needle, the stopper cooperates with the driving tube and the puncture needle respectively to limit a movement of the driving tube in the puncture needle (Examiner’s note: as stated by Griffin, the stopper 24 is used for preventing the relative movement of the distal and proximal handles; therefore, the modification encompasses wherein the stoper 24 prevents the relative movement of the proximal and distal locking structures such that the relative movement of the driving tube and the needle is limited. Additionally, the position of the anchor body is set before the introduction of the anchor into the body), and wherein during a movement of the anchoring body from a first position to the distal end of the puncture needle, the stopper is detached from a position between the driving tube and the puncture needle, wherein the first position is a position of the anchoring body when having the preset distance from the distal end of the puncture needle (Examiner’s note: the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed; with that said, because the stopper 24 prevents the distal movement of the pusher tube within the outer needle and is removeable, the prior art is capable of functioning in the manner claimed).
Regarding claim 16, as discussed above, it would have been obvious to modify the system of Hayhurst to incorporate the proximal and distal locking structures, as taught by Zhu, and the stopper, as taught by Griffin. Additionally, the combination teaches:
wherein the stopper (stopper 24 of Griffin) is arranged between a proximal locking structure (designated in annotated Fig. 42B of Zhu) and a distal locking structure (designated in annotated Fig. 42A of Zhu) of the anchor and selectively protrudes from a side wall of the driving tube (Examiner’s note: the prior art makes obvious wherein the stopper is placed on one of the proximal locking structure and the driving tube and the distal locking structure in order for the stopper to be able to restrict the relative movement of the driving tube and the distal locking structure);
at least when the anchoring body is located in the puncture needle and has the preset distance from the distal end of the puncture needle, the stopper protrudes from the side wall of the driving tube so that a proximal end of the driving tube is blocked by the stopper on a proximal end of the puncture needle (Examiner’s note: when the anchor is at the preset distance, the stopper is capable of being on the system, thereby protruding from the wall of the driving tube and blocking the proximal end / proximal locking structure of the driving tube from moving relative / on a proximal end of the needle); and
during the movement of the anchoring body from the first position to the distal end of the puncture needle, the stopper is detached from the side wall of the driving tube (Examiner’s note: in order for the anchor to be moved distally the stopper has to be removed). Therefore, the prior art combination teaches the device as claimed.
Regarding claim 17, as discussed above, it would have been obvious to modify the system of Hayhurst to incorporate the proximal and distal locking structures, as taught by Zhu, and the stopper, as taught by Griffin. Additionally, the combination teaches:
wherein the stopper (stopper 24 of Griffin) is detachably arranged on the driving tube (Examiner’s note: the prior art makes obvious wherein the stopper is placed on one of the proximal locking structure and the driving tube and the distal locking structure in order for the stopper to be able to restrict the relative movement of the driving tube and the distal locking structure; additionally, as stated in paragraph [0171] of Griffin the stopper 24 is removably attached); and
when the anchoring body moves from the first position toward the distal end of the puncture needle, the stopper is configured to be detached from the driving tube(Examiner’s note: in order for the anchor to be moved distally the stopper has to be removed). Therefore, the prior art combination teaches the device as claimed.
Regarding claim 18, as discussed above, it would have been obvious to modify the system of Hayhurst to incorporate the proximal and distal locking structures, as taught by Zhu, and the stopper, as taught by Griffin. Additionally, the combination teaches
wherein the stopper (stopper 24 of Griffin) is arranged at one end of the proximal locking structure of the anchor toward the distal locking structure (Examiner’s note: the prior art makes obvious wherein the stopper is placed on one of the proximal locking structures and the driving tube and the distal locking structure in order for the stopper to be able to restrict the relative movement of the driving tube and the distal locking structure); and
the preset distance is 0, and a length of the stopper is equal to a maximum length of the anchoring body extending out of the distal end of the puncture needle (Examiner’s note: the distance pre-set is any distance set prior to any moment in time; therefore, the distance prior to expulsion of the anchor from the distal end of the needle is the preset distance and it is zero. Additionally, it would be obvious for the maximum length of the stopper to equal the maximum length of the anchor body extending out of the distal end of the puncture needle, for the purpose of presetting the anchor at the required deployment distance they by preventing the over insertion of the anchoring body into the vasculature).
Related Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Heaton et al (US 5,879,357) discloses an anchor device comprising a traction line, a driving tube, an anchor, a needle, a distal locking structure, and a proximal locking structure.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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