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's arguments filed 12/03/2025 regarding the rejection of Claims 1 and 14 have been fully considered but they are not persuasive.
Regarding Claim(s) 1 and 14, Applicant contends that the combination of O’Malley (US 2003/0092969 A1) and Wilke (US 2006/0058842 A1) do not expressly or adequately disclose the limitations of “a first fixing device fixed to a target lesion and having a first joining part and a first auxiliary fixing portion” and “a cord-receiving device connected to the first joining part of the first fixing device” on the grounds that neither “wings 80” nor any other component of the “first fixing device” of O’Malley are configured to connect to any other device or component and thus O’Malley does not disclose a “first joining part” that is configured to connect to a “cord receiving device”, as incorporated from the teachings of Wilke.
The Examiner respectfully disagrees with Applicant’s interpretation of the disclosure of O’Malley in combatting the proposed combination. While O’Malley does not expressly disclose a “cord receiving device” (incorporated from the teachings of Wilke), there is no evidence within the disclosure of O’Malley that the “first fixing device”, and accompanying “first joining part” are unfit for connecting to the cord receiving device of Wilke. While O’Malley discloses wherein tension applied to the efac wire may be adjusted to either stretch or close a wound (see Para. [0021]-[0023] and [0092]), O’Malley does not provide an express recitation of a mechanism (aside from “pulling” the efac) that performs said adjustment of tension within the efac wire. Wilke, within the same field of endeavor of wound closure devices comprising a plurality of anchors and attached suture, teaches a “cord receiving device” (i.e., tensioning apparatus 40) that is connectable to a plurality of anchors positioned around a wound site (see Fig. 1) which is used to apply or adjust the amount of tension within the suture threat (see Wilke Para. [0056]). The Examiner contends that one of ordinary skill in the art would have been able to make the proposed combination of attaching the tensioning apparatus of Wilke to the “first fixing device” to incorporate the benefit of providing a known tensioning mechanism to perform tension adjustments on the efac wire of O’Malley. Since the tensioning apparatus would be attached to the “first fixing device”, all components of said “first fixing device” would be connected to the tensioning apparatus by the structure of said first fixing device. Therefore, even though O’Malley does not expressly disclose wherein the “First fixing device” is configured to connect to another component, one of ordinary skill in the art would have been able to include the tensioning apparatus of Wilke into the device of O’Malley to obtain the beneficial tensioning mechanism disclosed by Wilke, connected to the structure of the “first fixing device” and all components thereof.
Additionally, Applicant contends that the “cord-receiving device” of Wilke (i.e., tensioning apparatus 40), while secured to the skin adjacent to a wound, is not disclosed to be connected to the “skin anchors 20” of Wilke. In such a configuration, Applicant contends that adjusting the exposed length of the suture via the “cord receiving device” of Wilke, the cord receiving device would pull the skin adjacent the wound, causing discomfort to the patient or even hurting the wound.
The Examiner respectfully disagrees with Applicant’s interpretation that Wilke does not disclose that the tensioning apparatus is connected to the skin anchors. As shown in Wilke Fig. 1 below, the suture (30) passes through grooves within the structures of the anchors (20) and into the tensioning apparatus (40). Para. [0056] of Wilke further describes wherein the tensioning apparatus is configured to apply tension to the suture to draw the anchors inwardly toward one another and over the wound. The Examiner therefore contends that the tensioning apparatus is connected to all of the anchors within the system via the suture that passes through both the anchors and the tensioning mechanism, wherein actuation of the tensioning mechanism causes direct movement of the anchors toward one-another. Pertaining to the contention that the tensioning system of Wilke would cause “discomfort” or hurt the wound, the Examiner cannot find any support for the alleged interpretation within the disclosure of Wilke. In closing a wound, tension must be applied along the length of suture such that the anchors are moved toward one-another in order to close said wound. Any alleged discomfort would be an inherent effect of the wound closure systems of Wilke and O’Malley but do not result in a functional flaw of the device.
Lastly, Applicant contends that the “cord receiving device” of Wilke is secured to the skin of a patient, in contrast to the claimed invention in which the cord receiving device is connected to the first joining part of the first fixing device but “not directly secured on the skin adjacent a wound”, providing a benefit of preventing the cord receiving device from pulling the skin adjacent the wound. In response to Applicant’s argument pertaining to a difference in attachment between the prior art and the claimed invention, it is noted that the features upon which applicant relies (i.e., the lack of attachment between the cord receiving device and a skin surface adjacent a wound) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Drawings
Applicant’s arguments, see “Remarks”, filed 12/3/2025, with respect to the objection to the drawings for failing to show the claimed “resilient mountings” recited in Claims 8 and 17 have been fully considered and are persuasive in light of Applicant’s amendment to cancel Claims 8 and 17. The objection of the drawings for failing to show the claimed “resilient mountings” has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 12/3/2025, with respect to the objection to the drawings for failing to show the claimed “second fixing device” have been fully considered and are persuasive in light of Applicant’s clarification to cite the “second fixing device” as element(s) 140, 150, 160, 170 and 180 within the disclosed drawings. The objection of the drawings for failing to show the claimed “second fixing device” has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 12/3/2025, with respect to the objection to the drawings for failing to show the limitations of “wherein the first cord-receiving portion has a first engaging portion, and the second cord-receiving portion has a second engaging portion” have been fully considered and are persuasive in light of Applicant’s clarification within the included “Enlarged View of Fig. 5” which shows the claimed limitations. The objection of the drawings for failing to show “wherein the first cord-receiving portion has a first engaging portion, and the second cord-receiving portion has a second engaging portion” has been withdrawn
Claim Objections
Applicant’s arguments, see “Remarks”, filed 12/3/2025, with respect to the objection to Claim 3 for reciting “wherein the cord-receiving mechanism is the second cord-receiving portion's being pivotally rotatable relative to the first cord-receiving portion while being connected to the first cord-receiving portion” which was unclear as to what the phrase “wherein the cord-receiving mechanism is the second cord-receiving portion's being pivotally rotatable” was in reference to have been fully considered and are persuasive in light of Applicant’s amendments to now recite “wherein the second cord receiving portion is pivotally rotatable relative to the first cord-receiving portion while being connected to the first cord-receiving portion” which more clearly designates the “second cord receiving portion” as the structure rotatable relative to the first cord receiving portion. The objection of Claim 3 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 12/3/2025, with respect to the objection to Claim 9 for reciting “an warning signal” which included a grammatical error have been fully considered and are persuasive in light of Applicant’s amendments to now recite “a warning signal” which is in better grammatical form. The objection of Claim 9 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 12/3/2025, with respect to the objection to Claim 11 for reciting “an warning signal” which included a grammatical error have been fully considered and are persuasive in light of Applicant’s amendments to now recite “a warning signal” which is in better grammatical form. The objection of Claim 11 has been withdrawn.
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.
Claim(s) 1-2 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Malley (US 2003/0092969 A1)(previously of record) in view of Wilke (US 2006/0058842 A1)(previously of record).
Regarding claim 1, O’Malley discloses:
A medical fixing system (see Fig. 6), comprising:
a first fixing device (see Examiner’s Diagram of Fig. 6 below denoting “a first fixing device”) fixed to a target lesion (see Fig. 6 showing wherein the “first fixing device” is fixed to a target location at a wound site; see also Para. [0015] and [0020]) and having a first joining part (portion of the “first fixing device” disposed radially-outward from wings 80, see Fig. 6) and a first auxiliary fixing portion (see Examiner’s Diagram of Fig. 6 below denoting a “first auxiliary fixing portion” as the hook (62) which the suture passes through on the radially-inward side of the “first fixing device”);
a second fixing device (see Examiner’s Diagram of Fig. 6 below denoting “a second fixing device”) fixed to the target lesion (see Fig. 6) and having a second auxiliary fixing portion (see Examiner’s Diagram of Fig. 6 below denoting a “second auxiliary fixing portion” as the hook (62) which the suture passes through on the radially-inward side of the “second fixing device”);
a fixing cord (efac 40, see Fig. 6) in contact with the first auxiliary fixing portion (see Fig. 6 showing wherein the efac passes through the “first auxiliary portion”, see also Para. [0060]) and the second auxiliary fixing portion (see Fig. 6 showing wherein the efac passes through the “second auxiliary portion”, see also Para. [0060]);
However, while O’Malley discloses wherein tension applied to the efac may be adjusted to either stretch of close a wound (see Para. [0021]-[0023] and [0092]), O’Malley does not expressly disclose:
a cord-receiving device connected to the first joining part of the first fixing device;
wherein the fixing cord is connected to the cord-receiving device; and
wherein the cord-receiving device has a cord-receiving mechanism and adjusts an exposed length of the fixing cord with the cord-receiving mechanism.
In the same field of endeavor, namely wound closure devices comprising a plurality of tissue-affixing portions joined together by a suture thread, Wilke teaches wherein a cord-receiving device (tensioning apparatus 40, see Fig. 1) is provided within the wound closure system (see Fig. 1), attached at the “start” of a tension thread (30, see Fig. 1) received therein and configured to apply tension to the line, drawing the anchors, and thus the skin, inwardly towards each other and thus over the wound (see Para. [0056]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of O’Malley to include a tensioning device attached to the “first fixing member” of O’Malley, designated as the “starting point” for the efac (see Fig. 6), as taught and suggested by Wilke to, in this case, provide a known means within the art of applying varying tension to the efac to manipulate the opening/closing of the target wound site (see Wilke Para. [0056]).
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Examiner’s Diagram of Fig. 6
Regarding claim 2, the combination of O’Malley and Wilke disclose the invention of claim 1, O’Malley further discloses wherein the first fixing device has a first adhesive side and is fixed to the target lesion through the first adhesive side (see Para. [0065]-[0068]), and the second fixing device has a second adhesive side and is fixed to the target lesion through the second adhesive side (see Para. [0065]-[0068]).
Regarding claim 13, the combination of O’Malley and Wilke disclose the invention of claim 1, O’Malley further discloses wherein the fixing cord is one selected from medical sutures, elastic bands or wires (see Para. [0092] mentioning wherein the efac is a silicone elastomer).
Regarding claim 14, O’Malley discloses:
A medical fixing system (see Fig. 6), capable of adjusting an exposed length of a fixing cord (efac 40, see Fig. 6) at a target lesion (see Para. [0021]-[0023] and [0092]), the medical fixing system comprising:
a first fixing device (see Examiner’s Diagram of Fig. 6 below denoting “a first fixing device”) fixed to the target lesion (see Fig. 6 showing wherein the “first fixing device” is fixed to a target location at a wound site; see also Para. [0015] and [0020]) and having a first joining part (portion of the “first fixing device” disposed radially-outward from wings 80, see Fig. 6) and a first auxiliary fixing portion (see Examiner’s Diagram of Fig. 6 below denoting a “first auxiliary fixing portion” as the hook (62) which the suture passes through on the radially-inward side of the “first fixing device”);
a second fixing device (see Examiner’s Diagram of Fig. 6 below denoting “a second fixing device”) fixed to the target lesion (see Fig. 6) and having a second auxiliary fixing portion (see Examiner’s Diagram of Fig. 6 below denoting a “second auxiliary fixing portion” as the hook (62) which the suture passes through on the radially-inward side of the “second fixing device”); and
wherein the fixing cord is in contact with the first auxiliary fixing portion and the second auxiliary fixing portion (see Fig. 6 showing wherein the efac passes through the “first auxiliary portion”, see also Para. [0060]);
wherein the fixing cord may be adjusted change/alter the exposed length of the fixing cord to not only allow the fixing cord to drive the first fixing device and the second fixing device but to also allow the first fixing device and the second fixing device to be drawn closer to or away from each other. (see Para. [0021]-[0023] and [0092]).
However, while O’Malley discloses wherein tension applied to the efac may be adjusted to bring opposing fixing portions together to either stretch of close a wound (see Para. [0021]-[0023] and [0092]), O’Malley does not expressly disclose:
a cord-receiving device connected to the first joining part of the first fixing device;
wherein the fixing cord is connected to the cord-receiving device
wherein the cord-receiving device comprises a cord-receiving mechanism that is the mechanism that adjusts the exposed length of the fixing cord with the cord-receiving mechanism to not only allow the fixing cord to drive the first fixing device and the second fixing device, but also to allow the first fixing device and the second fixing device to be drawn closer to or away from each other.
In the same field of endeavor, namely wound closure devices comprising a plurality of tissue-affixing portions joined together by a suture thread, Wilke teaches wherein a cord-receiving device (tensioning apparatus 40, see Fig. 1) is provided within the wound closure system (see Fig. 1), attached at the “start” of a tension thread (30, see Fig. 1) received therein and configured to apply tension to the line, drawing the anchors, and thus the skin, inwardly towards each other and thus over the wound (see Para. [0056]) while adjusting the amount of exposed fixing cable within the system.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of O’Malley to include a tensioning device attached to the “first fixing member” of O’Malley, designated as the “starting point” for the efac (see Fig. 6), as taught and suggested by Wilke to, in this case, provide a known means within the art of applying varying tension to the efac to manipulate the opening/closing of the target wound site (see Wilke Para. [0056]).
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Examiner’s Diagram of Fig. 6
Claim(s) 3-4, 6-7, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Malley (US 2003/0092969 A1)(previously of record) in view of Wilke (US 2006/0058842 A1)(previously of record), further in view of Elliott (US 2006/0095076 A1)(previously of record).
Regarding claim 3, the combination of O’Malley and Wilke disclose all of the limitations of the invention of claim 1, O’Malley, as modified by Wilke, further discloses:
wherein the cord-receiving device comprises:
a first cord-receiving portion (base 60 and cover 70 forming a combined “first cord-receiving portion”, see Figs. 1-2 and Para. [0075]) having a second joining part (bottom, underside portion of the snout 62, see Fig. 4); and
a second cord-receiving portion (knob 90, see Wilke Fig. 2 and Para. [0086] and [0090]), with the fixing cord being fixed to the second cord-receiving portion (see Wilke Para. [0086] and [0090] mentioning wherein the suture line is connected to the knob via the spool to rotate therewith, thereby seen to be fixed thereto), wherein the second cord-receiving portion is pivotally rotatable relative to the first cord-receiving portion while being connected to the first cord-receiving portion (see Wilke Para. [0090]).
However, while the tension apparatus of Wilke is incorporated into and connected to the “first fixing device” of O’Malley since the “starting point” of the efac is located thereon, none of either O’Malley or Wilke expressly disclose a manner in which the device would be combined and thus do not expressly disclose wherein the cord-receiving device is connected to the first joining part of the first fixing device by the second joining part.
In the same field of endeavor, namely wound closure devices comprising a retractable thread/string, Elliott teaches wherein a tension apparatus (140, see Fig. 1) attached to an opposing “second fixing device” (125, see Examiner’s Diagram of Elliott Fig. 1 below), may be attached to said system by securing the underside portion thereof to a “first fixing device” to secure the two portions together within a common system (see Para. [0025] and Fig. 2 showing wherein the tensioning device is attached via the underside thereof to a “first fixing device” 125).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have connected the tension apparatus of Wilke to the “first fixing portion” at the radially-outward portion thereof (so as not to interfere with the efac route) as taught and suggested by Elliott to provide a known means of connection between a tensioning device and a fixing device within the knowledge of the prior art.
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Examiner’s Diagram of Elliott Fig. 1
Regarding claim 4, the combination of O’Malley, Wilke and Elliott disclose the invention of claim 3, O’Malley, as modified by Wilke, further discloses wherein the exposed length of the fixing cord increases gradually when the second cord-receiving portion rotates pivotally in a first direction relative to the first cord-receiving portion (see Wilke Para. [0091] mentioning wherein counterclockwise rotation of the knob causes the line to loosen and thus be more exposed from the tensioning device), wherein the exposed length of the fixing cord decreases gradually when the second cord-receiving portion rotates pivotally in a second direction relative to the first cord-receiving portion (see Wilke Para. [0087]-[0089] mentioning wherein rotation of the knob in a clockwise manner causes a tightening of the line and causes the line to be retracting into the tensioning member).
Regarding claim 6, the combination of O’Malley, Wilke and Elliott disclose the invention of claim 3, O’Malley, as modified by Wilke, further discloses wherein the second cord-receiving portion has a third auxiliary fixing portion (snout 62, see Wilke Fig. 4), and the fixing cord is fixed to the third auxiliary fixing portion of the cord-receiving device (the line is fixed to the snout within slot(s) 66, see Wilke Para. [0086]).
Regarding claim 7, the combination of O’Malley, Wilke and Elliott disclose the invention of claim 3, O’Malley, as modified by Wilke, further discloses wherein the first cord-receiving portion has a first engaging portion (tabs 74, see Fig. 7B), and the second cord-receiving portion has a second engaging portion (tabs 97, see Fig. 6B), wherein the first engaging portion and the second engaging portion are engaged with each other when the cord-receiving device is in a first state, allowing the first cord-receiving portion to be fixed to the second cord-receiving portion (see Para. [0088] mentioning wherein when the tabs (74) are within a space between adjacent tabs (97), counterclockwise rotation of the knob is prevented while the two sets of tabs abut against one-another), wherein the first engaging portion and the second engaging portion are separated from each other when the cord-receiving device is in a second state, allowing the second cord-receiving portion to rotate pivotally relative to the first cord-receiving portion (see Para. [0091] mentioning wherein when the knob is pushed down, the two sets of tabs (74 and 97) are disengaged, allowing for a counterclockwise rotation).
Regarding claim 15, the combination of O’Malley, Wilke and Elliott disclose all of the limitations of the invention of claim 14, O’Malley, as modified by Wilke, further discloses:
wherein the cord-receiving device comprises:
a first cord-receiving portion (base 60 and cover 70 forming a combined “first cord-receiving portion”, see Figs. 1-2 and Para. [0075]) having a second joining part (bottom, underside portion of the snout 62, see Fig. 4); and
a second cord-receiving portion (knob 90, see Wilke Fig. 2 and Para. [0086] and [0090]), with the fixing cord being fixed to the second cord-receiving portion (see Wilke Para. [0086] and [0090] mentioning wherein the suture line is connected to the knob via the spool to rotate therewith, thereby seen to be fixed thereto), wherein the second cord-receiving portion is pivotally rotatable relative to the first cord-receiving portion while being connected to the first cord-receiving portion (see Wilke Para. [0090]).
However, while the tension apparatus of Wilke is incorporated into and connected to the “first fixing device” of O’Malley since the “starting point” of the efac is located thereon, none of either O’Malley or Wilke expressly disclose a manner in which the device would be combined and thus do not expressly disclose wherein the cord-receiving device is connected to the first joining part of the first fixing device by the second joining part.
In the same field of endeavor, namely wound closure devices comprising a retractable thread/string, Elliott teaches wherein a tension apparatus (140, see Fig. 1) attached to an opposing “second fixing device” (125, see Examiner’s Diagram of Elliott Fig. 1 above), may be attached to said system by securing the underside portion thereof to a “first fixing device” to secure the two portions together within a common system (see Para. [0025] and Fig. 2 showing wherein the tensioning device is attached via the underside thereof to a “first fixing device” 125).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have connected the tension apparatus of Wilke to the “first fixing portion” at the radially-outward portion thereof (so as not to interfere with the efac route) as taught and suggested by Elliott to provide a known means of connection between a tensioning device and a fixing device within the knowledge of the prior art.
Regarding claim 16, the combination of O’Malley, Wilke and Elliott disclose the invention of claim 15, O’Malley, as modified by Wilke, further discloses wherein the first cord-receiving portion has a first engaging portion (tabs 74, see Fig. 7B), and the second cord-receiving portion has a second engaging portion (tabs 97, see Fig. 6B), wherein the first engaging portion and the second engaging portion are engaged with each other when the cord-receiving device is in a first state, allowing the first cord-receiving portion to be fixed to the second cord-receiving portion (see Para. [0088] mentioning wherein when the tabs (74) are within a space between adjacent tabs (97), counterclockwise rotation of the knob is prevented while the two sets of tabs abut against one-another), wherein the first engaging portion and the second engaging portion are separated from each other when the cord-receiving device is in a second state, allowing the second cord-receiving portion to rotate pivotally relative to the first cord-receiving portion (see Para. [0091] mentioning wherein when the knob is pushed down, the two sets of tabs (74 and 97) are disengaged, allowing for a counterclockwise rotation).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Malley (US 2003/0092969 A1)(previously of record) in view of Wilke (US 2006/0058842 A1)(previously of record), further in view of Elliott (US 2006/0095076 A1)(previously of record), as applied to claim 3, further in view of Ranchod (US 2011/0040307 A1)(previously of record).
Regarding claim 5, the combination of O’Malley, Wilke and Elliott disclose all of the limitations of the invention of claim 3.
However, while the tensioning device of Wilke is incorporated into and connected to the “first fixing device” of O’Malley, forming an attachment therebetween, the combination does not expressly disclose a method for such an attachment and thus does not expressly disclose wherein the first joining part is a dovetail male socket, and the second joining part is a dovetail sockets.
In the same field of endeavor, namely surgical tissue closure devices, Ranchod teaches wherein a connection between two components within a surgical closure system may be in the form of interlocking latch/key arrangements, clips, pins, a catch, clamp detent, fastener, adhesive, magnets, dovetails or any other connective means known in the art (see Para. [0092]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the connection between the tension apparatus and the “first fixing device” of O’Malley, as modified by Wilke, to include a mating dovetail assembly as taught and suggested by Ranchod to provide a known means of attachment to join the two components together.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Malley (US 2003/0092969 A1)(previously of record) in view of Wilke (US 2006/0058842 A1)(previously of record), further in view of Pereira (US 2012/0105242 A1)(previously of record).
Regarding claim 9, the combination of O’Malley and Wilke disclose all of the limitations of the invention of claim 1.
However, none of either O’Malley of Wilke expressly disclose wherein the cord-receiving device comprises a first sensing portion and a warning signal, wherein the first sensing portion senses a tension of the fixing cord and generates a data alert when the tension is less than a first tension threshold or greater than a second tension threshold, wherein the warning signal sends a warning signal according to the data alert.
The problem to be solved by the incorporation of a sensor and accompanying warning signal is understood to be tracking tension in a cable to prevent damage when said tension falls outside of a desired or intended range (see Spec. Para. [0046]). In addressing this problem, Pereira teaches wherein a tension sensor may be incorporated into a cable system to track and measure tension applied thereto. Wherein, if the tension is said cable were to fall outside of an intended or desired range (whether above or below pre-defined thresholds), a warning alert (either audible or visual) is activated which prevents the system from being further tensioned (see Para. [0005]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the tension apparatus of Wilke, as incorporated into the device of O’Malley, to comprise a tension sensor and accompanying alert system therein as taught and suggested by Pereira to, in this instance, track and measure the tension being applied to the anchors (and thereby the tissue) and, if said tension should fall outside of a pre-defined range, produce an alert to notify a user of undesirable tension in the system to prevent damage to the tensioned cable system (see Pereira Para. [0005]).
Regarding claim 10, the combination of O’Malley, Wilke and Pereira disclose the invention of claim 9, O’Malley, as modified by Wilke and Pereira, further discloses wherein the first sensing portion generates a tension data according to the tension of the fixing cord and sends the data alert and/or the tension data to a data-receiving device when the tension is less than the first tension threshold or greater than the second tension threshold (see Pereira Para. [0005] mentioning wherein said tension data is sent to a controller to alert a user of the tension parameters).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Malley (US 2003/0092969 A1)(previously of record) in view of Wilke (US 2006/0058842 A1)(previously of record), further in view of Narkiss (US 2019/0076100 A1)(previously of record).
Regarding claim 11, the combination of O’Malley and Wilke discloses all of the limitations of the invention of claim 1.
However, none of either O’Malley or Wilke expressly disclose wherein the cord-receiving device comprises a second sensing portion and a warning signal, wherein the second sensing portion senses a distance between the cord-receiving device and the second fixing device and generates a data alert when the distance is less than a first distance threshold or greater than a second distance threshold, wherein the warning signal sends a warning signal according to the data alert.
The problem to be solved by the incorporation of a sensor and accompanying warning signal is understood to be tracking a position of a portion of a surgical assembly and to alert a user when the position of said surgical assembly portion exceeds or falls outside of a threshold value (see Spec. Para. [0047]). In addressing this problem, Narkiss teaches wherein a position sensor may be incorporated into a medical device system to track and measure the distance of a surgical device relative thereto. Wherein, if the position of the tracked surgical device were to fall outside of an intended or desired range (whether above or below pre-defined thresholds), a warning alert (either audible or visual) is activated to alert a user of the deviation (see Para. [0060]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the tension apparatus of Wilke, as incorporated into the device of O’Malley, to comprise a position sensor and accompanying alert system therein as taught and suggested by Nikiss to, in this instance, track and measure the location of an additional “fixing device” relative thereto and, if said position should fall outside of a pre-defined range, produce an alert to notify a user of the position deviation (see Nikiss Para. [0060]).
Regarding claim 12, the combination of O’Malley, Wilke and Nikiss disclose the invention of claim 11, O’Malley, as modified by Wilke and Nikiss, further discloses wherein the second sensing portion generates a distance data according to the distance between the cord-receiving device and the second fixing device and sends the data alert and/or the distance data to a data-receiving device when the distance is less than the first distance threshold or greater than the second distance threshold (see Nikiss Para. [0060] mentioning wherein said position data is sent to a controller to alert a user of the position parameters).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 9597079 B2 to Elliot, US 10874395 B2 to Nezu, US 11000272 B2 to Wilke and US 2003/0163160 A1 to O’Malley disclose wound closure systems comprising a plurality of tissue anchors connected by a suture thread
THIS ACTION IS MADE FINAL. 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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771