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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/16/2026 has been entered.
Response to Arguments
Applicant's arguments filed 6/12/2026 regarding the rejection of Claims 1 and 14 have been fully considered but they are not persuasive.
Firstly, in regards to the amended limitations of claim 1 and 14, Applicant contends that none of either O’Malley (US 2003/0092969 A1) and Wilke (US 2006/0058842 A1) expressly disclose or adequately suggest the amended limitations of “wherein the first fixing device comprises…a first body portion, a first joining part and a first auxiliary fixing portion, the first body portion having a first side and a second side, the first fixing device being fixed to the target lesion through the first side, the first joining part being disposed on the second side”. This is on the grounds that the designated “first fixing device” of O’Malley is not fixed to the target lesion through the first side of the body portion, while the “first joining part” for connecting the cord-receiving device is disposed on the second side, which is opposite to the first side.
The Examiner respectfully disagrees with the proposed interpretation of the currently recited claim language. Examiner respectfully notes that O’Malley discloses, in Examiner’s Diagram of Fig. 6_Anchor of O’Malley (produced below), wherein the “first fixing device” comprises: A “first body portion” (main structural body of the “first fixing device”), comprising a “first side” (side of the “first body portion” facing and contacting the tissue surface; see Examiner’s Diagram of Fig. 6_Anchor below; see also Para. [0065]) and a second side opposite to the first side (side of the “first body portion” facing away from the tissue surface; shown in Examiner’s Diagram of Fig. 6_Anchor below); wherein the first fixing device is fixed to the target lesion through the first side (see Para. [0065] mentioning wherein the ”first fixing device” is affixed to the surface of a target tissue via adhesive; see also Fig. 6); and wherein the “first joining part” is disposed on the second side (see Examiner’s Diagram of Fig. 6_Anchor below; “first joining part” is attached to and disposed on the “second side” of the “first fixing device” facing away from the tissue surface).
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Examiner’s Diagram of Fig. 6_Anchor
Additionally, regarding claims 1 and 14, Applicant contends that O’Malley does not expressly disclose or adequately suggest “a cord-receiving device”. This is on the grounds that O’Malley provides a disclosure of wherein the efac 40 cooperates with anchor 58 to draw together the skin on opposite sides of wound to thereby close the wound. O’Malley does not provide any disclosure pertaining to a cord-receiving device for adjusting an exposed length of the line.
The Examiner respectfully notes that O’Malley was not relied upon to disclose the limitations of “a cord-receiving device for adjusting an exposed length of line”. Rather, Wilke was relied upon to disclose this feature by providing a teaching of a cord-receiving device (tensioning apparatus 40; see Fig. 1) provided within a wound closure system (see Fig. 1), attached at the “start” of a tension thread (line 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 Wilke Para. [0056]).
While O’Malley discloses wherein tension applied to the efac may be adjusted to either stretch of close a wound (see Para. [0021]-[0023], [0061] and [0092]), this tension system is manually operated and cumbersome, merely disclosing wherein a user may manually lock the efac within a locking wire 64. The Examiner maintains that one of ordinary skill in the art would have found it obvious to have included the cord-receiving device of Wilke into the device of O’Malley to 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]) to provide a more effective and efficient tensioning mechanism that would allow for more precise control of the tension applied to the efac.
Applicant further contends that Wilke, as utilized to modify the device of O’Malley, does not disclose “a cord-receiving device connecting to the first joining part of the first fixing device”. This is on the grounds that the tensioning apparatus 40 of Wilke is not disclosed to positioned at the location of the cord-receiving device recited in claims 1 and 14 (i.e., connected to a first joining part of a first fixing device”).
The Examiner respectfully contends that Wilke was not relied upon to disclose the precise connections between the cord-receiving device and first fixing device. Rather, Wilke was merely relied upon to provide a teaching of a tensioning device (i.e., a cord-receiving device) to be incorporated into the device of O’Malley to provide the benefit of providing a known alternative 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]). Examiner notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As the cord-receiving device of Wilke is provided at the “start” of the tension thread, one of ordinary skill in the art would have incorporated the cord-receiving device into the device of O’Malley to be positioned at the “start” of the thread therein (i.e., at the “first fixing member”). As Applicant has not provided arguments pertaining to the feasibility of functionality of the combination, Examiner respectfully contends that one of ordinary skill in the art would have made the resulting modification to obtain the disclosed benefit provided by the cord-receiving device of Wilke in providing a more effective, variable tensioning system.
Applicant additionally contends that the references of O’Malley and Wilke do not provide any motivation to combine the tensioning apparatus 40 of Wilke so as to be connected to the “first joining part” disposed on the second side of the first fixing device of O’Malley. Applicant contends that O’Malley provides disclosure of a force/tension applying system in the interaction between efac 40 being retained by locking wire 64 such that it is compressed and locked into a respective aperture, thereby locking the efac at a desired tension (see O’Malley Para. [0016] and [0061]. Therefore, one of ordinary skill in the art would not have looked to alternative forms of thread security and would thus not have been motivated to incorporate the tensioning apparatus of Wilke into the device of O’Malley.
The Examiner respectfully disagrees with the proposed “lack of motivation” contention. While O’Malley provides disclosure of a “locking feature” to secure the efac at a desired tension, the disclosed system is rudimentary and requires a user to manually lock and unlock the efac before increasing or releasing tension on a target site. Wilke provides a more sophisticated variable-tension system that allows a user to precisely control the length of efac (and thereby tension imparted thereto) in a single separate component, simplifying the complexity of the tensioning system.
Applicant additionally contends that the “first joining part” of O’Malley, designated as the “portion of anchor 58 disposed radially outward from wings 80” (see Examiner’s Diagram of Fig. 6_Anchor above) is not disclosed to connect with any device or component and thus would not be “connected to” the cord-receiving device incorporated from the teachings of Wilke.
The Examiner respectfully contends that the term “connected to” does not implicitly require a specific type of connection. So long as components are secured together such that they form a single integrated device, individual components of the integrated device are seen to be “connected” to one-another. Therefore, while the “first joining part” of O’Malley may not be in direct-abutment with the cord-receiving device, as incorporated from the teachings of Wilke, the two components are “connected” to one-another indirectly through the body of the “first fixing device” to which both components are secured during use.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 and 9-16 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites, “a first fixing device fixed to the target lesion”, “the first fixing device being fixed to the target lesion”, “a second fixing device fixed to the target lesion”. These limitations positively recite the target lesion of the body as part of the invention and thus attempt to claim a portion of a human organism. The Examiner suggests the language be amended to include a recitation of “configured to” or “capable of” so as not to directly claim the recited “target lesion” as a portion of the claimed invention.
Claims 2-7 and 9-13 are additionally rejected under U.S.C. 35 101 due to their dependency from and further modification of claim 1.
Claim 14 recites, “a first fixing device fixed to the target lesion”, “the first fixing device being fixed to the target lesion” and “a second fixing device fixed to the target lesion”. These limitations positively recite the target lesion of the body as part of the invention and thus attempt to claim a portion of a human organism. The Examiner suggests the language be amended to include a recitation of “configured to” or “capable of” so as not to directly claim the recited “target lesion” as a portion of the claimed invention.
Claims 15-16 are additionally rejected under U.S.C. 35 101 due to their dependency from and further modification of claim 14.
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 (see 35 U.S.C. 101 rejection above), 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(s). [0015]-[0020] and [0065]) and having a first body portion (see Examiner’s Diagram of Fig. 6_Anchor below designating a “first body portion” of the “first fixing device” as the main elongate structure thereof), a first joining part (see Examiner’s Diagram of Fig. 6_Anchor below designating a “first joining part” of the “first fixing device” as the portion(s) of the “first fixing device” that extend radially-beyond wings (80)) and a first auxiliary fixing portion (see Examiner’s Diagram(s) of Fig. 6 and Fig. 6_Anchor below designating a “first auxiliary fixing portion” of the “first fixing device” as the hook (62) through which the efac suture (40) passes), the first body portion having a first side (side of the “first body portion” facing and contacting the tissue surface; see Fig. 6) and a second side (side of the “first body portion” facing away from the tissue surface; shown in Fig. 6), the first fixing device fixed to the target lesion through the first side (see Para. [0065]; see also Fig. 6), the first joining part being disposed on the second side (see Examiner’s Diagram of Fig. 6_Anchor; “first joining part” attached to and disposed on the “second side” of the “first fixing device” facing away from the tissue surface);
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; see also Para(s) [0015]-[0020] and [0065]) 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) through which the efac suture (40) passes along 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]).
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Examiner’s Diagram of Fig. 6
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Examiner’s Diagram of Fig. 6_Anchor
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], [0061] 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 (line 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]) to provide a more effective and efficient tensioning mechanism that would allow for more precise control of the tension applied to the efac.
Regarding claim 2, the combination of O’Malley and Wilke disclose the invention of claim 1, O’Malley further discloses wherein the first side of 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]; adhesive applied to sides of fixing devices facing and contacting tissue (i.e., the “first side(s)”) to secure provide securement thereto, 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 (see 35 U.S.C. 101 rejection above), 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(s). [0015]-[0020] and [0065]) and having a first body portion (see Examiner’s Diagram of Fig. 6_Anchor below designating a “first body portion” of the “first fixing device” as the main elongate structure thereof), a first joining part (see Examiner’s Diagram of Fig. 6_Anchor below designating a “first joining part” of the “first fixing device” as the portion(s) of the “first fixing device” that extend radially-beyond wings (80)) and a first auxiliary fixing portion (see Examiner’s Diagram(s) of Fig. 6 and Fig. 6_Anchor below designating a “first auxiliary fixing portion” of the “first fixing device” as the hook (62) through which the efac suture (40) passes), the first body portion having a first side (side of the “first body portion” facing and contacting the tissue surface; see Fig. 6) and a second side (side of the “first body portion” facing away from the tissue surface; shown in Fig. 6), the first fixing device being fixed to the target lesion through the first side (see Para. [0065]; see also Fig. 6), the first joining part being disposed on the second side (see Examiner’s Diagram of Fig. 6_Anchor; “first joining part” attached to and disposed on the “second side” of the “first fixing device” facing away from the tissue surface);
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; see also Para(s) [0015]-[0020] and [0065]) 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) through which the efac suture (40) passes along the “second fixing device”);
wherein the fixing cord is in contact with the first auxiliary fixing portion (see Fig. 6 showing wherein the efac passes through the “first auxiliary fixing 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]);
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(s). [0021]-[0023] and [0092]).
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Examiner’s Diagram of Fig. 6
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Examiner’s Diagram of Fig. 6_Anchor
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], [0061] 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 (line 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]) to provide a more effective and efficient tensioning mechanism that would allow for more precise control of the tension applied to the efac.
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; see also 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; see also Para(s). [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]; see also 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; see also 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; see also Para(s). [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]; see also 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 2008/0147115 A1 to O’Malley, US 701313 A to Duffy and US 10524793 B2 to De Rezende Neto disclose wound closure systems comprising a plurality of tissue anchors connected by a suture thread
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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