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 12/31/2025 regarding the rejection of independent claims 1 and 15 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that none of either Lunn (US 2010/0152773 A1)(previously of record) or Zink (US 2022/0110664 A1)(previously of record) expressly disclose or suggest the amended limitations of “the screw actuatable to move the distal body into the shaft by rotation of the screw, trapping a suture threaded through the suture slot between an internal surface of the shaft and surfaces of the suture slot and resisting withdrawal of the suture from the anchoring system” on the grounds that rotating of the screw of Zink, as incorporated into the device of Lunn, is not in contact or communication with the suture positioned within the suture hole (12c) of Lunn and would therefore not be capable of trapping a suture thread between an internal surface of the shaft and surfaces of the suture slot.
While the Examiner agrees with the suture slot (12c) of Lunn, and corresponding suture disposed therein, are not in contact or communication with the screw of Zink which is configured to insert into a proprietary cavity within the distal portion (12) to cause rotating of said screw to bring the proximal portion and distal portion of the anchor of Lunn closer together, the Examiner respectfully contends that the current claim language does not limit the scope of the claims to require such a configuration. As the claim language recites, “the screw actuatable to move the distal body into the shaft by rotation of the screw, trapping a suture threaded through the suture slot between an internal surface of the shaft and surfaces of the suture slot and resisting withdrawal of the suture from the anchoring system”, the Examiner contends that rotation of the screw merely needs to cause (i.e., indirectly) the suture threaded through the hole (12c) to become trapped between surfaces of the proximal shaft and surfaces of the suture slot. Since rotation of the screw of Zink, as incorporated into the device of Lunn, is configured to bore into a cavity of the distal portion (12) to cause the proximal portion (11) and distal portion (12) to move closer toward one-another, should a suture be threaded through the suture slot prior to rotation of said screw (i.e., when the proximal and distal portions are substantially separated from one-another), rotation of the screw would cause the suture to become progressively more trapped between inner surfaces of the proximal portion and the surfaces of the suture slot. As shown in Examiner’s Diagram of Lunn Fig. 6A below, should the screw be rotated to cause the proximal and distal portions to become substantially coupled together, the portion of the suture threaded through the suture hole would become “trapped” between the radially-inward surfaces of said suture hole and co-axial inner surfaces of the proximal portion. Until the claim language is further limited to prevent such an interpretation, the Examiner contends that the combined disclosure of Lunn and Zink adequately read on the currently-presented claim language of claim 1.
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Examiner’s Diagram of Lunn Fig. 6A
Regarding claim 15, Applicant contends that the combination of Lunn, Zink and Lombardo (US 2005/0055052 A1)(previously of record) do not expressly disclose or suggest the amended limitations of “wherein in a first mode, the first suture slot and the second suture slot are aligned, and wherein in a second mode, wherein the square post is inserted into the shaft, the first suture slot and second suture slot are misaligned, trapping a suture threaded through the first suture slot and second suture slot when aligned between an internal surface of the shaft and a surface of the second suture slot and resisting withdrawal of the suture from the anchoring system” on the grounds that the additional suture slots of Lombardo, as incorporated into the device of Lunn, are not configured to cause the suture to become trapped between “an internal surface of the shaft and a surface of the second suture slot” as required by the cited amended limitations. Rather, Lombardo appears to have the suture being pinched between the two misaligned holes themselves, rather than the internal surface of the shaft and second suture slot.
The Examiner respectfully disagrees with the interpretation of Lombardo and contends that Lombardo provides a disclosure of wherein when the first and second suture slots are misaligned, the suture becomes trapped between an inner surface of the proximal shaft (120) and a surface of the second suture slot (240a) which would prevent the suture from being removed from the system (see Examiner’s Diagram of Lombardo Fig. 6B below for reference on a length of suture “trapped” between an inner surface of the proximal shaft an a “second suture slot”). In the resulting combination, suture slots are incorporated into the proximal portion of Lunn when the first and second suture slots of Lunn are misaligned, the suture would be trapped between an internal surface of the proximal shaft (as the suture is disposed between radially-inward surface of the proximal portion (11) as shown in Lunn Figs. 6A of Lunn above) and a surface of the second slot (since the suture is disposed within and radially-inward of all of the surfaces of the suture hole (12c) as shown in Figs. 6A-6B). Until further limitations are incorporated into the claims to prevent such an interpretation, the combination of Lunn, Zink and Lombardo are understood to adequately disclose the amended limitations of claim 15.
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Claim Objections
Applicant’s arguments, see “Remarks”, filed 12/31/2025, with respect to the objection of claim 15 for reciting “second suture slot in having at least one surface” which contained an errant “in” recitation have been fully considered and are persuasive in light of Applicant’s amendment to remove the errant “in” recitation. The objection of claim 15 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) 1-4 and 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lunn (US 2010/0152773 A1)(previously of record) in view of Zink (US 2022/0110664 A1)(previously of record), further in view of Wenstrom (US 6045573 A)(previously of record).
Regarding claim 1, Lunn discloses:
An anchoring system (see Fig. 1) for securing suture to bone, the anchoring system comprising:
a proximal body defining a shaft (proximal portion 11, see Fig. 1);
a distal body (distal portion 12, see Fig. 1) comprising:
a post (top portion 12b, see Figs. 4-5) for insertion into the proximal body shaft (see Fig. 5); and
a suture slot therein (hole 12c, see Fig. 5);
wherein a suture (suture 20, see Fig. 6A and Para. [0021] and [0025]), threaded through the suture slot (see Fig. 6A and Para. [0021] and [0025]) is trapped between an internal surface of the shaft and surfaces of the suture slot (see Examiner’s Diagram of Lunn Fig. 6A below showing wherein the suture, when inserted into hole 12c, is “trapped” between internal surfaces of the proximal portion 11 (above a portion of suture within hole 12c) and the distal surfaces of the hole 12c (below a portion of the suture within hole 12c)) and resisting withdrawal of the suture from the anchoring system (the suture resists withdrawal from hole 12c as the suture is contained within the opening of hole 12c, resisting axial and lateral movement of the suture thread out from the hole (i.e., the suture cannot be slid out from the hole without unthreading the suture)).
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Examiner’s Diagram of Lunn Fig. 6A
However, Lunn does not expressly disclose:
wherein the distal body post is square;
wherein an internal surface of the square post is threaded;
a screw at least partially encapsulated within the proximal body and extending into the shaft; and
wherein the screw is threaded to match the internal surface of the threaded square post, the screw is actuatable to move the distal body into the shaft by rotation of the screw.
In the same field of endeavor, namely bone anchor devices, Zink teaches a bone anchoring system (see Figs. 1-2 and Para. [0025]-[0029]) comprising distal body (104, see Figs. 1-2) and a proximal body (102, see Figs. 1-2), wherein the proximal body comprises a screw (118, see Figs. 1-2 and 7) partially embedded therein and extending into the shaft thereof (see Figs. 1-2 and 7 and Para. [0028]-[0029]) and comprising a threaded region at a distal end thereof (124, see Figs. 1-2 and 7) that mates with a corresponding threaded internal opening within the distal body (116, see Figs. 1-2 and Para. [0028]-[0029]) such that rotation of the screw causes the proximal body and distal body to either lock or unlock from one-another by sliding rotational movement between the interlocking threads (see Para. [0028]-[0029]).
Since Lunn expressly discloses wherein the proximal and distal portions of the anchor may be coupled together by “any known coupling method known to one of ordinary skill in the art” (see Para. [0025]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known bone anchor coupling mechanism for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of providing a threaded cavity within the top portion (12b) of the distal portion configured to receive a threaded screw portion at least partially embedded and encapsulated within the proximal portion as disclosed by Zink, as an alternative coupling mechanism for securing portions of a bone screw together known within the art. Since Lunn provides a disclosure that “any” coupling mechanism known within the art may be used interchangeably within the anchor system, one of ordinary skill in the art would have had a reasonable expectation of success that the bone anchor of Lunn would have operated equally well with either presently-disclosed interference fit, or with the mating threading disclosed by Zink. The Examiner notes that as the screw is actuated to bring the proximal portion closer to the distal portion, the suture is further trapped between the proximal portion and said distal portion as the two components compress to reduce a distance of separation, thereby “trapping” the suture further between the two components.
In the same field of endeavor, namely bone anchors, Wenstrom teaches wherein a bone anchor system (see Fig. 8) comprising a distal bone anchor (10, see Fig. 1) having a post extending proximally therefrom (30, see Fig. 1) and configured to be inserted into a proximal engagement member (220, see Fig. 8 and Col. 4, Lines 23-35 and 42-50), wherein the post may have any cross-section shape that mates with the corresponding engagement member socket including hexagonal, triangular, square, etc. (see Col. 3, Lines 51-59).
Since Lunn expressly discloses wherein the top portion of the distal portion and the internal surface of the proximal portion may “have a different shape” to the one shown in Figs. 4-5 (see Para. [0025]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known coupling mechanism for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the top portion of the distal portion and the internal mating surface of the proximal portion to have square cross-section shapes as disclosed to be known in the art by Wenstrom. Since Lunn provides a disclosure amounting to wherein “any” shape known within the art may be used interchangeably with the trapezoidal cross-section shape shown, one of ordinary skill in the art would have had a reasonable expectation of success that the bone anchor of Lunn would have operated equally well with either a trapezoidal or square-shaped cross section.
Regarding claim 2, the combination of Lunn, Zink and Wenstrom disclose the invention of claim 1, Lunn further discloses wherein the shaft is shaped for receipt of the square post (see Fig. 5-6A; as modified by the teachings of Wenstrom, the square top portion 12b of Lunn is configured to be received within a correspondingly-shaped portion of the proximal portion 11).
Regarding claim 3, combination of Lunn, Zink and Wenstrom disclose the invention of claim 1, Lunn further discloses wherein the proximal body comprises an external surface having a plurality of serrations (threads 11d, see Fig. 2).
Regarding claim 4, the combination of Lunn, Zink and Wenstrom disclose the invention of claim 1, Lunn further discloses wherein the distal body further comprises an end (distal-most tip of distal portion, see Fig. 5) configured for embedding in bone (see Para. [0020] and Fig. 6B), wherein the square post extends proximally from the end (see Fig. 5, as modified to have a square cross-section by the disclosure of Wenstrom).
Regarding claim 7, the combination of Lunn, Zink and Wenstrom disclose the invention of claim 4, Lunn further discloses wherein the suture slot is between the end and the internal surface of the square post cavity (see Fig. 5).
Regarding claim 8, the combination of Lunn, Zink and Wenstrom disclose the invention of claim 4, Lunn further discloses wherein the suture slot is proximate a top of the end (see Fig. 5).
Regarding claim 9, the combination of Lunn, Zink and Wenstrom disclose the invention of claim 4, Lunn further discloses wherein the suture slot is spaced proximally from a top of the end (see Fig. 5).
Regarding claim 10, the combination of Lunn, Zink and Wenstrom disclose the invention of claim 1, Lunn further discloses wherein the suture slot comprises a half-oval shape or a circular shape (see Fig. 5 showing wherein the hole comprises a half-oval shape).
Regarding claim 11, the combination of Lunn, Zink and Wenstrom disclose the invention of claim 1, Lunn further discloses wherein the internal surface of the square post cavity and the suture slot do not overlap (see Fig. 5 showing wherein the hole (12c) is located proximally to the “top portion 12b” and thus would not overlap with the threaded cavity disposed therein).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lunn (US 2010/0152773 A1)(previously of record) in view of Zink (US 2022/0110664 A1)(previously of record), further in view of Wenstrom (US 6045573 A)(previously of record), further in view of Smith (US 2003/0088272 A1)(previously of record).
Regarding claim 5, the combination of Lunn, Zink and Wenstrom disclose the invention of claim 1.
However, Lunn does not expressly disclose wherein the suture slot has at least one surface with serrations.
In the same field of endeavor, namely bone anchors comprising a slot receiving a suture therein, Smith teaches wherein a bone anchor (see Fig. 4A) comprises a suture eyelet (guide channel 235, see Figs. 4A-4B) having a plurality of grooves (250a-250d, see Figs. 4A-4B), each groove having two edges (253a-253d and 254a-254d, see Figs. 4A-4B) that act to permit the suture to be pulled in a first direction while limiting movement of the suture in a second opposite direction (see Para. [0060]-[0061]).
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 suture hole of Lunn to comprise at least one groove having a plurality of edges (i.e., serrations) as taught and suggested by Smith to, in this case, permit the suture to be pulled in a first direction while limiting movement of the suture in a second opposite direction (see Smith Para. [0060]-[0061]).
Claim(s) 6 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lunn (US 2010/0152773 A1)(previously of record) in view of Zink (US 2022/0110664 A1)(previously of record), further in view of Wenstrom (US 6045573 A)(previously of record), further in view of Arai (US 2014/0277129 A1)(previously of record).
Regarding claim 6, the combination of Lunn, Zink and Wenstrom disclose all of the limitations of the invention of claim 4.
However, Lunn further discloses wherein the end comprises a plurality of serrations.
In the same field of endeavor, namely bone anchor comprising suture locking mechanisms, Arai teaches wherein a bone anchor (see Fig. 1A) comprises a proximal portion (sleeve 101, see Fig. 1A) and a distal portion (tip structure 102, see Fig. 1A), wherein the distal portion comprises a plurality of radially-extending barbs (108, see Fig. 1A) which improve pullout strength (see Para. [0036]).
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 distal portion of Lunn to include a plurality of radially-extending barbs thereon as taught and suggested by Arai to, in this case, improve the pullout strength of the anchor (see Arai Para. [0036]).
Regarding claim 12, the combination of Lunn, Zink and Wenstrom disclose all of the limitations of the invention of claim 1.
However, Lunn does not expressly disclose one or more wings extending radially outward from the distal body.
In the same field of endeavor, namely bone anchor comprising suture locking mechanisms, Arai teaches wherein a bone anchor (see Fig. 1A) comprises a proximal portion (sleeve 101, see Fig. 1A) and a distal portion (tip structure 102, see Fig. 1A), wherein the distal portion comprises a proximal post (distal region 110, see Fig. 1C) configured to be inserted into a cavity of the proximal portion (see Figs. 1A-1D), wherein the distal portion further comprises a plurality of radially-extending barbs (108, see Fig. 1A) which improve pullout strength (see Para. [0036]).
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 distal portion of Lunn to include a plurality of radially-extending barbs thereon as taught and suggested by Arai to, in this case, improve the pullout strength of the anchor (see Arai Para. [0036]).
Regarding claim 13, the combination of Lunn, Zink, Wenstrom and Arai disclose the invention of claim 12, Lunn, as modified by Arai, further discloses wherein the one or more wings are distal of the square post (see Arai Fig. 1C showing wherein the barbs are located distally of the distal region post (111); this configuration would remain unchanged when incorporated into the device of Lunn so as not to change the diameter of the top portion which may alter the ability to be insertable into the proximal portion as shown in Lunn Fig. 5).
Regarding claim 14, combination of Lunn, Zink, Wenstrom and Arai disclose the invention of claim 12, Lunn, as modified by Arai, further discloses wherein the one or more wings comprise a ring around the distal body (see Arai Fig. 1C showing wherein the barbs extend in a ring around the circumference of the tip structure).
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lunn (US 2010/0152773 A1)(previously of record) in view of Zink (US 2022/0110664 A1)(previously of record), further in view of Wenstrom (US 6045573 A)(previously of record), further in view of Lombardo (US 2005/0055052 A1)(previously of record), further in view of Smith (US 2003/0088272 A1)(previously of record).
Regarding claim 15, Lunn discloses:
An anchoring system (see Fig. 1) for securing suture to bone, the anchoring system comprising:
a proximal body defining a shaft (proximal portion 11, see Fig. 1);
a distal body (distal portion 12, see Fig. 5) for insertion into the proximal body shaft (see Fig. 5), the distal body comprising:
a post (top portion 12b, see Fig. 2); and
a second suture slot (hole 12c, see Fig. 5).
However, Lunn does not expressly disclose:
Wherein the proximal body comprises a first suture slot;
Wherein the post of the distal body is square and comprises a threading on the internal surface thereof;
Wherein the second suture slot has at least one surface with serrations thereof; and
wherein in a first mode, the first suture slot and the second suture slot are aligned, and wherein in a second mode, where the square post is inserted into the shaft, the first suture slot and the second suture slot are misaligned trapping a suture threaded through the first suture slot and the second suture slot when aligned between an internal surface of the shaft and a surface of the second suture slot and resisting withdrawal of the suture from the anchoring system.
In the same field of endeavor, namely bone anchor devices, Zink teaches a bone anchoring system (see Figs. 1-2) comprising distal body (104, see Figs. 1-2) and a proximal body (102, see Figs. 1-2), wherein the proximal body comprises a screw (118, see Figs. 1-2 and 7) partially embedded therein and extending into the shaft thereof (see Figs. 1-2 and 7 and Para. [0028]-[0029]) and comprising a threaded region at a distal end thereof (124, see Figs. 1-2 and 7) that mates with a corresponding threaded internal opening within the distal body (116, see Figs. 1-2 and Para. [0028]-[0029]) such that rotation of the screw causes the proximal body and distal body to either lock or unlock from one-another by sliding rotational movement between the interlocking threads (see Para. [0028]-[0029]).
Since Lunn expressly discloses wherein the proximal and distal portions of the anchor may be coupled together by “any known coupling method known to one of ordinary skill in the art” (see Para. [0025]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known coupling mechanism for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of providing a threaded cavity within the top portion (12b) of the distal portion configured to receive a threaded screw portion at least partially embedded and encapsulated within the proximal portion as disclosed by Zink, as an alternative coupling mechanism for securing portions of a bone screw together known within the art. Since Lunn provides a disclosure that “any” coupling mechanism known within the art may be used interchangeably within the anchor system, one of ordinary skill in the art would have had a reasonable expectation of success that the bone anchor of Lunn would have operated equally well with either presently-disclosed interference fit, or with the mating threading disclosed by Zink.
In the same field of endeavor, namely bone anchors, Wenstrom teaches wherein a bone anchor system (see Fig. 8) comprising a distal bone anchor (10, see Fig. 1) having a post extending proximally therefrom (30, see Fig. 1) and configured to be inserted into a proximal engagement member (220, see Fig. 8 and Col. 4, Lines 23-35 and 42-50), wherein the post may have any cross-section shape that mates with the corresponding engagement member socket including hexagonal, triangular, square, etc. (see Col. 3, Lines 51-59).
Since Lunn expressly discloses wherein the top portion of the distal portion and the internal surface of the proximal portion may “have a different shape” to the one shown in Figs. 4-5 (see Para. [0025]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known coupling mechanism for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the top portion of the distal portion and the internal mating surface of the proximal portion to have square cross-section shapes as disclosed to be known in the art by Wenstrom. Since Lunn provides a disclosure amounting to wherein “any” shape known within the art may be used interchangeably with the trapezoidal cross-section shape shown, one of ordinary skill in the art would have had a reasonable expectation of success that the bone anchor of Lunn would have operated equally well with either a trapezoidal or square-shaped cross section.
In the same field of endeavor, namely bone anchor for securing a suture to bone, Lombardo teaches wherein a bone anchor (see Fig. 1) comprises a proximal body defining a shaft (proximal shaft 210, see Figs. 1-2) having a first suture slot (suture holes 240a, 240b, see Figs. 1-2 and Para. [0016]) and an overlapping distal body (collar member 120, see Fig. 1) having a second suture slot (suture holes 320a, 320b, see Fig. 1 and Para. [0019]), wherein in a first mode, when the distal body is proximal the distal end of the first body (see Para. [0019] and Fig. 6A), the first and second suture slots are aligned (see Para. [0019] and Fig. 6A), and wherein in a second mode, when distal body is slid distally to overlap the distal end of the first body (see Fig. 6B), the first suture slot and second suture slot are misaligned (see Para. [0019] and Fig. 6B) to define a locked position in which the suture is frictionally secured between the misaligned suture holes (see Para. [0025]) such that the suture is trapped through the misaligned suture holes (see Para. [0025]) when aligned between an internal surface of the proximal shaft and a surface of the second suture slot (see Examiner’s Diagram of Lombardo Fig. 6B below showing the suture in a locked position in which the suture is positioned between an internal surface of the proximal shaft and at least one of the “second suture slots” of the collar member).
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Examiner’s Diagram of Lombardo Fig. 6B
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 proximal portion of Lunn to comprise a suture hole therein and configured at least partially overlap with the hole (12c) of the distal portion, wherein the suture hole(s) of the proximal portion and distal portion are configured to be operable from a first aligned state in which the proximal portion is not fully seated onto the distal portion, to a second misaligned state in which the proximal portion is fully seated onto the distal portion as taught and suggested by Lombardo to, in this case, provide a suture locking mechanism (see Lombardo Para. [0025]). In the resulting “locked” misaligned configuration, the suture would become “trapped” between an internal surface of the hole 12c (within which the suture passes through as shown in Lunn Fig. 6A) and an internal surface of the proximal portion 11 (positioned proximally of the suture passing through the hole). See Examiner’s Diagram of Lunn Fig. 6A for positional reference).
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Examiner’s Diagram of Lunn Fig. 6A
In the same field of endeavor, namely bone anchors comprising a slot receiving a suture therein, Smith teaches wherein a bone anchor (see Fig. 4A) comprises a suture eyelet (guide channel 235, see Figs. 4A-4B) having a plurality of grooves (250a-250d, see Figs. 4A-4B), each groove having two edges (253a-253d and 254a-254d, see Figs. 4A-4B) that act to permit the suture to be pulled in a first direction while limiting movement of the suture in a second opposite direction (see Para. [0060]-[0061]).
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 suture hole(s) of Lunn, as modified by Lombardo, to comprise at least one groove having a plurality of edges (i.e., serrations) as taught and suggested by Smith to, in this case, permit the suture to be pulled in a first direction while limiting movement of the suture in a second opposite direction (see Smith Para. [0060]-[0061]).
Regarding claim 16, the combination of Lunn, Zink, Wenstrom, Lombardo and Smith disclose the invention of claim 15.
While Lunn illustrates wherein the hole (12c) comprises a half-oval shape (see Figs. 1-5), Lunn does not expressly disclose a written description pertaining to the shape of the hole and/or provide any criticality therefore and thus does not expressly disclose wherein the first suture slot and the second suture slot are circular.
Lombardo teaches wherein suture holes of a bone anchor device (240a, 240b and 340a,340b, see Figs. 1-2) comprise circular shapes (see Fig. 1).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known shape for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the suture hole(s) of Lunn, as modified by Lombardo, to comprise circular shapes as a known alternative shape within the art as disclosed by Lombardo. Since Lunn does not expressly recite and shape for the hole (12c), instead merely relying on the disclosed drawings, there appears to be no criticality imparted onto the half-oval shape shown in Lunn Figs. 1-5 and one of ordinary skill in the art would have therefore expected the suture hole(s) of Lunn to functional equally well with either a circular hole or half-oval hole as are both known configurations within the art.
Regarding claim 17, the combination of Lunn, Zink, Wenstrom, Lombardo and Smith disclose the invention of claim 15, Lunn, as modified by Lombardo and Smith, further discloses wherein the first suture slot and the second suture slot comprises serrations therein (serrations of Smith, as incorporated into the suture hole(s) of Lunn, as modified by Lombardo).
Allowable Subject Matter
Claims 18 and 20 are allowed.
Regarding claim 18, none of the prior art of record expressly discloses, teaches or suggests, in combination with the additional limitations of claim 18, the amended limitations of wherein “rotating a screw at least partially encapsulated within the first portion to draw the square post into the cavity to cause tightening of the one or more sutures by trapping the one or more suture between an internal surface of the cavity and the surfaces of the suture slot and resisting withdrawal of the one or more sutures.
The closest prior art of record, namely Lunn (US 2010/0152773 A1) discloses:
A method of tissue repair, the method comprising:
receiving a first portion (proximal portion 11, see Fig. 1) of an anchoring system (see Fig. 1), the first portion of the anchoring system defining a cavity for receiving a post (see Fig. 5 showing wherein proximal portion 11 defines a cavity therein for the reception of top portion 12b of the distal portion 12);
aligning a second portion (distal portion 12, see Figs. 1 and 5) of the anchoring system over the first portion of the anchoring system (see Fig. 5), the second portion of the anchoring system having the post (top portion 12b, see Figs. 5-6A);
threading one or more sutures (suture 20, see Fig. 6A) through a suture slot (hole 12c, see Fig. 6A) in the second portion of the anchoring system (see Fig. 6C);
embedding the anchoring system in bone (see Fig. 6B and Para. [0021]-[0022]); and
tightening the one or more sutures by moving the first portion of the anchoring system and the second portion of the anchoring system together (as the anchor is moved into position within bone, the suture is tied by a user as recited in Para. [0022]; the movement of the anchoring system is therefore a step in the sequence of tightening the suture).
However, Lunn does not expressly disclose:
wherein the post of the second portion is square-shaped; and
rotating a screw at least partially encapsulated within the first portion to draw the square post into the cavity, to cause tightening of the one or more sutures by trapping the one or more suture between an internal surface of the cavity and surfaces of the suture slot and resisting withdrawal of the one or more suture.
In the same field of endeavor, namely bone anchors, Wenstrom (US 6045573 A) teaches wherein a bone anchor system (see Fig. 8) comprising a distal bone anchor (10, see Fig. 1) having a post extending proximally therefrom (30, see Fig. 1) and configured to be inserted into a proximal engagement member (220, see Fig. 8 and Col. 4, Lines 23-35 and 42-50), wherein the post may have any cross-section shape that mates with the corresponding engagement member socket including hexagonal, triangular, square, etc. (see Col. 3, Lines 51-59).
Since Lunn expressly discloses wherein the top portion of the distal portion and the internal surface of the proximal portion may “have a different shape” to the one shown in Figs. 4-5 (see Para. [0025]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known coupling mechanism for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the top portion of the distal portion and the internal mating surface of the proximal portion to have square cross-section shapes as disclosed to be known in the art by Wenstrom. Since Lunn provides a disclosure amounting to wherein “any” shape known within the art may be used interchangeably with the trapezoidal cross-section shape shown, one of ordinary skill in the art would have had a reasonable expectation of success that the bone anchor of Lunn would have operated equally well with either a trapezoidal or square-shaped cross section.
In the same field of endeavor, namely bone anchor devices, Zink (US 2022/0110664 A1) teaches a bone anchoring system (see Figs. 1-2 and Para. [0025]-[0029]) comprising a first body (102, see Figs. 1-2) and a second body (104, see Figs. 1-2), wherein the first body comprises a screw (118, see Figs. 1-2 and 7) partially embedded therein and extending into the shaft thereof (see Figs. 1-2 and 7 and Para. [0028]-[0029]) and comprising a threaded region at a distal end thereof (124, see Figs. 1-2 and 7) that mates with a corresponding threaded internal opening within the second body (116, see Figs. 1-2 and Para. [0028]-[0029]) such that rotation of the screw causes the first body and second body to either lock or unlock from one-another by sliding rotational movement between the interlocking threads (see Para. [0028]-[0029]).
However, none of either Lunn, Zink or any other prior art of record expressly discloses “rotating the screw at least partially embedded within the first portion…to cause tightening of the one or more sutures by trapping the one or more sutures between an internal surface of the cavity and surfaces of the suture slot and resisting withdrawal of the one or more sutures”. Since the screw of Zink would be configured to secure the proximal shaft to the distal tip (per Zink Para. [0028]-[0029]), the screw would not have any inherent function pertaining to the tightening of the suture extending through slot 12c. Further, Lunn discloses wherein the suture is tied to affix soft tissue to bone after the anchor has been placed within the bone, taken to mean a user manually tightens the suture threads after the bone anchor is secured together and placed in a final location. It is not immediately evident how one of ordinary skill in the art would have utilized the screw of Zink to cause tightening of the suture passing through the device as since the screw is not connected to the suture in any way, in addition to Lunn already providing a means of tightening the suture thread after assembly of the screw.
However, none of the combination expressly disclose, teach or suggest the amended limitations of “rotating a screw at least partially encapsulated within the first portion to draw the square post into the cavity, to cause tightening of the one or more sutures by trapping the one or more suture between an internal surface of the cavity and surfaces of the suture slot and resisting withdrawal of the one or more suture”.
It would not have been obvious to one of ordinary skill in the art to have modified the combined device of Lunn and Zink to have rotation of the screw within the proximal portion of Lunn, as incorporated from the teachings of Zink, cause tightening of the one or more sutures as the suture of Lunn are disposed within opening 12c which is not connected to or in some communication with the cavity of the proximal portion. As the screw would be rotated within a cavity within the distal portion to cause the proximal and distal portions of the device of Lunn to be brought together, the suture hole 12c would not be impacted or indirectly affected by the actuation of the screw. Without a teaching from the prior art, one of ordinary skill in the art would not have had a reasonable expectation of success in modifying the suture to be tightened by actuation of the screw as there would be no motivation for doing so without relying on impermissible hindsight.
Claim 20 is allowable over the prior art due to the dependency from and further modification of claim 18.
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 11751863 B2 to Vijay, US 11490886 B2 to Carrier and US 9572563 B2 to Berelsman all disclose bone anchors for securing a suture to bone and having either one or more suture holes, different shapes of anchoring/connecting portions and method for bone anchoring pertinent to the claimed invention.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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