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 Amendment
In response to the amendment filed on10/3/2025, the status of claim 6 is unclear. Applicant indicated on page 7 of the remarks filed that claim 6 is canceled to render the drawing objection of the features of claim 6 moot. However, claim is presently listed with a claim status of “Currently Amended”. Therefore, claim 6 is treated as currently pending still and the drawing objection is maintained. Claims 1-20 as filed by Applicant are pending.
Response to Arguments
Applicant’s arguments with respect to the combination of Stchur in view of Fallin et al have been considered but are moot because the arguments do not apply to any of the new combination of references being used in the current rejection. Applicant has amended the claims, thus changing the scope and requiring additional consideration. A new grounds of rejections is set forth below which does not rely upon the previous interpretation of the reference(s) or any matter specifically challenged in the arguments. The Examiner has cited Nguyen et al to teach the amended limitations, specifically a suture passage separating distinct proximal ridges from distinct distal ridges.
Though Fallin et al is no longer being applied in the prior art rejections below, Applicant’s arguments specifically about the extension of the threads on Fallin et al on page 8 of the remarks still apply to Nguyen et al and will be addressed as follows: Applicant argues Fallin cannot disclose the suture passage separates proximal ridges from distal ridges as the external bone thread wraps around an entirety of the anchor body. Similarly, the now applied Nguyen et al also has ridges (28) extending in similar length to Fallin. However, the Examiner respectfully disagrees these references cannot disclose the suture passage separates proximal ridges from distal ridges. The claim recites an open-ended transitional phrase of “comprising” in the preamble. This phrase, as detailed in MPEP 2111.03, does not exclude additional, unrecited elements. Therefore, as seen in the annotated figure of Nguyen et al in the rejection of claim 1 below, only the top two ridges have been interpreted as the proximal ridges and only the bottom two ridges have been interpreted as the distal ridges. The suture passage (25) of Nguyen et al does in fact separate the proximal and distal ridges. The single ridge in between the proximal ridges and distal ridges have been interpreted as an unrecited element of an intermediate ridge, also separating the proximal ridges and distal ridges. The claim, as presently written, does not preclude additional ridges in between the proximal ridges and distal ridges. Nonetheless, such a feature of proximal ridges and distal ridges separated by a suture passage with no other element in between is also known in the art, see Nadim for example (US 2019/0216455), wherein distal ridges (22) are separated from proximal ridges (42) by a suture passage (passage between apertures 32a and 32b), wherein no ridges exist in the circumferential portion occupied by the suture passage. Therefore, such a feature is not considered novel.
Applicant argues the specification was amended to correct the erroneous reference to Fig. 30. However, in both the marked-up copy and clean copy of the specification, the reference to Fig. 30 is still found. Therefore, this objection is maintained.
Terminal Disclaimer
The terminal disclaimer filed on 8/6/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patented granted for co-pending application 17/401,263 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show
every feature of the invention specified in the claims. Therefore, the proximal step
(claim 6) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet" pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: [0110] discusses Fig. 30, however no such figure exists in the drawings as the figures only go up to Fig. 9.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“delivery device” in claim 18 because the term “device” (generic placeholder) is coupled to the functional language of “delivery” and “configured to releasably attach to the proximal end of the suture anchor” without further structural modifiers either preceding or following the generic placeholder. For the purpose of examination, the term will be read as delivery device 300/350 (which is the disclosed corresponding structure, as described in paragraph [0159] of the published application) or an equivalent structure, which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 7-9, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stchur (US 2011/0004242) in view of Nguyen et al (US 2011/0112576).
Claim 1. Stchur discloses a suture anchor (Fig. 10; wherein Fig. 10 is the cited embodiment but is disclosed as having the same interior features as the earlier embodiments, other than the ribs 31, and therefore previous figures are cited for interior structures claimed below) comprising:
an anchor body (2) having a proximal end (top end), a distal end (bottom end), a longitudinal axis, a first lateral side (left side seen in Fig. 3 or front side seen in Fig. 10) extending between the proximal and distal end, and a second lateral side (right side seen in Fig. 3 or back side seen in Fig. 10) extending between the proximal and distal end ([0028]);
a suture passage (8) comprising a proximal surface and a distal surface and extending through the anchor body from a first opening in the first lateral side to a second opening in the second lateral side (see annotated figure below; [0028]-[0030]);
one or more proximal ridges (31) disposed on the anchor body, wherein the one or more proximal ridges are distal to the proximal end and proximal to the suture passage (Fig. 10; [0037]);
a channel (space from proximal end through interior surface 30 in Fig. 10 is considered forms one continuous channel) defined within the anchor body and extending along the longitudinal axis of the anchor body from a proximal opening in the proximal end of the anchor body to an opening in the proximal surface of the suture passage (see annotated figure below; [0028], [0029]); and
an insert (3) comprising an insert body (14) having a proximal end and a distal end, wherein the insert is configured to translate longitudinally within the channel between the proximal end of the anchor body and the distal surface of the suture passage (Fig. 5; [0032]).
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Stchur fails to disclose a plurality of distal ridges disposed on the anchor body, wherein the plurality of distal ridges is proximal to the distal end and distal to the suture passage, wherein the suture passage separates the one or more proximal ridges from the plurality of distal ridges. However, in a similar field of endeavor, Nguyen et al teaches a suture anchor (10) for bone ([0003]), comprising an anchor body (20) and an insert (30) for inserting into a channel (23) of the anchor body, wherein the anchor body comprises a suture passage (25) extending from a first opening (25a) on a first lateral side to a second opening (25b) on a second lateral side, and a plurality of proximal ridges (see annotated figure below) and a plurality of distal ridges (see annotated figure below), wherein the distal ridges are proximal to the distal end and distal to the suture passage along the length of the anchor body, wherein the suture passage separates the one or more proximal ridges from the plurality of distal ridges (see annotated figure below, wherein the suture passage and intermediate ridge separate the proximal and distal ridges; [0073], [0095]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the anchor body of Stchur with a plurality of distal ridges disposed on the anchor body, wherein the plurality of distal ridges is proximal to the distal end and distal to the suture passage, wherein the suture passage separates the one or more proximal ridges from the plurality of distal ridges, as taught by Nguyen et al, to substantially reduce the possibility of removal of the anchor when inserted into bone ([0073]), thereby increasing the retention of the suture anchor in the bone hole as compared to an anchor which only has proximal ridges .
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Claim 2. The combination discloses the invention substantially as claimed above, but fails to disclose a suture groove disposed along the anchor body at least partially between the suture passage and the proximal end of the anchor body, the suture groove configured to receive a suture therein. However, in the same field of endeavor, Nguyen et al further teaches the anchor comprising a suture groove (29) disposed along the anchor body at least partially between the suture passage and the proximal end of the anchor body, the suture groove configured to receive a suture therein (Fig. 1; [0070]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination with a suture groove as further taught by Nguyen et al to allow the suture to project less or not at all from the sides of the anchor body to protect the suture from abrasion and to allow the suture to slide more easily while it is being routed and tensioned.
Claim 3. The combination discloses the invention substantially as claimed above, wherein Nguyen et al further discloses the suture groove is defined by a recess along each of the one or more proximal ridges (the gap at where slot 29 exists in each ridge 28 defines a recess at each ridge as seen in Fig. 1).
Claim 4. The combination discloses the invention substantially as claimed above, wherein Nguyen et al further discloses each recess comprises a rounded edge therein (see annotated figure below).
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Claim 5. The combination discloses the invention substantially as claimed above, wherein Nguyen et al further discloses the first lateral side comprises the suture groove (29) extending from the first opening (25a) to the proximal end of the anchor body, and wherein the second lateral side comprises a second suture groove (29) configured to receive the suture, the second suture groove extending from the second opening (25b) to the proximal end of the anchor body (Figs. 1, 2a; [0070], [0092]).
Claim 7. The combination discloses the invention substantially as claimed above, wherein Stchur discloses the channel comprises a threaded region (12) along at least a portion of an interior surface of the channel (Fig. 3; [0030], [0032], [0037]).
Claim 8. The combination discloses the invention substantially as claimed above, wherein Stchur discloses the distal surface of the suture passage (8) is v-shaped and has a first lateral plane (left side of v-shape) extending from the first opening towards a central normal plane and a second lateral plane (right side of v-shape) extending from the second opening towards the central normal plane, the central normal plane being substantially perpendicular to the longitudinal axis of the anchor body (Figs. 7 shows the suture lying at the bottom of the v-shaped passage 8).
Claim 9. The combination discloses the invention substantially as claimed above, wherein Stchur discloses the distal surface of the suture passage is substantially flat and substantially perpendicular to the longitudinal axis of the anchor body (Fig. 3).
Claim 13. The combination discloses the invention substantially as claimed above, wherein Stchur discloses one or more sutures (9) disposed through the suture passage (Figs. 1, 10; [0028]).
Claim 14. The combination discloses the invention substantially as claimed above, wherein Stchur discloses the insert body (3) is configured to clamp the one or more sutures to the distal surface of the suture passage ([0029], [0032], i.e. compression by edge 17).
Claim 6 is/are rejected under 35 U.S.C. 103 as being obvious over Stchur in view of Nguyen et al as applied to claim 2 above, and further in view of Bowman et al (US 2022/0054122).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim 6. The combination discloses the invention substantially as claimed above, but fails to disclose the suture groove about the proximal end comprises a proximal step that reduces a depth of the suture groove. However, in the same field of endeavor, Bowman et al teaches a suture anchor (10) comprising: an anchor body (20) having a a first lateral side extending between the proximal and distal end, and a second lateral side extending between the proximal and distal end; a suture passage (30) comprising a proximal surface and a distal surface and extending through the anchor body from a first opening (36) in the first lateral side to a second opening (38) in the second lateral side (Fig. 5A); a plurality of ridges disposed on the anchor body (18); a channel (40) defined within the anchor body and extending along the longitudinal axis of the anchor body from a proximal opening (42) in the proximal end of the anchor body to an opening (44) in the proximal surface of the suture passage; and an insert (50) comprising an insert body having a proximal end and a distal end, wherein the insert is configured to translate longitudinally within the channel between the proximal end of the anchor body and the distal surface of the suture passage ([0074]), where the suture groove about the proximal end comprises a proximal step that reduces a depth of the suture groove Fig. 33; [0131]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include a proximal step as taught by Bowman et al to make the proximal end of the anchor body more robust and stronger against suture forces ([0131]).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stchur in view of Nguyen et al as applied to claim 1 above, and further in view of Bowman et al1.
Claim 10. The combination discloses the invention substantially as claimed above, but fails to disclose at least a portion of the distal surface of the suture passage comprises a convex curvature extending proximally towards the opening in the proximal surface of the suture passage.
However, in the same field of endeavor, Bowman et al teaches at least a portion of the distal surface of the suture passage (30) comprises a convex curvature (37) extending proximally towards the opening in the proximal surface of the suture passage (Figs. 27A-27D; [0121], [0122]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include the suture passage comprising a convex curvature as claimed, as taught by Bowman et al, to provide a surface without sharp edges and therefore enables distribution of forces along a length of the suture instead of concentrated pressure points (which occur with sharp edges) when the insert is in the locked configuration. Spreading the forces over a length of the suture will benefit suture integrity, enabling better locking, less strain on the suture, and reduced risk to patients that the suture will fail after implantation ([0122]). Furthermore, such a configuration allows for the suture to be captured over at least three points (79a, 79b, 79c) (Fig. 27D; [0123]).
Claim 11. The combination discloses the invention substantially as claimed above, wherein Bowman et al discloses a proximal portion of the convex curvature extends into the channel ([0121]).
Claim 12. The combination discloses the invention substantially as claimed above, wherein Bowman et al discloses the convex curvature spans the entire distal surface ([0121]).
Claim(s) 15, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stchur in view of Nguyen et al and Graf et al (US 2011/0009885).
Claim 15. Stchur discloses a suture anchor kit comprising:
a suture anchor comprising:
a suture anchor (Fig. 10; wherein Fig. 10 is the cited embodiment but is disclosed as having the same interior features as the earlier embodiments, other than the ribs 31, and therefore previous figures are cited for interior structures claimed below) comprising:
an anchor body (2) having a proximal end (top end), a distal end (bottom end), a longitudinal axis, a first lateral side (left side seen in Fig. 3 or front side seen in Fig. 10) extending between the proximal and distal end, and a second lateral side (right side seen in Fig. 3 or back side seen in Fig. 10) extending between the proximal and distal end ([0028]);
a suture passage (8) comprising a proximal surface and a distal surface and extending through the anchor body from a first opening in the first lateral side to a second opening in the second lateral side (see annotated figure from claim 1; [0028]-[0030]);
one or more proximal ridges (31) disposed on the anchor body, wherein the one or more proximal ridges are distal to the proximal end and proximal to the suture passage (Fig. 10; [0037]);
a channel (space from proximal end through interior surface 30 in Fig. 10 is considered forms one continuous channel) defined within the anchor body and extending along the longitudinal axis of the anchor body from a proximal opening in the proximal end of the anchor body to an opening in the proximal surface of the suture passage (see annotated figure from claim 1; [0028], [0029]); and
an insert (3) comprising an insert body (14) having a proximal end and a distal end, wherein the insert is configured to translate longitudinally within the channel between the proximal end of the anchor body and the distal surface of the suture passage (Fig. 5; [0032]).
one or more sutures (9) configured to be received through the suture passage (Figs. 1, 10; [0028]), such that the insert (3) is configured to clamp the one or more sutures to the distal surface of the suture passage ([0029], [0032], i.e. compression by edge 17).
Stchur fails to disclose a plurality of distal ridges disposed on the anchor body, wherein the plurality of distal ridges is proximal to the distal end and distal to the suture passage, wherein the suture passage separates the one or more proximal ridges from the plurality of distal ridges. However, in a similar field of endeavor, Nguyen et al teaches a suture anchor (10) for bone ([0003]), comprising an anchor body (20) and an insert (30) for inserting into a channel (23) of the anchor body, wherein the anchor body comprises a suture passage (25) extending from a first opening (25a) on a first lateral side to a second opening (25b) on a second lateral side, and a plurality of proximal ridges (see annotated figure from claim 1) and a plurality of distal ridges (see annotated from claim 1), wherein the distal ridges are proximal to the distal end and distal to the suture passage along the length of the anchor body, wherein the suture passage separates the one or more proximal ridges from the plurality of distal ridges (see annotated figure from claim 1, wherein the suture passage and intermediate ridge separate the proximal and distal ridges; [0073], [0095]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the anchor body of Stchur with a plurality of distal ridges disposed on the anchor body, wherein the plurality of distal ridges is proximal to the distal end and distal to the suture passage, wherein the suture passage separates the one or more proximal ridges from the plurality of distal ridges, as taught by Nguyen et al, to substantially reduce the possibility of removal of the anchor when inserted into bone ([0073]), thereby increasing the retention of the suture anchor in the bone hole as compared to an anchor which only has proximal ridges .
Stchur further fails to disclose a broach tool comprising a shaft having a second longitudinal axis and one or more fins projecting outward from the shaft, wherein each fin of the one or more fins projects outward from the shaft with a first projection length located at a proximal portion of the fin, and a second projection length located at a distal portion of the fin, wherein the first projection length is greater than the second projection length, and wherein the fin tapers from the first projection length to the second projection length. Instead, Stchur broadly discloses using a punch or drill without further details of the structures of such a device ([0035]).
Instead, Stchur broadly discloses using a punch or drill without further details of the structures of such a device ([0035]). However, in a similar field of endeavor, Graf et al teaches a bone anchor kit for tissue repair ([0003], [0011]), comprising a bone anchor (10, 60) and a broach tool (80) comprising a shaft (82) having a second longitudinal axis and one or more fins (84a) projecting outward from the shaft, wherein each fin of the one or more fins projects outward from the shaft with a first projection length located at a proximal portion of the fin, and a second projection length located at a distal portion of the fin, wherein the first projection length is greater than the second projection length, and wherein the fin tapers from the first projection length to the second projection length. ([0042]; wherein fins 84a are disclosed as having a similar configuration to anchor 10, and the projection length as claimed can be seen in Fig. 1 for anchor 10 due to the taper). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination kit to include such a broach as claimed as taught by Graf et al for the purpose of providing a tool that will create a seat for the anchor ([0042], [0045]).
Claims 18-20. The combination discloses the invention substantially as claimed above, but fails to disclose a delivery device configured to releasably attach to the proximal end of the suture anchor (as per claim 18), wherein the delivery device comprises a handle, a shaft extending from the handle, and an internal driver disposed within the shaft configured to rotate the insert within the anchor body (as per claim 19), and wherein the delivery device further comprises one or more suture cleats configured to tension the one or more sutures prior to insertion of the suture anchor within the bone hole (as per claim 20). Instead, Stchur broadly refers to an insertion tool (28) ([0035]).
However, in the same field of endeavor, Nguyen et al further teaches a delivery device (40) (Fig. 4) configured to releasably attach to the proximal end of the suture anchor, wherein the delivery device comprises a handle (42), a shaft (41a) extending from the handle, and an internal driver (42b) disposed within the shaft configured to rotate the insert within the anchor body, and wherein the delivery device further comprises a suture cleat (45) configured to tension the one or more sutures prior to insertion of the suture anchor within the bone hole ([0072]-[0075]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include such a delivery tool as claimed as taught by Nguyen et al to provide the mechanisms necessary for making the necessary adjustments during delivery of the suture anchor.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stchur in view of Nguyen et al and Graf et al as applied to claim 15 above, and further in view of Daniels (US 2007/0162033).
Claim 16. The combination discloses the invention substantially as claimed above, but fails to disclose the broach tool further comprises a plurality of bone engaging ridges on an exterior surface of the one or more fins. However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely creating a hole or seat for the anchor in bone, Daniels teaches a broach (2) having fins (74) with a plurality of bone engaging ridges (43) on the exterior surface (Fig. 6; [0087], [0088]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include a plurality of bone engaging ridges on an exterior surface of the one or more finds as taught by Daniels for providing a structure that will help break up chips and create the hole/seat for the anchor ([0088]).
Claim 17. The combination discloses the invention substantially as claimed above, wherein Daniels further discloses one or more fins align with the first lateral side and the second lateral side of the anchor body (Fig. 7 of Daniels illustrates how there are diametrically opposed fins, wherein the lateral sides of the anchor body in Stchur are on diametrically opposing sides. Therefore, both of these diametrically opposing sides and fins allow for the fins of Daniels to align with the lateral sides of Stchur).
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nadim (US 2019/0216455) teaching a suture passage separating proximal ridges from distal ridges.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
1 See note about common inventor from the rejection header of claim 6