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 light of Applicant’s amendment, claim(s) 1, 6, 8-9 is/are amended and claim(s) 2-5 and 16-20 is/are canceled. Claims 21-26 are added. Claims 1, 6-15, and 21-26 are now pending examination. Claims 7-8 remain withdrawn.
Election/Restrictions
Newly submitted claim 26 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the inventions of claim 1, 6-15, and 21-25 and the invention of claim 26 are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the product can be used in a materially different process, as the device is not required to perform knotless tissue repair. For instance, the apparatus can be used in a different procedure for bone anchoring or outside of the medical arena and used to anchor into drywall or other construction purposes.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 26 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments, filed 2/26/2026, with respect to the rejection(s) of claim(s) 5 under U.S.C. 103 have been fully considered and are persuasive. Specifically, the argument that the cut out as previously cited by Vaughan (holes 60) being modified to include the cut-out extending radially into the side wall of the cap portion and opening through both the top surface and the bottom surface of the cap portion would not be obvious to one of ordinary skill in the art is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of and alternative interpretation of Vaughan in view of Schulz.
However, Examiner disagrees with the argument that the modification to the cap of Vaughan would not be obvious to one of ordinary skill in the art. Both references and the claimed invention are directed to bone anchors with similar structures incorporating a cap and barrel portion. As such, one of ordinary skill in the art would be motivated to modify the cap of Vaughan from a circular shape to include the cutout as taught by Schulz, as it would allow for more maneuverability by being less of an obstruction during a medical procedure. Schulz states the recesses 20 facilitate the subsequent passage of a graft, for example a tendon (paragraph 0052), and the same principle could be applied to allow the passing of the suture of Vaughan if necessary.
In response to applicant's argument that the device of Schulz is not meant to be used with a suture, thus does not teach “wherein the cut-out is configured to allow the suture to pass through the cap portion prior to entering the cannulation at a distal end of the barrel portion”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Structurally, since the recesses of Schulz are similar to that of the claimed invention, they are fully capable of meeting any functional requirements.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation “the barrel portion of the cannulation” and "the cap portion of the cannulation " in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “a barrel portion of the cannulation” and “a cap portion of the cannulation”.
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, 6, 9-12, 22 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaughan (US 9474592 B1) (noted on IDS) in view of Schulz (US 20190216456 A1) (previously of record).
Regarding claim 1, Vaughan discloses a locking ferrule for performing a knotless tissue repair ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.), comprising:
a body (10) (Figure 3-7; Col 7, line 24-25) including a cap portion (62) that includes a top surface (upper surface of 62), a bottom surface (lower surface of 62), and a side wall (circumferential side wall of 62) that extends between the top surface and the bottom surface (Figure 3-5), and a barrel portion (30) that protrudes from the bottom surface of the cap portion (Figure 3; Col 7, lines 28-34);
a cannulation (lumen of 30 between 42 and 36) formed through the body (Figure 3, 5; Col 9, line 11-14); and
a plurality of locking barbs (48) arranged within the cannulation and configured to establish a one-way locking mechanism for locking a suture that is shuttled through the cannulation (Figure 3-7; Col 7, lines 58-63).
Vaughan fails to disclose a cut-out formed in the body, the cut-out extending radially into the side wall of the cap portion and opening through both the top surface and the bottom surface of the cap portion, the cut-out being configured to allow the suture to pass through the cap portion prior to entering the cannulation at a distal end of the barrel portion that is opposite from the cap portion.
However, Schulz is directed to a bone anchor (10) and a cap portion (11) that includes a top surface (12), a bottom surface (15), and a side wall (circumferential side wall of 11) that extends between the top surface and the bottom surface (Figure 4; Paragraph 0052); a cut-out (20) formed in the body (Figure 4; Paragraph 0052); a barrel portion (16) that protrudes from the bottom surface of the cap portion (Figure 3; Paragraph 0052); wherein the cut-out extends radially into the side wall and opens through both the top surface and the bottom surface of the cap portion (Figure 1, 4; Paragraph 0052); wherein the cut-out is configured to allow the suture to pass through the cap portion prior to entering the cannulation at a distal end of the barrel portion ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.) (Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Vaughan such that wherein the cut-out extends radially into the side wall and opens through both the top surface and the bottom surface of the cap portion; wherein the cut-out is configured to allow the suture to pass through the cap portion prior to entering the cannulation at a distal end of the barrel portion, as taught by Schulz, as both references and the claimed invention are directed to bone anchors. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vaughan with the teachings of Schulz by incorporating wherein the cut-out extends radially into the side wall and opens through both the top surface and the bottom surface of the cap portion; wherein the cut-out is configured to allow the suture to pass through the cap portion prior to entering the cannulation at a distal end of the barrel portion in order to facilitate the subsequent passage of a graft, for example a tendon or potentially a suture (Schulz Paragraph 0052).
Regarding claim 6, Vaughan further discloses wherein the barrel portion (30) that includes an interior wall (32) and an outer diameter wall (34) (Col 7, lines 28-34).
Regarding claim 9, Vaughan further discloses wherein each of the plurality of locking barbs is angled in a direction toward a cap portion of the body (Figure 3, 5; Col 7, lines 43-46).
Regarding claim 10, Vaughan further discloses wherein each of the plurality of locking barbs protrudes inwardly from an interior wall that circumscribes the cannulation (Figure 3, 5; Col 7, line 38-40).
Regarding claim 11, Vaughan further discloses wherein the plurality of locking barbs are arranged in at least a first row (left side) and a second row (right side) within the cannulation (Figure 3, 5; Col 8, line 58-59).
Regarding claim 12, Vaughan further discloses wherein a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row (Figure 5; Col 8, lines 62-65).
Regarding claim 13, Vaughan further discloses wherein each of the plurality of locking barbs includes a pointed tip (52) (Figure 3, 5; Col 7, lines 43-46).
Regarding claim 22, Vaughan further discloses wherein the plurality of locking barbs are flexible structures (Col 8, line 3-8) (the barbs are deflectable and deformable, thus are flexible).
Regarding claim 25, Vaughan discloses a system for performing a knotless tissue repair, comprising:
a suture (26) (Col 8, line 42-48); and
a locking ferrule (10) configured to knotlessly fixate the suture ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.), the locking ferrule comprising:
a cap portion (62) that includes a top surface (upper surface of 62), a bottom surface (lower surface of 62), and a side wall (circumferential side wall of 62) that extends between the top surface and the bottom surface (Figure 3-5),
a barrel portion (30) that protrudes from the bottom surface of the cap portion (Figure 3; Col 7, lines 28-34);
a cannulation (lumen of 30 between 42 and 36) formed through the body (Figure 3, 5; Col 9, line 11-14); and
a plurality of locking barbs (48) arranged within the cannulation provided by both the cap portion and the barrel portion (the lumen extends through the barrel and cap as shown in Figure 4), the plurality of locking barbs being angled to permit movement of the suture in a first direction and resist movement of the suture in an opposite second direction (Figure 3-7; Col 7, lines 58-63).
Vaughan fails to disclose a scallop formed in the side wall of the cap portion, the scallop extending radially into the side wall and opening through both the top surface and the bottom surface of the cap portion, wherein the scallop establishes a pathway sized to permit the suture to be routed around the cap portion and thereafter introduced into the cannulation at a distal end of the barrel portion opposite the cap portion.
However, Schulz is directed to a bone anchor (10) and a cap portion (11) that includes a top surface (12), a bottom surface (15), and a side wall (circumferential side wall of 11) that extends between the top surface and the bottom surface (Figure 4; Paragraph 0052); comprising a barrel portion (16) that protrudes from the bottom surface of the cap portion (Figure 3; Paragraph 0052); a scallop (20) formed in the side wall of the cap portion and opening through both the top surface and the bottom surface of the cap portion (Figure 4; Paragraph 0052). As a result of the modification, the scallop establishes a pathway sized to permit the suture to be routed around the cap portion and thereafter introduced into the cannulation at a distal end of the barrel portion opposite the cap portion ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.) (Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Vaughan such that a scallop formed in the side wall of the cap portion, the scallop extending radially into the side wall and opening through both the top surface and the bottom surface of the cap portion, wherein the scallop establishes a pathway sized to permit the suture to be routed around the cap portion and thereafter introduced into the cannulation at a distal end of the barrel portion opposite the cap portion, as taught by Schulz, as both references and the claimed invention are directed to bone anchors. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vaughan with the teachings of Schulz by incorporating a scallop formed in the side wall of the cap portion, the scallop extending radially into the side wall and opening through both the top surface and the bottom surface of the cap portion, wherein the scallop establishes a pathway sized to permit the suture to be routed around the cap portion and thereafter introduced into the cannulation at a distal end of the barrel portion opposite the cap portion in order to facilitate the subsequent passage of a graft, for example a tendon or potentially a suture (Schulz Paragraph 0052).
Claim(s) 14-15 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaughan in view of Schulz and further in view of Ruff et al. (US 20050267531 A1) (previously of record).
Regarding claims 14-15, Vaughan as modified by Schulz discloses the locking ferrule as recited in claim 1, but fails to explicitly disclose wherein the suture includes a varying thickness and wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section.
However, Ruff is directed to a suture and teaches wherein the suture (90) includes a varying thickness (the barbs 94 and pointed end 96 create varied thickness) (Figure 1; Paragraph 0041) and wherein the suture includes at least one tapered region (96) where the suture transitions between a thickened section and a thinned section (Figure 1; Paragraph 0041).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Vaughan as modified by Schulz such that wherein the suture includes a varying thickness and wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section, as taught by Ruff, as both references and the claimed invention are directed to suture devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vaughan as modified by Schulz with the teachings of Ruff by incorporating wherein the suture includes a varying thickness and wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section in order to promote easy insertion of the suture into the tissue (Paragraph 0049).
Regarding claim 23, Vaughan further discloses wherein the plurality of locking barbs are sized and shaped to interdigitate with the suture at the thickened section to one-way lock the suture (the barbs of Vaughan are designed much like the barbs in the present disclosure. Further, Vaughan pulls a suture through the sleeve interior 28, thus depending on the thickness of the suture, the barbs would be fully capable of interdigitating with the suture at the thickened section to one-way lock the suture) (Figure 3; 5; Col 8, line 7-9; 42-48).
Regarding claim 24, Vaughan further discloses wherein each of the plurality of locking barbs includes a pointed tip (52) that is angled toward the cap portion (Figure 3, 5; Col 7, line 40-42).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaughan in view of Schulz and further in view of Lopez (US 20160296319 A1).
Regarding claim 21, Vaughan as modified by Schulz teaches the locking ferrule as recited in claim 1, a second portion of the plurality of locking barbs (barbs within sleeve interior 28) is arranged within a barrel portion of the cannulation (Figure 3; 5; Col 7, lines 58-63) but fails to explicitly disclose wherein a first portion of the plurality of locking barbs is arranged within a cap portion of the cannulation.
However, Lopez is directed to a tissue and bone anchor and teaches a cap portion (1) with a cannulation (18) and plurality of locking barbs (26) arranged within the cap portion of the cannulation (Figure 3A-B; Paragraph 0041).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Vaughan as modified by Schulz such that the anchor of Vaughan is provided a plurality of locking barbs arranged within a cap portion of the cannulation, as taught by Lopez, as both references and the claimed invention are directed to bone anchors. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vaughan as modified by Schulz with the teachings of Lopez by incorporating a plurality of locking barbs is arranged within a cap portion of the cannulation in order to increase the area of the barbs to enhance security of the inserted graft or tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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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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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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