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 .
Detailed Action
This is in response to the amendment filed 10/01/2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/03/2026 has been entered.
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.
Claim(s) 1-4, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 9,474,592 (Vaughan) in view of U.S. Patent Publication Number 2001/0051815 (Esplin)
Regarding claim 1-4, 12 Vaughan discloses as shown in Figures 3-5, a suture locking system capable of performing a tensionable knotless surgical procedure, comprising: a suture (suture 26, see col. 8, lines 42-47) a locking ferrule including cap portion (flange 62, see col. 10, lines 9-67) ; a barrel portion (sleeve wall 30, see col. 7, lines 28-46); a cannulation formed through the cap portion and the barrel portion; and a plurality of locking barbs (barbs 48, see col. 1, lines 28-46) arranged within the cannulation and capable of engaging the suture to establish a one-way locking mechanism for locking the suture within cannulation, wherein the cap portion includes a top surface, a bottom surface, and a side wall that extends between the top surface and the bottom surface, wherein the barrel portion protrudes from the bottom surface of the cap portion, wherein the barrel portion includes an interior wall and an outer diameter wall, wherein at least a portion of the plurality of locking barbs protrudes inwardly from the interior wall, wherein each of the plurality of locking barbs is angled in a direction toward the cap portion, wherein the plurality of locking barbs are arranged in at least a first row and a second row within the cannulation, 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, wherein each of the plurality of locking barbs includes a pointed tip, wherein the cap portion and the barrel portion establish a unitary structure that includes a top hat-like appearance, with each locking barb including a pointed tip tat is angled toward the cap portion and sized and spaced to interdigitate wit suture.
Vaughan fails to disclose a plurality of locking barbs is located within the cap, the plurality of locking barbs arranged in at least a first row and second row that are staggered relative to one another.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Vaughan by rearranging some of the plurality of locking barbs such that a plurality of locking barbs is located within the cap because it would only require a rearrangement of parts with modifying how the device operates (barbs would still engage tissue). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Esplin, from a related field of endeavor teaches a similar locking system as shown in Figures 7a-7c with similar locking barbs (teeth 22, see paragraph [0068] wherein) the plurality of locking barbs arranged in at least a first row and second row that are staggered relative to one another for the purpose of resisting lateral separation and greatly reducing the risk of tearing through tissue. See paragraph [0068].
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Vaughan by rearranging some of the plurality of locking barbs such that a plurality of locking barbs is located within the cap, the plurality of locking barbs arranged in at least a first row and second row that are staggered relative to one another in order to resist lateral separation and greatly reducing the risk of tearing through tissue advanced through the sleeve, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 10, 11, 23, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 9,474,592 (Vaughan) in view of U.S. Patent Publication Number 2001/0051815 (Esplin) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2014/0074158 (Feezor et al.)
Regarding claims 10, 11, Vaugh fails to disclose wherein the suture includes a varying thickness, wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section.
Feezor et al., from the same field of endeavor teaches as similar system with a suture as shown in Figure 4, where the suture includes a varying thickness, wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section for the purpose of configuring the suture to suspend tissue. See abstract.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Vaugh such that the suture includes a varying thickness, wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section in order to configure the suture to suspend tissue.
Regarding claim 23, Vaugh fails to disclose wherein the thickened section is twice as thick as the thinned section. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Vaugh such that the thickened section is twice as thick as the thinned section as a matter of engineering design choice.
Applicant has not disclosed the thickened section being twice as thick provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraphs [0074], [0075]. One of ordinary skill in the art, furthermore, would have expected Vaugh in view of Feezor’s thickened section, and applicant’s invention, to perform equally well with either the thickness by Vaugh in view of Feezor or the claimed twice as thick because both spacing dimensions would perform the same function of configuring the suture to suspend tissue equally well considering the relative dimensions disclosed.
Regarding claim 27, Vaugh discloses the locking sutures are configured to engage the suture. see col. 1, lines 28-46.
Vaugh fails to disclose wherein the suture includes a varying thickness, wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section.
Feezor et al., from the same field of endeavor teaches as similar system with a suture as shown in Figure 4, where the suture includes a varying thickness, wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section for the purpose of configuring the suture to suspend tissue. See abstract.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Vaugh such that the suture includes a varying thickness, wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section in order to configure the suture to suspend tissue.
Claim(s) 13-16, 19, 21, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0245932 (Fanton et al.) in view of U.S. Patent Publication Number 2008/0154286 (Abbott et al.)
Regarding claims 13, 14 Fanton et al. discloses as shown in Figure 8, a surgical method, comprising: shuttling a suture (suture 30, see paragraph [0059]) through a cannulation of a locking ferrule (anchor 240, see paragraph [0108]); inserting the locking ferrule into a passage formed in a bone; see Figure 8; tensioning the suture in a first direction relative to the bone; and locking the suture within the cannulation with a plurality of locking barbs (cleated members 254, see paragraph [0110]) that engage the suture, to prevent movement of the suture in a second direction relative to the bone, wherein the locking ferrule includes a cap portion (flange 245, see paragraph [0109]) that is received against an outer surface of the bone and a barrel portion (main body 242, see paragraph [0109]) that extends into the passage, each locking barb including a pointed tip angled toward a cap portion of the locking ferrule. See paragraph [0113].
Fanton fails to disclose the barbs are arranged in at least a first row and a second row that are staggered relative to one another.
Abbott et al., from the same field of endeavor teaches a similar surgical method that using a similar locking structure as shown in Figure 25A, wherein the barbs (abutments 346-1 and 346-2, see paragraph [0178]) are arranged in at least a first row and a second row that are staggered relative to one another for the purpose of facilitating locking a suture. See paragraph [0178].
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Fanton by rearranging some of the plurality of locking barbs such that a plurality of locking barbs is located within the cap, because it would only require a rearrangement of parts with modifying how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Fanton by rearranging some of the plurality of locking barbs such that the plurality of locking barbs arranged in at least a first row and second row that are staggered relative to one another as taught by Abbott et al in order to facilitate locking a suture.
Regarding claims 15, 16 Fanton is silent about wherein the suture is shuttled through the cannulation before inserting the locking ferrule into the passage or wherein the suture is shuttled through the cannulation after inserting the locking ferrule into the passage.
It is the position of the Office that it would have been obvious to try to modify the method disclosed by Fanton such that the suture is shuttled through the cannulation before inserting the locking ferrule into the passage or wherein the suture is shuttled through the cannulation after inserting the locking ferrule into the passage because it represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
In this case, the order in which steps are performed are necessarily finite. Switch the order such that the suture is shuttled through the cannulation before inserting the locking ferrule into the passage or wherein the suture is shuttled through the cannulation after inserting the locking ferrule into the passage would not substantially change the method and produce a predictable result.
Regarding claim 19, Fanton fails to disclose shuttling a second suture through a second cannulation of a second locking ferrule; inserting the second locking ferrule into a second passage formed in the bone; tensioning the second suture in the first direction relative to the bone; and locking the second suture within the second cannulation to prevent movement of the second suture in the second direction.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify method disclosed by Fanton to include the steps ofshuttling a second suture through a second cannulation of a second locking ferrule; inserting the second locking ferrule into a second passage formed in the bone; tensioning the second suture in the first direction relative to the bone; and locking the second suture within the second cannulation to prevent movement of the second suture in the second direction because it would only require the duplication of all of the steps already disclosed by Fanton without producing new and unexpected result or for the purpose of securing a second suture to the bone. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 21, Fanton et al. discloses wherein the plurality of locking barbs are arranged in at least a first row and a second row within the cannulation, and further wherein each of the locking barbs includes a pointed tip for interdigitating with the suture. See Figure 8.
Fanton et al. fails to disclose the locking barbs of the second row staggered relative to the locking barbs of the first row. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the location of the locking barbs of the second row disclosed by Fanton et al. such that they were staggered relative to the locking barbs of the first row because it would only require a rearrangement of parts without changing how the device operates (barbs would still lock the suture). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Regarding claim 22, Fanton fails to disclose wherein at least a portion of the plurality of locking barbs are provided along a portion of the cannulation that is formed through the cap portion.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the location of the locking barbs such that at least a portion of the plurality of locking barbs are provided along a portion of the cannulation that is formed through the cap portion because it would only require a rearrangement of parts without changing how the device operates (barbs would still lock the suture). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0245932 (Fanton et al.) in view of U.S. Patent Publication Number 2008/0154286 (Abbott et al.) as applied to claim 13 above, and further in view of U.S. Patent Publication Number 2016/0220347 (Hoover)
Regarding claim 17, Fanton et al. fails to disclose wherein the suture is attached to a graft, and wherein tensioning the suture in the first direction pulls the graft into a socket formed in the bone, wherein the passage is connected to the socket.
Hoover, from the same field of endeavor teaches a similar method as shown in Figure 1, where the suture is attached to a graft, and wherein tensioning the suture in the first direction pulls the graft into a socket formed in the bone, wherein the passage is connected to the socket for the purpose of attaching a graft to the bone.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Fanton in order to attaching a graft to the bone.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0245932 (Fanton et al.) in view of U.S. Patent Publication Number 2008/0154286 (Abbott et al.) as applied to claim 13 above, and further in view of U.S. Patent Publication Number 2011/0208198 (Anderson et al.)
Regarding claim 20, Fanton fails to disclose wherein the surgical method is an ulnar collateral ligament (UCL) reconstruction.
Anderson et al., from the same field of endeavor teaches a similar method as shown in Figure 12 where the method includes an ulnar collateral ligament (UCL) reconstruction. See paragraph [0002].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Fanton such that the method is an ulnar collateral ligament (UCL) reconstruction in order to reconstruct ulnar collateral ligament.
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 9,474,592 (Vaughan) ) in view of U.S. Patent Publication Number 2001/0051815 (Esplin)
Regarding claim 24, 26 Vaughan discloses as shown in Figures 3-5 a suture locking system capable of performing a tensionable knotless surgical procedure, comprising: a suture (suture 26, see col. 8, lines 42-47); and a locking ferrule including a cap portion (flange 62, see col. 10, lines 9-67), a barrel portion(sleeve wall 30, see col. 7, lines 28-46), a cannulation formed through the cap portion and the barrel portion, and a plurality of locking barbs(barbs 48, see col. 1, lines 28-46) arranged within the cannulation and sized and spaced to be capable of interdigitating with the suture to establish a one-way locking mechanism for locking the suture within the cannulation; the locking barbs are angled toward the cap portion and arranged in at least a first row and a second row, and the one-way locking mechanism permits the suture to move in a first direction through the cannulation and prevents movement of the suture in a second direction opposite to the first direction, wherein the plurality of locking barbs are flexible structures.
Vaughan fails to disclose with the locking barbs of the second row staggered relative to the locking barbs of the first row.
Esplin, from a related field of endeavor teaches a similar locking system as shown in Figures 7a-7c with similar locking barbs (teeth 22, see paragraph [0068] wherein) the plurality of locking barbs arranged in at least a first row and second row that are staggered relative to one another for the purpose of resisting lateral separation and greatly reducing the risk of tearing through tissue. See paragraph [0068].
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Vaughan by rearranging some of the plurality of locking barbs such that a plurality of locking barbs is located within the cap, the plurality of locking barbs arranged in at least a first row and second row that are staggered relative to one another in order to resist lateral separation and greatly reducing the risk of tearing through tissue advanced through the sleeve, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 25, Vaughan discloses a second portion of the barbs are arranged within the barrel portion of the cannulation. See Figures 3-5.
Vaughan fails to disclose a first portion of the barbs are arranged within the cap portion of the cannulation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the location of some of the locking barbs disclosed by Vaughan such that they were staggered relative to the locking barbs of the first row because it would only require a rearrangement of parts without changing how the device operates (barbs would still lock tissue). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Response to Arguments
Applicant's arguments filed 02/03/2026, see pages 6-14 have been fully considered but they are largely moot in view of the new grounds of rejection. The applicant argues Vaughan fails to disclose the flange 62 has a cannulation. In response, the Office respectfully disagrees. Figure 4 clearly shows the flange 62 has a cannulation. Figure 7 also shows sutures 26 pulled through the flange. In order for sutures 26 to be pulled through the flange 62, it would necessarily require a cannulation.
The applicant argues claim 1 distinguishable from Vaughn because Vaughn’s barbs are configured to grip tissue and not sutures. In response, the office respectfully disagrees. The applicant is arguing a functional limitation. The applicant describes the structure of the claimed locking barbs as structure with a sharp pointed tip made of a rigid or flexible material. See paragraphs [0071]-[0073]. This is exactly how Vaughn describes their barbs. See col. 1, lines 28-46 and col. 9, lines 50-52.
Function follows structure. Since the structural limitations (i.e., barbs protruding inwardly from a cannula, angled toward the cap, pointed tip, flexible or rigid) are met by the reference, then it may be reasonably concluded that the functional limitations are also met.
The fact that Vaughn discloses the barbs are intended to be used with tissue is of little relevance is it is not excluded by the claim. Claim 1 recites barbs which are capable of being used with a suture, and that is exactly what Vaughn discloses.
The applicant speculates a barb designed to restrain complaint, deformable mass of tissue do not inherently possess the structural features necessary to securely engage individual suture strands under tension. In response, the Office respectfully disagrees.
Arguments presented by the applicant cannot take the place of evidence in the record. See In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Applicant’s speculation is not supported by any evidence in the record. In fact, their position is undermined by their own specification. Their own specification does not describe any structure to the barb which is not taught in Vaughn. See paragraphs [0071]-[0073] of the specification. The applicant also does not claim or describe precision positioning of the barbs. In paragraph [0071] states the barbs may therefore occupy at least a portion of the open space of the cannulation. Paragraph [0141] of the specification also specifies that the disclosure should not be read as limiting.
Additionally, one of ordinary skill in the art would recognize barbs configured to engage tissue as barbs configured to engage a suture. See paragraph [0089] of U.S. Patent Publication Number 2012/0296345.
Furthermore, the applicant is not claiming barbs which are capable of engage individual suture strands under tension. Thus whether or not Vaughn is of little relevance as it does not relate to a limitation in the claims.
Regarding claim 13, the applicant argues Fanton fails to disclose a plurality of locking barbs that engage the suture to prevent movement of the suture in a second directions relative to bone. In response, the Office respectfully disagrees. Cleated members 254 are locking barbs that engage the suture, to prevent movement of the suture in a second direction relative to the bone. see paragraph [0110]).
The applicant argues the claimed barbs are structurally and functionally distinct from cleat members 254. Regarding the structure, the applicant argues that since Fanton does not disclose the cleats are barbs protruding inwardly from a cannulation wall.
In response, the Office respectfully disagrees. Whether or not Fanton uses the same term (barb as opposed to cleat) is of little relevance. A reference need not satisfy an ipsissimis verbis test, In re Bond, 910 F.2d 831, 832-33 (Fed. Cir. 1990).
The plain meaning of the term barb is a sharp projection with a point extending backwards (which is not inconsistent with the specification), which is exactly what Fanton discloses. Furthermore, claim 13 does not require the barbs to protrude inwardly from a cannulation wall. Thus, whether or not Fanton discloses this feature is of little relevance as it does not relate to a limitation in the claim.
Regarding functionality, the applicant admits Fanton discloses the cleats permit one-way movement of the suture ends but not locking the suture within the cannulation to prevent reverse movement. In response, the Office respectfully disagrees. Fanton specifically discloses the suture is locked from moving in a distal direction: “a physician cannot distally advance suture end 32a within passage 250”, see paragraph [0114].
The Office is unclear why the cleats disclosed Fanton should not be considered locking the suture to prevent movement of the suture in a second direction relative to the bone when they are specifically disclosed as preventing movement of the suture in a second direction relative to the bone.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771