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
This Office Action is a response to applicant’s arguments and amendment filed 04/24/2026. Claims 1, 12 and 43 are amended. Claims 2-3, 6-9, 11, 18, 20, 29-31, 33-34, 44-45 and 50 are cancelled. Claim 57 is new. Claims 1, 4-5, 10, 12-17, 19, 21-28, 32, 35-43, 46-49 and 51-57 are currently pending, with claims 51-56 withdrawn from consideration.
The rejection of claims 12-17, 19 and 43 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
The rejection of claims 12-17 and 19 under 35 U.S.C. 112(d) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/24/2026, with respect to the rejection(s) of claim(s) 1, 4-5, 10, 12-16, 21-25, 27-28, 32 and 35 under 35 U.S.C. 103 as being unpatentable over Brunsvold in view of Hendricksen; claims 1, 12, 17, 19, 26 and 40-43 under 35 U.S.C. 103 as being unpatentable over Fallin in view of Hendricksen; claims 1 and 36-39 under 35 U.S.C. 103 as being unpatentable over Rizk in view of Hendricksen; claims 46-48 under 35 U.S.C. 103 as being unpatentable over Brunsvold in view of Hendricksen and Jastifer; and claim 49 under 35 U.S.C. 103 as being unpatentable over Brunsvold in view of Hendricksen, Jastifer and Sengun, have been fully considered and are persuasive, in combination with the claims; specifically, Hendricksen does not teach the sutures placed within a fixed location of the cavity as claimed. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of West, Jr. as discussed below.
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 57 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.
Regarding claim 57, the claim recites “the threaded and unthreaded portions of the anchor”. There is insufficient antecedent basis for this limitation in the claim, since threaded and unthreaded portions of the anchor have not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to threaded and unthreaded portions of the anchor.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-5, 10, 12-14, 16-17, 19, 21-24, 26-28, 32, 35, 40-43 and 57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by West, Jr. (US 2012/0065677 A1).
Regarding claim 1, West, Jr. discloses (see abstract; paras. [0039]-[0085]; figs. 1-14) a device (anchor 100, figs. 8-13) comprising:
an anchor (100, para. [0069]) configured to at least partially reside within a rigid structure (driven into bone, para. [0072]), the anchor being further configured to hold one or more sutures (136), wherein the anchor comprises two crossbars (includes protrusions 168 and spacers 172 forming two crossbars in an ‘x’-shape, which appears consistent with fig. 2 of the instant spec., paras. [0070] and [0073]; fig. 13) laterally disposed (fig. 13) entirely within and transversing an interior cavity (bore 130, para. [0069]) of the anchor (disposed within bore, fig. 12), wherein the two crossbars intersect one another at a location within the interior cavity (depicted in fig. 13), wherein the two crossbars are configured to receive and secure the one or more sutures in place at a fixed location in the interior cavity (sutures are looped around attachment sites formed by longitudinal pin 162, which may be permanently fixed to threaded portion 160, considered to provide a fixed location within bore 130, paras. [0071] and [0077]-[0078]; figs. 12-14); and
the anchor comprising one or more flanges (formed by socket 122, para. [0072]) on an interior surface of the anchor (fig. 10) configured to engage corresponding flanges of a cap for securing the cap to the anchor (considered to be capable of engaging corresponding flanges of a cap, since socket 122 is configured to receive hex driver; further note the cap is not positively recited, such that flanges within the interior of the anchor are considered to be capable of engaging corresponding structures on an additional structure such as a cap).
Regarding claim 4, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the anchor comprises one or more sections (166, para. [0070]; fig. 10) configured to receive and hold at least a portion of the one or more sutures (para. [0070]).
Regarding claim 5, West, Jr. discloses the device of claim 4. West, Jr. further discloses wherein the one or more sections comprise wedges, notches, grooves, gaps, channels, or indentions (channels or indentions formed by protrusions and spacers, depicted in figs. 8-13).
Regarding claim 10, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the anchor comprises a first threaded portion (160, para. [0069]) configured to permit attachment of the anchor to the rigid structure (driven into bone, para. [0072]).
Regarding claim 12, West, Jr. discloses the device of any one of claims 1, 4-5, and 10. West, Jr. further discloses further comprising an applicator (hex driver, para. [0072]), the applicator comprising a dispenser (hex driver considered to be a dispenser) and a first alignment mechanism (hex shape of driver), wherein the first alignment mechanism is configured to interact with a second alignment mechanism (corresponding portions of socket, para. [0072]; fig. 10) disposed upon the cap (note the cap has not been positively recited and is interpreted as a functional limitation as discussed with respect to claim 1, such that the cap is considered to be functionally recited, and a first alignment mechanism configured to interact with a second alignment mechanism is considered to meet the claim limitation).
Regarding claim 13, West, Jr. discloses the device of claim 12. West, Jr. further discloses wherein the first and second alignment mechanisms are complementary to one another (hex socket and hex drive complementary to another, para. [0072]).
Regarding claim 14, West, Jr. discloses the device of claim 12. West, Jr. further discloses wherein the second alignment mechanism is configured to receive the first alignment mechanism (para. [0072]).
Regarding claim 16, West, Jr. discloses the device of claim 12. West, Jr. further discloses wherein the second alignment mechanism is removable (considered to at least be removable relative to hex driver, since hex driver is engaged and disengaged from hex socket, para. [0072]).
Regarding claim 17, West, Jr. discloses the device of claim 12. West, Jr. further discloses wherein the applicator further comprises one or more aligning bars (hex-shaped portions of hex driver) and the anchor further comprises one or more aligning notches (hex-shaped portions of socket) configured to receive the one or more aligning bars (para. [0072]).
Regarding claim 19, West, Jr. discloses the device of claim 12. West, Jr. further discloses wherein the anchor further comprises one or more aligning bars (see vertical hex-shaped portions of socket, considered to be aligning bars, annotated fig. 10) and the applicator further comprises one or more aligning notches (notches considered to be formed by protruding portions of hex-shaped driver that corresponds to hex socket) configured to receive the one or more aligning bars (para. [0072]).
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Annotated Figure 10 of West, Jr.
Regarding claim 21, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the rigid structure comprises a hard tissue of a subject (bone, para. [0072]).
Regarding claim 22, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the rigid structure comprises a bone of a subject (para. [0072]).
Regarding claim 23, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the rigid structure comprises cortical bone, cancellous bone (abstract describes use with cortical and cancellous bone tissue), flat bones, long bones (humerus bone which encompasses a long bone, paras. [0005] and [0065]; fig. 7), enamel, cartilage, or fibrocartilage.
Regarding claim 24, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the device is substantially cylindrical (depicted in figs. 8-14).
Regarding claim 26, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the anchor is configured to be removable when at least partially residing within the rigid structure (note this limitation is functional, such that threading is considered to be capable of being counter-rotated to allow the anchor to be removable, further note pin 162 may be temporarily fixed to threaded portion 160 and therefore considered to be removable, para. [0077]).
Regarding claim 27, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the anchor is configured to reversibly hold the one or more sutures (sutures extend proximally relative to anchor and therefore considered to be reversibly held, figs. 8-14).
Regarding claim 28, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the anchor is configured to be permanent or semi-permanent (anchor used in rotator cuff repair surgery, considered to at least be semi-permanent, paras. [0039] and [0065]).
Regarding claim 32, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the device is configured to permit adjustment of a tension within each of the one or more sutures (anchor slidably receives each suture, considered to permit adjustment of tension by allowing sutures to slide, such that tension applied to an object by the suture could be adjusted by sliding the sutures, abstract, paras. [0010] and [0077]-[0078]).
Regarding claim 35, West, Jr. discloses the device of claim 1. West, Jr. further discloses wherein the device comprises a metal or a synthetic polymer (para. [0046]).
Regarding claim 40, West, Jr. discloses the device of claim 1. West, Jr. further discloses the device configured for use in rotator cuff repair (abstract).
Regarding claim 41, West, Jr. discloses the device of claim 40. West, Jr. further discloses wherein the upper airway surgery comprises larynx repair, pharynx repair, or a combination thereof (note this is an alternative limitation and not required by the limitations of claim 40).
Regarding claim 42, West, Jr. discloses a method of securing soft tissue to a rigid structure comprising:
drilling a channel into the rigid structure (pilot hole may be drilled, para. [0065]; fig. 7);
inserting the anchor of the device of claim 1 into the rigid structure (bone anchor inserted into pilot hole);
suturing a soft tissue to the anchor with the one or more sutures (para. [0068]);
modifying the tension of the one or more sutures (considered to be modified via sliding, paras. [0067] and [0077]); and
placing the cap (note claim 1 previously recites the cap functionally, such that the claim language does not require the cap of the device, however, further note tip 178 may be interpreted as the cap with respect to method claims 42 and 43, para. [0076]; fig. 12) on the anchor to secure the one or more sutures in place (considered to be placed on distal end of threaded portion 160, para. [0077]).
Regarding claim 43, West, Jr. discloses the method of claim 42. West, Jr. further discloses further comprising:
looping each of the one or more sutures around the two intersecting crossbars disposed within the interior cavity of the anchor (via pre-threading, paras. [0052] and [0063]);
passing the one or more sutures through the soft tissue (para. [0068]);
temporarily securing at least a portion of the one or more sutures within a section (considered to be at least temporarily secured within section of pin 162, para. [0068]);
tensioning the one or more sutures (when slid across opening of the bore, paras. [0067] and [0077]); and
affixing the cap to the anchor (tip 178 may be permanently or temporarily fixed to threaded portion 160, para. [0077]).
Regarding claim 57, West, Jr. discloses (see abstract; paras. [0039]-[0085]; figs. 1-14) a device (anchor 100, figs. 8-13) comprising:
an anchor (100, para. [0069]) configured to at least partially reside within a rigid structure (driven into bone, para. [0072]), the anchor being further configured to hold one or more sutures (136), wherein the anchor comprises two crossbars (includes protrusions 168 and spacers 172 forming two crossbars in an ‘x’-shape, which appears consistent with fig. 2 of the instant spec., paras. [0070] and [0073]; fig. 13) laterally disposed (fig. 13) entirely within and transversing an interior cavity (bore 130, para. [0069]) of the anchor (disposed within bore, fig. 12), wherein the two crossbars intersect one another at a location within the interior cavity (depicted in fig. 13), wherein the two crossbars are configured to receive and secure the one or more sutures in place at a fixed location in the interior cavity (sutures are looped around attachment sites formed by longitudinal pin 162, which may be permanently fixed to threaded portion 160, considered to provide a fixed location within bore 130, paras. [0071] and [0077]-[0078]; figs. 12-14), wherein the one or more sutures are pre-threaded around the two crossbars (anchor distributed to practitioners with sutures threaded through bore 30, paras. [0052] and [0063]), wherein the two crossbars are located at an interface of the threaded and unthreaded portions of the anchor (see annotated fig. 12, depicting protrusions 168 and spacers 172 extending over a location between threaded and unthreaded portions of the anchor, shown as dotted lines extending across the device); and
the anchor comprising one or more flanges (formed by socket 122, para. [0072]) on an interior surface of the anchor (fig. 10) configured to engage corresponding flanges of a cap for securing the cap to the anchor (considered to be capable of engaging corresponding flanges of a cap, since socket 122 is configured to receive hex driver; further note the cap is not positively recited, such that flanges within the interior of the anchor are considered to be capable of engaging corresponding structures on an additional structure such as a cap).
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Annotated Figure 12 of West, Jr.
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) 15 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over West, Jr.
Regarding claim 15, West, Jr. discloses the device of claim 12.
West, Jr. further discloses wherein the second alignment mechanism is configured to receive the first alignment mechanism (para. [0072]).
However, West, Jr. fails to disclose wherein the first alignment mechanism is configured to receive the second alignment mechanism.
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 device of West, Jr. such that the first alignment mechanism is configured to receive the second alignment mechanism, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Regarding claim 25, West, Jr. discloses the device of claim 1.
However, West, Jr. fails to disclose wherein the device is polygonal.
There is no evidence of record that establishes that changing the shape of the device to be polygonal would result in a difference in function of the device of West, Jr. Further, a person having ordinary skill in the art, being faced with modifying the device of West, Jr., would have a reasonable expectation of success in making such a modification, and it appears the device would function as intended being given the claimed shape. Lastly, applicant has not disclosed that the claimed shape solves any stated problem (para. [0018] of the instant spec.) and therefore there appears to be no criticality placed on the shape of the device as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the device of West, Jr. to be polygonal as an obvious matter of design choice within the skill of the art.
Claim(s) 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over West, Jr. in view of Rizk (US 2015/0018878 A1) (previously of record).
Regarding claim 36, West, Jr. discloses the device of claim 1.
However, West, Jr. fails to disclose wherein the device comprises a bioprinted material.
Rizk teaches (paras. [0023], [0026], [0037] and [0103]), in the same field of endeavor, a device (20, fig. 1a) comprising bioprinted material (3D-printed bioceramic material, considered to be bioprinted, paras. [0023], [0026], [0037] and [0103]), for the purpose of improving osteointegration via resorbable materials and a soft suture anchor, reducing or eliminating bone loss following implantation, allowing the anchor to be inserted into a smaller bone hole to minimize damage to healthy tissue, and eliminating any hardware related issues (abstract, paras. [0009]-[0010]).
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 material of the anchor of West, Jr. to comprise bioprinted material, in order to improve osteointegration via resorbable materials and a soft suture anchor, reduce or eliminate bone loss following implantation, allow the anchor to be inserted into a smaller bone hole to minimize damage to healthy tissue, and eliminate any hardware related issues when desired, based on the teachings of Rizk (abstract, paras. [0009]-[0010]).
Regarding claim 37, West, Jr. (as modified) teaches the device of claim 36. West, Jr. (as modified) further teaches wherein the bioprinted material comprises a natural or synthetic protein, a mineral, or a combination thereof (includes collagen, para. [0050]).
Regarding claim 38, West, Jr. (as modified) teaches the device of claim 37. West, Jr. (as modified) further teaches wherein the protein comprises collagen, laminin, or a combination thereof (para. [0050]).
Regarding claim 39, West, Jr. (as modified) teaches the device of claim 37. West, Jr. (as modified) further teaches wherein the mineral comprises tricalcium phosphate (para. [0037]).
Claim(s) 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over West, Jr. in view of Jastifer (US 2018/0243078 A1) (previously of record).
Regarding claim 46, West, Jr. discloses the device of claim 1.
However, West, Jr. fails to disclose a kit for securing soft tissue to a rigid structure comprising the device of claim 1 and instructions for use.
Jastifer teaches (para. [0091]), in the same field of endeavor, a kit for anchoring tissue to a bone (abstract, para. [0088]) comprising instructions for use (para. [0091]), for the purpose of providing a kit with multiple anchors and instructions based on the treatment intended to be performed while taking into account various considerations (para. [0091]).
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 device of West, Jr. to further include a kit including multiple anchors and instructions for use, in order to provide varying anchors depending on the desired procedure, and instructions based on the treatment intended to be performed while taking into account various considerations, based on the teachings of Jastifer (para. [0091]).
Regarding claim 47, West, Jr. discloses the device of claim 10.
However, West, Jr. fails to disclose a kit for securing soft tissue to a rigid structure comprising the device of claim 10 and instructions for use.
Jastifer teaches (para. [0091]), in the same field of endeavor, a kit for anchoring tissue to a bone (abstract, para. [0088]) comprising instructions for use (para. [0091]), for the purpose of providing a kit with multiple anchors and instructions based on the treatment intended to be performed while taking into account various considerations (para. [0091]).
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 device of West, Jr. to further include a kit including multiple anchors and instructions for use, in order to provide varying anchors depending on the desired procedure, and instructions based on the treatment intended to be performed while taking into account various considerations, based on the teachings of Jastifer (para. [0091]).
Regarding claim 48, West, Jr. (as modified) teaches the kit of claim 46 or claim 47.
However, West, Jr. (as modified) fails to teach further comprising a drill.
Jastifer teaches (para. [0088]), in the same field of endeavor, a kit (200) further comprising a drill (212), for the purpose of providing tools for drilling a passageway at a desired location on a bone (paras. [0103]-[0104]).
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 kit of West, Jr. (as modified) to further include a drill, in order to provide the appropriate tools for drilling a passageway corresponding to the structural arrangement of the tissue anchor into the desired location in a bone when desired, based on the teachings of Jastifer (paras. [0103]-[0104]).
Claim(s) 49 is rejected under 35 U.S.C. 103 as being unpatentable over West, Jr. in view of Jastifer as applied to claim 47 above, and further in view of Sengun (US 2014/0081325 A1) (previously of record).
Regarding claim 49, West, Jr. (as modified) teaches the kit of claim 47.
However, West, Jr. (as modified) fails to teach wherein the kit further comprises a second anchor comprising a second threaded portion that is larger than the first threaded portion.
Sengun teaches (para. [0076]), in the same field of endeavor, a device (suture anchor) comprising a kit (para. [0076]), wherein the kit comprises a first anchor comprising a first threaded portion and a second anchor comprising a second threaded portion that is larger than the first threaded portion (each outer member can have a different size, considered to include threaded portions of outer members 14 being larger/smaller than other outer members 14), for the purpose of providing the most appropriate size, shape and configuration for use in a particular surgical procedure, which helps a single kit accommodate different situations (para. [0076]).
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 kit of West, Jr. (as modified) to include anchors of varying sizes, in order to provide the most appropriate size, shape and configuration for use in a particular surgical procedure, which helps the single kit accommodate different situations, based on the teachings of Sengun (para. [0076]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2013/0331885 A1 to Stone, disclosing a suture anchor including crossbars.
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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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/BRIGID K BYRD/Examiner, Art Unit 3771
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