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 .
Election/Restrictions
Applicant’s election without traverse of Group I and Species A in the reply filed on 03/23/2026 is acknowledged. Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected system for tissue repair, there being no allowable generic or linking claim.
Claim Objections
Claims 8 and 19 are objected to because of the following informalities: In lines 1-2, “a humeral component of shoulder prosthesis assembly” is assumed to be a typo. The examiner suggests amending the informality to “a humeral component of a shoulder prosthesis assembly” and had been examined as such. Appropriate corrections are required.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagner et al. (US PG Pub No. 2021/0045887 A1).
Regarding claim 1, Wagner discloses a system for tissue repair (see Abstract), the system comprising: one or more sutures (Figs. 3-4, strands 192); a suture anchor (188) configured to couple with the one or more sutures (Figs. 3-4 and 6); and a prosthesis (shoulder base component 120) configured to be inserted in a bone of a patient (Fig. 6), the prosthesis (120) having a first surface (Fig. 6, Proximal end surface 122) and at least one passage (opening 160) (Paragraph [0035], Fig. 6), the at least one passage having a first opening (160a) (Paragraph [0035]) at the first surface (Fig. 6, Proximal end surface 122) and a second opening (Fig. 6, 160b); wherein the suture anchor (188) is configured to couple with the prosthesis (shoulder base component 120) at one or more of the first surface (122) or the at least one passage (160; see Fig. 6), and wherein the one or more sutures (192) are configured to pass through the prosthesis (120) via the at least one passage (160; see Fig. 6).
Regarding claim 2, Wagner discloses further comprising a guide element (Paragraph [0044], leading needle) configured to couple with the one or more sutures (192) at a first end thereof (at 192b; Paragraph [0041], “184 pulled through bone with leading needle”, Paragraph [0044], leading needled pulls 184 and 188 through passage 160), wherein the first end (at 192b) opposes a second end (Fig. 3, 192a) of the one or more sutures (192) that is coupled with the suture anchor (188), wherein the guide element (leading needle) is configured to facilitate passage of the one or more sutures (192) through the at least one passage (160; see Paragraph [0044]).
Regarding claim 6, Wagner discloses wherein, when the prosthesis is inserted in the bone of the patient (Fig. 6, Shoulder base component 120), the first surface (proximal end surface 122) and first opening (160a) are at a proximal side of the prosthesis (Paragraph [0035]) and the second opening (160b) is at one of: a lateral side surface, a medial side surface, an anterior side surface, a posterior side surface or a distal side of the prosthesis (Fig. 6, distal end 149 at the distal side).
Regarding claim 7, Wagner discloses wherein the suture anchor (188) comprises one of a non-deformable member or a deformable member (Fig. 6, 188 is a non-deformable member as it locks in place as seen in Fig. 6) having a passage therethrough (Fig. 6, 189; note the prior art does not need to disclose the suture anchor comprises a deformable member configured as claimed in order to meet the limitation as recited in claim 7).
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.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. (US PG Pub No. 2021/0045887 A1) in view of Pasque (US Patent No. 5,423,821).
Regarding claim 3, Wagner fails to disclose wherein the guide element comprises a bone cutting needle configured to cut and pass through the bone of the patient. Pasque also discloses a system for tissue repair (Fig. 1 sternal closure assembly 10), comprising a suture anchor (Fig. 1, suture strand fastener device 30) and a guide element (Fig. 1, curved needle 12) coupled to sutures (Col. 7, lines 1-20, Fig. 1, suture strand 20). Pasque teaches wherein the guide element (12) comprises a bone cutting needle (Fig. 1, curved needle 12) configured to cut and pass through the bone of the patient (Col. 6, lines 59-69). Therefore, it would have been obvious to try, by one having ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the guide needle of Pasque into the system for tissue repair of Wagner, as it obviates the need for a separate cutting tool (e.g., 200) to drill through bone since the leading needle would be modified to drill/cut through bone to deploy the suture anchor assembly through opening (160). The modification merely involves a substitution of one known surgical needle for another that obtains predictable results.
Regarding claim 4, Wagner fails to disclose wherein the bone cutting needle is crimped to the first end of the one or more sutures. Pasque also discloses a system for tissue repair (Fig. 1 sternal closure assembly 10), comprising a suture anchor (Fig. 1, suture strand fastener device 30) and a guide element (Fig. 1, curved needle 12) coupled to sutures (Col. 7, lines 1-20, Fig. 1, suture strand 20). Pasque teaches wherein the bone cutting needle (12) is crimped to the first end (Col. 7, lines 1-20, Fig. 1, tubular structure 16) of the one or more sutures (20).
Regarding claim 5, Wagner fails to disclose wherein the bone cutting needle is one of straight or curved with respect to a longitudinal axis thereof. Pasque also discloses a system for tissue repair (Fig. 1 sternal closure assembly 10), comprising a suture anchor (Fig. 1, suture strand fastener device 30) and a guide element (Fig. 1, curved needle 12) coupled to sutures (Col. 7, lines 1-20, Fig. 1, suture strand 20). Pasque teaches wherein the bone cutting needle (12) is one of straight or curved with respect to a longitudinal axis thereof (Fig. 1, curved needle 12).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. (US PG Pub No. 2021/0045887 A1) as applied to claim 1 above, and further in view of Emerick et al. (US PG Pub No. 2017/0273800 A1).
Regarding claim 8, Wagner discloses wherein the prosthesis comprises a humeral component of a shoulder prosthesis assembly (300; Paragraph [0032]), but fails to disclose the one or more sutures (192) are configured to connect a rotator cuff to the bone via the suture anchor (188) coupled to the humeral component (300) of the shoulder prosthesis assembly. Emerick also discloses a system for tissue repair (Fig. 13, humeral anchor assembly 200), a shoulder prosthesis (Fig. 1, humeral anchor 204), one or more sutures (suture 408), and a suture anchor (suture anchor 404). Emerick teaches one or more sutures (408) are configured to connect a rotator cuff to the bone (Paragraph [0073], “coupled with soft tissue”, example of soft tissue as rotator cuff in Paragraph [0072]) via the suture anchor (404) coupled to the humeral component (Humerus H) of the shoulder prosthesis assembly (204). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wagner’s system wherein the one or more sutures are configured to connect a rotator cuff to the bone via the suture anchor coupled to the humeral component of the shoulder prosthesis assembly, as taught by Emerick, in order repair a rotator cuff (Paragraph [0072]).
Regarding claim 9, Wagner in view of Emerick discloses wherein the humeral component of the shoulder prosthesis assembly (Fig. 6, Shoulder base component 120) is configured for stem-free anchoring to the bone (Paragraph [0031]).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. (US PG Pub No. 2021/0045887 A1) in view of Pasque (US Patent No. 5,423,821).
Regarding claim 16, Wagner discloses a system for tissue repair (see Abstract), the system comprising: one or more sutures (Figs. 3-4, strands 192); a prosthesis configured to be inserted in a bone of a patient (Fig. 6, Shoulder base component 120), the prosthesis having at least one passage therein (Fig. 6, Paragraph [0035], opening 160), the at least one passage having a first opening (Paragraph [0035], 160a) on a first side (Fig. 6, Proximal end surface 122) of the prosthesis (120) and a second opening (Fig. 6, 160b) at a second side (Fig. 6, distal end 149) of the prosthesis; a suture anchor (Figs. 3-4, and 6, 188) configured to couple with the one or more sutures (192) and is configured to deploy against the prosthesis (120). Wagner fails to disclose a bone cutting needle configured to cut and pass through the bone of the patient, wherein the bone cutting needle is configured to guide the one or more sutures (192) to pass through the prosthesis (120) via the at least one passage (160).
Pasque also discloses a system for tissue repair (Fig. 1 sternal closure assembly 10), comprising a suture anchor (Fig. 1, suture strand fastener device 30) and a guide element (Fig. 1, curved needle 12) coupled to sutures (Col. 7, lines 1-20, Fig. 1, suture strand 20). Pasque teaches a bone cutting needle (Fig. 1, curved needle 12) configured to cut and pass through the bone of the patient (Col. 6, lines 59-69), wherein the bone cutting needle (12) is configured to guide the one or more sutures (20) to pass through the prosthesis via the at least one passage (Col. 6, lines 59-69). Therefore, it would have been obvious to try, by one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the guide needle of Pasque into the system for tissue repair of Wagner, as it obviates the need for a separate cutting tool (e.g., 200) to drill through bone since the leading needle would be modified to drill/cut through bone to deploy the suture anchor assembly through opening (160) and guide the sutures (192) to pass through the prosthesis (120) via the at least one passage (160).
Regarding claim 17, Wagner in view of Pasque discloses wherein, when the prosthesis (Fig. 6, Shoulder base component 120) is inserted in the bone of the patient (Fig. 6), the first side is a proximal side of the prosthesis (proximal end 122) and the second side is at one of: a lateral side surface, a medial side surface, an anterior side surface, a posterior side surface or a distal side of the prosthesis (Fig. 6, distal end 149 at the distal side).
Regarding claim 18, Wagner in view of Pasque discloses wherein the suture anchor (188) comprises one of a non- deformable member or a deformable member (Paragraph [0048], Fig. 6, 188 is non-deformable as it locks in place) having a passage therethrough (Fig. 6, 189), and wherein the deformable member (188) is configured to be collapsible upon engagement with the prosthesis to form an anchoring mass having a locking profile (Paragraph [0048], Fig. 6).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. (US PG Pub No. 2021/0045887 A1) in view of Pasque (US Patent No. 5,423,821), as applied to claim 16 above, and further in view of Emerick et al. (US PG Pub No. 2017/0273800 A1).
Regarding claim 19, Wagner in view of Pasque discloses wherein the prosthesis comprises a humeral component of a shoulder prosthesis assembly (Paragraph [0032]), but fails to disclose the one or more sutures (192) are configured to connect a rotator cuff to the bone via the suture anchor (188) coupled to the humeral component (300) of the shoulder prosthesis assembly. Emerick also discloses a system for tissue repair (Fig. 13, humeral anchor assembly 200), a shoulder prosthesis (Fig. 1, humeral anchor 204), sutures (suture 408), and a suture anchor (suture anchor 404). Emerick teaches the one or more sutures (408) are configured to connect a rotator cuff to the bone ((Paragraph [0073], “coupled with soft tissue”, example of soft tissue as rotator cuff in Paragraph [0072])) via the suture anchor (404) coupled to the humeral component (Humerus H) of the shoulder prosthesis assembly (204). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wagner’s system wherein the one or more sutures are configured to connect a rotator cuff to the bone via the suture anchor coupled to the humeral component of the shoulder prosthesis assembly, as taught by Emerick, in order repair the rotator cuff (Paragraph [0072]).
Regarding claim 20, Wagner in view of Pasque and Emerick discloses wherein the humeral component of the shoulder prosthesis assembly (Fig. 6, Shoulder base component 120) is configured for stem-free anchoring to the bone (Paragraph [0031]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KARI L COCHRAN/Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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