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 Arguments
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claims Status
Specification and drawing objections are overcome.
Claims 1-5, 9-12, 14-19 and 21-24 are examined below.
Priority
The instant application claims priority to several applications, however, the washer portion claimed in claim 1 is referenced only in U.S. Non-Provisional Patent Application No. 16/430,647, filed on June 4, 2019 and entitled Soft Tissue Retention Devices, Instrumentation and Related Methods. Thus, a priority date of June 4, 2019 has been granted to claims 1-5, 9-12, 14-19 and 21-24.
Claim Objections
Claim 1 is objected to because of the following informalities: "the first shaft portion are define a cannulated opening" in lines 3-4 should read "the first shaft portion define a cannulated opening." Appropriate correction is required.
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.
Claims 17-18 are 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 17 recites “a pair of projections” on the second head portion. It is unclear if these are the same projections recited in claim 1 lines 5-6 or separate and additional projections. There is no support in the drawings or specification for projections and pairs of projections on the second head portion. The examiner understands these to be referring to the same set of projection, with specificity to where they are located in claim 17. Dependent claim 18, is likewise rejected.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 9, 11-12, 19, 21-22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blacklidge (US 2018/0055623 A1) in view of Schmieding (US 2003/0105465 A1) and Re (US 2006/0052787 A1).
Regarding claim 1, Blacklidge discloses device for retaining soft tissue to a bone (100, tendon retention device, fig. 1), the device comprising:
a first member (10, first component, fig. 2) comprising a first shaft portion (11, shank, fig. 2), the first head portion and the first shaft portion are define a cannulated opening that extends at least partially through the first member (27, fig. 4); and
a second member (20, second component, fig. 2) comprising a second head portion (22, head, fig. 2), projections extending from an inner side of the second head portion (25, tang, fig. 2), and a second shaft portion extending from the inner side of the second head portion (21, tubular body, fig. 2), the second head portion and the second shaft portion define a cannulated opening that extends at least partially through the second member (fig. 12, ¶ [0045]).
Blacklidge fails to teach a first member comprising a washer portion. However, a first embodiment of Schmieding discloses a fixation device for securing soft tissue to bone that includes comprising a washer portion (30, washer, fig. 10), a first head portion (15, head, fig. 1)
wherein the washer portion comprises a top side (see annotated fig. 10, below), a bottom side (see annotated fig. 10, below), an inner adjustment opening (see annotated fig. 10, below) and an outer periphery (see annotated fig. 10, below),
PNG
media_image1.png
236
441
media_image1.png
Greyscale
an annular raised transition portion that slopes downwardly toward the top side as it extends from the inner adjustment opening toward the outer periphery (see annotated fig. 12, below), and an annular concave depression (see annotated fig. 12, below) formed by an inner side portion of the row of the plurality of projections and an inner portion of the transition portion (see annotated fig. 12, below),
PNG
media_image2.png
251
463
media_image2.png
Greyscale
wherein the first head portion is received with the inner adjustment opening such that the washer portion is movably coupled with the first head portion with respect to an angle of variation between an axis of the first shaft portion and a plane defined by the washer portion (inherent to a screw/washer interaction). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge to include a washer portion as taught by a first embodiment Schmieding in order to provide additional means for securing soft tissue to the bone (¶ [0003], Schmieding).
Blacklidge in view of a first embodiment of Schmieding fails to teach a plurality of projections on the bottom side of the washer portion. However, a second embodiment of Schmieding includes the bottom side of the washer portion comprises a row of a plurality of projections (48, teeth, figs. 13-14) disposed about the outer periphery of the washer portion. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge and the first embodiment of Schmieding to include the teaching by a second embodiment Schmieding in order to engage the soft tissue to be securing in a stationary manner (¶ [0056], Schmieding).
Blacklidge in view of the first and second embodiments of Schmieding fails to teach a plurality of apertures on the washer portion. However, Re discloses a device for securing soft tissue to bone including the washer portion further comprises a plurality of apertures (175E, openings, fig. 39) that extend through the washer portion between the top side and the bottom side, the plurality of apertures being disposed in the concave depression at the bottom side (fig. 39 shows they are in between the central bore and the outer perimeter, this would be where the concave depression is). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge and Schmieding to include the washer comprised of a plurality of apertures as taught by Re in order to provide a more tortuous path for the soft tissue as to help hold the tissue (¶ [0113], Re).
Regarding claim 2, Blacklidge further discloses the first and second shaft portions each comprise threading and are configured to threadably engage with one another (¶ [0045]).
Regarding claim 3, Blacklidge further discloses the first shaft portion comprises a threading on an exterior surface thereof (12, threaded shaft, fig. 17).
Regarding claim 4, Blacklidge further discloses the second shaft portion comprises a threading on an interior surface of the cannulated opening (32, lower opening, fig. 17, ¶ [0045]).
Regarding claim 5, Blacklidge further discloses the first and second shaft portions share a common longitudinal axis when threadably engaged with one another (fig. 17).
Regarding claim 9, Blacklidge fails to teach the dimension of the first head is greater than the dimension of the inner adjustment opening of the washer. However, the first embodiment of Schmieding further discloses the first head portion comprises a first lateral dimension (see annotated fig. 16), wherein the first lateral dimension is greater than a lateral dimension of the inner adjustment opening of the washer portion (fig. 16, in order for the head to not go through the washer its dimension must be larger than the dimension of the washer opening). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge to include the dimension of the first head is greater than the dimension of the inner adjustment opening of the washer as taught by a first embodiment of Schmieding in order to provide additional means for securing soft tissue to the bone (¶ [0003], Schmieding).
PNG
media_image3.png
292
354
media_image3.png
Greyscale
Regarding claim 11, Blacklidge in view of a first embodiment of Schmieding fails to teach the projections are equidistant from the inner adjustment opening. However, the second embodiment of Schmieding further discloses the plurality of projections are substantially equidistant from the inner adjustment opening (figs. 13-14). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge and a first embodiment of Schmieding to include the teaching by a second embodiment of Schmieding in order to engage the soft tissue to be securing in a stationary manner (¶ [0056], Schmieding).
Regarding claim 12, Blacklidge in view of a first embodiment of Schmieding fails to teach the projections extend in a direction orthogonal to the washer. However, the second embodiment of Schmieding further discloses each of the plurality of projections extend from and in a direction substantially orthogonal relative to the plane defined by the washer portion (figs. 13 and 15). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge and a first embodiment of Schmieding to include the teaching by a second embodiment of Schmieding in order to engage the soft tissue to be securing in a stationary manner (¶ [0056], Schmieding).
Regarding claim 19, Blacklidge further discloses the second head portion is integral with the second shaft portion (fig. 12).
Regarding claim 21, Blacklidge fails to teach the annular concave depression is arcuately concave. However, the first embodiment of Schmieding further discloses the annular concave depression is arcuately concave (fig. 12). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge to include the teaching by the first embodiment of Schmieding in order to provide additional means for securing soft tissue to the bone (¶ [0003], Schmieding).
Regarding claim 22, Blacklidge fails to teach a relief surface. However, the first embodiment of Schmieding further discloses an inner portion of the inner adjustment opening that is proximate to the bottom side of the washer portion includes a relief surface portion extending from the bottom side (see annotated fig. 12, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge to include the teaching by the first embodiment of Schmieding in order to provide additional means for securing soft tissue to the bone (¶ [0003], Schmieding).
PNG
media_image4.png
248
463
media_image4.png
Greyscale
Regarding claim 24, Blacklidge in view of the first and second embodiments of Schmieding fails to teach the apertures extend from the inner portion of the transition portion at the bottom side. However, Re further discloses the plurality of apertures extend from the inner portion of the transition portion at the bottom side (figs. 39-40, the apertures are centrally located and the inner portion of the transition portion is centrally located on the ring of the washer). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge and Schmieding to include the teaching of Re in order to provide a more tortuous path for the soft tissue as to help hold the tissue (¶ [0113], Re).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blacklidge (US 2018/0055623 A1) in view of Schmieding (US 2003/0105465 A1) and Re (US 2006/0052787 A1) as applied to claim 9 above, and further in view of Cianfrani (US 2009/0192551 A1).
Regarding claim 10, Blacklidge in view of Schmieding and Re fails to teach the range of motion of the washer portion. However, Cianfrani discloses a fixation prosthesis for bone including a washer portion that includes the angle of variation ranges from about 70 degrees to about 110 degrees (¶ [0034], fig. 9). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge in view of Schmieding and Re to include a washer having a range of motion as taught by Cianfrani in order to distribute the load on the washer evenly (¶ [0033], Cianfrani).
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blacklidge (US 2018/0055623 A1) in view of Schmieding (US 2003/0105465 A1) and Re (US 2006/0052787 A1) as applied to claim 1 above, and further in view of Grafton (US 2001/0051807 A1).
Regarding claim 14, Blacklidge in view of Schmieding and Re fails to teach the second head portions comprises a first and second protuberance. However, Grafton discloses a sutureless soft tissue fixation to bone device including a second head portion that comprises a first protuberance (see annotated fig. 3, below) and a second protuberance (see annotated fig. 3, below) disposed and extending laterally from substantially opposite sides of the second head portion (see annotated fig. 3, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge in view of Schmieding and Re to include a first and second protuberance on the second head portion as taught by Grafton since it is a simple substitution of one known element for another to obtain predictable results.
PNG
media_image5.png
184
304
media_image5.png
Greyscale
Regarding claim 15, Blacklidge in view of Schmieding and Re fails to teach the protuberances extend from the second head portions at a substantially orthogonal angle to the second shaft portion. However, Grafton further teaches the first and second protuberances extend from the second head portion at an angle substantially orthogonal relative to the second shaft portion (see annotated fig. 2, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge in view of Schmieding and Re to include protuberances that extend from the second head portions at a substantially orthogonal angle to the second shaft portion as taught by Grafton since it is a simple substitution of one known element for another to obtain predictable results.
PNG
media_image6.png
186
408
media_image6.png
Greyscale
Regarding claim 16, Blacklidge in view of Schmieding and Re fails to teach the protuberances comprise an angulation in the direction of the second shaft. However, Grafton further teaches each of the first and second protuberances comprises an angulation in the direction of the second shaft portion (see annotated fig. 2, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge in view of Schmieding and Re to include protuberances that comprise an angulation in the direction of the second shaft as taught by Grafton since it is a simple substitution of one known element for another to obtain predictable results.
PNG
media_image7.png
205
403
media_image7.png
Greyscale
Regarding claim 17, Blacklidge in view of Schmieding and Re fails to teach the protuberances comprise a pair of projections. However, Grafton further teaches each of the first and second protuberances comprise a pair of projections (25, barbs, fig. 1) disposed at substantially opposite ends of the first and second protuberances (fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge in view of Schmieding and Re to include protuberances comprised of a pair of projections as taught by Grafton in order to increase pressure (¶ [0023], Grafton).
Regarding claim 18, Blacklidge in view of Schmieding and Re fails to teach the projections extend orthogonally from the protuberances in the direction of the first member. However, Grafton further teaches each projection of the pair of projections extends toward the first member in a direction substantially orthogonal relative to the first and second protuberances (see annotated fig. 2, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge in view of Schmieding and Re to include projections that extend orthogonally from the protuberances in the direction of the first member as taught by Grafton in order to increase pressure (¶ [0023], Grafton).
PNG
media_image8.png
165
343
media_image8.png
Greyscale
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blacklidge (US 2018/0055623 A1) in view of Schmieding (US 2003/0105465 A1) and Re (US 2006/0052787 A1) as applied to claim 1 above, and further in view of apexfasteners.com.
Regarding claim 23, Blacklidge in view of Schmieding and Re fails to teach lip portions. However, apexfasteners.com discloses commonly used washers that includes the inner adjustment opening includes lip portions that restrict the angle of variation along a single direction (see annotated fig. A, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Blacklidge in view of Schmieding and Re to include lip portions as taught by apexfasteners.com since it is combing prior art elements according to known methods to yield predictable results.
PNG
media_image9.png
241
227
media_image9.png
Greyscale
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH C EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774