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) 1-5, 11-12, 14-19, 21, and 24 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.
The Applicant has argued the instant application is entitled to priority Appl. 15/687,450 filed on 8/26/2017, Appl. 62/379,789 filed on 8/26/2016, Appl. 62/454,100 filed on 2/03/2017, Appl. 62/500,574 filed on 5/03/2017, Appl. 62/666,918 filed on 5/04/2018 and Appl. 62/794,565 filed on 1/19/2019. However, the limitation of a washer portion does not have support until the filing of continuation-in-part of Appl. 16/430647 filed on 06/04/2019. With respect to domestic benefit claims under 35 U.S.C. 120, MPEP 211.05, subsection I.B. states the following: If there is a continuous chain of copending nonprovisional applications, each copending application must disclose the claimed invention of the later-filed application in the manner provided by 35 U.S.C. 112(a) in order for the later-filed application to be entitled to the benefit of the earliest filing date. Under 35 U.S.C. 120, a claim in a U.S. application is entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) except for the best mode requirement, in the earlier filed application. The applications filed prior to 06/04/2019 does not have support under 35 U.S.C. 112(a), written description.
Claims Status
The claim objection and 35 U.S.C. 112(b) rejection are overcome.
Claims 1-5, 11-12, 14-19, 21, and 24-28 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, 11-12, 14-19, 21, and 24-28.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25-27 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 25-27, the drawings and the specification fail to show or describe an embodiment wherein the washer is integral with the first head portion. The washer is only associated as a separate component from the head as can be seen in figs. 65-94 of the instant application. The examiner cannot find support for an integral (single component) head and washer portion. Further, Cambridge Dictionary defines “a washer as a flat ring of metal, rubber, or plastic that is put somewhere, especially between a screw or a bolt and a surface, or between joined pipes, in order to make a better connection between them.” A washer by definition is a separate component from a screw and its head portion.
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, 11-12, 19, 21 and 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sevrain (US 2002/0004661 A1) in view of Schmieding (US 2003/0105465 A1) and Re (US 2006/0052787 A1).
Regarding claim 1, Sevrain teaches a device for retaining soft tissue to a bone (10, fastener, fig. 5), the device comprising:
a first member (60, cap, fig. 2) comprising a first head portion (61, disk, fig. 6) and a first shaft portion extending from the first head portion (68, threaded stud, fig. 2), the first member define a cannulated opening that extends at least partially through the first member (64, recess, fig. 6), and
a second member (38, base, fig. 2) comprising a second head portion (22, head, fig. 2), projections extending from an inner side of the second head portion (52, barbs, fig. 2), and a second shaft portion extending from the inner side of the second head portion (46, collar, fig. 2), the second head portion and the second shaft portion define a cannulated opening that extends at least partially through the second member (48, bore, fig. 6).
Sevrain fails to teach a first member comprising a washer portion. However, a first embodiment of Schmieding teaches a fixation device for securing soft tissue to bone that includes
the first head portion forms a washer portion that extends circumferentially from the shaft portion (30, washer, fig. 10); wherein the washer portion comprises a top side (see annotated fig. 10, below), a bottom side (see annotated fig. 10, below) and an outer periphery (see annotated fig. 10, below),
wherein the bottom side of the washer portion comprises an annular raised transition portion that slopes downwardly toward the top side as it extends from the first shaft portion toward the outer periphery (see annotated fig. 12, below), and an annular concave depression 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).
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 Sevrain 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).
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Sevrain 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 disposed about the outer periphery of the washer portion (48, teeth, 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 head portion of Sevrain 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).
Sevrain in view of the first and second embodiments of Schmieding fails to teach a plurality of apertures on the washer portion. However, Re teaches 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 annular 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 Sevrain 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, Sevrain further teaches the first and second shaft portions each comprise threading (fig. 6) and are configured to threadably engage with one another (¶ [0061]).
Regarding claim 3, Sevrain further teaches the first shaft portion comprises a threading on an exterior surface thereof (68, threaded stud, fig. 6, ¶ [0061]).
Regarding claim 4, Sevrain further teaches the second shaft portion comprises a threading on an interior surface of the cannulated opening (48, threaded bore, fig. 6, ¶ [0061]).
Regarding claim 5, Sevrain further teaches the first and second shaft portions share a common longitudinal axis when threadably engaged with one another (fig. 5).
Regarding claim 11, Sevrain 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 teaches 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 Sevrain 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, Sevrain 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 teaches 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 Sevrain 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, Sevrain further teaches the second head portion is integral with the second shaft portion (fig. 6).
Regarding claim 21, Sevrain fails to teach the annular concave depression is arcuately concave. However, the first embodiment of Schmieding further teaches 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 Sevrain 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 24, Sevrain 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 teaches 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 Sevrain 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).
Regarding claims 25-27, a washer is only associated with a sperate component from the head as can be seen in figs. 65-94 of the instant application. The examiner cannot find support for an integral (single component) head and washer portion. Further, Cambridge Dictionary defines “a washer as a flat ring of metal, rubber, or plastic that is put somewhere, especially between a screw or a bolt and a surface, or between joined pipes, in order to make a better connection between them.” A washer by definition is a separate component from a screw and its head portion. If the applicant is to take the stance a washer can be integral with a screw (thus making a screw with an enlarged head) the examiner takes the stance it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. (see MPEP 2144.04).
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sevrain in view of Schmieding and Re as applied to claim 1 above, and further in view of Grafton (US 2001/0051807 A1).
Regarding claim 14, Sevrain in view of Schmieding and Re fails to teach the second head portions comprises a first and second protuberance. However, Grafton teaches 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 Sevrain 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.
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Regarding claim 15, Sevrain 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 Sevrain 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.
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Regarding claim 16, Sevrain 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 Sevrain 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.
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Regarding claim 17, Sevrain 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 one of the projections extending from the inner side of the second head portion disposed at substantially opposite ends of the first and second protuberances (25, barbs, 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 Sevrain 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, Sevrain 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 first and second protuberances extends toward the first member in a direction substantially orthogonal relative to the first and second protuberances (fig. 2). 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 Sevrain 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).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sevrain in view of Schmieding and Re as applied to claim 1 above, and further in view of Kollmer (US 2016/0135861 A1).
Regarding claim 28, Sevrain further teaches the cannulated opening of the second member extends fully through the second head portion and the second shaft portion (¶ [0058]).
Sevrain fails to teach the cannulated opening of the second member extends fully through the second head portion and the second shaft portion. However, Kollmer teaches a bone compression system that includes the cannulated opening of the second member extends fully through the second head portion and the second shaft portion (¶ [0058]).
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 cannulated opening of the second member of Sevrain, Schmieding and Re to include the cannulated opening of the second member extends fully through the second head portion and the second shaft portion as taught by Kollmer in order to provide access through the fastener (¶ [0064] Kollmer).
Conclusion
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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