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
Examiner disagrees with applicants’ assertion element 120 and element 121 are included within the specification. Paragraph [0100] does not contain the cited statement indicating elements 120 and 121. However, a similar statement is found in paragraph [0098], “Each of the radial grooves 115 may have a first leading angle 116 and a second trailing angle 117.” The examiner maintains the drawing objection as failing to comply with 37 CFR 1.84(p)(5) because 120 and 121 do not appear in the description.
Applicant’s arguments with respect to claim(s) 16-20 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.
Claim Status
Claims 16-25 are examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 120 and 121. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Netravali (US 2016/0030126 A1) in view of Marks (US 2020/0078185 A1), Ochoa (US 6,139,584 A) and Schwartz (US 9,216,085 B2).
Regarding claim 16, Netravali discloses a method of performing a revision surgical procedure on a metatarsal bone comprising(¶ [0008]):
removing a first metatarsal implant from the metatarsal bone (150, fig. 2, ¶ [0018]); and
inserting a second metatarsal implant into the metatarsal bone (200, fig. 2, ¶ [0024]).
Netravali fails to teach the first and second implant comprise a central shaft. However, Marks discloses a metatarsal implant that includes
a first metatarsal arthroplasty implant (12, implant fig. 4) comprising a first central shaft (22, stem, fig. 4) having a first proximal portion with a first diameter (see annotated fig. 3, below); and
a second metatarsal arthroplasty implant (12, implant, fig. 4) comprising a second central shaft (22, stem, fig. 4) having a second proximal portion with a second diameter (see annotated fig. 3, below), the second proximal portion extends from a concave inner surface of the second metatarsal arthroplasty implant (32, interior surface, fig. 6).
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 method of Netravali to include metatarsal implants as taught by Marks since it is a simple substitution of one known element for another to obtain predictable results.
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Netravali and Marks fail to teach the second diameter is larger than the first diameter. However, Ochoa discloses a revision bone implant that includes the second diameter of the second proximal portion is larger than the first diameter of the first proximal portion (col 1 lines 49-58). 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 method of Netravali and Marks to include the teaching by Ochoa in order to make up for bone loss (col 1, lines 49-58, Ochoa).
Netravali, Marks and Ochoa fail to teach the second proximal portion is cylindrical and the distal portion of the second central shaft is not cylindrical. However, Schwartz teaches a joint resurfacing implant that includes the second proximal portion is cylindrical (34, proximal cylindrical section, fig. 2) and a distal portion of the second central shaft is not cylindrical (35, distal bone fixation section, fig. 2). Therefore, it would have been obvious matter of design choice to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the second central shaft of Netravali, Marks and Ochoa to include the second proximal portion is cylindrical and the distal portion is not cylindrical as taught by Schwartz, since applicant has not disclosed that the second proximal portion being cylindrical and the distal portion being not cylindrical solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well when both the second proximal portion and the distal portion are not cylindrical.
Regarding claim 18, Netravali fails to teach forming a recess. However, Ochoa further discloses forming a recess within the metatarsal bone configured to receive the second proximal portion of the second metatarsal arthroplasty implant therein (col 1 lines 49-58 and col 6, lines 4-20). 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 method of Netravali to include the teaching by Ochoa in order to accommodate the larger implant (col 1, lines 49-58, Ochoa).
Regarding claim 19, Netravali fails to teach reaming the recess into the bone. However, Ochoa further discloses reaming the recess into the metatarsal bone (col 1 lines 49-58 and col 6, lines 4-20). 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 method of Netravali to include the teaching by Ochoa in order to accommodate the larger implant (col 1, lines 49-58, Ochoa).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Netravali in view of Marks, Ochoa and Schwartz as applied to claim 16 above, and further in view of Hazebrouck (US 2004/0087944 A1).
Regarding claim 17, Netravali fails to teach a notch. However, Marks further discloses at least one notch formed in the first metatarsal arthroplasty implant (36, notch, fig. 4, ¶ [0040]); and at least one undercut surface (see annotated fig. 4, 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 method of Netravali to include a notch as taught by Marks since it is a simple substitution of one known element for another to obtain predictable results.
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Netravali in view of Marks, Ochoa and Schwartz fails to teach grasping the notch. However, Hazebrouck discloses a bone prosthesis that includes
grasping at least one notch formed in the first metatarsal arthroplasty implant (¶ [0053], fig. 18); and
transmitting at least one extraction force proximally through at least one undercut surface associated with the at least one notch to remove the first metatarsal arthroplasty implant form the metatarsal bone (¶ [0053]).
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 method of Netravali, Marks, Ochoa and Schwartz to include the teaching by Hazebrouck in order to loosen a connection without damaging the components (¶ [0005], Hazebrouck).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Netravali in view of Marks, Ochoa and Schwartz as applied to claim 16 above, and further in view of McDevitt (US 2003/0055507 A1).
Regarding claim 20, Netravali fails to teach a convex articular surface. However, Marks further discloses a convex articular surface of an articular member of the second metatarsal arthroplasty implant (30, exterior surface, fig. 3). 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 method of Netravali to include a convex articular surface as taught by Marks since it is a simple substitution of one known element for another to obtain predictable results.
Netravali in view of Marks, Ochoa and Schwartz fails to teach an inserter tool. However, McDevitt discloses a bone prosthesis that includes
engaging a concave abutment surface of an inserter tool against a convex articular surface of an articular member of the second metatarsal arthroplasty implant (¶ [0040], the abutment surface is adapted to mate with the bearing surface); and
transmitting at least one insertion force distally through the concave abutment surface of the inserter tool to the convex articular surface of the second metatarsal arthroplasty implant to insert the second metatarsal arthroplasty implant into the metatarsal bone (¶ [0043], fig. 10).
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 method of Netravali, Marks, Ochoa and Schwartz to include the teaching by McDevitt since it is combining prior art elements according to known method to yield predictable results.
Claim(s) 21 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Netravali (US 2016/0030126 A1) in view of Marks (US 2020/0078185 A1), Ochoa (US 6,139,584 A) and Linderman (US 2014/0208578 A1).
Regarding claim 21, Netravali discloses a method of performing a revision surgical procedure on a metatarsal bone comprising(¶ [0008]):
removing a first metatarsal implant from the metatarsal bone (150, fig. 2, ¶ [0018]); and
inserting a second metatarsal implant into the metatarsal bone (200, fig. 2, ¶ [0024]).
Netravali fails to teach the first and second implant comprise a central shaft. However, Marks teaches a metatarsal implant that includes
a first metatarsal arthroplasty implant (12, implant fig. 4) comprising a first central shaft (22, stem, fig. 4) having a first proximal portion with a first diameter (see annotated fig. 3, below); and
a second metatarsal arthroplasty implant (12, implant, fig. 4) comprising a second central shaft (22, stem, fig. 4) having a second proximal portion with a second diameter (see annotated fig. 3, below), the second proximal portion extends distally from a concave inner surface of the second metatarsal arthroplasty implant (32, interior surface, fig. 6).
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 method of Netravali to include metatarsal implants as taught by Marks since it is a simple substitution of one known element for another to obtain predictable results.
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Netravali and Marks fail to teach the second diameter is larger than the first diameter. However, Ochoa teaches a revision bone implant that includes the second diameter of the second proximal portion is larger than the first diameter of the first proximal portion (col 1 lines 49-58). 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 method of Netravali and Marks to include the teaching by Ochoa in order to make up for bone loss (col 1, lines 49-58, Ochoa).
Netravali, Marks and Ochoa fail to teach a distally facing shoulder. However, Linderman teaches a revision joint implant that includes the second proximal portion comprises a distally facing shoulder (510, flat surface, fig. 7). 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 second central shaft of Netravali, Marks and Ochoa to include a distally facing shoulder as taught by Linderman in order to control depth and prevent toggle (Linderman, ¶ [0262]).
Regarding claim 23, Netravali fails to teach forming a recess. However, Ochoa further teaches forming a recess within the metatarsal bone configured to receive the second proximal portion of the second metatarsal arthroplasty implant therein (col 1 lines 49-58 and col 6, lines 4-20). 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 method of Netravali to include the teaching by Ochoa in order to accommodate the larger implant (col 1, lines 49-58, Ochoa).
Regarding claim 24, Netravali fails to teach reaming the recess into the bone. However, Ochoa further teaches reaming the recess into the metatarsal bone (col 1 lines 49-58 and col 6, lines 4-20). 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 method of Netravali to include the teaching by Ochoa in order to accommodate the larger implant (col 1, lines 49-58, Ochoa).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Netravali in view of Marks, Ochoa and Linderman as applied to claim 21 above, and further in view of Hazebrouck (US 2004/0087944 A1).
Regarding claim 22, Netravali fails to teach a notch. However, Marks further teaches at least one notch formed in the first metatarsal arthroplasty implant (36, notch, fig. 4, ¶ [0040]); and at least one undercut surface (see annotated fig. 4, 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 method of Netravali to include a notch as taught by Marks since it is a simple substitution of one known element for another to obtain predictable results.
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Netravali in view of Marks, Ochoa and Linderman fails to teach grasping the notch. However, Hazebrouck teaches a bone prosthesis that includes
grasping at least one notch formed in the first metatarsal arthroplasty implant (¶ [0053], fig. 18); and
transmitting at least one extraction force proximally through at least one undercut surface associated with the at least one notch to remove the first metatarsal arthroplasty implant form the metatarsal bone (¶ [0053]).
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 method of Netravali, Marks, Ochoa and Linderman to include the teaching by Hazebrouck in order to loosen a connection without damaging the components (¶ [0005], Hazebrouck).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Netravali in view of Marks, Ochoa and Linderman as applied to claim 16 above, and further in view of McDevitt (US 2003/0055507 A1).
Regarding claim 25, Netravali fails to teach a convex articular surface. However, Marks further discloses a convex articular surface of an articular member of the second metatarsal arthroplasty implant (30, exterior surface, fig. 3). 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 method of Netravali to include a convex articular surface as taught by Marks since it is a simple substitution of one known element for another to obtain predictable results.
Netravali in view of Marks, Ochoa and Linderman fails to teach an inserter tool. However, McDevitt teaches a bone prosthesis that includes
engaging a concave abutment surface of an inserter tool against a convex articular surface of an articular member of the second metatarsal arthroplasty implant (¶ [0040], the abutment surface is adapted to mate with the bearing surface); and
transmitting at least one insertion force distally through the concave abutment surface of the inserter tool to the convex articular surface of the second metatarsal arthroplasty implant to insert the second metatarsal arthroplasty implant into the metatarsal bone (¶ [0043], fig. 10).
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 method of Netravali, Marks, Ochoa and Linderman to include the teaching by McDevitt since it is combining prior art elements according to known method to yield predictable results.
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, 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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