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 .
Claim Status
The drawing objection, claim objections, and 112 rejections have been overcome.
Claims 1-5, 7, 9, 12, 17-19 and 21-28 are examined below.
Response to Amendment
The amendment filed 08/19/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Claims 22 and 27.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 22 and 27 are 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 22 and 27, the drawings and specification do not support "wherein the allograft implant is configured to be assembled by vertically translating the first plant relative to the at least on interior plank such that the first mating surface contacts the third mating surface, and by translating the second plank relative to the at least one interior plank such that the second mating surface contacts the fourth mating surface." Pages 9-11 of the specification refer to the method of manufacturing. Page 10, lines 10-19 refer to the planks being in a vertically stacked arrangement but has no description of being assembled by vertically translated the planks relative to each other.
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 9 and 25 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 9 recites “a first end of the at least one transverse connector” in lines 1-2. As claim 9 is dependent on claim 7, it is unclear if this first end is the same or a separate and additional first end of the at least one transverse connector in claim 7 lines 1-2. Examiner interprets them to be the same end and recommends amending claim 9 to read “the first end of the at least one transverse connector.”
Claim 25 recites “a second side of the allograft implant” in lines 2-3. As claim 25 is dependent on claim 1, it is unclear if this second side is the same or a separate and additional second side of the allograft implant in claim 1 lines 10-11. Examiner interprets them to be the same side and recommends amending claim 25 to read “the second side of the allograft implant.”
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, 7, 9, 12, 17-19 and 21-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over DuLurio (US 2014/0039628 A1) in view of Ferreira (US 2003/00669640 A1).
Regarding claim 1, a first embodiment of DeLurio teaches an allograft implant (10, T-PLIF implant, figs. 1A-2D) comprising:
a first plank formed of allograft (50, first member, fig. 2A, ¶ [0047]), the first plank comprising a first fusion surface (30, upper surface, fig. 2A) and a first mating surface (see annotated fig. 2C, below) opposite the first fusion surface, the first plank having a first curved side (22, curved front surface, fig. 2A) extending between the first fusion surface and the first mating surface on a first side of the allograft implant (fig. 2A) and intersecting the first fusion surface along a first curved edge (see annotated fig. 2C, below), the first fusion surface including a first series of longitudinally-extending ridges (¶ [0048]);
a second plank formed of allograft (80, second member, fig. 2A, ¶ [0047]), the second plank comprising a second fusion surface (32, lower surface, fig. 2A) and a second mating surface (see annotated fig. 2C, below) opposite the second fusion surface, the second plank having a first curved side (24, curved back surface, fig. 2B) extending between the second fusion surface and the second mating surface on a second side of the allograft implant opposite the first side of the allograft implant (fig. 2A) and intersecting the second fusion surface along a second curved edge (see annotated fig. 2C, below);
at least one transverse connector interconnecting the first plank, the second plank and the at least one interior plank (62, pins, fig. 2A, ¶ [0055]).
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The first embodiment of DeLurio fails to teach at least one interior plank. However, a second embodiment taught by DeLurio teaches at least one interior plank formed of allograft (600, second member, fig. 8C, ¶ [0047]), the at least one interior plank comprising a third mating surface (see annotated fig. 8C, below) attached to the first mating surface, and a fourth mating surface (see annotated fig. 8C, below) opposite the third mating surface and attached to the second mating surface. DeLurio states embodiments are combinable (¶ [0093]). 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 implant of DeLurio’s first embodiment to include at least one interior plank as taught by DeLurio’s second embodiment in order to obtain a sufficiently large piece of allograft (¶ [0050], DeLurio).
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The first and second embodiments of DuLurio fail to teach the first curved edge, the second curved edge, and each longitudinal ridge from the first series of longitudinal ridges extending along respective parallel curves. However, Ferreira discloses an allograft spinal implant that includes the first curved edge, the second curved edge, and each longitudinal ridge from the first series of longitudinal ridges extending along respective parallel curves (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 implant of DeLurio to include the first curved edge, the second curved edge, and each longitudinal ridge from the first series of longitudinal ridges extending along respective parallel curves as taught by Ferreira in order to prevent mitigation and retropulsion of the implant (¶ [0062], Ferreira).
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Regarding claim 2, the first embodiment of DeLurio further teaches the first plank, the second plank, and the at least one interior plank define at least one transverse passage (64, holes, fig. 2C), the at least one transverse passage extending through at least a portion of the first plank, at least a portion of the second plank, and at least a portion of the at least one interior plank (¶ [0055]).
Regarding claim 3, the first embodiment of DeLurio further teaches the at least one transverse passage comprises at least one through-passage that extends from the first fusion surface of the first plank to the second fusion surface of the second plank (¶ [0055]).
Regarding claim 4, the first embodiment of DeLurio further teaches the at least one transverse connector interconnects the first plank, the second plank and the at least one interior plank through the at least one transverse passage (¶ [0055]).
Regarding claim 5, the first embodiment of DeLurio further teaches the at least one transverse connector is configured to be secured in the at least one transverse passage via a press fit (¶ [0055]).
Regarding claim 7, the first embodiment of DeLurio further teaches a first end of the at least one transverse connector (see annotated fig. 2C, below) is positioned flush with the first fusion surface of the first plank (¶ [0055], fig. 2A), and a second end of the at least one transverse connector (see annotated fig. 2C, below) is positioned flush with the second fusion surface of the second plank (¶ [0055]).
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Regarding claim 9, the first embodiment of DeLurio further teaches the first end of the at least one transverse connector comprises a surface (see annotated fig. 2C, below) including at least one longitudinally-extending ridge portion (¶ [0048]) configured to align with at least one longitudinally-extending ridge from the first series of longitudinally-extending ridges to form a continuous pattern of longitudinally-extending ridges (fig. 2A shows the projections on the pins blend with the projection on the surface, it would be an obvious design choice for the ridges on the pins to blend with the rides on the surface as well).
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Regarding claim 12, the first embodiment of DeLurio further teaches the first plank and the second plank are arc-shaped (figs. 2A-2B).
Regarding claim 17, the first embodiment of DeLurio further teaches the at least one transverse connector is formed of allograft (¶ [0047]).
Regarding claim 18, the first embodiment of DeLurio further teaches the at least one transverse connector comprises a first transverse pin (see annotated fig. 2C, below) and a second transverse pin (see annotated fig. 2C, below) extending parallel to the first transverse pin (¶ [0058], fig. 2C).
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Regarding claim 19, the first embodiment of DeLurio further teaches the at least one transverse connector and the at least one transverse passage are cylindrical (¶ [0055]).
Regarding claim 21, the first embodiment of DeLurio further teaches a set of transverse connectors including the at least one transverse connector (1st and 2nd pin, see annotated fig. 2C, below), the set of transverse connectors interconnecting the first plank, second plank and the at least one interior plank (¶ [0055]), a first transverse connector from the set of transverse connectors interconnecting the first plank and the at least one interior plank (¶ [0055]), a second transverse connector from the set of transverse connectors interconnecting the second plank and the at least one interior plank (¶ [0055]), an end of the first transverse connector disposed within a portion of a first transverse passage defined by the at least one interior plank (¶ [0055]), an end of the second transverse connector disposed within a portion of a second transverse passage defined by the at least one interior plank (¶ [0055]).
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Regarding claims 22 and 27, the first embodiment of DeLurio fails to teach first mating surface contacts the third mating surface, and the second mating surface contacts the fourth mating surface. However, the second embodiment further teaches the allograft implant is configured to be assembled by vertically translating the first plank relative to the at least one interior
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plank such that the first mating surface contacts the third mating surface, and by translating the second plank relative to the at least one interior plank such that the second mating surface contacts the fourth mating surface (figs. 8A-8C). The first mating surface contacts the third mating surface, and the second mating surface contacts the fourth mating surface as seen in fig. 8A and thus meet the final structure necessitated by the product-by process limitation (MPEP 2113). 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 implant of DeLurio’s first embodiment to include first mating surface contacts the third mating surface, and the second mating surface contacts the fourth mating surface as taught by DeLurio’s second embodiment in order to obtain a sufficiently large piece of allograft (¶ [0050], DeLurio).
Regarding claim 23, the first embodiment of DeLurio further teaches the second fusion surface includes a second series of longitudinally-extending ridges (¶ [0048]).
Regarding claim 24, the first embodiment and second embodiments of DeLurio fail to teach the first curved edge, the second curved edge, each longitudinal ridge from the first series of longitudinal ridges, and each longitudinal ridge from the second series of longitudinal ridges extend along respective parallel curves. However, Ferreira further discloses the first curved edge, the second curved edge, each longitudinal ridge from the first series of longitudinal ridges, and each longitudinal ridge from the second series of longitudinal ridges extend along respective parallel curves (see annotated fig. 2, below, fig. 3 shows the first and second series of ridges on the first and second fusion surfaces are in parallel). 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 implant of DeLurio to include the first curved edge, the second curved edge, each longitudinal ridge from the first series of longitudinal ridges, and each longitudinal ridge from the second series of longitudinal ridges extend along respective parallel curves as taught by Ferreira in order to prevent mitigation and retropulsion of the implant (¶ [0062], Ferreira).
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Regarding claim 25, the first embodiment of DeLurio further teaches the first plank has a second curved side (24, curved back surface, fig. 2B) extending between the first fusion surface and the first mating surface on a second side of the allograft implant (fig. 2A) and intersecting the first fusion surface along a third curved edge (see annotated fig. 2C, below).
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Regarding claim 26, the first embodiment and second embodiments of DeLurio fail to teach the first curved edge, the second curved edge, each longitudinal ridge from the first series of longitudinal ridges, and the third curved edge extend along respective parallel curves. However, Ferreira further discloses the first curved edge, the second curved edge, each longitudinal ridge from the first series of longitudinal ridges, and the third curved edge extend along respective parallel curves (see annotated fig. 2, below, fig. 3 shows the first series of ridges and the edges are in parallel). 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 implant of DeLurio to the first curved edge, the second curved edge, each longitudinal ridge from the first series of longitudinal ridges, and the third curved edge extend along respective parallel curves as taught by Ferreira in order to prevent mitigation and retropulsion of the implant (¶ [0062], Ferreira).
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Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over DuLurio (US 2014/0039628 A1) in view of Ferreira (US 2003/00669640 A1) as applied to claim 1 above, and further in view of Randall (US 2005/0240267 A1).
Regarding claim 28, the first embodiment of DeLurio further teaches the at least one transverse connector comprises a first transverse pin (see annotated fig. 2C, below) and a second transverse pin (see annotated fig. 2C, below).
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The first embodiment and second embodiments of DeLurio in view of Ferreira fails to teach the first and second pins are non-parallel. However, Randall discloses an allograft implant that includes a first transverse pin and a second transverse pin extending non-parallel to the first transverse pin (figs. 7-8, ¶ [0084]-[0085]).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 implant of DeLurio and Ferreira to include the first and second pins are non-parallel as taught by Randall in order to provide an additional locking feature (¶ [0085], Randall).
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.
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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.
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/T.M.D./
Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774