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 .
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 36 and 37 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 36, line 2, “the head” (two instances) lacks antecedent basis.
Claim 37, line 2, “the head” lacks antecedent basis.
Claim 37, line 3, “the head” lacks antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 34-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schlaepfer (EP-2732782-B1).
Regarding claim 34, Schlaepfer discloses an anchoring assembly 100 (Fig. 1C) for anchoring a rod to a bone or a vertebra, the anchoring assembly comprising:
a shank 10;
a monolithic receiving part 20 pivotably connectable to the shank 10, the receiving part defining a first end (top), a second end (bottom) below the first end, a central axis extending between the first and second ends, a coaxial passage 22 (cf. Fig. 1A), and a channel 29 at the first end that extends transversely to the passage for receiving a rod (Fig. 1C); and
a pressure element 40 (Fig. 1C and paras. 0025-0030) movable in the passage 22 to hold the shank 10 relative to the receiving part 20, the pressure element comprising a first cylindrical surface portion (annotated Fig. 1C, below) with a first diameter, a second cylindrical portion (id.) below the first cylindrical portion with a second diameter smaller than the first diameter, and a downwardly facing step (id.) that extends radially between the first and second cylindrical portions, wherein the step is positionable axially lower (see bold dashed line in annotated Fig. 1C, below) than a rod that is inserted in the channel 29 of the receiving part 20 (id.);
wherein when the pressure element 40 is in the receiving part 20, the shank 10 is connectable to the receiving part 20, and the pressure element 40 is movable axially downwardly in the passage to a position where the shank 10 is restricted from being separated from the receiving part 20, and wherein the passage 22 of the receiving part 20 forms an upwardly facing stop (annotated Fig. 1C) configured to abut against the step (id.) of the pressure element 40 to limit the downward axial movement of the pressure element 40 in the receiving part 20 (id.).
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Regarding claim 35, the pressure element 40 further comprises a rod contacting surface (annotated Fig. 1C, above) for contacting the rod in the receiving part 20 (id.).
Regarding claim 36, the pressure element 40 is configured to directly engage the head 14 (cf. Fig. 1A) of the shank 10 to exert pressure on the head 14 to lock an angular position of the shank 10 relative to the receiving part 20 (Fig. 1C).
Regarding claim 37, at least part, e.g., the arms 45 (cf. Fig. 1A), of the pressure element 40 is positionable below a greatest diameter of the head 14 (id.) measured in a direction perpendicular to the central axis and forms a seat (Figs. 1A and 1C) to hold the head 14 in the receiving part 20 (id.).
Regarding claim 38, the pressure element 40 is monolithic (Fig. 1C).
Regarding claim 39, the first and second diameters are configured to remain fixed and unadjustable (Fig. 1C; paras. 0025-0030; e.g., embodiment optionally not including a slot extending from the upper end, para. 0028).
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.
Claims 1, 21, 22 and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Matthis et al. (2007/0055241; of record) in view of Biedermann (EP-2851021; of record; hereinafter “Biedermann EP”) and Larroque-Lahitette et al. (2013/0274808; of record).
Regarding claim 1, Matthis et al. disclose an anchoring assembly (Figs. 1, 2, 4 and 6; paras. 0035-0036) for anchoring a rod to a bone or a vertebra, the anchoring assembly comprising:
a shank 2;
a receiving part 5 pivotably connectable to the shank, the receiving part defining a channel 12 for receiving a rod 14;
a pressure element 20 configured to lock an angular position of the shank 2 relative to the receiving part 5;
a first closure element 30 (Fig. 6) configured to cooperate with the receiving part 5 and to contact the inserted rod 14 for the inserted rod to exert pressure onto the pressure element 20 (para. 0027) to lock the angular position of the shank 2 relative to the receiving part 5 in the channel 12, while the first closure element 30 remains spaced apart from the pressure element 20 (para. 0025); and
a second closure element 40, 45 (Fig. 6; paras. 0008, 0036, 0037) configured to cooperate with the receiving part 5, wherein the second closure element 40, 45 comprises a first locking member 40 configured to directly exert pressure on the pressure element 20 to lock the angular position of the shank relative to the receiving part (para. 0035) and a second locking member 45 positionable in the first locking member and configured to directly exert pressure on the inserted rod 14 to fix inserted rod in the channel 12,
wherein the first closure element 30 and the second closure element 40 are configured to interchangeably cooperate with the receiving part 5 (paras. 0008, 0036, 0037).
It is also noted that Matthis et al. explicitly recites multiple locking members provided in the assembly (e.g., including 30 and 40; Fig. 6) from which a surgeon can advantageously choose (paras. 0008, 0036, 0037).
Thus, Matthis et al. disclose the claimed invention except for the pressure element comprising a V-shaped base configured to contact an inserted rod at two contact areas, while a gap separates the inserted rod and a bottom of the V-shaped base that extends between the two contact areas; and except wherein a surface of the first locking member 40 that faces the pressure element 20 in the receiving part 5 explicitly forms a stop to limit movement of a second locking member relative to the first locking member.
Biedermann EP discloses a pressure element 8 (Figs. 1 and 3; para. 0037) comprising a V-shaped base configured to contact an inserted rod 100 at two contact areas P1 and P2, while a gap (immediately below the rod 100; Fig. 3) separates the inserted rod 100 and a bottom of the V-shaped base that extends between the two contact areas P1 and P2. This configuration provides secure support for rods having different diameters to accommodate different patients and surgical applications (paras. 0004 and 0037).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the pressure element of Matthis et al. with a V-shaped base configured to contact an inserted rod at two contact areas, while a gap separates the inserted rod and a bottom of the V-shaped base that extends between the two contact areas, and to provide rods of different diameters, in view of Biedermann EP, to provide secure support for the rods having different diameters and accommodate different patients and surgical applications.
Laroque-Lahitette et al. disclose an anchoring assembly (Fig. 6) comprising first locking member 2 having a downwardly facing surface (the bottom of the thread) that forms a stop to limit movement of a second locking member 7 configured with a broadened distal end 24 (Fig. 6; para. 0056). This configuration limits upward movement of a second locking member relative to a first locking member and prevents any undesired removal of the second locking member.
Therefore, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to configure another optional locking member such as the first locking member 40 of Matthis et al. to have a bottom surface of the threads thereof that face the pressure element 20 to explicitly form a stop to limit movement of a second provided locking member 45 configured with a broadened distal end, further in view of Laroque-Lahitette et al., to limit upward movement of the modified second locking member 45 relative to the modified first locking member and prevent any undesired removal of the modified second locking member.
Regarding claim 21, the first and second locking members 40, 45 of the combination are independently drivable from one another relative to the receiving part 5 (Figs. 4 and 6 of Matthis et al., note the independent drive features 43 and 46; para. 0035).
Regarding claim 22, in a first configuration, the first and second locking members 40, 45 of the combination are rotationally fixed relative to one another (e.g., at least by some degree of friction) and movable together (e.g., as by rotating the first locking member 40 relative to the receiving part 5 (para. 0035; note the second locking member 45 does not rotate until separately acted upon).
Regarding claim 24, a third member of the combination, e.g., the first locking member 40 (as modified at claim 1), is different structurally from the unmodified first locking member 40 and is configured to directly exert pressure on the pressure element 20, wherein the second closure element 40, 45 (supra) can be formed either by connecting the second locking member 45 to the first locking member 40 or by connecting the second locking member 45 to the third locking member 40 (as modified at claim 1), if desired, at least because the threads are the same.
Regarding claim 25, the anchoring assembly of the combination (supra) comprises at least a rod 14 (Fig. 6 of Matthis et al.).
Regarding claim 26, the two contact areas P1 and P2 (Biedermann EP; Figs. 1 and 3; para. 0037) between the rod(s) of the combination and the base of the pressure element as modified (supra) each forms a line that extends substantially parallel to an axis of extension of the rod (Fig. 3 and para. 0037 of Biedermann EP).
Regarding claim 27, the anchoring assembly of the combination (supra) comprises a second rod having a smaller diameter than a provided first rod and the first and second rods are interchangeably receivable in the channel 12 of the receiving part 5 of the combination (supra at claim 1; cf. Biedermann EP; Figs. 1 and 3; paras. 0004 and 0037).
Regarding claim 28, the first closure element 30 and the second closure element 40, 45 of the combination each comprises a projection (30 has projection 32, Fig. 6 of Matthis et al.; 40, 45 has the bottom of 45; id. or as modified in view of Laroque-Lahitette et al.; supra) that has a length such that when either the first closure element 30 or the second closure element 40, 45 including as modified is inserted into the receiving part 5 and advanced therein, the inserted closure element is configured to contact the first rod when the first rod is in the channel 12 and rests on the base, and to contact the second rod when the second rod is in the channel 12 and rests on the base (supra; Matthis et al. Figs. 1 and 6; paras. 0027, 0035 and 0036; Biedermann EP, para. 0037).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Matthis et al. (2007/0055241; of record) in view of Biedermann (EP-2851021; of record; hereinafter “Biedermann EP”) and Larroque-Lahitette et al. (2013/0274808; of record), as applied to claim 1 above, and further in view of Biedermann (2013/0345758, hereinafter “Biedermann ‘758”).
Regarding claim 23, the anchoring assembly of the combination (supra) discloses the claimed invention except for disclosing a single drive portion formed at the second locking member, without a separate drive portion provided at the first locking member.
Biedermann ‘758 discloses a single drive portion 106 (Fig. 11) formed at a second locking member 10, without a separate drive portion provided at a first locking member 9 (Figs. 1 and 11; para. 0048). This configuration provides for one tool and motion to drive both locking members simultaneously until the first locking member 9 touches a pressure element 7, which increases the torque until the second locking member 10 is released and can clamp to the rod 6 (para. 0048). This configuration allows independent adjustment with minimal tools and gives feedback to the surgeon that allows for precise adjustments (id.).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide the anchoring assembly of the combination (supra) with an optional locking member configuration wherein a single drive portion is formed at the second locking member, without a separate drive portion provided at the first locking member, further in view of Biedermann ‘758, to allow independent adjustment with minimal tools and give feedback to the surgeon that allows for precise adjustments.
Claims 29-31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Matthis et al. (2007/0055241; of record) in view of Larroque-Lahitette et al. (2013/0274808; of record).
Regarding claim 29, Matthis et al. disclose an anchoring assembly (Figs. 1, 2, 4 and 6; paras. 0035-0036) for anchoring a rod to a bone or a vertebra, the anchoring assembly comprising:
a shank 2;
a receiving part 5 pivotably connectable to the shank, the receiving part defining a channel 12 for receiving a rod 14;
a pressure element 20 configured to lock an angular position of the shank 2 relative to the receiving part 5;
a first locking member 40 (Fig. 6) engageable with the receiving part 5 and to directly exert pressure on the pressure element 20 to lock the angular position of the shank 2 relative to the receiving part 5, the first locking member 40 having an end face (bottom) and an inner surface defining a bore that extends from the end face through the first locking member 40, wherein the inner surface has an internal thread 42 (Fig. 4; para. 0032) formed on at least a portion thereof; and
a monolithic second locking member 45 with a first end (top) insertable from the end face (bottom) into the bore (e.g., if desired, because the threads of the second locking member 45 extend to the first end, i.e., top, of the first locking member 40), a second end (bottom), an external thread (para. 0033) engageable with the internal thread 42 of the first locking member 40 (id.), wherein the second locking member 45 is movable relative to the first locking member 40 to directly exert pressure on an inserted rod 14 to fix the inserted rod in the channel 12 (Fig. 7b). It is noted that Matthis et al. explicitly recites multiple locking members provided in the assembly (e.g., including 30 and 40; Fig. 6) from which a surgeon can advantageously choose (paras. 0008, 0036, 0037).
Matthis et al. thus disclose the claimed invention except for the first locking member having a stop that is distinct from the end face, the inner surface having an internal thread formed on at least a portion that is spaced from the end face, and the second locking member having an abutment surface distinct from the external thread that is near the second end and that faces the first end, wherein the abutment surface is configured to abut against the stop of the first locking member to limit advancement of the second locking member into the bore.
Laroque-Lahitette et al. also disclose an anchoring assembly (Fig. 6) and teach a locking member 2 having a stop (annotated Fig. 6, i.e., the bottom of the thread, which is spaced from the end face; id.), an internal thread formed on at least a portion thereof that is spaced from the end face (id.), and a second locking member 7 having an abutment surface, i.e., upper surface of 24 (Fig. 6), distinct from the external thread (id. and cf. Figs. 9, 10 and 13), that is near a second end (bottom) of the second locking member and that faces the first end (top) thereof, wherein the abutment surface (top of 24; supra) is configured to abut against the stop (bottom of the thread; Fig. 6; supra) of the first locking member 2 to limit advancement of the second locking member into the bore and prevent undesired removal of the second locking member 7 (para. 0056).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure another optional locking member such as the first locking member 40 of Matthis et al. to have a stop that is distinct from the end face (bottom), the inner surface having an internal thread formed on at least a portion that is spaced from the end face, and the second locking member 45 to have an abutment surface distinct from the external thread that is near the second end and that faces the first end, wherein the abutment surface is configured to abut against the stop of the first locking member, in view of Laroque-Lahitette et al., to limit upward advancement of the second locking 45 member into the bore and prevent any undesired removal of the second locking member.
Regarding claim 30, the first and second locking members 40, 45 of the combination are independently drivable from one another relative to the receiving part 5 (Figs. 4 and 6, note the independent drive features 43 and 46; para. 0035).
Regarding claim 31, in a first configuration, the first and second locking members 40, 45 of the combination are rotationally fixed relative to one another (e.g., at least by some degree of friction) and movable together (e.g., as by rotating the first locking member 40 relative to the receiving part 5 (para. 0035; note the second locking member 45 does not rotate until separately acted upon).
Regarding claim 33, a third member of the combination, e.g., the optional locking member of the combination (i.e., 40, as modified; supra), is different structurally from the unmodified first locking member 40 and is configured to directly exert pressure on the pressure element 20, wherein the second locking member 45 (Fig. 6) is configured to interchangeably cooperate with the first locking member 40 or the third locking member 40 as modified (supra), if desired (e.g., at least because the threads are the same).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Matthis et al. (2007/0055241; of record) in view of Larroque-Lahitette et al. (2013/0274808; of record), as applied to claim 29 above, and further in view of Biedermann et al. (2013/0345758, hereinafter “Biedermann ‘758”).
Regarding claim 32, the anchoring assembly of the combination of Matthis et al. and Laroque-Lahitette et al. discloses the claimed invention except for disclosing a single drive portion formed at the second locking member, without a separate drive portion provided at the first locking member.
Biedermann ‘758 discloses a single drive portion 106 (Fig. 11) formed at a second locking member 10, without a separate drive portion provided at a first locking member 9 (Figs. 1 and 11; para. 0048). This configuration allows one tool and motion to drive both locking members simultaneously until the first locking member 9 touches a pressure element 7, which increases the torque until the second locking member 10 is released and can clamp to the rod 6 (para. 0048). This configuration allows independent adjustment with minimal tools and gives feedback to the surgeon that allows for precise adjustments (id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the anchoring assembly of the combination (supra) with an optional locking member configuration wherein a single drive portion is formed at the second locking member, without a separate drive portion provided at the first locking member, further in view of Biedermann ‘758, to allow independent adjustment with minimal tools and give feedback to the surgeon that allows for precise adjustments.
Response to Arguments
Applicant's arguments filed 12 June 2026 have been considered but they are not fully persuasive.
The double patenting rejection set forth in the Office action mailed 12 March 2026 has been withdrawn in light of the amendments to the claim 1 adding subject matter not set forth in the claims of either U.S. Pat. Nos. 11,166753 or 12,232,775. New independent claims 29 and 34 are not subject to any double patenting rejection.
It is noted that claim 1 was amended and is subject to new grounds of rejection. Insofar as it pertains to the present grounds of rejection, Biedermann EP (supra) includes and teaches the V-shaped base as claimed, including the gap below the rod, as set forth in the rejection. Likewise, though applied to modified or new claims, Laroque-Lahitette teaches the claimed surface/stop limiting movement of the second locking member, as claimed and applied above in the rejection. New claims 29 and 34 are subject to new grounds of rejection as set forth above.
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.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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