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 § 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 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larroque-Lahitette et al. (2013/0274808).
Regarding claim 18, Larroque-Lahitette et al. disclose a closure element for a polyaxial bone anchoring device, the closure element comprising:
a first locking member 2 (Fig. 6) comprising a first end (top of opening 9; Fig. 5), a second end (bottom of opening 9; Fig. 6), and an inner surface defining a bore 9 that extends from the first end to the second end, wherein an internal thread is formed on the inner surface (Figs. 5 and 6); and
a second locking member 7 that is insertable from the second end of the first locking member 2 into the bore 9 of the first locking member 2 (para. 0056), the second locking member 7 having a first end (top) that is directed towards the first end of the first locking member during insertion (id.), a second end (bottom), an external thread (Fig. 6) configured to engage the internal thread (id.) of the first locking member 2, and an abutment surface (i.e., upper surface of the larger diameter broadened distal end 24; para. 0056; Fig. 6) near the second end of the second locking member (id.), wherein the abutment surface faces the first end of the second locking member and is distinct from the external thread (para. 0056; Fig. 6);
wherein the abutment surface (supra; upper surface of the larger diameter portion of the broadened distal end 24) of the second locking member 7 is configured to abut against a stop (e.g., the lower thread flank of the internal thread having a smaller diameter; para. 0056) of the first locking member 2 to limit advancement of the second locking member 7 towards the first end of the first locking member 2 when the second locking member 7 is inserted in the first locking member 2 (para. 0056).
Regarding claim 19, the second locking member 7 is configured to be rotationally fixed relative to the first locking member via a holding force, e.g., friction, and wherein when a torque greater than the holding force is applied to the second locking member, the rotational fixation between the first and second locking members is released and the second locking member becomes rotatable relative to the first locking member (i.e., when the second locking member is rotated, the torque is sufficient to overcome the friction).
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 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Matthis et al. (2007/0055241).
Regarding claim 1, Mathis et al. disclose an anchoring assembly (Figs. 1, 2, 4 and 6) 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 rod 14 having a diameter and configured to be received in the channel 12;
a first closure element 30 (Figs. 1-3 and 6) configured to cooperate with the receiving part 5 and to act on the first rod 14 in the receiving part, such that the first rod exerts pressure onto the pressure element 20 to lock the angular position of the shank 2 relative to the receiving part 5 while the first rod is simultaneously fixed in the channel; and
a second closure element 40, 45 configured to cooperate with the receiving part 5,
wherein the second closure element 40, 45 is configured to act on the pressure element 20 to lock the angular position of the shank 2 relative to the receiving part 5 and to act separately on the first rod 14 to fix the first rod in the channel 12;
wherein the first closure element 30 and the second closure element 40, 45 are configured to interchangeably cooperate with the receiving part 5 (Fig. 6; para. 0036). It is noted that the first closure element 30 is capable of causing pressure from a second rod of a smaller diameter, if desired, to be exerted onto the pressure element 20 to lock the angular position of the shank 2 relative to the receiving part 5 while such rod is simultaneously fixed in the channel 12 because the gap 35 (Fig. 7; para. 0029) at the time of final tightening allows for further downward travel of the closure element 30 in a desired range within the gap. It is further noted that the second closure element 40, 45 is also configured to act separately on a second rod of a smaller diameter, if desired, via portion 45, to fix such second rod in the channel.
Matthis et al. thus discloses the claimed invention except for explicitly reciting a second rod having a smaller diameter.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date to provide a second rod having a smaller diameter, e.g., to accommodate an existing rod having a smaller diameter or to utilize a rod having a smaller diameter to accommodate different patients.
Regarding claim 2, the pressure element 20 (Fig. 1) defines a recess (id.) that forms a base 13 and two free legs 21 configured to extend above the first rod 14 or the second rod of a smaller diameter (supra) when either the first rod or the second rod is respectively inserted into the recess and rests on the base 13.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Matthis et al. (2007/0055241), as modified, in view of Biedermann (EP-2851021).
Regarding claim 3, Mathis et al. as modified disclose a first closure element 30 and a second closure element 40, 45 (supra) configured to clamp the first rod 14 or the second rod (supra) at a distinct contact area on a lower side of the closure element (i.e., the line defined at the point of tangency with the rod and extending parallel with the rod).
Mathis et al. do not disclose the pressure element providing at least two distinct contact areas such that when either the first rod or the second rod is received in the channel between the pressure element and the first closure element, the pressure element and the first closure element are configured to clamp the first rod or the second rod at at least three distinct contact areas, and wherein when either the first rod or the second rod is received in the channel between the pressure element and the second closure element, the pressure element and the second closure element are configured to clamp the first rod or the second rod at at least at three distinct contact areas.
However, Biedermann teaches that a pressure element 8 (Fig. 1) can be defined with a bottom surface forming a V-shape (Figs. 1 and 3; para. 0040) which provides at least two distinct areas of contact P1, P2 (id.). This configuration provides a secure support surface including for rods having a different diameter (id.).
Therefore, 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 at least two distinct contact areas, in view of Biedermann as modified, to provide a secure support surface including for rods having a different diameter. It is noted that when either the first rod or the second rod is received in the channel between the modified pressure element and the first closure element, the modified pressure element and the first closure element are thus configured to clamp the first rod or the second rod at at least three distinct contact areas (i.e., at least two from the pressure element and one from the closure element), and wherein when either the first rod or the second rod is received in the channel between the modified pressure element and the second closure element, the modified pressure element and the second closure element are configured to clamp the first rod or the second rod at at least at three distinct contact areas (i.e., at least two from the pressure element and one from the closure element).
Regarding claim 4, the pressure element of the combination has a base on which at least two of the distinct contact areas P1, P2 are located (Fig. 3 of Biedermann).
Regarding claim 5, the distinct contact areas P1, P2 (id.) each forms a line substantially parallel to a longitudinal axis of the channel 12 (i.e., the line defined at the point of tangency with the rod and extending parallel with the rod).
Regarding claim 6, one of the distinct contact areas is located on a lower side of the first closure element 30 or on a lower side of the second closure element 40, 45 (i.e., along a line defined on the lower side of each closure element at the point of tangency with the rod and extending parallel with the rod).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 18 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 19 and 20 of U.S. Patent No. 11,166,753. Although the claims at issue are not identical, they are not patentably distinct from each other because the substantive difference between the application claims and the patent claims is that the patent claims include more elements and are more specific (e.g., independent patent claim 1 further recites “to act on the first rod when the first rod is received in the receiving part” and “to act on the second rod when the first rod is received in the receiving part”; independent patent claim 19 further recites “a lower thread flank that is positioned closest to the second end but distinct from an end face at the second end” and “wherein the lower thread flank of the internal thread of the first locking member forms a stop”) . Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims. The claims directly correspond to each other apart from this difference.
Regarding independent application claim 1, independent patent claim 1 recites an anchoring assembly for anchoring a rod to a bone or a vertebra, the anchoring assembly comprising:
a shank;
a receiving part pivotably connectable to the shank, the receiving part defining a channel for receiving a rod;
a pressure element configured to lock an angular position of the shank relative to the receiving part;
a first rod and a second rod having different diameters and configured to be interchangeably received in the channel;
a first closure element configured to cooperate with the receiving part, such that the first rod or the second rod exerts pressure onto the pressure element to lock the angular position of the shank relative to the receiving part while the first rod or the second rod is simultaneously fixed in the channel; and
a second closure element configured to cooperate with the receiving part,
wherein the second closure element is configured to act on the pressure element to lock the angular position of the shank relative to the receiving part and to act separately on the first rod or the second rod to fix the first rod or the second rod in the channel;
wherein the first closure element and the second closure element are configured to interchangeably cooperate with the receiving part.
The dependent application claims likewise correspond directly to the dependent patent claims, as set forth in the table at the end of this section.
Regarding independent application claim 18, independent patent claim 19 recites a closure element for a polyaxial bone anchoring device, the closure element comprising:
a first locking member comprising a first end, a second end, and an inner surface defining a bore that extends from the first end to the second end, wherein an internal thread is formed on the inner surface; and
a second locking member that is insertable from the second end of the first locking member into the bore of the first locking member, the second locking member having a first end that is directed towards the first end of the first locking member during insertion, a second end, an external thread configured to engage the internal thread of the first locking member, and an abutment surface near the second end of the second locking member, wherein the abutment surface faces the first end of the second locking member and is distinct from the external thread;
wherein the abutment surface of the second locking member is configured to abut against a stop of the first locking member to limit advancement of the second locking member towards the first end of the first locking member when the second locking member is inserted in the first locking member.
The dependent application claims likewise correspond directly to the dependent patent claims, as set forth in the table at the end of this section.
Claims 1-6 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10 and 18 of U.S. Patent No. 12,232,775. Although the claims at issue are not identical, they are not patentably distinct from each other because the substantive difference between the application claims and the patent claims is that the patent claims include more elements and are more specific. For example, independent patent claim 1 further recites: “wherein the pressure element comprises a base configured to simultaneously contact an inserted rod at at least two circumferentially distinct and spaced apart contact areas around a rod axis of the inserted rod”; “and to contact the inserted rod”; “while the first closure element remains spaced apart from the pressure element”; “contact and directly exert pressure on” instead of just “act on”; “a second locking member positionable in the first locking member”; and “wherein a stop is provided on the first locking member to limit an advancement of the second locking member relative to the first locking member, wherein the stop is at or close to a lower end of the first locking member and faces the pressure element when the pressure element and the second closure element are in the receiving part”. Independent patent claim 18 further recites: “formed on at least a portion thereof that is spaced apart from an end face at the second end and a stop that is distinct from the end face at the second end; and a monolithic”) . Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims. The claims directly correspond to each other apart from this difference.
Regarding independent application claim 1, independent patent claim 1 recites an anchoring assembly for anchoring a rod to a bone or a vertebra, the anchoring assembly comprising:
a shank;
a receiving part pivotably connectable to the shank, the receiving part defining a channel for receiving a rod;
a pressure element configured to lock an angular position of the shank relative to the receiving part;
a first rod and a second rod having different diameters and configured to be interchangeably received in the channel;
a first closure element configured to cooperate with the receiving part, such that the first rod or the second rod exerts pressure onto the pressure element to lock the angular position of the shank relative to the receiving part while the first rod or the second rod is simultaneously fixed in the channel; and
a second closure element configured to cooperate with the receiving part,
wherein the second closure element is configured to act on the pressure element to lock the angular position of the shank relative to the receiving part and to act separately on the first rod or the second rod to fix the first rod or the second rod in the channel;
wherein the first closure element and the second closure element are configured to interchangeably cooperate with the receiving part.
The dependent application claims likewise correspond directly to the dependent patent claims, as set forth in the table at the end of this section.
Regarding independent application claim 18, independent patent claim 18 recites a closure element for a polyaxial bone anchoring device, the closure element comprising:
a first locking member comprising a first end, a second end, and an inner surface defining a bore that extends from the first end to the second end, wherein an internal thread is formed on the inner surface; and
a second locking member that is insertable from the second end of the first locking member into the bore of the first locking member, the second locking member having a first end that is directed towards the first end of the first locking member during insertion, a second end, an external thread configured to engage the internal thread of the first locking member, and an abutment surface near the second end of the second locking member, wherein the abutment surface faces the first end of the second locking member and is distinct from the external thread;
wherein the abutment surface of the second locking member is configured to abut against a stop of the first locking member to limit advancement of the second locking member towards the first end of the first locking member when the second locking member is inserted in the first locking member.
The dependent application claims likewise correspond directly to the dependent patent claims, as set forth in the table at the end of this section.
Appl. 19/045,083
Pat. 11,166,753
Pat. 12,232,775
1
1
1
2
2
8
3
3
9
4
4
9
5
5
10
6
6
9
7 (canceled)
8 (canceled)
9 (canceled)
10 (canceled)
11 (canceled)
12 (canceled)
13 (canceled)
14 (canceled)
15 (canceled)
16 (canceled)
17 (canceled)
18
19
18
19
20
N/A
20 (canceled)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773