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 .
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.
Claim(s) 1-6, 8-11, 13-19, 24 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-6, 8-11, 13-19, 24 of U.S. Patent No. 11,090,088 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A polyaxial bone anchoring device for coupling a rod to a bone, the bone anchoring device comprising: a bone anchoring element comprising a shank and a head; a receiving part comprising an upper member having a first end, a second end, a passage extending axially between the first and second ends, and a recess at the first end for receiving the rod, and a lower member separate from and connectable around at least part of the second end of the upper member; and a pressure member positionable at least partially in the upper member to exert pressure on the head; wherein the lower member is movable from a first position where the head is pivotable relative to the receiving part, to a second position that is closer axially to the first end of the upper member where an angular position of the head is locked relative to the receiving part while the recess for the rod remains vacant or unobstructed; wherein when the lower member is at the second position, at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member.
1. A polyaxial bone anchoring device for coupling a rod to a bone, the bone anchoring device comprising: a bone anchoring element comprising a shank and a head; a receiving part comprising an upper member having a first end, a second end, a passage extending axially between the first and second ends, and a recess at the first end for receiving the rod, and a lower member separate from and connectable around at least part of the second end of the upper member; and a pressure member positionable at least partially in the upper member to exert pressure on the head; wherein when the pressure member and the head are in the receiving part, the lower member is configured to assume a first position representing an axial position farthest away from the first end of the upper member where the lower member is attached to the upper member, wherein in the first position, the head is pivotable relative to the receiving part but is restricted from removal from the second end of the receiving part; and wherein the lower member is movable from the first position to a second position that is closer axially to the first end of the upper member, where an angular position of the head is locked relative to the receiving part while the recess for the rod remains sufficiently unobstructed for the rod to extend and move therethrough, and where at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member.
2. The polyaxial bone anchoring device of claim 1, wherein the pressure member is configured to abut a stop in the upper member when the head and the pressure member are in the receiving part and the lower member is at the second position.
2. The polyaxial bone anchoring device of claim 1, wherein the pressure member is configured to abut a stop in the upper member when the head and the pressure member are in the receiving part and the lower member is at the second position.
3. The polyaxial bone anchoring device of claim 1, wherein a clamping force exerted on the head is greater when the lower member is at the second position than when the lower member is at the first position.
3. The polyaxial bone anchoring device of claim 1, wherein a clamping force exerted on the head is greater when the lower member is at the second position than when the lower member is at the first position.
4. The polyaxial bone anchoring device of claim 1, wherein the lower member is movable from the first position to the second position with an instrument.
4. The polyaxial bone anchoring device of claim 1, wherein the lower member is movable from the first position to the second position with an instrument.
5. The polyaxial bone anchoring device of claim 4, wherein the lower member is configured to remain at the first position or at the second position without the instrument.
5. The polyaxial bone anchoring device of claim 4, wherein the lower member is configured to remain at the first position or at the second position without the instrument.
6. The polyaxial bone anchoring device of claim 1, wherein the lower member is further movable from the second position back to the first position.
6. The polyaxial bone anchoring device of claim 1, wherein the lower member is further movable from the second position back to the first position.
8. The polyaxial bone anchoring device of claim 1, wherein the lower member comprises an outer engagement structure for engagement with an instrument to move the lower member from the first position to the second position.
8. The polyaxial bone anchoring device of claim 1, wherein the lower member comprises an outer engagement structure for engagement with an instrument to move the lower member from the first position to the second position.
9. The polyaxial bone anchoring device of claim 1, further comprising a fixation element for locking the rod in the recess.
9. The polyaxial bone anchoring device of claim 1, further comprising a fixation element for locking the rod in the recess.
10. The polyaxial bone anchoring device of claim 9, wherein the fixation element is configured to exert pressure on the pressure member via the rod.
10. The polyaxial bone anchoring device of claim 9, wherein the fixation element is configured to exert pressure on the pressure member via the rod.
11. The polyaxial bone anchoring device of claim 1, wherein when the lower member is connected to the upper member, the lower member defines an opening at an end opposite the first end of the upper member with an inner diameter that is greater than a largest width of the head of the bone anchoring element.
11. The polyaxial bone anchoring device of claim 1, wherein when the lower member is connected to the upper member, the lower member defines an opening at an end opposite the first end of the upper member with an inner diameter that is greater than a largest width of the head of the bone anchoring element.
13. The polyaxial bone anchoring device of claim 11, wherein the pressure member comprises an expandable portion for holding the head, and wherein a free end of the pressure member defines an opening configured to be smaller than the opening of the lower member.
13. The polyaxial bone anchoring device of claim 11, wherein the pressure member comprises an expandable portion for holding the head, and wherein a free end of the pressure member defines an opening configured to be smaller than the opening of the lower member.
14. The polyaxial bone anchoring device of claim 13, wherein the head of the bone anchoring element is insertable through the opening of the lower member into the receiving part.
14. The polyaxial bone anchoring device of claim 13, wherein the head of the bone anchoring element is insertable through the opening of the lower member into the receiving part.
15. The polyaxial bone anchoring device of claim 1, wherein the upper member comprises an inner wall portion with a spherical shape at or near the second end that is adapted to a spherical shape of the head.
15. The polyaxial bone anchoring device of claim 1, wherein the upper member comprises an inner wall portion with a spherical shape at or near the second end that is adapted to a spherical shape of the head.
16. The polyaxial bone anchoring device of claim 15, wherein the inner wall portion of the upper member is expandable to facilitate insertion of the head.
16. The polyaxial bone anchoring device of claim 15, wherein the inner wall portion of the upper member is expandable to facilitate insertion of the head.
17. The polyaxial bone anchoring device of claim 1, wherein the head has a spherically-shaped outer surface portion.
17. The polyaxial bone anchoring device of claim 1, wherein the head has a spherically-shaped outer surface portion.
18. The polyaxial bone anchoring device of claim 1, wherein the upper member comprises a lower surface and the lower member comprises an upper surface that faces the lower surface of the upper member when the lower member is connected to the upper member, and wherein a gap is formed between the upper and lower surfaces when the lower member is at the second position.
18. The polyaxial bone anchoring device of claim 1, wherein the upper member comprises a lower surface and the lower member comprises an upper surface that faces the lower surface of the upper member when the lower member is connected to the upper member, and wherein a gap is formed between the upper and lower surfaces when the lower member is at the second position.
19. The polyaxial bone anchoring device of claim 1, wherein when the lower member is at the second position, another part of the lower member is at a same axial height as another part of the upper member.
19. The polyaxial bone anchoring device of claim 1, wherein when the lower member is at the second position, another part of the lower member is at a same axial height as another part of the upper member.
24. A polyaxial bone anchoring device for coupling a rod to a bone anchoring element, the bone anchoring device comprising: a receiving part comprising an upper member having a first end, a second end, a passage extending axially between the first and second ends, and a recess at the first end for receiving the rod, and a lower member separate from and connectable around at least part of the second end of the upper member; and a pressure member positionable at least partially in the upper member to exert pressure on a head of the bone anchoring element, wherein when the pressure member is in the upper member, the upper member is configured to restrict movement of the pressure member towards the first end of the upper member while permitting movement of the pressure member away from the first end of the upper member; wherein the lower member is movable relative to the upper member from a first position to a second position that is closer axially to the first end of the upper member to reduce a size of an opening defined at an end of the receiving part opposite the first end of the upper member; wherein when the lower member is at the second position, at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member.
24. A polyaxial bone anchoring device for coupling a rod to a bone anchoring element, the bone anchoring device comprising: a receiving part comprising an upper member having a first end, a second end, a passage extending axially between the first and second ends, and a recess at the first end for receiving the rod, and a lower member separate from and connectable around at least part of the second end of the upper member; and a pressure member positionable at least partially in the upper member to exert pressure on a head of the bone anchoring element, wherein when the pressure member is in the upper member, the upper member is configured to restrict movement of the pressure member towards the first end of the upper member while permitting movement of the pressure member away from the first end of the upper member; wherein when the lower member is attached to the upper member with the pressure member in the receiving part, the lower member is movable relative to the upper member from a first position to a second position that is closer axially to the first end of the upper member to reduce a size of an opening defined at an end of the receiving part opposite the first end of the upper member; wherein when the lower member is at the second position, at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member.
As is evident from the table above Patent claim 1 discloses all of the features of application claim 1, with additional limitations not required by application claim 1. While Patent claim 1 uses slightly different wording, e.g. “where an angular position of the head is locked relative to the receiving part while the recess for the rod remains sufficiently unobstructed for the rod to extend and move therethrough, and where at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member” instead of “where an angular position of the head is locked relative to the receiving part while the recess for the rod remains vacant or unobstructed; wherein when the lower member is at the second position, at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member” as required by application claim 1. However it is clear that the rod being sufficiently unobstructed for the rod to extend and move therethrough would mean that the recess would be unobstructed.
As is evident from the table above Patent claim 24 discloses all of the features of application claim 24, with additional limitations not required by application claim 24.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-11, 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (U.S. Pub. No. 2014/0012337 A1, hereinafter “Biedermann I”).
Biedermann I discloses, regarding claim 1, a polyaxial bone anchoring device (see Figs. 1-14B) for coupling a rod (100) to a bone (see para. [0054]), the bone anchoring device comprising: a bone anchoring element (1) comprising a shank (2) and a head (3); a receiving part (5) comprising an upper member (8) having a first end (81), a second end (82), a passage (85) extending axially between the first and second ends (see Fig. 5), and a recess (86) at the first end for receiving the rod (see Fig. 5), and a lower member (10) separate from and connectable around at least part of the second end of the upper member (see Fig. 1); and a pressure member (6) positionable at least partially in the upper member to exert pressure on the head (see para. [0041]); wherein the lower member is movable from a first position where the head is pivotable relative to the receiving part (see Fig. 12a, see para. [0051]), to a second position that is closer axially to the first end of the upper member where an angular position of the head is locked relative to the receiving part while the recess for the rod remains vacant or unobstructed (see Figs. 14A-B, see para. [0053]); wherein when the lower member is at the second position, at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member (see Fig. 2, see para. [0046], “flat surface portion 105 correspond to flat surface portion of the upper member in the fully assembled state”).
Regarding claim 2, wherein the pressure member is configured to abut a stop (e.g. crimp) in the upper member when the head and the pressure member are in the receiving part and the lower member is at the second position (see para. [0049], “temporarily held … crimping”).
Regarding claim 3, wherein a clamping force exerted on the head is greater when the lower member is at the second position than when the lower member is at the first position (see paras. [0052]-[0053]).
Regarding claim 4, wherein the lower member is movable from the first position to the second position with an instrument (see Fig. 1, note that the flat surface portions 105 would enable an instrument to grip and move the lower member from the first position to the second position, see also para. [0046] “facilitate gripping”).
Regarding claim 5, wherein the lower member is configured to remain at the first position or at the second position without the instrument (see Fig. 1, note that the threaded connection 90 and 103 would enable the lower member to remain that the first position without being rotated by an instrument).
Regarding claim 6, wherein the lower member is further movable from the second position back to the first position (see Fig. 1, note that the threaded connection 90 and 103 would enable the lower member 10’ to be movable from the second position back to the first position).
Regarding claim 8, wherein the lower member comprises an outer engagement structure (105) for engagement with an instrument to move the lower member from the first position to the second position (see para. [0046], “facilitate gripping”, note that the flat surface facilitates gripping and would enable an instrument to grip and move the lower member to the second position).
Regarding claim 9, further comprising a fixation element (7) for locking the rod in the recess (see para. [0054]).
Regarding claim 10, wherein the fixation element is configured to exert pressure on the pressure member via the rod (see para. [0054]).
Regarding claim 11, wherein when the lower member is connected to the upper member (104), the lower member defines an opening at an end opposite the first end of the upper member with an inner diameter that is greater than a largest width of the head of the bone anchoring element (E, see Fig. 12a, see para. [0046] “inner diameter of the passage at any portion of the lower member is larger than the outer diameter of the shank 2 and is also larger than the maximum outer diameter E of the head 3 of the bone anchoring element 1”).
Regarding claim 15, wherein the upper member comprises an inner wall portion with a spherical shape at or near the second end that is adapted to a spherical shape of the head (see para. [0044] “protrusion 93 is annular and spherically rounded”).
Regarding claim 16, wherein the inner wall portion of the upper member is expandable to facilitate insertion of the head (see Fig. 11B, see paras. [0049]-0050], note that when the balls 20 shift outward from the inner wall portion, the inner wall portion is expanded to facilitate insertion of the head).
Regarding claim 17, wherein the head has a spherically-shaped outer surface portion (see Fig. 1).
Regarding claim 18, wherein the upper member comprises a lower surface and the lower member comprises an upper surface that faces the lower surface of the upper member when the lower member is connected to the upper member (see annotated Fig. 12B below), and wherein a gap is formed between the upper and lower surfaces when the lower member is at the second position (see annotated Fig. 14B below).
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Regarding claim 19, wherein when the lower member is at the second position, another part of the lower member is at a same axial height as another part of the upper member (see annotated Fig. 14a below).
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Claim(s) 1-6, 8-9, 13-14, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (U.S. Pub. No. 2014/0012337 A1, hereinafter “Biedermann II”).
Biedermann II discloses, regarding claim 1, a polyaxial bone anchoring device (see Figs. 15-23) for coupling a rod to a bone (see Fig. 15), the bone anchoring device comprising: a bone anchoring element (1) comprising a shank (2) and a head (3); a receiving part (5’) comprising an upper member (8’) having a first end (81), a second end (82), a passage (85) extending axially between the first and second ends (see Fig. 16), and a recess (86) at the first end for receiving the rod (see Fig. 16), and a lower member (10’) separate from and connectable around at least part of the second end of the upper member (see Fig. 15); and a pressure member (200) positionable at least partially in the upper member to exert pressure on the head (see Fig. 23, see para. [0060]); wherein the lower member is movable from a first position where the head is pivotable relative to the receiving part (see Fig. 21, see para. [0060]), to a second position that is closer axially to the first end of the upper member where an angular position of the head is locked relative to the receiving part while the recess for the rod remains vacant or unobstructed (see Fig. 23, see para. [0060]); wherein when the lower member is at the second position, at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member (see Fig. 15, see para. [0046], “flat surface portion 105 correspond to flat surface portion of the upper member in the fully assembled state”).
Regarding claim 2, wherein the pressure member is configured to abut a stop (see annotated Fig. 23 below) in the upper member when the head and the pressure member are in the receiving part and the lower member is at the second position (see annotated Fig. 23 below).
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Regarding claim 3, wherein a clamping force exerted on the head is greater when the lower member is at the second position than when the lower member is at the first position (see Figs. 21-23, see para. [0060]).
Regarding claim 4, wherein the lower member is movable from the first position to the second position with an instrument (see Fig. 15, note that the flat surface portions 105 would enable an instrument to grip and move the lower member from the first position to the second position, see also para. [0046] “facilitate gripping”).
Regarding claim 5, wherein the lower member is configured to remain at the first position or at the second position without the instrument (see Fig. 21, note that the threaded connection 90 and 103 would enable the lower member to remain that the first position without being rotated by an instrument).
Regarding claim 6, wherein the lower member is further movable from the second position back to the first position (see Fig. 21, note that the threaded connection 90 and 103 would enable the lower member 10’ to be movable from the second position back to the first position).
Regarding claim 8, wherein the lower member comprises an outer engagement structure (105) for engagement with an instrument to move the lower member from the first position to the second position (see para. [0046], “facilitate gripping”, note that the flat surface facilitates gripping and would enable an instrument to grip and move the lower member to the second position).
Regarding claim 9, further comprising a fixation element (7) for locking the rod in the recess (see para. [0055]).
Regarding claim 13, wherein the pressure member comprises an expandable portion for holding the head (see paras. [0059]-[0060]), and wherein a free end of the pressure member defines an opening configured to be smaller than the opening of the lower member (see Fig. 23, see para. [0060]).
Regarding claim 14, wherein the head of the bone anchoring element is insertable through the opening of the lower member into the receiving part (see para. [0058]).
Regarding claim 17, wherein the head has a spherically-shaped outer surface portion (see Fig. 15).
Claim Rejections - 35 USC § 103
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.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farris et al. (U.S. Pub. No. 2009/0069852 A1, hereinafter “Farris”).
Farris discloses, regarding claim 24, a polyaxial bone anchoring device (see Fig. 27) for coupling a rod to a bone anchoring element (see Fig. 27), the bone anchoring device comprising: a receiving part (114 and 120) comprising an upper member (114) having a first end (see annotated Fig. 27 below), a second end (see annotated Fig. 27 below), a passage extending axially between the first and second ends (see annotated Fig. 27 below), and a recess at the first end for receiving the rod (see annotated Fig. 27 below), and a lower member (120) separate from and connectable around at least part of the second end of the upper member (see para. [0096]); and a pressure member (116) positionable at least partially in the upper member to exert pressure on a head of the bone anchoring element (see para. [0096]), wherein when the pressure member is in the upper member, the upper member is configured to restrict movement of the pressure member towards the first end of the upper member while permitting movement of the pressure member away from the first end of the upper member (via 150, see para. [0094]); wherein when the lower member is connected to the upper member with the pressure member in the receiving part, the lower member is movable relative to the upper member from a first position to a second position that is closer axially to the first end of the upper member to reduce a size of an opening defined at an end of the receiving part opposite the first end of the upper member (see para. [0096] “flex inwardly (contract) to secure”).
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Farris fails to explicitly disclose in the embodiment shown in Figures 24-29, regarding claim 24, wherein when the lower member is at the second position, at least part of the lower member is aligned axially with at least part of an end face at the second end of the upper member.
Farris discloses in an alternative embodiment shown in Figures 30-31, wherein the lower member includes a recess (176) that engages a projection (178) on the upper member to axially align the two members during assembly and limit translation of the lower member (see para. [0102]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the lower member and the upper member in the embodiment shown in Figures 24-29 of Farris to include structures that align axially in view of the embodiment shown in Figures 30-31 of Farris in order to axially align the two members during assembly and limit translation of the lower member.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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