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.
Claim 22 is 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 22 recites the limitation "the shank of the bone anchor" in line 12. There is insufficient antecedent basis for this limitation in the claim. It appears as though the limitation should read “the shank of the bone anchoring element”.
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 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.
(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) 1-3, 5, 6, 8-18, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kishan et al. (Pub. No. US 2015/0272628 A1).
Regarding claims 1-3, 5, 6, 8, and 9, Kishan et al. discloses a coupling device 110 for use with a bone anchoring element 160 comprising a head and a shank for anchoring in bone (figure 1), the coupling device 110 comprising: a receiving part 120 connectable to the head of the bone anchoring element 160 (figure 4), the receiving part 120 having a first end, a second end, and a longitudinal axis B extending between the first and second ends (figure 1), and defining a coaxial passage 121 extending from the first end towards the second end (figure 1); a pressure member 140 comprising a first portion (upper portion) and an expandable portion (lower portion) that forms a seat for the head (figure 4), wherein the pressure member 140 is movable in the passage to a position where the receiving part 120 acts on the expandable portion to exert pressure on and clamp the head when the head is held in the seat (figure 14B; paragraph 0037, 0044, and 0045); wherein when the pressure member 140 is in the receiving part 120, the seat is configured to be arranged asymmetrically relative to the longitudinal axis of the receiving part 120 while a central axis of the first portion of the pressure member 140 is substantially coaxial with the longitudinal axis (figure 4), such that the seat facilitates pivoting of a connected bone anchoring element 160 in at least a first direction at a first maximum angle relative to the longitudinal axis, and a second direction opposite the first direction at a second maximum angle relative to the longitudinal axis that is smaller than the first maximum angle (figures 4 and 5; paragraphs 0047 and 0048). A wall thickness of the expandable portion of the pressure member 140 is greater in the second direction than in the first direction (figure 4). The second maximum angle is substantially 0 relative to the longitudinal axis (figure 5; paragraphs 0047 and 0048). At least one of the pressure member 140 or the receiving part 120 defines an opening 146 at or near the second end of the receiving part with a non-circular profile (the protrusion 145 results in the opening having a non-circular profile, figures 1 and 4). The opening 146 is substantially elliptical (as a result of the protrusion extending into the opening 146 on one side, the opening is substantially elliptical- figures 1 and 4). The expandable portion of the pressure member 140 comprises a surface 145 in the second direction that extends vertically to facilitate increased contact with the shank (figures 1, 4, and 5). The pressure member 140 is configured to extend out of the second end of the receiving part 120 (figures 5 and 14B).
PNG
media_image1.png
679
412
media_image1.png
Greyscale
Regarding claims 10-18 and 21, Kishan et al. discloses a bone anchoring device 100 (figure 1) comprising: a bone anchoring element 160 comprising a head 162 and a shank 164 for anchoring in bone (figure 1); and a coupling device 110 for use with the bone anchoring element 160, the coupling device 110 comprising: a receiving part 120 connectable to the head 162, the receiving part 120 having a first end, a second end, and a longitudinal axis B extending between the first and second ends (figure 1), and defining a coaxial passage 121 extending from the first end towards the second end (figures 1 and 4); a pressure member 140 comprising a first portion (upper portion) and an expandable portion (lower portion- entire pressure member is expandable/contractable due to the slit shown in figure 1) that forms a seat for the head (figures 1 and 4), wherein the pressure member 140 is movable in the passage 121 to a position where the receiving part 120 acts on the expandable portion to exert pressure on and clamp the head 162 when the head is held in the seat (figure 14B; paragraph 0037, 0044, and 0045); wherein when the pressure member 140 is in the receiving part with a central axis of the first portion of the pressure member extending substantially coaxially with the longitudinal axis and when the head 162 is held in the seat, the bone anchoring element 160 is pivotable in at least a first direction at a first maximum angle alpha relative to the longitudinal axis (figure 5), and a second direction opposite the first direction at a second maximum angle relative to the longitudinal axis that is smaller than the first maximum angle (figure 5), wherein the pressure member 140 prevents the bone anchoring element from directly contacting the receiving part 120 in at least the second direction (figures 2, 4, 5, and 14b). The pressure member 140 forms an abutment 145 that limits the pivoting of the bone anchoring element 160 in the second direction (figure 5; paragraphs 0047-0050). When the head 162 is in the seat and the bone anchoring element 160 is pivoted in the second direction, a neck of the bone anchoring element 160 located between the head 162 and the shank 164 is configured to abut against the abutment 145 (figures 4 and 5). The abutment 145 extends vertically to facilitate increased contact with the neck of the bone anchoring element 160 (figure 4). The expandable portion of the pressure member 140 defines an opening 146 for inserting the head 162 into the seat, and wherein an edge of the opening comprises the abutment 145 (figures 1 and 4). A wall thickness of the expandable portion of the pressure member 140 is greater in the second direction corresponding to the abutment 145 than in the first direction (figure 4). The second maximum angle is substantially 00 relative to the longitudinal axis (figure 5; paragraphs 0047-0050). The expandable portion of the pressure member 140 is configured to extend over at least part of a region of the head 162 that defines a greatest width of the head (figure 4). The seat is configured to clamp the head 162 by friction prior to final locking of the head 162 relative to the receiving part 120 (paragraph 0045). The receiving part 120 and/or the pressure member 140 limit pivoting of the bone anchoring element 160 to the second maximum angle in substantially every direction other than the first direction relative to the longitudinal axis (paragraph 0050).
Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Wirth et al. (Pub. No. DE 102017124734 A1).
Regarding claim 22, Wirth et al. discloses a method for implanting a bone anchoring device 2, the bone anchoring device 2 comprising a bone anchoring element 4 comprising a head 8 and a shank 6 for anchoring in bone (figure 2A) and a coupling device 10/18 comprising a receiving part 10, the receiving part 10 having a first end, a second end, and a longitudinal axis 24 extending between the first and second ends (figure 2A), and defining a coaxial passage 16 extending from the first end towards the second end (Figure 2a-2d), a pressure member 18 comprising a first portion (upper portion) and an expandable portion (lower portion) that forms a seat 44 for the head (figures 2a-2d, 3a-3g), wherein when the pressure member 18 is in the receiving part 10, the seat is configured to be arranged-25-113229715.3200285 asymmetrically relative to the longitudinal axis of the receiving part 10 while a central axis of the first portion of the pressure member 18 is substantially coaxial with the longitudinal axis (figure 2b), and a locking element “grub screw” (paragraph 0009 of the translation), the method comprising: anchoring the shank 6 of the bone anchor to bone (paragraph 0001); adjusting an angular position of the receiving part 10 relative to the shank 6 when the pressure member 18 is in the receiving part 10 and the head 8 is held in the seat 44, wherein the seat 44 facilitates pivoting of the receiving part 10 relative to the bone anchoring element 4 in at least a first direction at a first maximum angle relative to the longitudinal axis (figure 2d), and a second direction opposite the first direction at a second maximum angle relative to the longitudinal axis that is smaller than the first maximum angle (paragraphs 0030-0032 of the translation); advancing the locking element “grub screw” in the passage to move the pressure member 18 in the passage to a position where the receiving part 10 acts on the expandable portion to exert pressure on and clamp the head 8 in the seat 44 (paragraph 0009), for locking the head 8 relative to the receiving part 10 (paragraph 0009).
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 1-3, 5, 6, 8-18, 21, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11751918 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus more specific. Thus the invention of the patent claims are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO form 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynnsy Summitt whose telephone number is (571)270-78567856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773