DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 12/802849, 12/924802, 61/278240, 61/336911, 61/343737, 61/395564, 61/395752, 61/396390, 61/398807, 61/400504, 61/402959, 61/268708, 61/270754, 61/336911, 61/402959, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The Application Nos. fail to disclose a pivotal bone anchor assembly with an open retainer, and as required by claim 1, an uppermost surface of the open retainer engageable with the downward-facing abutment structure above the upper region of the internal chamber so as to inhibit the open retainer from moving back up into the upper region; and as required by claim 9, an uppermost surface of the open retainer engaging with a downwardly facing surface of the abutment structure so as to inhibit the open retainer from moving back up into the upper region; and as required by claim 15, wherein the open retainer is thereafter downwardly displaceable toward the lower region of the internal chamber and the pressure insert is wedged downwardly against a protrusion integrally formed in the receiver so as to thereafter inhibit the pressure insert from moving back up into the first position.
Claims 1-19 have been given the benefit of an earlier filing date of Application No. 61/403696 (September 20, 2010).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-5, 8-14 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Biedermann et al. (U.S. Pub. No. 2010/0234902 A1, hereinafter “Biedermann”).
Biedermann discloses, regarding claim 1, a pivotal bone anchor assembly (see Figs. 15-26) for securing an elongate rod (6, see Fig. 15) to a bone of a patient with a closure top (7), the pivotal bone anchor assembly comprising: a receiver (5) comprising a lower portion (see annotated Fig. 20 below) defining an internal chamber (19) communicating with a bottom (11) of the receiver through a bottom opening (18), an upper portion (see annotated Fig. 20 below) defining a channel (13) sized and shaped for receiving a portion of the elongate rod (see Fig. 15, see para. [0041]), the internal chamber communicating with the channel and including a lower region adjacent the bottom opening (see annotated Fig. 20 below), and an upper region adjacent to and above the lower region (see annotated Fig. 20 below), and a downward-facing abutment structure (e.g. bottom surface of 93) above the upper region (see annotated Fig. 20 below); a bone anchor (1) comprising a capture portion (3) and an anchor portion (2) opposite the capture portion configured for attachment to the bone (see Fig. 15, note threads), the capture portion positionable in the internal chamber of the lower portion of the receiver with the bone anchor extending downward through the bottom opening (see Figs. 20-21); and an open retainer (8’, note open via coaxial bore 90 and slits 89) configured to be positioned and restrained in the upper region of the internal chamber prior to the capture portion of the bone anchor being uploaded through the bottom opening and into the open retainer (retained via upper surface of 93, see Fig. 20, also note that since the retainer 8’ is compressible it would be capable of being compressed to be uploaded through 18), wherein the open retainer is configured to expand about the capture portion of the bone anchor upon its uploading through the bottom opening so as to receive and capture the capture portion within the internal chamber (via 89, see Figs. 20-21), and wherein the open retainer is thereafter downwardly displaceable toward the lower region of the internal chamber (see Fig. 23) with an uppermost surface of the open retainer (e.g. uppermost surface of 92, see Figs. 23-24) engageable with the downward-facing abutment structure above the upper region of the internal chamber so as to inhibit the open retainer from moving back up into the upper region (see Figs. 23-24, see para. [0058]).
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Regarding claim 2, wherein the open retainer is configured as a ring (see Fig. 19, note that retainer forms a generally circular ring around bore 90).
Regarding claim 3, wherein the open retainer is resilient (see Figs. 21 and 22, see para. [0058] “resilient fingers 91a, 91b”, see also para. [0044] “slits 89 are such that the wall of the second portion is flexible enough”).
Regarding claim 4, wherein the open retainer includes an upper portion (81’) defining the uppermost surface (upper surface of 92, see Fig. 16), the upper portion configured to extend above the capture portion of the bone anchor when the capture portion is positioned in the internal chamber of the receiver (see Fig. 21).
Regarding claim 5, wherein the downward-facing abutment structure is integrally formed with the receiver (see Fig. 20, note that once pins 9a’-9b’ are inserted into the receiver they become integrally formed with the receiver).
Regarding claim 8, wherein the open retainer includes at least one slot (89) in a side surface of the open retainer (see Fig. 16).
Biedermann discloses, regarding claim 9, a method of assembling a pivotal bone anchor assembly (see Figs. 15-26) for securing an elongate rod (6, see Fig. 15) to a bone of a patient with a closure top (7), the method comprising: positioning an open retainer (8’) in a receiver (5), the receiver comprising a lower portion (see annotated Fig. 20 above) defining an internal chamber (19) communicating with a bottom (11) of the receiver through a bottom opening (18), and an upper portion (see annotated Fig. 20 above) defining a channel (13) sized and shaped for receiving a portion of the elongate rod (see Fig. 15), the internal chamber communicating with the channel and including a lower region adjacent the bottom opening (see annotated Fig. 20 above), an upper region adjacent to and above the lower region (see annotated Fig. 20 above) and an abutment structure (92) above the upper region with the open retainer being positioned and initially restrained in the upper region of the internal chamber at least in part by engagement with the abutment structure (93, see Figs. 20-21); uploading a bone anchor (1) into the receiver (see Figs. 20-21), the bone anchor comprising a capture portion (3) and an anchor portion (2) opposite the capture portion configured for attachment to the bone (see Fig. 15, note threads), the capture portion positionable with in the open retainer with the bone anchor extending downward through the bottom opening of the receiver (see Fig. 21), and downwardly displacing the open retainer toward the lower region of the internal chamber (see Figs. 22-23), with an uppermost surface (e.g. upper surface of 92) of the open retainer engaging with a downwardly facing surface (e.g. bottom surface of 93) of the abutment structure so as to inhibit the open retainer from moving back up into the upper region (see Figs. 23-24, see para. [0058]), wherein the open retainer is configured to expand about the capture portion of the bone anchor upon its uploading to receive and capture the capture portion within the internal chamber (via 89, see Figs. 20-21).
Regarding claim 10, wherein the open retainer includes an upper portion (81’) defining the uppermost surface (upper surface of 92, see Fig. 16), the upper portion configured to extend above the capture portion of the bone anchor when the capture portion is positioned in the internal chamber of the receiver (see Fig. 21).
Regarding claim 11, where the abutment surface is integrally formed with the receiver (see Fig. 20, note that once pins 9a’-9b’ are inserted into the receiver they become integrally formed with the receiver).
Regarding claim 12, wherein the open retainer is resilient (see Figs. 21 and 22, see para. [0058] “resilient fingers 91a, 91b”, see also para. [0044] “slits 89 are such that the wall of the second portion is flexible enough”).
Regarding claim 13, wherein the open retainer is configured as a ring (see Fig. 19, note that retainer forms a generally circular ring around bore 90).
Regarding claim 14, wherein the open retainer includes at least one slot in a side surface of the retainer (see Fig. 20, note that once pins 9a’-9b’ are inserted into the receiver they become integrally formed with the receiver).
Claim(s) 1-19 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Walsh et al. (U.S. Pub. No. 2010/0160980 A1, hereinafter “Walsh”).
Walsh discloses, regarding claim 1, a pivotal bone anchor assembly (see Fig. 1) for securing an elongate rod (106) to a bone of a patient with a closure top (112), the pivotal bone anchor assembly comprising: a receiver (102) comprising a lower portion (see annotated Fig. 2A below) defining an internal chamber (see annotated Fig. 2A below) communicating with a bottom of the receiver (see annotated Fig. 2A below) through a bottom opening (118), an upper portion (see annotated Fig. 2A below) defining a channel (121) sized and shaped for receiving a portion of the elongate rod (see Fig. 2A), the internal chamber communicating with the channel and including a lower region adjacent the bottom opening (see annotated Fig. 2A below), and an upper region adjacent to and above the lower region (see annotated Fig. 2A below), and a downward-facing abutment structure above the upper region (see annotated Fig. 2A below); a bone anchor (104) comprising a capture portion (140) and an anchor portion (142) opposite the capture portion configured for attachment to the bone (see Fig. 1, via threads 144), the capture portion positionable in the internal chamber of the lower portion of the receiver with the bone anchor extending downward through the bottom opening (see Fig. 2A); and an open retainer (108) configured to be positioned and restrained in the upper region of the internal chamber prior to the capture portion of the bone anchor being uploaded through the bottom opening and into the open retainer (see para. [0042]), wherein the open retainer is configured to expand about the capture portion of the bone anchor upon its uploading through the bottom opening so as to receive and capture the capture portion within the internal chamber (see Fig. 2A, see para. [0044]), and wherein the open retainer is thereafter downwardly displaceable toward the lower region of the internal chamber with an uppermost surface (upper surface of 158) of the open retainer engageable with the downward-facing abutment structure above the upper region of the internal chamber so as to inhibit the open retainer from moving back up into the upper region (via 172 and external surface of 110, see Fig. 2B, see paras. [0049]-[0050], note inhibits moving back upward without use of a driver or tool).
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Regarding claim 2, wherein the open retainer is configured as a ring (see Fig. 5A).
Regarding claim 3, wherein the open retainer is resilient (see para. [0044]).
Regarding claim 4, wherein the open retainer includes an upper portion defining the uppermost surface (upper surface of 158), the upper portion configured to extend above the capture portion of the bone anchor when the capture portion is positioned in the internal chamber of the receiver (see Fig. 2A).
Regarding claim 5, wherein the downward-facing abutment structure is integrally formed with the receiver (see annotated Fig. 2A).
Regarding claim 6, and further comprising a pressure insert (110) at least partially positioned within the channel of the receiver above the open retainer (see Fig. 2A).
Regarding claim 7, wherein the pressure insert has an upwardly-open rod seat (168) configured to downwardly receive the elongate rod through the channel of the receiver (see Fig. 2A), and a recess (see annotated Fig. 2A above) below the rod seat configured to receive an upper portion (158) of the open retainer prior to the capture portion of the bone anchor being uploaded through the bottom opening (see Fig. 2A).
Regarding claim 8, wherein the open retainer includes at least one slot in a side surface of the open retainer (see annotated Fig. 5A below).
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Walsh discloses, regarding claim 9, a method of assembling a pivotal bone anchor assembly (see Figs. 1-2B) for securing an elongate rod (106) to a bone of a patient with a closure top (112), the method comprising: positioning an open retainer (108) in a receiver (102), the receiver comprising a lower portion defining an internal chamber communicating with a bottom of the receiver (see annotated Fig. 2A above) through a bottom opening (118), and an upper portion (see annotated Fig. 2A above) defining a channel (121) sized and shaped for receiving a portion of the elongate rod (see Fig. 2A), the internal chamber communicating with the channel and including a lower region adjacent the bottom opening (see annotated Fig. 2A above), an upper region adjacent to and above the lower region and an abutment structure above the upper region with the open retainer being positioned and initially restrained in the upper region of the internal chamber at least in part by engagement with the abutment structure (see annotated Fig. 2A above); uploading a bone anchor into the receiver (see Fig. 2A), the bone anchor comprising a capture portion (140) and an anchor portion (142) opposite the capture portion configured for attachment to the bone (via threads 144), the capture portion positionable with in the open retainer with the bone anchor extending downward through the bottom opening of the receiver (see Fig. 2A), and downwardly displacing the open retainer toward the lower region of the internal chamber (see Fig. 2B), with an uppermost surface (158) of the open retainer engaging with a downwardly facing surface of the abutment structure (via 172 and external surface of 110) so as to inhibit the open retainer from moving back up into the upper region (see Fig. 2B, see paras. [0049]-[0050], note inhibits moving back upward without use of a driver or tool), wherein the open retainer is configured to expand about the capture portion of the bone anchor upon its uploading to receive and capture the capture portion within the internal chamber (see para. [0042]).
Regarding claim 10, wherein the open retainer includes an upper portion (158) defining the uppermost surface (see Fig. 2A), the upper portion configured to extend above the capture portion of the bone anchor when the capture portion is positioned in the internal chamber of the receiver (see Fig. 2A).
Regarding claim 11, where the abutment surface is integrally formed with the receiver (see annotated Fig. 2A above).
Regarding claim 12, wherein the open retainer is resilient (see para. [0044]).
Regarding claim 13, wherein the open retainer is configured as a ring (see Fig. 5A).
Regarding claim 14, wherein the open retainer includes at least one slot in a side surface of the retainer (see annotated Fig. 5A above).
Walsh discloses, regarding claim 15, a pivotal bone anchor assembly (see Fig. 1) for securing an elongate rod (106) to a bone of a patient with a closure top (112), the pivotal bone anchor assembly comprising: a receiver (102) comprising a lower portion defining an internal chamber communicating with a bottom of the receiver through (see annotated Fig. 2A below) a bottom opening (118), and an upper portion (see annotated Fig. 2A below) defining a channel (12) sized and shaped for receiving a portion of the elongate rod (see Fig. 2A), the internal chamber communicating with the channel and including a lower region adjacent the bottom opening and an upper region adjacent to and above the lower region (see annotated Fig. 2A above); a bone anchor (104) comprising a capture portion (140) and an anchor portion (142) opposite the capture portion configured for attachment to the bone (see Fig. 2A, via threads 144), the capture portion positionable in the internal chamber of the receiver with the bone anchor extending downward through the bottom opening (see Fig. 2A); an open retainer (108) configured to be positioned and restrained in the upper region of the internal chamber prior to the capture portion of the bone anchor being uploaded through the bottom opening and into the open retainer (see para. [0042]), the open retainer including an upper portion defining an uppermost surface (e.g. top surface of 158) and configured to extend above the capture portion of the bone anchor when the capture portion is positioned in the internal chamber of the receiver (see Fig. 2A); and a pressure insert (110) positioned within the internal chamber at least partially above the open retainer in a first position (see Fig. 2A), the pressure insert having an upwardly-open rod seat (168) configured to downwardly receive the elongate rod through the channel (see Fig. 2A), and a recess (see annotated Fig. 2A above) below the rod seat configured to receive the upper portion of the open retainer prior to the capture portion of the bone anchor being uploaded through the bottom opening (via 158 and 172, see Fig. 2A), wherein the open retainer is configured to expand about the capture portion of the bone anchor upon its uploading through the bottom opening so as to receive and capture the capture portion within the internal chamber (see Fig. 2A, see para. [0044]), and wherein the open retainer is thereafter downwardly displaceable toward the lower region of the internal chamber (see Fig. 2B), and the pressure insert is wedged downwardly against a protrusion (see annotated Fig. 2A above) integrally formed in the receiver so as to thereafter inhibit the pressure insert from moving back up into the first position (see Fig. 2B, see paras. [0049]-[0050], note inhibits moving back upward without use of a driver or tool).
Regarding claim 16, wherein the open retainer is engageable with the pressure insert prior to uploading the bone anchor (see Fig. 2A, see paras. [0044]-[0045]).
Regarding claim 17, wherein the open retainer together with the capture portion of the bone anchor secured therein are downwardly displaceable within the internal chamber with outer surfaces of the open retainer entering into engagement with the lower region of the internal chamber to impede repeated expansion of the open retainer (see Fig. 2B, note engagement of 156 with 116).
Regarding claim 18, wherein the upper portion and the lower portion of the receiver are integrally formed together (see Fig. 2A).
Regarding claim 19, wherein the open retainer is resilient (see para. [0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose bone anchors with rings / pressure inserts:
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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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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773