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 .
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. 119(e) and 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 disclosures of the prior-filed applications, Application No.’s 15521163, PCT/US2015/056706, 62/066,806, 62066813, 62078154, 62078173, 62137713, 62137707, 62194955, 62200501, 62200491, 62212253 each fail 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 above listed applications fail to disclose at least: the receiver having a non-resilient inwardly protruding structure with an upwardly facing abutment surface and a downwardly facing abutment surface, the insert having a downwardly facing side abutment surface disposed adjacent to and above the upwardly facing abutment surface in a first position, as required by claim 1. Therefore, all of the claims receive a priority date of 6/21/2016, which is the filing date of 62352876.
Claim Objections
Claim 1 is objected to because of the following informalities: There should be a “,” in line 14 after “closure top” in order to improve the clarity of the claim. Appropriate correction is required.
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 10 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 10 recites the limitation "the upwardly facing saddle surface" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
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.
(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) 1-4, 6-8, 10, 11, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson et al. (Pub. No. US 2014/0121703 A1).
Regarding claim 1, Jackson et al. discloses a pivotable medical implant assembly 1 (figure 1) intended for securing an elongate rod to a bone of a patient with tooling (this is an intended use recitation. The implant assembly can secure an elongate rod to a bone of a patient with tooling, so it meets the claimed limitations), the pivotal medical implant assembly 1 comprising: a shank 4 comprising a longitudinal axis, a head 8 at a proximal end, and a body 6 extending distally from the head with an anchor portion 24 configured for anchoring to the bone (figure 2); a receiver 10 comprising a base 60 defining a lower portion of a central bore 61 centered about a vertical centerline axis and communicating with a bottom of the base 60 through a bottom opening 110, and a pair of upright arms 62 extending upwardly from the base 60 with interior arm surfaces 70 defining an open channel 64 extending between front and back faces of the receiver and configured to receive the elongate rod (figure 1), the central bore 61 extending upward from the bottom opening 110 through the open channel to tops of the upright arms 62 and including a closure mating structure 72 adjacent the tops of the upright arms 62 configured to mate with a closure top and at least one non-resilient inwardly-protruding structure 94 (figure 8; paragraph 0134) with an upwardly-facing abutment surface 93 and a downwardly-facing abutment surface (illustrated in figure 8) preformed into the central bore below the closure mating structure, the at least one inwardly-protruding structure 94 extending continuously and circumferentially around the central bore between vertical planar surfaces (illustrated in figures 7 and 9) formed into the interior arm surfaces 70 adjacent the front and back faces of the receiver (figure 7), the lower portion of the central bore 61 configured to receive the head of the shank upon its uploading through the bottom opening 110 with the shank being pivotal with respect to the receiver (figures 23-29); and an insert 14 positionable into the central bore 61 of the receiver, the insert 14 having a downwardly- facing lower surface 188 (figure 1) configured to transfer a downward force toward the head 8 of the shank (figure 28), a central opening 180 centered on a central axis (figure 15 and 17), a top abutment surface (top surface of ridge 172, figure 16), and outer side surfaces having at least one one inwardly-protruding structure 94 so as to inhibit vertical axial movement of the insert 14 within the central bore 61 and to hold the insert 14 in a stabilized first position prior to and during the uploading of the head 8 of the shank into the lower portion of the central bore through the bottom opening (figures 23-26; paragraph 0131).
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Regarding claim 2, the insert 14 is configured for forced downward axial displacement within the central bore to a second position via direct engagement from the tooling so as to move the downwardly-facing lower surface 188 of the insert 14 into a shank engageable configuration with the head 8 of the shank and to move the top abutment surface of the insert 14 under the downwardly-facing abutment surface of the at least one inwardly-protruding structure 94 (figures 27-29), and wherein after the forced downward axial displacement of the insert 14 to the second position (figure 29), the downwardly-facing abutment surface of the at least one inwardly-protruding structure 94 is overlappingly engageable with the top abutment surface on the insert 14 so as to restrict the insert from returning to the first position within the central bore of the receiver (figure 29; p[paragraph 0134), and the shank 6 remains pivotal relative to the receiver 10 and to the insert 14 prior to locking the pivotal medical implant assembly with the closure top (figure 29; paragraph 0134).
Regarding claim 3, the assembly further comprising a resilient retainer 12 (figure 1), wherein the resilient retainer 12 is configured to capture the head 8 of the shank within the lower portion of the central bore 61 upon the uploading of the head 8 of the shank 6 through the bottom opening 110 (figures 23-29).
Regarding claim 4, the lower portion of the central bore 61 includes an expansion chamber region 98 and the resilient retainer 12 is configured to expand within the expansion chamber region 98 to capture the head 8 of the shank upon the uploading of the head of the shank through the bottom opening 110 (figure 24).
Regarding claim 6, the insert 14 includes an upwardly-facing surface 183 configured to engage the elongate rod (figure 1).
Regarding claim 7, the insert 14 is uploadable through the bottom opening into the central bore of the receiver into the stabilized first position (paragraph 0006- “retainers and compression inserts are downloaded into the receiver, but uploaded embodiments are also foreseen”).
Regarding claim 8, the receiver 10 further includes vertically-aligned guide surfaces 84 formed into the central bore 61 below the closure mating structure 72 and configured to slidably engage with vertically-aligned outer surfaces 174 of the insert, upon the uploading of the insert 14 into the central bore 61, to inhibit rotation of the insert 14 relative to the receiver 10 (figures 19 and 27; paragraph 0131).
Regarding claim 10, the insert 14 further comprises a cylindrical base portion 15 (figure 15) having a central aperture 180 and a pair of insert arms 160 extending upwardly from the cylindrical base portion 15 to define a upwardly- facing saddle surface 183 therebetween (figure 15).
Regarding claim 11, the assembly further comprising the elongate rod 21, wherein the closure top 18 is configured for positioning entirely within the central bore 61 of the receiver 10 above the elongate rod 21 and in engagement with the closure mating structure 72 to apply a downward pressure to the elongate rod 21, so as to secure the elongate rod 21 to the bone of the patient (figure 33).
Regarding claim 23, the resilient retainer is constrained in the expansion chamber region prior to the head of the shank being uploaded into the receiver through the bottom opening (figure 26- the receiver is restrained between the edge 101 and the insert 14).
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (Pub. No. US 2014/0121703 A1) in view of Mishra et al. (Pub. No. US 2014/0188175 A1).
Regarding claim 9, Jackson et al. discloses the claimed invention except wherein the at least one downwardly-facing side abutment surface of the insert further defines
However, Mishra et al. teaches wherein an insert retaining feature 54 comprises at least one downwardly-facing side abutment surface of the insert 8 that further defines
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the insert and receiver such that the at least one downwardly-facing side abutment surface of the insert further defines .
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 1-4, 6, 7, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12167872 in view of Mishra et al. (Pub. No. US 20140188175 A1).
Regarding claims 1-4, 6, 7, the patent claims the same invention, except for the specifics regarding the non-resilient inwardly protruding structure having an upwardly facing abutment surface and a downwardly facing abutment surface, and the insert having at least one downwardly facing side abutment surface disposed above the upwardly facing abutment surface of the inwardly protruding structure.
However, Mishra et al. teaches a receiver and insert wherein the non-resilient inwardly protruding structure 78 having an upwardly facing abutment surface and a downwardly facing abutment surface, and the insert 8 having at least one downwardly facing side abutment surface (upper portion of groove 54) disposed above the upwardly facing abutment surface of the inwardly protruding structure (figures 5-7), for the purpose of maintaining the position of the insert within the receiver during insertion of the shank head (figures 12-14).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the patent claims to include such limitations, as taught by Mishra et al., for the purpose of maintaining the position of the insert within the receiver during insertion of the shank head (figures 12-14).
Regarding claim 9, the patent claims the same invention except wherein the at least one downwardly-facing side abutment surface of the insert further defines inwardly-protruding structure upon positioning the insert within the central bore of the receiver into the stabilized first position.
However, Mishra et al. teaches wherein an insert retaining feature 54 comprises at least one downwardly-facing side abutment surface of the insert 8 that further defines
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the insert and receiver of the patent such that the at least one downwardly-facing side abutment surface of the insert further defines .
Claims 1-4, 6, 7, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6-8 of U.S. Patent No. 12082853 in view of Mishra et al. (Pub. No. US 20140188175 A1).
Regarding claims 1-4, 6, 7, the patent claims the same invention, except for the specifics regarding the non-resilient inwardly protruding structure having an upwardly facing abutment surface and a downwardly facing abutment surface, and the insert having at least one downwardly facing side abutment surface disposed above the upwardly facing abutment surface of the inwardly protruding structure.
However, Mishra et al. teaches a receiver and insert wherein the non-resilient inwardly protruding structure 78 having an upwardly facing abutment surface and a downwardly facing abutment surface, and the insert 8 having at least one downwardly facing side abutment surface (upper portion of groove 54) disposed above the upwardly facing abutment surface of the inwardly protruding structure (figures 5-7), for the purpose of maintaining the position of the insert within the receiver during insertion of the shank head (figures 12-14).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the patent claims to include such limitations, as taught by Mishra et al., for the purpose of maintaining the position of the insert within the receiver during insertion of the shank head (figures 12-14).
Regarding claim 9, the patent claims the same invention except wherein the at least one downwardly-facing side abutment surface of the insert further defines
However, Mishra et al. teaches wherein an insert retaining feature 54 comprises at least one downwardly-facing side abutment surface of the insert 8 that further defines result of providing an overlapping engagement which maintains the insert in a stabilized first position during upward loading of the shank head (figure 12).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the insert and receiver of the patent such that the at least one downwardly-facing side abutment surface of the insert further defines .
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
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