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.
Claims 1. 4 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 16 and 17 of U.S. Patent No. 12,161,368. Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claim 11 of the patent recites all of the elements of independent claim l of the application. The difference between independent claim 11 of the patent and independent claim 1 of the application lies in the fact that the patent further recites: “wherein the first bone anchor comprises a distal bone fastener member, and a proximal rod housing having a first rod channel” (col.10, ll.55-58), “using a guide assembly, guiding the spinal rod into the second bone anchor” (col.10, ll.66-67), and “wherein the guide assembly comprises: an elongate tower member having a proximal end, a distal end, and a longitudinal axis extending therebetween; a first rod holder having a first rod engagement feature at a distal end of the first rod holder and a first translating shaft connected to the first rod engagement feature, wherein the first translating shaft is configured to translate at a first translation velocity relative to the elongate tower member; and a second rod holder having a second rod engagement feature at a distal end of the second rod holder and a second translating shaft connected to the second rod engagement feature, wherein the second translating shaft is configured to translate at a second translation velocity relative to the elongate tower member” (col.11, ll.1-20). Thus the invention of claim 11 of the patent is in effect a "species" of the “generic” invention of claim 1 of the application. It has been held that the generic invention is “anticipated” by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the application is anticipated by respective claim 11 of the patent, it is not patentably distinct from claim 11 of the patent.
Furthermore, claims 11, 16 and 17 of the patent recite all of the elements of dependent claims 4 and 5 of the application:
Claim 17 of the patent, including the limitations from claims 11 and 16 from which claim 17 depends from, recites “wherein extending the spinal rod comprises rotating a rod magnet disposed within the spinal rod” (claim 16), and “emitting a rotating magnetic field configured to rotate the rod magnet” (claim 17), thus reciting all of the elements of claim 4 of the application.
Claim 17 of the patent, including the limitations from claims 11 and 16 from which claim 17 depends from, recites “using an external adjustment device, emitting a rotating magnetic field configured to rotate the rod magnet” (claim 17), thus reciting all of the elements of claim 5 of the application.
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.
Claims 1-16 are 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 1 recites the limitation "the first and second bone anchors" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the first and second bone anchors” will be interpreted as “a first bone anchor and a second bone anchor”.
Claim 1 recites the limitation "the extended configuration" in line 6. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the extended configuration” will be interpreted as “an extended configuration”.
Claim 9 recites the limitation "the first and second bone anchors" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the first and second bone anchors” will be interpreted as “a first bone anchor and a second bone anchor”.
Claim 9 recites the limitation "the extended configuration" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the extended configuration” will be interpreted as “an extended configuration”.
Claim 16 recites the limitation "a channel" in line 2. It is unclear whether “a channel” is referring to the rod channel disclosed in line 4 of claim 9, or if a new channel is being claimed. For the purpose of examining the claim, “a channel” will be interpreted as “the rod channel”.
Claim 16 recites the limitation "a tulip" in line 2. It is unclear whether “a tulip” is referring to the tulip disclosed in line 4 of claim 9, or if a new tulip is being claimed. For the purpose of examining the claim, “a tulip” will be interpreted as “the tulip”.
Appropriate corrections are required.
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 1 and 4-7, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pool et al. (U.S. Publication No.2012/0035661 A1; hereinafter “Pool”).
Regarding claim 1, Pool discloses a method of fixating a first vertebra to a second vertebra in a patient spine (Figure 4) comprising: fastening first and second bone anchors respectively to the first and second vertebra (hooks 600, 601 attach the distraction device 200 to the spine 500 at the upper end of the distraction rod 206, and pedicle screw system 531 attaches the distraction device 200 to the spine 500 directly to the lower short rod 209, as shown in Figure 4); inserting a telescoping spinal rod (200) into the first bone anchor in a collapsed configuration (para.0042-0043); extending the telescoping spinal rod from the collapsed to an extended configuration to cause the telescoping spinal rod to extend into the second bone anchor (para.0043); and locking the telescoping spinal rod in position in the first and second bone anchors (positioned within hooks 600, 601 and pedicle screw system 531).
Regarding claim 4, Pool further discloses wherein the telescoping spinal rod (200) includes a magnet (254) and extending includes exposing the magnet to a spinning magnetic field and causing the telescoping spinal rod to extend (para.0043).
Regarding claim 5, Pool further discloses wherein exposing includes positioning an external adjustment device having the spinning magnetic field near the inserted telescoping spinal rod (end of para.0047).
Regarding claim 6, Pool further discloses wherein the telescoping spinal rod (200) further includes: a first elongate element (209) having a cavity therein; a second elongate element (206) dimensioned to at least partially fit within the cavity of the first elongate element; and a lead screw (260) rotatably coupled to the magnet (254) and configured to threadably engage the second elongate element (Figure 5C), wherein when the magnet is exposed to the spinning magnetic field, the lead screw rotates and causes the second elongate element to translate relative to the first elongate element (para.0047-0048).
Regarding claim 7, Pool further discloses wherein the first bone anchor and the telescoping spinal rod are each at least partially composed of a non-absorbable biocompatible material (para.0047).
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Allowable Subject Matter
Claims 9-16 would be allowed once the rejections under 35 U.S.C. 112(b) discussed above have been appropriately corrected.
Claims 2, 3 and 8, as best understood, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and once the rejections under 35 U.S.C. 112(b) discussed above have been appropriately corrected.
Claim 2 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest wherein locking includes inserting a locking screw into a rod housing of the first anchor and tightening the locking screw against the rod, as required by claim 2.
Claim 3 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest wherein inserting includes inserting the telescoping rod into a channel defined by two arms of a tulip of the first bone anchor, as required by claim 3.
Claim 8 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest wherein the telescoping spinal rod is coupled to an inserter and guided into a channel defined by two arms of a tulip of the first bone anchor, as required by claim 8.
Claims 9-16 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 9. In particular, none of the cited references teach or suggest wherein the first and second bone anchors each comprise a tulip defining a rod channel where the telescoping spinal rod is inserted therethrough, as required by claim 9.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 4-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon, but considered pertinent to applicant's disclosure has been cited in the PTO-892 Notice of References Cited.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. 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.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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