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 Objections
Claim 8 is objected to because of the following informalities:
Claim 8, line 9, “primal” should be changed to “proximal”.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Metzinger et al. (2009/0326541) in view of Durante et al. (2012/0303038).
Regarding claim 1, Metzinger et al. disclose a system (e.g., Figs. 1-3) for implanting an intramedullary nail 10 into a bone, the system comprising:
an intramedullary nail 10;
an aiming guide (Fig. 1) comprising a body 32 having an elongate proximal handle portion 46 and a generally arcuate distal implant alignment tip connector portion 36 having a distal implant alignment tip 37 (para. 0026 and Fig. 1) defining a tip axis extending substantially parallel to a longitudinal axis of the proximal handle portion 46 (Fig. 1);
a recon module 60 configured to releasably couple to a first attachment location at a proximal end of the handle portion 46 of the aiming guide (Fig. 1).
Metzinger et al. do not disclose an oblique module configured to releasably couple to a second attachment location positioned distally from the proximal end of the handle portion.
Durante et al. disclose an aiming guide comprising an oblique module 618 (Fig. 2) configured to releasably couple to a location positioned distally from a corresponding proximal end of a handle portion (i.e., a portion suitable for being gripped, e.g., because of its size) (Fig. 5). The oblique module allows the aiming guide to be attached to a support frame to provide support to the intramedullary nail.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the system of Metzinger et al. with an oblique module configured to releasably couple to a second attachment location positioned distally from the proximal end of the handle portion, in view of Durante et al., to allow the aiming guide to be attached to a support frame as desired to provide support to the intramedullary nail.
Regarding claim 2, the recon module 60 has an arcuate body (i.e., a body defined by arcuate portions, e.g., 62, 72 and the curved edge profile; Fig. 1) having a first recon portion 66 extending from a first side of the proximal handle portion 46 and a second recon portion 72 extending from a second side of the proximal handle portion, distal from the first side (cf. Fig. 5).
Regarding claim 3, the arcuate body (Fig. 1; supra) has a plurality of recon through holes, e.g., 73, 74, etc.) extending therethrough, each of the plurality of recon through holes extending along an axis intersecting the tip axis (Fig. 3).
Regarding claim 6, the recon module 60 is configured to receive a bone screw to be inserted into the intramedullary nail 10 (paras. 0036-0037).
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 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-14 of U.S. Patent No. 10,751,096 in view of Durante et al. (2012/0303038).
Regarding independent application claim 1, issued patent claim 10 discloses a system for implanting an intramedullary nail into a bone, the system comprising:
an aiming guide (a “generally J-shaped aiming guide”) comprising a body having an elongate proximal handle portion and a generally arcuate distal implant alignment tip connector portion having a distal implant alignment tip defining a tip axis extending substantially parallel to a longitudinal axis of the proximal handle portion;
a recon module configured to releasably couple to a first attachment location at a proximal end of the handle portion of the aiming guide; and
an oblique module configured to releasably couple to a second attachment location positioned distally from the proximal end of the handle portion.
Issue patent claim 10 does not explicitly recite the intramedullary nail with which it is designed to be used.
However, Durante et al. show an intramedullary nail 602 used with an aiming guide assembly 98, to allow the aiming guide assembly to be utilized for its intended purpose and to facilitate the implantation of an intramedullary nail (see, e.g., paras. 0005 and 0039-0040; Fig. 5).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided and claimed an intramedullary nail, in view of Durante et al., to utilize the aiming guide for its intended purpose and facilitate the implantation of an intramedullary nail.
Except for dependent application claim 6, each of dependent claims 2-5 and 7 directly correspond to dependent issued patent claims, as set forth in the table at the end of this section.
Regarding dependent application claim 6, issued patent claim 10 discloses the claimed invention except for explicitly reciting the recon module being configured to receive a bone screw to be inserted in the intramedullary nail.
However, Durante et al. teach that bone screws can be inserted via openings 112 in an aiming guide assembly 98 and into an intramedullary nail 602 (Fig. 5 and para. 0039). This facilitates accurate alignment and guidance of the bone screws into the intramedullary nail (id.).
Therefore, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to have configured the openings of the recon module to receive bone screws to be inserted into the intramedullary nail, in view of Durante et al., to facilitate accurate alignment and guidance of the bone screws into the intramedullary nail.
Claims 8-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,178,489. Although the claims at issue are not identical, they are not patentably distinct from each other because the differences amount to minor changes in the arrangement of the claim limitations. The claims of both the present application and the issued patent are directed to the substantially same invention.
Regarding independent application claim 8, independent patent claim 1 discloses a J-shaped aiming guide for inserting an intramedullary nail into a bone, the aiming guide comprising:
a collet configured to engage the intramedullary nail, the collet including internal threads;
a connection bolt configured to engage the internal threads of the collet to connect the collet with the intramedullary nail; and
a connection bolt driver configured to engage the connection bolt, wherein the J-shaped aiming guide comprises an elongate proximal handle portion and a distal implant alignment tip extending parallel to a longitudinal axis of the primal handle portion, and the connection bolt comprises a head containing a circlip, the circlip configured to splay open upon insertion of the connection bolt driver into the head and provide tension around the connection bolt driver to retain the connection bolt driver in the head of the connection bolt.
The dependent application claims directly correspond to the dependent issued patent claims, as set forth in the table below.
Appl. 18/969,771
Pat. 10,751,096
Pat. 12,178,489
1
10 v. Durante et al
N/A
2
11 (w/1)
N/A
3
12 (w/2/1)
N/A
4
13 (w/1)
N/A
5
14 (w/4/1)
N/A
6
10 v. Durante et al.
N/A
7
14 (w/1)
N/A
8
N/A
1
9
N/A
2
10
N/A
3
11
N/A
4
12
N/A
5
13
N/A
6
14
N/A
7
15
N/A
8
16
N/A
9
17
N/A
10
Allowable Subject Matter
No claims are currently allowed.
Reasons for Allowance
No claims are currently allowed. However, with regard to independent claims and claims dependent thereon, it is noted that claims 8-17 have not been rejected using prior art (apart from the double patenting rejection) because no references, or reasonable combination thereof, could be found which disclose or suggest the claimed combination of limitations recited in independent claim 8. In particular, none of the cited references teach or suggest the claimed limitations in combination with a J-shaped aiming guide comprising an elongate proximal handle portion and a distal implant alignment tip extending parallel to a longitudinal axis of the proximal handle portion, as required by independent claim 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773