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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 24 and 34 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.
Applicant asserts that the claimed subject matter has an earlier effective filing date than the cited art Smith (USPAP 2016/0374738). Although the second paragraph of the specification states “this application is also related to… ”, this is not a proper claim for domestic priority to another application. The statement in the specification does not indicate this application claims priority to 15/893,911, nor does the application data sheet include a claim to priority to 15/893,911. The MPEP explains that a benefit claim under 35 U.S.C. 119(e), 120, 121, or 365(c) must be in the application data sheet (37 CFR 1.76) for all applications filed on or after September 16, 2012.
This application properly claims priority to 16/887,033 and 16/027,605, wherein the earliest priority date of this application is 7/5/2017 (based on filing date of provisional application 62/528,675). Since Smith was published on 12/29/2016, the reference qualifies as prior art until 102(a)(1). Therefore, the rejections based on Smith have been maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 32-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 34 now requires that a femoral nail be inserted through a femoral component that is in direct contact with an exterior surface of bone, but the originally filed specification lacks sufficient support for this procedure. The claims appear to be directed to an embodiment in Figures 25-33, which is a procedure for total shoulder arthroplasty. The method includes an extramedullary component (shoulder 23A-50) placed in contact with an external surface of bone, an IM nail (26-30) is inserted through the extramedullary component, an alignment arms is attached to the IM nail, and fixation screws (31-10) are inserted through the nail (26-30) and extramedullary component (20A-50). The originally filed specification fails to disclose that this process may be performed on a femur. Therefore, the claimed method of a femoral nail positioned through an opening of a femoral component appears to lack sufficient support. Claims 35-39 are rejected as being dependent on claim 34.
Claim Rejections - 35 USC § 102
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.
Claim(s) 23-33 and 42-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (USPAP 2016/0374738; hereafter Smith ‘738).
Regarding claim 23, Smith ‘738 discloses a surgical method comprising the steps of:
positioning an intramedullary structure (intramedullary nail 610) at least partially within a bone (see Fig. 14A-B; an IM nail having a first hole (apertures 826a-c shown in Figures 24A-B; [0069]);
positioning an extramedullary structure (fixation plate 102) having a second hole within a bone plate surface directly in contact with a surface of the bone (see Fig. 14A-B); the
attaching an alignment arm (606) to the intramedullary structure (610; see Fig. 14A-B);
and using the alignment structure to guide insertion of a first fastener (screw 1206) into a first hole (826c) of the intramedullary structure and a second hole (208) of the extramedullary structure (see especially Fig. 24a; [0079]; [0081]; [0101]).
Regarding claim 24, further comprising the step of positioning the alignment arm (606) to be aligned with the first (826c) and second holes (208) (see Fig. 14A; 24A-B).
Regarding claim 25, a first cannula is aligned with first (826c) and second holes (208) (see Fig. 14A; 24A-B) (see cannulas in Figures 22A-B).
Regarding claim 26, Smith further discloses the step of using the alignment structure (606) to guide insertion of a second fastener (screw 1204) into a third hole (826b) of the intramedullary structure (see Fig. 24A; [0069]; [0077]; [0099]).
Regarding claim 27, a second cannula (1102b) is aligned with the third hole (see Figures 24A-B; [0099]).
Regarding claim 28, Smith discloses guiding the insertion of a third fastener through a fourth hole of the extramedullary structure (plate 102) (see screw 404b in Figure 9; 0071]).
Regarding claim 29, a third cannula (402) is aligned with the fourth hole of the extramedullary structure (plate 102) (see holes 206a-c in Figure 2A).
Regarding claim 30, Smith discloses the attaching step includes threading the alignment structure (606) to the intramedullary structure (610) (see Fig. 8A-B and paragraph [0066] - [0067], triangulating screw guide 606 has a threaded portion 802 which threads through a thumb screw socket 806 and into a first coupler 812 that is on intramedullary nail 610 to attach the triangulating screw guide to the intramedullary nail).
In regard to claim 31, the long bone into which the IM nail is inserted may be a femur [0039].
In regard to claim 32, Smith discloses a bone plate (102) placed adjacent the bone, wherein the bone may be a femur [0039].
In regard to claim 33, the step of guiding insertion of the first fastener (1206) through the first hole (826c) of the IM nail and second hole (208) of the plate (102) comprises the first fastener (1206) extending through a portion (604) of the alignment arm (606) having an opening (824) aligned with these openings (see Fig. 12A; [0068]; [0075]; [0077]).
Regarding claim 42, Smith ‘738 discloses a surgical method comprising the steps of:
positioning an intramedullary structure (intramedullary nail 610) at least partially within a bone (see Fig. 14A-B);
positioning an extramedullary structure (fixation plate 102) on an exterior surface of the bone (see Fig. 14B);
attaching an alignment structure (606) to the intramedullary structure (610; see Fig. 14A-B);
and using the alignment structure to guide insertion of a first fastener (screw 1206) into a first hole (826c) of the intramedullary structure and a second hole (208) of the extramedullary structure.
Regarding claim 43, Smith ‘738 further discloses the method of claim 42, wherein the attaching step includes threading the alignment structure (606) to the intramedullary structure (610) (see Fig. 8A-B and paragraph [0066] - [0067], triangulating screw guide 606 has a threaded portion 802 which threads through a thumb screw socket 806 and into a first coupler 812 that is on intramedullary nail 610 to attach the triangulating screw guide to the intramedullary nail).
Regarding claim 44, Smith further discloses the method of claim 42, further comprising the step of using the alignment structure (606) to guide insertion of a second fastener (screw 1204) into a third hole (826b) of the intramedullary structure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5,776,194 generally discloses femoral intermedullary and extramedullary components.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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, Melanie Tyson can be reached at 571-272-9062. 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.
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights