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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, Species I in the reply filed on 11/24/25 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/25.
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, 5, 7-9, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richelsoph US Patent 5,514,136.
NOTE: as disclosed in the specification, the phrase: “the superior/inferior direction” in claim 3 is referring to the direction of the insertion prong during the procedure with respect to the patient’s natural anatomy. Additionally, the Examiner wants to point out that language used in claim 1, such as, “for implanting a cemented femoral stem…” and “for use in a directs anterior approach…” have been interpreted as functional language. The Examiner just needs to find a reference capable of performing the claimed function.
Richelsoph discloses an orthopaedic surgical instrument (see Fig. 8) capable for implanting a cemented femoral stem component during a direct anterior approach orthopaedic hip replacement surgical procedure on a patient's femur. The instrument comprising: a stem insertion instrument (11) comprising a handle (33) positioned on a proximal end of the stem insertion instrument (See Fig. 8), an insertion prong (59) positioned on a distal end of the stem insertion instrument (see Fig. 1). The insertion prong (59) being sized and shaped to be received into an insertion aperture formed in a lateral shoulder of the femoral stem component (13). An elongated shaft (41) extending distally away from the handle (33) to the insertion prong (59). A depth stop (73) rotatably secured to the elongated shaft, the depth stop (73) comprising a guide arm (75 and 77) extending away from the elongated shaft (41).
NOTE: the words “rotatably secured to” has been interpreted broadly. For example, under broadest reasonable interpretation, the word “secured to” does not required a direct contact with the shaft. Therefore, element (73) is indirectly secured to the shaft (41) by element (81) and is rotatable because element (73) rotates relative to the whole instrument because to pivot point (89).
Regarding claim 5, element (73) can have the claimed angle of 40-45 degrees since it can rotate 180 degrees freely until bolt/lock means (101) secures the desired angle.
Regarding claim 7, the Examiner wants to point out that many of the language used in claim 7 have been interpreted as functional language. For example, the phrases: “for use in a directs anterior approach…”; “the depth stop is rotatable between (a) a guide position… (b) an access position…” The Examiner just needs to find a reference capable of performing the claimed position.
Regarding the femoral stem component, see Fig. 8 showing the shoulders, the elongated neck and the tapered stem and where those structures are located with respect to the patient’s natural anatomy.
Regarding the depth stop rotation, see Figure 8 showing element (73) in the “guide position” in contact with the step component and is capable of being spaced apart from the stem if element (73) is moved from the position of Fig. 8 toward the handle (33).
Regarding claim 8, see Fig. 8 showing the guide arm (75) in contact with the anterior side of the stem component.
Regarding claim 9, see Figure below showing the area that the Examiner interpreted as the proximal body.
PNG
media_image1.png
460
522
media_image1.png
Greyscale
Regarding claim 13, element (73) can have the claimed angle of 40-45 degrees since it can rotate 180 degrees freely until bolt/lock means (101) secures the desired angle.
Claims 1, 2, 6, 7, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samuelson et al US Patent 5,792,143.
Samuelson et al discloses an orthopaedic surgical instrument (see Figures 6-8) capable of implanting a cemented femoral stem component (60) during a direct anterior approach orthopaedic hip replacement surgical procedure on a patient's femur. The instrument comprising a stem insertion instrument (50) comprising a handle (not numbered) positioned on a proximal end of the stem insertion instrument, an insertion prong (at location 52, see Fig. 6) positioned on a distal end of the stem insertion instrument. The insertion prong being sized and shaped to be received into an insertion aperture (52) formed in a lateral shoulder of the femoral stem component. An elongated shaft (50) extending distally away from the handle to the insertion prong, and a depth stop (40) rotatably secured to the elongated shaft (50). The depth stop (40) comprising a guide arm (81) extending away from the elongated shaft.
Regarding claims 2 and 10, the depth stop (40) comprises: a hub (79) indirectly coupled to the elongated shaft, an extension arm (72 and part of 81, see Fig. below) extending away from the hub (79) and transitioning to an elbow (see figure below) and the guide arm (81 or 72 for claim 6, see below for explanation) extending away from the elbow.
PNG
media_image2.png
306
513
media_image2.png
Greyscale
NOTE: in order to reject claim 6, the Examiner is giving the guide arm/first guide arm a different interpretation. For example, in claim 6, the Examiner is interpreting element (72) as the guide arm instead of element (81). See below of the interpretation of claim 6.
Regarding claim 6, the depth stop (40) comprises a second guide arm (75) extending away from the elongated shaft (50) from an opposite side of the elongated shaft (50) as the first guide arm (72) and the first guide arm (72) and the second guide arm (75) rotate relative to the elongated shaft (50) independently of one another (see the configuration of Figures 7 and 8 making possible the independent rotation.
Regarding claim 7, the applicant’s representative has not defined what is the guide position, therefore, the Examiner has defined the guide position as the step disclosed in Fig. 7 in order to measure the most appropriate neck length and the access position is any other position of element (72) before element (81) is lock by locking means (78). For example, any rotational position of element (72) along axis (54) (up/down) in Figure 8.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3, 4, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Richelsoph US Patent 5,514,136 in view of Bastian et al US Patent Pub. 2007/0233134A1.
Richelsoph discloses the invention substantially as claimed. However, Richelsoph does not disclose an elongated shaft angled in the medial direction between 15-45 degrees relative to the insertion prong.
Bastian et al discloses an instrument having an elongated shaft (18) angled in the medial anterior directions within the claimed range (See Figs. 1 and 2) for the purpose of providing a safer, less-traumatic surgical procedure to replace the femoral head. Inserting the implant in an anterior approach eliminates the need for a second incision or a single large incision. Additionally, an anterior approach requires less muscle dissection compared to a posterior approach using the traditional instruments, such as straight or single plane angled handles. This type of straight instruments cannot be used using an anterior approach because this procedure typically does not allow for straight-line access. See paragraph 0003.
Regarding the range in angle, paragraph 40 disclosed a lateral bend (32) placing the elongated shaft (18) angled in the medial side of the natural occurring femoral bone. The angle is between 15 to 45 degrees.
It would have been obvious to one ordinary skill in the art to modify only the angle of the elongated shaft of the Richelsoph reference (keeping the same connection between the instrument and the implant) with the claimed angle range in order to provide an anterior approach eliminating the need for a second incision and have a safer, less-traumatic surgical procedure to replace the femoral head.
Allowable Subject Matter
Claims 14 and 15 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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, Thomas Barrett can be reached at 571-272-4746. 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.
/ALVIN J STEWART/Primary Examiner, Art Unit 3799 12/4/25