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 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 7, 8, 11-14, and 18 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 7 recites the limitation "the drive shaft" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the female threads” and “the pedicle screw head” in lines 13 and 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the female threads" in line 17. 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 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.
Claim(s) 1-8 and 10-14, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin (Pub. No. US 2014/0074106 A1).
Regarding claims 1-7, Shin discloses a rod reducer 700 (figures 26-29) comprising: a body “OS” having a lumen (figure 28); a ram 720 configured to apply a load to a fixation rod for reduction into a pedicle screw head (figures 27-29); a driver shaft 710 configured to advance a set screw to secure the fixation rod in the pedicle screw head (paragraphs 0137-0144; figures 27-29), a distal end of the ram 720 extending distally beyond a distal end of the driver shaft 710 (figure 28); the driver shaft 710 and the ram 720 being configured to fit within the lumen (figures 27-29); a handle 730/740 (figure 28) coupled to the ram 720 and the driver shaft 710 (figure 28) having actuation features including; a ram actuation feature 730 configured to distally advance the ram 720 to reduce the fixation rod into the pedicle screw head below female threads on the pedicle screw head (figure 28; paragraphs 0142 and 0143), and then once below female threads, a driver shaft actuation feature 740 configured to advance the set screw “S” in threaded engagement with the female threads on the pedicle screw head 11 to secure the fixation rod within the pedicle screw head (paragraph 0142-0143). During ram actuation, the distal end of the ram 720 is configured to apply a load to reduce the fixation rod to in the pedicle screw head (figure 28). During driver shaft actuation, the driver shaft 710 advances the set screw “S” using the female threads on the pedicle screw head to secure the fixation rod within the pedicle screw head (figure 29). The body “OS” is configured to be inserted into a screw extender (this is an intended use recitation. The screw extender is not positively recited and the body can be inserted into a screw extender if one so desires). Actuating the driver shaft 710 includes rotating the drive shaft 710 to advance the set screw to secure the fixation rod to the pedicle screw head (paragraphs 0142-0143).
Regarding claims 8 and 10-12, Shin discloses a rod reducer 700 (figures 26-29) comprising: a body “OS” (figure 28); a driver shaft 710 slidably positioned in a lumen in the body (figure 28), the driver shaft having a distal end configured to engage a set screw (figure 28); a ram 720 extending distally from the distal end of the driver shaft 710 (figures 27-29; paragraphs 0137-0144), the ram 720 having a distal end 721 configured to contact a fixation rod (figure 28); a handle 730/740 (figure 28) coupled to the ram 720 and the driver shaft 710 (figure 28) having actuation features configured to actuate the ram 720 and driver shaft 710 including; a ram actuation feature 730 configured to distally advance the ram to reduce the fixation rod (paragraphs 0142 and 0143), and a driver shaft actuation feature 740 configured to advance the driver shaft 710 and the set screw “S” in threaded engagement with the female threads on the pedicle screw head 11 to secure the fixation rod within the pedicle screw head (paragraph 0142-0143). The distal end of the ram 720 is configured to contact the fixation rod and apply a load to reduce the fixation rod in the pedicle screw head (figure 28). The driver shaft 710 is configured to advance the set screw “S” into the pedicle screw head to secure the fixation rod within the pedicle screw head (figure 29).
Regarding claim 13, in an alternate interpretation, the body is element 120 of figure 4 and the screw extender is element 110. The body 120 is configured to be inserted into a screw extender 110 (figure 4).
Regarding claims 14 and 18, Shin discloses a rod reducer 700 (figures 26-29) comprising: a body “OS” having a lumen (figure 28); a driver shaft 710 being slidably positioned in the lumen in the body (figure 28), the driver shaft having a lumen and a distal end configured to engage a set screw (figure 28); a ram 720 extending distally beyond the distal end of the driver shaft having a distal end configured to contact a fixation rod (figures 27-29; paragraphs 0137-0144), a handle 730/740 (figure 28) coupled to the ram 720 and the driver shaft 710 (figure 28), the handle 730/740 having handle actuation features including; a ram actuation feature 730 configured to distally advance the ram into contact with the fixation rod (figure 28); and apply a load to reduce the fixation rod into a pedicle screw head (figure 28; paragraphs 0142-0143); then a driver shaft actuation feature 740 configured to advance the set screw “S” in threaded engagement with the female threads on the pedicle screw head 11; and secure the fixation rod to the pedicle screw head (paragraph 0142-0143).
Regarding claim 18, in an alternate interpretation, the body is element 120 of figure 4 and the screw extender is element 110. The body 120 is configured to be inserted into a screw extender 110 (figure 4).
Response to Arguments
Applicant’s amendments have overcome the 35 U.S.C. 112 rejections.
Applicant's arguments filed 12/2/2025 have been fully considered but they are not persuasive. Applicant’s arguments regarding the rejection of the claims over Shin are not persuasive. Applicant argues that Shin does not disclose a handle coupled to the ram and the driver shaft. Applicant alleges that Shin must use two different “handle” components to advance and secure the fixation rod to the pedicle screw head. However, it is noted that the claims do not preclude a handle which is comprise of multiple parts. The claims require “a handle” having multiple actuation features. The handle 730/740 of Shin comprises a ram actuation feature 730 and a driver shaft actuation feature 740. The two components collectively define a handle which can be grasped and manipulated by a user. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the handle cannot comprise more than one component) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynnsy Summitt whose telephone number is (571)270-7856. 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.
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/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773