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 of the species of Figs. 1A-1D in the reply filed on August 27, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 1 is objected to because of the following informalities: “a band clamp” (line 3) should be “the band clamp” as a band clamp is introduced in line 1. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “herein” (line 1) should be “wherein.” Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “a band clamp” (line 2) should be “the band clamp” as a band clamp is introduced in line 1. Appropriate correction is required.
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.
Claim 16 is 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 16 recites “an inserter opening defined in a cavity of the band clamp” (line 2). It is unclear how an opening is defined in a cavity as a cavity is an absence of material. The Examiner notes that the disclosure states that surfaces of housing 12 include openings, such as inserter opening 18, to allow access to a cavity (see para. 0029). Thus, it is also unclear if Applicant intends the band clamp to include a cavity in addition to the inserter opening. For examination purposes, the Examiner is interpreting claim 16 as reciting “an inserter opening defined in a cavity” (line 3).
Claims 17-19 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 17 recites “the inserter opening being formed in a cavity defined by a housing of the band clamp” (lines 4-5). It is unclear how an opening is formed in a cavity as a cavity is an absence of material. The Examiner notes that the disclosure states that surfaces of housing 12 include openings, such as inserter opening 18, to allow access to a cavity (see para. 0029). Thus, it is also unclear if Applicant intends the housing to include a cavity in addition to the inserter opening. Claims 18 and 19 are rejected because they depend from claim 17. For examination purposes, the Examiner is interpreting claim 17 as reciting “the inserter opening being formed in a cavity to tension the band” (lines 7-8).
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 2-7 and 9-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hsu et al. (US 2016/0262806 A1). The Examiner notes that Hsu incorporates by reference in its entirety Akbarnia et al. (US 2014/0257397 A1) in para. 0039 and is thus considered as fully disclosing housing 40 shown in Figs. 14-17 of Akbarnia.
Claim 2. Hsu discloses a method of inserting a band clamp comprising:
passing a band (band 18; see also implant 12 of Akbarnia) around a portion of a vertebral body (see para. 0066 and Figs. 7-16);
passing the band through a band opening (passage 46 of Akbarnia) of a band clamp (clamp 12; see also housing 40 of Akbarnia) (see Figs. 7-16; see also Figs. 14-15 of Akbarnia);
passing the band between a housing (clamp 12; see also body 41 of Akbarnia) and a first cam (one of cam bosses 174) of an inserter (inserter 10) (see Figs. 10-15);
passing the band between the housing and a second cam (the other of cam bosses 174) of the inserter (see Figs. 10-15);
coupling the band clamp to the inserter (see Figs. 5-8);
applying a force to the inserter to tension the band (see para. 0072-0075 and Figs. 13-15); and
applying a force to the band clamp to tension the band (see paras. 0074-0075) (Figs. 1-16; paras. 0039-0077).
Claim 3. Hsu discloses wherein passing the band through the band opening includes passing the band through a first band opening (opening of passage 46 adjacent loop of implant 12 of Akbarnia as shown in Fig. 15) and a second band opening (opening of passage 46 adjacent free ends of implant 12 of Akbarnia as shown in Fig. 15) opposing the first band opening (see Figs. 7-16; see also Fig. 15 of Akbarnia) (Figs. 1-16; paras. 0039-0077).
Claim 4. Hsu discloses wherein passing the band through the band opening includes overlapping the band on itself within the band clamp (see Fig. 15 of Akbarnia) (Figs. 1-16; paras. 0039-0077).
Claim 5. Hsu discloses wherein coupling the band clamp to the inserter includes positioning the inserter within an inserter opening (notches 14 and notches 16; note that implant 12 of Akbarnia includes similar notches as shown in Fig. 16) of the band clamp and attaching projections (tabs 36 and tab 59) extending from a distal end of the inserter to the inserter opening (see para. 0064 and Figs. 5-8) (Figs. 1-16; paras. 0039-0077).
Claim 6. Hsu discloses wherein attaching the projections includes friction fitting the projections into the inserter opening (see para. 0064) (Figs. 1-16; paras. 0039-0077).
Claim 7. Hsu discloses applying a force to a sleeve (securement arm 40) of the inserter to couple the inserter to the band clamp (see para. 0064 and Figs. 5-8) (Figs. 1-16; paras. 0039-0077).
Claim 9. Hsu discloses wherein applying the force to the inserter includes a user applying the force to at least one of the first cam and the second cam (see paras. 0072 and 0074) (Figs. 1-16; paras. 0039-0077).
Claim 10. Hsu discloses wherein applying the force to the inserter includes applying the force to the second cam of the inserter (see paras. 0072 and 0074) (Figs. 1-16; paras. 0039-0077).
Claim 11. Hsu discloses wherein applying the force to the band clamp includes inserting a tool (tool 200) into a bore (opening 34a) of the inserter, engaging the tool with a screw (screw 15; see also screw 47 of Akbarnia) of the band clamp, and rotating the screw (see paras. 0074-0075) (Figs. 1-16; paras. 0039-0077).
Claim 12. Hsu discloses wherein rotating the screw moves an anvil (see chock 48 of Akbarnia) to press the band between the anvil and a ledge (see ledge adjacent ref. char. 41 in Fig. 17 of Akbarnia) of the band clamp (see para. 0061 and Fig. 15 of Akbarnia) (Figs. 1-16; paras. 0039-0077).
Claim 13. Hsu discloses disengaging the tool from the screw and removing the tool from the inserter (see para. 0076 and Fig. 16) (Figs. 1-16; paras. 0039-0077).
Claim 14. Hsu discloses actuating a proximal end (tensioning screw 90 and tensioning assembly 60) of the inserter to tension the band (see para. 0073 and Figs. 13-14) (Figs. 1-16; paras. 0039-0077).
Claim 15. Hsu discloses wherein actuating the proximal end includes rotating a proximal element (tool engagement portion 92 or finger engagement portion 93) of the inserter (see para. 0051) rotatably coupled to a threaded shaft (threaded body 94) of the inserter to translate the proximal element relative to the housing (note that tool engagement portion 92 or finger engagement portion 93 are rotationally translated relative to clamp 12) (Figs. 1-16; paras. 0039-0077).
Claim 16. Hsu discloses wherein the band clamp is coupled to the inserter via an inserter opening (notches 14 and notches 16; note that implant 12 of Akbarnia includes similar notches as shown in Fig. 16) defined in the band clamp (see para. 0064 and Figs. 5-8), and wherein applying the force to the band clamp includes rotating a screw (screw 15; see also screw 47 of Akbarnia) of the band clamp to advance the screw within a cavity (see opening 43 of Akbarnia) (see paras. 0074-0075) (Figs. 1-16; paras. 0039-0077).
Claim 17. Hsu discloses a method of using a band clamp assembly comprising:
passing a band (band 18; see also implant 12 of Akbarnia) through a band opening (passage 46 of Akbarnia) of the band clamp (clamp 12; see also housing 40 of Akbarnia) (see Figs. 7-16; see also Figs. 14-15 of Akbarnia);
coupling the band clamp to an inserter (inserter 10) by positioning the inserter in an inserter opening (notches 14 and notches 16; note that implant 12 of Akbarnia includes similar notches as shown in Fig. 16) of the band clamp, the inserter opening being formed in a housing (clamp 12; see also body 41 of Akbarnia) of the band clamp (see para. 0064 and Figs. 5-8);
applying a force to the inserter to tension the band (see para. 0072-0075 and Figs. 13-15); and
actuating a screw (screw 15; see also screw 47 of Akbarnia) of the band clamp to move the screw within a cavity (see opening 43 of Akbarnia) to tension the band (see paras. 0074-0075) (Figs. 1-16; paras. 0039-0077).
Claim 18. Hsu discloses wherein actuating the screw includes translating the screw distally (see paras. 0074-0075) toward a ledge (see ledge adjacent ref. char. 41 in Fig. 17 of Akbarnia) of the band clamp (Figs. 1-16; paras. 0039-0077).
Claim 19. Hsu discloses, before the step of actuating the screw, inserting a tool (tool 200) through a bore (opening 34a) defined by the inserter to engage the tool with the screw (see paras. 0074-0075 and Fig. 15) (Figs. 1-16; paras. 0039-0077).
Claim 20. Hsu discloses a method of using a band clamp assembly comprising:
coupling a band (band 18; see also implant 12 of Akbarnia) to a band clamp (clamp 12; see also housing 40 of Akbarnia) (see Figs. 7-16; see also Figs. 14-15 of Akbarnia);
coupling the band to an inserter (inserter 10) (see Figs. 5-8);
coupling the inserter to the band clamp by positioning projections (tabs 36 and tab 59) extending from the inserter within an inserter opening (notches 14 and notches 16; note that implant 12 of Akbarnia includes similar notches as shown in Fig. 16) defined by the band clamp and actuating a sleeve (securement arm 40) of the inserter to secure the inserter to the band clamp (see para. 0064 and Figs. 5-8);
actuating an anvil (see chock 48 of Akbarnia, which is actuated via screw 47 of Akbarnia; this is similar to screw 15 shown in Fig. 15 of Hsu) of the band clamp to inhibit movement of the band relative to the band clamp (see paras. 0074-0075; see also para. 0061 of Akbarnia) (Figs. 1-16; paras. 0039-0077).
Claim 21. Hsu discloses wherein actuating the anvil includes inserting a tool (tool 200) through a bore (opening 34a) defined by the inserter (see Fig. 15), engaging the tool with a screw (screw 15; see also screw 47 of Akbarnia) in the band clamp (see Fig. 15) coupled to the anvil, and rotating the screw to translate the anvil toward the band and a ledge (see ledge adjacent ref. char. 41 in Fig. 17 of Akbarnia) of the band clamp (see paras. 0074-0075) (Figs. 1-16; paras. 0039-0077).
Allowable Subject Matter
Claim 8 is 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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
