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 .
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the features in the gray-scale drawings are unclear. Black and white drawings are recommend. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 26 and 29 are objected to because of the following informalities:
Claim 26, line 8 recites “struts the define” and should be amended to recite “struts that define”.
Claim 29, line 2 recites “and then in the proximal section” and should be amended to recite “and than in the proximal section”.
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.
Claims 18, 27 and 28 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 18 recites the limitation "the proximal central" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the proximal central” will be interpreted as “the proximal section”.
Claim 27 recites the limitation "the proximal central" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the proximal central” will be interpreted as “the proximal section”.
Claim 27 recites the limitation "the distal tapered section" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the distal tapered section” will be interpreted as “the tapered distal section”.
Appropriate corrections are 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 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.
Claims 26-28, 30, 31, 33 and 34, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Tempco (U.S. Publication No.2019/0343565 A1) in view of Armstrong et al. (U.S. Publication No.2014/0012334 A1; hereinafter “Armstrong”).
Regarding claim 26, Tempco discloses a threaded bone implant, comprising: an elongate body (18) extending from a proximal end (see end 24 in Figure 2) to a distal end (see end 42 in Figure 3), the elongate body including, one or more threads (28) in a tapered distal section of the body (see annotated Figure 1 below), a central section of the body (see annotated Figure 1 below), and a proximal section of the body (see annotated Figure 1 below), a network of interconnected struts the define a plurality of openings between the interconnected struts to provide for one or more of bony on-growth, ingrowth or through-growth (see lattice 56 in Figure 4), the network of interconnected struts having a helical configuration (Figure 5) between the one or more threads in the central section (Figure 1). However, Tempco fails to disclose wherein the one or more threads axially spaced further apart in the central section than in the tapered distal section and in the proximal section, and wherein the tapered distal section is multi-lead, the central section is single-lead, and the proximal section is multi-lead.
However, Armstrong discloses a bone fastener having a thread (see thread 44 in Figure 1 of Armstrong) that is axially spaced further apart in a central section (34) than in a distal section (32) and in a proximal section (36), and wherein the distal section is multi-lead, the central section is single-lead, and the proximal section is multi-lead (see para.0025). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tempco’s thread to be axially spaced further apart in the central section than in the tapered distal section and in the proximal section, and wherein the tapered distal section is multi-lead, the central section is single-lead, and the proximal section is multi-lead, as taught by Armstrong, in order to fix the screw within bone having distinct regions with different characteristics such as bone density (see beginning of para.0025).
Regarding claim 27, Tempco further discloses wherein a first thread of the one or more threads is continuous from within the proximal section, into the central section, and into the tapered distal section (see thread 28 in Figure 1).
Regarding claim 28, Tempco further discloses wherein the first thread includes a plurality of thread interruptions in the central section, the plurality of thread interruptions having a helical arrangement (see openings within the thread as shown in the embodiment of Figure 6).
Regarding claim 30, Tempco further discloses wherein the one or more threads and the network of interconnected struts are integral, formed together with an additive manufacturing process (see para.0034).
Regarding claim 31, Tempco further discloses wherein the elongate body has a central lumen (see longitudinal cavity 254 in Figure 6).
Regarding claim 33, Tempco further discloses wherein the network of interconnected struts is free of strut free ends extending radially outward (para.0039).
Regarding claim 34, Tempco further discloses wherein the network of interconnected struts approximates an outer cylindrical profile to facilitate a smooth rotation of the implant through bone (see the different embodiments of surface configurations that comprise a
cylindrical profile in Figures 4-6).
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Allowable Subject Matter
Claims 16-25 are allowed, pending the rejections under 35 U.S.C. 112(b) disclosed above.
Claims 16-25 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 16. In particular, none of the cited references teach or suggest wherein the one or more threads in the central section having a plurality of thread interruptions that together are helically arranged in a direction that is different than a direction of the helical configuration of the network of interconnected struts as required by claim 16.
Claims 29 and 32 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.
Claim 29 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 26. In particular, none of the cited references teach or suggest wherein the network of interconnected struts has a greater surface area in the central section than in the tapered distal section and then in the proximal section, as required by claim 29.
Claim 32 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 26. In particular, none of the cited references teach or suggest wherein the network of interconnected struts has a continuous helical configuration from within the distal section, into the central section, and into the proximal section, as required by claim 32.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cordaro U.S. Publication No.2025/0099259 A1
Sommers et al. U.S. Patent No.11,000,325 B2
Zucherman et al. U.S. Publication No.2013/0253595 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. 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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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773