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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/15/2026 has been entered. Claims 1, 3, 5-17 and 38-40 are pending. Claims 2, 4 and 18-37 are canceled. Claims 13-17 remain withdrawn.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification fails to disclose the claimed limitation “the bending stiffness of the flexible portion of the engagement member decreases towards the distal end of the device.” The specification also fails to disclose the claimed limitation of “an engagement member having a length and extending from a distal end of the rigid shank to the distal end of the device, wherein the engagement member comprises a flexible portion and a rigid portion.”
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a drawing illustrating and identifying “the bending stiffness of the flexible portion of the engagement member decreasing towards the distal end of the device,” and a drawing illustrating “an engagement member having a length and extending from a distal end of the rigid shank to the distal end of the device, wherein the engagement member comprises a flexible portion and a rigid portion” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1, 3, 5-12, and 38-40 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 1 has been amended to recite "wherein the bending stiffness of the flexible portion of the engagement member decreases towards the distal end of the device." The original disclosure does not describe the bending stiffness of the flexible portion varying along its length, much less decreasing towards the distal end of the device. The specification never relates any geometric variations to bending stiffness, and never discloses the direction in which bending stiffness changes along the flexible portion. Furthermore, the distal end of the elected embodiment (see Fig. 6A) is not identified.
It is further noted that a distally decreasing bending stiffness is not the necessary result of the disclosed geometry. The bending stiffness of a helical engagement member depends jointly on its outer diameter, inner diameter, cross-sectional size and shape, pitch and material. A distally narrowing outer diameter does not necessarily reduce bending stiffness, since it may be accompanied by changes in inner diameter, cross-section or pitch that maintain or increase stiffness. Furthermore, elected Species a, shown in Fig. 6A lacks any identified geometric changes towards the distal end. The distal end is not identified.
Claims 3, 5-12, 38 and 39 are rejected by virtue of their dependency on claim 1.
Claim 40 was amended to recite that the engagement member (see Fig. 6A, element 208) comprises a flexible portion and a rigid portion. It is noted that the specification and drawings lack support for the newly claimed rigid portion of the engagement member.
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 3, 38 and 39 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 3 recites that "the rigid portion of the engagement member extends proximally along the outer surface of the rigid shank." Claim 1, from which claim 3 depends, recites an engagement member "extending from a distal end of the rigid shank to the distal end of the device." It is unclear how an engagement member that extends from the distal end of the rigid shank can also have a portion that extends proximally along the outer surface of the rigid shank.
Claim 38 recites the limitation "the flexible engagement member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, as amended, recites "an engagement member" having "a flexible portion." For purposes of examination, the limitation is interpreted as "the flexible portion of the engagement member."
Claim 39 recites the limitation "the flexible engagement member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is interpreted as "the flexible portion of the engagement member."
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.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt (U.S. 4,959,064) in view of Kuntz et al. (U.S. 2022/0175433 A1).
Concerning claim 40, Engelhardt discloses a flexible implant device (see Fig. 5, element 30A), comprising: a length extending between a proximal end and a distal end; a screw head (32) at the proximal end; a rigid shank (see annotated Fig. 5 below) having a length extending from the screw head towards the distal end of the device for a portion of the length of the device; and an engagement member (i.e., the threaded portion of shank 34 comprising spring 43 and distal end member 40 – see Fig. 4) having a length and extending from a distal end of the rigid shank to the distal end of the device; wherein the engagement member comprises a flexible portion (43); wherein a distal end of the flexible portion of the engagement member comprises a tip (40) configured to mate to a screw head of a second flexible implant device, wherein the tip comprises a mating connector selected from the group consisting of: a push lock fitting, a threaded connector, and a magnet (i.e., the external threads of distal end member 40).
[AltContent: connector][AltContent: textbox (Self-tapping tip)][AltContent: connector][AltContent: textbox (Rigid Shank)]
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Engelhardt does not explicitly disclose that the engagement member further comprises a rigid portion.
Kuntz et al. teach an implant comprising an engagement member (see Fig. 9A, threading 940) that extends proximally along an outer surface of a rigid shank (i.e., through solid portion 970 of shank 930) and from a screw head (910) to a distal end of the device, in the same field of endeavor for the purpose of fixing the implant to bone.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Engelhardt's implant such that the engagement member includes a rigid portion extending proximally along the outer surface of the rigid shank from the screw head, the concept of which is disclosed by Kuntz et al., in order to enhance the security of the implant to bone by extending the purchase region of the implant to bone. The engagement member would then comprise a flexible portion (43) and a rigid portion (the threaded portion along the rigid shank), and the tip (40) located at the distal end of the flexible portion.
Response to Arguments
Applicant's arguments with respect to the newly added limitations of claims 1 and 40, namely that the engagement member has a flexible portion and a rigid portion and that the bending stiffness of the flexible portion decreases towards the distal end of the device, 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.
In response to applicant’s argument that Engelhardt does not describe a mating connector, it is noted that element 40 is a mating connector. It has an outer threaded surface that can engage a mating threaded surface thereby forming a threaded connection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited art relates to bone screws having flexible portions and regions of differing bending stiffness: Moumene (U.S. 2013/0041412 A1) discloses a pedicle screw having a slotted distal portion that is more flexible than a slot-free proximal portion and a minor diameter that decreases in a proximal-to-distal direction; White et al. (U.S. 6,656,184 B1) disclose a bone screw having an intermediate helical spring portion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. 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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/ELLEN C HAMMOND/ Primary Examiner, Art Unit 3773
