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 .
This Office action is in response to the amendment filed 02/06/2026. Claims 1, 3-17 and 38-40 are pending. Claims 13-17 remain withdrawn.
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 3-11 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 the limitation "the engagement member" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the engagement member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the engagement member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the engagement member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the engagement member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the engagement member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the engagement member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding amended claims 3 and 4, merely adding the term “flexible” in front of “engagement member” will lead to further 112 rejections. It is noted that applicant amended claim 1 to distinguish that the shankless portion of the screw is flexible. Accordingly, claims 3 and 4 – as amended, conflict with the flexible distinction. The engagement member, i.e., threads on the solid shaft portion of Applicant’s device, are not flexible when positioned on the rigid shank section. Please keep this in mind during amendment of the claims.
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.
Claim(s) 1, 9-11, 38 and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Engelhardt (U.S. 4,959,064).
Concerning claim 1, 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 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 a flexible engagement member (43) having a length and extending from a distal end of the rigid shank to the distal end of the device, wherein the flexible engagement member is bendable along its length (see col. 4, lines 36-38).
[AltContent: connector][AltContent: textbox (Self-tapping tip)][AltContent: connector][AltContent: textbox (Rigid Shank)]
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Concerning claim 9, wherein the distal end of the flexible engagement member (43) comprises a self-tapping tip (see above).
Concerning claim 10, wherein the distal end of the flexible engagement member (43) comprises a tip (see above) configured to mate to a screw head of a 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.
Concerning claim 11, wherein the flexible engagement member (43) comprises an engagement structure on an outer-facing surface selected from the group consisting of: a screw thread, a knurling pattern, a grating pattern, and combinations thereof.
Concerning claim 38, wherein the flexible engagement member is configured to bend (see col. 4, lines 68-69) to the curvature of a pre-drilled channel in a bone (see Fig. 6, elements 50 and 52).
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 above) 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 a flexible shank-less engagement member (36) having a length and extending from a distal end of the rigid shank to the distal end of the device; wherein a distal end of the engagement member comprises a tip (see above) configured to
mate to a screw head of a 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.
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt (U.S. 4,959,064) as applied to claim 1 above, in view of Kuntz et al. (U.S. 2022/0175433 A1).
Regarding claims 3-4, as best understood, Engelhardt discloses the invention substantially as described above. However, Engelhardt does not explicitly disclose that the flexible engagement member extends proximally along the outer surface of the rigid shank for at least a portion of the length of the rigid shank, or that the flexible engagement member extends form the screw head to the distal end of the device. Engelhardt does explicitly disclose that “spring 43 may be a separate component joined in some suitable manner, as by welding, to the head member 32 and to the distal end member 40.”
Kuntz et al. teach an implant comprising an engagement member (see Fig. 9A, element 940) that extends proximally along an outer surface of a rigid shank for at least a portion of the length of the rigid shank, and that extends 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 extends 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. There are several biomechanical and clinical reasons to increase thread count or add threaded zone to a bone fixation device. More threads equates to more bone-implant interface contact area which leads to greater resistance to axial pull-out forces. This is especially critical in osteoporotic bone where trabecular density is low and each individual thread engages less material.
Claim(s) 5-8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt (U.S. 4,959,064) as applied to claims 1 and 11 above, in view of Bottlang et al. (U.S. 8,740,955 B2) and Pohl (DE 908906).
Engelhardt disclose the invention substantially as described above. However, Engelhardt does not explicitly disclose that the engagement member comprises a variable cross-sectional shape selected from the group consisting of triangle, square, pentagon, hexagon, rectangular, rhombus, diamond, and trapezoid, or that the engagement member has an outer diameter that is variable along the length of the engagement member, or that the engagement member has an inner diameter that is variable along the length of the engagement member, or a variable pitch.
Bottlang et al. disclose an implant device having an engagement member (see Figs. 7 and 8, element 46) comprising a variable cross-sectional shape selected from the group consisting of triangle, square, pentagon, hexagon, rectangular, rhombus, diamond, and trapezoid, and an outer diameter that is variable along the length of the engagement member in the same field of endeavor for the purpose of providing positive-locking but flexible engagement to a bone (see col. 1, lines 14-18).
Pohl also teaches an implant having an engagement member that has an outer diameter that is variable along the length of the engagement member, and an inner diameter that is variable along the length of the engagement member (see Fig. 17, threads) 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 the engagement member to have a variable cross-sectional shape, and to modify the inner and outer diameter of the engagement member to vary along the length, the concept of which is disclosed by Bottlang et al. and Pohl, in order to improve biomechanical stability by increasing bone-implant contact which leads to better stress distribution and reduced stress on bone. The concept of changing the engagement member diameter based on the specific bone density and implant site is well known in the art. For example, those of ordinary skill in the art understand that proximal coarse and large diameter threads anchor in soft cancellous bone. Distal fine and variable profile threads engage cortical bone or the far cortex precisely. The transition between zones can generate controlled compression at a fracture or fusion site without requiring external compression instrumentation.
Regarding claim 12, Pohl also teaches a variable thread pitch along the implant (see Fig. 14) wherein the screw thread has a thread pitch that is variable along the length of the screw thread.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to vary the thread pitch along the length of the screw thread, the concept of which is disclosed by Pohl, in order to improve stability by increasing the surface areas for better bone-to-implant contact and more even stress distribution. It is noted that a smaller pitch can enhance anchorage and primary stability, while larger pitches are beneficial in osteoporotic bone.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt (U.S. 4,959,064) as applied to claim 1 above.
Engelhardt disclose the invention substantially as described above. However, Engelhardt does not explicitly disclose that the flexible engagement member has a bending angle of up to about 27 degrees relative to the rigid shank.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a bending angle of up to about 27 degrees relative to the rigid shank, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments filed 02/26/2026 have been considered but 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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