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 without traverse of Group I, Species a in the reply filed on 10/17/2025 is acknowledged.
Claims 18-37 are pending. Claims 31-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 19, 22, 23, 25 and 26-30 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.
Claims 19, 22, 23, 25 and 27-29 recite “the engagement member” in line 1. It is noted that the elected embodiment includes engagement member 208 (see Fig. 6A) which spans across a rigid shank 210 and spans across a shankless space 211. Independent claim 18 previously recites a flexible engagement member. For purposes of examination the recited “flexible engagement member” will be interpreted as the portion of engagement member 208 that spans across the shankless space 211. Accordingly, the recitation in claims 19 and 22 of “the engagement member” lacks clarity and specificity as to whether applicant is referencing the engagement member spanning the rigid shank portion, or the engagement member spanning the shankless space.
Claim 26 recites the limitation "the cross-sectional shape" in line 1. 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 (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) 18-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben-Arye et al. (U.S. 2010/0305700 A1).
Concerning claim 18, Ben-Arye et al. disclose a U-bridge implant device comprising: a length extending between a proximal end and a distal end; a driving head at the proximal end (see Fig. 9A below and see Fig. 8A, element 88); a mating connector at the distal end (see Fig. 9A below); and a flexible engagement member (see Fig. 4B, element 49, i.e., a cable) positioned between the driving head and the mating connector.
[AltContent: arrow][AltContent: textbox (Engagement Member)][AltContent: connector][AltContent: arrow][AltContent: textbox (Mating Connector the Distal End)][AltContent: textbox (Shank)][AltContent: connector][AltContent: textbox (Driving Head at the Proximal End)]
PNG
media_image1.png
455
470
media_image1.png
Greyscale
Concerning claim 19, wherein the flexible engagement member (cable, see Fig. 4B, element 49) is attached to the driving head at the proximal end and the mating connector at the distal end, such that the engagement member extends for the length of the implant device.
Concerning claim 20, wherein the driving head is attached to a shank (see Fig. 9A above; and see Fig. 8A, element 85) that extends towards the distal end for a portion of the length of the implant device.
Concerning claim 21, wherein the length of the implant device comprising the shank (see Fig. 9A above; see Fig. 8A, element 85) is rigid.
Concerning claim 22, wherein the engagement member (see Fig. 9A above; see Fig. 8A, element 86) attaches to an exterior of the shank for at least a portion of a length of the shank.
Concerning claim 23, wherein the engagement member (see Fig. 9A above, i.e., thread; see Fig. 8A, element 86) extends from the shank at a proximal end and is attached to the mating connector at a distal end. It is noted that Applicant is not claiming direct attachment.
Concerning claim 24, wherein the mating connector is selected from the group consisting of: a push lock fitting (ball and socket – see par. 0067; or see Fig. 7, element 73 – a winged deployable washer device), a threaded connector, and a magnet.
Concerning clam 25, wherein the engagement member comprises a variable cross-sectional shape (see Fig. 8A, elements 86 to 84; threads to ridges).
Concerning claim 26, wherein the cross-sectional shape is selected from the group consisting of: a triangle shape (threads), a square shape (ridges), a pentagon shape, a hexagon shape, a rectangular shape, a rhombus shape, a diamond shape, and a trapezoid shape.
Concerning claim 27, wherein the engagement member has an outer diameter that is variable along the length of the engagement member, i.e., from threads to ridges (see Fig. 8A, elements 86 and 84).
Concerning claim 28, wherein the engagement member has an inner diameter that is variable along the length of the engagement member, i.e., from threads to ridges (see Fig. 8A, elements 86 and 84).
Concerning claim 29, the engagement member comprises an engagement structure on an outer-facing surface selected from the group consisting of: a screw thread (see Fig. 8A, element 86), a knurling pattern, a grating pattern (see Fig. 8A, element 84), and combinations thereof.
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) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Arye et al. (U.S. 2010/0305700 A1) as applied to claims 18 and 29 above, in view of Zucherman et al. (U.S. 2013/0253594 A1).
Ben-Arye et al. discloses the invention substantially as described above. However, Ben-Arye et al. do not explicitly disclose that the screw thread has a thread pitch that is variable along the length of the screw thread.
Zucherman et al. teach a bone fixation device having a screw thread with a thread pitch that is variable along the length of the screw thread (see Fig. 1A, elements 112 and 114) in the same field of endeavor for the purpose of enhancing bone purchase for the specific stabilization technique.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ben-Arye’s thread to have a thread pitch that is variable along the length, the concept of which is disclosed by Zucherman et al., in order to reduce the chance of screw stripping. It is known that smaller thread pitches increase the surface area contact between the screw and bone. This is particularly beneficial in low-density bone. Modifying Ben-Arye’s thread to having a smaller pitch at the distal end would enhance security between the distal end and the bone within the vertebral body which is less dense than the outer cortical rim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The art relates to bone fixation devices having variable thread pitch along the shaft, and varying flexibility along the bone penetrating 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773