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 is the initial Office action for the 19/103,643 application. Claims 1-16 are pending.
Claim Objections
Claims 3 and 7 are objected to because of the following informalities:
In claim 3, change “engage” to --engaged--;
In claims 7, change “t” to --to--. 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 the limitation "the second fixation member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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) 1, 2 and 5-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. 2020/0297390 A1) in view of Vikinsky et al. (U.S. 2017/0071632 A1).
Concerning claim 1, Zhang et al. disclose an external fixation system comprising: a first elongate rod (see Fig. 7C below) having a first end (see below) and a first fixation end (see below) a second elongate rod (see below) having a second end (see below) and a second fixation end (see below); a first fixation member (see below) attached to the first fixation end; and a second fixation member (see below) attached to the second fixation end.
[AltContent: connector][AltContent: textbox (First Fixation Member)][AltContent: connector][AltContent: textbox (Second Fixation Member)][AltContent: textbox (Second End)][AltContent: textbox (Second Fixation End)][AltContent: arrow][AltContent: connector][AltContent: arrow][AltContent: connector][AltContent: arrow][AltContent: textbox (First Fixation End)][AltContent: arrow][AltContent: textbox (First End)][AltContent: textbox (Second Elongate Rod)][AltContent: textbox (First Elongate Rod)]
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However, Zhang et al. do not disclose that the first end and second end include a ratchet, or a ratchet assembly attached to the first ratchet end and the second ratchet end, the ratchet assembly configured to compress the first and second elongate rods to each other.
Vikinsky et al. disclose an external fixation system comprising an adjustable strut (see Fig. 1B) having a first ratchet end, a second ratchet end and a ratchet assembly (see Fig. 1B, element 132 and par. 0104) configured to compress the first and second elongate rods to each other (see par. 0105) in the same field of endeavor for the purpose of providing adjustable support.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to simply substitute Vikinsky’s ratchet assembly for Zhang’s adjustable connector in order to permit incremental one-directional movement while preventing backsliding. The concept of an orthopedic support having an adjustable component – such as a threaded rod, telescoping sleeves, and cams is well known in the art. A ratchet is simply another known mechanism that yields predictable results. It is further noted that Applicant has not demonstrated that incorporating a ratchet mechanism produces any result that would have been unexpected or surprising. Incorporation of a ratchet permits incremental unidirectional displacement while resisting reversal.
Concerning claim 2, Vikinsky et al. also disclose that the ratchet assembly is configured to alternatively distract the first and second elongate rods from each other (see par. 0104).
Concerning claim 5, wherein Vikinsky’s ratchet assembly is motor operated (see par. 0072).
Concerning claim 6, wherein Vikinsky’s ratchet assembly further comprises an electronic receiver configured to electronically receive a signal to operate the motor (see par. 0096).
Concerning claim 7, wherein Vikinsky’s further discloses a transmitter configured to remotely transmit a signal to the receiver to operate the motor (see par. 0096).
Concerning claim 8, 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 external fixation system of Zhang et al. in view of Vikinsky such that the head is rotatably attached to the rod support in order to accommodate the complex, non-uniform geometry of fractured or deformed limbs. Rigid, non-rotatable connections between fixation components create stress concentrations at the bone interface when components can’t be precisely aligned. Incorporation of a rotatable connection to accommodate angular misalignment is a well-known and obvious solution.
[AltContent: connector][AltContent: textbox (Second Screw)][AltContent: textbox (First Screw)][AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: textbox (Fixation Rod)][AltContent: textbox (Rod Support)]
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Concerning claim 9, wherein the first fixation member further comprises a fixation rod (see Fig. 7C above) extending through the rod support (see above).
Concerning claim 10, wherein the fixation rod is (see above) longitudinally translatable along the rod support (see above).
Concerning claim 11, further comprising a first screw (see Fig. 7C above) attached to the rod on a first side of the rod support.
Concerning claim 13, wherein the first screw (see above) is longitudinally translatable along the fixation rod.
Concerning claim 12, further comprising a second screw (see above) attached to the rod on a second side of the rod support.
Concerning claim 14, wherein the first fixation member comprises a straight rod (see Fig. 7C – Fixation Rod above).
Concerning claims 15 and 16, as best understood, Zhang et al. discloses the claimed invention except for the rod having five segments. It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the rod in five segments since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. 2020/0297390 A1) in view of Vikinsky et al. (U.S. 2017/0071632 A1) as applied to claim 1 above, further in view of Penn (U.S. 2022/0387086 A1).
Zhang et al. in view of Vikinsky et al. disclose the invention substantially as described above. However, Zhang et al. in view of Vikinsky et al. do not explicitly disclose that the first ratchet end comprises a first tooth rack, the second ratchet end comprises a second tooth rack, and the ratchet assembly comprises a pinion engaged with the first rack and the second rack.
Penn teaches a manually operating ratchet assembly (see Figs. 24 and 25) comprising a first ratchet end comprising a first tooth rack (2431C), a second ratchet end comprising a second tooth rack (2420C), and wherein the ratchet assembly comprises a pinion (2333) engaged with the first rack and the second rack in the same field of endeavor for the purpose of causing retraction or distraction of an orthopedic implant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to simply substitute a ratchet assembly operating as disclosed by Penn for the ratchet assembly disclosed by Vikinsky because doing so is a simple substitution of one known ratchet mechanism for another in order to obtain the predictable result of retracting or distracting two end of an orthopedic device.
Conclusion
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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