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 with traverse of Invention I, Species I in the reply filed on 12/18/2025 is acknowledged. The traversal is on the ground(s) that “all the original claims of the application were directed to an intra-vertebral body device or method of restoring a fractured vertebral body that comprises relatively movable upper plates and lower plates of a device.” This is not found persuasive because consideration of the plurality of inventions that Applicant has claimed would significantly compromise and preclude a quality examination on the merits. Furthermore, execution of a search encompassing the entirety of Applicant's device and method claims would not only constitute an undue burden on the Examiner, but consideration of the findings of such a search in accordance with the requirements of the law under 35 U.S.C. §§101,102, 103 and 112 would be unduly onerous.
Moreover, it is further noted that a comprehensive search for the presently claimed subject matter is not solely limited to a search of the classes and subclasses in which they are classified. Therefore, it is obvious that a comprehensive search of the copious amounts of patent and non-patent literature for each of the patentably distinct inventions and their permutations presently claimed would necessarily place an undue burden on the Examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 12 is objected to because of the following informalities:
In claim 12, line 2, replace “a” with –the-- before “base.” 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 1-5, 10-13 and 21-29 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 1-5 and 21-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the structural connection between plates 18, 22, and 24 that permits translation of plates 22 and 24 to move outward and up with respect to plate 18 and base 12, and the structural connection between plates 26, 28 and 32 that permits translation of plates 28 and 32 to move outward and down with respect to plate 26 and base 12. Simply put, it is unclear how plates 22 and 24 move from the orientation illustrated in Fig. 1 to the orientation illustrated in Fig. 3. Likewise, it is unclear how plates 28 and 32 move from the orientation illustrated in Fig. 1 to the orientation illustrated in Fig. 3. The specification merely states that “an expansion mechanism 34 incorporated into the base 12 enables lateral sliding movements of adjacent plates on the device.” This in no way explains the structural connection and mechanism responsible for moving the plates from the first position (Fig. 1) to the final position (Fig. 3).
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Claims 10-13 and 25-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the structural connection between the plurality of upper plates on the top of the base that permits movement of the upper plates in a lateral direction on the top of the base, and the structural connection between the plurality of lower plates on the bottom of the base being movable in the lateral direction on the bottom of the base. Simply put, it is unclear how plates 22, 24, 28 and 32 move from the orientation illustrated in Fig. 1 to the orientation illustrated in Fig. 3.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the structural connection between the plurality of upper plates on the top of the base that permits lateral movement of the upper plates on the top of the base, and the structural connection between the plurality of lower plates on the bottom of the base that permits lateral movement of the lower plates on the bottom of the base. Simply put, it is unclear how plates 22, 24, 28 and 32 move from the orientation illustrated in Fig. 1 to the orientation illustrated in Fig. 3.
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) 1-5, 10-13 and 21-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suddaby (U.S. 2023/0118386 A1).
Concerning claim 1, Suddaby discloses an intra-vertebral body device for restoring a fractured vertebral body comprising: a base (see Fig. 10, element 350); a plurality of upper plates (see below) operatively connected to a top of the base; a plurality of lower plates operatively connected to a bottom of the base (see below); and an expansion mechanism (see Fig. 10, elements 352, 354, 356 and 358) operatively connected to the plurality of upper plates and the plurality of lower plates, the base, the plurality of upper plates, the plurality of lower plates and the expansion mechanism being configured for surgical positioning inside an interior of a fractured vertebral body between an upper interior surface and a lower interior surface of the fractured vertebral body, the expansion mechanism being operable to cause the plurality of upper plates to move relative to each other to side-by-side positions (see Fig. 8A below noting that the plurality of upper plates are side by side) and achieve medio-lateral expansion of the plurality of upper plates and an expansion of the combined surface areas of the plurality of upper plates at the top of the base with the combined surface areas of the plurality of upper plates being configured to engage against and push against additional surface areas of the upper interior surface of the fractured vertebral body and the expansion mechanism being operable to cause the plurality of lower plates to move relative to each other to side-by-side positions (see Fig. 8A below noting that the plurality of lower plates are side by side) and achieve medio-lateral expansion of the plurality of lower plates and an expansion of the combined surface areas of the plurality of lower plates at the bottom of the base with the combined surface areas of the plurality of lower plates being configured to engage against and push against additional surface areas of the lower interior surface of the fractured vertebral body.
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Lower Plates)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Upper Plates)]
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[AltContent: arrow][AltContent: arrow][AltContent: textbox (Lower Plates – side by side)][AltContent: textbox (Lower Plates – side by side)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Upper Plates – side by side)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Upper Plates – side by side)]
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Concerning claim 2, the plurality of upper plates (see Fig. 10 above) being connected to the top of the base in overlapped, stacked relative positions of the plurality of upper plates; the plurality of lower plates (see Fig. 10 above) being connected to the bottom of the base in overlapped, stacked relative positions of the plurality of lower plates; the expansion mechanism being operable to cause the plurality of upper plates to move from the overlapped, stacked relative positions of the plurality of upper plates to side-by-side positions of the plurality of upper plates (see Fig. 8B above); and the expansion mechanism being operable to cause the plurality of lower plates to
move from the overlapped, stacked relative positions of the plurality of lower plates to the
side-by-side positions of the plurality of lower plates.
Concerning claim 3, further comprising: the plurality of upper plates (see Figs. 8A and 10 above) being operatively connected for relative linear sliding movement between adjacent plates of the plurality of upper plates (linear outward movement – tongue and groove connection); and the plurality of lower plates (see Figs. 8A and 10) being operatively connected for relative linear sliding movement between adjacent plates of the plurality of lower plates (linear outward movement – tongue and groove connection).
Concerning claim 4, the base, the plurality of upper plates, the plurality of lower plates and the expansion mechanism being adapted and configured for surgical insertion into an interior of a fractured vertebral body and then expanded longitudinally and medio-laterally. It is noted that the device could be inserted into a vertebrae of a large mammal, i.e., a whale vertebra.
Concerning claim 5, the base, the plurality of upper plates, the plurality of lower plates and the
expansion mechanism being adapted and configured for surgical insertion into an interior of a fractured vertebral body (e.g., a whale vertebral body) with the plurality of upper plates opposing an upper interior surface of the fractured vertebral body and the plurality of lower plates opposing a lower interior surface of the fractured vertebral body and then expanded longitudinally and medio-laterally (see Figs. 10 and 8A).
Concerning claim 21, the plurality of upper plates (see Fig. 12B below) is operatively connected to the top of the base on opposite sides of the top of the base (see Fig. 12B below, where the base is located directly under element 162); and the plurality of lower plates is operatively connected to the bottom of the base on opposite sides of the bottom of the base (bottom not shown but it is identical to the top shown in Fig. 12B).
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Plurality of Upper Plates)]
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Concerning claim 22, the plurality of upper plates (see below) is separated from the plurality of lower plates (see below) by the expansion mechanism (354, 352, 356 and 358) positioned vertically between the plurality of upper plates and the plurality of lower plates.
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Lower Plates)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Upper Plates)]
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Concerning claim 23, the expansion mechanism being operable to cause the plurality of upper plates to move from overlapped relative positions (see Fig. 10 above) to adjacent side-by-side relative positions (see Fig. 8B above) and to cause the plurality of lower plates to move from overlapped relative positions (see Fig. 10 above) to adjacent side-by-side relative positions (see Fig. 8B above).
Concerning claim 24, the expansion mechanism being operable to cause the plurality of upper plates (see Fig. 10 above) to move relative to each other to side-by-side positions with the plurality of upper plates positioned on opposite sides of the top of the base (see Fig. 10, element 356); and the expansion mechanism being operable to cause the plurality of lower plates (see Fig. 10 above) to move relative to each other to side-by-side positions with the plurality of lower plates positioned on opposite sides of the bottom of the base (see Fig. 10, element 356).
Concerning claim 10, Suddaby discloses a device for intra-vertebral body restoration comprising: a base, the base having a longitudinal dimension that is dimensioned for insertion between an upper interior surface of a fractured vertebral body and a lower interior surface of a fractured vertebral body (large mammal, e.g., whale or bear), the base having a top of the base and a bottom of the base that are longitudinally spaced; the base having a lateral dimension, the lateral dimension being mutually
perpendicular with the longitudinal dimension; a plurality of upper plates (see Fig. 10 below) on the top of the base, the plurality of upper plates on the top of the base being movable in a lateral direction on the top of the base (see Fig. 8A); and a plurality of lower plates (see Fig. 10 below) on the bottom of the base, the plurality of lower plates on the bottom of the base being movable in the lateral direction on the bottom of the base (see Fig. 8A).
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Lower Plates)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Upper Plates)][AltContent: arrow][AltContent: textbox (Base)]
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[AltContent: connector][AltContent: connector][AltContent: textbox (Adjacent Plates)][AltContent: connector][AltContent: connector][AltContent: textbox (Adjacent Plates)][AltContent: connector][AltContent: connector][AltContent: textbox (Adjacent Plates)][AltContent: connector][AltContent: connector][AltContent: textbox (Adjacent Plates)]
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Concerning claim 11, the plurality of upper plates (see Fig. 10 above) on the top of the base being movable in laterally sliding movements between adjacent upper plates (see Fig. 8B above) on the top of the base (see Fig. 10).
Concerning claim 12, the plurality of lower plates (see Fig. 10 above) on the bottom of the base being movable in laterally sliding movements between adjacent lower plates (see Fig. 8B above) on the bottom of the base.
Concerning claim 13, further comprising tongue and groove connections (e.g., 138 between within groove 130) between adjacent plates of the plurality of upper plates and adjacent plates of the plurality of lower plates.
Concerning claim 25, the plurality of upper plates (see Fig. 12B below) is operatively connected to the top of the base on opposite sides of the top of the base (see Fig. 12B below, where the base is located directly under element 162); and the plurality of lower plates is operatively connected to the bottom of the base on opposite sides of the bottom of the base (bottom not shown but it is identical to the top shown in Fig. 12B).
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Plurality of Upper Plates)]
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Concerning claim 26, the plurality of upper plates (see below) is separated from the plurality of lower plates (see below) by the expansion mechanism (354, 352, 356 and 358) positioned vertically between the plurality of upper plates and the plurality of lower plates.
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Lower Plates)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Upper Plates)]
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Concerning claim 27, the expansion mechanism being operable to cause the plurality of upper plates to move from overlapped relative positions (see Fig. 10 above) to adjacent side-by-side relative positions (see Fig. 8B above) and to cause the plurality of lower plates to move from overlapped relative positions (see Fig. 10 above) to adjacent side-by-side relative positions (see Fig. 8B above).
Concerning claim 28, the expansion mechanism being operable to cause the plurality of upper plates (see Fig. 10 above) to move relative to each other to side-by-side positions with the plurality of upper plates positioned on opposite sides of the top of the base (see Fig. 10, element 356); and the expansion mechanism being operable to cause the plurality of lower plates (see Fig. 10 above) to move relative to each other to side-by-side positions with the plurality of lower plates positioned on opposite sides of the bottom of the base (see Fig. 10, element 356).
Concerning claim 29, Suddaby discloses an intra-vertebral body device for restoring a fractured vertebral body comprising: a base (see Fig. 10 below), the base having a longitudinal dimension that is configured for surgical positioning inside an interior of a fractured vertebral body between an upper interior surface and a lower interior surface of the fractured vertebral body (e.g., whale vertebral body), the base having a top of the base and a bottom of the base that are longitudinally spaced; the base having a lateral dimension, the lateral dimension being mutually perpendicular with the longitudinal dimension; a plurality of upper plates (see Fig. 10 below) on the top of the base, the plurality of upper plates on the top of the base being movable laterally on the top of the base (see Fig. 8B); a plurality of lower plates (see Fig. 10 below) on the bottom of the base, the plurality of lower plates on the bottom of the base being movable laterally on the bottom of the base (see Fig. 8B); and an expansion mechanism (352, 354, 356 and 358) inside the base operatively connected to the plurality of upper plates and the plurality of lower plates, the expansion mechanism being operable to cause the plurality of upper plates to move laterally relative to each other to side-by-side positions (see Fig. 10 below) and achieve an increased combined surface area of the plurality of upper plates at the top of the base with the combined surface area being configured to oppose additional surface area of the upper interior surface at the top of the fractured vertebral body and to cause the plurality of lower plates to move laterally relative to each other to side-by-side positions (see Fig. 10 below) and achieve an increased combined surface area of the plurality of lower plates at the bottom of the base with the combined surface area being configured to oppose additional surface area of the lower interior surface at the bottom of the fractured vertebral body.
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Lower Plates)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Upper Plates)][AltContent: arrow][AltContent: textbox (Base)]
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[AltContent: connector][AltContent: connector][AltContent: textbox (Adjacent Plates)][AltContent: connector][AltContent: connector][AltContent: textbox (Adjacent Plates)][AltContent: connector][AltContent: connector][AltContent: textbox (Adjacent Plates)][AltContent: connector][AltContent: connector][AltContent: textbox (Adjacent Plates)]
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited art relates to expansion mechanisms for vertebral devices.
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