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 .
Preliminary Amendment
Applicant’s cancellation of claims 3-5, 7, 15, 17, 19-20, 23-25, 27-28, 30-41, 47 and 49 in the preliminary amendment filed on 8/1/25 is acknowledged.
Specification
The amendment filed 8/1/25 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The amendment incorporates by reference a foreign priority document (Dutch Application NL2034197). Incorporations by reference to foreign priority documents when added by amendment at the time of entry to the national stage are objected to as adding new matter because this is after the filing date. The filing date of this application is not the date of filing the national stage application, rather it is the filing date of the international stage application. See MPEP 608.01(p) I B and 1893.03(b).
Applicant is required to cancel the new matter in the reply to this Office Action.
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 terms “plateau” (claim 21-22) and “overhanging moveable part” (claim 16) are not found in the specification.
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, 2, 6, 8-10, 13, 14, 16, 18, 21, 22, 26, 29, 42, 43, 46, 48 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.
Regarding claims 1, 42 and 43, the preamble recites ….”a bone, such as a vertebra…”. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the vertebra is not positively required by any of claims 1, 42 or 43.
Dependent claims 2, 6, 8-10, 13, 14, 16, 18, 21, 22, 26, 29, 46, 48 are rejected under 112(b) as they contain all the deficiencies of claims 1, 42 and 43 from which they depend.
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) 1-2, 6, 9, 10, 13, 14, 16, 18, 21, 22, 29, 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suddaby (US Publication No. 2021/0228250 A1).
Regarding Claim 1, Suddaby discloses an expandable implant (150) fully capable of being used intra-osseously a bone, such as a vertebra, of a human or non-human mammal, the implant (150) (Fig. 7-12) comprising:
a support structure (external structure defining threads 160) defining a longitudinal axis (axis 10-10 shown in Fig. 8);
a first set of movable parts (180 shown below) movably mounted to the support structure and in an unexpanded state (unexpanded shown in Fig. 7 and 9) of the implant circumferentially spaced around the longitudinal axis from each other (Fig. 9);
a second set of movable parts (180 shown below) movably mounted to the support structure and circumferentially spaced around the longitudinal axis from each other in the unexpanded state (unexpanded shown in Fig. 7 and 9), which second set of movable parts is offset in a longitudinal direction from the first set of movable parts (second set is located closer to tip 152, see Figure below) [0064-0065];
PNG
media_image1.png
523
700
media_image1.png
Greyscale
each movable part (180) in the first set of movable parts and the second set of movable parts being movable relative to the support structure in a radial direction away from the longitudinal axis from a first position in the unexpanded state (Fig. 7 and 9) to a second position in an expanded state of the implant (Fig. 8 and 10) [0064-0065], and each movable part comprising a load resisting surface for resisting a load external to the implant (either sliding leg of 180; or high point 186; or moving plate 192, 194 could be considered the load resisting surface see below);
PNG
media_image2.png
489
687
media_image2.png
Greyscale
a transmission (190+196) (Fig. 10) [0065] for actuating movement of each movable part of the first and second sets of movable parts along a predetermined path from the first position to the second position, wherein in the expanded state said movable parts are supported against the external load to maintain the respective movable part in its second position [0065] (Fig. 10).
Regarding Claim 2, the first set of movable parts comprises a first movable part which is movable from its first position in a first radial direction and a second movable part which is movable from its first position in a second radial direction extending in a direction opposite to the first radial direction; the second set of movable parts comprises a first movable part (shown below as “third movable part”) which is movable from its first position in a third radial direction and a second movable part (shown below as “fourth movable part”) which is movable from its first position in a fourth radial direction extending in a direction opposite to the third radial direction. (see figure below)
PNG
media_image3.png
509
677
media_image3.png
Greyscale
Regarding Claim 6, the first set of movable parts comprises a first movable part and the second set of movable parts comprises a first movable part and the first position of the first movable part of the first set is circumferentially spaced around the longitudinal axis relative to the first position of first movable part of the second set (shown in Fig. 7-12).
Regarding Claim 9, the transmission (190+196) couples the movement of at least one movable part of the first set of movable parts to a movement of at least another movable part of the first set of movable parts [0065] (nut 190 and connector 196 moves plate 192 which simultaneously pushes both first movable parts 180 as shown in Fig. 10).
Regarding Claim 10, the transmission (190+196) couples the movement of at least one movable part of the second set of movable parts to a movement of at least another movable part of the second set of movable parts [0065] (nut 190 and connector 196 moves plate 194 which simultaneously pushes both second movable parts 180 as shown in Fig. 10).
Regarding Claim 13, wherein, in the expanded state, the load resisting surface of at least one of the movable parts of the first set of movable parts is oriented parallel to the load resisting surface of at least one movable part of the second set of movable parts (shown below).
PNG
media_image4.png
465
688
media_image4.png
Greyscale
Regarding Claim 14, in the expanded state, the load resisting surface of at least one of the movable parts of the first set of movable parts is oriented non-parallel to the load resisting surface of at least one movable part of the second set of movable parts (see figure below).
PNG
media_image5.png
471
688
media_image5.png
Greyscale
Regarding Claim 16, the first set of movable parts and the second set of movable parts both comprise at least one overhanging movable part which comprises a base and of which overhanging movable part the load resisting surface projects in the longitudinal direction from the base, and wherein the base of the overhanging movable part of the first set is located further away from a proximal end of the implant and closer to a distal end of the implant than a base of the overhanging movable parts in the second set of movable parts (see figure below).
PNG
media_image6.png
509
677
media_image6.png
Greyscale
Regarding Claim 18, further comprising: a tool interface for a surgical tool (opening in nut 190), the tool interface engaging on the transmission to actuate the movement of the movable parts with the surgical tool [0065].
Regarding Claim 21, at least one of the pluralities of movable parts (180) is a movable bulk part (moving part 180 has mass, therefore is a bulk part), the movable bulk part comprises: a plateau (186) with a load facing side at which the load resisting surface is located (surface on high point 186 can be considered the load resisting surface); a base (184+182) extending in the expanded state from a side of the plateau facing away from the load facing side, in a direction opposite to the direction of expansion (towards the longitudinal axis), the base defining the volume of the movable bulk part (see figure below).
PNG
media_image7.png
471
688
media_image7.png
Greyscale
Regarding Claim 22, the base comprises a first panel (184) extending in the direction opposite to the direction of expansion from a top-side surface and a second panel (182) extending in the direction opposite to the direction of expansion from the top side surface, the panels being spaced apart and enclosing at respective sides the volume (shown in figure above).
Regarding Claim 29, the implant (150) is dimensioned for percutaneous placement in a vertebra [0070], it is also fully capable of being inserted into an opening in the vertebrae.
Regarding Claim 43, Suddaby discloses a tool (e.g., screwdriver, Allen wrench, socket, etc.) for expanding the implant described in claim 1 above, the surgical tool comprising: a driver engageable with the transmission of the implant to selectively move at least one movable part along the predetermined path [0065].
Claim(s) 1, 26, 42, 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Major et al. (US Publication No. 2021/0113250 A1).
Regarding Claim 1, Major discloses an expandable implant (100) fully capable of being used intra-osseously a bone, such as a vertebra, of a human or non-human mammal (Fig. 11B), the implant (100) comprising:
a support structure (130) defining a longitudinal axis (axis x-x shown in Fig. 3);
a first set of movable parts (150 shown below) movably mounted to the support structure and in an unexpanded state (unexpanded shown in Fig. 1B) of the implant circumferentially spaced around the longitudinal axis from each other (Fig. 1-2);
PNG
media_image8.png
680
556
media_image8.png
Greyscale
a second set of movable parts (150 shown above) movably mounted to the support structure and circumferentially spaced around the longitudinal axis from each other in the unexpanded state (unexpanded shown in Fig. 1B), which second set of movable parts is offset in a longitudinal direction from the first set of movable parts (second set is located closer to tip 135a, see Figure above);
each movable part (150) in the first set of movable parts and the second set of movable parts being movable relative to the support structure in a radial direction away from the longitudinal axis from a first position (Fig. 1B) in the unexpanded state (150 swings radially outward and the length of 150 transitions from a longitudinal direction to a radial direction and therefore the tips 154 move radially away from the longitudinal axis, [0069]) to a second position (Fig. 2B) in an expanded state of the implant, and each movable part comprising a load resisting surface (surface of bore which engages with pin 160, Fig. 3) [0062] for resisting a load external to the implant;
a transmission (170) (Fig. 3) [0069] for actuating movement of each movable part of the first and second sets of movable parts along a predetermined path from the first position to the second position, wherein in the expanded state said movable parts are supported against the external load to maintain the respective movable part in its second position [0069] (Fig. 2D).
Regarding Claim 26, Major discloses an expansion structure (see figure below) to be admitted in an intra-osseous cavity (shown in Fig. 11B), which comprises the first set of movable parts, the second set of movable parts, and the support structure (see figure below);
an anchor body (see figure below) for anchoring the implant to a part of the bone outside the cavity, the anchor body being fixated to the expansion structure for holding the expansion structure in the intra-osseous cavity in position relative to the part of the bone outside the cavity (shown in Fig. 11B), which anchor body comprises a distal end (end closest to expansion structure) and a proximal end (end at 110), in a longitudinal direction from the distal end towards the proximal end at a distance from the distal end;
PNG
media_image9.png
598
711
media_image9.png
Greyscale
a tool interface (110) for a surgical tool located at the proximal end (fig. 3), the tool interface engaging on the transmission to actuate the movement of the movable parts with the tool [0082] and the tool interface (110) comprising:
a coupling for the tool (110),
the coupling being movable relative to the proximal end of the anchor body by a force exerted on the coupling by the tool (rotational forces by tool screw down coupling 110 as described in [0082]), and
the coupling engaging on the transmission (170) to transfer at least a part of said force, when exerted on the coupling, to at least one engaged movable part out of the movable parts and thereby actuate movement of the engaged movable part along the predetermined path in the direction of expansion [0082].
Regarding Claim 42, Major discloses a method of orthopaedic surgery of a bone, such as a vertebra, of a human or non-human mammal with an expandable intra-osseous implant (shown in Fig. 11b) [0078], the method comprising:
positioning the implant (100) in the bone (Fig. 11B), the implant comprising: the structure as described in the rejection of claim 1 above. The method further comprising expanding the implant [0074], the expanding comprising the transmission (170) actuating said movement for at least one movable part (150) of at least one set of movable parts [0074].
Regarding Claim 43, Major discloses a tool (60+70, Fig. 13-14) for expanding the implant described in claim 1 above [0074], the surgical tool comprising: a driver (60) engageable with the transmission (170) of the implant to selectively move at least one movable part along the predetermined path [0074].
Claim Rejections - 35 USC § 103
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.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Major et al. (US Publication No. 2021/0113250 A1) in view of Oglaza et al. (US Publication No. 2022/0240987 A1).
Regarding Claim 44, Major describes the tool as recited in claim 43 above. Major shows a part of the tool is a tubular body (70, Fig. 14, [0083]), and another part of the tool is an elongated part 62 having a tip 66 for engaging with the transmission of the implant [0082-0083]. However Major is silent to the tubular body 70 having two open ends and the elongated part fitting into the tubular body when in use.
Oglaza discloses a tool (5) and implant in the same field of endeavor, wherein the tool has a driving portion (52) which fits through a tubular body (51) [0098] (fig. 5), the driving portion 52 expanding the implant in the bone [0100]. Oglaza discloses that the tubular body (51) screws in the outer part of the implant [0098], in the same way that Major describes the tubular body screws in the tapered threaded portion of the implant.
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the tubular body of Major to have two open ends such that the driving portion can fit therethrough in order to be able to engage and drive both parts of the implant with the tools attached as taught by Oglaza.
Allowable Subject Matter
Claims 8, 45, 46, 48 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, See PTO-892
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
Prosecution Insights