DETAILED ACTION
This is the first office action on the merits in this application. The preliminary amendment of May 31, 2024, is under consideration. Claims 3-7, 9, and 11-13 were amended. Claims 1-16 stand pending.
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 .
Claim Objections
Claim 3 is objected to because of the following informalities: at line 2, the claim should read “planar contact surface is a [[are]] curved contact surface.” 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 1-16 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 and 14 both require the limitation that the second mounting location includes a contact element “for the surgical instrument to be inserted in use…” Examiner finds this limitation to be contradictory to what is demonstrated in the originally presented disclosure. Rather, examiner believes the contact element is intended to be inserted into the surgical instrument, for instance, as seen at applicant’s figures 2A and 2B (and the case will be examined with this understanding in mind). If the surgical instrument is indeed to be inserted into the contact element, examiner wishes clarification of how this is done, and will issue a subsequent drawing objection requiring such be shown in the figures. If the wording is simply unclear, examiner requests clarification of the claim. Clarification is required.
Claim 16 requires the kit include “different profile inserter devices”. It is unclear what is meant by this term. Is this intended to require differently shaped contact elements? Which other shapes? The metes and bounds of this limitation are not clear, as it is unclear what other profiles are intended to be included or excluded from the scope of the claim. Further, this is a limitation which does not find further description in the originally presented disclosure such that it is clarified by the specification. Clarification is required.
Claim Rejections - 35 USC § 102
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) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (US 2017/0056194 A1).
Regarding claim 1, as best understood, Biedermann teaches a surgical instrument inserter device as at fig. 1, the inserter device comprising:
a body 50;
a first mounting location provided at the proximal end of the body (seen retaining nut 60 in fig. 1);
a second mounting location 53 provided at the distal end of the body;
wherein the second mounting location 53 includes a contact element for insertion into a surgical instrument 1 as at fig. 1, the contact element 57/61 having one non-planar contact surface sections 57. (Once a single alternative is met, the further alternatives are not considered).
Regarding claim 2, the contact element 57/61 provides a single non-planar contact surface 57.
Regarding claim 3, the non-planar contact surface 57 is a curved contact surface (see the shape of 57 in fig. 3C).
Regarding claim 4, one of the non-planar contact surface sections 57 are articulation surfaces (for articulating relative to 1; compare figures 7A-9B when demonstrate the articulation between 57 and 1 [0017]).
Regarding claim 5, one of the contact surface sections 57 are provided by a deformed partial sphere (e.g. a sphere with removed segments [0020]).
Regarding claim 6, the term “compressed sphere” has been studied. Applicant refers to portion 149 as being a compressed sphere at p. 19 of the disclosure. In the same way that this is a compressed sphere, the contact surfaces sections 57 of Biedermann are considered a compressed sphere, with the compression along a single axis. See fig. 3A-3E of Biedermann.
Regarding claim 7, the contact element 57/61 includes one or more other contact surface sections 61, the one or more other contact surface sections 61 being planar (once a first alternative is met, the other alternatives are not considered).
Regarding claim 8, the one or more other contact surface sections 61 are sections of the same continuous surface as the one or more non-planar contact surface sections 57 are part of (the entirety of 57/61 is built of a single structure, and are thereby considered continuously extending).
Regarding claim 9, the contact element 57/61 comprises two other contact surface sections 61 that are flattened compared with the curvature of the one or more non-planar contact surface sections 57.
Regarding claim 10, the two flattened other contact surface sections 61 are in opposition to one another and are on posterior and anterior sides of the inserter device. (See fig. 3A, 3B, 3E) There is no definition of a posterior/anterior directionality in the claim, such that there is no reason that these surfaces cannot be declared to be located in posterior and anterior directions.
Regarding claim 11, the contact element 57/61 has a first extent and a second extent (see fig. 3E – first extent left and right on 53 in the fig.; second extent up/down on 53 in the fig.), wherein the first extent is between a first pair of points on opposite sides of the contact element and wherein the second extent is between a second different pair of points on different opposite sides of the contact element, wherein the first extent is greater than the second extent (left/right extent is longer than up/down extent).
Regarding claim 12, the body 50 includes a body portion 62 and includes an elongate portion 51, together with a transition portion 56 that connects the body portion 62 to the elongate portion 51.
Regarding claim 13, the first mounting location (portion seen receiving nut 60) is adapted to connect the inserter device to the distal end of a tool 60 (or some other inferred tool with a threaded coupling thereon).
Regarding claim 14, Biedermann teaches a kit comprising:
a surgical instrument inserter device of claim 1, as shown in the rejection of claim 1, above; and
a tool 60 for attachment to the first mounting location of the surgical instrument inserter device. (The tool is given no structure. There is no reason that a nut cannot be said to be a tool; a screw (inclined plane) is known to be one of the “simple tool” examples in engineering).
Regarding claim 15, the tool 60 further includes one or more abutment surfaces (the flats seen on the nut 60). (Once a single alternative is met, no further consideration is given to the other alternatives, as the claim has already been met).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann.
Regarding claim 16, the limitations of claim 14 are taught as above, but it is not taught that the kit further includes a plurality of different profile inserter devices.
It is, though, taught that the device will have a form-fit connection with an implant [0003], [0005], [0130], etc..
Implants are known to be provided in different shapes and sizes.
It would have been obvious to one with ordinary skill in the art at the time of the invention to provide a kit with multiple devices, of different sizes, for correlating in a form-fit fashion with implants of different sizes. Patients have various anatomies and boney structures sizes and conformations which require particularly sizes and shaped implants, which would require differently sized and shaped insertion tools. A different size/shape is considered to inherently have a different profile.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799