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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8 and 17-20, drawn to a system and smart drill bit, classified in A61B17/1615.
II. Claims 9-16, drawn to a method of using a smart drill, classified in A61B17/56.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different method of using that product, namely, drilling into wood or metal.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classifications;
The inventions have acquired a separate status in the art due to their recognized divergent subject matter;
The inventions require a different field of search (for example, searching different groups/subgroups or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Sudip K. Mitra on 27 October 2025 a provisional election was made with traverse to prosecute the invention of group I, claims 1-8 and 17-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Drawings
The drawings are objected to because reference numbers should be added for the first end, the second end, the threaded portion, and the shaft. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Reference numbers should be added for the first end, the second end, the threaded portion, and the shaft.
Appropriate correction is required.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1, line 9: “to” (before “provide”) should be removed.
Claim 6, line 1: “relate” should be changed to --related--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-18 and 17-20 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.
Claim 1 recites “a threaded portion” in line 4, claim 17 recites “a threaded portion” in line 3. However, applicant’s disclosure, specification and drawings, fails to provide reference numbers for the “threaded portion” and the drawing appear to be absent a “threaded portion.” The drawing appears to show a fluted portion as can be seen in the annotated Fig. 1 of applicant’s drawings below.
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For examination purposes, the “threaded portion” will be interpreted as a fluted portion. A further clarifying amendment 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 6, 8, 17 and 18, as best understood, is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Schornagel et al., U.S. PG-Pub 2021/0085340.
Regarding claim 1, Schornagel et al. discloses a system comprising: at least one drill bit (1) having a first end and a second end located at a distal end of the first end; a threaded portion in proximity to the second end; a shaft (4) connected to the threaded portion; wherein the at least one drill bit is configured with at least one embedded processor (16) configured to execute computer executable instructions, wherein the system is further configured to: provide real-time intra-operative reading of at least one variable measurement parameter of at least one bone during a certain medical procedure (examiner annotated Fig. 1 below, Fig. 4 and paragraphs [0021], [0031]).
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Regarding claims 2, 5, 6 and 8, Schornagel et al. discloses wherein the at least one variable measurement parameter comprises a length (paragraphs [0028], [0036] and [0038]); wherein the system if fully capable of being used for a long bone and for restoration of a fractured bone; and wherein the processor (16) is further configured to connect and communicate with at least one external device (2) over at least one network (Fig. 7 and paragraph [0028]).
Regarding claim 17, Schornagel et al. discloses a smart drill comprising: a first end and a second end located at a distal end of the first end; a threaded portion in proximity to the second end; a shaft (4) connected to the threaded portion; wherein the smart drill is configured with at least one embedded processor (16) configured to execute computer executable instructions, wherein the system is further configured to: provide real-time intra-operative reading of at least one variable measurement parameter of at least one bone during a certain medical procedure (examiner annotated Fig. 1 above, Fig. 4 and paragraphs [0021], [0031]).
Regarding claim 18, Schornagel et al. discloses wherein the at least one variable measurement parameter comprises a length (paragraphs [0028], [0036] and [0038]).
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.
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) 3, 7 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schornagel et al., U.S. PG-Pub 2021/0085340 in view of Gao, EP 3 476 357.
Regarding claims 3, 7 and 19, Schornagel et al. discloses the invention essentially as claimed except for wherein the at least one variable measurement parameter comprises an alignment and wherein the processor is further configured to connect with at least one sensor in order to sense a three-dimensional position in space.
Gao discloses a system having a drill bit (31a) that is configured to connect with a sensor in order to sense a three-dimensional position in space as such provides real-time spatial relationship between the drill bit and bone and a pre-planned spatial relationship between the drill bit and the bone (which is understood to be an alignment of the drill bit with respect to the bone) (paragraph [0018]).
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 system of Schornagel et al. such that the at least one variable measurement parameter is an alignment and the processor is further configured to connected with a sensor in order to sense a three-dimensional position in space in view of Gao to permit providing real-time spatial relationship between the drill bit and bone and a pre-planned spatial relationship between the drill bit and the bone to help a surgeon be more accurate with placement of the drill bit.
Claim(s) 4 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schornagel et al., U.S. PG-Pub 2021/0085340 in view of Brianza et al., U.S. PG-Pub 2013/0338669.
Regarding claims 4 and 20, Schornagel et al. discloses the invention essentially as claimed except for wherein the at least one variable measurement parameter comprises a rotation.
Brianza et al. discloses a system having a system having a drill bit (1) with a processor (10) configured to measure rotation (torque) (Figs. 1 and paragraph [0045]) as such helps distinguish between differing bone mineral density helping to prevent a surgeon from making a wrong decision when drilling into the bone (paragraph [0003]).
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 processor such that the at least one variable measurement parameter is rotation in view of Brianza et al. to permit better distinguishing between differing bone mineral densities to help prevent a surgeon from making a wrong decision when drilling into bone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
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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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775