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 .
Claim Objections
Claims 15-20 are objected to because of the following informalities:
For each of claims 15-20, in line 1, --burr-- should be added between “The” and “guide”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: engagement feature in claims 9 and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 11-13 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Arlettaz et al., U.S. PG-Pub 2014/0236156.
Regarding claim 11, Arlettaz et al. discloses a burr instrument, comprising: a shaft (100) having a first end (110) opposite a second end (140), wherein the first end is configured to comprise at least one geometry that facilitates being releasably coupled to a tool (Fig. 3 and paragraph [0034]), wherein the second end comprises an engagement feature (10) and wherein the engagement feature comprises: five members (26a-26e) protruding from an outer surface of the engagement feature and spaced apart substantially equidistantly form one another about a circumference of the engagement feature and extending along a length thereof (Figs. 1c, 1d, 3 and paragraph [0035]).
Regarding claims 12 and 13, Arlettaz et al. discloses wherein the engagement feature (10) comprises a geometry that is greater in at least one lateral dimension than that of the shaft (100) or the first end (140) (engagement feature 10 is wider than portion 120 of the shaft and first end 140); and wherein the engagement feature is configured to function as a mechanical stop, and further comprises a substantially cylindrical geometry, wherein the members (26a-26e) extend in an outward direction from the outer surface at an angle that is at least one of orthogonal or oblique to the outer surface (Figs. 1c, 1d and 3).
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) 1, 3-7 and 14-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hollis et al., U.S. PG-Pub 2021/0038260 in view of Wong et al., U.S. PG-Pub 2022/0265288.
Regarding claims 1 and 21, Hollis et al. discloses an orthopedic instrument system, comprising: a burr (paragraph [0004]); and a guide (200a), comprising: a body; an elongated opening (210a, 210b, 210c) opening through the body, wherein at least a portion of the elongated opening comprises a substantially circular opening (210b, 210c) having a greater lateral dimension than that of an adjacent portion of the elongated opening (210b, 210c is wider than the elongated portions of 210a), wherein the circular opening is configured to receive at least a portion of the burr therein and therethrough such that the burr may be manipulated along a length of the elongated opening, and at least one lobe extending laterally from the body, wherein the at least one lobe comprises: at least one slot (212a) extending through the at least one lobe from a top surface through to a bottom surface; and wherein the at least one slot of the at least one lobe is positioned to align with the circular opening of the body (examiner annotated Fig. 14E below).
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Hollis et al. does not disclose the at least one slot extending along the at least one lobe perpendicular to the elongated opening of the body.
Wong et al. discloses a guide (12) have a slot (40) extending from a top surface to a bottom surface and extends along a lateral portion of the guide perpendicular to an opening (26) (Figs. 1-2) as such accommodates a plurality of positions for a wire to pass through (paragraph [0029]).
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 slot of the lobe of Hollies et al. such that the at least one slot extends along the at least one lobe perpendicular to the elongated opening of the body in view of Wong et al. to permit accommodating a plurality of positions for a k-wire to pass through.
Regarding claims 3-5, Hollis et al. discloses wherein the at least one lobe comprises a pair of lobes extending laterally from opposite sides of the body; wherein each lobe of the pair of lobes comprises a slot (212a, 214a) of the at least one slot positioned in a central portion of the respective lobe (examiner annotated Fig. 14E above); and further comprises at least one stabilization wire configured to releasably couple the guide to a bone of a patient (paragraph [0077] discloses a k-wire).
Regarding claims 6 and 7, Hollis et al. discloses wherein the guide (200a) is substantially symmetrical about at least one plane extending therethrough; and wherein the at least one plane intersects or is coplanar with a longitudinal axis extending along a length of the elongated opening (210a, 210b, 210c) (examiner annotated Fig. 14E below).
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Regarding claim 14, Hollis et al. discloses a burr guide, comprising: a body, comprising: an elongated opening (210a) extending form a top surface through to a bottom surface of the body; and a circular opening (via 210b and 210c) extending from the top surface through to the bottom surface of the body; and a pair of lobes extending laterally from the body, wherein each lobe of the pair of lobes comprises: a slot (212a, 214a) extending through each of the lobes from a top surface through to a bottom surface (examiner annotated 14E below).
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Hollis et al. does not disclose wherein each slot extends along each lobe perpendicular to the elongated opening of the body.
Wong et al. discloses a guide (12) have a slot (40) extending from a top surface to a bottom surface and extends along a lateral portion of the guide perpendicular to an opening (26) (Figs. 1-2) as such accommodates a plurality of positions for a wire to pass through (paragraph [0029]).
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 slots of the lobes of Hollies et al. such that each slot extends along each lobe perpendicular to the elongated opening of the body in view of Wong et al. to permit accommodating a plurality of positions for a k-wire to pass through.
Regarding claims 15 and 16, Hollis et al. discloses wherein the elongated opening (210a) and the circular opening (210b, 210c) are in fluid communication with one another; and wherein the circular opening comprises a lateral dimension that is greater than a lateral dimension of the elongated opening (210b, 210c is wider than 210a) (Fig. 14E).
Regarding claims 17 and 18, Hollis et al. discloses wherein each slot (212a, 214a) of the respective lobe is positioned to align with the circular opening (210b, 210c) of the body; and wherein each of the lobes comprises a substantially curved geometry (each lobe has rounded ends) (examiner annotated Fig. 14E above).
Regarding claim 19, Hollis et al. discloses wherein the burr guide is symmetrical about a plane that overlaps with a longitudinal axis extending along a length of the elongated opening (210a) (examiner annotated Fig. 14E below).
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Regarding claim 20, Hollis et al. discloses wherein the elongated opening (210a) comprises a depression extending along at least a portion of a length of the elongated opening, wherein the depression is positioned adjacent the top surface of the body; and wherein the circular opening (210b, 210c) is positioned adjacent the depression (examiner annotated Figs. 14A and 14E below and paragraph [0077] discloses 200a is similar to 200; therefore, fig. 14A is being used to show the depression from a different angle).
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Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hollis et al., U.S. PG-Pub 2021/0038260 in view of Wong et al., U.S. PG-Pub 2022/0265288 as applied above, and further in view of Mincieli et al., U.S. PG-Pub 2021/0121186.
Regarding claims 8-10, Hollis et al. in view of Wong et al. discloses the invention essentially as claimed except for wherein the burr comprises a first end opposite a shaft from a second end, wherein the first end comprises geometry configured to releasably couple with a powered instrument; wherein the second end of the burr comprises an engagement feature; and wherein the engagement feature comprises geometry that is greater in at least one dimension than that of the shaft of the first end of the burr.
Mincieli et al. discloses a burr having a first end (end near 158) opposite a shaft from a second end (end near 32), wherein the first end comprises geometry (158) configured to releasably couple with a powered instrument; wherein the second end of the burr comprises an engagement feature (32) that comprises a geometry that is greater in at least one dimension (width) than that of the shaft of the first end of the burr (32 is wider than tapered portion between 32 and 33) (Fig. 3A and paragraph [0041]).
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 burr of Hollis et al. to have a first end opposite a shaft from a second end, wherein the first end comprises geometry configured to releasably couple with a powered instrument; wherein the second end of the burr comprises an engagement feature; and wherein the engagement feature comprises geometry that is greater in at least one dimension than that of the shaft of the first end of the burr further in view of Mincieli et al. to permit the burr to be driven by a drill motor in order to remove desired bone material.
Response to Arguments
Applicant’s arguments, see Remarks, filed 23 March 2023, with respect to the objection of claims 4 and 14 have been fully considered and are persuasive. The objection of claims 4 and 14 has been withdrawn.
Applicant’s arguments, see Remarks, filed 23 March 2026, with respect to the rejection of claims 1-13 and 19 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 1-13 and 19 under 35 U.S.C. 112 (b) has been withdrawn.
Applicant’s arguments, see Remarks, filed 23 March 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) and 102(a)(2) to Bobo et al., U.S. PG-Pub 2012/0130377 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 to Hollis et al., U.S. PG-Pub 2021/0038260 in view of Wong et al., U.S. PG-Pub 2022/0265288.
Applicant’s arguments with respect to claim(s) 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see Remarks, filed 23 March 2026, with respect to the rejection(s) of claim(s) 14 under 35 U.S.C. 102(a)(1) and 102(a)(2) to Hollis et al., U.S. PG-Pub 2021/0038260 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 to Hollis et al., U.S. PG-Pub 2021/0038260 in view of Wong et al., U.S. PG-Pub 2022/0265288.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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