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 of Group II in the reply filed on July 30th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-8, 11 and 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 30th, 2026.
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.
The Examiner notes the use of “means for” language in claim 13 where Applicant uses the term “means for retaining and releasing” and is being treated as such.
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.
Claim 20 is 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 20 recites the limitation "the retention member" in line. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of examination, the term has been interpreted to read “the means for retaining and releasing the bone marker”.
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.
Claims 13, 15-16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keene et al. (US 2021/0106436).
Regarding claim 13, Keene et al. disclose an installation tool for a bone marker, the installation tool comprising an elongated shaft (100) defining a distal end (104) and a proximal end (102); a handle (¶38) disposed at the proximal end of the elongated shaft; a receptacle (110) disposed at the distal end, the receptacle defines an inside surface (figures 5, 11) having a shape complementary to an outside surface of a bone marker (e.g. 34, figure 11 ¶40 if one so chooses to use the installation tool with the functionally recited bone marker), the bone marker comprising a set of fiducial markers (examiner notes the bone marker is only functionally recited); and a means for retaining and releasing the bone marker from the receptacle (120), the means for retaining and releasing operable without interaction by a user interacting with the handle (capable if the handle is not present and attached).
Regarding claim 15, Keene et al. disclose the means for retaining and releasing further comprises a retention member (122) disposed in operational relationship to the receptacle, the retention member configured to interact with a notch or groove (e.g. 52) of the bone marker to retain bone marker within the receptacle (e.g. ¶36, ¶39).
Regarding claim 16, Keene et al. disclose the retention member is at least one selected from a group consisting of: an elastomeric material; an O-ring; and a spring (“resilient bias of tang” ¶40).
Regarding claim 20, Keene et al. disclose the retention member is configured with relief cuts (gap “G” forms relief cuts in the elongated shaft, figures 6, 9) in order to prevent contact with the set of fiducial markers.
Claims 11 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCormick (US 2014/0142715).
Regarding claim 11, McCormick discloses an installation tool for a bone marker, the installation tool comprising an elongated shaft (516) defining a distal end (520) and a proximal end (where 532 and 516 meet); a handle (532) disposed at the proximal end of the elongated shaft (figure 26); a receptacle (512, figure 22) disposed at the distal end, the receptacle defines an inside surface (figures 21-22) having a shape complementary to an outside surface of a bone marker (e.g. 104 ¶82 if one so chooses to use the installation tool with the functionally recited bone marker), the bone marker comprising a set of fiducial markers (examiner notes the bone marker is only functionally recited); and a means for retaining and releasing the bone marker from the receptacle (544), the means for retaining and releasing operable without interaction by a user interacting with the handle (¶87-88).
Regarding claim 17, McCormick discloses wherein the means for retaining and releasing further comprises a friction member (544) configured to be disposed between the bone marker and the inside surface of the receptacle, the friction member including an inside surface (see figure below) configured to abut an outside surface of the bone marker; and an outside surface defining a protrusion (see figure below), the protrusion configured to interact with an aperture (510) through a side wall of the receptacle (figures 28A-28B, ¶87).
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556
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Regarding claim 18, McCormick discloses wherein friction member holds the bone marker within the receptacle by retention force, and where the installation tool is configured to release the bone marker by a force applied along the longitudinal central axis overcoming the friction force (¶87-88).
Regarding claim 19, McCormick discloses wherein the retention force is based on a friction force between the retention member and the bone marker (¶87-88).
Claims 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olsen et al. (US 2012/0215232).
Regarding claim 24, Olsen et al. disclose an installation tool for a bone marker, the installation tool comprising an elongated shaft (272) defining a distal end (271) and a proximal end (291); a handle (264) disposed at the proximal end of the elongated shaft (figures 11, 15); a receptacle (formed via 282’s, figures 12-13) disposed at the distal end, the receptacle defines an inside surface (inside surface of 282’s) having a shape complementary to an outside surface of a bone marker (e.g. 298’s, figure 14, ¶68, if one so chooses to use the installation tool with the functionally recited bone marker), the bone marker comprising a set of fiducial markers (examiner notes the bone marker is only functionally recited; and a release button (260) comprising a plunger (276), the plunger configured as an elongated member (figure 15) that internally traverses the elongated shaft, the plunger accessible by an operating user of the installation tool via an aperture on the elongated shaft (figure 15, ¶67-69). Regarding claim 25, Olsen et al. disclose wherein upon the installation of the bone marker into a bone, activating the release button to distally disconnect the installation tool from the bone marker (¶69-70).
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over McCormick (US 2014/0142715) in view of Harari et al. (US 2002/0107525).
Regarding claim 14, McCormick discloses the claimed invention except for the teaching of the means for retaining and releasing further comprises a magnet disposed within the elongated shaft proximal to the receptacle. Harari et al. disclose the use of a magnet (¶18) disposed in an elongate shaft (22) proximal to a receptacle (formed via elastic arms, ¶18, figure 1). As the magnet can provide an additional level of fixation and holding of the bone marker within the installation tool (¶18).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the installation tool of McCormick to include a magnet as part of its means for retaining and releasing as taught by Harari et al. as the magnet can provide an additional level of fixation and holding of the bone marker within the installation tool.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/ Primary Examiner, Art Unit 3619
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