DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on August 23, 2024. Claims 1-5 are currently 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 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.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Concerning claim 1, lines 8 and 11 recite the phrase “stabilization based”, wherein the word “based” appears to be a misspelling of the word “base”.
Concerning claim 3, line 2 of the claim recites the word “complimentarily”, wherein this appears to be a misspelling of the word “complementarily”.
Appropriate correction 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, 2, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dominguez et al. (US 2002/0038126, hereinafter Dominguez).
Concerning claim 1, the Dominguez et al. prior art reference teaches a system for fixing an anchor to a subject (Figures 1-8; 10), wherein said anchor may be a used as a tracking device or to fix a tracking device, comprising: an anchor configured to be passed through an incision in a subject to engage a bone (Figure 8; 156); an elongated member (Figure 2; 22) having an anchor engaging portion to engage the anchor (Figure 6; 134); a stabilization base having a passage (Figure 2; 18), wherein the elongated member is operable to pass through the passage such that the stabilization base is operable to move toward the anchor along the elongated member ([¶ 0031], base may extend or move/slide relative to the anchor such that distal points approach a level of the distal end of the anchor tube, and thus the anchor); and a knob to abut the stabilization base and move the stabilization base toward the subject along the elongated member (Figure 1; 16); wherein the stabilization base is operable to contact the subject with at least a portion of the stabilization base to hold the elongated member relative to the subject ([¶ 0035]).
Concerning claim 2, the Dominguez reference teaches the system of claim 1, further comprising: a driving tool to drive the anchor into the bone of the patient (Figure 7; 150).
Concerning claim 5, the Dominguez reference teaches the system of claim 1, wherein the elongated member includes a distal end opposite the anchor engaging portion (Figure 2; 12, mounting bracket may be interpreted as comprising the distal end of the elongated member); wherein the distal end includes a smooth tapered outer wall (Figure 2; starburst teeth 44 of the mounting bracket may be interpreted as a smooth tapered portion of the outer wall given the tapering of the teeth) and a distal portion configured to puncture a drape (Figure 2; starburst teeth 44 capable of puncturing a drape).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dominguez et al. (US 2002/0038126, hereinafter Dominguez) in view of Biedermann et al. (US 2015/0257797, hereinafter Biedermann).
Concerning claim 3, the Dominguez reference teaches the system of claim 1, wherein the Dominguez reference teaches the anchor having a head (Figure 8; 156) operable to engage a complementarily shaped anchor engagement portion of the elongated member (Figure 6; 134 | [¶ 0036]), but it does not specifically teach the head of the anchor being spherical.
However, the Biedermann reference teaches a bone anchor (Figure 21; 100), wherein the head of the anchor is spherical (Figure 21; 102) and is operable to engage a complementarily shaped anchor engagement portion (Figure 21; 26) of an elongated member (Figure 21; 2).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the head of the anchor of the Dominguez reference have a spherical shape as in the Biedermann given it is a common shape for polyaxial bone screws (Biedermann; [¶ 0039]), and to further have the anchor engagement be complementarily shaped to provide a seat for the head (Biedermann; [¶ 0045]).
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dominguez et al. (US 2002/0038126, hereinafter Dominguez) in view of Kreidler (US 2005/0216015, hereinafter Kreidler)
Concerning claim 4, the Dominguez reference teaches the system of claim 1, but does not specifically teach the maximum exterior diameter of the anchor.
However, the Kreidler reference teaches a bone screw, wherein the reference teaches that the maximum diameter for a small fragment screw head may be about 3-4 mm ([¶ 0003]), which is about 2.3 mm, given the bounds of “about” have not been defined.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the maximum exterior dimension of the anchor of the Dominguez and Biedermann combination, which is defined at the head, be about 3-4 mm, which is about 2.3 mm, to allow the bone screw to be used for such applications as for cranial injuries, hand surgeries, or maxillofacial surgeries (Kreidler; [¶ 0003]).
Conclusion
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/MARTIN T TON/Examiner, Art Unit 3771 12/2/2025