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 without traverse of Group I (claims 1-12) in the reply filed on 9/8/25 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/8/25.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 4 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In claim 4 at line 4-5 the limitation recites “upon the implantation, the staple moves from the active position to the relaxed position thereby providing multiplanar compression to the bony fragments”. This limitation cannot be satisfied without the inclusion of the human organism, or the bony fragments, therefore, applicant is claiming the bony fragments as part of the invention. Instead, applicant should use “adapted to” or “configured to” language to overcome the 101 rejection.
Claims 5-12 are also rejected under 35 U.S.C. 101 since they depend from claim 4.
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 1-12 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 is rejected as indefinite for the recitation of “a third leg and a fourth leg connected to the bridge in line along a central axis spanning a length of the bridge between the first leg and the second leg” (emphasis added) in lines 4-5. The limitation renders the claim indefinite since it unclear if between the first leg and the second leg is meant to modify the length of the bridge which is mentioned just prior to the legs. If that is the case then the limitation would be going against the specification which shown the length as reference character (122) in Fig. 1.
Claim 1 is rejected as indefinite as for the recitation of “a y-axis” in line 12. It is unclear if this is meant to be a new y-axis or a further recitation of the same axis recited previously in lines 9-10. In the interest in compact prosecution, the limitation will be interpreted as being a further recitation of the same axis.
Claims 2-12 are rejected as indefinite since they depend upon an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claim 3 recites “wherein the staple is configured to move from the active position to the relaxed position” in lines 1-2 which is substantially similar to the subject matter recited in claim 1 at lines 6-7 which states “staple is deformable from a relaxed position to an active position”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent Pub. 20190117219A1 to Ritz et al; US Patent D773666S to Cheney et al; and US Patent Pub. 20130184768A1 to McIff et al were considered in regards to the claims. The Ritz and Cheney references each describe a staple comprising a first leg and a second leg connected substantially in parallel to a bridge at a first end; and a third leg and a fourth leg connected to the bridge in line along a central axis along the length of the staple and positioned between the first and second legs, and wherein the staples move from an active to relaxed positions. While the McIff reference involves a staple having four legs connected to a torsion bar that is configured to twist and deform to place the staple at the needed angle. However, none of the cited references state that in the relaxed position the first and second legs are positioned at a first bend angle relative to a y-axis while the third and fourth legs are at a second bend angle relative to the y-axis; the bridge comprises a twist angle that positions the third and fourth legs at first and second torsion angles relative to the y-axis; and that in the active position all angles are approximately zero degrees.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775