DETAILED ACTION
This action is in response to Applicant’s amendment filed on October 16, 2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The priority date of this application will be set as April 2, 2020. The earliest filing that provides support for the method and apparatus is the Application 16/838827.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 2, 6-8 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Sommers (U.S. Patent No. 8092505).
Sommers discloses a method for fixing a first bone (48) to a second bone (50), the method comprising: providing an anchor comprising a core (138), extending along an axis (Figure 11) defining axial (length of the anchor along its central axis), radial (the distance from the central axis to the outer edge of the anchor body), and circumferential directions (the anchor is cylindrical (Figure 11-13, thus has a circumferential direction), a plurality of splines (142, 144), each spline a helix extending radially away from and axially along the core and having a hyper pitch (Figure 11), meaning a pitch length greater than a maximum length of the anchor (From figure 17, it can be extrapolated that the pitch length is longer than the maximum length of the anchor); providing access to two bones (Figure 4), each presenting a cortical surface to be joined to the other (see figure);
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penetrating, by the anchor, fixing each of the cortical surfaces in at least two degrees of freedom with respect to the other in response to engagement of each by the splines (as can be seen in the figures, the bone fragments are fixed from shifting laterally from each other and longitudinally).
Regarding claim 2, penetrating is urged by forces including an impact load from a mallet (96) (Figure 6).
Regarding claim 4, the splines progress helically, the anchor turning circumferentially with axial progression through or between the bones, in response to engagement of, by the plurality of splines, the cortical surfaces (Column 7, Lines 54-63).
Regarding claim 6, the access is provided by at least one of an incision, a dilation, insertion of a guide (92), reaming, broaching, installing a portal, and inserting tools along a guided path.
Regarding claim 7, the access is provided by a process including an incision (it can be construed that to insert wire 90, an incision is made), a dilation (the pilot hole 94 is drilled through a cannula, which dilates), insertion of a guide (90), installing a portal (the cannula), and inserting tools through the portal (Drill) (Column 7, 19-25).
Regarding claim 8, the method further comprising installing multiple anchors engaging the two bones (Column 11, Lines 43), effecting fixation with respect to one another in six degrees of freedom (The bones don’t move once fixed thus they are fixed in six degrees of freedom).
Response to Arguments
In response to Applicant’s argument that Sommers fails to disclose a hyper pitch, the Examiner respectfully disagrees. As seen in the stock photo provided, the pitch length of a thread is measured from crest to crest. As seen in annotated Figure 17 of Sommers, the crest to crest length is projected to extend beyond the length of the screw.
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Allowable Subject Matter
Claims 15-20 are allowed.
Claims 3, 5, 9-14 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose a method of fixing a sacrum and ilium with an anchor having a core extending in axial, radial, and circumferential directions, a plurality of helical splines extending radially and axially away along the core. The splines having a hyper pitch, such that the pitch is longer than the maximum length of the anchor.
The prior art alone or in combination fails to disclose the method of fixing first and second bones with an anchor having a core extending in axial, radial, and circumferential directions, a plurality of helical splines extending radially and axially away along the core. The splines having a hyper pitch, such that the pitch is longer than the maximum length of the anchor and the splines having a helical angle of progression such that the anchor turns less than 360 degrees.
The prior art alone or in combination fails to disclose the method of fixing first and second bones with an anchor having a core extending in axial, radial, and circumferential directions, a plurality of helical splines extending radially and axially away along the core. The splines having a hyper pitch, such that the pitch is longer than the maximum length of the anchor. The method further including the first or second anchor crossing the cortical surfaces in a perpendicular direction and the remaining anchor passes along a joint region between the cortical surfaces generally parallel thereto.
The prior art alone or in combination fails to disclose the method of fixing first and second bones with an anchor having a core extending in axial, radial, and circumferential directions, a plurality of helical splines extending radially and axially away along the core. The splines having a hyper pitch, such that the pitch is longer than the maximum length of the anchor. The splines having a wedge angle formed as a right triangle where the hypotenuse equals a helical distance along a spline and an opposite side equal one pitch distance. A sine of the wedge angle is greater than a cosine thereof.
The prior art alone or in combination fails to disclose the method of fixing first and second bones with an anchor having a core extending in axial, radial, and circumferential directions, a plurality of helical splines extending radially and axially away along the core. The splines having a hyper pitch, such that the pitch is longer than the maximum length of the anchor. The pitch angle is less than 15 degrees measured form a first plane through the axis and a base of the spline by the head of the anchor to the spline unwrapped about a circumference of the anchor onto a second plane orthogonal to the first plane and a tangent to a core at the base of the spline.
The prior art alone or in combination fails to disclose the method of fixing first and second bones each having a cortical portion and medullar portion with an anchor having a hollow core extending in axial, radial, and circumferential directions, a plurality of helical splines extending radially and axially away along the core. The splines having a hyper pitch, such that the pitch is longer than the core, multiplied by the number of splines.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/ Primary Examiner, Art Unit 3775