DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 16, 2025 has been entered.
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) 27-40 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 fastener (104) comprising: a head (106) having a central axis (coinciding with axis 90) and a head cross-section perpendicular to the central axis (Figure 9); a shank (108) having a substantially circular cross section along at least a portion thereof (Figure 9, 10), the shank extending from the head along the central axis (Figure 9, 10); splines (Figure 9, 10, shown as 64, 66 in other figures) extending from the shank a distance from the shank (Figure 9, 10), radially away with respect to the central axis (Figure 9, 10), wherein each spline makes less than one full wrap around the shank along an entire length thereof (Figure 9, 10); and a point (182), extending from the shank opposite the head, the point comprising an edge sized and shaped to penetrate bone (Figure 15) (it is noted that in column 12, lines 35-41, it states that bone nail 104 can include any of the features disclosed elsewhere in the present disclosure).
Regarding claim 28, the shank and splines are each sized and shaped to resist withdrawal in response to a force on the head (Column 1, Lines 53-67 and Column 2, lines 1-5, it can be construed that the bone nail of the disclosure is improved because of its resistance to withdrawal).
Regarding claim 29, it can be seen from the figures that any withdrawal force would be a force acting along the central axis at the head.
Regarding claim 30, the shank defines a length thereof, a circumference therearound, a diameter corresponding to the circumference, and an aspect ratio of the length to the diameter greater than three (It can be seen that the length of the bone nail shank in figures 9 and 10 is at least three times greater than the diameter of the shank); and the shank has a flattened end opposite the head (it can be considered that tip 182, is flattened compared to the rest of the shank).
Regarding claim 31, the fastener is shaped to maintain the bone in compression following insertion of the fastener into the bone (Figure 9, 10).
Regarding claim 32, the compression is supported by resistance of the splines to motion toward a head end thereof by the resistance of the splines to movement in a direction other than the central axis (Figure 9, 10).
Regarding claim 33, Sommers discloses an apparatus (104) operable as a fastener anchoring to a bone, the apparatus comprising: an axis (Figure 9, coinciding with 90) defining a radial direction, circumferential direction, and axial direction along the axis (Figure 9, 10); a head end (106) defining a proximal end of the fastener; a distal end of the fastener (opposite proximal end), defining a length along the axis and capable of initiating penetrating of the bone (tip 182) in the axial direction in response to a force applied to the head end (Figure 9, 10); and a shank (104) having a substantially circular cross section along at least a portion thereof, the shank extending between the head and the distal end and comprising splines extending radially away from the axis (Figure 9, 10, shown as 64, 66 in other figures), wherein each spline makes less than one full wrap around the shank along an entire length thereof (Figure 9, 10).
Regarding claim 34, the splines are each defined by an outer surface that is smooth (Figure 9-11).
Regarding claim 35, the shank is defined by an outer surface that is smooth (Figure 9-11).
Regarding claim 36, the splines and shank are solid, devoid of apertures therethrough (Figure 15, Column 2, Lines 43-46).
Regarding claim 37, the bone is vertebral (Column 10, Line 54-64).
Regarding claim 38, the bone is secured by the apparatus to a another bone to be immobilized with respect to the bone (Column 10, Lines 54-67).
Regarding claim 39, wherein the splines progress linearly about the axis with distance from the point end toward the head end, thereby positioning the point end to promote arthrodesis by maintaining compression in the bone between the head end and point end (Column 3, Lines 33-37).
Regarding claim 40, the apparatus is oriented by a penetration through a plate sized and shaped to pass the shank therethrough and retain the head end therein (Column 8, Lines 61-67).
Response to Arguments
Applicant’s arguments with respect to claim(s) 27-40 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.
Allowable Subject Matter
Claims 21-26 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose the method as currently amended.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached 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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/ANDREW YANG/Primary Examiner, Art Unit 3775