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 .
Claim Objections
Claims 22-40 are objected to because of the following informalities: Claims 22-40 all depend from cancelled claims. The examiner will interpret the claims and their dependency as best understood. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,864,754. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claim 21 of the current application and the invention of claims 1 and 2 of the patent lies in the fact that the invention of claims 1 and 2 of the patent includes more elements and is thus more specific. Thus the invention of claims 1 and 2 of the patent is in effect a "species" of the "generic" invention of claim 21 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 21 is anticipated by claims 1 and 2, claim 21 is not patentably distinct from claims 1 and 2.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 14 of U.S. Patent No. 10,258,328. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claim 21 of the current application and the invention of claims 1, 3, and 14 of the patent lies in the fact that the invention of claims 1, 3, and 14 of the patent includes more elements and is thus more specific. Thus the invention of claims 1, 3, and 14 of the patent is in effect a "species" of the "generic" invention of claim 21 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 21 is anticipated by claims 1, 3, and 14, claim 21 is not patentably distinct from claims 1, 3, and 14.
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 21, 22, 24, 29, 31, 37, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stofella (U.S. Patent 6,203,545).
Stofella discloses a device comprising:
(claim 21) a post member
(claim 21) the post member configured for transverse insertion in a first bone or bone fragment (all bone anchors are capable of being inserted transverse into a bone or fragment since they all transverse the surface of the bone or fragment)
(claim 21) the post member including
(claim 21) a curved head portion (4) including
(claim 21) bore (6)
(claim 22) wherein the bore includes an interior surface
(claim 21) a slot (see Figure 2)
(claim 21) an anchoring portion coupled to the curved head portion
(claim 21) the anchoring portion including
(claim 21) two substantially parallel legs (3)
(claim 29) wherein the legs extend from about the slot (see Figure 2)
(claim 21) wherein the legs terminate at a first and second tip
(claim 21) wherein the curved head portion is offset from the anchoring portion by a first angle (see Figures 1 and 3)
(claim 21) a screw member (7)
(claim 21) wherein the screw member is configured to couple with the bore
(claim 21) wherein the first angle is configured such that the screw member is capable of being fixed diagonally to the first bone or bone fragment and a second bone of bone fragment (the bone screw is capable of being inserted at an angle relative to a first bone and a second bone)
(claim 24) wherein the bone screw includes
(claim 24) a bulbous portion (see Figure 1)
(claim 40) wherein the screw member comprises threads to engage the second bone fragment of bone fragment
(claim 37) wherein the device is capable of being implanted below the cortex of a bone (for example see Figure 1)
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.
Claims 23, 25, 26, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Stofella (U.S. Patent 6,203,545) in view of Tyber (U.S. Patent 9,017,329).
Stofella discloses the invention as claimed except for the interior surface of the bore being tapered and the bulbous portion having a mating taper to engage the interior surface. Tyber teaches a device (for example see Figures 9A-9B) comprising a fixation member (900) including a head portion (910) with a bore (925) and a screw member (905) including a bulbous portion (965), wherein the head portion and the bulbous portion are connected by an interference fit, such as a Morse taper (see column 5 line 30 to column 6 line 54), in order to lock the head portion to the bulbous portion. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Stofella wherein the interior surface of the bore is tapered and the bulbous portion includes a matching taper to engage the interior surface in view of Tyber in order to lock the head portion to the bulbous portion.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Stofella (U.S. Patent 6,203,545) in view of Ogilvie (U.S. Patent 6,325,805).
Stofella discloses the invention as claimed except for the screw member including a coating. Ogilvie teaches a device comprising a screw member, wherein the screw member includes a coating, such as an osteoconductive coating, in order to enhance fixation of the screw member (column 5 line 65 to line 6 line 3). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Stofella wherein the screw member includes an osteoconductive coating in view of Ogilvie in order to enhance fixation of the screw member.
Claims 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Stofella (U.S. Patent 6,203,545) in view of Ogilvie (U.S. Patent 6,325,805).
Stofella discloses the invention as claimed except for the legs comprising a semi-circular cross-section, wherein the first and second tips taper from oppositely disposed flat outer facing surface to curved inner facing surfaces terminating at a point. Ogilvie teaches a device (for example see Figures 1A and 1B) comprising a post member including a pair of substantially parallel legs with a first tip (104) and a second tip (105), wherein the parallel legs include a semi-circular cross-section and wherein the tips taper from oppositely disposed flat outer facing surfaces to curved inner facing surface each terminating at a point (see Figure 1A). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to provide the device of Stofella where in the legs include a semi-circular cross-section and wherein the tips taper from oppositely disposed flat outer facing surfaces to curved inner facing surface each terminating at a point in view of Ogilvie, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a leg and the tips of the leg in a bone anchor. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claims 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Stofella (U.S. Patent 6,203,545) in view of Tyber (U.S. Patent 9,017,329).
Stofella discloses the invention as claimed except for the screw member comprising a first bore along a second longitudinal axis, i.e. the central longitudinal axis of the screw, and a second bore along the second longitudinal axis. Tyber teaches a device comprising a screw member including a first bore (214) extending the length of the screw member along a central longitudinal axis and a second bore (208) extending the length of a bulbous head portion (202) along the central axis in order receive a guidewire and to transmit torque to the screw member. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Stofella wherein the screw member includes a first bore and a second bore in view of Tyber in order to receive a guidewire and to transmit torque to the screw member.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Stofella (U.S. Patent 6,203,545) in view of Tyber (U.S. Patent 9,017,329).
Stofella discloses the invention was claimed except for the screw member including a self-tapping leading edge. Tyber teaches a screw member including a self-tapping leading edge (222) in order to cut bone material during implantation of the screw member. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Stofella wherein the screw member includes a self-tapping leading edge in view of Tyber in order to cut bone material during implantation of the screw member.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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