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 .
Specification
The disclosure is objected to because of the following informalities. On page 1, para [0001]: the status of copending applications which have since issued as patents must be updated.
Appropriate correction is required.
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 1-20 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.
In claims 1 and 16, the recitation “..properly seated on the interbody implant” renders the claim vague and indefinite because it is unclear when the screw is properly seated. Applicant’s disclosure states “The interbody implant 10 further includes one or more screw holes 30 angled to allow screws to pass through the holes and when fully seated, engage the vertebral bodies adjoining the target disc space to secure the implant 10 in position.” Applicant’s disclosure also describes “As shown most clearly in the sectional view of Fig. 1B, the screw holes 30 of the implant 10 may include an internal spherical surface 38. As described more fully below, the spherical surface may interact with the head of a bone screw 618 and provide feedback when the screw is fully seated.” Applicant’s disclosure does not describe how the screw is properly seated except for passing the screw through the hole in the implant into the vertebral bone adjoining the target disc space with prevention of additional rotation after the screw enters bone with an insertion depth determined by the tool.
In claims 2 and 17, the recitation “…on a surface of the interbody implant” renders the claim vague and indefinite because it is unclear where the surface is and what properly seated on a surface is and how the determination is made. See previous discussion for claim 1.
In claims 3 and 18, the recitation “…on a spherical surface of the interbody implant” renders the claim vague and indefinite because it is unclear where the spherical surface is and how the determination that the screw is properly seated is made. See previous discussion for claim 1.
For purposes of examination, with regard to “properly seated” it is assumed that Applicant intended to recite when the screw is implanted in the proper orientation (i.e., engages the vertebral bones adjoining the disc space) and the head of the screw is seated on a surface of a screw hole in the interbody implant.
In claim 16, the preamble recites “an interbody into a bone” which is incomplete. It appears Applicant intended to recite “…an interbody implant between adjacent vertebral bodies...”
In claim 16, the recitation “a bone screw configured to secure the interbody implant to a bone” renders the claim vague and indefinite because it is unclear what the bone is. It is suggested that Applicant recite “a bone screw configured to secure the interbody implant to bone of adjacent vertebral bodies” in order to clarify the placement of the bone screw with respect to the interbody implant which is placed in disc space between adjacent vertebral bodies.
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.
As interpreted in light of the rejection under 35 USC 112(b), claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-14 of U.S. Patent No. 12138180.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claims of the present application and the patented claims is that patented claims include more elements and are thus more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the claims of the present 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 the claims of the present application are anticipated by the patented claims, they are not patentably distinct from the patented claims.
As interpreted in light of the rejection under 35 USC 112(b), claims 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-9 of U.S. Patent No. 12138180 in view of McDonough et al. (US 10531960).
Patented claims 6-9 disclose all elements of the claimed invention except for an interbody implant wherein a bone screw with a head, for e.g. a spherical head, is received in a hole of the interbody implant wherein the head of the bone screw is seated in the hole such that a spherical surface of the head of the bone screw is in contact with a spherical surface of the hole when the interbody implant is implanted.
McDonough et al. disclose an interbody implant (10, Fig. 1) configured to be positioned between adjacent vertebral bodies wherein bone screws 70 are configured to secure the interbody implant to an adjacent vertebral body wherein a bone screw 70 is received in a hole 40 of the interbody implant and a spherical head of screw 70 is seated on a spherical surface of hole 40 (col. 5, lines 18-67, col. 6 and col. 7, lines 1-45 and col. 8, lines 1-31).
It would have been obvious to one of ordinary skill in the art to have utilized the driver of the patented claims to secure an interbody implant, as taught by McDonough et al., in a cervical region of the spine where space is limited.
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 1-2 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over DeFalco et al. (US 9539043) in view of Bourlion et al. (US 20050119660 A1).
Regarding claims 1-2, 15 and 16, DeFalco et al. disclose a system (Fig. 1B) including: an interbody implant 26; a bone screw 28 configured to secure the interbody implant to adjacent vertebral bodies wherein a head of bone screw 28 is positioned on a surface of a screw hole 30; an insertion instrument (implant holder or positioner 16) for providing a trajectory for placement of the bone screw during implantation of the interbody implant by ensuring proper positioning of driver 10 relative to implant 26; and a driver 10 (Fig. 1) is configured to drive the bone screw into the bone until a desired torque is achieved, the driver including: a shaft extending between a distal end and a proximal end; a terminal member or handle 20 coupled to the shaft at the proximal end (col. 3, lines 23-67, col. 4, lines 1-39, col. 5 lines 38-55 and col. 6, lines 49-58).
Regarding claim 17, DeFalco et al. disclose inserting screw 28 into aperture 30 of implant 26 so that the screw is flush with the surface of the implant (interpreted to mean properly seated on a surface of the implant).
DeFalco et al. disclose all elements of the claimed invention except for a visual, audio, and touch (VAT) mechanism positioned between the proximal end and the distal end of the shaft, wherein the VAT mechanism is configured to indicate when the bone screw is set in the bone.
Bourlion et al. disclose providing an electronic card (VAT mechanism) that can be attached by a surgeon to a screw driver to monitor progressive penetration of the screw attached to the screw driver (paras [0033], [0118] and [00119]).
It would have been obvious to one of ordinary skill in the art to have provided the VAT mechanism of Bourlion et al., on the drive shaft of DeFalco et al., to provide visual, audible and tactile indicators that the screw has been properly installed (seated on a surface of the implant).
Claims 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over DeFalco et al. (US 9539043) and Bourlion et al. (US 20050119660 A1) further in view of McDonough et al. (US 10531960).
The combination of DeFalco et al. and Bourlion et al. discloses all elements of the claimed invention, as previously discussed for claim 16, except for the screw holes in the interbody implant to have a spherical surface.
McDonough et al. disclose holes 40 in an interbody implant to have a spherical interior surface and the head of the bone screw, used to fix the interbody implant, to have a spherical surface to enable angulation of the screw with respect to implant to enable selected of a variety of trajectory angles to enable the implant to settle during healing (col. 7, lines 11-29, col. 8, lines 21-31).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the holes of DeFalco et al. with a spherical surface and screws with a spherical head to enable placement of the screws along a surgeon-selected trajectory,
Claims 1-2, 9-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shaolin et al. (US 7083621 B2) in view of Bourlion et al. (US 20050119660 A1).
Regarding claim 1, Shaolin et al. disclose a driver 150 (Fig. 2) for implanting a bone screw, the driver including: a shaft (152, 154) extending between a distal end and a proximal end; a handle (torque applicator connected to the hexagonal proximal end 158) coupled to the shaft at the proximal end.
Regarding claims 9, 13 and 14, Shaolin et al. disclose a driver tip (distal end of 152, Fig. 2C) at the configured to engage the bone screw; a driver tip (projections 156, Fig. 2A) at the distal end of the shaft, the driver tip being configured to engage the bone screw; a set screw driver (Fig. 2A, 158) disposed within the driver tip and configured to engage a set screw 106 disposed within the bone screw; and a first rotational grip (hexagonal proximal end 158) and a second rotational grip (hexagonal proximal end 156) disposed at the proximal end of the shaft, wherein the first rotational grip is configured to rotate the driver tip and the second rotational grip is configured to rotate the set screw driver (Figs. 2, 2A-2C, 26-31, col. 5, lines 25-67, col. 6, col. 7, lines 1-2, col. 17, lines 52-67 and col. 18, lines 1-8).
Regarding claim 10, the driver tip includes crenallations 156 configured to engage a complementary crenellated head of the bone screw (Fig. 2C, col. 8, lines 54-62).
Regarding claim 11, set screw driver is a hexabit driver (158, Fig. 2C) configured to engage a hex recess of the set screw 106.
Regarding claim 15, Shaolin et al. disclose an interbody implant including the driver of claim 1 and the bone screw (Figs. 1 and 31).
Shaolin et al. disclose all elements of the claimed invention except for a visual, audio, and touch (VAT) mechanism positioned between the proximal end and the distal end of the shaft, wherein the VAT mechanism is configured to indicate when the bone screw is set in the bone.
Bourlion et al. disclose providing an electronic card (VAT mechanism) that can be attached by a surgeon to a screw driver to monitor progressive penetration of the screw attached to the screw driver (paras [0033], [0118] and [00119]).
It would have been obvious to one of ordinary skill in the art to have provided the VAT mechanism of Bourlion et al., on the drive shaft of Shaolin et al. to provide visual, audible and tactile indicators that the screw has been properly installed (seated on a surface of the implant).
Allowable Subject Matter
Non application of prior art to claims 4-8, 12, 19 and 20 indicates allowable subject matter provided the double-patenting rejections and rejections under 35 USC 112(b) are overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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January 22, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775