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 .
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 23-25 of U.S. Patent No. 11,497,614 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claim 1 recites all of the elements of independent claim 1 of the patent. The difference between independent claim 1 of the application and independent claim 1 of the patent lies in the fact that the patent claim further recites “a through hole extending through the first endplate, the coupling member, and the second endplate” (see col.19, ll.65-67 of the patent). Thus, the invention of claim 1 of the patent is in affect a “species of the generic” invention of claim 1 of the 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 1 of the application is anticipated by respective claim 1 of the patent, they are not patentably distinct from each other.
Furthermore, dependent claims 2-14 of the application recite all of the elements of dependent claims 2-15 of the patent.
Claim 2 of the patent recites “wherein the at least two horizonal members further comprise: a posterior portion coupled to and extending between the first endplate and the second endplate; a first lateral side coupled to and extending between the first endplate and the second endplate, and wherein the first lateral side is coupled to the posterior portion along a length of the first lateral side and posterior portion; and a second lateral side coupled to and extending between the first endplate and the second endplate, and wherein the second lateral side is coupled to the posterior portion along a length of the second lateral side and posterior portion”, thus reciting all of the elements of claim 2 of the application.
Claim 3 of the patent recites “wherein the first lateral side and the second lateral side extend away from the posterior portion towards an anterior side of the interbody spacer”, thus reciting all of the elements of claim 3 of the application.
Claim 4 of the patent recites “wherein each of the first lateral side and the second lateral side comprise a free end”, thus reciting all of the elements of claim 4 of the application.
Claim 5 of the patent recites “wherein the free ends are curved between the first endplate and the second endplate”, thus reciting all of the elements of claim 5 of the application.
Claim 6 of the patent recites “wherein the free ends are planar between the first endplate and the second endplate”, thus reciting all of the elements of claim 6 of the application.
Claim 8 of the patent (including all of the elements of claim 7 from which claim 8 depends from) recites “wherein the coupling member further comprises: at least one longitudinal member connecting adjacent lateral members; wherein the first endplate further comprises: at least one first aperture extending through the first endplate from a top surface to a bottom surface, and wherein the second endplate further comprises: at least one second aperture extending through the second endplate from a top surface to a bottom surface”, thus reciting all of the elements of claim 7 of the application.
Claim 9 of the patent recites “wherein the lateral members extend across an anterior side of the interbody spacer, down a first lateral side of the interbody spacer, across a posterior side of the interbody spacer, and down a second lateral side of the interbody spacer forming a square shaped lateral member”, thus reciting all of the elements of claim 8 of the application.
Claim 10 of the patent recites “further comprising: at least one pore positioned adjacent to the at least one lateral member and extending into the interbody spacer from an exterior surface”, thus reciting all of the elements of claim 9 of the application.
Claim 11 of the patent recites “further comprising: at least one tab positioned perpendicular to at least one of the first endplate and the second endplate”, thus reciting all of the elements of claim 10 of the application.
Claim 12 of the patent recites “wherein the at least one tab is two tabs, and wherein a first tab is coupled to and extends away from the first endplate and a second tab is coupled to and extends away from the second endplate”, thus reciting all of the elements of claim 11 of the application.
Claim 13 of the patent recites “wherein at least one of the first endplate and the second endplate further comprise: at least one aperture extending through at least one of the first endplate and the second endplate from an interior surface to an exterior surface”, thus reciting all of the elements of claim 12 of the application.
Claim 14 of the patent recites “wherein the at least one gap is formed by a first surface and a second surface, and wherein the first surface and the second surface extend parallel to each other”, thus reciting all of the elements of claim 13 of the application.
Claim 15 of the patent recites “wherein the at least one gap is formed by a first surface and a second surface, and wherein the first surface and the second surface diverge from each other as the first surface and the second surface extend from a posterior surface of the interbody spacer to an anterior surface of the interbody spacer”, thus reciting all of the elements of claim 14 of the application.
Independent claim 15 recites all of the elements of independent claim 16 of the patent. The difference between independent claim 15 of the application and independent claim 16 of the patent lies in the fact that the patent claim further recites “a through hole extending from a superior surface of the first endplate, through the coupling member, to an inferior surface of the second endplate” (see col.21, ll.27-29 of the patent). Thus, the invention of claim 16 of the patent is in affect a “species of the generic” invention of claim 15 of the 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 15 of the application is anticipated by respective claim 16 of the patent, they are not patentably distinct from each other.
Furthermore, dependent claims 16 and 17 of the application recite all of the elements of dependent claims 17 and 18 of the patent.
Claim 17 of the patent recites “wherein the coupling member further comprises: an opening extending into a central portion of the interbody spacer and positioned between the at least one first longitudinal member and the at least one second longitudinal member”, thus reciting all of the elements of claim 16 of the application.
Claim 18 of the patent recites “wherein the coupling member further comprises: at least one channel extending into the interbody spacer between the at least one first longitudinal member and the at least one second longitudinal member”, thus reciting all of the elements of claim 17 of the application.
Independent claim 18 recites all of the elements of independent claim 23 of the patent. The difference between independent claim 18 of the application and independent claim 23 of the patent lies in the fact that the patent claim further recites “wherein the interbody spacer comprises a through hole extending through the first cage, the at least one intermediate cage, and the second cage” (see col.22, ll.38-40 of the patent). Thus, the invention of claim 23 of the patent is in affect a “species of the generic” invention of claim 18 of the 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 18 of the application is anticipated by respective claim 23 of the patent, they are not patentably distinct from each other.
Furthermore, dependent claims 19 and 20 of the application recite all of the elements of dependent claims 24 and 25 of the patent.
Claim 24 of the patent recites “inserting bone graft material into the interbody spacer after insertion of the interbody spacer into the patient”, thus reciting all of the elements of claim 19 of the application.
Claim 25 of the patent recites “inserting bone graft material into the interbody spacer before insertion into the patient”, thus reciting all of the elements of claim 20 of the application.
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 2, 8 and 9 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 2 recites the limitation "the at least two horizontal members" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the at least two horizontal members” will be interpreted as “the at least two lateral members”.
Claim 8 recites the limitation "the lateral members" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the lateral members” will be interpreted as “the at least two lateral members”.
Claim 9 recites the limitation "the at least one lateral member" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the at least one lateral member” will be interpreted as “the at least two lateral members”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-8 and 10-20, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trescony et al. (U.S. Publication No.2012/0277748 A1; hereinafter “Trescony”).
Regarding claim 1, Trescony discloses an interbody spacer, comprising: a first endplate (see first end portion 112 in Figure 2); a second endplate (see second end portion 122 in Figure 2); and a coupling member (see Figure 2C) coupled to and extending between the first endplate and the second endplate, wherein the coupling member comprises: at least two lateral members; and at least one gap formed between every two adjacent lateral members of the at least two lateral members (see annotated Figure 2C below).
Regarding claim 2, Trescony further discloses wherein the at least two lateral members further comprise: a posterior portion coupled to and extending between the first endplate and the second endplate (see annotated Figure 2C below); a first lateral side coupled to and extending between the first endplate and the second endplate, and wherein the first lateral side is coupled to the posterior portion along a length of the first lateral side and posterior portion (see annotated Figures 2A and 2C below); and a second lateral side coupled to and extending between the first endplate and the second endplate, and wherein the second lateral side is coupled to the posterior portion along a length of the second lateral side and posterior portion (see annotated Figures 2A and 2C below).
Regarding claim 3, Trescony further discloses wherein the first lateral side and the second lateral side extend away from the posterior portion towards an anterior side of the interbody spacer (see Figures 2A and 2C below).
Regarding claims 4-6, Trescony further discloses wherein each of the first lateral side and the second lateral side comprise a free end (at a posterior portion and an anterior side as shown in annotated Figure 2C below), wherein the free ends are curved between the first endplate and the second endplate (see the embodiment shown in Figure 2G), or wherein the free ends are planar between the first endplate and the second endplate (see embodiment shown in Figure 2C).
Regarding claim 7, Trescony further discloses wherein the coupling member further comprises: at least one longitudinal member connecting adjacent lateral members (see segments 140 and 160 in Figure 2), wherein the first endplate further comprises at least one first aperture extending through the first endplate from a top surface to a bottom surface (see first fastener hole 110 in Figure 2), and wherein the second endplate further comprises at least one second aperture extending through the second endplate from a top surface to a bottom surface (see second fastener hole 120 in Figure 2).
Regarding claim 8, Trescony further discloses wherein the at least two lateral members extend across an anterior side of the interbody spacer (see reference numeral 140 in Figure 2C), down a first lateral side of the interbody spacer (Figure 2), across a posterior side of the interbody spacer (Figure 2C), and down a second lateral side of the interbody spacer forming a square shaped lateral member (see Figures 2A and 2C).
Regarding claim 10, Trescony further discloses at least one tab positioned perpendicular to at least one of the first endplate and the second endplate (see segments 140 and 160 in Figure 2).
Regarding claim 11, Trescony further discloses wherein the at least one tab is two tabs, and wherein a first tab is coupled to and extends away from the first endplate and a second tab is coupled to and extends away from the second endplate (see segments 140 and 160 in Figure 2).
Regarding claim 12, Trescony further discloses wherein at least one of the first endplate and the second endplate further comprise: at least one aperture extending through at least one of the first endplate and the second endplate from an interior surface to an exterior surface (see fastener holes 110 and 120 in Figure 2).
Regarding claim 13, Trescony further discloses wherein the at least one gap is formed by a first surface (near reference numeral 145 in Figure 2) and a second surface (above reference numeral 145 in Figure 2), and wherein the first surface and the second surface extend parallel to each other (see Figure 2).
Regarding claim 14, Trescony further discloses wherein the at least one gap is formed by a first surface (near reference numeral 145 in Figure 2) and a second surface (see surface perpendicular to reference numeral 145 in Figure 2), and wherein the first surface and the second surface diverge from each other as the first surface and the second surface extend from a posterior surface of the interbody spacer to an anterior surface of the interbody spacer (see Figure 2).
Regarding claim 15, Trescony discloses an interbody spacer, comprising: a first endplate (see first end portion 112 in Figure 2); a second endplate (see second end portion 122 in Figure 2); and a coupling member coupled to and extending between the first endplate and the second endplate (intermediary portion 150), wherein the coupling member comprises: a posterior member extending between the first endplate and the second endplate (segments 160); at least one first longitudinal member extending from the first endplate on an anterior side of the interbody spacer (a single segment 140); and at least one second longitudinal member extending from the second endplate on an anterior side of the interbody spacer (another segment 140).
Regarding claim 16, Trescony further discloses wherein the coupling member further comprises: an opening extending into a central portion of the interbody spacer and positioned between the at least one first longitudinal member and the at least one second longitudinal member (see gaps in annotated Figure 2C below).
Regarding claim 17, Trescony further discloses wherein the coupling member further comprises: at least one channel extending into the interbody spacer between the at least one first longitudinal member and the at least one second longitudinal member (see gaps in annotated Figure 2C below).
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Regarding claim 18, Trescony discloses a method for using an interbody spacer, comprising: obtaining the interbody spacer comprising: a first cage; a second cage; and at least one intermediate cage, wherein the at least one intermediate cage may be coupled to the first cage on a first end and the second cage on a second end; inserting the first cage and second cage into a patient between two vertebral bodies; and inserting the at least one intermediate cage between the first cage and the second cage (see annotated Figure 2C below).
Regarding claim 19, Trescony further discloses inserting bone graft material into the interbody spacer after insertion of the interbody spacer into the patient (para.0061).
Regarding claim 20, Trescony further discloses inserting bone graft material into the interbody spacer before insertion into the patient (insertion of interbody device 55, see para.0029).
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Allowable Subject Matter
Claim 9 is 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, and once the double patenting rejections and rejection under 35 U.S.C. 112(b) have been appropriately addressed.
Claim 9 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found to disclose, or suggest the claimed combination of limitation recited in independent claim 1 and dependent claim 8 (from which claim 9 depends from). In particular, none of the cited references teach or suggest at least one pore positioned adjacent to the at least two lateral members and extending into the interbody spacer from an exterior surface, as required by claim 9. Trescony (U.S. Publication No.2012/0277748 A1) discloses the claimed invention except for at least one pore that is positioned adjacent to the at least two lateral members.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sharifi-Mehr U.S. Patent No.8,753,399 B2
Melkent U.S. Patent No.8,092,533 B2
Overes et al. U.S. Publication No.2010/0152856 A1
Francis U.S. Publication No.2006/0247781 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773