DETAILED ACTION
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 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12156817 in view of Iott et al. (US 20140039623 A1).
The patented claim includes all elements of pending claim except for: a first anti-backout lock disposed on the anterior side between the first and third holes and adapted to prevent a backout of the first and third bone screw after insertion; and a second anti-backout lock disposed on the anterior side between the second and third holes and adapted to prevent backout of the second and third bone screw after insertion.
Iott et al. disclose blocking screws between first and third holes and second and third holes, respectively, to prevent backout of screws placed in the respective holes (Figs. 22-28 and paras [0083]-[0087]).
It would have been obvious to one of ordinary skill in the art to have provided blocking screws or anti-backout locks, as taught by Iott et al., in the implant of the patented claim to prevent backout of screws placed in the first and third holes, and the second and third holes, respectively.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1,3-4 and 6-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 1 and 13, the recitation “a plate having a frame…” seeks to introduce new matter. Applicant’s disclosure, as originally filed, does not describe a plate having a frame. Applicant’s disclosure refers to endplates which are portions of the implant interacting with upper and lower vertebral bodies.
In claim 7, the recitation “each of the second and third holes extends from the anterior side to the upper surface of the body” in combination with the amendment to claim 1 “..a second hole shaped to receive a bone screw in an upward direction for insertion into an upper vertebral body.” seeks to introduce new matter.
In claim 8, the recitation “..the third hole extends from the anterior side to a lower surface of the body” in combination with the amendment to claim 1 “..a second hole shaped to receive a bone screw in an upward direction for insertion into an upper vertebral body.” seeks to introduce new matter.
Regarding claims 7 and 8, Applicant’s disclosure, as originally filed, discloses openings that are angled to receive screws and the drawings show two openings angled downward and one opening angled upward.
Appropriate correction is required.
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, 3-4 and 6-19 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 13, the recitation “a plate having a frame…” renders the claim vague and indefinite because it is unclear what structure or relationship thereof is being claimed by the Applicant. The elected species (Fig. 18) does not describe a plate. Applicant’s disclosure refers to endplates which are portions of the implant interacting with upper and lower vertebral bodies. For examination, it is assumed that Applicant intended to recite a frame defined by opposing endplate portions, each endplate portion configured to engage opposing vertebral bodies.
In claim 12, the third hole lacks antecedent basis. While claim 1 recites a plurality of openings implying two or more, claim 12 does not recite an additional third hole to provide antecedent basis. It is suggested that the claim be amended in the same manner as claim 7.
In claim 19, the recitation “…the first and third holes..” and “…the second and third holes..” lacks antecedent basis.
Appropriate correction is required.
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.
Claim(s) 1, 3, 9, 11-12, 14, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iott et al. (US 20140039623 A1).
Regarding claim 1, Iott et al. disclose an intervertebral implant for implantation in an intervertebral space between adjacent vertebrae, the implant including: a frame (400H, Fig. 22) including a body having an anterior side (front side) and a posterior side (rear side opposite the front side) connected to the anterior side by left and right sides, the body having an interior surface defining at least one through opening; at least one spacer configured to be snap-fit into the at least one through opening, an upper surface of the spacer and an upper surface of the body forming an upper surface of the implant configured to be in contact with an endplate of an upper vertebral body, wherein the spacer includes a side surface between the upper and lower surfaces and the side surface includes one of a ridge or recess and the interior surface defining at least one through opening includes a side surface including the other of the ridge or recess for the snap fit configuration; and a hole or first hole that extends from the anterior side to a first side of the joint (upward direction Fig. 22) and a hole or second hole that extends from the anterior side to a second side of the joint (downward direction, Fig. 23).
Regarding claims 3 and 14, the upper surface of the body and the spacer include a plurality of protrusions, and the protrusions of the body aligns with and matches the protrusions of the spacer (assembled configuration in Fig. 23, shows teeth or protrusions 222 on edges 418 which align with teeth 222 on spacer 200H, para [0085]).
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Regarding claims 9 and 18, the spacer body and the frame are fabricated from PEEK (para [0055]).
Regarding claim 11, an anti-backout lock or screw 106H is disposed on the anterior side for preventing backout of the first bone screw after insertion (see marked up Fig. 22 above and para [0087]).
Regarding claim 12, a first anti-backout screw or lock 106H is disposed on the anterior side between the first and third holes and adapted to prevent a backout of the first and third bone screw after insertion; and a second anti-backout screw or lock is disposed on the anterior side between the second and third holes and adapted to prevent a backout of the second and third bone screw after insertion (see marked up Fig. 22 above and para [0087]).
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.
Claim(s) 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Iott et al. (US 20140039623 A1) in view of Wing et al. (US 20090192613 A1).
Iott et al. disclose all elements of the claimed invention except for: (1) providing a third hole which extends from the anterior side to the upper surface of the body; and (2) providing a third hole that extends from the anterior side to a lower surface of the body.
Wing et al. disclose fastener holes or openings on the anterior side of an implant wherein the cross sectional shape of the openings allows for translation and pivoting of the screws wherein screws are placed either downward or upward orientation to provide greater resistance to translation of the screws during subsidence (Figs. 1 and para [0056]).
It would have been obvious to one of ordinary skill in the art to have angled the openings in the Iott et al. implant, as taught by Wing et al. to provide greater resistance to translation of screws.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Iott et al. (US 20140039623 A1) in view of Hanson et al. (US 7018416).
Iott et al. disclose all elements of the claimed invention except for the use of allograft to construct the implant.
Hanson et al. disclose the use of natural and synthetic materials or a combination of natural and synthetic materials to make an orthopedic implant wherein natural materials include allograft and synthetic materials include PEEK (col. 4, lines 1-67 and col. 5, lines 1-6).
Therefore, it would have been obvious to one of ordinary skill in the art to have utilized a natural material such as allograft to construct the Iott et al. spacer, as taught by Hanson et al., since this amounts to simple substitution of one known material for another for the predictable result of making an implant or components thereof biocompatible.
Response to Arguments
Applicant's arguments have been fully considered by the Examiner but are not found to be persuasive with respect to the rejections under 35 U.S.C. 102(a)(1) over Iott et al., as discussed in this office action.
New grounds of rejection have been made in this office action.
Non application of prior art to claims 4, 6, 13, 15, 16 and 19 indicates allowable subject matter provided the rejections made in this office action are overcome.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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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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August 3, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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