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 .
Election/Restrictions
Applicant’s election without traverse of species 18 (Representative Fig. 18A) in the reply filed on March 18, 2026 is acknowledged. Claims 1-18 have been examined on the merits in this office action.
Claim Objections
Claim 5 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 2 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 12156817. This is a statutory double patenting rejection.
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, 3-13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-17 of U.S. Patent No. 12156817.
Patented claims 1, 3-13 and 15 include all of the elements of the claims of the present application. 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 the 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.
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 1-12, 14 and 16-18 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 claim 7, “the first and second holes” lack antecedent basis. It appears that this claim should depend on claim 2.
In claim 1, the recitation “..and the interior surface defining at least one through opening” renders the claim vague and indefinite because it is unclear whether this is the same as the previously recited “at least one through opening” or a different through opening. It is suggested that Applicant recite “..the interior surface defining the at least one through opening” to refer back to the previous recitation and provide 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) 1-5 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thalgott (US 6558424).
Regarding claim 1, Thalgott discloses an intervertebral implant (10, Fig. 1) for implantation in an intervertebral space between adjacent vertebrae, the implant including: a frame or ring member 40 having a body having a front or anterior side and a back or posterior side connected to the anterior side by left and right sides (curved portions) to enclose at least one through opening; a ramp member or spacer 20 configured to be snap-fit into the at least one through opening via a tongue 12 and groove 14, 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. (Figs. 1-3B, 4A, col. 4, lines 8-67 and cols. 5-9; see marked up Fig. 2 on the following page).
Regarding claims 2 and 5, the upper surface of the body 40 and the spacer 20 include a plurality of ridges or teeth or protrusions, and the protrusions of the body align with and match the protrusions of the spacer (marked up Fig. 2 on the following page).
Regarding claims 3 and 5, the spacer includes a side surface between the upper and lower surfaces and the side surface includes a tongue 12 and the inside wall of the body defining the through opening includes a groove or recess 14 for the snap fit configuration (col. 8, lines 38-67).
Regarding claim 4, Thalgott discloses both side surfaces of the spacer to include a tongue or ridge 12 (col. 8, lines 38-67).
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Regarding claim 10, Thalgott discloses the spacer to be made of allograft material (col. 9, lines 53-60).
Claim(s) 1, 4, 6, 10, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhattacharya et al. (US 8685099).
Regarding claims 1, 4 and 13, Bhattacharya et al. disclose intervertebral implant (Fig. 28) for implantation in an intervertebral space between adjacent vertebrae, the implant including: a frame or body 202 having an anterior side and a posterior side connected to the anterior side by left and right sides to enclose a plurality of through openings, the through openings through the body 202; and a plurality of spacers 200 each configured to be snap-fit into a corresponding 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 each spacer includes a side surface between the upper and lower surfaces and the side surface includes one of a ridge or recess and the corresponding through opening includes the other of the ridge or recess for the snap fit configuration (Fig. 28, col. 16, lines 59-67 and col. 17, lines 1-14).
Regarding claims 4 and 15, the ridge or protrusion of spacer 200 extends around the side surface of the spacer (Fig. 28).
Regarding claim 6, Bhattacharya et al. disclose more than one (which includes three) center portions or spacers received in a corresponding through opening (Fig. 28, col. 16, lines 59-67 and col. 17, lines 1-14).
Regarding claim 10, Bhattacharya et al. disclose the use of allograft to construct the spacer (col. 5, lines 65-67, col. 6 and col. 7, lines 1-13).
Claim(s) 1-3, 5, 7-9, 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 and a posterior 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 (see marked up Fig. 22 on the following page).
Regarding claim 2, the frame includes a first hole for receiving a first screw and a
second hole for receiving a second screw (see marked up Fig. 22 on the following page).
Regarding claims 3, 5 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 claim 7, each of the first and second holes 232H extends from the anterior side to the upper surface of the body (Fig. 23).
Regarding claims 8 and 17, the frame includes a third hole for receiving a third screw, and the third hole extends from the anterior side to a lower surface of the body (see marked up Fig. 22 above).
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) 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharya et al. (US 8685099) in view of Anderson et al. (US 6458158).
Bhattacharya et al. disclose all elements of the claimed invention (see previous discussion for claim 1) except for providing texture on the bone-contacting surfaces of the composite implant.
Anderson et al. disclose providing a texture in the form of protrusions on the bone-contacting surfaces of an implant (Figs. 2, 6, 27 and 28, col. 15, lines 53-65).
Therefore, it would have been recognized by one of ordinary skill in the art that applying the known technique of providing a texture, taught by Anderson et al., to the Bhattacharya et al. implant would have yielded the predictable result of engagement of the implant to adjacent bone due to increased friction.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Thalgott (US 6558424) in view of Hanson et al. (US 7018416).
Thalgott discloses the spacer to be made from a variety of materials that are bio-compatible and suitable for medical applications (col. 9, lines 53-60).
Thalgott discloses all elements of the claimed invention except for the spacer to be made of PEEK.
Hanson et al. disclose the use of synthetic materials including PEEK suitable for use in an orthopedic implant (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 biocompatible synthetic material such as PEEK to construct the Thalgott 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 and components thereof biocompatible.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharya et al. (US 8685099) in view of Hanson et al. (US 7018416).
Bhattacharya et al. disclose all elements of the claimed invention except for the spacer to be made of PEEK.
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 biocompatible synthetic material such as PEEK to construct the Bhattacharya 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 and components thereof biocompatible.
Claim(s) 9 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.
Allowable Subject Matter
Non application of prior art to claim 16 indicates allowable subject matter provided the double-patenting rejections and rejections under 35 USC 112(b) made in this office action are overcome.
Reasons for indicating allowable subject matter: the closest prior art cited in the attached PTO-892 and in related parent applications cite some features of Applicant’s claimed invention, either singly or in combination, as discussed in this office action. However, no references or a reasonable combination thereof, could be found which disclose all the elements of Applicant’s claimed invention.
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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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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March 27, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775