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
Claim 69 is objected to because of the following informalities:
Claim 69, line 11: --the-- should be added between “of” and “interbody”.
Claim 69, line 12: “a” (between “along” and “length”) should be changed to --the--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: complementary retention feature in claim 69; retention feature in claim 69; and engagement features in claim 72.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 69-74 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 69 recites the limitation "the length" in line 11. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 69-74 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Blain et al., U.S. PG-Pub 2009/0012529.
Regarding claim 69, Blain et al. discloses an implant comprising: a cervical plate (2) comprising a complementary retention feature (12), an interbody spacer (4) comprising a threaded lumen (14) (Figs. 3A-3C and paragraph [0031] discloses member 32, which engages with lumen 14, having a complementary mechanical interfit such as a threaded lock; therefore, it’s understood lumen 14 is threaded), wherein the cervical plate and the interbody space are configured for combined coupling to an interbody implant inserter, wherein the implant inserter comprises a retention feature configured to couple with the complementary retention feature of the cervical plate, wherein the interbody implant inserter comprises a threaded portion configured to couple with the threaded lumen of the interbody spacer, wherein the interbody spacer is configured to be inserted into a disc space when the cervical plate and the interbody spacer are coupled to the interbody implant inserter and the cervical plate is spaced apart from the interbody spacer along a length of the interbody implant inserter, wherein the cervical plate is configured to translate along the length of the interbody implant inserter when coupled to the interbody implant inserter toward the interbody spacer inserter in the disc space (Figs. 1A-1B).
Regarding claim 70, Blain et al. discloses wherein the interbody spacer (4) comprises two guide lumens (both 16) diametrically opposed to the threaded lumen (14) (Fig. 1A).
Regarding claim 71, Blain et al. discloses wherein the interbody implant inserter comprises two projections configured to couple with the two guide lumens as such limitations of the interbody implant inserter merely further define the functional language of claim 69, i.e. “configured for combined coupling to an interbody implant inserter.
Regarding claim 72, Blain et al. discloses wherein the interbody spacer (4) comprises engagement features (both 16) configured to allow insertion of the interbody spacer in one direction but resist movement in the opposite direction (Fig. 1A).
Regarding claims 73 and 74, Blain et al. discloses wherein the cervical plate (2) comprises a concavity (surface 8 is concave) to accept the interbody spacer (4) at least partially therewithin (Fig. 3B); and wherein the cervical plate is configured to extend at least partially around a corner or edge of adjacent vertebrae (via superior and inferior portions of cervical plate having openings 10) (Figs. 1A-1B).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 75-81 and 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blain et al., U.S. PG-Pub 2009/0012529 in view of Walkenhorst et al., U.S. PG-Pub 2016/0324657.
Regarding claims 75-81 and 83, Blain et al. discloses an implant comprising: an anchor; a cervical plate (2) comprising a hole (either of inferior holes 10) configured to receive the anchor and a ledge disposed within the tool, an interbody spacer (4) comprising a convex portion (front surface 18), wherein the cervical plate and the interbody spacer are configured for combined coupling to an interbody implant inserter, wherein the spacer is configured for insertion within a disc space region; wherein the cervical plate (2) comprises a concave portion (rear surface 8), wherein the concave portion of the cervical plate and the convex portion (front face 18) of the interbody spacer (4) are configured to mate; and an anchor configured to be recessed in the cervical plate (Figs. 1A, 1B and 3B and paragraph [0021]).
Blain et al. does not disclose wherein the ledge extends below the convex portion of the interbody spacer when the cervical plate is within the disc space region to position the anchor to extend into a corner of a vertebra; wherein the interbody spacer comprises a cutout configured to allow a portion of the cervical plate to extend into the disc space region and wherein the hole aligns with the cutout such that the interbody spacer does not obstruct a trajectory of an anchor; wherein the hole comprises a portion directly over the interbody spacer when the interbody spacer is disposed within the disc space region; wherein the ledge of the hole rests on the convex portion of the interbody spacer when the interbody spacer is disposed within the disc space region; the anchor having a head configured to be recessed in the cervical plate when the head of the anchor abuts the ledge; and wherein the ledge extends to a bone facing surface of the cervical plate.
Walkenhorst et al. discloses an implant having a plate (200) with a hole (either of inferior holes 208) and ledge disposed in the hole (via extension portion 212) that extends to a bone face surface (202) of the plate (Figs. 6-7), an interbody spacer (52) having a cutout (either of inferior cutouts 144) that aligns with the hole such that the hole has a portion directly over the interbody spacer with the ledge resting in the cutout, and an anchor (236) with a head (238) that is recessed in the hole and abuts the ledge to permit the implant be low profile when assembled (Figs. 5, 9 and 13 and paragraph [0062]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Blain et al. such that the ledge extends below the convex portion of the interbody spacer when the cervical plate is within the disc space region to position the anchor to extend into a corner of a vertebra; wherein the interbody spacer comprises a cutout configured to allow a portion of the cervical plate to extend into the disc space region and wherein the hole aligns with the cutout such that the interbody spacer does not obstruct a trajectory of an anchor; wherein the hole comprises a portion directly over the interbody spacer when the interbody spacer is disposed within the disc space region; wherein the ledge of the hole rests on the convex portion of the interbody spacer when the interbody spacer is disposed within the disc space region; the anchor having a head configured to be recessed in the cervical plate when the head of the anchor abuts the ledge; and wherein the ledge extends to a bone facing surface of the cervical plate in view of Walkenhorst et al. to permit the implant be more low profile upon insertion within a patient.
Claim(s) 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blain et al., U.S. PG-Pub 2009/0012529 in view of Walkenhorst et al., U.S. PG-Pub 2016/0324657 as applied to claim 81 above, and further in view of Fraser, U.S. Patent 6,432,106.
Regarding claim 82, Blain et al. in view of Walkenhorst et al. discloses the invention essentially as claimed except for wherein the ledge comprises an anchor insertion angle between 30 degrees and 40 degrees.
Fraser discloses an implant having holes with at angle alpha that can range from 15-60 degrees determined on a particular situation and a patient’s anatomy (Fig. 3 and Col. 3 lines 21-30).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hole of Blain et al. such that the ledge has a anchor insertion angle between 30 degrees and 40 degrees further in view of Fraser to permit suitability based upon a particular situation and a patient’s anatomy.
Claim(s) 84-88 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blain et al., U.S. PG-Pub 2009/0012529 in view of Fraser, U.S. Patent 6,432,106 and Blain et al., U.S. Patent 8,100,955.
Regarding claims 84-88, Blain et al. (2009/0012529) discloses an implant comprising: a cervical plate (2) comprising a hole (10); an interbody spacer (4) uncoupled from the cervical plate; and an anchor configured to be inserted into the hole, wherein the anchor is configured to be inserted into a vertebra while the cervical plate and the interbody spacer are coupled to an interbody implant inserter; wherein the hole is configured to allow the anchor to maintain a constant trajectory from an access surface to a bone facing surface of the cervical plate (Fig. 1 and paragraph [0021]).
Blain et al. does not disclose the anchor at a high angle screw insertion between 15 degrees and 35 degrees.
Fraser discloses an implant having holes with at angle alpha that can range from 15-60 degrees determined on a particular situation and a patient’s anatomy (Fig. 3 and Col. 3 lines 21-30).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hole of Blain et al. such that the anchor is configured to be inserted into the hole at a high angle screw insertion between 15 degrees and 35 degrees in view of Fraser to permit suitability based upon a particular situation and a patient’s anatomy.
Blain et al. also does not disclose a secondary anchor, wherein the anchor comprises a corresponding indentation configured to accept the secondary anchor; a retainer ring positioned to resist backout of the anchor; wherein the retainer ring is configured to resist backout of the anchor; and wherein the secondary anchor is configured to expand a retainer ring.
Blain et al. (8,100,955) discloses an implant comprising: a cervical plate (102) comprising a hole (112), an interbody spacer (114) (Figs. 5A, 26A), an anchor (330) configured to be inserted into the hole, a secondary anchor (332), wherein the anchor comprises a corresponding indentation (334) configured to accept the secondary anchor; a retainer ring (338) positioned relative to the secondary anchor (332), wherein the retainer ring is configured to resist backout of the anchor (336), and the second anchor is configured to expand the retainer ring (Figs. 29A-29B and Col. 34 line 63-Col. 35 line 27) to thereby prevent or resist backout of the anchor (Col. 35 lines 35-38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Blain et al. (2009/0012529) to include a secondary anchor and such that the anchor comprises a corresponding indentation configured to accept the secondary anchor; a retainer ring positioned to resist backout of the anchor; wherein the retainer ring is configured to resist backout of the anchor; and wherein the secondary anchor is configured to expand a retainer ring in view of Blain et al. (8,100,955) to permit preventing or resisting backout of the anchor from the cervical plate.
Response to Arguments
Applicant’s arguments, see Remarks, filed 20 August 2026, with respect to the objection of claim 73 have been fully considered and are persuasive. The objection of claim 73 has been withdrawn.
Applicant's arguments filed 20 August 2026, regarding the interpretation of complementary retention feature, retention feature and engagement feature in claims 69 and claim 72 have been fully considered but they are not persuasive. Applicant has not provided any specific argument with respect to the interpretations; therefore, they are being maintained.
Applicant’s arguments, see Remarks, filed 20 August 2026, with respect to the rejection of claim 78 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 78 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed 20 August 2026, regarding the rejection of claim 69 under 35 U.S.C. 102(a)(1) and 102(a)(2) have been fully considered but they are not persuasive. Applicant amended claim 69, but did not provide any specific arguments as to why the prior art does not disclose the new limitations.
Regardless, the new limitations regarding the cervical plate and interbody spacer with respect to the “interbody implant inserter” are functional/intended use limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
For such reasons, claim 69 still stands rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as set forth above.
Applicant's arguments filed 20 August 2026, regarding the rejection of claim 75 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant amended claim 75, but did not provide any specific arguments as to why the prior art does not disclose the new limitations.
Regardless, Blain et al. discloses an anchor in paragraph [0021] (i.e. “screws or other fasteners”).
Furthermore, the other newly added limitations are functional/intended use recitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
For such reasons, claim 75 still stands rejection under 35 U.S.C. 103.
Applicant’s arguments with respect to claim(s) 84 have been considered but are moot because of the new ground of rejection.
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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, 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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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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