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 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: anti-backout device in claims 37 and 38.
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 § 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) 25-36 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al., U.S. Patent 8,740,983 in view of Gorek et al. U.S. PG-Pub 2011/0230918.
Regarding claims 25-36, Arnold et al. discloses an implant comprises a body (110) defining a central opening (130); said body includes a top side (112), a bottom side (114), a front side (118), a back side (120), a left side and a right side (both 116); said top side and bottom sides are spaced from one another; said front side and back side are spaced from one another; said front side and said back side are positioned between said top side and bottom side; said top side and bottom side at least partially defines said central opening; a majority of said front side and said back side lie in a flat plane that are parallel to one another; a majority of said left side and said right side lie in a flat plane; said front side includes first (122), second (124) and third (also 122) openings; saif first second and third openings are located on a flat plane portion of said front side; said second opening is positioned between said first and third openings; said first opening provides access to a first primary screw opening that is configured to receive a screw; said second opening provided access to a second primary screw opening that is configured to receive a screw; said third opening provided access to a third primary screw opening that is configured to receive a screw; said first primary screw opening extends along an axis from said first opening to said bottom side; said second primary screw opening extends along an axis from said second opening to said top side; said third primary screw opening extends along an axis from said third opening to said bottom side (Figs. 1, 2, 9 and examiner annotated Figs. 3-4 below);
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wherein said axis of said first primary screw opening and said third primary screw opening are non-parallel to one another; said axis of said second primary screw opening is non-parallel to said axis of said first primary screw opening and said third primary screw opening (examiner annotated Fig. 9 below);
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wherein a height of said front side (118) is greater than a height of said back side (120); said top side (1120 lies in a top side plane; said bottom side (114) lies in a bottom side plane; said top side plane and said bottom side plane are non-parallel to one another (Fig. 3 and Col. 5 lines 3-9); and wherein said first (122), second (124) and third (also 122) openings are spaced from one another (Fig. 1).
Arnold et al. does not disclose wherein the first opening further provides access to a first secondary screw opening that is configured to receive a screw, and wherein said first secondary screw opening extends along an axis from said first opening to said top side; wherein said third opening provided access to a third secondary screw opening that is configured to receive a screw, and wherein said third secondary screw opening extends along an axis from said third opening to said top side; and wherein said second opening further provides access to a second secondary screw opening that is configured to receive a screw, and wherein said second secondary screw opening extends along an axis from said second opening to said bottom side; the openings positioned along different axes.
Gorek et al. discloses an implant having a front side with openings (312, 314) that both provide access to first primary screw openings (top openings 322) and secondary screw openings (bottom openings 322), each configured to receive a screw along an axis that goes from each opening to top and bottom sides (each 320) (Figs. 5A-5B) as such provides an improved angle for insertion of the screws therethrough (paragraph [0053]).
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 first, second and third openings of Arnold et al. such that the first opening further provides access to a first secondary screw opening that is configured to receive a screw, and wherein said first secondary screw opening extends along an axis from said first opening to said top side; wherein said third opening provided access to a third secondary screw opening that is configured to receive a screw, and wherein said third secondary screw opening extends along an axis from said third opening to said top side; and wherein said second opening further provides access to a second secondary screw opening that is configured to receive a screw, and wherein said second secondary screw opening extends along an axis from said second opening to said bottom side such that the openings are positioned along different axes in view of Gorek et al. to permit providing an improved angle for insertion of the screws therethrough and to provide additional fixation to help further prevent inadvertent removal from a disc space.
Regarding claim 39, Arnold et al. discloses wherein said body (110) is at least partially formed of polyether ether ketone “PEEK” (Col. 4 lines 14-20).
Claim(s) 37, 38 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al., U.S. Patent 8,740,983 in view of Gorek et al. U.S. PG-Pub 2011/0230918 as applied above, and further in view of Gray et al., U.S. Patent 10,034,768.
Regarding claims 37 and 38, Arnold et al. discloses the invention essentially as claimed except for further comprising first and second anti-backout devices that are configured to be coupled to said front side of said body, said first anti-backout device is configured to be positionable to cover a portion of said first opening, and said second anti-backout device is configured to be positionable to cover a portion of said third opening.
Gray et al. discloses an implant having first and second anti-backout devices (44 and 46) coupled to a front side of the implant configured to be positionable to cover a portion of multiple openings (Fig. 1) to block one or more fixation members from backing out (Col. 4 lines 55-57).
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 Arnold et al. to include first and second anti-backout devices that are configured to be coupled to said front side of said body, said first anti-backout device is configured to be positionable to cover a portion of said first opening, and said second anti-backout device is configured to be positionable to cover a portion of said third opening further in view of Gray et al. to permit retaining the screws disposed within the implant and preventing them from backing out after implantation.
Regarding claim 40, Arnold et al. discloses wherein said body (110) is at least partially formed of polyether ether ketone “PEEK” (Col. 4 lines 14-20).
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al., U.S. Patent 8,740,983 in view of Gorek et al. U.S. PG-Pub 2011/0230918 as applied above, and further in view of Ullrich, Jr. et al., U.S. Patent 10,687,956.
Regarding claim 41, Arnold et al. discloses the invention essentially as claimed except for wherein said body includes a plurality of micro-apertures and a plurality of macro-apertures; each of said micro-apertures has an average size of 2-10 micrometers; each of said macro-apertures has an average size of 300-800 micrometers.
Ullrich, Jr. et al. discloses an implant body defining a plurality of micro-apertures and macro-apertures with varying micrometer sizing that are capable of facilitating bone growth (claim 15).
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 body of Arnold et al. to include a plurality of micro-apertures and a plurality of macro-apertures; each of said micro-apertures has an average size of 2-10 micrometers; each of said macro-apertures has an average size of 300-800 micrometers further in view of Ullrich, Jr. et al. to permit facilitation of bone growth within the implant.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al., U.S. Patent 8,740,983 in view of Gorek et al. U.S. PG-Pub 2011/0230918 and Gray et al., U.S. Patent 10,034,768 as applied above, and further in view of Ullrich, Jr. et al., U.S. Patent 10,687,956.
Regarding claim 42, Arnold et al. discloses the invention essentially as claimed except for wherein said body includes a plurality of micro-apertures and a plurality of macro-apertures; each of said micro-apertures has an average size of 2-10 micrometers; each of said macro-apertures has an average size of 300-800 micrometers.
Ullrich, Jr. et al. discloses an implant body defining a plurality of micro-apertures and macro-apertures with varying micrometer sizing that are capable of facilitating bone growth (claim 15).
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 body of Arnold et al. to include a plurality of micro-apertures and a plurality of macro-apertures; each of said micro-apertures has an average size of 2-10 micrometers; each of said macro-apertures has an average size of 300-800 micrometers further in view of Ullrich, Jr. et al. to permit facilitation of bone growth within the implant.
Response to Arguments
Applicant’s arguments, see Remarks, filed 17 August 2026, with respect to the objection of claim 25 have been fully considered and are persuasive. The objection of claim 25 has been withdrawn.
Applicant’s arguments, see Remarks, filed 17 August 2026, with respect to the rejection of claim 25 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 25 under 35 U.S.C. 112(b) has been withdrawn.
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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