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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 January 2026 has been entered.
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: driving mechanism in claims 90 and 96.
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) 90 and 93-99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al., U.S. PG-Pub 2015/0066145 in view of Seifert et al., U.S. PG-Pub 2018/0042732.
Regarding claims 90 and 93-99, Rogers et al. discloses an apparatus comprising an interbody fusion device (10) comprising a housing (12), a first wedge member (34, 38), a second wedge member (36, 40), a first drive shaft (42), and a second drive shaft (46) (Figs. 1 and 6), wherein the housing comprises a first shell member (14) and a second shell member (16) (Fig. 1), the first and second shell members engaging the first wedge member along a first lateral area of the housing (left side of the housing), and engaging the second wedge member along a second lateral area of the housing (right side of the housing) (Figs. 4 and 6), the first wedge member (34, 48) and the second wedge member (36, 40) are provided with a through opening (44) configured to allow the first drive shaft (42) to pass through the first wedge member and the second drive shaft (46) to pass through the second wedge member (Figs. 5A-6), and the first drive shaft (42) is operable to drive the first wedge member (34, 38) along the first lateral area of the housing, the second drive shaft (46) is operable to drive the second wedge member (36, 40) along the second lateral area of the housing, causing the first and second shell member (14, 16) to move relative to each other providing an expanded configuration of the interbody fusion device (Fig. 7A-7C), wherein the first drive shaft and the second drive shaft are operable independently, allowing the first shell member and the second shell member to move relative to each other at the first lateral side and the second lateral side of the housings separately and simultaneously to form a plurality of expanded and/or contracted housing configurations including parallel (Fig. 15A) and unparallel (Figs. 15B-15C) configurations wherein the first lateral side of the housing is higher than, lower than, and as high as the second lateral side of the housing (Figs. 15B-15C show the first lateral side higher than the second lateral side due to manipulation of wedge members 36 and 40, however, it is understood that the first lateral side would be lower than the second lateral side with manipulation of wedge members 34 and 38 in a manner opposite to what is show in Figs. 15B-15C due to wedge members 34, 38 working in a similar manner to wedge members 36,40), and wherein the parallel or unparallel expanded configurations of the interbody fusion device allow either linear or angular-offset movement (paragraph [0049]).
Rogers et al. does not disclose a fixation assembly comprising a modular, first fixation plate configured to be attachable to the interbody fusion device in the expanded configuration in situ and secured to a first vertebral body to stabilize and/or prevent migration of the interbody fusion device and a modular, second fixation plate configured to be attached to the interbody fusion device in the expanded configuration in situ and secured to a second vertebral body to stabilize and/or prevent migration of the interbody fusion device, wherein the first fixation plate is coupled to the first shell member and the second fixation plate is coupled to the second shell member, thereby allowing the first and second fixation plate to be implanted with the interbody fusion device, angle-adjusted in situ with movement of the first shell member and/or second shell member at an angle form 0-11 degrees clockwise and/or counterclockwise.
Seifert et al. discloses an apparatus having an interbody fusion device (602, 604) and a fixation assembly having a modular, first fixation plate (648) integrally formed with/coupled to a first shell member (602) and configured to be secured to a first vertebral body and having a first aperture (650) for insertion of a first fastener (651); and a modular, second fixation plate (660) integrally formed with/coupled to a second shell member (604) and configured to be coupled to a second vertebral body and having a second aperture (662) for insertion of a second fastener (663); and wherein the fixation plates are separate pieces coupled to shell members by an interference fit (Fig 12A and paragraphs [0127] and [0130] disclose the plates can be attached to the shell members by a dovetail joint, which are well-known for connecting by interference fit) and wherein the plates are adjusted in situ with movement of the first and second shell members (Figs. 12D and 12F).
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 apparatus of Rogers et al. to include a fixation assembly having a first fixation plate coupled to the first shell member and a second fixation plate coupled to the second shell member such that the fixation plates are angle-adjustable in situ with movement of the shell members at an angle from 0 to 11 degrees clockwise and/or counterclockwise and configured to be secured to first and second vertebral bodies in view of Seifert et al. since using fixation plates with an interbody fusion device is well known in the art for providing additional securement of the interbody fusion device within a vertebral disc space.
Response to Arguments
Applicant’s arguments, see Remarks, filed 13 January 2026, with respect to the rejection of claim 96 have been fully considered and are persuasive. The rejection of claims 96-98 has been withdrawn.
Applicant's arguments filed 28 April 2025, with respect to claims 90 and 96, have been fully considered but they are not persuasive. Applicant contends Rogers et al. cannot achieve configurations of an interbody fusion device wherein the first lateral side of the housing is higher than, lower than, and as high as the second lateral side of the housing. However, as can be seen in the rejection of claims 90 and 96 above, such configurations are achievable by Rogers by wedge members 34, 38 and 36, 40 working similar to one another with wedge members 34, 38 being manipulatable independently of wedge members 36, 40 and vice versa with an example of such shown in Figs. 15A-15C and paragraph [0049]). Therefore, claims 90 and 96 still remain rejected.
Applicant’s arguments, see Remarks, filed 13 January 2026, with respect to the rejection of claims 90 and 93-98 under non-statutory double patenting have been fully considered and are persuasive. The rejection of claims 90 and 93-98 under non-statutory double patenting has been withdrawn.
Conclusion
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