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 .
Response to Arguments
Applicant’s amendments have overcome the previous 102 rejections made with Shepard has been overcome,
Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references since Fraser already discloses bonding as a locking mechanism, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation is found in the references themselves. Applicant already pointed out that the fixation plate can be bonded and thus fixed in plate or can move (col 2 lines 43-50). The modification in view of Doty allows the fixation to plate to be moved and locked in place (see rejections below). Furthermore, this also has the added benefit that instead of having two different embodiments (a fixed plate or a moveable plate), the modification allows the plate to be fixed while also be allowed to move. As such the rejection of Fraser in view of Doty is maintained. The rejections were modified accordingly in view of applicant’s amendments.
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: bone screw locking features in claim 10, 19.
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 11-19 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.
Claim 11 recites the limitation "a spring loaded lock tab" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is not clear if this is the same spring loaded lock tab recited in line 4 or a different. For examining purposes, the examiner is treating the tab of line 6 as the same as the one recited in line 4.
The way lines 7-9 of Claim 11 and lines 6-8 of Claim 16 are written, it is not clear if it is the protrusion or the tab engagement recess that is configured to “compress the spring loaded lock tab inward in the bore”. For examining purposes, the examiner is treating this limitation as the protrusion compresses the spring loaded lock tab.
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.
Claims 1-6, 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser US 6,432,106 in view of Doty US 4,599,086.
Regarding Claim 1, Fraser discloses a modular interbody spacer (figs 1-3) for placement between adjacent vertebrae (Fig 8) comprising:
a spacer body (#10) having upper (#16) and lower (#18) vertebrae engagement surfaces (Fig 2) and a vertical slot (#26, Fig 1) from the upper surface (Fig 1); and
a fixation plate (#20) having upper and lower bone vertebrae surfaces (upper and lower surfaces that engages the vertebra, as seen in Fig 8) and a protrusion (#24) configured to slidably insert in the vertical slot in a vertical direction (as seen in Fig 1, Col 2 lines 42-50, the plate slides vertically in the slot).
Fraser does not disclose a bore or hole; a locking system slidable within the bore or hole, the locking system including a spring loaded lock tab extending from the bore, the protrusion engages the locking system, the protrusion having a tab engagement recess, during vertical insertion, the protrusion is configured to compress the spring loaded lock tab inward in the bore, the locking system being configured to lock the fixation plate to the spacer body in a completely joined position, when the fixation plate to the spacer body are a completely joined position, the spring loaded lock tab is configured to extend outward from the bore and engage the tab engagement recess.
Doty, in the same field of endeavor as interbody spacers, discloses a spacer body (#12, Fig 3-4), a vertical opening (where #20 is located) with a bore or hole (where #52 or #54 is located), a member (#20) configured to slide within the vertical opening in a vertical direction (Figs 3-4), a locking system (#52 or #54) slidable within the bore or hole (Figs 3-4), the member has a tab engagement recess (#60 or #62) that engages the locking system (Figs 3-4). Doty also discloses the locking system includes a spring loaded lock tab (#52 or #54 in Doty, Col 4 lines 25-46), during vertical movement, the member is configured to compress the spring loaded lock tab inward in the bore (Fig 3-4, Col 4 lines 25-46), the spring loaded lock tab is configured to extend outward from the bore and engage the tab engagement recess to lock the member to the spacer body (Fig 3-4, Col 4 lines 25-46)
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the vertical slot of Fraser to include a bore or hole, to include a locking system and the protrusion having a hole that engages the locking system in view of Doty above because this helps to lock the plate to the spacer body and prevent vertical translation. The examiner notes that bore or hole and the locking system would be placed in the vertical slot, either above or below opening #46 in Fraser.
Regarding Claim 3, Fraser as modified discloses the protrusion (#24 in Fraser) includes a first portion (Fig 3-4 in Doty, surface adjacent the hole would be a considered a first portion) configured to compress the spring loaded lock tab during the vertical insertion (see Fig 3 in Doty where the spring loaded tabs are compressed against the surface adjacent hole #60).
Regarding Claim 4, Fraser as modified discloses the first portion of the protrusion includes an inclined (Fig 3-4 in Doty, Fig 1 in Fraser where the first portion is an surface inclined about 90 degrees with respect to the spring loaded tabs) or ramped portion configured to engage and move the spring loaded lock tab inward in the bore or hole (Fig 3-4 in Doty).
Regarding Claim 6, Fraser as modified discloses the locking system is configured to provide an audible click when the fixation plate is locked to the spacer body (Col 4 lines 25-46 in Doty, where with the modification and the locking system providing a detent/ spring loaded tab, it would be obvious that when actuated, an audible click would be heard).
Regarding Claim 8, Fraser as modified discloses the claimed invention as discussed above where Fraser further discloses the vertical slot (#26, Fig 1) is positioned on a proximal end (end of the spacer that faces the fixation plate, Fig 1) of the spacer and the protrusion (#24, Fig 1) is positioned on a distal end (end of the fixation plate that faces the spacer, Fig 1) of the fixation plate (Fig 1).
Regarding Claim 9, Fraser as modified discloses the claimed invention as discussed above where Fraser further discloses the fixation plate includes one or more fastener holes (#40, #38) on a proximal end (Fig 2) sized to receive a bone engagement fastener (#46, #48) to attach the fixation plate to: the vertebra above or below the spacer body (Fig 8), or both the vertebra above and below the spacer body (Fig 8).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fraser US 6,432,106 and Doty US 4,599,086, as applied to claim 9 above, and in further view of Ross US 2017/0049491.
Fraser as modified discloses the claimed invention as discussed above but does not disclose the fixation plate includes bone screw locking features configured to cover a portion of the fastener holes to prevent the bones screws from withdrawing from the fastener holes.
Ross discloses a fixation plate (Fig 1) with fastener holes (#14), that receives bone engagement fasteners (#16), the fixation plate includes bone screw locking features (#20) configured to cover a portion of the fastener holes to prevent the bones screws from withdrawing from the fastener holes and “backing out” (Fig 3-4, paragraph 13, abstract).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the fixation plate of Fraser as modified to include bone screw locking features in view of Ross above because they help prevent backing out of the bone engagement fasteners.
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser US 6,432,106 in view of Doty US 4,599,086.
Regarding Claim 11, Fraser discloses a modular interbody spacer (Fig 1-2) for placement between adjacent vertebrae (Fig 8) comprising:
a spacer body (#10) having upper (#16) and lower (#18) vertebrae engagement surfaces (Fig 1-2) and a vertical slot (#26, Fig 1) from the upper surface (Fig 1); and
a fixation plate (#20) having upper and lower bone vertebrae surfaces (upper and lower surfaces that engages the vertebra, as seen in Fig 8) and a protrusion (#24) configured to slidably insert in the vertical slot in a vertical direction (as seen in Fig 1, Col 2 lines 42-50, the plate slides vertically in the slot)
Fraser does not disclose a bore or hole; a spring loaded lock tab extending from the bore, and a spring slidable within the bore or hole, the protrusion having a tab engagement recess and compress the spring loaded lock tab inward in the bore, the spring loaded lock tab being configured to extend out from the bore and engage the tab engagement recess to lock the fixation plate to the spacer body in a completely joined position.
Doty, in the same field of endeavor as interbody spacers, discloses a spacer body (#12, Fig 3-4), a vertical opening (where #20 is located) with a bore or hole (where #52 or #54 is located), a spring loaded lock tab (#52 or #54) slidable within and extending from the bore or hole (Figs 3-4), a member (#20) having tab engagement recess (#60 or #62), the member configured to slide within the vertical opening in a vertical direction (Figs 3-4) to compress the spring loaded lock tab inward in the bore (Figs 3-4), Col 4 lines 25-46), the spring loaded lock tab being configured to extend outward from the bore and engage the tab engagement recess to lock the member to the spacer body and prevent vertical translation (Fig 3-4, Col 4 lines 25-46).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the vertical slot of Fraser to include a bore or hole, to include a spring loaded lock tab and the protrusion having a hole that engages the spring loaded lock tab in view of Doty above because this helps to lock the plate to the spacer body and prevent vertical translation. The examiner notes that bore or hole and the spring loaded lock tab would be placed in the vertical slot, either above or below opening #46 in Fraser.
Regarding Claim 12, Fraser as modified discloses the vertical slot is position on a proximal end of the spacer body (as seen in Fig 1 in Fraser) and the protrusion is positioned on a distal end of the fixation plate (as seen in Fig 1 in Fraser).
Regarding Claim 13, Fraser as modified discloses the protrusion (#24 in Fraser) includes a first portion (with the modification, the protrusion would include a hole #60 in view of Doty and the surface adjacent the hole would be a considered a first portion) configured to compress the spring loaded lock tab during the vertical insertion (see Fig 3 in Doty where the spring loaded tabs are compressed against the surface adjacent hole #60) and a second portion (hole #60 in view of Doty) configured to lock the spring loaded lock tab when the fixation plate and spacer body are in the completely joined position (Fig 3-4 in Doty, Col 4 lines 25-46).
Regarding Claim 14, Fraser as modified discloses the first portion of the protrusion includes an inclined (Fig 3-4 in Doty, Fig 1 in Fraser where the first portion is an surface inclined about 90 degrees with respect to the spring loaded tabs) or ramped portion configured to engage and move the spring loaded lock tab inward in the bore or hole (Fig 3-4 in Doty).
Regarding Claim 15, Fraser as modified discloses the second portion of the protrusion includes a tab engagement recess (hole #60 in view of Doty) configured to engage and allow the spring loaded lock tab to move outward from the bore and lock the spring loaded lock tab (Fig 3-4 in Doty, Col 4 lines 25-46).
Claims 16- are rejected under 35 U.S.C. 103 as being unpatentable over Fraser US 6,432,106 in view of Doty US 4,599,086.
Regarding Claim 16, Fraser discloses a modular interbody spacer (Fig 1-2) for placement between adjacent vertebrae (Fig 8) comprising:
a spacer body (#10) having a vertical slot (#26, Fig 1);
a fixation plate (#20) having a protrusion (#24) configured to slidably insert vertically in the vertical slot until the fixation plate to the spacer body are a completely joined position (Fig 1, Col 2 lines 42-50).
Fraser does not disclose the vertical slot has a bore or hole, a locking system slidable within the bore or hole, the locking system includes a spring loaded lock tab extending from the bore; the protrusion having a tab engagement recess, the protrusion configured to slide in the vertical slot and compress the loaded lock inward in the bore until the fixation plate to the spacer body are a completely joined position, in the completely joined position the spring loaded lock tab engages the tab engagement recess to lock the fixation plate to the spacer body in the joined position.
Doty, in the same field of endeavor as interbody spacers, discloses a spacer body (#12, Fig 3-4), a vertical opening (where #20 is located) with a bore or hole (where #52 or #54 is located), a spring loaded lock tab (#52 or #54) slidable within and extending from the bore or hole (Figs 3-4), a member (#20) having tab engagement recess (#60 or #62), configured to slide in the vertical slot and compress the loaded lock inward in the bore until the fixation plate to the spacer body are a completely joined position (Fig 3-4, Col 4 lines 25-46), in the completely joined position the spring loaded lock tab engages the tab engagement recess to lock the fixation plate to the spacer body in the joined position (Fig 3-4, Col 4 lines 25-46)
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the vertical slot of Fraser to include a bore or hole, to include a spring loaded lock tab and the protrusion having a tab engagement recess that engages the spring loaded lock tab in view of Doty above because this helps to lock the plate to the spacer body and prevent vertical translation. The examiner notes that bore or hole and the spring loaded lock tab would be placed in the vertical slot, either above or below opening #46 in Fraser.
Regarding Claim 17, Fraser as modified discloses the spacer body includes upper and lower vertebrae engagement surfaces (#16, #18, Fig 1 in Fraser), and the fixation plate includes upper and lower bone vertebrae surfaces (#40’ and #38’ as seen in Fig 3 in Fraser).
Regarding Claim 18, Fraser as modified discloses the fixation plate includes at least one fastener hole (#40, Fig 2-3 in Fraser) tilted at an upward angle so that a bone screw engages the vertebra above the modular interbody spacer (as seen in Fig 3 in Fraser, where screw #46 is tiled upward), and
at least one fastener hole (#38, Fig 2-3 in Fraser) tilted at a downward angle so that a bone screw engages the vertebra below the modular interbody spacer (as seen in Fig 3 in Fraser where screw #48 is tilted downward).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Fraser US 6,432,106 and Doty US 4,599,086, as applied to claim 18 above, and in further view of Ross US 2017/0049491.
Fraser as modified discloses the claimed invention as discussed above but does not disclose the fixation plate includes bone screw locking features configured to cover a portion of the fastener holes to prevent the bones screws from withdrawing from the fastener holes.
Ross discloses a fixation plate (Fig 1) with fastener holes (#14), that receives bone screws (#16), the fixation plate includes bone screw locking features (#20) configured to cover a portion of the fastener holes to prevent the bones screws from withdrawing from the fastener holes and “backing out” (Fig 3-4, paragraph 13, abstract).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the fixation plate of Fraser as modified to include bone screw locking features in view of Ross above because they help prevent backing out of the bone engagement fasteners.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Examiner would have contacted the applicant but a power of attorney was not filed. It is suggested to file one.
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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773