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: “drive mechanism” in claim 25; “drive member” in claim 36 (does not include threadable coupling of claim 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.
Double Patenting
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 19-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, 10, and 12-14 of U.S. Patent No. 12,156,818 B2 (Aghayev) in view of U.S. Patent Application Publication No. 2015/0073552 (To) and U.S. Patent Application Publication No. 2010/0222884 (Greenhalgh).
Regarding claim 19 of the present application, claim 1 of Aghayev (see claim 1 below) discloses an intervertebral cage comprising (line 1): a first bar pair (line 2) including a first upper bar and a first lower bar (lines 3-4); a first pin extending between the first upper bar and the first lower bar (lines 5-6); a first separator to direct vertical movement between the first upper bar and the first lower bar (lines 7-9); a second bar pair (line 10) including a second upper bar and a second lower bar (lines 11-12); and a drive member (spacer in line 13) movable along a space between the first and second bar pairs (lines 13-14), wherein the drive member is rotatably coupled to the first separator (lines 15-18, first separator and spacer are pivotably coupled).
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Further regarding claim 19, Aghayev fails to disclose the first separator movable towards the first pin to move apart the first upper and lower bars. However, To discloses an intervertebral cage (905) comprising: a first bar pair (916/918, see paragraph [0076]) including a first upper bar (916) and a first lower bar (918); a first pin (990) extending between the first upper bar and the first lower bar (see Fig. 9); a first separator (first side wedge, see paragraph [0017]) movable toward the pin to move apart the first upper bar and the first lower bar (see paragraphs [0017] and [0018] and Figs. 3-5, 9A, and 9B; proximal to distal movement of first side wedge toward the distally located pin moves apart the upper and lower bars). It would have been prima facie obvious to a person of ordinary skill in the art to modify the cage of Aghayev to have the first separator movable towards the first pin to move apart the first upper and lower bars in order to allow a proximally located separator to move to expand the implant without interference from the distally located pin, while still allowing the pin to limit expansion to a desired range (see To, paragraphs [0017], [0076], and [0077]).
Further regarding claim 19, Aghayev fails to disclose the drive member configured to threadably couple to a threaded driver. However, Greenhalgh discloses an intervertebral cage (2, see Fig. 59, e.g.) in which a drive member (108) is configured to threadably couple to a threaded driver (via tool connector 184, see paragraph [0146]).
Regarding claims 20 and 28, Greenhalgh discloses wherein the drive member includes an internally threaded opening (internally threaded cylinder, see paragraph [0146]) positioned along a midline plane of the intervertebral cage and configured to receive the threaded driver (see Fig. 62B and paragraph [0146]).
Further regarding claims 19, 20, and 28, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the cage of Aghayev to have the drive member configured to threadably couple to a threaded driver in order to facilitate deployment of the drive member along the cage via a tool (see Greenhalgh, paragraph [0146]).
Regarding claim 21, claim 1 of Aghayev discloses further comprising at least one pin rotatably coupling the first separator with the drive member (see lines 16-18 of claim 1 of Aghayev above).
Regarding claim 22, claim 1 of Aghayev discloses wherein the first upper bar and the first lower bar are configured to move in a vertical direction (see lines 7-9 of claim 1 of Aghayev above. Claim 1 of Aghayev is silent on the first pin extending in the vertical direction. However, To discloses the first pin (990) extending in the vertical direction between the first upper bar and the first lower bar (see Fig. 9), and it would have been prima facie obvious to a person of ordinary skill in the art to modify the cage of Aghayev to have the pin extend in the vertical direction in order to allow the pin to limit expansion in the vertical direction to a desired range (see To, paragraphs [0017], [0076], and [0077]).
Regarding claim 23, claim 1 of Aghayev is silent on wherein the first upper bar and the first lower bar move along the first pin when the first separator moves apart the first upper bar and the first lower bar. However, To discloses first upper and lower bars move along the first pin when the first separator moves apart the bars (see Fig. 9 and paragraphs [0076] and [0077]), and it would have been prima facie obvious to a person of ordinary skill in the art to modify the cage of Aghayev to have the bars move along the first pin as the first separator moves the bars apart in order to allow the pin to limit expansion in the vertical direction to a desired range (see To, paragraphs [0017], [0076], and [0077]).
Regarding claim 24, claim 2 of Aghayev discloses further comprising: a second pin extending between the second upper bar and the second lower bar, and a second separator movable toward the second pin to move apart the second upper bar and the second lower bar.
Regarding claim 25, claim 3 of Aghayev discloses further comprising a drive mechanism with the threaded driver and configured to direct lateral expansion of the first bar pair and the second bar pair.
Regarding claim 26, claim 4 of Aghayev discloses wherein the drive mechanism is configured to direct vertical movement between the first upper bar and the first lower bar.
Regarding claim 27, claim 5 of Aghayev discloses wherein the first separator is coupled to the drive mechanism via the drive member, and the drive mechanism is configured to move the threaded driver along a longitudinal axis of the drive mechanism and towards a midline of the intervertebral cage during lateral expansion of the first and second bar pairs.
Regarding claim 28, claim 6 of Aghayev discloses wherein the drive member includes an internally threaded opening for engaging the threaded driver.
Regarding claim 29, claim 7 of Aghayev discloses wherein the drive member is movable into the space between the first and second bar pairs during lateral expansion of the first and second bar pairs.
Regarding claim 30, claim 9 of Aghayev discloses wherein at least one of the first upper bar and the first lower bar include a sloped contact surface, and wherein the first separator includes a bar contact surface configured to contact the sloped separator contact surface.
Regarding claim 31, claim 10 of Aghayev discloses wherein the first separator is moveable along the sloped contact surface to cause movement of the first upper and lower bar away from each other.
Regarding claim 32, claim 12 of Aghayev discloses wherein a portion of the first separator is slidably retained by at least one of the first upper bar or the first lower bar.
Regarding claim 33, claim 12 of Aghayev discloses wherein the first separator includes a protrusion positioned in a groove of at least one of the first upper bar or the first lower bar.
Regarding claim 34, claim 13 of Aghayev discloses wherein at least a portion of the groove is inclined.
Regarding claim 35, claim 14 of Aghayev discloses wherein the first pin includes a head received within a recess included in at least one of the first upper bar and the first lower bar. Additionally, To suggests the head of the pin being enlarged (head 997) and it would be obvious to have the head be enlarged to in order to allow the pin to limit expansion in the vertical direction to a desired range (see To, paragraphs [0017], [0076], and [0077]).
Claims 36-40 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 24 of Aghayev in view of To.
Regarding claim 36, claim 20 of Aghayev (see claim 20 below) discloses an intervertebral cage, comprising (line 1): a first bar pair including a first upper bar and a first lower bar (lines 2-3); a first pin extending between the first upper and first lower bars (lines 4-5); a first separator movable toward the first pin to push apart the first upper bar and the first lower bar (see lines 6-7); a second bar pair including a second upper bar and a second lower bar (lines 8-9); a drive member (spacer) movable along a space between the first and second bar pairs (lines 10-11); and at least one pin rotationally coupling the first separator with the drive member to allow rotational movement between the first separator and the drive member when the drive member moves along the space (lines 13-16).
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Further regarding claim 36, Aghayev fails to disclose the first separator movable towards the first pin to push apart the first upper and lower bars. However, To discloses an intervertebral cage (905) comprising: a first bar pair (916/918, see paragraph [0076]) including a first upper bar (916) and a first lower bar (918); a first pin (990) extending between the first upper bar and the first lower bar (see Fig. 9); a first separator (first side wedge, see paragraph [0017]) movable toward the pin to push apart the first upper bar and the first lower bar (see paragraphs [0017] and [0018] and Figs. 3-5, 9A, and 9B; proximal to distal movement of first side wedge toward the distally located pin moves apart the upper and lower bars). It would have been prima facie obvious to a person of ordinary skill in the art to modify the cage of Aghayev to have the first separator movable towards the first pin to move apart the first upper and lower bars in order to allow a proximally located separator to move to expand the implant without interference from the distally located pin, while still allowing the pin to limit expansion to a desired range (see To, paragraphs [0017], [0076], and [0077]).
Regarding claim 37, claim 20 of Aghayev discloses wherein the drive member is movable along the space between the first and second bar pairs during lateral expansion of the first and second bar pairs (see lines 10-12).
Regarding claim 38, claim 24 of Aghayev discloses further comprising a connector, and wherein the at least one pin includes: a first pin rotatably coupling the connector to the first separator; and a second pin rotatably coupling the connector to the drive member.
Regarding claim 39, claim 20 of Aghayev discloses further comprising at least one pin configured to allow for pivotable movement between the first separator and the drive member (see lines 13-16).
Regarding claim 40, claim 20 of Aghayev discloses wherein the first upper bar and the first lower bar are configured to move in a vertical direction away from the drive member when the first separator moves apart the first upper bar and the first lower bar (see lines 6-7).
Regarding claim 42, claim 20 of Aghayev is silent on wherein the first upper bar and the first lower bar move along the first pin when the first separator moves apart the first upper bar and the first lower bar. However, To discloses first upper and lower bars move along the first pin when the first separator moves apart the bars (see Fig. 9 and paragraphs [0076] and [0077]), and it would have been prima facie obvious to a person of ordinary skill in the art to modify the cage of Aghayev to have the bars move along the first pin as the first separator moves the bars apart in order to allow the pin to limit expansion in the vertical direction to a desired range (see To, paragraphs [0017], [0076], and [0077]).
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of Aghayev in view of To and Greenhalgh.
Regarding claim 41, Aghayev fails to disclose the drive member includes a threaded opening positioned along a midline plane of the intervertebral cage and configured to receive a threaded rod. However, Greenhalgh discloses an intervertebral cage (2, see Fig. 59, e.g.) in which a drive member (108) is configured to threadably couple to a threaded rod (via tool connector 184, see paragraph [0146]), wherein the drive member includes an internally threaded opening (internally threaded cylinder, see paragraph [0146]) positioned along a midline plane of the intervertebral cage and configured to receive the threaded rod (see Fig. 62B and paragraph [0146]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the cage of Aghayev to have the drive member configured to threadably couple to a threaded rod in order to facilitate deployment of the drive member along the cage via a tool (see Greenhalgh, paragraph [0146]).
Allowable Subject Matter
Claims 19-42 would be allowable if a terminal disclaimer is filed to overcome the double patenting rejection(s) as set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Independent claim 19 (and claims 20-35 which are dependent thereon) has not been rejected because no reference, or reasonable combination of references, can be found which disclose or suggest an intervertebral cage as recited in the claim. To (U.S. Patent Application Publication No. 2015/0073552) discloses a similar cage, but fails to disclose the drive member rotatably coupled to the separator. Alheidt (U.S. Patent Application Publication No. 2013/0211526) discloses a similar cage, but fails to disclose a drive member movable along a space between the first and second bar pairs.
Independent claim 36 (and claims 37-42 which are dependent thereon) has not been rejected because no reference, or reasonable combination of references, can be found which disclose or suggest an intervertebral cage as recited in the claim. To (U.S. Patent Application Publication No. 2015/0073552) discloses a similar cage, but fails to disclose at least one pin rotationally coupling the first separator with the drive member to allow rotational movement between the first separator and the drive member when the drive member moves along the space. Alheidt (U.S. Patent Application Publication No. 2013/0211526) discloses a similar cage, but fails to disclose a drive member movable along a space between the first and second bar pairs, and at least one pin rotationally coupling the first separator with the drive member to allow rotational movement between the first separator and the drive member when the drive member moves along the space.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773