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 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 1-22 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.
Regarding claim 1, from which claims 2-22 depend, “the proximal ends of the first and second arms are mounted on the hand grippable support to prevent increase in separation between the first and third sides simultaneously with increase in separation between the second and fourth sides” is indefinite, as it is unclear if the scope of the claim includes preventing the sides from increasing, or only allows for uneven increasing of the sides from each other. Additionally, it is unclear how the arms are mounted so as to prevent the simultaneous increase in separation. For the purpose of examination, it is assumed that preventing the sides from simultaneously increasing in separation to a given amount of force satisfies the claim language.
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.
Claims 1-7 and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Patent Application Publication No. WO 2021/014173 A1 (Arcos), as cited on Applicant’s IDS filed on May 6, 2026.
Regarding claim 1, Arcos discloses an insertion instrument (100) for inserting a modular Oblique Lumbar Interbody Fusion device into an intervertebral space (see Abstract, modular intervertebral fusion device; capable of being used with a device for oblique lumbar insertion), the insertion instrument comprising: a hand grippable support (112/114) defining a longitudinal axis (longitudinal axis of instrument 100, see Fig. 5A); a first elongate arm (116) mounted at a proximal end thereof on the hand grippable support and extending from the hand grippable support along the longitudinal axis (see Figs. 5A and 5B and page 23, lines 2-4), the first elongate arm configured at a distal end (140) thereof to grip a superior plate (see page 26, lines 12-14); a second elongate arm (118) mounted at a proximal end thereof on the hand grippable support and extending from the hand grippable support along the longitudinal axis (see Figs. 5A and 5C and page 23, lines 2-4), the second elongate arm configured at a distal end (140) thereof to grip an inferior plate of the modular OLIF device (see page 27, lines 11-12), the distal ends of the first and second elongate arms opposing each other (see Fig. 5A; distal ends 140 of each arm 118/120 oppose each other) whereby, in use, an inferior surface of the superior plate and a superior surface of the inferior plate face each other (in use, inferior and superior surfaces of the superior plate and inferior plate, respectively, can face each other; it is noted that the inferior and superior plates are not positively recited as part of the insertion instrument), wherein the proximal ends of the first and second arms are mounted on the hand grippable support for relative rotation of the first and second arms about the longitudinal axis (instrument can be rotated such that the arms relatively rotate about the longitudinal axis), the proximal end of the first arm has first and second sides (lateral sides of the proximal end of the first arm) facing away from each other and spaced apart in a direction orthogonal to the longitudinal axis and to a direction of separation of the first and second arms, the proximal end of the second arm has third and fourth sides (lateral sides of the proximal end of the second arm), facing away from each other and spaced apart in a direction orthogonal to the longitudinal axis and to a direction of separation of the first and second arms, the first and third sides on a first side of the insertion instrument (left side of the instrument, e.g.), the second and fourth sides on a second side of the insertion instrument (right side of the instrument, e.g.), and the proximal ends of the first and second arms are mounted on the hand grippable support to prevent increase in separation between the first and third sides simultaneously with increase in separation between the second and fourth sides (see page 25, lines 8-16; resistance to separation of the supports from each other).
Regarding claim 2, Arcos discloses wherein at least one of the first and second arms is configured at a location along its length for rotation of the distal end of the arm about an arm rotation axis which is orthogonal to the longitudinal axis and to a direction of separation of the first and second arms, rotation about the arm rotation axis changing separation between the distal ends of the first and second arms (see Fig. 5A and page 23, line 12 – page 24, line 2).
Regarding claim 3, Arcos discloses wherein at least one of the first and second arms is biased to reduce a separation between the distal ends of the first and second arms (page 25, lines 8-16).
Regarding claim 4, Arcos discloses wherein the arm rotation axis is at or adjacent the proximal end of the arm whereby the whole arm rotates about the arm rotation axis (see Fig. 5A and page 23, lines 12-27).
Regarding claim 5, Arcos discloses wherein the insertion instrument comprises a hinge (124/126) which provides for rotation about the arm rotation axis, the hinge comprising first and second hinge parts (122/128) which are hingedly coupled to each other, the first hinge part (122) comprised in the proximal end of the arm and the second hinge part (128) comprised in the hand grippable support.
Regarding claim 6, Arcos discloses wherein the hand grippable support comprises a first support portion (112) on which the first arm is mounted, and a second support portion (114) on which the second arm is mounted, the first and second support portions coupled for their relative rotation about the longitudinal axis (instrument can be rotated such that the support portions relatively rotate about the longitudinal axis), relative rotation of the first and second support portions causing relative rotation of the first and second arms about the longitudinal axis (via the mounting of the arms on the support portions and rotation of the support portions).
Regarding claim 7, Arcos discloses wherein the first and second support portions are coaxially disposed (see Fig. 5A).
Regarding claim 19, Arcos discloses wherein the distal end of each of at least one of the first and second arms comprises two legs (142) which extend along the longitudinal axis (see Figs. 5B and 5C), the two legs spaced apart in a direction orthogonal to the longitudinal axis (see Figs. 5B and 5C), each of the two legs configured to engage with a superior or inferior plate whereby the plate is gripped (see page 25, lines 23-25 and page 27, lines 9-17).
Regarding claim 20, Arcos discloses wherein at least one of the two legs is mounted on the distal end of the arm for change in separation between the two legs against a bias (see page 25, line 20 – page 27, line 7).
Regarding claim 21, Arcos discloses wherein the arm comprises a leg separation member (144) which is mounted for movement on the arm along the longitudinal axis and which when moved towards the distal ends of the two legs bears against at least one of the two legs to change their separation (see page 26, line 5 – page 28, line 18).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Arcos.
Regarding claim 8, Arcos discloses wherein the first support portion is contained along a part of its length (portion 128) within a space defined by the second support portion (122/125), the contained part of the second support portion rotatable within the space defined by the first support portion (see page 24, lines 23-24). Additionally, 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 instrument of Arcos such that the second support portion is contained within a space defined by the first support portion as it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. See In reGazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification.).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Arcos in view of U.S. Patent Application Publication No. 2020/0337860 (Kuyler).
Regarding claim 22, Arcos discloses a kit for an OLIF procedure comprising an insertion instrument according to claim 1 (see analysis of claim 1 above), a superior plate (50, e.g.), an inferior plate (60, e.g.), and at least one core component (100, see Fig. 4, e.g.). the lumbar interbody fusion device constituted by the superior plate, the inferior plate, and the core component.
Arcos is silent regarding the lumbar interbody fusion device being oblique. However, Kuyler discloses a spinal implant system wherein a lumbar interbody fusion implant can be anterior or oblique, and the instrument can insert either type of implant in a patient (see paragraphs [0102], [0137], and [0145]), and 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 kit of Arcos to have the fusion device be oblique as Kuyler suggests an oblique implant is a suitable lumbar interbody fusion device for insertion into a patient by an instrument that can also insert an anterior lumbar interbody fusion implant (see Kuyler, paragraphs [0102], [0137], and [0145]). The user will determine what approach (anterior, oblique, lateral, etc.) is best for a patient.
Allowable Subject Matter
Claims 9-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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
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