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 .
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 1-14, 16, 17 & 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 & 15-16 of U.S. Patent No. 12,364,529.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the application recites an expandable spinal implant (See Claim 1, Line 1 of the patent), comprising: a first endplate and a second endplate extending along a longitudinal axis (See Claim 1, Lines 2-3 of the patent); a sliding frame operatively coupled to the first endplate and the second endplate (See Claim 1, Lines 4-5 of the patent); and a screw guide disposed between the first endplate and the second endplate rotatably supporting a first set screw and a second set screw (See Claim 1, Lines 6-11 and Claim 12 of the patent), wherein rotation of the first set screw and second set screw selectively moves the sliding frame along the longitudinal axis thereby expanding or contracting the first endplate and the second endplate (See Claim 1, Lines 6-11 of the patent), and wherein rotation of one of the first set screw and second set screw selectively rotates the sliding frame about the longitudinal axis thereby adjusting an angle of inclination between the first endplate and the second endplate (See Claim 1, Lines 12-16 of the patent).
Claim 16 of the application recites a system for performing a spinal surgery (See Claim 15, Line 1 of the patent), comprising: an expandable spinal implant and a surgical tool for inserting and expanding the expandable spinal implant (See Claim 15, Lines 2-3 of the patent); the expandable spinal implant comprising: a first endplate and a second endplate extending along a longitudinal axis (See Claim 15, Lines 4-6 of the patent); a sliding frame operatively coupled to the first endplate and the second endplate (See Claim 15, Lines 7-8 of the patent); and a screw guide disposed between the first endplate and the second endplate and rotatably supporting a first set screw and a second set screw (See Claim 15, Lines 9-16 of the patent), wherein rotation of the first set screw and second set screw selectively moves the sliding frame along the longitudinal axis thereby expanding or contracting the first endplate and second endplate (See Claim 15, Lines 17-21 of the patent), and wherein rotation of one of the first set screw and second set screw selectively rotates the sliding frame about the longitudinal axis thereby adjusting an angle of inclination between the first endplate and the second endplate (See Claim 15, Lines 22-26 of the patent).
Claims 1-14, 16 & 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14 & 18 of U.S. Patent No. 11,969,196.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the application recites an expandable spinal implant (See Claim 1, Line 1 of the patent), comprising: a first endplate and a second endplate extending along a longitudinal axis (See Claim 1, Lines 2-3 of the patent); a sliding frame operatively coupled to the first endplate and the second endplate (See Claim 1, Lines 4-6 of the patent); and a screw guide disposed between the first endplate and the second endplate rotatably supporting a first set screw and a second set screw (See Claim 1, Lines 7-11 & Claim 11 of the patent), wherein rotation of the first set screw and second set screw selectively moves the sliding frame along the longitudinal axis thereby expanding or contracting the first endplate and the second endplate (See Claim 1, Lines 12-18 of the patent), and wherein rotation of one of the first set screw and second set screw selectively rotates the sliding frame about the longitudinal axis thereby adjusting an angle of inclination between the first endplate and the second endplate (See Claim 1, Lines 19-23 of the patent).
Claim 16 of the application recites a system for performing a spinal surgery (See Claim 14, Line 1 of the patent), comprising: an expandable spinal implant and a surgical tool for inserting and expanding the expandable spinal implant (See Claim 14, Lines 4-6 of the patent); the expandable spinal implant comprising: a first endplate and a second endplate extending along a longitudinal axis (See Claim 14, Lines 7-8 of the patent); a sliding frame operatively coupled to the first endplate and the second endplate (See Claim 14, Lines 9-11 of the patent); and a screw guide disposed between the first endplate and the second endplate and rotatably supporting a first set screw and a second set screw (See Claim 14, Lines 12-18 of the patent), wherein rotation of the first set screw and second set screw selectively moves the sliding frame along the longitudinal axis thereby expanding or contracting the first endplate and second endplate (See Claim 14, Lines 24-30 of the patent), and wherein rotation of one of the first set screw and second set screw selectively rotates the sliding frame about the longitudinal axis thereby adjusting an angle of inclination between the first endplate and the second endplate (See Claim 14, Lines 31-35 of the patent).
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 1-20 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 1 at Line 2 recites the limitation “a first endplate and a second endplate extending along a longitudinal axis;” which renders the claim indefinite as it is unclear if the claim is reciting that each endplate extends along a respective longitudinal axis of that endplate, or if both endplates are arranged relative to a shared/single longitudinal axis, such as a long. axis of the implant itself. The specification does not disclose a longitudinal axis other than the rotation axis Ai which is disclosed in Paragraph [0100] as “In the disclosed embodiment, rotation axis A1 extends longitudinally along the center of expandable spinal implant and may be defined, at least partly, by first and second set screws 252, 254.” For purposes of examination, the limitation of Line 2 is being interpreted as “a first endplate extending longitudinally about a longitudinal axis through a first set screw of the expandable spinal implant and a second endplate extending longitudinally about a longitudinal axis through a second set screw of the expandable spinal implant”, the limitation of Line 5 is being interpreted as “the first set screw and the second set screw”, and the limitations of Lines 7 & 10 are being interpreted as “the longitudinal axis of the first set screw”. Appropriate correction is required.
Claim 16 at Line 5 recites the limitation “a first endplate and a second endplate extending along a longitudinal axis;” which renders the claim indefinite as it is unclear if the claim is reciting that each endplate extends along a respective longitudinal axis of that endplate, or if both endplates extend along a shared/single longitudinal axis, such as a long. axis of the implant itself. The specification does not disclose a longitudinal axis other than the rotation axis Ai which is disclosed in Paragraph [0100] as “In the disclosed embodiment, rotation axis A1 extends longitudinally along the center of expandable spinal implant and may be defined, at least partly, by first and second set screws 252, 254.” For purposes of examination, the limitation of Line 5 is being interpreted as “a first endplate extending longitudinally about a longitudinal axis through a first set screw of the expandable spinal implant and a second endplate extending longitudinally about a longitudinal axis through a second set screw of the expandable spinal implant”, the limitation of Line 8 is being interpreted as “the first set screw and the second set screw”, and the limitations of Lines 10 & 13 are being interpreted as “the longitudinal axis of the first set screw”. Appropriate correction is required.
Claim Objections
Applicant is advised that should claim 17 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 14 is objected to because of the following informalities and should be amended as follows:
“14. The expandable spinal implant of claim 1, wherein: [[wherein]] the sliding frame includes a bottom sliding frame component and a top sliding frame component, [[and wherein]] the first set screw is operably coupled to the bottom sliding frame component, [[and]] the second set screw is operably coupled to a wedge, and the wedge is operably coupled to the top sliding frame component.” Appropriate correction is required.
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.
Claim(s) 1-4, 9, 11-13, 16, 17, & 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Engstrom et al. (US PG Pub No. 2019/0336301).
Regarding Claim 1 as best understood, Engstrom et al. discloses an expandable spinal implant (10, Figs. 1-6, 41, 50, Paragraphs [0076, 0144, 0059-0118]), comprising: a first endplate (superior plate 22, Fig. 5) extending longitudinally about a longitudinal axis through a first set screw of the expandable spinal implant (left axis X1 extending through left screw 96, Fig. 5) and a second endplate (inferior plate 20, Fig. 5) extending longitudinally about a longitudinal axis through a second set screw of the expandable spinal implant (right axis X1 extending through right screw 94, Fig. 5); a sliding frame (left 53 & 54, Figs. 5-6, 29-31, 41) operatively coupled to the first endplate and the second endplate (via 51 connected to 22 and via 54 connected to 20, Figs. 30-31); and a screw guide (left 51 and right 51, Fig. 5, Paragraphs [0085-0086]) disposed between the first endplate and the second endplate rotatably supporting (via channel 158, Fig. 10) a first set screw (left actuator 96, Fig. 5) and a second set screw (right actuator 94, Fig. 5) (Paragraphs [0090, 0076-0081]), wherein rotation of the first set screw and second set screw selectively moves the sliding frame along the respective longitudinal axis (the left axis X1) thereby expanding or contracting (in a vertical direction, Fig. 37, contracted position shown in Figs. 2-3 and expanded position shown in Figs. 32-33) the first endplate and the second endplate (Paragraphs [0076, 0083, 0118]), and wherein rotation of one of the first set screw and second set screw selectively rotates the sliding frame about the respective longitudinal axis thereby adjusting an angle of inclination (lordotic angle β, Fig. 40, lordotic expansion shown in Fig. 40) between the first endplate and the second endplate (Paragraphs [0076-0077]).
Regarding Claim 2, Engstrom et al. discloses a wedge (left 52, Figs. 5 & 30-31) coupled to the sliding frame (Fig. 29) and at least one of the first endplate and the second endplate (Figs. 29-31), and wherein rotation of the first set screw is configured to move the wedge forward and backward along the respective longitudinal axis (Figs. 30-31, 34-35) while simultaneously rotating the sliding frame about the longitudinal axis (Fig. 41, Paragraphs [0047, 00141-0144]).
Regarding Claim 3, Engstrom et al. discloses wherein: the wedge includes a first protrusion (left overhang/dovetail at 190, Fig. 29) on a first outside lateral side surface thereof (left external side surface, Fig. 29) and a second protrusion (right overhang/dovetail, not labeled, Fig. 29) on a second outside lateral side surface (right external side surface, Fig. 29) thereof.
Regarding Claim 4, Engstrom et al. discloses wherein the sliding frame includes a top sliding frame component (53, Fig. 41) operatively coupled to the first endplate (via 52, Fig. 30) and a bottom sliding frame (54, Fig. 41) component operatively coupled to the second endplate (via 51, Fig. 30).
Regarding Claim 9, Engstrom et al. discloses wherein the sliding frame includes a bottom sliding frame component (54, Fig. 41) and a top sliding frame component (53, Fig. 41), and the top sliding frame component is operably coupled to an interior surface of the first endplate (via 52, Figs. 29-31) and the bottom sliding frame component is operably coupled to the interior surface of the second endplate (via 51, Figs. 29-31).
Regarding Claim 11, Engstrom et al. discloses wherein the sliding frame includes a bottom sliding frame component (54, Fig. 41) and a top sliding frame component (53, Fig. 41), the bottom sliding frame component being operatively coupled to the first set screw (via 264, Figs. 22-23, 45).
Regarding Claim 12, Engstrom et al. discloses a wedge (left 52, Figs. 5 & 30-31) coupled to the sliding frame (Fig. 29) and at least one of the first endplate and the second endplate (Figs. 30-31).
Regarding Claim 13, Engstrom et al. discloses wherein the sliding frame comprises a bottom sliding frame component (54, Fig. 41) and a top sliding frame component (53, Fig. 41), and wherein the bottom sliding frame component, the top sliding frame component, and the wedge are configured to move forward and backwards along the respective longitudinal axis (left axis X1) upon simultaneous rotation of the first set screw and the second set screw.
Regarding Claim 16 as best understood, Engstrom et al. discloses a system for performing a spinal surgery (Fig. 50), comprising: an expandable spinal implant (10, Figs. 1-6, 41, 50, Paragraphs [0076, 0144, 0059-0118]) and a surgical tool (tool 300, Paragraphs [0161-0164]) for inserting and expanding the expandable spinal implant; the expandable spinal implant comprising: a first endplate (superior plate 22, Fig. 5) extending longitudinally about a longitudinal axis of the expandable spinal implant (left axis X1 extending through left screw 96, Fig. 5) and a second endplate (inferior plate 20, Fig. 5) extending longitudinally about a longitudinal axis of the expandable spinal implant (right axis X1 extending through right screw 94, Fig. 5); a sliding frame (left 53 & 54, Figs. 5-6, 29-31, 41) operatively coupled to the first endplate and the second endplate (via 51 connected to 22 and via 54 connected to 20, Figs. 30-31); and a screw guide (left 51 and right 51, Fig. 5, Paragraphs [0085-0086]) disposed between the first endplate and the second endplate and rotatably supporting (via channel 158, Fig. 10) a first set screw (left actuator 96, Fig. 5) and a second set screw (right actuator 94, Fig. 5) (Paragraphs [0090, 0076-0081]), wherein rotation of the first set screw and second set screw selectively moves the sliding frame along the respective longitudinal axis (the left axis X1) thereby expanding or contracting (in a vertical direction, Fig. 37, contracted position shown in Figs. 2-3 and expanded position shown in Figs. 32-33) the first endplate and second endplate (Paragraphs [0076, 0083, 0118]), and wherein rotation of one of the first set screw and second set screw selectively rotates the sliding frame about the longitudinal axis thereby adjusting an angle of inclination (lordotic angle β, Fig. 40, lordotic expansion shown in Fig. 40) between the first endplate and the second endplate (Paragraphs [0076-0077]).
Regarding Claims 17 & 19, Engstrom et al. discloses a wedge (left 52, Figs. 5 & 30-31) coupled to the sliding frame (Fig. 29) and at least one of the first endplate and the second endplate (Figs. 29-31), and wherein rotation of the first set screw or second set screw is configured to move the wedge forward and backward along the respective longitudinal axis (Figs. 30-31, 34-35) while simultaneously rotating the sliding frame about the longitudinal axis (Fig. 41, Paragraphs [0047, 00141-0144]).
Allowable Subject Matter
Claims 5-8, 10, 14, 15, 18 & 20 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.
The following is a statement of reasons for the indication of allowable subject matter: Engstrom discloses the claimed invention as stated above, except wherein the bottom sliding frame component includes a first channel on a first inside lateral side surface thereof for disposal of the first protrusion therein and a second channel on a second inside lateral side surface thereof for disposal of the second protrusion therein; wherein: the top sliding frame component includes at least one inclined contact surface that is configured to contact an interior surface of the first endplate and the bottom sliding frame component includes at least one inclined contact surface that is configured to contact an interior surface of the second endplate; wherein the top sliding frame component comprises a plurality of guide walls that are operably coupled to a plurality of grooves of the first endplate; wherein: the first set screw is operably coupled to the bottom sliding frame component and the second set screw is operably coupled to a wedge and the wedge is operably coupled to the top sliding frame component; wherein the screw guide comprises a rail configured to support a sliding block movable forward and backward along the longitudinal axis, and wherein the first set screw and second set screw are coupled to opposite sides of the sliding block. Furthermore, there is no reasonable motivation to modify Engstrom as claimed without destroying the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
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