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 1-2 & 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5 & 9 of related U.S. Patent No. 11,534,307.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the application recites a spinal implant (See Claim 9, Line 1 of the patent) comprising: an interbody configured to be disposed between vertebrae, the interbody comprising: a leading surface and a trailing surface opposite the leading surface; and a first passageway extending from the trailing surface to a bone-facing surface of the interbody separate from the trailing surface, the first passageway being sized for receipt of a bone fastener, wherein a cavity is defined within the interbody, the cavity having one end at the trailing surface (See Claim 9, Lines 2-15 of the patent); and an insert receivable in the cavity defined within the interbody, the insert comprising: an elongate head having a length extending from a first end to a second end, the elongate head having an elongate dimension oriented in alignment with the trailing surface; and a shaft extending from a first location on the elongate head, the first location being in between the first end of the elongate head and the second end of the elongate head, wherein the shaft includes a flexible portion that is movable to control fixation of the insert to the interbody when the insert is disposed in the cavity of the interbody (See Claim 9, Lines 16-34 of the patent).
As to Claim 2 of the application: The limitations of Claim 2 of the application are found in Claim 9 of the patent.
Claim 9 of the application recites a spinal implant (See Claim 1, Line 1 of the patent) comprising: an interbody configured to be disposed between vertebrae, the interbody comprising: a first side surface; a second side surface opposite the first side surface; a superior surface separating the first and second side surfaces; an inferior surface opposite the superior surface; a third side surface extending between the first and second side surfaces; and a fourth side surface extending between the first and second side surfaces, wherein one of the first side surface, second side surface, third side surface or fourth side surface defines one end of a cavity in the interbody (See Claim 1, Lines 2-13 of the patent); and an insert receivable in the cavity, the insert comprising: an outer body including an elongate head; a shaft extending from the elongate head (See Claim 1, Lines 14-25 of the patent); and a pin receivable within a cannulation of the outer body, wherein when the pin is received in the outer body and the outer body is received in the cavity, the insert is held in place within the interbody (See Claim 5 of the patent).
As to Claim 10 of the application: The limitations of Claim 10 of the application are found in Claim 4 of the patent.
Claim Objections
Claim 9 is objected to because of the following informalities: In Line 9, the word --the-- should be added before the word “second” and the word “third”, and in Line 10, the word --the-- should be added before the word “fourth”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In Line 5, the word “includes” should be replaced with the words --and including--. Appropriate correction is required.
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 1-8 & 12 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 Lines 10-11 recites the limitation “an elongate head having a length extending from a first end to a second end, the elongate head having an elongate dimension oriented in alignment with the trailing surface;” which renders the claim indefinite as it is unclear 1) if the length and the elongate dimension are separate dimensions and 2) what is meant by an elongate dimension oriented in alignment with the trailing surface. It appears from the figures that the length of the elongate head embodiments depicted define the elongate dimension of the head, which is arranged along and in alignment with the trailing surface. Thus, there is only one length/elongate dimension of the elongate head and not two. For purposes of examination, the limitation is being interpreted as “an elongate head having a length extending from a first end to a second end, a portion of the elongate head in alignment with the trailing surface”. Appropriate correction is required.
Claim 3 at Line 2 recites the limitation “the one end of the cavity adjacent to the trailing surface”. There is insufficient antecedent basis for this limitation in the claim and since the cavity could have multiple ends adjacent the trailing surface, it is unclear which end is being referred to. For purposes of examination, the limitation is being interpreted as “one end of the cavity adjacent to the trailing surface”. Appropriate correction is required.
Claim 5 at Line 2 recites the limitation “the one end of the cavity at the trailing surface”. There is insufficient antecedent basis for this limitation in the claim and since the cavity could have multiple ends adjacent the trailing surface, it is unclear which end is being referred to. For purposes of examination, the limitation is being interpreted as “one end of the cavity at the trailing surface”. Appropriate correction is required.
Claim 12 at Line 2 recites the limitation “the one end of the cavity”. It is unclear if the end of the cavity defined by the one or the first, second, third or fourth side surface from Claim 9 is being referred to, or if another different end is being recited. For purposes of examination, the limitation is being interpreted as “one end of the cavity”. 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) 1-2, 4, 6-11 & 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altarac et al. (US PG Pub No. 2018/0318100).
Regarding Claim 1 as best understood, Altarac et al. discloses a spinal implant (10, Figs. 1-27, Paragraphs [0038-0056]) comprising: an interbody (cage 12) configured to be disposed between vertebrae (Paragraphs [0038, 0056]), the interbody comprising: a leading surface and a trailing surface opposite the leading surface (See examiner annotated Fig. 1 below); and a first passageway (left 54, Fig. 2) extending from the trailing surface to a bone-facing surface of the interbody separate from the trailing surface (See examiner annotated Fig. 1 below), the first passageway being sized for receipt of a bone fastener (left bone screw 18, Fig. 2, Paragraphs [0040, 0048]), wherein a cavity (lock aperture 40, Fig. 23) is defined within the interbody (See examiner annotated Fig. 3 below), the cavity having one end at the trailing surface (Figs. 1 & 3); and an insert (lock assembly 16, Figs. 1-3, 9-22, & 27) receivable in the cavity defined within the interbody (Paragraphs [0038-0043]), the insert comprising: an elongate head (head 64, Figs. 9, 12, 14-15) having a length (lengthwise dimension measured between left and right sidewalls 82 when viewing Fig. 15) extending from a first end (left sidewall 82, Fig. 15) to a second end (right sidewall 82, Fig. 15), a portion of the elongate head (top surface 70, Figs. 14-15) in alignment with the trailing surface (Fig. 3); and a shaft (66, Figs. 9-11, 14, 16-18) extending from a first location on the elongate head (Figs. 16-18), the first location being in between the first end of the elongate head and the second end of the elongate head (Figs. 17-18), wherein the shaft includes a flexible portion (flexible prongs 92, Figs. 9-10) that is movable to control fixation of the insert to the interbody when the insert is disposed in the cavity of the interbody (“With the retaining ring 104 in position, the lock assembly 16 is fully installed. The retaining ring 104 has a diameter that is larger than the diameter of the lock aperture 40 and abuts the inner surface 46 of the cage 12 connecting the lock assembly 16 to the cage 12 and preventing the lock assembly 16 from backing out of the cage 12.”, Paragraphs [0042, 0045, 0051]).
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Regarding Claim 2, Altarac et al. discloses wherein an internal wall of the interbody defines the cavity (See examiner annotated Fig. 3 above), the internal wall including an indentation (each 56, Fig. 23), the flexible portion of the insert including a protruding part (Fig. 19) receivable in the indentation (“The side apertures 56 are sized and configured to receive the prongs 92 of the timing lock 102 and fix the timing lock 102 with respect to the cage 12 to prevent the timing lock 102 from rotating or moving with respect to the cage 12.”, Paragraph [0045]).
Regarding Claim 4, Altarac et al. discloses wherein the flexible portion (each prong 92) is a flexible arm with a first end (end of each prong 92 at 90, Fig. 19) and a free end opposite the first end (end of each prong 92 at 95, Fig. 19), the free end being further from the elongate head than the first end (Figs. 9-10), the flexible arm including a protrusion (each enlarged face at 94, Fig. 19).
Regarding Claim 6, Altarac et al. discloses wherein the insert defines a lumen (socket 72, Figs. 14-15, 18) therein capable of receiving a pin (tip of driver, Paragraph [0040], “The socket 72 is configured to receive an instrument such as a driver having a complementary shaped tip for engaging and rotating the screw lock 100 between an unlocked position and a locked position.”)(“an instrument having a distal end that is complementary to the size and shape of the socket 72 formed in the top surface 70 of the main body 64 is used.”, Paragraph [0054]), wherein when the pin is received in the lumen and the insert is in the cavity, the pin prevents the insert from disengaging from the interbody (when 16 is in the locked position via use of the instrument, the insert is prevented from backing out of the interbody, Paragraph [0056]).
Regarding Claim 7, Altarac et al. discloses wherein the flexible portion is configured such that movement of the flexible portion within the cavity (via 56) controls whether the flexible portion is fixed within the cavity (Paragraphs [0042, 0051, 0056]).
Regarding Claim 8, Altarac et al. discloses wherein the elongate head of the insert further comprises a drive (socket 72, Figs. 14-15, 18) configured to receive a drive tool (“The socket 72 is configured to receive an instrument such as a driver having a complementary shaped tip for engaging and rotating the screw lock 100 between an unlocked position and a locked position.”, Paragraph [0040]), and the insert defines an opening through the elongate head and the shaft (aperture extending beyond 72 as seen in Fig. 18), the drive having a different shape than a portion of the opening through the shaft (Fig. 18).
Regarding Claim 9, Altarac et al. discloses a spinal implant (10, Figs. 1-27, Paragraphs [0038-0056]) comprising: an interbody (12) configured to be disposed between vertebrae (Paragraph [0038]), the interbody comprising: a first side surface; a second side surface opposite the first side surface; a superior surface separating the first and second side surfaces; an inferior surface opposite the superior surface; a third side surface extending between the first and second side surfaces; and a fourth side surface extending between the first and second side surfaces (See examiner annotated Fig. 6 below), wherein the first side surface defines one end of a cavity (lock aperture 40, Fig. 23, See examiner annotated Fig. 3 above) in the interbody (See examiner annotated Fig. 6 below); and an insert (lock assembly 16, Figs. 1-3, 9-22, & 27) receivable in the cavity, the insert comprising: an outer body including an elongate head (head 64, Figs. 9, 12, 14-15); a shaft (66, Figs. 9-11, 14, 16-18) extending from the elongate head; and a pin (tip of driver, Paragraph [0040], “The socket 72 is configured to receive an instrument such as a driver having a complementary shaped tip for engaging and rotating the screw lock 100 between an unlocked position and a locked position.”)(“an instrument having a distal end that is complementary to the size and shape of the socket 72 formed in the top surface 70 of the main body 64 is used.”, Paragraph [0054]) receivable within a cannulation (circular aperture within socket 72, Figs. 14-15, 18) of the outer body, wherein when the pin is received in the outer body and the outer body is received in the cavity, the insert is held in place within the interbody (when 16 is in the locked position via use of the instrument, the insert is prevented from backing out of the interbody, Paragraph [0056]).
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Regarding Claim 10, Altarac et al. discloses wherein the shaft of the insert includes a distal portion (104, Figs. 9-11) having a first arm and a second arm (left and right arms 92, Figs. 19-20, Paragraph [0042]).
Regarding Claim 11, Altarac et al. discloses wherein the first arm and the second arm have respective lengths that extend from a base end (end of each prong 92 at 90, Fig. 19) to a free end region (end of each prong 92 at 95, Fig. 19), the free end region bulging outward relative to the base end (each enlarged face at 94, Fig. 19).
Regarding Claim 13, Altarac et al. discloses wherein the elongate head includes a surface (top surface 70, Figs. 14-15) facing away from the interbody (Fig. 1), the surface including a planar portion (70 is planar, Fig. 14) and defining a drive (socket 72, Figs. 14-15 & 18) therein for receipt of a drive tool (Paragraph [0040]), the drive being in fluid communication with the cannulation of the outer body (Fig. 18).
Regarding Claim 14, Altarac et al. discloses wherein the drive has a first cross-sectional shape (Fig. 14) and the cannulation of the outer body has a second cross-sectional shape different from the first cross-sectional shape (Fig. 15).
Regarding Claim 15, Altarac et al. discloses wherein a shape of the pin is complementary to an inner wall of the outer body that defines the cannulation such that receipt of the pin in the cannulation provides an interference fit (“The socket 72 is configured to receive an instrument such as a driver having a complementary shaped tip for engaging and rotating the screw lock 100 between an unlocked position and a locked position. ”, Paragraph [0040]).
Regarding Claim 16, Altarac et al. discloses a method of positioning an implant in a spine of a patient (Paragraphs [0038, 0056]) comprising: advancing an interbody (cage 12) in between adjacent vertebrae of the spine (Paragraph [0056]); placing an insert (lock assembly 16, Figs. 1-3, 9-22, & 27) into a cavity (lock aperture 40, Fig. 23) within the interbody such that an elongate head (head 64, Figs. 9, 12, 14-15) of the insert is aligned with a side surface (trailing surface, See examiner annotated Figs. 1 & 3 above) of the interbody (Fig. 3) and a shaft (66, Figs. 9-11, 14, 16-18) extending from the elongate head (Fig. 18) and including a free end portion (tip of 66, Fig. 18) remote from the side surface (Fig. 3); and placing a pin (tip of driver, Paragraph [0040]) within a cannulation of the insert (circular aperture within socket 72, Figs. 14-15, 18, “The socket 72 is configured to receive an instrument such as a driver having a complementary shaped tip for engaging and rotating the screw lock 100 between an unlocked position and a locked position.”)(“an instrument having a distal end that is complementary to the size and shape of the socket 72 formed in the top surface 70 of the main body 64 is used.”, Paragraph [0054]) such that the insert is prevented from being removed from the interbody (when 16 is in the locked position via use of the instrument, the insert is prevented from backing out of the interbody, Paragraph [0056]).
Allowable Subject Matter
Claims 17-20 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.
Claims 3, 5-6 & 12 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: Altarac et al. discloses the claimed invention as stated above, except wherein an internal wall of the interbody that defines the cavity having a first cross-sectional dimension at the one end of the cavity adjacent to the trailing surface and a second cross-sectional dimension at a closed end of the cavity opposite the one end of the cavity, the second cross-sectional dimension being larger than the first cross-sectional dimension, the internal wall having a terminal portion that flares outward at the closed end such that the protrusion of the flexible arm is receivable in the terminal portion, wherein the cavity defined in the interbody includes a neck between the one end of the cavity and a closed end of the cavity remote from the one end, and wherein the method comprises advancing the shaft of the insert through a neck of the cavity narrower than a closed end portion of the cavity, a cross-sectional dimension of the shaft narrowing while passing through the neck until the free end portion of the shaft reaches the closed end portion of the cavity. Furthermore, there is no reasonable motivation to modify Altarac et al. as claimed with the claimed features without destroying the invention since the insert of Altarac et al. is designed to extend completely through the cavity of the interbody and beyond in order for the retaining ring to act as a distal stop that abuts the inner surface of the interbody and prevent the insert from moving proximally out of the interbody.
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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