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 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-19 of U.S. Patent No. 12,115,073.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 14 recites a system for insertion of a plate and cage assembly between vertebral bodies (See Claim 14, Lines 1-2 of the patent), comprising: the plate and cage assembly (See Claim 14, Lines 3-4 of the patent); and an insertion tool for inserting the plate and cage assembly between two of the vertebral bodies (See Claim 14, Lines 3-4 of the patent), wherein the insertion tool comprises: a carriage for holding at least one bone fastener by at least one clip having two opposing resilient arms and two opposing clasps attached respectively to the two opposing resilient arms; and push rods for pushing the at least one bone fastener through the carriage, through the plate and cage assembly, and into the adjacent vertebral bodies (See Claim 14, Lines 24-42 of the patent).
As to Claims 15-19 of the application: Claims 15-19 of the application are substantially similar to Claims 15-19 of the patent, respectively.
Claims 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 & 16-20 of U.S. Patent No. 11,576,785.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 14 recites a system for insertion of a plate and cage assembly between vertebral bodies (See Claim 13, Lines 1-3 of the patent), comprising: the plate and cage assembly (See Claim 13, Lines 3-33 of the patent); and an insertion tool for inserting the plate and cage assembly between two of the vertebral bodies (See Claim 13, Line 34 of the patent), wherein the insertion tool comprises: a carriage for holding at least one bone fastener by at least one clip having two opposing resilient arms and two opposing clasps attached respectively to the two opposing resilient arms; and push rods for pushing the at least one bone fastener through the carriage, through the plate and cage assembly, and into the adjacent vertebral bodies (See Claim 13, Lines 34-55 of the patent).
As to Claims 15-19 of the application: Claims 15-19 of the application are substantially similar to Claims 16, 20, 17, 18 & 19 of the patent, respectively.
Claim Objections
Claim 1 is objected to because of the following informalities:
In Line 15, the limitation --configured to be-- should be added before the word “coupled”.
In Line 15, the word “case” should be replaced with the word --cage--.
Appropriate correction is required.
Claim 14 is objected to because of the following informalities:
In Line 3, the limitation “the plate and cage assembly” should be replaced with --a plate and cage assembly--.
In Line 11, the word “adjacent” should be replaced with the word --two--.
Appropriate correction is required.
Claim 15 is objected to because of the following informalities: In Line 3, the word “adjacent” should be replaced with the word --two--. Appropriate correction is required.
Claim 20 is objected to because of the following informalities:
In Line 6, the word --tool-- should be added after the word “insertion”.
In Line 8, the word --two-- should be added before the word “adjacent”.
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 1-13 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 18-19 recites the limitation “the cage comprises a body section extending under both the engagement flange of the plate and the engagement channel of the cage;” which renders the claim indefinite as Lines 13-15 previously recite “the cage comprises an engagement flange disposed on a proximal side of the cage adjacent the plate, the plate comprises an engagement channel coupled to the engagement flange of the case” and thus it is unclear if the cage comprises the engagement flange or the engagement channel, and if the plate comprises the engagement channel or the engagement flange, since each instance is recited. For purposes of examination, Lines 18-19 are being interpreted as “the cage comprises a body section extending under both the engagement flange of the cage and the engagement channel of the plate;”. Appropriate correction is required.
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(s) 1, & 3-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouidja et al. (US PG Pub No. 2020/0352739).
Regarding Claim 1, Ouidja et al. discloses an assembly for stabilization of adjacent vertebral bodies (Figs. 15-20), comprising: a cage (200, Figs. 8-9) having a proximal wall (202), a distal wall (212), opposing sidewalls (208 & 210, Fig. 8), a superior surface (204) and an inferior surface (206, Fig. 9), the superior surface and the inferior surface for respectively engaging the adjacent vertebral bodies (Figs. 26 & 57, Paragraph [0138]); and a plate (300, Figs. 10-15) coupled to the cage at the proximal wall (via projections 378/378 coupling to apertures 226/226, Figs. 9 & 16-20, Paragraph [0196]), the plate having at least one hole (four holes 310-316, Fig. 10) traversing the plate at an angle (Figs. 10-14) for insertion of at least one bone fastener (400) into adjacent vertebral bodies (Fig. 57), wherein: the cage has an engagement hole (224, Fig. 9) in the proximal wall for engaging with a tip portion (126, Fig. 7) of an insertion device (100, Fig. 3, Paragraph [0139]), the plate has an alignment hole (354, Fig. 13) extending therethrough and aligned with the engagement hole in the proximal wall (Fig. 15, Paragraphs [0187-0188]), the cage comprises engagement recesses (226/226, Fig. 9) disposed on a proximal side of the cage (202) adjacent the plate, the plate comprises engagement flanges (378/378, Fig. 12) coupled to the engagement flange of the case (Paragraph [0196], Figs. 16-20), the engagement channel and the engagement flange configured to secure the plate to the cage (Paragraphs [0196, 0237]), the cage comprises a body section (222, Fig. 9) extending under both the engagement flanges and the engagement channels (Figs. 9, 12, 15), and the engagement hole (224) in the proximal wall of the cage is disposed at least partially in the body section of the cage (Fig. 9).
Ouidja et al. does not disclose that the engagement flanges are on the cage and the engagement channels are on the plate. However, Ouidja et al. discloses in Paragraph [0142] that “In other embodiments, the anterior surface 202 can comprise any of a variety of other shapes… The anterior surface 202 is dimensioned to allow stable connection to the cervical plate 300, as described herein. The convex portion 222 of the anterior surface 202 can have a curvature to match or mate with a curvature of the cervical plate 300, as described herein.”
It would have been obvious to one having ordinary skill in the art before the filing date of the invention to rearrange the respective engagement flanges and engagement channels of the plate and cage of Ouidja et al. such that the cage comprises the engagement flanges on the proximal side thereof and the plate comprises the engagement holes arranged for correspondingly coupling with the flanges of the cage as an alternate and functionally equivalent coupling arrangement between the plate and the cage since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding Claim 3, Ouidja et al. discloses the claimed invention as stated above in Claim 1, and further discloses wherein the cage and the plate are secured together by sliding the engagement channel of the plate and the engagement flange of the cage together (projections 378/378 are configured to slide into the respective holes 226/226 for coupling the plate to the cage, Paragraph [0196]).
Regarding Claim 4, Ouidja et al. discloses the claimed invention as stated above in Claim 1, and further discloses wherein the sliding is stopped by the body section comprising a landing (solid areas of 222 between left hole 226 & 224, and between 224 & right hole 226) at an intermediate position between the superior surface and the inferior surface (Fig. 9)(sliding stops when the surface 306 of plate 300 at the base of 378/378 abuts the solid areas of 222 between the holes 226/226 & 224, Figs. 18 & 20).
Regarding Claim 5, Ouidja et al. discloses the claimed invention as stated above in Claim 1, and further discloses wherein respective centers of the engagement hole and the alignment hole (central axes running through 224 & 354) lie on a common axis extending away from the proximal wall of the cage (224 & 354 are coaxial as seen in Figs. 15 & 20).
Regarding Claim 6, Ouidja et al. discloses the claimed invention as stated above in Claim 1, and further discloses a retention member (retainer ring, Paragraphs [0183-0184]) on the plate for preventing the at least one bone fastener from backing out from one of the adjacent vertebral bodies (“The retainer ring allows insertion of the anchor 400 in one direction but resists movement of the anchor 400 in the opposite direction. The retainer ring can resist backout of the anchor 400.”).
Regarding Claim 7, Ouidja et al. discloses the claimed invention as stated above in Claim 1, and further discloses corrugations (232, Fig. 8, Paragraphs [0146-0147]) on the superior surface and the inferior surface of the cage (“The engagement features 232 can include angled projections, barbs, teeth, or ramped surfaces which incline outwardly from one or more surface of the interbody implant 200.”, Figs. 8 & 17).
Regarding Claims 8-13, Ouidja et al. discloses the claimed invention as stated above in Claim 1, and further discloses wherein the least one bone fastener (anchors 400) comprises a curved bone fastener; wherein the curved bone fastener comprises corrugations disposed on exterior sidewalls of the curved bone fastener member, the exterior sidewalls separated from each other by a channel extending along a length of the curved bone fastener; wherein the curved bone fastener comprises: a proximal end, and a distal end having a tapered bone piercing element; wherein the tapered bone piercing element comprises a first tapered section and a second tapered section, the first tapered section extends from the corrugations to the second tapered section; and the second tapered section extends from the first tapered section to a tip of the first tapered section; wherein the curved bone fastener comprises: a rim at the proximal end for stopping against the at least one hole of the plate when the curved bone fastener is driven into one of the adjacent vertebral bodies; and wherein the curved bone fastener has a threaded hole in the proximal end for removal of the curved bone fastener from a vertebra (It is noted that the at least one bone fastener is not positively recited in Claim 1. Thus, the holes 310-316 of the plate 300 are fully and structurally capable of accepting bone fasteners having the structure recited in Claims 8-13 above as recited in the functional language of the claims.).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouidja et al. (US PG Pub No. 2020/0352739) in view of Pasquet et al. (US PG Pub No. 2003/0109928).
Regarding Claim 2, Ouidja et al. discloses the claimed invention as stated above in Claim 1, except wherein the engagement hole in the proximal wall of the cage comprises a blind hole.
Pasquet et al. discloses an intervertebral implant (10, Figs. 1-2, Abstract) comprising upper and lower walls (upper and lower surfaces 12 & 14, Fig. 1), a proximal wall (rear wall with 22, Fig. 2), a distal wall (leading wall opposite wall with 22, Fig. 1), and opposing side walls (left and right side walls of 10, Fig. 2), wherein the proximal wall comprises a blind engagement hole (22, Paragraph [0049]) for engaging with a tip portion of an insertion device (tool shown dashed in Fig. 2), wherein “The end of the insertion tool is inserted into the blind hole 22 and bears against said reinforcing second portion 16 so as to hold and guide the implant while it is being pushed into the intersomatic space.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the engagement hole in the proximal wall of the cage of Ouidja et al. to be a blind hole as taught by Pasquet et al. in order to allow the tip of the insertion tool to bear against the end of the blind hole as an alternate and functionally equivalent shaft/bore coupling arrangement between the cage and insertion tool.
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) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donner et al. (US PG Pub No. 2016/0338853).
Regarding Claim 14, Donner et al. discloses a system for insertion of a plate and cage assembly between vertebral bodies (Fig. 13F), comprising: a plate and cage assembly (100, Figs. 9K-9M, 13F, Paragraph [0104]); and an insertion tool (208, Figs. 13A-13F, Paragraphs [0145-154]) for inserting the plate and cage assembly between two of the vertebral bodies (Paragraph [0153]), wherein the insertion tool comprises: a carriage (216, Fig. 13A & 13F) for holding (via 210) at least one bone fastener (12C) by at least one clip (216, Fig. 13A) having two opposing resilient arms (224/224) and two opposing clasps (226/226) attached respectively to the two opposing resilient arms (Paragraph [0148]); and push rods (210, 240, Fig. 13E) for pushing the at least one bone fastener through the carriage (Fig. 13E), through the plate and cage assembly (Fig. 13E), and into the two vertebral bodies (Paragraph [0154]).
Allowable Subject Matter
Claims 15-20 are 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. The following is a statement of reasons for the indication of allowable subject matter: Donner et al. discloses the claimed invention as stated above in Claim 14, except wherein the push rods comprise three rods arranged to push a) two superior bone fasteners of the at least one bone fastener and b) an inferior bone fastener of the at least one bone fastener into the adjacent vertebral bodies simultaneously. Furthermore, there is no reasonable motivation to modify Donner with a third push rod without destroying the invention. Donner et al. does disclose three push rods in the embodiment of Figs. 14, however that embodiment does not comprise at least one clip with two opposing resilient arms and two opposing clasps in addition thereto and there is no reasonable motivation to this embodiment with the claimed carriage, arms and clasps 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