DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 1 is objected to because of the following informalities: In Line 10, the word --fixation-- should be added before the word “body”. 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 10 & 16-19 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 10 recites “wherein the guidance member comprises a keel and two adjacent flutes.” which renders the claim indefinite as Claim 9 from which Claim 10 depends previously recites “wherein the guidance member comprises a keel and at least one adjacent flute.” and thus it is unclear if Claim 10 is reciting an additional keel and two adjacent flutes, or if the claim is further defining that the at least one adjacent flute is two flutes. For purposes of examination, the claim is being interpreted as “wherein the at least one adjacent flute comprises two adjacent flutes”. Appropriate correction is required.
Claim 16 at Line 1 recites the term “wherein the at least one opening”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “further comprising at least one opening”. Appropriate correction is required.
Claim 17 at Line 1 recites the term “wherein the at least one opening”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “further comprising at least one opening”. Appropriate correction is required.
Claim 18 at Line 3 recites the term “and the at least one opening”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “further comprising at least one opening”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3-11, 13, 16, 17, 20 & 21 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Bae et al. (US PG Pub No. 2010/0204796).
Regarding Claim 1, Bae et al. discloses an implant (110, Figs. 1-4B, 7) for implantation in an intervertebral space defined between an upper vertebral body and a lower vertebral body (2, 4, Fig. 7), the implant comprising: a spacer body (intervertebral spacer 112, Figs. 3A-3B) having an outer wall (peripheral outer wall defining 112, Fig. 3B) that defines a periphery of the spacer body, the outer wall defining an outer surface (outer surface of peripheral outer wall defining 112, Fig. 3B) and an inner surface (inner surface of peripheral outer wall defining 112, Fig. 3B) opposite the outer surface; a guide aperture (upper 162 of 114, Fig. 4A); and a bone fixation member (upper 116, Figs. 6A-6B) configured to be inserted at least partially through the guide aperture (Figs. 1-2B) and into engagement with the upper vertebral body (Fig. 7), the bone fixation member comprising: a fixation body (body defining 116, Fig. 6A) having opposing proximal and distal ends (170, 168, respectively, Fig. 6A) that are spaced from one another along a longitudinal axis (axis running centrally through 116 through entire length between 170 & 168, Fig. 6B), the fixation body including a curved intermediate portion (172; OR See examiner annotated Fig. 6A below) extending between the proximal and distal ends, the distal end defining a tip (190, Figs. 6A-6B) configured to cut into bone; wherein the fixation body comprises tapered surfaces (left 194/right 194/197, Figs. 6A-6B, Paragraphs [0062-0063]) that at least partially define the tip and extend toward the proximal end (Fig. 6A).
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Regarding Claim 3, Bae et al. discloses wherein the guide aperture (upper 162, Fig. 4A) comprises a first open end (open end of 162 defined in surface 158, Fig. 4A) and a second open end (flared main opening of 162, Fig. 4A), and wherein the guide aperture is curved from the first open end to the second open end (162 is curved between the flared main opening and the open end portion as seen in Fig. 4A) such that the guide aperture is configured to receive the curved intermediate portion of the fixation body (at concave fillets, Fig. 1).
Regarding Claim 4, Bae et al. discloses wherein the fixation body comprises a concavity (window 191, Fig. 6B) that extends through at least a portion (184, Fig. 6A) near the tip of the fixation body.
Regarding Claim 5, Bae et al. discloses wherein the concavity extends at least from near the tip toward the proximal end (Fig. 6B).
Regarding Claim 6, Bae et al. discloses wherein the fixation body comprises a guidance member (plate 184, Fig. 6A-6B) disposed near the tip and extending toward the proximal end, the guidance member configured to guide the tip along an insertion trajectory as the fixation member is inserted into the vertebral body (Paragraphs [0059-0062]).
Regarding Claim 7, Bae et al. discloses wherein the guidance member comprises a concavity (window 191, Fig. 6B) that extends through at least a portion near the tip of the fixation body.
Regarding Claim 8, Bae et al. discloses wherein the guidance member comprises a keel (196, Fig. 6A), a first wing (first 195 on right of 184, Figs. 6A-6B) disposed adjacent the keel, and a second wing (first 195 on left of 184, Figs. 6A-6B) adjacent the keel opposite the first wing.
Regarding Claims 9-10 as best understood, Bae et al. discloses wherein the guidance member comprises a keel (198, Fig. 6A) and two adjacent flutes (each groove formed between the two rear-most 195 on either side of 184, Fig. 6A).
Regarding Claim 11, Bae et al. discloses wherein the outer wall defines at least one opening (holes 164 & 166, Fig. 4A & 1) extending from the outer surface to the inner surface.
Regarding Claim 13, Bae et al. discloses wherein the curved intermediate portion defines laterally extending teeth (teeth 195, when the curved intermediate portion is as seen in the examiner annotated Fig. above).
Regarding Claim 16, Bae et al. discloses wherein the at least one opening is configured for boney growth ingress (as seen in Fig. 1, the holes 164 & 166 extend through the implant in communication with central windows formed in the implant and thus are fully and structurally capable of boney growth ingress after implantation.).
Regarding Claim 17, Bae et al. discloses wherein the at least one opening comprises a pair of openings defined by the outer wall (holes 164 & 166, Figs. 4A & 1).
Regarding Claim 20, Bae et al. discloses wherein the fixation body of the bone fixation member defines a plurality of gripping structures (teeth 195, Figs. 6A-6B) configured to retain the curved bone fixation member in an inserted position within the at least one of the upper and lower vertebral bodies (Paragraph [0062]).
Regarding Claim 21, Bae et al. discloses wherein the plurality of gripping structures are defined on a keel (184, Figs. 6A-6B) of the bone fixation member.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12 & 14-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bae et al. (US PG Pub No. 2010/0204796).
Regarding Claim 12 as best understood, Bae et al. discloses the claimed invention as stated above in claim 1, except wherein the longitudinal axis is a curved longitudinal axis, wherein the curved intermediate portion extends along the curved longitudinal axis from the proximal end to the distal end. Bae et al. does disclose in Paragraph [0061] that “The present embodiment of the plate 184 is flat in the side view, as seen in FIG. 6A. Alternatively, plate 184 could be bent, curved, rounded, or otherwise shaped to resemble a “T”, “L”, “O'”, “Y”, “V”, rectangle, circle, oval, concave, convex, and variations thereof in the side view, or alternately, in a view from the leading end 168 or trailing end 170”. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the plate 184 of Bae et al. to be curved such that the longitudinal axis therethrough respectively curves as taught by Bae et al. as an alternate and functionally equivalent blade variation for engaging adjacent vertebrae.
Regarding Claim 14, Bae et al. discloses the claimed invention as stated above in claim 1, and further discloses an additional fixation member (lower 116, Figs. 6A-6B & 1) configured to be inserted at least partially through an additional guide aperture (lower 162, Figs. 4A & 1) of the implant. Bae et al. does not disclose a plurality of additional fixation members configured to be inserted at least partially through respective ones of additional guide apertures of the implant. However, in Fig. 11, a related implant embodiment 510 is depicted which includes two upper guide apertures and two upper fixation members (516) each inserted through one of the two upper guide apertures, and two lower guide apertures and two lower fixation members (516) each inserted through one of the two lower guide apertures.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the implant of Bae et al. to include two upper fixation members and two respective upper guide apertures therefor and two lower fixation members and two respective lower guide apertures as taught by Bae et al. as an alternate and functionally equivalent fixation arrangement for securably attaching the spinal implant to the patient’s surgical site.
Regarding Claim 15, Bae et al. discloses the claimed invention as stated above in claim 14, and further discloses wherein the implant comprises a fixation plate (114, Figs. 4A-4B & 5) joined to the spacer body (Fig. 1), the fixation plate defining the guide aperture and the additional guide apertures extending therethrough (Figs. 4A-4B, & 11).
Claims 18-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bae et al. (US PG Pub No. 2010/0204796) in view of Hochschuler et al. (US PG Pub No. 2010/0185292).
Regarding Claims 18-19 as best understood, Bae et al. discloses the claimed invention as stated above in claim 1, and further discloses wherein the outer wall comprises first and second sidewalls (left and right 126 & 126, Fig. 3B) opposite each other along a first direction (left to right horizontal direction when viewing Fig. 3A) and a posterior wall (124, Fig. 3B) opposite a fixation plate (114, Figs. 1, 2B 4A-4B) along a second direction (front to back horizontal direction between 122 & 124 when viewing Fig. 3B) that is perpendicular to the first direction. Bae et al. does not disclose wherein at least one opening extends through at least one of the first and second sidewalls, wherein the at least one opening comprises a first opening extending through the first sidewall and a second opening extending through the second sidewall. It is noted that the fixation plate 114 of Bae et al. does comprise a first opening extending through a first (left) sidewall thereof and a second opening extending through a second (right) sidewall thereof as seen in Figs. 4A, 5 & 1. One having ordinary skill in the art would recognize that it is well known and common in the art to provide intervertebral implants with various openings/apertures in the sidewalls thereof for bone ingrowth and promoting osteointegration.
Hochschuler et al. discloses various embodiments of vertebral implants, where one particular embodiment depicted in Fig. 8G comprises a spacer body defined by a peripheral outer wall including proximal and distal wall portions opposite each other in a front to back direction, left and right side wall portions opposing each other in a side to side direction and perpendicular to the front to back direction, wherein each of the left and right side wall portions comprise a plurality of windows/apertures formed therethrough.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the spacer body of Bae et al. to add a first plurality of openings extending through the first sidewall and a second plurality of openings extending through the second sidewall as taught by Hochschuler in order to provide the implant with additional locations for boney ingrowth.
Response to Arguments
In regards to Applicant’s arguments, filed 03/17/26, regarding the Lambrecht et al. rejection of Claim 1: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection based on the newly amended claims.
In regards to Applicant’s arguments, filed 03/17/26, regarding the Bae et al. rejection of Claim 2: The Applicant’s arguments have been fully considered but are moot as claim 2 has been cancelled.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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