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 .
Terminal Disclaimer
The terminal disclaimer filed on 03/31/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of related US Patent No. 12,150,863 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Drawings
The replacement drawings filed 03/31/26 have been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: In Line 14, the words --configured to be-- should be added before the word “located”. 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 1-6 & 8 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 14 recites the term “the posterior side bent portions”. There is insufficient antecedent basis for more than one posterior side bent portion. For purposes of examination, the limitation is being interpreted as “the posterior side bent portion”. Appropriate correction is required.
Claim 3 at Lines 2-3 recites the limitation “an anterior side straight portion of the anterior side straight portions” and at Lines 3-4 recites the limitation “posterior side straight portion of the posterior side straight portions”. (See also Claim 5 at Lines 2-3 where the posterior side straight portions are further disclosed.) There is insufficient antecedent basis for the terms “the anterior side straight portions” and “the posterior side straight portions” as these terms were deleted from Claim 1 in the amendment filed 03/31/26. For purposes of examination, the limitations are being interpreted as “an anterior side straight portion” and “a posterior side straight portion”. 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 & 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dye (US PG Pub No. 2008/0065219).
Regarding Claims 1 & 10 as best understood, Dye discloses an oblique spinal fusion cage (100, Figs. 1-8B, Paragraphs [0029-0062]) capable of being inserted in a direction inclined to a belly from a flank between vertebral bodies (Figs. 8A-8B), comprising: an anterior side portion (110, Fig. 4); a posterior side portion (112) formed at a distance from the anterior side portion; a medial side portion (106, Fig. 4) connected to the anterior side portion and the posterior side portion, at which insertion of the cage between vertebral bodies is initiated (Figs. 8A-8B); a lateral side portion (108, Figs. 2, 4 & 6A-7B) connected to the anterior side portion and the posterior side portion and configured to be coupled to an insertion device (insertion instrument 200, Figs. 6A-7B, Paragraphs [0036, 0052, 0054]); and an anterior side bent portion and a posterior side bent portion formed at central portions of the anterior side portion and the posterior side portion (See Fig. 4 depiction and notations below), respectively, which are bent so that centers of curvatures thereof are capable of facing an anterior side of a patient, such that the posterior side bent portion, the medial side portion, and the lateral side portion are capable of being located in cortical regions of the vertebral bodies (Figs. 8A-8B)), wherein the posterior side bent portion is capable of being located in posterior cortical regions of the vertebral bodies (The cage 100 is fully and structurally capable of being inserted and located between vertebral bodies and in the claimed regions of the vertebral bodies as recited in the functional language above.); wherein, in the anterior side portion, anterior side straight portions, which are straight sections, are formed between the medial side portion and the lateral side portion with the anterior side bent portion interposed therebetween (See Fig. 4 depiction and notations below), and in the posterior side portion, posterior side straight portions, which are straight sections, are formed between the medial side portion and the lateral side portion with the posterior side bent portion interposed therebetween (See Fig. 4 depiction and notations below), and wherein the anterior side straight portions and the posterior side straight portions are symmetrically disposed about an imaginary line which extends through centers of the posterior side portion and the medial side portion (See Fig. 4 depiction and notations below).
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Regarding Claim 7, Dye discloses wherein a maximum height H1 of the posterior side portion (112) is equal to or less than a maximum height H2 of the anterior side portion (110) (Fig. 1D, Paragraph [0041]).
Claim(s) 1 & 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maguire et al. (US PG Pub No. 2018/0116819).
Regarding Claims 1 & 10 as best understood, Maguire et al. discloses an oblique spinal fusion cage (10, Figs. 1-11D, Paragraphs [0056-0086]) capable of being inserted in a direction inclined to a belly from a flank between vertebral bodies (Fig. 1), comprising: an anterior side portion (See examiner annotated Fig. 7A depiction below); a posterior side portion formed at a distance from the anterior side portion (See examiner annotated Fig. 7A depiction below); a medial side portion (insertion end 12, Fig. 7A) connected to the anterior side portion and the posterior side portion (See examiner annotated Fig. 7A depiction below), at which insertion of the cage between vertebral bodies is initiated (Paragraph [0057]); a lateral side portion (trailing end 14, Fig. 7A) connected to the anterior side portion and the posterior side portion (See examiner annotated Fig. 7A depiction below), the lateral side portion configured to couple to an insertion device (via indentations 98 for engagement with insertion tool, Fig. 2B, Paragraphs [0069, 0077]); and an anterior side bent portion and a posterior side bent portion formed at central portions of the anterior side portion and the posterior side portion, respectively (See examiner annotated Fig. 7A depiction below), which are bent so that centers of curvatures thereof are configured to face an anterior side of a patient (Figs. 4A & 1), such that the posterior side bent portion, the medial side portion, and the lateral side portion are configured to be located in cortical regions of the vertebral bodies (Fig. 1, Paragraph [0080]), wherein the posterior side bent portion is capable of being located in posterior cortical regions of the vertebral bodies (The cage 10 is fully and structurally capable of being inserted and located between vertebral bodies and in the claimed regions of the vertebral bodies as recited in the functional language above); wherein, in the anterior side portion, anterior side straight portions, which are straight sections, are formed between the medial side portion and the lateral side portion with the anterior side bent portion interposed therebetween (See examiner annotated Fig. 7A depiction below), and in the posterior side portion, posterior side straight portions, which are straight sections, are formed between the medial side portion and the lateral side portion with the posterior side bent portion interposed therebetween (See examiner annotated Fig. 7A depiction below), and wherein the anterior side straight portions and the posterior side straight portions are inclined at the same angle on both sides symmetrically about an imaginary line which extend through the posterior side portion and the medial side portion (See examiner annotated Fig. 7A depiction below).
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Regarding Claim 7, Maguire et al. discloses wherein a maximum height H1 of the posterior side portion is equal to a maximum height H2 of the anterior side portion (D2 is the expanded height of the implant, Fig. 7D, Paragraph [0076]. D2 measured at the center portion adjacent to 28 of the anterior and posterior side portions as seen in Figs. 2A-2B, 7C & 7D is equal. Paragraph [0079]).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dye (US PG Pub No. 2008/0065219) in view of Messerli et al. (US PG Pub No. 2011/0160864).
Regarding Claim 2, Dye discloses the claimed invention as stated above in claim 1, and further discloses wherein the anterior side bent portion has a radius of curvature R1 and wherein the posterior side bent portion has a radius of curvature R2 (See Fig. 6A depiction and notations below).
Dye does not disclose that the radius of curvature R1 of the anterior side bent portion is equal to or less than the radius of curvature R2 of the posterior side bent portion. Although it appears from the figures that R1 would be ≤ R2, Dye does not specifically recite or describe R1 or R2.
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Messerli discloses an arcuate fusion cage (implant 22, Figs. 16A-16E, Paragraph [0058]) comprising opposing anterior (26) and posterior sides (24, Fig. 16C), and opposing medial (left side 25) and lateral sides (right side 79, Fig. 16C), wherein the anterior and posterior sides are substantially parallel and are each defined by radii of curvature (R2 is the radius of curvature of the anterior side 26, and R1 is the radius of curvature of the posterior side 24, Fig. 16C, Paragraph [0058]), wherein R2 may be in the range of 15 to 25 mm and R1 may be in the range of 25 to 35 mm (Paragraph [0058]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cage of Dye so that R1 ≤ R2 as taught by Messerli in order to provide an arcuate shaped implant arranged based on a particular patient’s needs.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US PG Pub No. 2018/0116819) in view of Messerli et al. (US PG Pub No. 2011/0160864).
Regarding Claim 2, Maguire et al. discloses the claimed invention as stated above in claim 1, and further discloses wherein the anterior side bent portion has a radius of curvature R1 and wherein the posterior side bent portion has a radius of curvature R2 (Figs. 4G, 4H, 7C).
Maguire et al. does not disclose that R1 is equal to or less than R2. Although it appears from the figures that R1 would be less than or equal to R2, Maguire et al. does not specifically recite or describe R1 or R2.
Messerli discloses an arcuate fusion cage (implant 22, Figs. 16A-16E, Paragraph [0058]) comprising opposing anterior (26) and posterior sides (24, Fig. 16C), and opposing medial (left side 25) and lateral sides (right side 79, Fig. 16C), wherein the anterior and posterior sides are substantially parallel and are each defined by radii of curvature (R2 is the radius of curvature of the anterior side 26, and R1 is the radius of curvature of the posterior side 24, Fig. 16C, Paragraph [0058]), wherein R2 may be in the range of 15 to 25 mm and R1 may be in the range of 25 to 35 mm (Paragraph [0058]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cage of Maguire et al. so that R1 < R2 as taught by Messerli in order to provide alternate and functionally equivalent arcuate-shaped implant which is shaped based on a particular patient’s needs.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dye (US PG Pub No. 2008/0065219).
Regarding Claim 3 as best understood, Dye discloses the claimed invention as stated above in claim 1, and further discloses a radius of curvature R2 of the posterior side bent portion (See Fig. 6A depiction and notations above), a radius of curvature R1 of the anterior side bent portion (See Fig. 6A depiction and notations above), and wherein a maximum distance between an outer edge of an anterior side straight portion and an outer edge of a posterior side straight portion is a width of the fusion cage W1 (See Fig. 6A depiction and notations above).
Dye does not disclose wherein a radius of curvature R2 of the posterior side bent portion is equal to a sum of a radius of curvature R1 of the anterior side bent portion and the width W1. However, as seen in the figures, the implant of Dye is structurally similar to the implant of the instant application, and although Dye does not teach any values for R1, R2, or W1, one having ordinary skill in the art would recognize that the relationships therebetween appear to be taught by Dye.
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 cage of Dye so that the radius of curvature R2 of the posterior side bent portion is equal to a sum of the radius of curvature R1 of the anterior side bent portion and the width W1 since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233. Furthermore, it would have been routine optimization to arrive at the claimed invention based on the size and anatomy of a particular patient (i.e. a child versus an adult) and a person having ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range since it is well known and common in the art to provide fusion cages in varying sizes and shapes for different patients and different procedures.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US PG Pub No. 2018/0116819).
Regarding Claim 3 as best understood, Maguire et al. discloses the claimed invention as stated above in claim 1, and further discloses wherein the anterior side bent portion has a radius of curvature R1 and wherein the posterior side bent portion has a radius of curvature R2 (Figs. 4G, 4H, 7C), and wherein a maximum distance between an outer edge of an anterior side straight portion and an outer edge of a posterior side straight portion is a width of straight portion W1 (See examiner annotated Fig. 7A depiction above, Fig. 7C, Paragraph [0076]).
Maguire et al. does not disclose wherein a radius of curvature R2 of the posterior side bent portion is equal to a sum of a radius of curvature R1 of the anterior side bent portion and W1. However, Maguire does disclose in Paragraph [0076] that “It is noted that in Paragraph [0079], Maguire discloses that “The implant 10 also has a width, and in one embodiment, the first and second bone contacting surfaces 32 and 132 can define a dimension in the lateral direction A as desired, such as between 8 mm and 12 mm.” (Fig. 2A) Furthermore, as seen in the figures, the implant of Maguire is structurally similar to the implant of the instant application, and although Maguire does not teach any values for R1 & R2, one having ordinary skill in the art would recognize that the relationships therebetween appear to be taught by Maguire et al.
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 cage of Maguire et al. so that the radius of curvature R2 of the posterior side bent portion is equal to a sum of the radius of curvature R1 of the anterior side bent portion and the width W1 since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233. Furthermore, it would have been routine optimization to arrive at the claimed invention based on the size and anatomy of a particular patient (i.e. a child versus an adult) and a person having ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range since it is well known and common in the art to provide fusion cages in varying sizes for different patients and different procedures.
Allowable Subject Matter
Claims 4-6 & 8 would be allowable if rewritten to properly 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 clarify the claims, and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s replacement drawings, filed 03/31/26, have overcome the drawing objection.
Applicant’s amendments, filed 03/31/26, have overcome the objections to claims 1, 2, 4, 7, & 9.
Applicant’s amendments, filed 03/31/26, have overcome the 112(b) rejections for claims 1, 3, 4, 8, & 9.
In regards to Applicant’s arguments, filed 03/31/26, with respect to the contention that Dye and Messerli are TLIF cages configured to be positioned in the vertebral body exactly opposite to the cage of present claim 1, and Maguire is a TLIF implant and thus the references fail to disclose or suggest a OLIF cage inserted and located in the manner recited in claim 1: The Applicant’s arguments have been fully considered but are not persuasive as a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The cages of both Dye and Maguire are fully and structurally capable of being inserted in a direction inclined to a belly from a flank between vertebral bodies such that the posterior side bent portion is located in posterior cortical regions of the vertebral bodies. The overall peripheral shape and footprint of the instant invention and the Dye and Maguire cages is structurally similar and thus can be inserted and located in a disc space with respect to the vertebral bodies in the same manner as the Applicants cage. It is suggested that further structure be added to clarify the invention over the art in order to overcome the rejections above.
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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