Prosecution Insights
Last updated: August 06, 2026
Application No. 19/218,561

EXPANDABLE LATERAL LUMBAR INTERBODY SPACER

Final Rejection §102§112
Filed
May 26, 2025
Priority
May 24, 2024 — provisional 63/651,902
Examiner
HARVEY, JULIANNA NANCY
Art Unit
3773
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Astura Medical Inc.
OA Round
2 (Final)
78%
Grant Probability
Favorable
3-4
OA Rounds
1y 7m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 78% — above average
78%
Career Allowance Rate
957 granted / 1228 resolved
+7.9% vs TC avg
Strong +19% interview lift
Without
With
+19.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
56 currently pending
Career history
1269
Total Applications
across all art units

Statute-Specific Performance

§101
3.9%
-36.1% vs TC avg
§103
38.9%
-1.1% vs TC avg
§102
26.0%
-14.0% vs TC avg
§112
23.8%
-16.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1228 resolved cases

Office Action

§102 §112
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 . Drawings The drawings were received on May 28, 2026. These drawings have been entered. 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 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 6 recites the limitation "the upper and lower anterior vertical endplate ramps" in line 2 of the paragraph beginning with “an anterior vertical expansion wedge.” There is insufficient antecedent basis for this limitation in the claim. Claims 7 and 8 are rejected because they depend from claim 6. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Valkoun et al. (US 2022/0395381 A1). Claim 1. Valkoun discloses an expandable spacer with lordosis for placement between adjacent vertebrae comprising: upper and lower anterior endplates (upper endplate 102A and lower endplate 104A) having upper and lower anterior endplate ramps (ramped features 132); an anterior vertical expansion wedge (vertical expansion shuttles 116A) having upper and lower anterior expansion wedge ramps (shuttle ramps 136) configured to engage the upper and lower anterior endplate ramps (see para. 0032) to vertically expand the upper and lower anterior endplates away from each other at a first expansion rate (see para. 0023 and Fig. 3); upper and lower posterior endplates (upper endplate 102B and lower endplate 104B) having upper and lower posterior endplate ramps (ramped features 132); and a posterior vertical expansion wedge (vertical expansion shuttles 116B) having upper and lower posterior expansion wedge ramps (shuttle ramps 136) configured to engage the upper and lower posterior endplate ramps (see para. 0032) to vertically expand the upper and lower posterior endplates away from each other at a second expansion rate (see para. 0023 and Fig. 3); wherein the first expansion rate is not the same as the second expansion rate (see Fig. 3, which shows that upper endplate 102A and lower endplate 104A expand at a greater rate than upper endplate 102B and lower endplate 104B), the unequal expansion creates lordosis for the expandable spacer (see para. 0023) (Figs. 1-8B; paras. 0021-0050). Claim 2. Valkoun discloses a drive means (screw 112, housing 110, and frame 108) coupled to the anterior and posterior expansion wedges (Figs. 1-8B; paras. 0021-0050). Claim 3. Valkoun discloses wherein the drive means includes a drive housing (housing 110) and a drive frame (frame 108) rotatably coupled to a drive screw (screw 112) configured to translate the drive housing and drive frame toward each other (see para. 0036) (Figs. 1-8B; paras. 0021-0050). Claim 4. Valkoun discloses anterior (expansion wedge 106A) and posterior (expansion wedge 106B) lateral expansion wedges coupled to the drive housing and drive frame, wherein actuation of the drive screw translates the drive housing toward the drive frame and laterally expand the anterior and posterior lateral expansion wedges away from each other (see para. 0036) (Figs. 1-8B; paras. 0021-0050). Claim 5. Valkoun discloses wherein the anterior and posterior vertical expansion wedges are positioned within anterior and posterior lateral expansion wedge slots (openings 134) (see Fig. 5) (Figs. 1-8B; paras. 0021-0050). Claim 6. Valkoun discloses an expandable spacer with lordosis for placement between adjacent vertebrae comprising: an anterior endplate (upper endplate 102A and lower endplate 104A) having anterior endplate ramps (ramped features 132) and a posterior endplate (upper endplate 102B and lower endplate 104B) having upper and lower posterior vertical endplate ramps (ramped features 132); an anterior vertical expansion wedge (vertical expansion shuttles 116A) with upper and lower anterior vertical expansion wedge ramps (shuttle ramps 136) configured to engage the upper and lower anterior vertical endplate ramps (see para. 0032); a posterior vertical expansion wedge (vertical expansion shuttles 116B) having upper and lower posterior vertical expansion wedge ramps (shuttle ramps 136) configured to engage the upper and lower posterior vertical endplate ramps (see para. 0032); and a drive means (screw 112, housing 110, and frame 108) coupled to the anterior and posterior expansion wedges, wherein actuation of the drive means is configured to translate anterior and posterior vertical expansion wedges (see paras. 0036-0037) and vertically expand the anterior endplates away from each other at a first expansion rate (see para. 0023 and Fig. 3), and vertically expand the posterior endplates away from each other at a second expansion rate (see para. 0023 and Fig. 3), wherein the difference between the first and second expansion rates create lordosis for the expandable spacer (see para. 0023) (Figs. 1-8B; paras. 0021-0050). Claim 7. Valkoun discloses wherein the drive means includes a drive housing (housing 110) coupled to the anterior and posterior vertical expansion wedges, a drive frame (frame 108), and a drive screw (screw 112), the drive screw having a distal end rotatably coupled to the drive housing and a proximal end rotatably coupled to the drive frame (see para. 0034), where actuation of the drive screw translates the drive housing toward the drive frame (see para. 0036) (Figs. 1-8B; paras. 0021-0050). Claim 8. Valkoun discloses anterior (expansion wedge 106A) and posterior (expansion wedge 106B) lateral expansion wedges having lateral expansion wedge ramps (see “angled ramp ends” in para. 0036) configured to engage drive frame ramps and drive housing ramps (see “angled ramps 126, 128 on the frame 108 and housing 110” in para. 0036)), wherein rotation of the drive screw translates the drive frame toward the drive housing and laterally translating the anterior and posterior lateral expansion wedges away from each other (see para. 0036) (Figs. 1-8B; paras. 0021-0050). Claim 9. Valkoun discloses an expandable spacer with lordosis for placement between adjacent vertebrae comprising: upper and lower anterior endplates (upper endplate 102A and lower endplate 104A) having upper and lower anterior endplate ramps (ramped features 132); an anterior expansion wedge (vertical expansion shuttles 116A) having two upper and lower anterior expansion wedge ramps (shuttle ramps 136) with flat sections (grooves that receive a projection of ramped features 132 as shown in Fig. 4; note that these grooves are flat surfaces) in between (the flat sections are in between the top and bottom shuttle ramps 136) configured to engage the upper and lower anterior endplate ramps (see para. 0032) to vertically expand upper and lower anterior endplates away from each other (see para. 0023 and Fig. 3); upper and lower posterior endplates (upper endplate 102B and lower endplate 104B) having upper and lower posterior endplate ramps (ramped features 132); a posterior expansion wedge (vertical expansion shuttles 116B) having upper and lower posterior expansion wedge ramps (shuttle ramps 136) with flat sections (grooves that receive a projection of ramped features 132 as shown in Fig. 4; note that these grooves are flat surfaces) in between (the flat sections are in between the top and bottom shuttle ramps 136) configured to engage the upper and lower posterior endplate ramps (see para. 0032) to vertically expand the upper and lower posterior endplates away from each other (see para. 0023 and Fig. 3); and a drive means (screw 112, housing 110, and frame 108) couple to the anterior and posterior expansion wedges, wherein activation of the drive means is configured to vertically expand the upper and lower anterior endplates away from each other at a first expansion rate and vertically expand the upper and lower posterior endplates away from each other at a second expansion rate (see paras. 0023 and 0036-0037; see Fig. 3), the difference between the first expansion rate and the second expansion rate creates lordosis for the expandable spacer (see para. 0023) (Figs. 1-8B; paras. 0021-0050). Claim 10. Valkoun discloses anterior (expansion wedge 106A) and posterior (expansion wedge 106B) lateral expansion wedges coupled to the drive means, wherein activation of the drive means is configured to laterally expand the anterior and posterior lateral expansion wedges away from each other (see para. 0036) (Figs. 1-8B; paras. 0021-0050). Response to Arguments Applicant's arguments filed May 28, 2026 have been fully considered but they are not persuasive. Applicant arguments regarding the Valkoun reference not qualifying as prior art due to common ownership (see pg. 7) are not persuasive. The Valkoun reference was published on December 15, 2022 and qualifies as a 35 U.S.C. 102(a)(1) reference. 35 U.S.C. 102(b)(1)(A) provides an exception for 35 U.S.C. 102(a)(1) for inventor-originated disclosures and states that the disclosure must (a) be made one year or less before the effective filing date of the claimed invention and (b) be made by the inventor or joint inventor (see MPEP 2153.01(a)). In the instant case, while the Valkoun reference satisfies (b) above, it fails to satisfy (a) above. The effective filing date of the claimed invention, taking the priority claim into consideration, is May 24, 2024 (the filing date of 63/651,902). The Valkoun reference, which as stated above was published on December 15, 2022, was published more than one year prior to the effective filing date of the claimed invention and therefore the grace period for an inventor-originated disclosure does not apply. Conclusion 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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
Read full office action

Prosecution Timeline

May 26, 2025
Application Filed
Nov 28, 2025
Non-Final Rejection mailed — §102, §112
May 28, 2026
Response Filed
Jun 17, 2026
Final Rejection mailed — §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
78%
Grant Probability
97%
With Interview (+19.0%)
2y 10m (~1y 7m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1228 resolved cases by this examiner. Grant probability derived from career allowance rate.

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