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 .
Information Disclosure Statement
The information disclosure statement filed October 23, 2025, fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claims 3, 9 and 15 are objected to because of the following informalities:
In Claim 3, at line 1, “a K-wire” should read ---the K-wire---
In Claim 9, at line 2, ---, respectively--- should be added following “the first or second retract arm”
In claim 15, at line 2, “the orthogonality” should read ---orthogonality---
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 12-14, 16-17 and 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.
Claims 12, 13 and 14 each recite the limitation "the alignment feature" (in line 1) and each depend from claim 10. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, claims 12, 13 and 14 will each be interpreted as depending from claim 11 in order to provide proper antecedent basis for the limitation noted above.
Claim 13 recites the limitation “the first or second retractor” (in line 2). There is insufficient antecedent basis for this limitation. For examination purposes, this limitation is interpreted as ---the first or second retractor arm---.
Claim 14 recites the limitation “the first or second retractor” (in line 2). There is insufficient antecedent basis for this limitation. For examination purposes, this limitation is interpreted as ---the first or second retractor arm---.
Claims 16-17 and 19 are rejected due to dependency on claim 14.
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 1-7, 9-13, 15, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miles (US 2015/0133735 A1).
Regarding claim 1, Miles teaches a method of using a surgical retractor, the method comprising:
(A) making an incision in a patient's skin at a position lateral to the patient's spine (it is understood that a lateral incision is made to perform the minimally invasive lateral surgical approach shown in Figs. 1 and 7-15, described in para. 0005, 0037 and 0040);
(B) locating a surgical site on the spine (shown in at least Fig. 7; para. 0024);
(C) inserting posterior and anterior retractor blades of the surgical retractor (see posterior blade 12 and anterior blade 14 of retractor 10 in Figs. 1 and 12; para. 0043), the surgical retractor comprising:
a base portion (mounting structure 20; Fig. 1; para. 0043) comprising first and second extensions (defined by first and second struts 26 and 28, respectively), the first extension having a first receiving area, the second extension having a second receiving area (first and second receiving areas defined between corresponding locking elements and respective first and second extensions/struts; Figs. 1, 15; para. 0056), and one or more engagement portions (defined by at least fixed strut 32, shown having a protrusion configured for fixing the base portion on a structure such as an articulating arm mounted to an operating table; Fig. 1; para. 0044);
a posterior retractor blade with proximal and distal ends, the posterior retractor blade having a first retractor arm extending from the proximal end (posterior blade structure 12 includes with a distal end engaging the spine and an opposite proximal end with a forked first retractor arm extending from the proximal end; Figs. 1-3; para. 0044), the first retractor arm configured to be slidingly received by the first receiving area of the base portion (first retractor arm of posterior blade structure 12 is split or forked to accommodate the respective locking assembly 36, as described in para. 0044, and slidably connected to the blade holder apparatus to move inward/outward with respect to the operative corridor, i.e. in the first receiving area defined between strut 26 and the locking assembly 36, as understood from claim 2; Fig. 1); and
an anterior retractor blade with proximal and distal ends, the anterior retractor blade having a second retractor arm extending from the proximal end (anterior blade structure 14 includes with a distal end engaging the spine and an opposite proximal end with a forked second retractor arm extending from the proximal end; Figs. 1-3; para. 0044), the second retractor arm configured to be slidingly received by the second receiving area of the base portion (second retractor arm of anterior blade structure 14 is split or forked to accommodate the respective locking assembly 36, as described in para. 0044, and slidably connected to the blade holder apparatus to move inward/outward with respect to the operative corridor, i.e. in the second receiving area defined between strut 28 and the locking assembly 36, as understood from claim 2; Figs. 1, 12-13);
wherein the posterior and anterior retractor blades together create an adjustable surgical corridor (see Figs. 12-15 and para. 0042); and
wherein the posterior and anterior retractor blades are independently adjustable relative to the base portion (as described in para. 0044 and claim 2; Fig. 1);
(D) advancing the surgical retractor toward the surgical site to create a surgical corridor to access the surgical site (as shown in Figs. 1 and 10-15);
(E) positioning the distal end of the posterior retractor blade at a posterior position of the surgical site (as shown in Figs. 10-11);
(F) anchoring the posterior retractor blade at the posterior position (via posterior shim element 22, as shown in Figs. 11-15; para. 0028, 0032, 0046); and
(G) enlarging the surgical corridor (shown in Figs. 7-15).
Regarding claim 2, Miles teaches the method of claim 1, wherein locating the surgical site on the spine comprises:
advancing a K-wire (42; Fig. 7; para. 0024) toward the surgical site and embedding a distal end (52; Fig. 7) of the K-wire into a tissue at the surgical site (shown in Fig. 7, described in para. 0053); and
sequentially advancing an inner dilator (defined by split dilator 48; Fig. 8; para. 0054) and an outer dilator (defined by dilating cannula 44; Fig. 7; para. 0069) over the K-wire toward the surgical site (as shown in Figs. 7-9).
Regarding claim 3, Miles teaches the method of claim 2, wherein advancing a K-wire toward the surgical site comprises traversing at least a portion of the psoas muscle (para. 0064, and claims 6 and 17, describe the retractor and dilator assemblies as being advanced in a trans-psoas path to the spine, so that advancing the K-wire 42 as shown in Fig. 7 is understood to involve traversing at least a portion of the psoas muscle).
Regarding claim 4, Miles teaches the method of claim 2, wherein at least one of the inner and outer dilators comprises at least one electrode and is configured to provide neural monitoring as the dilator is advanced toward the surgical site (inner dilator 48 includes electrode 62 and outer dilator 44 includes electrode 64, shown in Fig. 7 and described in para. 0051 “for the purpose of determining the location of nerves or neural structures relative to these components as they are advanced towards or positioned at or near the surgical target site”, i.e. to provide neural monitoring).
Regarding claim 5, Miles teaches the method of claim 4, wherein the at least one electrode is configured to provide a plexus map (where electrodes 62, 64 are described in para. 0051 for determining the location of nerves or neural structures, the electrodes are capable for providing a plexus map as generally shown in Figs. 17-19).
Regarding claim 6, Miles teaches the method of claim 2, wherein the inner and outer dilators are circular in cross section (see inner and outer dilators 48, 44 in at least Fig. 7, having a circular cross-section).
Regarding claim 7, Miles teaches the method of claim 2, wherein the inner and outer dilators are oval in cross section (see inner and outer dilators 48, 44 in at least Fig. 7, having a circular cross-section, i.e. an oval shape with zero eccentricity).
Regarding claim 9, Miles teaches the method of claim 1, wherein at least one of the posterior and anterior retractor blades is integral with the first or second retractor arm (see Figs. 1-3, the respective blade and forked arm portions of each of posterior blade 12 and anterior blade 14 are integral).
Regarding claim 10, Miles teaches the method of claim 1, wherein the posterior retractor blade defines an axis that is substantially orthogonal to an axis defined by the first retractor arm; and wherein the anterior retractor blade defines an axis that is substantially orthogonal to an axis defined by the second retractor arm (as shown in Figs. 1-3 and 10-15, the blade portion of each of posterior and anterior blade assemblies 12, 14 is substantially perpendicular to the forked arm portion at the proximal end) and wherein the respective axes of the posterior and anterior retractor blades are substantially parallel to each other and remain substantially parallel as the posterior and anterior retractor blades are independently adjusted relative to the base portion so as to adjust the size of the surgical corridor (as shown in at least Figs. 1 and 14).
Regarding claims 11-13, Miles teaches the method of claim 1, and further discloses [Claim 11] wherein at least one of the posterior and anterior retractor blades comprises at least one alignment feature at its proximal end, the alignment feature configured to provide an indication of the orthogonality of the surgical retractor relative to a surgical site (where the instant application, in para. 0037, describes the alignment feature as a bore “that extends from a top surface to a bottom surface” or a partial bore that provides indication of orthogonality due to visibility of the bore or partial bore, the split or forked configuration at the proximal portion of each of posterior blade 12 and anterior blade 14 defines an alignment feature providing visibility that can provide indication of the orientation, e.g. orthogonality, of the retractor relative to the surgical site; Figs. 1-3; para. 0044), [Claim 12] wherein the alignment feature is radiographically identifiable (the opening formed by the forked structure is radiographically identifiable; Fig. 1), and [Claim 13] wherein the alignment feature comprises a through hole in the proximal end of the first or second retractor (as shown; Figs. 1-3).
Regarding claim 15, Miles teaches the method of claim 10, wherein the surgical site is a disc space of a patient's spine and wherein the orthogonality of the surgical retractor relative to the disc space is achieved through a lateral procedure (as shown in Figs. 1 and 7-15).
Regarding claim 18, Miles teaches the method of claim 1, wherein the posterior and anterior retractor blades together form a tube when abutting each other (posterior blade 12 and anterior blade 14, together with blades 16 and 18, form a tube when positioned inwardly so as to abut each other; Fig. 1).
Regarding claim 20, Miles teaches the method of claim 1, wherein the posterior and anterior retractor blades (12, 14; Fig. 1) are configured to slide over a dilator (as shown between Figs. 7-15, over dilator(s) 44, 48 and/or 50).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Miles (US 2015/0133735 A1) in view of Lynn (US 2017/0143325 A1).
Regarding claim 8, Miles teaches the method of claim 1.
Miles does not disclose wherein at least one of the first and second receiving areas comprises an advancement mechanism that when rotated adjusts the position of the first or second retractor arm relative to the base portion.
Lynn, in analogous art, is directed towards a surgical retractor (2000; Fig. 1) that is “particularly useful in procedures using a lateral access approach to a targeted position of the spine” (see para. 0021), the retractor including a base (2010; Fig. 1) with receiving areas for slidably receiving retractor arms (as shown for receiving retractor arm portions 2020A-D in respective receiving areas of the base; Figs. 1-14; para. 0022-0023), and Lynn teaches wherein each receiving area comprises an advancement mechanism that when rotated adjusts the position of the first or second retractor arm (retractor arms 2020A-D are translatable through respective receiving areas of the base by means of a rack and pinion system coupled with respective knobs 2028A-D, each knob defining the claimed adjustment mechanism; Figs. 1-2; para. 0026-0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miles’s retractor by replacing the locking mechanisms tightened to secure each respective retractor arm in place relative to the base portion with Lynn’s rack and pinion system and adjustment knob for adjusting the position of the arms relative to the base portion, as claimed, because Lynn recognizes that such a configuration is useful to permit a surgeon to adjust the position of the retractor arms individually, and thus the blades connected thereto, enabling precise and easy adjustment of the blades into any one of a number of positions during a retraction procedure (see Lynn, para. 0026 and 0038).
Allowable Subject Matter
Claims 14, 16-17 and 19 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:
Claims 14, 16-17 and 19 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in claim 14. In particular, none of the cited references teach or suggest “wherein the alignment feature comprises a triangular-shaped through hole in the proximal end of the first or second retractor with the triangular-shaped through hole pointing toward the surgical corridor, as required by claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p 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.
/ANNA V. LITTLE/Examiner, Art Unit 3773
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
Prosecution Insights