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 .
Response to Arguments
Applicant's arguments filed July 1st, 2026 have been fully considered but they are not persuasive.
Applicant argues that Blackwell fails to teach or disclose the newly amended features of claims 1 and 14. The Examiner respectfully disagrees with this assertion. As outlined below in greater detail, the new interpretation of Blackwell teaches the newly amended subject matter. The frames are now considered elements 100 and 102 which comprise the blocking mechanism 28 as required by the newly amended claims. Additionally, the disclosure in ¶33 of Blackwell is a sufficient teaching of the channel oriented along a direction that differs from the blade direction.
Next, Applicant argues that Prasad et al. fails to teach or disclose the newly amended features of claims 1 and 14. The Examiner respectfully disagrees with this assertion. As outlined below in greater detail, the new interpretation of Blackwell teaches the newly amended subject matter. The frames (38, 40) have features (38a, 40a) in which a blocking mechanism (20) is included on the frame (features 20d, 2e) engage features (38a, 40a) to place it ON the frame as they are in engagement with one another. Element 20 of Prasad et al. acts as a blocking mechanism as it prevents lateral translation/movement of the blades and frames relative to one another when connected to the blocking mechanism. Lastly, Applicant argues that the drawing objection is inappropriate. Specifically stating that “The applicant shall furnish a drawing where necessary for the understanding of the subject matter south to be patented”. The Examiner agrees and it is necessary for Applicant to furnish a drawing depicting the scope of claims 9 and 17. One cannot ascertain the distal end and its radio opaque distal end/marker without the presence of the drawing. The same rationale applies to the specification objection. The absence of disclosure in the current specification and the parent PCT specification lack antecedence for these claimed features. The Examiner suggest applicant cancel these claims to rectify the drawing and specification issues.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification fails to provide support for “the dilator having a radio opaque distal end or includes any kind of marker and can be used to measure or control the position of a cage or implant to be placed in between the vertebral bodies” as required by claims 9 and 17.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the dilator having a radio opaque distal end or includes any kind of marker and can be used to measure or control the position of a cage or implant to be placed in between the vertebral bodies” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-7, 11 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blackwell et al. (US 2009/0036746).
Regarding claim 1, Blackwell et al. disclose a retractor system for spine surgery comprising two retractor members (22+100 , 24+102) each comprising a blade (22, 24) and a proximal part forming a frame (100, 102), at least two pins (26a, 26b) having each a distal end (72) configured to be anchored in a vertebra, and a blocking mechanism (28) included on the frame (¶43) and configured for maintaining the retractor members at a certain distance from each other (figure 1); wherein at least one retractor member contains a channel (50) that is configured to slidably hold a pin (figures 1, 4); wherein the channel is oriented along a direction that differs from the blade direction (the blade extends at 90 degrees relative to the pin and is also laterally offset from the centerline, ¶33).
Regarding claim 2, Blackwell et al. disclose the channel (50) is extending along the full blade length (figures 2-4, ¶37).
Regarding claim 3, Blackwell et al. disclose the channel is a groove (50, figure 2).
Regarding claim 6, Blackwell et al. disclose a dilator (160) for expanding the retractor, wherein said dilator is configured to be slidably mounted between the blades (figure 6).
Regarding claim 7, Blackwell et al. disclose the dilator contains at least one groove (164a, 164b) that is configured to slidably hold said pin (10), together with the said blade groove (figure 7). Regarding claim 11, Blackwell et al. disclose wherein each retractor member includes two arms (88, 94, figure 2). Regarding claim 14, Blackwell et al. disclose a retractor system for spine surgery comprising two blades (22+100, 24+102) having each a proximal part forming a frame (100, 102), a blocking mechanism (28) included on the frame (¶43) and configured for maintaining the blades at a certain distance from each other (figure 1), and at least one dilator (160) for expanding the retractor, wherein said dilator is configured to be slidably mounted between the blades (figure 6).
Regarding claim 15, Blackwell et al. disclose the dilator contains at least one groove (164a, 164b) that is configured to slidably hold said pin, together with the said blade groove (figure 7).
Claims 1, 4-5, 10 and 12-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Prasad et al. (US 2020/0237358).
Regarding claim 1, Prasad et al. disclose a retractor system for spine surgery comprising two retractor members (see figure below) each comprising a blade (26, 28) and a proximal part forming a frame (38, 40), at least two pins (32’s) having each a distal end (32b) configured to be anchored in a vertebra (figure 8), and a blocking mechanism (20) included on the frame (via engagement of 38a and 40a with 20d and 20e) and configured for maintaining the retractor members at a certain distance from each other (figure 2); wherein at least one retractor member contains a channel (50) that is configured to slidably hold a pin (¶19, figure 2); wherein the channel is oriented along a direction that differs from the blade direction (the blade differs in direction as it flairs at its distal end and the pin is entirely straight).
Regarding claim 4, Prasad et al. disclose the channel distal part is a groove (see figure below) and the channel proximal part is a ring (see figure below). Regarding claim 5, Prasad et al. disclose each blade contains a channel that is configured to slidably hold one pin (figure 2).
Regarding claim 10, Prasad et al. disclose a shim (36) located between the blades (figures 3-4)
Regarding claim 12, Prasad et al. disclose each retractor member includes only one arm (38, 40 are arms).
Regarding claim 13, Prasad et al. disclose a retractor system for spine surgery comprising two blades (26, 28) having each a proximal part forming a frame (38, 40), a blocking mechanism (20) included on the frame (via engagement of 38a and 40a with 20d and 20e) for maintaining the blades at a certain distance from each other (figure 2), and at least one shim (36) slidably mounted between the blades and comprising lateral linear guiding grooves (formed between 36c and main shim body); characterized by the fact that the guiding grooves end before the shim distal end (figures 3-4).
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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.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Blackwell et al. (US 2009/0036746) in view of Villamil et al. (US 2022/0265256).
Regarding claims 8 and 16, Blackwell et al. disclose the claimed invention except for the dilator being made of two members that interlock together by means of guides.
Villamil et al. disclose the use of a dilator (110) made of two members (111, 112) that interlock together (¶38) by means of guides (¶38, inner surface of 112 and outer surface of 111 act as guides and interlock and nest 111 within 112) as the use of two members allows for gradual, progressive dilation of the tissue reducing the likelihood of ripping or tearing of the tissue.
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Blackwell et al. (US 2009/0036746) in view of Altarac et al. (US 2007/0239159).
Regarding claims 9 and 17, Blackwell et al. disclose the claimed invention except for the dilator has a radio opaque distal end or includes any kind of marker and can be used to measure or control the position of a cage or an implant to be placed in between vertebral bodies. Altarac et al. disclose a dilator (1112) which has a radiopaque distal end (¶301, figures 56-58) or includes any kind of marker (¶301) these elements may be used for a variety of purposes, such as to facilitate rotational alignment or orientation (within a single tool, between different tools, and/or between one or more tools and the patient's spine), to measure insertion depth or rod length, to determine engagement or deployment status, or any combination thereof (¶323).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the dilator of Blackwell et al. to include a radio opaque distal end or includes any kind of marker as taught by Altarac et al. as these indicators may be used for a variety of purposes, such as to facilitate rotational alignment or orientation (within a single tool, between different tools, and/or between one or more tools and the patient's spine), to measure insertion depth or rod length, to determine engagement or deployment status, or any combination thereof as taught by Altarac et al.
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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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