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 .
Status of the Claims
This Office Action is responsive to the amendment filed July 3, 2025. As directed by the amendment: Claims 1, 4, 6-8, and 10-17 have been amended. Claims 1-17 are presently pending in this application.
Examiner’s Note
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.
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) 1-3, 5-9, and 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perrow (US 8,702,600).
Regarding claim 1, Perrow discloses a blade alignment device (410) (figures 20 and 21) adapted for (i.e. capable of) use with a retractor device (600) (figures 20 and 21) to maintain a position of a plurality blades (412, 414) of the retractor device (600) relative to one another while the blade alignment device (410) is removably inserted in the retractor (600) (figure 20), and wherein the blade alignment device (410) is configured to (i.e. capable of) releasably disengage from the retractor device (600) (figure 21) and allow the plurality of blades (412, 414) to move relative to one another (figure 24) when the blade alignment device (410) is removed from the retractor device (600) (figure 21), the blade alignment device (410) comprising an elongated body (410) and a blade engagement arrangement (e.g. 416, 418, 432), the elongated body (410) includes first and second ends (figure 8), a first end portion (opposite of element 434), and a second end portion (434), the blade engagement arrangement (e.g. 416, 418, 432) located at the second end portion (434), the blade engagement arrangement (e.g. 416, 418, 434) has a longitudinal length that is less than the longitudinal length of the elongated body (410) (figures 8 and 21), the blade engagement arrangement (e.g. 416, 418, 434) is only located on a bottom half of the elongated body (410) (figures 8 and 21), the blade engagement arrangement (e.g. 416, 418, 434) is 2-40% of a longitudinal length of the elongated body (410) (figure 8), the blade engagement arrangement (e.g. 416, 418, 434) includes a first retention structure (416), the first retention structure (416) is configured to (i.e. capable of) at least partially surround or engage a portion of a plurality of blades (412, 414) on the retractor device (600) (figure 20) to facilitate in maintaining alignment or position of the plurality of blades (412, 414) relative to one another when the plurality blades are in a closed position (figure 20) on the retractor device (600).
Regarding claim 2, Perrow discloses wherein the elongated body has a generally cylindrical shape (figure 8) between the first end portion (opposite of element 434) and the second end portion (434).
Regarding claim 3, Perrow discloses wherein the elongated body (410) has an internal cavity (figure 8) that runs along 50-100% a longitudinal length of the elongated body (figure 8).
Regarding claim 5, Perrow discloses wherein the first retention structure (416) includes first and second side walls (figure 8) that are configured to (i.e. capable of) at least partially entrap or surround at least a portion of a plurality of blades of the retractor device when the blades are in the closed position (figure 20).
Regarding claim 6, Perrow discloses wherein the first and second side walls (figure 8) angle inwardly toward one another (figures 3A and 8), the first and second side walls (figure 8) extends outwardly from an outer perimeter of the elongated body (figures 3A and 8).
Regarding claim 7, Perrow discloses further including a second retention structure (418) on the blade engagement arrangement (figure 8), the second retention structure (418) is configured to (i.e. capable of) at least partially surround or engage a portion of a plurality of blades on the retractor device (600) to facilitate in maintaining alignment or position of the plurality of blades relative to one another when the plurality blades are in a closed position (figure 20), the first and second retention structures (416, 418) are spaced from one another (figure 8).
Regarding claim 8, Perrow discloses wherein the second retention structure (418) includes first and second side walls (figures 8 and 9) that are configured to (i.e. capable of) at least partially entrap or surround at least a portion of a plurality of blades of the retractor device (600) when the blades are in a closed position (figure 20), the first and second side walls on the second retention structure (418) angle inwardly toward one another (figures 3A and 8), the first and second side walls on the second retention structure (418) extends outwardly from an outer perimeter of the elongated body (figures 3A and 8).
Regarding claim 9, Perrow discloses wherein at least one of the first and second retention structures (416 or 418) has a generally C-shaped configuration (figure 8).
Regarding claim 12, Perrow discloses a method of using a blade alignment device (410) (figures 20 and 21) to at temporarily maintain alignment or positioning of a plurality of retractor device blades (412, 414) relative to one another when the plurality of retractor device blades (412, 414) are in a closed position (figure 20) and while the blade alignment device (410) is releasably connected to the plurality of retractor device blades (412, 414) (figures 20 and 21), the method comprising providing a retractor device (600), the retractor device (600) comprising a body (figures 20 and 21), first and second arms (604, 606), a first blade (412) connected to the first arm (604), and a second blade (414) connected to the second arm (606), the first and second blades (412, 414) are movable between a closed position (figure 21) and an open position (figure 24), the first and second blades (412, 414) at least partially form a blade cavity (figures 21 and 22) when the first and second blades (412, 414) are in the closed position (figure 21), providing a blade alignment device (410), the blade alignment device (410) is adapted for (i.e. capable of) use with the retractor device (600), the blade alignment device (410) comprising an elongated body (410) (figure 8) and blade engagement arrangement (e.g. 416, 418, 432), the elongated body (410) includes first and second ends (figure 8), a first end portion (opposite of element 434), a second end portion (434), the blade engagement arrangement (e.g. 416, 418, 432) located at the second end portion (434) (figure 8), the blade engagement arrangement (e.g. 416, 418, 432) has a longitudinal length (figure 8) that is less than the longitudinal length of the elongated body (410) (figure 8), the blade engagement arrangement (e.g. 416, 418, 432) is only located on a bottom half of the elongated body (figure 8), the blade engagement arrangement (e.g. 416, 418, 432) is 2-40% of a longitudinal length of the elongated body (figure 8), the blade engagement arrangement (e.g. 416, 418, 432) includes a first retention structure (416), the first retention structure (416) is configured to (i.e. capable of) at least partially surround or engage a portion of a plurality of blades (412, 414) on the retractor device (600) to facilitate in maintaining alignment or position of the plurality of blades relative to one another when the plurality of blades (412, 414) are in a closed position on the retractor device (figure 20), positioning the plurality of blades of the retractor device (600) in the closed position (figure 20), releasably inserting the blade alignment device (410) (figure 20) in the blade cavity while the plurality of blades (412, 414) of the retractor device (600) in the closed position (figure 20) such that the first retention structure (416) at least partially surrounds or engages a portion of the first and second blades (412, 414) to facilitate in maintaining alignment or position of the first and second blades relative to one another when the first and second blades (412, 414) are in the closed position (figure 20), and removing the blade alignment device (410) from the retractor device (600) (figure 21) to enable the plurality of blades (412, 414) of the retractor device (600) to move relative to one another during use of the retractor device (figure 24).
Regarding claim 13, Perrow discloses wherein each of the first and second blades (412, 414) includes first and second side walls (figures 20 and 21) that are arcuate shaped (figures 20 and 21), and wherein an end portion of each of the first and second side walls (figures 5, 5A, 6) includes an outwardly extending wall flange (figures 5, 5A, 6), the first and second wall flanges (figures 5, 5A, 6) run partially or fully along a longitudinal length of the first and second blades (412, 414), and wherein the first retention structure (416) is configured to (i.e. capable of) at least partially surround, engage, or entrap a portion of the first side wall on the first blade (412) and the second side wall of the second blade (414) when the blade alignment device (410) is at least partially inserted in the blade cavity (figure 20).
Regarding claim 14, Perrow discloses wherein the longitudinal length of the elongated body (410) is 80-150% a longitudinal length of the first blade (412) or the second blade (414).
Regarding claim 15, Perrow discloses a method for using a retractor device (600) (figures 20 and 21) in a patient comprising providing a retractor device (600), the retractor device (600) comprising a body (figures 20 and 21), first and second arms (604, 606), a first blade (412) connected to the first arm (604), and a second blade (414) connected to the second arm (606), the first and second blades (412, 414) are movable between a closed position (figure 21) and an open position (figure 24), the first and second blades (412, 414) at least partially form a blade cavity (figures 21 and 22) when the first and second blades (412, 414) are in the closed position (figure 21), positioning the first and second blades (412, 414) of the retractor device (600) in the closed position (figure 20), providing a blade alignment device (410), the blade alignment device (410) is adapted for (i.e. capable of) use with the retractor device (600) (figures 20 and 21), the blade alignment device (410) comprising an elongated body (figure 8) and a blade engagement arrangement (e.g. 416, 418, 432), the blade engagement arrangement (e.g. 416, 418, 432) includes first and second ends (figure 8), a first end portion (opposite of element 434), and a second end portion (434), the blade engagement arrangement (e.g. 416, 418, 432) has a longitudinal length (figure 8) that is less than the longitudinal length of the elongated body (410) (figure 8), the blade engagement arrangement (e.g. 416, 418, 432) is only located on a bottom half of the elongated body (410) (figure 8), the blade engagement arrangement (e.g. 416, 418, 432) is 2-40% of a longitudinal length of the elongated body (410) (figure 8), the blade engagement arrangement includes a first retention structure (416), the first retention structure (416) is configured to (i.e. capable of) at least partially surround or engage a portion of a plurality of blades (412, 414) on the retractor device (600) to facilitate in maintaining alignment or position of the plurality of blades (412, 414) relative to one another when the plurality of blades (412, 414) are in a closed position (figure 20) on the retractor device (600), at last partially inserting the blade alignment device (410) (figure 20) in the blade cavity (figure 20) such that the first retention structure (416) at least partially surrounds or engages a portion of the first and second blades (412, 414) to facilitate in maintaining alignment or position of the first and second blades (412, 414) relative to one another when the first and second blades (412, 414) are in the closed position (figure 20) while the blade alignment device (410) is at least partially positioned in the blade cavity (figure 20), inserting at least a portion of the first and second blades (412, 414) of the retractor device (600) into the patient (figure 20) until a front end of the first and second blades (412, 414) is located at a desired location in the patient (figure 20), removing the blade alignment device (10) from the retractor device (600) (figure 21), and, causing the first and second blades (412, 414) to move from the closed position (figure 22) to the open position (figure 24) while at least a portion of the first and second blades (412, 414) are located in the patient (figures 22 and 24), and wherein the maintaining alignment or position of the first and second blades (412, 414) relative to one another by the blade alignment device (410) inhibits or prevents one or more of a) a distal end of the first and second blades of the retractor device from becoming misaligned due to contact with bone or tissue as the first and second blades of the retractor device are inserted into the patient, b) damage to the first and second blades of the retractor device or other components of the retractor device due to bending or twisting of one or more of the first and second blades, c) improper insertion of the retractor device (600) into the patient (figure 20), and d) undesired injury or damage to bone or tissue as the first and second blades of the retractor device are inserted into the patient.
Regarding claim 16, Perrow discloses wherein each of the first and second blades (412, 414) includes first and second side walls (figures 20 and 21) that are arcuate shaped (figures 20 and 21), and wherein an end portion of each of the first and second side walls (figures 5, 5A, 6) includes an outwardly extending wall flange (figures 5, 5A, 6), the first and second wall flanges (figures 5, 5A, 6) run partially or fully along a longitudinal length of the first and second blades (412, 414), and wherein the first retention structure (416) is configured to (i.e. capable of) at least partially surround, engage, or entrap a portion of said first side wall on the first blade (412) and the second side wall of the second blade (414) when the blade alignment device (410) is at least partially inserted in the blade cavity (figures 21 and 22).
Regarding claim 17, Perrow discloses wherein the longitudinal length of the elongated body (410) is 80-150% a longitudinal length of the first blade (412) or the second blade (414) (figure 21).
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) 4, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perrow (US 8,702,600) in view of Bush, JR. et al. (US 2019/0053826), herein referred to as Bush, JR.
Regarding claim 4, Perrow’s blade alignment device discloses all the features/elements as claimed but lacks further including a gripping member that is positioned on the first end portion of the elongated body, the gripping member includes one or more features selected from the group consisting of a groove, a rib, a slot, and a roughened region, the gripping member is located no more than 30% of the longitudinal length of the elongated body.
However, Bush, JR. teaches a gripping member (320) that is positioned on a first end portion (301) of an elongated body (300) (figure 9), the gripping member (320) includes one or more features selected from the group consisting of a groove, a rib (¶62), a slot, and a roughened region, the gripping member (320) is located no more than 30% of the longitudinal length of the elongated body (300) (figure 9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perrow’s blade alignment device with a gripping member that is positioned on the first end portion of the elongated body, the gripping member includes one or more features selected from the group consisting of a groove, a rib, a slot, and a roughened region, the gripping member is located no more than 30% of the longitudinal length of the elongated body as taught by Bush, JR., since such a modification would aid in providing grip for a user (¶62).
Regarding claims 10, 11, Perrow’s blade alignment device discloses all the features/elements as claimed including wherein the blade engagement arrangement (figure 8) is spaced inwardly from the second end (434) of the elongated body (410) (figure 8) but lacks a detailed description on the blade arrangement is spaced inwardly from the second end of the elongated body a distance of 0.5% the longitudinal length of the elongated body, wherein the longitudinal length of the blade engagement arrangement is 2-10% the longitudinal length of the elongated body.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Perrow’s blade alignment device with the blade arrangement is spaced inwardly from the second end of the elongated body a distance of 0.5% the longitudinal length of the elongated body, wherein the longitudinal length of the blade engagement arrangement is 2-10% the longitudinal length of the elongated body, since such a modification is considered optimization of the size of the prior art.
Response to Arguments
Applicant's arguments filed July 3, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 10-11, under 35 U.S.C. 102(a)(1), of the Remarks are directed to the amended claims 1, 12, and 15 and the reference Perrow. Applicant argues “Perrow teaches a blade connector to connect blades to the guide dilator 10. Perrow does not teach a blade alignment device that is removably connected to a retractor for use in maintaining the blades in a closed position while the retractor is positioned in a treatment area, and thereafter, the blade alignment device is removed from the tractor so that the retractor can be operated at the treatment site. The blade alignment device has a different function and configuration from the guide dilator disclosed in Perrow.” In response to applicant's argument that the blade alignment device has a different function and configuration from the guide dilator disclosed in Perrow, 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.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775