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 .
This Office action is in response to the amendment filed 07/02/2025. Claims 1-7 and 21-33 remain pending.
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.
Claim(s) 1-3, 6 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mast et al. (U.S. 9,572,560 B2).
Concerning claim 1, Mast et al. disclose a medical retractor, the medical retractor comprising: a first retractor blade with a shim channel disposed in the first retractor blade (see Figs. 8A-8N), the shim channel having a back wall, a major lobe dimension (see Fig. 8I below) and a minor lobe dimension (see Fig. 8I below), the shim channel having a cross-sectional area which remains unchanged for an entire length of the shim channel to permit medical tools to slide therethrough to engage a surgical site or to permit the medical retractor to slide down over the medical tools that are engaged with the surgical site; one or more channels (see below) disposed in the back wall of the shim channel that has a uniform depth and width for substantially all of the channel’s entire length; and wherein the minor lobe dimension and the major lobe dimension remain constant for the entire length of the shim channel.
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[AltContent: arrow][AltContent: connector][AltContent: textbox (Channel in Back wall with uniform depth and width)][AltContent: connector][AltContent: connector][AltContent: textbox (Major Lobe Dimension
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Concerning claim 2, further comprising: a retractor body (see Fig. 1 below); a first outer arm (see Fig. 1 below) extending from the retractor body, the first retractor blade (120) rotatably supported (see col. 5, line 61 – col. 6, line 2) by the first outer arm; a second outer arm (see Fig. 1 below) extending from the retractor body, a second retractor blade (118) rotatably supported by the second outer arm; and a middle arm (see Fig. 1 below) extending from the retractor body, a third retractor blade (122) rotatably supported by the middle arm.
[AltContent: arrow][AltContent: textbox (Middle arm)][AltContent: arrow][AltContent: textbox (Second outer arm)][AltContent: arrow][AltContent: textbox (First outer arm)][AltContent: textbox (Retractor Body)][AltContent: arrow]
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Concerning claim 3, wherein the first retractor blade (120), the second retractor blade (118) and the third retractor blade (122) are identical.
Concerning claim 6, wherein the first outer retractor blade and the second outer retractor blade each have an axis of rotation for each retractor blade’s toeing (see col. 5, line 61 – col. 6, line 2 and see Fig. 6A), the axis of rotation for each retractor blade’s toeing has some other relationship to an axis of translation (away from middle arm) of each retractor blade other than parallel or perpendicular.
Concerning claim 7, wherein the first retractor blade, the second retractor blade and the third retractor blade each have a shim channel (see Fig. 8I below) disposed therein that has a cross-sectional area which remains unchanged for an entire length of the shim channel.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mast et al. (U.S. 9,572,560 B2) in view of Villamil et al. (U.S. 2018/0206834 A1).
Mast et al. disclose the invention substantially as described above. Mast et al. disclose that a first threaded shaft (see Fig. 2, element 204) is rotationally disposed along a first axis of the retractor body such that when rotated one direction moves the middle arm along the first axis towards the retractor body and when rotated the other direction moves the middle arm along the first axis away from the retractor body. However, Mast et al. do not explicitly disclose a second threaded shaft rotationally disposed along a second axis of the retractor body that when rotated one direction moves the first outer arm along the second axis towards the middle arm and when rotated the other direction moves the first outer arm along the second axis away from the middle arm.
Villamil et al. teach the use of threaded drive shafts to move the retractor arms (see par. 0085 and Figs. 21A-21C).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mast’s retractor by simply substituting a threaded drive shaft for the worm drive mechanism in order to permit movement of the first outer arm along an axis towards the middle arm and away from the middle arm because doing so would be a simple substitution of one known moveable connection for another in order to permit the predictable result of securing a retractor blade to a body in a translating fashion.
Claim(s) 21-23, 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woolley et al. (U.S. 2024/0325058 A1) in view of Mast et al. (U.S. 9,572,560 B2).
Wooley et al. disclose a medical retractor, the medical retractor comprising: a retractor body (see below); a first outer arm (26) extending from the retractor body, a first retractor blade (see Fig. 6, element 14) supported by the first outer arm; a second outer arm (28) extending from the retractor body, a second retractor blade (see Fig. 6, element 16) supported by the second outer arm; a middle arm (24) extending from the retractor body, a third retractor blade (see Fig. 5, element 18) supported by the middle arm; and a table-arm fixation point (see below and see par. 0200) disposed in the middle arm for fixing the position of the medical retractor relative to an operating table; and wherein the first outer arm and the second outer arm are nonrotatable relative to the retractor body.
[AltContent: arrow][AltContent: textbox (Table-arm fixation point)][AltContent: arrow][AltContent: textbox (Body)]
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However, Wooley et al. do not explicitly disclose a table arm fixation point disposed in the first or second outer arm.
Mast et al. disclose the use of table arm fixation points (see Fig. 1, element 132) disposed in retractor arms in the same field of endeavor for the purposed of retractor stabilization during use.
[AltContent: arrow][AltContent: textbox (Middle arm)][AltContent: arrow][AltContent: textbox (Second outer arm)][AltContent: arrow][AltContent: textbox (First outer arm)][AltContent: textbox (Retractor Body)][AltContent: arrow]
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the retractor of Wooley et al. having a plurality of table arm fixation points disposed in the retractor arms, the concept of which is disclosed by Mast et al., i.e., one located in the first outer arm and one located in the second outer arm, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Table arm fixation points on retractor’s provide enhanced stability by securely attaching the retractor to the operating room table, which eliminates the risk of slippage and allows for a consistent and precise surgical field. Furthermore, since manual holding of the retractor is not required the surgeon and staff experience less fatigue while improving accessibility to the surgical site.
Concerning claim 22, wherein the first retractor blade (14), the second retractor blade (16) and the third retractor blade (18) are identical (see Fig. 4).
Concerning claim 23, wherein the first retractor blade, the second retractor blade and the third retractor blade are rotatably supported by the first outer arm, the second outer arm and the middle arm, respectively (see Figs. 2 and 3).
Concerning claim 26, wherein the first outer retractor blade and the second outer retractor blade each have an axis of rotation for each retractor blade’s toeing (see par. 0213, and Fig. 6, elements 240 and 166), the axis of rotation for each retractor blade’s toeing has some other relationship to an axis of translation of each retractor blade other than parallel or perpendicular.
Concerning claim 27, wherein the first retractor blade, the second retractor blade and the third retractor blade each have a shim channel disposed therein that has a cross-sectional area which remains unchanged for an entire length of the shim channel (see par. 0218 lines 28-30; and Fig. 58, element 302).
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woolley et al. (U.S. 2024/0325058 A1) in view of Mast et al. (U.S. 9,572,560 B2), as applied to claims 21 and 23 above, further in view of Villamil et al. (U.S. 2018/0206834 A1).
Wooley et al. in view of Mast et al. disclose the retractor substantially as described above. However, Wooley et al. in view of Mast et al. do not disclose the use of first and second threaded shafts rotationally disposed along the retractor body for movement of the first outer arm towards or away from the middle arm.
Villamil et al. disclose that first and second blades move along a single axis towards and away from each other, while a third blade is adjustable to move toward and away from the first and second blades. Villamil et al. disclose that movement of the blades is possible via a threaded drive shafts (see par. 0085).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a threaded drive shaft or two to move the retractor arms, the concept of which is disclosed by Villamil et al., because doing so is a simple substitution of one known actuator for another in order to obtain the predictable result of moveably attaching blades to a retractor body.
Regarding claim 25, it is noted that the above described modification would result in the axis of rotation of a drive tool used to rotate the first threaded shaft being in line with an axis the first threaded shaft rotates around and the axis of rotation of the drive tool used to rotate the second threaded shaft being in line with an axis the second threaded shaft rotates around. See Fig. 4 and par. 0085 of Villamil et al.
Claim(s) 28-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woolley et al. (U.S. 2024/0325058 A1) in view of Villamil et al. (U.S. 2018/0206834 A1).
Concerning claim 28, Wooley et al. disclose a medical retractor, the medical retractor comprising: a retractor body (see Fig. 9 below); a first outer arm (26) extending from within the retractor body, a first retractor blade (see Fig. 1, element 14) supported by the first outer arm; a second outer arm (28) extending from within the retractor body, a second retractor blade (see Fig. 1, element 16) supported by the second outer arm; and a middle arm (24) extending from within the retractor body, a third retractor blade (see Fig. 1, element 18) supported by the middle arm.
[AltContent: arrow][AltContent: textbox (Table-arm fixation point)][AltContent: arrow][AltContent: textbox (Body)]
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However, Wooley et al. do not disclose a drive shaft that extend through the first outer arm, the second outer arm and the middle arm.
Villamil et al. teach a medical retractor (see Fig. 4) in the same field of endeavor including a threaded drive shaft (see par. 0085) for moving the retractor arms.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator of Wooley et al. to be a threaded drive shaft, the concept of which is disclosed by Villamil et al. because doing so is a simple substitution of one known retracting mechanism for another in order to obtain the predictable result of moving arms with respect to a retractor body.
Concerning claim 29, wherein the first retractor blade (14), the second retractor blade (16) and the third retractor blade (118) are identical and the first retractor blade, the second retractor blade and the third retractor blade are rotatably supported (see Fig. 6, element 240) by the first outer arm, the second outer arm and the middle arm, respectively.
Regarding claim 30, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the actuating assembly with first and second threaded shafts, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. It should also be noted that Villamil’s shaft (see Fig. 4 below) could be separated into two separate components since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claim 31, it is noted that the above described modification would result in a configuration that results in the axis of rotation of a drive tool used to rotate the first threaded shaft being in line with an axis the first threaded shaft rotates around and the axis of rotation of the drive tool used to rotate the second threaded shaft being in line with an axis the second threaded shaft rotates around.
Concerning claim 32, wherein the first outer retractor blade and the second outer retractor blade each have an axis of rotation for each retractor blade’s toeing (see Fig. 3) the axis of rotation for each retractor blade’s toeing has some other relationship to an axis of translation (away from middle arm) of each retractor blade other than parallel or perpendicular.
Concerning claim 33, wherein the first retractor blade, the second retractor blade and the third retractor blade each have a shim channel (see Fig. 38, element 302) disposed therein that has a cross-sectional area which remains unchanged for an entire length of the shim channel.
Response to Arguments
Applicant's arguments filed 07/02/2025 have been fully considered but they are not persuasive. In response to Applicant’s argument that “regarding claim 1, the Mast reference dose not teach a first retractor blade with a shim channel disposed in the first retractor blade that has one or more channels disposed in the back wall of the shim channel that has a uniform depth and width for substantially all of the channel’s entire length.” Applicant’s attention is directed to Fig. 6B below which illustrates the channel of Mast. In Fig. 5A, Applicant’s channel is shown. It is clear that the claimed channel of Mast and the current application are equivalent.
[AltContent: arrow][AltContent: textbox (channel disposed in the back wall of the shim channel that has a uniform depth and width for substantially all of the channel’s entire length)]
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[AltContent: arrow][AltContent: textbox (Applicant’s channel disposed in the back wall of the shim channel that has a uniform depth and width for substantially all of the channel’s entire length)]
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Applicant’s arguments with respect to claim(s) 21 and 28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773