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 .
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.
Claim(s) 79-82, 84-90, 92, 94-95, and 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales et al (US Patent No. 5312332) in view of Kokhanenko et al. (WO 2020/036498 A1).
Regarding Claims 79 and 97, Bales discloses an accessory or sheath (600c) for arranging a surgical instrument (probe 689c) within a cannula shaft (114+112) (Fig. 6C) [col. 13; ln. 60-col 14; ln. 29], the accessory (600c) including:
an accessory body (body/walls of 600c) defining:
a bore (607c) configured to receive the instrument such that arranging the instrument within the bore defines a first flow path between the accessory body and the instrument (shown below),
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at least one aperture (shown above, see description of lateral holes 606a, 607a, 607b in col. 13; ln. 26-59) arranged to allow fluid flow into the bore and along the first flow path when the at least one aperture is positioned at a first location relative to the cannula shaft (first location shown in Fig. 6C),
the accessory body comprising:
a proximal portion defining an open proximal end (602c) [col. 13; ln. 60-col 14; ln. 29],
a distal portion defining an open distal end (612c), the bore (607c) defined between the open proximal end and the open distal end (Fig. 6C) [col. 13; ln. 60-col 14; ln. 29],
an intermediate portion interposed between the proximal portion and the distal portion and configured to seal against the cannula shaft (o-ring in intermediate section-see description of 508 in col. 12; ln. 1-21 -will seal against the cannula shaft) ,
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the accessory body configured to be received within the cannula shaft such that arranging the accessory body within the cannula shaft so the at least one aperture is positioned at a second location relative to the cannula shaft (see the location shown in Fig. 5C where the accessory body is pulled proximally such that o-ring is proximal of 122) defines a second flow path between the accessory body and the cannula shaft (in this position which 600c is capable of being moved to as it is similar to the probe shown in Fig. 5, col. 13; ln. 62-63, the flow through 122 will go along the outside of the body through the distal end of the cannula),
the accessory body configured to allow fluid flow into the cannula shaft and towards a distal end of the surgical instrument via one or more of the first flow path and the second flow path (irrigation through port 122 is directed in (first flow path) or over (second flow path) the body depending on whether o-ring is proximal or distal of port 122).
However, Bales does not show the body 600c comprising: a plurality of internal projections extending into the bore and configured to position the accessory body relative to the instrument, and a plurality of external projections extending away from the bore and configured to position the accessory body relative to the cannula shaft.
Kokhanenko discloses a cannula in the analogous art of insufflation cannulas which has a bore to accept an instrument (2610) (Fig. 26A-B), the bore having a plurality of internal rib projections (2620, Fig. 26B) to center the instrument within the bore to allow gasses to pass around the instrument [0319-0320]. It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the bore 607c of Bales to have a plurality of internal rib projections as taught by Kokhanenko in order to center the tool 689c within the bore allowing gasses to pass evenly around the instrument.
Bales discloses that the body (probe) of other embodiments contacts the inner wall of the canula with a bump on the outer surface of the body to add stabilization to the probe within the cannula (see col. 19; ln. 15-16 or element 511 in Fig. 5a). Kokhanenko teaches a stabilization feature between two telescopically arranged members could be many bumps (claim 45, [0302]), or alternatively shaped projections in order to space the elements while allowing fluid flow therebetween [0302].
It would have been obvious to one having ordinary skill in the art to modify the bump on the outside of the body/probe of Bales to be multiple bumps/projections on the outside as taught by Kokhanenko in order to use a known configuration of stabilizing two telescopically connected parts while still allowing fluid flow therebetween. The projections are fully capable of directing fluid flow axially as Kokhanenko discloses elongated longitudinally oriented projections and ones of this shape would be obvious to use since they are known configurations of stabilization projections.
Regarding Claim 80-82, as modified by Kokhanenko, the internal projections define an internal profile configured to position the accessory body on, or close to, the instrument in at least two locations of the internal profile (ribs would extend inward to engage tool in at least two places as shown in Fig. 26B of Kokhanenko ), and the external projections define an external profile configured to position the accessory body in the cannula shaft in at least two locations of the external profile (as modified above with the configuration of opposed ribs shown in Fig. 26B of Kokhanenko). This configuration would also be shaped to tangentially abut at least one of the instrument in the at least two locations of the internal profile and the cannula shaft in the at least two locations of the external profile as they could contact the outer perimeter of the tool/inner surface of the cannula at singular locations. As modified by Kokhanenko, the internal projections are shaped to extend at least partially along the instrument in at least two locations to define the first flow path (first path being inside the probe/accessory), and the external projections are shaped to extend at least partially along the cannula shaft in at least two locations to define the second flow path (second flow path being outside the accessory/probe at the distal end).
Regarding Claim 84, as modified by Kokhanenko, the internal projections and the external projections (ribs arranged as shown in Fig. 26B of Kokhanenko ) are arranged in an annular array and evenly spaced about the bore.
Regarding Claim 85, as modified by Kokhanenko, the internal projections are at least partially arranged in one or more opposed pairs to position the accessory body at opposed sides of the instrument (ribs arranged as shown in Fig. 26B of Kokhanenko).
Regarding Claim 86, the external projections (as modified by Kokhanenko) are at least partially arranged in one or more opposed pairs to position the accessory body at opposed sides of the cannula shaft (Kokhanenko shows a configuration of paired ribs in Fig. 26B).
Regarding Claim 87, as modified by Kokhanenko, one or more of the projections (as taught/modified by Kokhanenko) are longitudinally extending ribs (Fig. 26A-B, Kokhanenko).
Regarding Claim 88, the accessory body (600c, Bales) is shaped to itself coaxially to the cannula shaft (fig. 6C, Bales).
Regarding Claim 89, Bales discloses the at least one aperture is adjacent the intermediate portion (see below).
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Regarding Claim 90, Bales discloses the accessory body further defines a tapered region extending away from the intermediate portion (see figure below).
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Regarding Claim 92, the at least one aperture is spaced proximally to the intermediate portion (see below).
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Regarding Claim 94, Bales discloses the accessory body is configured to seal against the instrument at a location spaced proximally from the at least one aperture (seal 625c, Fig. 6c Bales, col. 14; ln. 15-20).
Regarding Claim 95, Bales discloses the intermediate portion carries a resiliently deformable first seal (o-ring) configured to seal against the cannula shaft (o-ring in intermediate section-see description of 508 in col. 12; ln. 1-21 -will seal against the cannula shaft).
Claim(s) 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales et al (US Patent No. 5312332) in view of Kokhanenko et al. (WO 2020/036498 A1) in further view of Edwards et al. (US Publication NO. 2014/0100567 A1).
Regarding the method of Claim 96, the structure of the surgical instrument of Bales as modified by Kokhanenko is described above in the rejection of claims 79 and 97. Bales discloses inserting the surgical instrument (689c) into the bore (607c) of the sheath (600c) (shown in Fig. 6c) [col. 13; ln. 60-col 14; ln. 29]. Bales describes a first flow path between the body of the sheath and the instrument when the sheath (with o-ring) is in the position shown in Fig. 5a where the fluid comes through port 122 and into the apertures through the bore of the accessory (col. 11; ln. 28-60). In the case of the embodiment shown in Fig. 6c, this path would lead the fluid to pass through the bore and between the bore and the surgical instrument. Bales shows moving the sheath body to a second flow position (in Fig. 5c) where the fluid comes through port 122 and flows between the outside wall of the sheath and the inner wall of the cannula (col. 12; ln. 7-21). In the case of the embodiment shown in Fig. 6c, this path would lead the fluid to pass similarly between the sheath/accessory body and the inside of the cannula.
Bales discloses that irrigation “fluid” is sent through the flow paths but is silent to the fluid being specifically gases.
Edwards discloses an electrocautery instrument in the analogous art of fluid delivery systems for surgical tools. Edwards discloses that fluid in the form of liquid and/or gas is supplied through the device for use during the surgical procedure [0048].
It would have been obvious to one having ordinary skill in the art before the effective filing date to use gasses as the fluid as taught by Edwards in order to use a known fluid suitable for surgical/electrocautery irrigation purposes to clear the surgical site.
Allowable Subject Matter
Claims 91 and 93 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claims 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773