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) 1-2, 6-8, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buma (US Patent No. 5092850) in view of in view of Castillenti (US Patent No. 5147316).
Regarding Claim 1, Buma discloses a cannula comprising:
a body (10, Fig. 1) having a proximal end (end opposite 13 shown in Fig. 1 by reference numeral 12) and a distal end (13), the body defining a through hole (12) extending from the proximal end to the distal end, the distal end of the body comprising a flange (14, 15) for engaging a surface of tissue, an outer surface of the body comprising a plurality of axially spaced first engagement features (saw tooth rings 18) extending around a circumference of the body; and
a moveable member (32, Fig. 5-6) having a lumen (ribbed hole shown in Fig. 7) for receiving the body therethrough (Fig. 8), an inner surface of the lumen comprising a plurality of second axially spaced engagement features (internally molded saw teeth 39 and valleys 40, Fig. 7) for selectively engaging a corresponding one of the first engagement features (col. 4; ln. 18-24);
wherein the first engagement features (saw tooth rings 18) are cylindrical barbs and the second engagement features (internally molded saw teeth 39 and valleys 40, Fig. 7) are cylindrical channels, each channel configured to simultaneously receive a corresponding one of the barbs (col. 4; ln. 18-24); and wherein the moveable member is moveable along a length of the body to adjust a distance between the flange and the moveable member(col. 4; ln. 18-24).
However, Buma is silent to the cylindrical barbs (saw tooth rings 18) having a negative rake angle such that the face of the barb slopes away from the outer edge of the barb.
Castillenti discloses a ratcheting connection in the same field of endeavor wherein the moveable flange (44) ratchets down along ratchet ribs (60) of the tubular body (12, Fig. 7) of the cannula to hold the components in place (col. 4; ln 26-48). The ribs of the tubular body (60) have a negative rake angle such that the face of the barb slopes away from the outer edge of the barb (see below) in order to hold the components together. 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 shape of the ratchet ribs of Buma to have a negative rake angle as taught by Castillenti in order to substitute a known ratchet tooth shape which would allow the movement and securement of the movable flange relative to the tubular body of the cannula.
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Regarding Claim 2, the moveable member (32, Fig. 5-6 Buma) is a flange (col. 3; ln. 65-66).
Regarding Claim 6, the plurality of second engagement features(internally molded saw teeth 39 and valleys 40, Fig. 7) is at least three second engagement features (Fig. 7 of Buma shows at least 3 teeth and/or valleys).
Regarding Claim 7, the plurality of second engagement features (39/40) is five second engagement features (Fig. 7 of Buma shows 5 teeth and/or valleys).
Regarding Claim 8, at least one of the body and the moveable member comprise a flexible material (silicone, col. 3; ln. 8-10).
Regarding Claim 15, Buma discloses a method of inserting a cannula into a body of a patient, the method comprising: placing a flange (14, 15) of the cannula into contact with an internal tissue the patient (col. 4; ln. 7-19), the cannula further comprising: a body (10) having a proximal end (end by ref. #12 in Fig. 1) and a distal end (13) , the body defining a through hole (12) extending from the proximal end to the distal end, the distal end of the body comprising the flange (14, 15), an outer surface of the body comprising a plurality of axially spaced first engagement features extending around a circumference of the body (18) (col. 3; ln. 25-26); and a moveable member (32) having a lumen for receiving the body therethrough (Fig. 7), an inner surface of the lumen comprising a plurality of axially-spaced second engagement features (internally molded saw teeth 39 and valleys 40, Fig. 7) for selectively engaging a corresponding one of the first engagement features (col. 4; ln. 18-24); wherein the first engagement features are cylindrical barbs, and the second engagement features are cylindrical channels (col. 3; ln. 25-26, col. 4; ln. 1-5), each channel configured to simultaneously receive a corresponding one of the barbs (Fig. 8); and moving the moveable member along a length of the body to adjust a distance between the flange and the moveable member (col. 4; ln. 18-24).
However, Buma is silent to the cylindrical barbs (saw tooth rings 18) having a negative rake angle such that the face of the barb slopes away from the outer edge of the barb.
Castillenti discloses a ratcheting connection in the same field of endeavor wherein the moveable flange (44) ratchets down along ratchet ribs (60) of the tubular body (12, Fig. 7) of the cannula to hold the components in place (col. 4; ln 26-48). The ribs of the tubular body (60) have a negative rake angle such that the face of the barb slopes away from the outer edge of the barb (see below) in order to hold the components together. 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 shape of the ratchet ribs of Buma to have a negative rake angle as taught by Castillenti in order to substitute a known ratchet tooth shape which would allow the movement and securement of the movable flange relative to the tubular body of the cannula.
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Regarding Claim 16, Buma discloses moving the moveable member (32) comprises placing the moveable member into contact with an outside skin of the patient. (claim 1, also see abstract: “A portion of the tubular member exists outside the body and is provided on its outer surface with engagement elements. An external coupling has matching engagement elements for selective, adjustable securement to the tubular member.)
Regarding Claim 17, further comprising trimming the body of the cannula distal to the moveable member (col. 4; ln. 42-44, Buma).
Regarding Claim 18, Buma discloses a method of inserting a surgical instrument into a body of a patient, the method comprising: placing a flange (14, 15) of a cannula into contact with an internal tissue the patient (col. 4; ln. 7-19), the cannula further comprising: a body (10) having a proximal end (end by ref. #12 in Fig. 1) and a distal end (13) , the body defining a through hole (12) extending from the proximal end to the distal end, the distal end of the body comprising the flange (14, 15), an outer surface of the body comprising a plurality of axially spaced first engagement features extending around a circumference of the body (18) (col. 3; ln. 25-26); and a moveable member (32) having a lumen for receiving the body therethrough (Fig. 7), an inner surface of the lumen comprising a plurality of axially-spaced second engagement features (internally molded saw teeth 39 and valleys 40, Fig. 7) for selectively engaging a corresponding one of the first engagement features (col. 4; ln. 18-24);; and wherein the first engagement features are cylindrical barbs and the second engagement features are cylindrical channels, each channel configured to simultaneously receive a corresponding one of the barbs (col. 3; ln. 25-26, col. 4; ln. 1-5); and moving the moveable member (32) along a length of the body to adjust a distance between the flange and the moveable member (col. 4; ln. 18-24); and passing the surgical instrument (30) through the cannula into the body of the patient (Fig. 4).
However, Buma is silent to the cylindrical barbs (saw tooth rings 18) having a negative rake angle such that the face of the barb slopes away from the outer edge of the barb.
Castillenti discloses a ratcheting connection in the same field of endeavor wherein the moveable flange (44) ratchets down along ratchet ribs (60) of the tubular body (12, Fig. 7) of the cannula to hold the components in place (col. 4; ln 26-48). The ribs of the tubular body (60) have a negative rake angle such that the face of the barb slopes away from the outer edge of the barb (see below) in order to hold the components together. 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 shape of the ratchet ribs of Buma to have a negative rake angle as taught by Castillenti in order to substitute a known ratchet tooth shape which would allow the movement and securement of the movable flange relative to the tubular body of the cannula.
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Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Buma (US Patent No. 5092850) in view of Castillenti (US Patent No. 5147316), in further view of Kucklick (US Publication No. 2021/0128142 A1).
Regarding Claim 13, Buma in view of Castillenti discloses the cannula as described in the rejection of claim 1 above. Buma describes the flange and cannula as being made from flexible, resilient material [silicone]; however, Buma is silent to a cross section of the flange comprises a plurality of webbed areas, a width of the webbed areas selected to be thinner than a width of a surrounding area of the flange to allow the flange to bend along the webbed areas.
Kucklick discloses a cannula in the same field of endeavor which comprises a distal flange comprised of webbed areas with a thinner width (D shown in Fig. 17) to allow the webbed areas to bend during insertion [0032]. It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the distal flange to be a plurality of webbed areas with a thinner width as taught by Kucklick in order to substitute a known distal flange configuration which would predictably allow for the bending and insertion of the flange into the tissue.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Buma (US Patent No. 5092850) in view of in view of Castillenti (US Patent No. 5147316), in further view of Kucklick (US Publication No. 2021/0128142 A1), and in further view of Pilgeram et al. (US Patent No. 11172957 B2).
Buma in view of Castillenti and Kucklick is silent to holes in opposing webbed areas of the flange for engaging an instrument.
Pilgeram discloses a flexible distal flange of a cannula in the same field of endeavor which has two holes on either side of the central passageway. In such a configuration, both portions of the distal flange are folded towards each other such that their respective holes align with the distal tip 255 of the inserter such that the tip can be passed through both holes. In this manner, an even smaller distal profile may be provided prior to insertion within the tissue (col. 8; ln. 35-44).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify opposing webbed areas of the distal flange of Buma in view of Castillenti and Kucklick to have holes as taught by Pilgeram in order to allow an inserter tool to collapse the flange for insertion into the tissue.
Claims 3, 9-10, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Buma (US Patent No. 5092850) in view of in view of Castillenti (US Patent No. 5147316), in further view of Balboa et al. (US Publication No. 2021/0236163 A1).
Regarding Claim 3, Buma in view of Castillenti discloses the cannula as described in the rejection of claim 1 above. But is silent to the movable member (32, Buma) including a plurality of suture management features.
Balboa discloses a two piece cannula (500, Fig. 5) in the same field of endeavor wherein the proximal flange member (530) has suture docking stations (510) in order to manage a plurality of sutures or filaments that may extend from inside a body cavity and through the flexible cannula [0020].
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 moveable member of Buma which is the proximal flange member of the cannula to include suture docking stations (management features) as taught by Balboa in Fig. 5 in order to in order to manage a plurality of sutures or filaments that may extend from inside a body cavity and through the flexible cannula.
Regarding Claim 9-10, 19, Buma in view of Castillenti discloses the cannula as described in the rejection of claim 1 and 18 above. Buma describes the through hole (12) as receiving a surgical instrument (30 shown in Fig. 4) but is silent to the through hole includes an internal dam defining an opening therethrough, a diameter of the opening selected to be smaller than a diameter of the through hole. And a size of the opening is selected to allow passage of a surgical instrument while simultaneously forming a seal around the surgical instrument.
Balboa discloses a two piece cannula in the same field of endeavor and in [0012] that the interior of the cannula can have a membrane with a slit or opening to seal fluid when instruments are placed through the cannula.
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 through hole of the cannula of Buma with a membrane with slit (internal dam) as contemplated by Balboa in [0012] in order to seal an instrument passed through the cannula. The slit would necessarily be sized smaller than the diameter of the through hole since it fits within the through hole and seals against an instrument passed through the through hole.
Claims 11, 12, 20, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Buma (US Patent No. 5092850) in view of in view of Castillenti (US Patent No. 5147316), in further view of Webb (US Patent No. 9119663 B2).
Buma in view of Castillenti disclose the cannula as described in the rejection of claims 1 and 19 above. Buma discloses a surgical tool (30, Fig. 4) is inserted through the cannula on a temporary basis (therefore teaching removal of the tool also) but is silent to a Y-shaped slit feature configured to allow for passage and removal of a surgical instrument while simultaneously forming a seal around the surgical instrument.
Webb discloses a cannula (300, Fig. 7A-B) in the same field of endeavor which comprises a y-shaped slit seal (502, 507, 506) at the proximal end of the cannula to allow for passage and removal of a surgical instrument while simultaneously forming a seal around the surgical instrument so fluid doesn’t squirt through the dam and around the instrument (col. 8; ln. 19-32).
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 proximal end of the cannula to have a y-shaped slit feature as taught by Webb in order to provide a seal which allows for passage of the surgical instrument without fluid leaking out.
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 6-21 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
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