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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6, 16, 18 and 23 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “causing the fluid, such as insufflated fluid” in line 4. The recitation of “such as” introduces ambiguity about whether “insufflated fluid” is limiting or merely exemplary. To overcome this rejection please remove “such as” to better define the boundary of this limitation.
Claim 6 recites “containing the fluid, such as insufflated fluid” in lines 3-4. The recitation of “such as” introduces ambiguity about whether “insufflated fluid” is limiting or merely exemplary. To overcome this rejection please remove “such as” to better define the boundary of this limitation.
Claim 16 recites “wherein the outer membrane cover a significant portion of the cannula body, preferably more than a third, more preferably more than half of the cannula body”. There are several issues regarding the boundaries of this limitation: a) “significant portion” is subjective and lacks objective boundaries; b) “preferably” and “more preferably” are not generally appropriate in claims because they express preference rather than limitation and, thus, create uncertainty as to the boundaries of the claim.
Claim 18 recites “at least one macro structure such as a knob” in line 2. The recitation of “such as” introduces ambiguity about whether “knob” is limiting or merely exemplary. To overcome this rejection please remove “such as” to better define the boundary of this limitation.
Claim 23 recites “wherein its axis of rotation is parallel to or coincide with the longitudinal axis of the cannula body.” The term “its” is vague: does it refer to the dial, pump, or something else? The antecedent is not perfectly clear.
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, 16 and 18-23 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Mikol (US 20190274725).
With respect to claim 1, Mikol discloses a cannula (10 or 100) comprising: a cannula body (e.g., 12, see para. 173 or 102) defining a lumen (e.g., 26, see para. 174; or 104, see para. 192) and having a longitudinal axis (see fig. 1 and 7 below), an outer membrane (e.g., 16/36 or 106) covering a portion of an outside surface of the cannula body (see fig. 1 and 7 below, fig. 3c, para. 178, 192), a pump (e.g., vacuum source- see para. 186, syringe- see para. 188, 192, fig. 7 below, pump 142- see fig. 12) fluidly connected to a port (e.g., 39, 115) on the cannula body and to the outer membrane to transport a fluid (e.g., 44) through the port to inflate the outer membrane (see para. 174, 176, 180, 191), and a dial (e.g., any of 18, 20, 22) rotatable to actuate the pump (para. 191).
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As for claim 2, Mikol further discloses the cannula of claim 1, wherein a rotation of the dial moves the fluid to inflate the outer membrane (see para. 190, 192), and a counter-rotation of the dial reverses the flow of the fluid (see para. 190, 192).
As for claim 3, Mikol further discloses the cannula of claim 1, wherein the pump is an impeller pump (e.g., 108, 122) comprising a pump chamber (e.g., 114) having a cam surface (e.g., 116) including an outlet and an inlet (e.g., ports 118, see para. 193), and an impeller (122) comprising a plurality of flexible radial arms (e.g., tabs 120 or O, I, B, see para. 38, 198, also note that the cannula components are 3-D printed, see para. 30, 199) that contact the pump chamber, wherein a rotation of the dial rotates the impeller causing the fluid, such as insufflated fluid, to enter the pump chamber through the inlet and exit through the outlet, wherein the inlet is fluidly connected to said port (see para. 192-193).
As for claim 5, Mikol further discloses the cannula of claim 3, wherein the dial is keyed to the impeller to rotate the impeller as the dial is rotated (see para. 193, 198, fig. 1 above).
As for claim 16, Mikol further discloses the cannula of claim 1, wherein the outer membrane covers a significant portion of the cannula body, preferably more than a third, more preferably more than half of the cannula body (see fig. 1 above).
As for claim 18, Mikol further discloses the cannula of claim 1, wherein the outer membrane has an outer micro-textured surface (see para. 179), or the outer membrane has at least one macro texture such as a knob.
As for claim 19, Mikol further discloses the cannula of claim 1, wherein the outer membrane is a distal balloon (see fig. 9a).
As for claim 20, Mikol further discloses the cannula of claim 1, wherein the rotatable dial (e.g., 110, 112, 114) comprises an installed core (e.g., 114) and a removable dial (110, 112), wherein the removable dial rotates a corresponding drive hub to operate the pump (see para. 192).
As for claim 21, Mikol further discloses the cannula of claim 1, wherein said port opens to the lumen or to a distal end of the cannula body (see abstract and para. 7-8).
As for claim 22, Mikol further discloses the cannula of claim 1, wherein the pump is modular (see fig. 12 above), wherein the pump and the dial (110) form a first modular part and a second modular part comprises the cannula body (102), the outer membrane (106) and a pump receiving receptacle (e.g., at 115).
As for claim 23, Mikol further discloses the cannula of claim 1, wherein its axis of rotation is parallel to or coincides with the longitudinal axis of the cannula body (see fig. 1, 7, 12 above).
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) 6-8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mikol (US 20190274725), as applied to claim 1 above, in view of Tesar (US 20140005555).
As for claims 6-8 and 12, Mikol teaches the use of a variety of interchangeable pumps used with the cannula (see para. 212) and further teaches wherein the wherein the dial is keyed to actuate the pump (see fig. 1 above, para. 41 and note that the dial is the actuator), but does not appear to explicitly teach wherein the pump is a peristaltic pump comprising a roller member, sized and dimensioned to press a flexible tube containing the fluid, such as insufflated fluid, wherein as the roller rotates, it presses against the flexible tube to move the fluid through the flexible tube and through the peristaltic pump; wherein the pump is a peristaltic pump comprising a peristaltic chamber, a tubing assembly and a roller assembly, wherein the tubing assembly is positioned inside the peristaltic chamber and the roller assembly is located inside the tubing assembly; wherein the roller assembly comprises at least one roller rotatably mounted on a roller hub; wherein the dial is keyed to acuate a roller.
Tesar, also drawn to medical tissue retractor devices, teaches the incorporation of a cassette, containing a pump (e.g., 1522), incorporated within the medical device (see para. 66), including wherein the pump is a peristaltic pump (1522) comprising a roller member (1524), sized and dimensioned to press a flexible tube (1526) containing the fluid, such as insufflated fluid (e.g., 1514), wherein as the roller rotates, it presses against the flexible tube to move the fluid through the flexible tube and through the peristaltic pump (see para. 486-487); wherein the pump is a peristaltic pump (e.g., 1522) comprising a peristaltic chamber (e.g., body of 1522), a tubing assembly (1526) and a roller assembly (1524), wherein the tubing assembly is positioned inside the peristaltic chamber and the roller assembly is located inside the tubing assembly (see fig. 35a, 35b, para. 486-487); wherein the roller assembly comprises at least one roller rotatably mounted on a roller hub (see fig. 35a, 35b, para. 486-487); and manual actuation of the roller assembly (see para. 486) in order to provide a known cassette assembly, including a known pump (peristaltic), that provides a convenient and disposable hydraulic system to a medical device (see para. 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mikol wherein the pump is a peristaltic pump comprising a roller member, sized and dimensioned to press a flexible tube containing the fluid, such as insufflated fluid, wherein as the roller rotates, it presses against the flexible tube to move the fluid through the flexible tube and through the peristaltic pump; wherein the pump is a peristaltic pump comprising a peristaltic chamber, a tubing assembly and a roller assembly, wherein the tubing assembly is positioned inside the peristaltic chamber and the roller assembly is located inside the tubing assembly; wherein the roller assembly comprises at least one roller rotatably mounted on a roller hub; and wherein the dial is keyed to the roller assembly to rotate the roller assembly as the dial is rotated; in view of Tesar, in order to provide a known cassette assembly, including a known pump (peristaltic) as a matter of engineering design choice, that provides a convenient and disposable hydraulic system to a medical device.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mikol (US 20190274725), as applied to claim 1 above, in view of Voegele (US 20090118587).
As for claim 13, Mikol does not teach further comprising a sealing cap with a diaphragm to cover the lumen.
Voegele, also drawn to cannulas (see abstract), teaches a sealing cap (e.g., 16) with a diaphragm (e.g., 24, 20) to cover the lumen of the cannula (18) in order to provide known sealed access to a body cavity (see para. 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mikol to include a sealing cap with a diaphragm to cover the lumen, in view of Voegele, in order to provide known sealed access to a body cavity.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mikol (US 20190274725) and Voegele (US 20090118587), as applied to claim 13 above, in view of Beane (US 5906577).
As for claims 14-15, Mikol, as modified by Voegele, further teaches wherein the diaphragm comprises at least one disk having a slit cut thereon, wherein the disk is arranged so that the slit is at an angle and wherein the slit is arranged to be aligned with the lumen (see Voegele fig. 1 and note slits in seal 20). Mikol does not teach wherein the diaphragm comprises at least two disks each having a slit cut thereon, wherein the at least two disks are arranged so that the slits are at an angle to each other and wherein the slits are arranged to be aligned with the lumen; and wherein the diaphragm comprises at least two disks, wherein one disk has a slit cut thereon and the other disk has an opening that is sized to allow a medical instrument to pass through while maintaining a seal with an outer surface of the medical instrument.
Beane, also drawn to cannulas, teaches a variety of alternate equivalent seals (see all the figures), specifically wherein the diaphragm (114) comprises at least two disks (e.g., 118, 120, see fig. 8); wherein the other disk has an opening that is sized to allow a medical instrument to pass through while maintaining a seal with an outer surface of the medical instrument (see col. 10 lines 1-13) in order to provide gas-tight sealable openings for insertion of multiple instruments through the cannula (see col. 10 lines 1-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mikol, as modified by Voegele, to include a diaphragm with two disks with slits instead of one, wherein the diaphragm comprises at least two disks each having a slit cut thereon, wherein the at least two disks are arranged so that the slits are at an angle to each other and wherein the slits are arranged to be aligned with the lumen; and wherein the diaphragm comprises at least two disks, wherein one disk has a slit cut thereon and the other disk has an opening that is sized to allow a medical instrument to pass through while maintaining a seal with an outer surface of the medical instrument, in view of Beane, as a matter of engineering design choice, in order to provide gas-tight sealable openings for insertion of multiple instruments through the cannula.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mikol (US 20190274725), as applied to claim 1 above, in view of Kramer (US 20200390454).
As for claim 17, Mikol further discloses wherein the outer membrane can have several shapes (see para. 173) but does not appear to teach wherein the outer membrane has a dog bone or hour-glass shape.
Kramer, also drawn to expandable cannulas (see abstract), teaches wherein the outer membrane has a dog bone or hour-glass shape (see fig. fig. 3b) in order to provide a shape that will anchor the cannula to the site as needed (see para. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mikol wherein the outer membrane has a dog bone or hour-glass shape, in view of Kramer, as a matter of engineering design choice, in order to provide a known shape that will anchor the cannula to the site as needed.
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest wherein each flexible radial arm comprises an enlarged terminal in contact with the pump chamber as required by claim 4.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claims 7 and 8. In particular, none of the cited references teach or suggest wherein the tubing assembly comprises at least one tube fluidly connected to the lumen and the outer membrane as required by claims 9 and 10.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claim 7. In particular, none of the cited references teach or suggest wherein the peristaltic chamber comprises an inlet and an outlet, wherein the inlet is fluidly connected to the lumen or is located at a distal end of the cannula body and the outlet is fluidly connected to the outer membrane, wherein the inlet is fluidly connected to said port as required by claim 11.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowable Subject Matter
Claims 4 and 9-11 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 5499969 (teaches a roller pump/cassette attached to a surgical handpiece, however the tubing is external to the handpiece) and US 20170325798 (teaches a surgical cannula and a pump connectable to the outside proximal surface of the cannula).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo 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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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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