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 2-5, 11 and 20 are 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 2 recites the limitation “first and second positions” on line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “arc path” rendering the claim indefinite because it is unclear what the shape or degree of arc the path relies on. Appropriate action is required.
The term “substantially parallel” in claims 11 and 20 is a relative term which renders the claim indefinite. The term “substantially parallel” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate action is required.
All remaining claims are rejected by virtue of dependency from the rejected claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahn et al. (US 20030181876 A1, herein, Ahn).
Regarding claim 1, Ahn discloses a device (delivery assembly 120 – Fig.1) for clearing obstructions from a medical tube (catheter 112 – Fig.1), comprising:
a housing (housing 132 – Fig.1) defining an interior and an exterior;
an elongated guide wire (coil 124 – Fig.1) residing at least partially within said interior (“the stripping coil 124 includes a proximal end 152 which is stored within the housing 132 and includes a stop 150 to prevent excessive passage”, see para [0034]); and
first (drive wheel 146 – Fig.1) and second (driven wheel 148 – Fig.1) rollers disposed within said interior and rotatable about first and second roller axes, respectively, wherein a position of said second roller axis is adjustable relative to said first roller axis (under broadest reasonable interpretation, examiner interprets the capability of being changed, altered, moved etc. as adjustable hence, the act of locking/unlocking the driven wheel against the drive wheel makes it adjustable (“the physician slides the capstan slide lock 194 to lock the capstan driven wheel 148 against the capstan drive wheel 146, pinching the stripping coil 124”, see para [0043]-[0044])),
wherein said first and second rollers are adapted to rotate about said first and second roller axes, respectively, to advance said elongated guide wire out of said interior or retract said elongated guide wire into said interior (“a drive wheel 146 and driven wheel 148 which push the stripping coil 124 forward within the system when thumb wheel 144 is rotated”, see para [0030]).
Regarding claim 2, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 1, wherein the second roller axis (axis of rotation of 148) is movable relative to the first roller axis (axis of rotation of 146) between first and second positions, wherein in the first position, each of said first and second rollers engages the elongated guide wire (“slide lock 194 to lock the capstan driven wheel 148 against the capstan drive wheel 146, pinching the stripping coil 124”, see para [0043]), and wherein in the second position, at least one of said first and second rollers does not engage said elongated guide wire (“slide the capstan slide lock 194 rearwardly to unlock the capstan driven wheel 148. This allows the stripping coil 124 to "float" between the capstan drive and driven wheels 146, 148”, see para [0044])
Regarding claim 3, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 2, wherein in the second position, each of said first and second rollers does not engage said elongated guide wire (“slide the capstan slide lock 194 rearwardly to unlock the capstan driven wheel 148. This allows the stripping coil 124 to "float" between the capstan drive and driven wheels 146, 148”, see para [0044]).
Regarding claim 4, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 2, wherein in the first position, the first and second rollers physically contact one another (“slide lock 194 to lock the capstan driven wheel 148 against the capstan drive wheel 146, pinching the stripping coil 124”, see para [0043]).
Regarding claim 9, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 1, further comprising a carriage (capstan lock slide 194 – Fig.4) that rotatably supports said second roller, said carriage being movable between a disengaged position where the second roller is withdrawn from the first roller, and an engaged position where the second roller is advanced toward the first roller (examiner interprets the locked driven wheel as the engaged position and the unlocked/release driven wheel as the disengaged position (“slide lock 194 to lock the capstan driven wheel 148 against the capstan drive wheel 146, pinching the stripping coil 124 ...slide the capstan slide lock 194 rearwardly to unlock the capstan driven wheel 148... to "float" between the capstan drive and driven wheels 146, 148”, see para [0043] - [0044]))
Regarding claim 10, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 9, wherein in said engaged position, the second roller physically contacts the first roller (“slide lock 194 to lock the capstan driven wheel 148 against the capstan drive wheel 146, pinching the stripping coil 124”, see para [0043]).
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.
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.
Claims 5-6 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn in view of Zirps (US 20140276948 A1, herein, Zirps).
Regarding claim 5, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 1, as recited above.
Ahn does not appear to expressly disclose wherein the second roller axis is moveable relative to the first roller axis along an arc path.
Zirps teaches wherein the second roller axis is moveable relative to the first roller axis along an arc path (“capstans 40 and capstan sockets 46 are one embodiment of a motor coupler, coupling the motors to axial and rotation drive mechanisms”, see para [0050], Fig.6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Zirps with the disclosure of Ahn so that the roller axes are relatively moveable along an arc path in order to enhance the “positioning rotational drive mechanism 56 closer to the patient provides for increased control of rotation of the guide wire” (Zirps para [0057]).
Regarding claim 6, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 1, as recited above.
Ahn does not appear to expressly disclose further comprising a motor disposed within said interior, wherein said first and second rollers are rotatable via said motor.
Zirps teaches a motor disposed within said interior, wherein said first and second rollers are rotatable via said motor (“a rotational force to be transmitted from motors located in the motor drive base 22 to the axial and rotational drive mechanisms within the cassette”, see para [0050], Fig.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Zirps with the disclosure of Ahn so that the first and second rollers are rotatable via said motor in order to enhance the “positioning rotational drive mechanism 56 closer to the patient provides for increased control of rotation of the guide wire” (Zirps para [0057]).
Regarding claim 11, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 9, as recited above.
Ahn does not appear to expressly disclose wherein said carriage is pivotable about a carriage axis in order to move the carriage between the disengaged and engaged positions, said carriage axis being spaced from and substantially parallel to said second roller axis.
Zirps teaches wherein said carriage is pivotable about a carriage axis in order to move the carriage between the disengaged and engaged positions, said carriage axis being spaced from and substantially parallel to said second roller axis (“axial drive assembly 324 in the "loading" configuration with handle 358 (shown in broken lines) rotated such that it is generally parallel to guide wire channel 364…. Generally, when handle 358 is moved from the position of FIG. 22 to the position of FIG. 21… increasing the space between the pairs of wheels in the drive mechanisms”, see para [0131]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Zirps with the disclosure of Ahn to include a movebale carriage between the disengaged and engaged positions in order to enhance the “positioning rotational drive mechanism 56 closer to the patient provides for increased control of rotation of the guide wire” (Zirps para [0057]).
Regarding claim 12, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 9, as recited above, further comprising an actuator (advance/retract knob 168 – Fig.4) that is accessible from the exterior (“an advance/retract knob 168 accessible to a user along the upper portion of the housing ”, see para [0032]), the actuator being configured to move the carriage from the disengaged position to the engaged position as the actuator is moved from a first position to a second position.
Ahn does not appear to expressly disclose further comprising an actuator that is accessible from the exterior, the actuator being configured to move the carriage from the disengaged position to the engaged position as the actuator is moved from a first position to a second position.
Zirps teaches an actuator that is accessible from the exterior, the actuator being configured to move the carriage from the disengaged position to the engaged position as the actuator is moved from a first position to a second position (“when guide wire axial drive mechanism 350 is placed in the "use" or "engaged" position (shown in FIG. 22), guide wire 301 is positioned between drive wheel 410 and roller 418”, see para [0113]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Zirps with the disclosure of Ahn so that the first and second rollers move between the two positions by an actuator being configured to move the carriage in order to enhance the “positioning rotational drive mechanism 56 closer to the patient provides for increased control of rotation of the guide wire” (Zirps para [0057]).
Claims 7-8, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn in view of O’Keefe et al. (US 20150231313 A1, herein, O’Keefe).
Regarding claim 7, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 1, as recited above, further comprising:
a first roller shaft, the first roller (drive wheel 146 – Fig.4) being coupled to the first roller shaft and rotatable therewith about said first roller axis (see annotated Fig.4);
a second roller shaft, the second roller (driven wheel 148 – Fig.4) being coupled to the second roller shaft and rotatable therewith about said second roller axis (see annotated Fig.4).
Ahn does not appear to expressly disclose a transmission operatively connected to each of the first and second roller shafts and configured to synchronize rotation thereof about said first and second roller axes, respectively, in opposing directions.
O’Keefe teaches a transmission (transmission mechanism 120 – Fig.12) operatively connected to each of the first and second roller shafts and configured to synchronize rotation thereof about said first and second roller axes, respectively, in opposing directions (“the transmission mechanism 120 may be coupled to and configured to transmit rotational force between the motor 106 and the drive shaft 82”, see para [0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of O’Keefe with the disclosure of Ahn to include a transmission operatively connected to the rollers so that the device can further “help dislodge and/or draw obstructing material within the medical tube 12 without compromising a sterile field ” (O’Keefe para [0042]).
PNG
media_image1.png
502
738
media_image1.png
Greyscale
Regarding claim 8, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 7, as recited above.
Ahn does not appear to expressly disclose the transmission comprising a first gear fixed to the first roller shaft and a second gear fixed to the second roller shaft.
However, it is known in the art that transmission components include gears which would interact with rollers, and thus would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have first and second gears fixed to the first and second roller shafts, respectively, as part of the function of the transmission.
Regarding claim 16, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 1, as recited above.
Ahn does not appear to expressly disclose further comprising a spool within the housing for dispensing and accumulating the elongated guide wire, the spool being rotatable relative to the housing about a spool axis.
O’Keefe teaches a spool (spool 20 – Fig.2) within the housing for dispensing and accumulating the elongated guide wire, the spool being rotatable relative to the housing about a spool axis (“a spool 20 that is rotatable about an axis X”, see para [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of O’Keefe with the disclosure of Ahn to include a spool so that the device can further “help dislodge and/or draw obstructing material within the medical tube 12 without compromising a sterile field ” (O’Keefe para [0042]).
Regarding claim 17, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 16, as recited above.
Ahn does not appear to expressly disclose wherein:
the elongated guide wire is coupled to the spool, and
the spool is configured to freely rotate relative to the housing such that the spool passively rotates in response to compressive and tensile forces in the elongated guide wire as the elongated guide wire is advanced out of said interior or retracted into said interior.
O’Keefe teaches wherein:
the elongated guide wire is coupled to the spool (“the guide member 22 can be coupled to the spool 20”, see para [0043], Fig.2), and
the spool is configured to freely rotate relative to the housing such that the spool passively rotates in response to compressive and tensile forces in the elongated guide wire as the elongated guide wire is advanced out of said interior or retracted into said interior (“the guide member 22 can be coupled to the spool 20 such that rotation of the spool 20 about the axis X causes the guide member 22 to wind or unwind about the spool 20 and move between an advanced state and a retracted state”, see para [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of O’Keefe with the disclosure of Ahn such that the spool passively rotates in response to compressive and tensile forces in the elongated guide wire so that the device can further “help dislodge and/or draw obstructing material within the medical tube 12 without compromising a sterile field ” (O’Keefe para [0042]).
Regarding claim 18, Ahn discloses the device (delivery assembly 120 – Fig.1) according to claim 16, as recited above.
Ahn does not appear to expressly disclose further comprising a guide conduit disposed within said interior and configured to guide the elongated guide wire between said spool and said first and second rollers, said guide conduit extending tangentially from a circumference of said spool.
O’Keefe teaches a guide conduit (guide portion 124 – Fig.15-16) disposed within said interior and configured to guide the elongated guide wire between said spool and said first and second rollers, said guide conduit extending tangentially from a circumference of said spool (“a guide portion 124 that can be configured to help direct the guide member 22 onto or off of the spool 20”, see para [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of O’Keefe with the disclosure of Ahn to include a guide conduit configured to guide the elongated guide wire so that the device can further “help dislodge and/or draw obstructing material within the medical tube 12 without compromising a sterile field ” (O’Keefe para [0042]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn in view of O’Keefe, further in view of McDevitt (US 20040087966 A1, herein, McDevitt).
Regarding claim 19, modified Ahn in view of O’Keefe disclose the device according to claim 18, as recited above.
Ahn in view of O’Keefe does not appear to expressly disclose said guide conduit including a pair of walls that define a conduit channel therebetween, each wall of said pair of walls including a plurality of recesses formed therein.
McDevitt teaches a guide conduit including a pair of walls (rims 30, 32 – Fig.1) that define a conduit channel therebetween, each wall of said pair of walls including a plurality of recesses formed therein (openings 36 – Fig.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Ahn include a guide conduit including a pair of walls with a plurality of recesses formed therein as taught by McDevitt so that the device can further “permit the cleaning solution to flow across the surface of the hub 16” (McDevitt para [0031]).
Allowable Subject Matter
Claims 13-15 and 20 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.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 13-15 and 20 in this application have been indicated as allowable subject matter
because the prior art of record fails to disclose or make obvious the claimed invention including
the following features:
“ wherein the actuator includes a cam body with a cam surface that engages the carriage as the actuator is moved from the first position to the second position to move the carriage from the disengaged position to the engaged position”.
“further comprising:
a guide passage formed in said housing and having an inner surface, the actuator being slidably received through the guide passage, and
a guide-passage seal configured to establish a seal between the actuator and the inner surface of the guide passage”.
“A device for clearing obstructions from a medical tube, comprising:
a housing defining an interior and an exterior;
an elongated guide wire residing at least partially within said interior;
first and second rollers disposed within said interior and configured to simultaneously rotate about first and second roller axes, respectively, to advance said elongated guide wire out of said interior or retract said elongated guide wire into said interior;
a spool within the housing for dispensing and accumulating the elongated guide wire, the spool being rotatable relative to the housing about a spool axis;
a carriage that rotatably supports said second roller, said carriage being pivotable about a carriage axis between a disengaged position where the second roller is withdrawn from the first roller, and an engaged position where the second roller is advanced toward the first roller, said carriage axis being spaced from and substantially parallel to said second roller axis;
an actuator that is accessible from the exterior, the actuator being configured to move the carriage from the disengaged position to the engaged position as the actuator is moved from a first position to a second position; and
a spring that biases the carriage into said disengaged position”.
Claim 15 is allowable by virtue of dependency on claim 14.
The combination of the claimed limitations are novel and found to be allowable over the prior art. The cited references taken singly or in combination do not anticipate or make obvious the Applicant' s claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights