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, 10, 18 and all dependents thereof 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.
With regard to claim 2, the claim recites “tubing extending from the first spike and the second spike”. However a tube set is already recited in claim 1 where the tube set is coupled to the first and second fluid source. Therefore, it is unclear if the tube set is the same as the tubing extending from the spike because the spike is designed to be attached to the first and second fluid source. For purposes of examination the tube set and the tubing are the same structure unless further defined.
With regard to claim 10, the claim recites “deflection elements” plural. Claim 1 only recites a singular deflection element. It appears this is a typo and the deflection element of claim 10 is considered to also only be a single deflection element unless another deflection element is introduced.
With regard to claim 18, the claim recites “at least one deflection element”, however, only a single deflection element is introduced in claim 11 from which claim 18 depends. For purposes of examination it is being interpreted that only a single deflection element is introduced.
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) 1-2, 4, 6-13, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson et al. (US 5,944,686) in view of Nowosielski et al. (US 5,605,545).
With regard to claim 1, Patterson discloses A system (Fig. 1 and 2) for aspirating thrombus (through 24) and delivering an agent (through 26) comprising: a first fluid source (connected to 50) containing a first fluid; a tube set (26) coupled to the first fluid source; and an aspiration catheter (22) in fluid communication with both the first fluid source (see Fig. 1 and 2, the fluid delivery tube is coaxial with the aspiration catheter and the distal openings are in fluid communication), the aspiration catheter comprising: an aspiration lumen (24) comprising a distally positioned deflection element (36 and 38); and a supply tube (26) disposed within the aspiration lumen (see Fig. 1 and 2), the supply tube comprising an orifice (30) at or adjacent the distal end of a supply lumen of the supply tube, the orifice is configured to direct at least one of the first fluid as a spray pattern such that upon impinging upon the deflection element at least one of the first fluid and the second fluid is directed substantially distally to exit the open distal end of the aspiration lumen (see arrow 32 in Fig. 1 and 2 showing the fluid flow that is directed towards the deflection element and exiting out of the opening in the aspiration catheter 22).
However, Patterson does not disclose a second fluid source.
Nowosielski teaches an irrigation/aspiration system (1) having a first fluid source (22) and a second fluid source (24) ; a tube set coupled to the first and second fluid source (tubes 32 and 34 that converge into the fitting 30 into tube 28 into the handheld aspiration/irrigation device 20).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson with a second fluid source as taught by Nowosielski for the purpose of providing enough fluid for flushing during laparoscopic surgery (Col 1, lines 27-39).
With regard to claim 2, Patterson discloses the claimed invention except for a first and second spike.
Nowosielski teaches wherein the tube set comprises: a first spike (Col 2, line 45 to Col 3, line 7, suitable fittings for the bags such as spiking) configured to cooperate with a first interface of the first fluid source; a second spike (Col 2, line 45 to Col 3, line 7, suitable fittings for the bags such as spiking) configured to cooperate with a second interface of the second fluid source; and tubing (32 and 34) extending from the first spike and the second spike to a fitting (30) associated with the aspiration catheter.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson with a second fluid source as taught by Nowosielski for the purpose of providing enough fluid for flushing during laparoscopic surgery (Col 1, lines 27-39).
With regard to claim 4, Patterson discloses wherein the first fluid is the same as the second fluid (Col 2, line 45 to Col 3, line 7).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson with a second fluid source as taught by Nowosielski for the purpose of providing enough fluid for flushing during laparoscopic surgery (Col 1, lines 27-39).
With regard to claim 6, Patterson discloses the claimed invention except for the first and second fluid
Nowosielski teaches wherein the first fluid and the second fluid are pressurized (Col 1, lines 5-12).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson with a second fluid source as taught by Nowosielski for the purpose of providing enough fluid for flushing during laparoscopic surgery (Col 1, lines 27-39).
With regard to claim 7, Patterson discloses the claimed invention except for a second fluid source.
Nowosielski teaches wherein one of the first fluid and the second fluid is saline (Col 2, lines 36-44).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson with a second fluid source as taught by Nowosielski for the purpose of providing enough fluid for flushing during laparoscopic surgery (Col 1, lines 27-39).
With regard to claim 8, Patterson discloses the spray pattern is a jet (Col 1, lines 25-44).
With regard to claim 9, Patterson discloses wherein the spray pattern impacts the deflection element at an oblique angle that is distally-orientated and/or an oblique angle that is proximally-orientated (see Fig. 3 and 4, showing the stream 32 at an oblique angle that is distally directed).
With regard to claim 10, Pattern discloses wherein the deflection element (36/38) is a deformation in a wall of the aspiration catheter (38).
With regard to claim 11, Patterson discloses A system (Fig. 1 and 2) for aspirating thrombus (through 24) and delivering an agent (through 26) comprising: a first fluid source (connected to 50) containing a first fluid; a tube set (26) coupled to the first fluid source; and an aspiration catheter (22) in fluid communication with both the first fluid source (see Fig. 1 and 2, the fluid delivery tube is coaxial with the aspiration catheter and the distal openings are in fluid communication), the aspiration catheter comprising: an aspiration lumen (24) comprising a distally positioned deflection element (36 and 38); and a supply tube (26) disposed within the aspiration lumen (see Fig. 1 and 2), the supply tube comprising an orifice (30) at or adjacent the distal end of a supply lumen of the supply tube, the orifice is configured to direct at least one of the first fluid as a spray pattern such that upon impinging upon the deflection element at least one of the first fluid and the second fluid is directed substantially distally to exit the open distal end of the aspiration lumen (see arrow 32 in Fig. 1 and 2 showing the fluid flow that is directed towards the deflection element and exiting out of the opening in the aspiration catheter 22).
However, Patterson does not disclose a second fluid source.
Nowosielski teaches an irrigation/aspiration system (1) having a first fluid source (22) and a second fluid source (24) ; a tube set coupled to the first and second fluid source (tubes 32 and 34 that converge into the fitting 30 into tube 28 into the handheld aspiration/irrigation device 20). Nowosielski further teaches wherein the tube set comprises: a first spike (Col 2, line 45 to Col 3, line 7, suitable fittings for the bags such as spiking) configured to cooperate with a first interface of the first fluid source; a second spike (Col 2, line 45 to Col 3, line 7, suitable fittings for the bags such as spiking) configured to cooperate with a second interface of the second fluid source; and tubing (32 and 34) extending from the first spike and the second spike to a fitting (30) associated with the aspiration catheter.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson with a second fluid source as taught by Nowosielski for the purpose of providing enough fluid for flushing during laparoscopic surgery (Col 1, lines 27-39).
With regard to claim 12 and 13, Patterson discloses wherein the deflection element (38) comprises a first portion and a second portion separated by a circumferentially extending dividing line with a forward-facing ramp and a reverse-facing ramp (38 is a semi-circle ball shape that would necessarily have a distal facing face and a proximal facing face that joins at the top of the ball-shape).
With regard to claim 20, Patterson discloses wherein the first spray pattern has a directional vector that is angled at an angle with respect to an axis of the orifice (see 32 in Fig. 3 and 4 showing direction of the spray pattern).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson et al. (US 5,944,686) in view of Nowosielski et al. (US 5,605,545) and in further view of Lal (US 2012/0041416 A1).
With regard to claim 3, Patterson/Nowosielski teaches the claimed invention except for a clamp.
Lal teaches a similar system that further comprises a clamp ([0029]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson/Nowosielski with a clamp as taught by Lal for the purpose of preventing fluid from entering the line and preventing air from entering the fluid supply container ([0046]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson et al. (US 5,944,686) in view of Nowosielski et al. (US 5,605,545) and in further view of Childers et al. (US 2007/0276328 A1).
With regard to claim 5, Patterson/Nowosielski teach the first and second fluid source but do not teach the temperature of the fluids.
Childers teaches a similar system having a first fluid source (24a) and a second fluid source (24b) wherein the first and second fluid are a different temperature from each other ([0106], each of the fluid bags can be brough to its desired temperature and thus would be prima facie obvious to have the fluids at different temperature).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson/Nowosielski with the temperatures of the fluid as taught by Childers for the purpose of bringing the fluid to the appropriate temperature for delivery to the patient ([0027]).
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson et al. (US 5,944,686) in view of Nowosielski et al. (US 5,605,545) and in further view of Padgett et al. (US 6,196,989).
With regard to claim 14-16, Patterson/Nowosielski teach the claimed invention except for a tip extension.
Padget teaches an irrigation-aspiration system (Fig. 12) having an aspiration tube (328) and a fluid supply tube (330) within the aspiration tube, the fluid supply tube directs fluid within the aspiration tube towards a wall of the aspiration tube. Padget further teaches the supply lumen having a hollow tip extension that is curved (see Fig. 13a for close-up on the supply tube and showing element 327 that is attached at a the distal end. The drawings show 327 divided by a line from the fluid supply tube 330). The curved tip extension can be part of the first or second supply lumen and providing a second spray pattern. (claim do not require the first and second spray pattern to be different, thus the same type of extension can be used on the first and second lumens of the system and have the same spray pattern).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Patterson/Nowosielski with the hollow tip extension as taught by Padget for the purpose of directing the fluid towards a deflecting element on the wall of the aspiration tube (Col 4, line 66 to Col 5, line 5).
With regard to claim 17, Patterson discloses a spray pattern that is directed generally distally (see stream 32, Fig. 1 and 2).
In a different embodiment of Patterson (Fig. 6 and 7), the spray can be directed proximally (32). The stream in this case hits the deflector (92) of the aspiration catheter. This type of stream in a proximal direction could be used alternatively or in addition to the distal spray pattern for performing the same function.
It would be prima facie obvious for one of ordinary skill in the art to modify the embodiment of Fig. 1 and 2 of Patterson with a proximal spray patter as taught by the embodiment of Fig. 6 and 7 for the purpose of performing the same function of impinging on the deflector to diffuse the transverse jet stream (Col 4, lines 6-24).
With regard to claim 18, Patterson discloses wherein the at least one deflection element (36/38) is configured to deflect one or both of the first spray pattern and the second spray pattern.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson et al. (US 5,944,686) in view of Nowosielski et al. (US 5,605,545) and in further view of Nitsan et al. (US 2010/0298773 A1).
With regard to claim 19, Patterson/Nowosielski teach the claimed invention except for the shape of the first spray pattern.
Nisan teaches a catheter with fluid spray that can have a conical spray pattern ([0097]).
It would be prima facie obvious for one of ordinary skill in the art to modify the device of Patterson/Nowosielski with the conical spray pattern as taught by Nitsan for the purpose of providing a softer fluid flow ([0097]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783