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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “U-shaped tubing that wraps longitudinally around the sheath body” must be shown or the feature(s) canceled from the claim (See claim 5). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 2-7 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 “batten pocket” in line 1. It is not understood by what it is, and whether a batten is present in the invention. Spec. pages 3-4, which discusses this merely discloses it as a pocket, and there is no explanation to what a “batten” is with regards to the invention. Examiners search finds that a batten / batten pocket is used in sails. Hence, it Is not understood what is being recited here with regards to a catheter system. Examiner interprets as some pocket / space for the tubing to be placed in,
Claims 3-4 are rejected in view of dependency.
Claim 5 recites “U-shaped tubing that wraps longitudinally around the sheath body” it is not understood if the tubing itself is in some u-shape, or if some u-shape is formed by the wrapping of the tubing around sheath body. Examiner interprets as a helical or spiral arrangement around something that provides the claimed u-shape.
Claims 6-7 are rejected in view of dependency.
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.
Claims 1, 8, 10 rejected under 35 U.S.C. 103 as being unpatentable over Beyhan [US 20070219446 A1] in view of Smith [US 20180049658 A1].
As per claim 1, Beyhan teaches an apparatus (Beyhan Fig 1) comprising:
a flexible sheath body (Beyhan Fig 1, catheter shaft 101)
configured to receive at least a portion of an ultrasound probe having a transducer portion (Beyhan Fig 1, Fig 2, ¶0051 “an ultrasound imaging probe 201, in the form of a linear array 202, slideably positioned inside the central lumen 102”);
a balloon portion secured to the sheath body proximate the transducer portion (Beyhan Fig 1, Fig 2 item 104),
wherein the balloon portion includes a fluid introduction port for allowing fluid to inflate the balloon portion (Beyhan Fig 1 item 108, ¶0050 “A fluid such as saline is introduced through the balloon inflation port 109 and lumen 108 to inflate the balloon’); and
a gas and liquid removal portion (Beyhan Fig 1 ¶0050 “closed flow path defined by port 107, central lumen 102, fluid communication port 103, fluid return channel 105 and fluid return port 106, purging air out of the central lumen 102… interstitial communication port 111 to remove fluid and gases” this is the claimed gas and liquid removal portion) comprising:
a valve coupled to an open end of the gas and liquid removal portion Beyhan ¶0047 “Central lumen port 107 may comprise a Touhy-Borst valve”),
wherein the valve is configured to permit application of a source of negative pressure therein to the gas and liquid removal portion Beyhan ¶0046 “ Application of negative pressure at port 111” None the whole structure, including valve at 107 needs to be configured for providing the negative pressure from 111 )
to remove gases or liquids from within the gas and liquid removal portion Beyhan removal of air, fluids, seroma, tissue as in ¶0046, ¶0050).
Beyhan does not expressly teach the channel 105 is a gas and liquid removal tubing having a plurality of gas and liquid removing holes therein.
Smith in a related field of pressure catheters, teaches a gas and liquid removal tubing having a plurality of gas and liquid removing holes therein (Smith Figs 2-4, ¶0037 “hollow tube 15, which extends from the tip 20 … A plurality of holes or apertures 16 are formed through the wall of the hollow tube 15 b to allow fluid to be aspirated or otherwise collected from the patient”, ¶0016 “the term “fluid” used herein refers both to compressible fluids (gases, such as air, etc.)”)
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Beyhan by utilizing a tubing with multiple holes as in Smith. The motivation would be that if any one or more holes 16 should become clogged or blocked, other holes 16 will be available for allowing passage of fluid (Smith ¶0037).
As per claim 8, Beyhan in view of Smith further teaches wherein the gas and liquid removal tubing comprises 1/8" outside diameter polyurethane tubing (Smith ¶0041 “hollow tube 15 comprises an extruded thermoplastic, an elastomer, or a combination of the two having an outside diameter ranging from about 0.09 to about 0.13 inches”).
As per claim 10, Beyhan in view of Smith further teaches wherein the source of negative pressure comprises a syringe (Smith ¶0037 “…hollow tube 15 is coupled to a connector 19. The connector 19 is used to attach a syringe or other device used for the collection (e.g. aspiration)”).
Claims 2-4 rejected under 35 U.S.C. 103 as being unpatentable over Beyhan in view of Smith as applied to claim 1 above, and further in view of Willard [US 5536242 A].
As per claim 2, In view of 112 rejection above, Beyhan in view of Smith does not expressly teach further comprising a batten pocket secured to the flexible sheath body at a position opposite to the balloon portion.
Willard, in a related field of intravascular devices, teaches a batten pocket secured to the flexible sheath body at a position opposite to the balloon portion (Willard Fig 1a, Fig 6, Col 8 lines 63 to Col 9 line 5, extraction tube manifold 37b with female luer fitting for the extraction tube 13, in a proximal position as compared to balloon).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Beyhan in view of Smith by integrating manifolds as in Willard so as to facilitate easy connection to pressurized fluid collectors (Willard Col 9 lines 1-2).
As per claim 3, Beyhan in view of Smith and Willard further teaches wherein the gas and liquid removal tubing passes through the batten pocket and is secured to a distal end of the balloon portion (Willard Fig 1a, Fig 2c, Fig 5).
As per claim 4, Beyhan in view of Smith and Willard further teaches wherein the plurality of gas and liquid removing holes are formed in a distal end of the gas and liquid removal tubing proximate to the balloon portion (Smith Fig 2 Fig 3a items 16 proximate to the tip 20 where the balloon portion 40 is).
Claims 5-6 rejected under 35 U.S.C. 103 as being unpatentable over Beyhan in view of Smith as applied to claim 1 above, and further in view of Nash [US 20070282303 A1].
As per claim 5, Beyhan in view of Smith does not expressly teach wherein the gas and liquid removal tubing comprises U- shaped tubing that wraps longitudinally around the sheath body, wherein the U-shaped tubing is secured to a periphery of the sheath body.
Nash in a related field of removal of obstructions in a vessel or lumen, teaches tubing comprises U- shaped tubing that wraps longitudinally around the sheath body, wherein the U-shaped tubing is secured to a periphery of the sheath body (Nash Fig 3, ¶0056 “features a hollow lumen core tube 342 around which is wound a coiled member to form aspiration windings 346 … which causes the aspiration of debris proximally, which may then be directed towards a waste reservoir 354 by a waste lumen 356.”).
As per MPEP2143.I Examples of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results;. In the instant case, the claims are only directed to combine known prior art features of winding a tubing. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Beyhan in view of Smith, by utilizing the helical windings as in Nash, so as to provide the predictable result of providing and routing technique for a aspiration tubes.
As per claim 6, Beyhan in view of Smith and Nash further teaches wherein the plurality of gas and liquid removing holes are formed in portions of the gas and liquid removal tubing proximate or adjacent to the balloon portion (Smith Fig 2 Fig 3a items 16 proximate to the tip 20 where the balloon portion 40 is).
Claim 7 rejected under 35 U.S.C. 103 as being unpatentable over Beyhan in view of Smith and Nash as applied to claims 6 above, and further in view of Sutton [US 20030181942 A1].
As per claim 7, Beyhan in view of Smith and Nash does not expressly teach further teaches comprising a Y-connector for joining open ends of the U-shaped tubing , wherein the valve is coupled to the Y-connector.
Sutton, in a related field of delivering a medical device, teaches Y-connector for joining open ends of the tubing, wherein the valve is coupled to the Y-connector (Sutton ¶0097 “radial compression valve assembly 810 may, for example, be a large bore Touhy Borst valve assembly. The side-arm or Y-arm 814 of the Touhy Borst valve assembly…” ).
As per MPEP2143.I Examples of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results;. In the instant case, the claims are only directed to combine known prior art features of winding a tubing, including providing the y-arm to the Touhy Borst. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Beyhan in view of Smith and Nash, by utilizing valves and connectors, so as to provide the predictable result of allowing intermittent or continuous flushing (Sutton ¶0097).
Claim 9 rejected under 35 U.S.C. 103 as being unpatentable over Beyhan in view of Smith as applied to claim 1 above, and further in view of Sutton [US 20030181942 A1].
As per claim 9, Beyhan in view of Smith does not expressly teach wherein the valve comprises a stopcock.
Sutton, in a related field of delivering a medical device, teaches a stopcock (Sutton ¶0097 “A multi-way stopcock 816 may be attached to Y-arm 814”).
As per MPEP2143.I Examples of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results;. In the instant case, the claims are only directed to combine known prior art features of winding a tubing, including providing the y-arm to the Touhy Borst. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Beyhan in view of Smith and Nash, by utilizing valves and connectors, so as to provide the predictable result of allowing intermittent or continuous flushing (Sutton ¶0097).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/Primary Examiner, Art Unit 3797
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