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 Objections
Claim 3 is objected to because of the following informalities:
Regarding claim 3, in line 2, a semi colon should replace the comma after “tube or rod”.
Appropriate correction is required.
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 1-19 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.
Regarding claim 1 and 2, it is unclear what the limitation “variable material omissions” specifically entails. Claims 2-19 are also rejected due to their dependency on claim 1.
Regarding claim 10, the term “substantially” is a relative term which renders the claim indefinite. The term “substantially” 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.
Regarding claim 15, it is unclear what “wherein ones of the orthogonal pairs are proximal from the curved deflection and other ones of the orthogonal pairs are distal from the curved deflection”. It is unclear what “ones” and “other ones” specifically means. Claim 19 is also rejected due to its dependency on claim 15.
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.
Claims 1, 4, 8, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Sullivan (US 8273016 B2).
Regarding claim 1, O’Sullivan teaches an esophageal deflection device (“an esophagus isolation catheter for deflecting an esophagus of a patient”, abstract), the device comprising:
An elongate outer tube of biocompatible material comprising a proximal end and a distal end and a central portion therebetween (catheter body 12, shown in annotated Fig. 1 below), wherein the elongate outer tube is capable of being flexed if a threshold amount of force is applied, the elongate outer tube comprising a curved deflection between the distal end and the central portion (“the deflected intermediate section forms a generally C-shaped curve”, Col. 3, lines 9-10);
The curved deflection comprising a stiffness sufficient to cause the esophagus to conform to the shape of the curved deflection when the elongate outer tube is inserted into the esophagus (“deflected intermediate section…deflects the esophagus away from an ablation site in the left atrium of a heart”, Col. 3, lines 9-11);
An elongate insertion tube or rod (stiffening tube 22) comprising a distal end and a proximal end, the elongate insertion tube being smaller in diameter than the elongate outer tube (“diameter of the stiffening tube 22 is…slightly smaller than the inner diameter of the outer wall 20”, Col. 5, lines 7-9), the elongate insertion tube being formed of material comprising a stiffness sufficient to create the threshold amount of force applied from within the elongate outer tube to at least partially straighten the curved deflection when the elongate insertion tube or rod is inserted in the deflection (“stiffening tube 22, which can be made of any suitable material…improved torsional stability”, Col. 5, lines 1-5), wherein a length of the elongate outer tube from a central portion to the distal end is predetermined to place the curved deflection at a targeted esophagus location near the left atrium of the heart (“deflected intermediate section…deflects the esophagus away from an ablation site in the left atrium of a heart”, Col. 3, lines 9-11) and the curved deflection is U-shaped or is compound curve shaped (“the deflected intermediate section forms a generally C-shaped curve”, Col. 3, lines 9-10);
An elongate outer tube handle at the proximal end of the elongated outer tube forming a grip for a practitioner (control handle 16 shown in annotated Fig. 1 below);
An elongate insertion tube or rod handle at the proximal end of the elongate insertion tube or rod forming a grip for a practitioner (control handle 16 shown in annotated Fig. 1 below);
And variable stiffness sections disposed longitudinally in the curved deflection to provide variation in stiffnesses in the longitudinal direction, wherein the variable stiffness sections comprise one or more of variable material properties, variable wall thicknesses, and variable material omissions (“spacer 25 lies within the catheter body 12 between the distal end of the stiffening tube 22 and the proximal end of the intermediate section 13…spacer 25 can be made of a material that is stiffer than the material of the intermediate section…but not as stiff as the material of the stiffening tube 22”, Col. 5, lines 33-38).
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Regarding claim 4, O’Sullivan teaches a domed tip at the distal end of the elongate outer tube (domed tip 17 shown in Fig. 1).
Regarding claim 8, O’Sullivan teaches the insertion tube or rod comprising a lumen (“the catheter body 12 comprises an elongated tubular construction having a single central lumen 18”, Col. 4, lines 49-50).
Regarding claim 13, O’Sullivan teaches a three-dimensional arrangement of a plurality of temperature sensors disposed near an outermost surface of the elongate outer tube (“one or more temperature sensors may be provided along the length of the catheter body 12 to monitor the temperature of the esophageal tissue”, Col. 11, lines 41-44).
Regarding claim 14, O’Sullivan teaches the elongate outer tube comprising an outer coating and the temperature sensors are embedded in the outer coating (“temperature sensors…covered with a short piece of plastic tubing 57, e.g. polyimide, and covered with epoxy”, Col. 11, lines 56-63).
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 2 is rejected under 35 U.S.C. 103 as being obvious over O’Sullivan in view of Salahieh (CN 103764216 B).
Regarding claim 2, O’Sullivan teaches all the limitations of claim 1, but does not teach the variable material omissions comprising holes.
However, Salahieh teaches an esophageal deflection device comprising variable material omissions comprising holes (“fixed area 52 includes a plurality of holes 57”, page 11, paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of O’Sullivan with the device of Salahieh and add holes to the device in order to provide variable stiffness along the device to promote curvature at inflection points.
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being obvious over O’Sullivan in view of Vazales (US 20130104884 A1).
Regarding claim 3, O’Sullivan teaches all the limitations of claim 1, but does not teach view holes in the handle and markings on the elongate insertion tube or rod to provide a depth insertion indicator of the relative position of the elongate insertion tube or rod in the elongate outer tube.
However, Vazales teaches an esophageal deflection device (“endotracheal tube”, abstract) comprising a view hole in the handle (visualization port 133, Fig. 3A) and markings on the elongate insertion tube or rod; the markings and view holes combing to provide a depth insertion indicator of the relative position of the elongate insertion tube or rod in the elongate outer tube (“markings to indicate depth of insertion”, paragraph [0234]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of O’Sullivan with the view hole and markings of Vazales in order to provide a visual indicator for the depth insertion of the elongate insertion tube or rod.
O’Sullivan in view of Vazales does not teach a plurality of view holes, however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to duplicate the view hole of Vazales and make a plurality of view holes in the handle in order to provide a better view of the elongate insertion tube or rod for the operator, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 9, O’Sullivan teaches all the limitations of claim 1, but does not teach the insertion tube or rod comprising or consists of an endoscope.
However, Vazales teaches the insertion tube or rod comprising an endoscope (“the endotracheal tube adapter can be configured to receive a device…endoscopes”, paragraph [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of O’Sullivan with the endoscope of Vazales in order to provide further visual assistance in insertion of the deflection device for the operator.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being obvious over O’Sullivan in view of Mitchell (US 20150173589 A1).
Regarding claims 5 and 6, O’Sullivan teaches all the limitations of claim 4, but does not teach an opening in the domed tip at the distal end of the elongate outer tube, and the distal end of the elongate rod or tube comprising and a portion of the taper to extend through the opening in the domed tip.
However, Mitchell teaches an esophageal deflection device (“the tip…guided through the esophagus”, paragraph [0086]) comprising an opening in the domed tip (“tip 58 is substantially dome-shaped”, paragraph [0060], “opening 60 in the tip 58”, paragraph [0055]) at the distal end of the elongate outer tube, and the distal end of the elongate rod or tube comprising a taper and the distal end and opening in the domed tip are sized to permit a portion of the taper to extend through the opening in the domed tip (“the tip has an eccentric tapered shape that includes a distal portion of the taper that is aligned with one of the tool lumens extending through the sheath”, paragraph [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of O’Sullivan with the domed tip of Mitchell in order to help guide the deflection device down the esophagus.
Claims 7, 10-12, and 17 are rejected under 35 U.S.C. 103 as being obvious over O’Sullivan in view of Ricker (US 20080033415 A1).
Regarding claim 7, O’Sullivan teaches all the limitations of claim 1, but does not teach a radio opaque marker in the insertion tube or rod.
However, Ricker teaches an esophageal deflection device (“apparatus for moving the esophagus”, abstract) comprising a radio opaque marker in the insertion tube or rod (“components of the apparatus 100 may be formed from or include radio opaque materials…any of the tip, the controlled curvature section or the flexible section may include a radio opaque marker”, paragraph [0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of O’Sullivan with the radio opaque markers of Ricker in order to allow the device and its shape within the esophagus to be visible under x-ray.
Regarding claim 10, O’Sullivan teaches all the limitations of claim 1, but does not teach an outer diameter of the elongate outer tube being substantially matched to an esophagus inner diameter.
However, Ricker teaches an outer diameter of the elongate outer tube being substantially matched to an esophagus inner diameter (“the diameter of esophagus movement devices may be as large as the inner diameter of the esophagus”, paragraph [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of O’Sullivan with Ricker and make the outer diameter of the elongate outer tube to be equal to the inner diameter of the esophagus in order to make the device variable to the esophagus.
Regarding claims 11 and 12, O’Sullivan teaches all the limitations of claim 1, but does not teach an outer diameter of the elongate outer tube being at least half or less than half of an esophagus inner diameter, and the elongate outer tube further comprising suction ports for drawing a vacuum to draw esophagus walls into contact around the circumference of the elongate outer tube.
However, Ricker teaches an outer diameter of the elongate outer tube to be as large as the inner diameter of the esophagus (paragraph [0086]), as well as the elongate outer tube further comprises suction ports for drawing a vacuum to draw esophagus walls into contact around the circumference of the elongate outer tube (“grooves 164 are also in communication with a conventional vacuum source…vacuum is applied to…hold the esophagus against the section during movement”, paragraph [0073]).
It would have been obvious to one of ordinary skill in the art to have recognized that the outer diameter of the elongate outer tube being at least half of the esophagus inner diameter would be subject to optimization within the claimed range by routine experimentation with a reasonable expectation of success, in order to allow for the device to be variable to the esophagus. Moreover, it would have been obvious to one of ordinary skill in the art at the time for the invention to choose the instantly claimed ranges through process optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 II and in re Boesch, 205 USPQ 215 (1980). It would also have been obvious to one of ordinary skill in the art to combine the device of O’Sullivan with the suction ports of Ricker in order to ensure that the esophagus is in fuller contact with the outer surface of the elongate outer tube.
Regarding claim 17, O’Sullivan teaches all the limitations of claim 1.
Furthermore, Ricker teaches vacuum suction ports in the elongate outer tube (“there is a vacuum source coupled to or in communication with the plurality of apertures formed in the wall of the controlled curvature section”, paragraph [0008]) configured to draw esophagus walls onto the circumference of the elongate outer tube when a vacuum is applied to the outer tube through a lumen in the insertion rod or tube (“grooves 164 are also in communication with a conventional vacuum source…vacuum is applied to…hold the esophagus against the section during movement”, paragraph [0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of O’Sullivan with the vacuum suction ports of Ricker in order to ensure that the esophagus is in fuller contact with the outer surface of the elongate outer tube.
Allowable Subject Matter
Claims 15, 16, 18 and 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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