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 1-20 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.
Regarding claim 1, “the second cuff” on line 17 and “the elongated body” on line lacks antecedent basis.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 5, 8, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frass et al. (5,499,625) in view of Harautuneian et al. (3,848,605).
Regarding claim 1, Frass discloses a laryngeal tube (i.e. tube capable of entering the larynx) comprising: a first tube comprising a connector (24), a first pilot balloon (25), and a first cuff inflation line (23); a second tube comprising a second connector (20), a second pilot balloon (21), and a second cuff inflation line (19); a suction lumen (11); a pharyngal lumen (14); a suction port (i.e. 16) (col. 3 lines 50-55, col. 6 lines 15-23); a radiopaque cover (i.e. stripe 27 and/or shaft 28 as cover which covers at least a portion of the tube); and a proximal cuff (22) and a distal cuff (18), wherein the proximal cuff (22) is configured to secure a pharyngal area of a patient and the distal cuff (18) is configured to prevent oxygen escape into a stomach of the patient (col. 2 lines 1-10, col. 4 lines 10-35); wherein the first tube is fluidly connected to the proximal cuff (22) and the second tube is fluidly connected to the second cuff (18);wherein the suction lumen (11), the pharyngal lumen (14), the first tube (23, 24, 25), and the second tube (19, 20, 21) are at least partially disposed in the elongated body (10) and at least partially covered by the radiopaque cover (as shown in fig. 2, the cover 28 extends on an upper portion of the airway thereby extending at least partially above the lumens and tubes); and wherein the suction lumen (11) and the pharyngal lumen (14) have a common outer wall (inner perimeter wall) inside the elongated body and a common separator wall (fig. 3 shows a common internal vertical wall separating lumens 11 and 14).
Frass discloses connectors 20, 24 with pilot ballons (21, 25) but does not specifically
disclose the connectors include a first self-sealing valve and a second self-sealing valve and wherein the first self-sealing valve surrounds a periphery of the first cuff inflation line and the second self-sealing valve surrounds a periphery of the second cuff inflation line. However, Harautuneian discloses in figs. 8-10, each connector include a sealing valve (check valve) (col. 5 lines 50-67 through col. 6 lines 1-10 disclose a check valve with flaps that are biased closed) and wherein the valve surrounds a periphery of a cuff inflation line (11). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the pilot ballon and connectors of the first and second tubes of Frass with a self-sealing valve as taught by Harautuneian to provide the advantage of enhanced sealing of the cuff inflation lines to maintain cuff pressure.
Regarding claim 2, Frass discloses wherein the cuff inflation line is made of polyvinyl chloride (PVC) (col. 3 lines 45-60).
Regarding claim 8, Frass discloses the proximal cuff (22) accommodates a volume of fluid ranging from 60 milliliters (mL) to 100 mL (col. 6 lines 1-7 discloses 100mL which is within the claimed range).
Regarding claim 18, Frass discloses the proximal cuff (22) comprises a proximal cuff
seal (col. 4 lines 30-35).
Regarding claim 19, Frass discloses the distal cuff (18) comprises a distal cuff seal (col. 4 lines 8-15).
Regarding claim 20, Frass discloses in fig. 1, the proximal cuff (22) is axially longer than the distal cuff (18).
Claim(s) 3, 4, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frass et al. in view of Harautuneian, as applied to claim 1 above, and further in view of Sandmore et al. (2012/0024292).
Regarding claim 3, Frass discloses a separator wall but does not specifically disclose the separator wall has a semicircular profile and the outer wall defines a tube having a circular cross section, wherein the radius of the semicircular profile of the separator wall is greater than the radius of the circular cross section of the outer wall. However, Sandmore teaches in i.e. figs. 5, 7 the separator wall (26) has a semicircular profile (as shown, the wall is curved as a semi-circle) and the outer wall (perimeter wall 70) defines a tube having a circular cross section (as shown, the cross section would be circular) wherein the radius of the semicircular profile of the separator wall is greater than the radius of the circular cross section of the outer wall (fig. 5 and [0031] lines 1-25 disclose the radius i.e. 72 larger than the radius of the outer wall; see also figs. 7-10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lumen and separator wall of Frass to include a semi-circular wall with circular cross section as taught by Sandmore to provide the advantage of enhanced accommodation of tube sizes.
Regarding claim 4, the modified Frass discloses (i.e. see fig. 7 of Sandmore) the separator wall has a height that is 0.5-0.9 times the inner diameter of the outer wall (as shown, the separator wall is slightly off center being less than 1 but greater than half the diameter. In addition, [0034] last 10 lines disclose the divider can divide into unequal volume lumens thus being off center). While Sandmore does not specifically disclose a value within the claimed range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the separator wall within the claimed range as such would be considered a design choice well within an artisan’s skill. In addition it has been held that where the general conditions of a claim are known, it is not inventive to determine optimum or workable ranges by routine experimentation.
Regarding claim 12, Frass discloses an adapter (i.e. 30) fixedly attached to the suction lumen (11) by the suction port (16).
Regarding claim 13, Frass discloses a suction connector (i.e. 30) attached to the suction lumen (11).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frass et al. in view of Harautuneian, as applied to claim 1 above, and further in view of Sujis (2019/0217033).
Regarding claims 6 and 7, Frass substantially teaches the claimed invention except for the proximal cuff operates at a pressure of from 20 and 50 cm H20 and the distal cuff operates at a pressure of from 20 and 60 cm H20. However Suji’s discloses the cuffs operate at a press between 20-30cm water ([0070] last 5 lines) which is within the claimed ranges. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the cuffs of Frass with pressures within the claimed range as taught by Sujis to provide the advantage of adequate pressure for sealing without undue over pressurization damage.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frass et al. in view of Harautuneian, as applied to claim 1 above, and further in view of Singh (2010/0163023).
Regarding claim 9, the modified Frass substantially teaches the claimed invention except for the distal cuff accommodates a volume of fluid ranging from 60 milliliters (mL) to 80 mL. However, Singh teaches cuffs accommodating 60ml which is within the claimed range ([0108] lines 1-15 disclose the cuffs can accommodate 60 ml) which is within the claims range. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cuffs of Frass to be able to accommodate pressures within the claimed range as taught by Singh to provide the advantage of adequate pressure for sealing without undue over pressurization damage.
Regarding claim 10, Frass discloses in fig. 1 the suction lumen (11) has a first diameter at a distal end of the suction lumen and a second diameter at a proximal end of the suction lumen (as shown, the lumen is annular and semi-circular extending along the length of the tube and thus includes a diameter at both proximal and distal ends).
Regarding claim 11, Frass discloses in fig. 1 the pharyngal lumen (14) has a first diameter (i.e. outer diameter) at a distal end of the pharyngal lumen and a second diameter (inner diameter) at a proximal end of the pharyngal lumen; and wherein the second diameter is less than the first diameter (as shown the outer diameter is greater than the inner diameter).
Claim(s) 5 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frass et al. in view of Harautuneian, as applied to claim 1 above, and further in view of Sheridan et al. (3,605,750).
Regarding claim 5, Frass substantially teaches the claimed invention except for the radiopaque cover comprises at least eight pharyngal perforations. However, Frass discloses the tube can include at least 8 perforations (26; figs. 1 and 2). Frass also discloses an internal stripe can be interrupted by the perforations thereby including perforations in the cover to accommodate the perforations in the tube (col. 5 lines 1-15). Sheridan teaches an annular cover (66) encircling an outside wall of the tube (col. 5 lines 70-75). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the perforated radiopaque cover stripe of Frass as a band fused outside of the tube as taught by Sheridan to provide the advantage of enhanced location and identification of the full circumference of the tube for enhanced feedback and precision in placement.
Regarding claims 14-17, Frass discloses an opaque stripe or rod but does not specifically disclose an inner diameter of the radiopaque cover is from 1.1 to 1.4 times greater than an outer diameter of the suction port, an outer diameter of the cuff inflation line, an outer diameter of the self-sealing valve, and an outer diameter of the pilot balloon. However, Sheridan discloses the opaque cover in the form of a band (66) encircling an outside wall of the tube (col. 5 lines 70-75) and thus having a diameter larger than a suction port, cuff inflation line, sealing valve, or pilot balloon. While, Sheridan does not specifically disclose the diameter is within the claimed range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the radiopaque cover of Frass as a band fused outside of the tube as taught by Sheridan to provide the advantage of enhanced location and identification of the full circumference of the tube for enhanced feedback and precision in placement. In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the diameter within the claimed range as such would be considered a design choice well within an artisan’s skill. In addition it has been held that where the general conditions of a claim are known, it is not inventive to determine optimum or workable ranges by routine experimentation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Totz (2007/0017527) disclose X-ray markers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/Primary Examiner, Art Unit 3785