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 .
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.
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 7 and 14 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.
It is at least unclear to examiner if the “second aperture” in claim 7 is the same “second aperture” cited in claim 6, or different “second aperture.”
Claim 14 recites “wherein the first elongated prong has a length of the first elongated prong is five times larger.” It is at least unclear what is meant by this. Furthermore, it is unclear of “a length of the first elongated prong” is the same as “a length of the first elongated prong” as in claim 13, or a different length of the first elongated prong.
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.
Claim(s) 11-14 and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rozenberg (US 2010/0324483).
Regarding claim 11, Rozenberg teaches a nasal cannula comprising:
a fluid supply connector hub configured to connect to a fluid supply line (20);
a first elongated prong comprising an axial fluid channel that is fluidly coupled to a lumen of the fluid supply connector hub (prong 30a with fluid channel coupled to a lumen of the fluid supply connector hub 20), the first elongated prong projecting from the fluid supply connector hub and having a curved shape (30a projecting from hub 20); and
a fluid egress aperture positioned on a side of the first elongated prong opposite a curve of the first elongated prong (fluid egress through 40a on a side of 30a opposite a cylindrical curve of 30a).
Regarding claim 12, Rozenberg teaches a second elongated prong that projects from the fluid supply connector hub and runs parallel with the first elongated prong (prong 40b coming from the connector hub).
Regarding claim 13, Rozenberg teaches wherein a length of the first elongated prong is more than twice a distance between an axis of the first elongated prong and an axis of the second elongated prong (at least Fig. 1, ports 12 cm long as in par. [0036]).
Regarding claim 14, Rozenberg teaches wherein the first elongated prong has a length of the first elongated prong is five times larger than a distance between the first elongated prong and the second elongated prong (Fig. 1, ports 12 cm long as in at least par. [0036]).
Regarding claim 16, Rozenberg teaches a proximal flange that is configured to axially slide along at least a portion of the proximal portion of the first elongated prong to set a proximal stop portion of the nasal cannula (26 to set the proximal stop portion as in at least par. [0037]).
Regarding claim 17, Rozenberg teaches wherein a line normal to the fluid egress aperture at a center of the fluid egress aperture is angled relative to an angle of an axis of the first elongated prong at a proximal base of the first elongated prong by an angle of less than 90 degrees (a line normal to the center of aperture 40a may be angled relative to an axis of the elongated prong by an angle of less than 90 degrees, depending on the lines drawn).
Regarding claim 18, Rozenberg teaches the fluid egress aperture has a circular shape (at least Fig. 2).
Regarding claim 19, Rozenberg teaches wherein the first elongated prong is detachable from the fluid supply connector hub (40a connectable to source 10 as in at least par. [0046] with different sizes provided for different patients).
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, 6-8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rozenberg (US 2010/0324483) in view of Whiteley (US 2019/0254866).
Regarding claim 1, Rozenberg teaches a nasal cannula system, comprising:
a nasal cannula (par. [0028] nasal catheter) comprising:
a first elongated prong configured to be inserted into a cavity of a subject (prong 30a), the first elongated prong having a first axial fluid channel (30a with a fluid channel 60); and
a first aperture on a side wall of the first elongated prong (aperture 40a on a side wall of prong 30a), the first aperture providing access to the first axial fluid channel (40a connecting to channel 60);a fluid supply configured to direct the fluid through the first axial fluid channel of the first elongated prong and out of the first aperture to a target area (source 10 to connect fluid from 60 out of 40a to a target area).Rozenberg is not explicit regarding a temperature controller configured to regulate a temperature of a fluid prior to the fluid being directed through the first axial fluid channel.However, Whiteley teaches a cooling device with a temperature controller to regulate a temperature of a fluid prior to the fluid being directed through a device to a target area (controller for modulating temperature as in par. [0046], which is in the handle prior to going through a lumen to the target area).It would have been obvious to one of ordinary skill in the art to modify Rozenberg with the temperature controller of Whiteley to control the temperature of the fluid to treat tissue to control the temperature delivered to the patient (par. [0030] of Rozenberg, par. [0010] of Whiteley).
Regarding claim 2, Rozenberg teaches wherein a distal end of the first elongated prong is sealed (distal end of prong 30a is ballon 50a which is sealed).
Regarding claim 6, Rozenberg teaches wherein the nasal cannula further comprises a second elongated prong with a second aperture being located at a terminal end of the second elongated prong (second elongated prong 30b and second aperture as opening to balloon 50b).
Regarding claim 7, Rozenberg teaches wherein the second elongated prong has a second aperture on a side wall of the second elongated prong (30b with one of 40b on a side wall of the prong).
Regarding claim 8, Rozenberg is not explicit regarding a second elongated prong that comprises a temperature sensor electrically coupled to the temperature controller.However, Whiteley teaches a temperature sensor coupled to the temperature controller to measure the tissue temperature and relay that to the controller (par. [0118]). One of ordinary skill in the art would modify Rozenberg with the temperature sensor of Whitley, to relay temperature information to the controller. One of ordinary skill in the art would appreciate that in order to measure tissue surface temperature, the sensor would have to be near the tissue surface, where the prong is.
Regarding claim 10, Rozenberg teaches wherein the temperature controller comprises a thermoelectric device configured to cool fluid passed over a surface thereof.However, Whiteley teaches a thermoelectric device to cool fluid as in par. [0039].It would have been obvious to one of ordinary skill in the art to use a thermoelectric device as the temperature controller as in Whiteley, as a known device that can heat or cool fluid.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rozenberg (US 2010/0324483) in view of Whiteley (US 2019/0254866), in view of Hobson (US 2015/0209542).
Regarding claim 3, Rozenberg is not explicit wherein the first aperture has a diameter that is larger than a diameter of the first elongated prong.However, Hobson teaches apertures with diameters larger than a diameter of the elongated prong (Fig. 8, holes 41 larger than diameter of 43).It would have been obvious to one of ordinary skill in the art to modify Rozenberg with the larger diameter of Hobson, depending on the number of apertures and amount of fluid flow desired in treatment.
Regarding claim 4, Rozenberg teaches wherein the first elongated prong has a length configured to extend from nares of a subject to within about 2 to 3 cm of the target area, the target area being one of an internal carotid artery, a circle of Willis, or a basal cistern of the subject (cooling through at least the circle of Willis as in fig. 10 and par. [0009]).
Regarding claim 5, Rozenberg teaches wherein the length of the first elongated prong is five times larger than a distance between the first elongated prong and a second elongated prong (Fig. 1).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rozenberg (US 2010/0324483) in view of Whiteley (US 2019/0254866), in view of Kreck (US 2013/0030411).
Regarding claim 9, Rozenberg is silent wherein the first elongated prong includes one or more depth markings on a proximal portion of the first elongated prong.However, Kreck teaches nasal catheters with markings to indicate depth of insertion (par. [0328]).It would have been obvious to one of ordinary skill in the art to modify Rozenberg with depth markings on the device to indicate the depth of insertion, to visually indicate the target area.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rozenberg (US 2010/0324483) in view of Kreck (US 2013/0030411).
Regarding claim 15, Rozenberg is silent wherein a proximal portion of the first elongated prong includes a plurality of depth markings.However, Kreck teaches nasal catheters with markings to indicate depth of insertion (par. [0328]).It would have been obvious to one of ordinary skill in the art to modify Rozenberg with depth markings on the device to indicate the depth of insertion, to visually indicate the target area.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rozenberg (US 2010/0324483) in view of Landis (US 2023/0084620).
Regarding claim 20, Rozenberg is not explicit regarding a plurality of rib projections that run along a length of the first elongate prong to create a gap and reduce friction between tissue and the nasal cannula.However, Landis teaches flanges in a nasal insert device to create a gap between tissue (par. [0108] with flanges 560 and 561 creating a gap between tissue and the nasal cannula).It would have been obvious to one of ordinary skill in the art to modify Rozenberg with the gap of Landis to allow for respiration (par. [0108]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794