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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/16/2024 and 09/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 3, 8-10, 21, 26, and 27 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 term “portion” is broad which renders the claim unclear. The term “portion” 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 claims 3, 8, 9, 26, and 27 the term “fluid portion” is ambiguous since the recitation of “fluid portion” went from being a single fluid portion to now being a first and second fluid portion. Hence the term “fluid portion” renders the term unclear as the singular fluid portion is later recited as a plural fluid portion.
Regarding claim 10, the term “at least twice a distance” is an open-ended range since it is unclear which distance is being referenced as there is no upper bound of the range. The examiner is taking this to mean a physical range.
Regarding claim 21, the term “about” is a relative term which renders the claim indefinite. Additionally, it is unclear whether the distance is measured from the proximal end or the distal end. The term “about” 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 claims 2, 4, 5, 22-25, and 28, the claims are also seen as indefinite as they inherit the deficiencies of the independent claim 1.
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 1-4, 10, 21-23, 24-25 and 28 are rejected are rejected under 35 U.S.C. 103 as being unpatentable over Russell et al (WO2022031178A1) herein referred to as “Russell” in view of Rozenberg (US20130073015A1) herein referred to as “Rozenberg”.
Regarding claim 1, Russell discloses: A method for cooling a portion of a body of a subject using a nasal cannula ([00354] a method for providing a patient with respiratory support, which is seen as a method for cooling, since conditions such as therapeutic hypothermia, which require cooling, fall under respiratory support) comprising: a hub ([00418] the interface connector 35 is seen as the hub since the fluid passes through this to go to the prongs) and an elongated prong having a proximal end portion and a distal end portion, (See annotated FIG 7 below where the proximal and distal ends are labelled) the proximal end portion coupled to the hub, (See annotated FIG 4 below where 35 is the hub) the elongated prong defining an axial fluid channel ([00413] the gas flows through the body to the nasal prongs which is seen as defining an axial fluid channel) and having a curved shape; ([00413] prongs 33 and 34 curve; See also annotated FIG 4 below where elongated prongs 33 and 34 are curved) a side wall of the distal end portion of the elongated prong defining an aperture, in fluid communication with the axial fluid channel, (See FIG 7 where 41 is the aperture which is at a side wall of the distal end of the prong; [00407] the prongs which contain the aperture are in fluid connection with the interface connector 35, which is seen as the hub, which is seen as also being in fluid communication with each other) however, Russell does not explicitly disclose: the method comprising: inserting the elongated prong into a nasal cavity of the subject to position the aperture facing a pharyngeal wall of the subject; and delivering a fluid portion through the axial fluid channel and out of the aperture to the pharyngeal wall.
Rozenberg discloses: the method comprising: inserting the elongated prong into a nasal cavity of the subject to position the aperture facing a pharyngeal wall of the subject; and delivering a fluid portion through the axial fluid channel and out of the aperture to the pharyngeal wall ([0009] method for insertion into the nostril of a patient, [0111] the length of the catheter, which is seen as the elongated prong, extends into the pharyngeal region and consists of ports which disperse liquid perpendicular to the longitudinal axis of the catheter, which is seen as opposite to the pharyngeal wall).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed in Russell to include the method of inserting the nasal cannula as disclosed in Rozenberg. The motivation being that making it long enough so that it is opposite the pharyngeal wall is critical in dispersing the spray over a larger region in the nasal cavity and permits greater cooling (Rozenberg [0111]).
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Regarding claim 2, Russell discloses: The method of claim 1, wherein: a longitudinal axis of the elongated prong defines a radius of curvature; the aperture is facing outside of the radius of curvature; however, Russell does not explicitly disclose: a distal end surface of the elongated prong is sealed.
Rozenberg discloses: a distal end surface of the elongated prong is sealed ([0096] the nasal catheter which is seen as the elongated prong, has a rounded seal tip 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prong as disclosed in Russell to include a distal end surface of the prong sealed as disclosed in Rozenberg. The motivation being that a smooth surface avoids damaging the sensitive nasal tissue (Rozenberg [0020]).
Regarding claim 3, Russell in view of Rozenberg discloses: The method of claim 1, wherein the fluid portion is a first fluid portion (Russell See annotated FIG 7 above where one of the prongs is seen as a first fluid portion) and a distal end surface of the elongated prong defines a distal axial aperture, (Russell See FIG 7 where there is a distal axial aperture) the method further comprising: delivering a second fluid portion through the axial fluid channel and out of the distal axial aperture of the elongated prong (Russell See annotated FIG 7 above where the other prong is seen as a second fluid portion) however, Russell does not explicitly disclose: into a larynx of the subject.
Rozenberg discloses: into a larynx of the subject ([0169] the ports are in fluid communication with the patient’s larynx which is seen as the port being inserted into a larynx of the subject).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed in Russell to explicitly include the larynx as disclosed in Rosenberg. The motivation being that through inserting it into the larynx, is a pathway to cool the brain via the nasal cavity (Rozenberg [0169]).
Regarding claim 4, Russell in view of Rozenberg discloses: The method of claim 1, wherein: the inserting the elongated prong includes inserting the elongated prong such that the hub contacts an external nare of the subject; (Russell See annotated FIG 18 below where the hub which is part of 30, contacts the external nare of the subject) however, Russell does not explicitly disclose: and the elongated prong has a length configured such that the aperture is opposite the pharyngeal wall.
Rozenberg discloses: and the elongated prong has a length configured such that the aperture is opposite the pharyngeal wall ([0111] the length of the catheter, which is seen as the elongated prong, extends into the pharyngeal region and consists of ports which disperse liquid perpendicular to the longitudinal axis of the catheter, which is seen as opposite to the pharyngeal wall).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the prong as disclosed in Russell to include it to be long enough to be opposite the pharyngeal wall as disclosed in Rozenberg. The motivation being that making it long enough so that it is opposite the pharyngeal wall is critical in dispersing the spray over a larger region in the nasal cavity and permits greater cooling (Rozenberg [0111]).
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Regarding claim 10, Russell discloses: The method of claim 5, however, Rozenberg does not explicitly disclose: wherein a length of the first elongated prong is at least twice a distance between the first elongated prong and the second elongated prong.
Rozenberg discloses: wherein a length of the first elongated prong is at least twice a distance between the first elongated prong and the second elongated prong ([0161] the catheters which is seen as the elongated prongs is placed a distance apart and made a length appropriate for administration at the targeted tissue).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the prongs of Russell by making the length of the first elongated prong at least twice the distance between the first elongated prong and the second elongated prong as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 21, Russell in view of Rozenberg discloses: The method of claim 2, wherein: the aperture is positioned at a distance of between about 80% and about 90% of a length of the elongated prong (Russell See FIG 7 where the aperture is positioned a distance of between about 80% and about 90% from the proximal end).
Regarding claim 22, Russell in view of Rozenberg discloses: The method of claim 4, wherein the length of the elongated prong is such that the aperture is opposite a nasopharynx (Russell [00378] a flushing effect is generated in the nasopharynx, which is seen as the aperture being opposite the nasopharynx to allow for the flushing effect to be generated).
Regarding claim 23, Russell discloses: The method of claim 4, however, Russell does not explicitly disclose: wherein a size of the aperture is greater than a diameter of the axial fluid channel.
Rozenberg discloses: wherein a size of the aperture is greater than a diameter of the axial fluid channel ([0164] the liquid tube 926, which is seen as the axial fluid channel, has a diameter smaller than the aperture).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimension of the aperture as disclosed in Russell to include the aperture being greater than a diameter of the axial fluid channel as disclosed in Rozenberg. The motivation being that this design requires less pressure to drive the liquid (Rozenberg [0164]).
Regarding claim 24, Russell in view of Rozenberg discloses: The method of claim 1, wherein: the elongated prong is configured such that, after the inserting, a fluid can pass within the nasal cavity around the elongated prong (Russell [00418] the prongs deliver gases to flow to a patient which is seen as the gas passing into the nasal cavity and around the prong).
Regarding claim 25, Russell in view of Rozenberg discloses: The method of claim 1, wherein: the fluid portion is a gas; and the delivering includes delivering the gas at a flow rate of between 1 liter per minute and 40 liters per minute (Russell [00377] the flow rate can be between 1 liter per minute and 100 liters per minute, which includes the range of between 1 liter per minute and 40 liters per minute).
Regarding claim 28, Russell in view of Rozenberg discloses: The method of claim 25, wherein the gas is a humidified gas (Russell [00418] The prongs deliver humidified gas flow; See also [0049] the system contains a humidifier for adding humidity to the gas which is seen as the gas being humidified gas).
Claims 5, 8-9, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Russell in view of Rozenberg in further view of Sweeney et al (US10675432B2) herein referred to as “Sweeney”.
Regarding claim 5, Russell in view of Rozenberg discloses: The method of Claim 1, wherein: the elongated prong is a first elongated prong; and the nasal cannula further comprises a second elongated prong, a distal end portion of the second elongated prong including a sensor (Russell See FIG 10 where there is a sensor 29b at a distal end portion of the second elongated prong), however, Russell in view of Rozenberg does not explicitly disclose: a temperature sensor.
Sweeney discloses: a temperature sensor ([col 9: lines 29-39] the apparatus can include a temperature sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor as disclosed in Russell in view of Rozenberg to include a temperature sensor as disclosed in Sweeney. The motivation being that this allows for control of the heater to maintain an acceptable temperature of the breathable gas delivered to the patient (Sweeney [col 9: lines 34-39]).
Regarding claim 8, Russell in view of Rozenberg discloses: The method of claim 5, further comprising modifying a temperature of the first fluid portion based on a measurement from the sensor, (Russell [002] sensors are used to monitor different parameters then through feedback control, the temperature of the gas can be adjusted), however, Russell in view of Rozenberg does not explicitly disclose: the temperature sensor.
Sweeney discloses: the temperature sensor ([col 9: lines 29-39] the apparatus can include a temperature sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors as disclosed in Russell in view of Rozenberg to include a temperature sensor as disclosed in Sweeney. The motivation being that this allows for control of the heater to maintain an acceptable temperature of the breathable gas delivered to the patient (Sweeney [col 9: lines 34-39]).
Regarding claim 9, Russell in view of Rozenberg discloses: The method of claim 5, further comprising: modifying a flow rate of the first fluid portion based on a measurement from the sensor, (Russell [002] sensors are used to monitor different parameters then through feedback control, the flow rate of the gas can be adjusted) however, Russell in view of Rozenberg does not explicitly disclose: the temperature sensor.
Sweeney discloses: the temperature sensor ([col 9: lines 29-39] the apparatus can include a temperature sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors as disclosed in Russell in view of Rozenberg to include a temperature sensor as disclosed in Sweeney. The motivation being that this allows for control of the heater to maintain an acceptable temperature of the breathable gas delivered to the patient (Sweeney [col 9: lines 34-39]).
Regarding claim 26, Russell in view of Rozenberg discloses: The method of claim 25, further comprising: modifying a flow rate of the fluid portion based on a measurement from a sensor, (Russell [002] sensors are used to monitor different parameters then through feedback control, the flow rate of the gas can be adjusted) however, Russell in view of Rozenberg does not explicitly disclose: a temperature sensor.
Sweeney discloses: the temperature sensor ([col 9: lines 29-39] the apparatus can include a temperature sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors as disclosed in Russell in view of Rozenberg to include a temperature sensor as disclosed in Sweeney. The motivation being that this allows for control of the heater to maintain an acceptable temperature of the breathable gas delivered to the patient (Sweeney [col 9: lines 34-39]).
Regarding claim 27, Russell in view of Rozenberg discloses: The method of claim 26, further comprising: modifying a temperature of the fluid portion based on a measurement from the sensor, (Russell [002] sensors are used to monitor different parameters then through feedback control, the temperature of the gas can be adjusted), however, Russell in view of Rozenberg does not explicitly disclose: the temperature sensor.
Sweeney discloses: the temperature sensor ([col 9: lines 29-39] the apparatus can include a temperature sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors as disclosed in Russell in view of Rozenberg to include a temperature sensor as disclosed in Sweeney. The motivation being that this allows for control of the heater to maintain an acceptable temperature of the breathable gas delivered to the patient (Sweeney [col 9: lines 34-39]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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