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 .
This office action is in response to the claims filed 9/10/24. Claims 1-20 are pending in the instant application.
Claim Objections
Claims 5-6 and 15 are objected to because of the following informalities:
Regarding claim 5, the language “claim 4, the sensor” (line 1) is objected to for matters of form; Examiner suggests amending to read –claim 4, wherein the sensor--.
Regarding claim 6, the language “claim 4, the attribute” (line 1) is objected to for matters of form; Examiner suggests amending to read –claim 4, wherein the attribute--.
Regarding claim 15, the language “claim 14, the sensor” (line 1) is objected to for matters of form; Examiner suggests amending to read –claim 14, wherein the sensor--.
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 7, 10, and 16-20 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.
Claim 7 recites the limitation "the outflow fluid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the bag chamber" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the user" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 17-20 are rejected based on dependency on a rejected claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the language “the outflow gas having been exhaled into the body chamber” (line 12-13) appears to claim the user/human organism which is non-statutory subject matter. It appears that the outflow gas is exhalation gas and is being positively claimed which necessarily requires the human user to be part of the claimed invention. Examiner suggest amending to utilize functional/intended use type language.
Regarding claim 4, the language “the outflow gas having been exhaled” (line 2) appears to claim the user/human organism which is non-statutory subject matter. It appears that the outflow gas is exhalation gas and is being positively claimed which necessarily requires the human user to be part of the claimed invention. Examiner suggest amending to utilize functional/intended use type language.
Regarding claim 11, the language “the outflow gas having been exhaled into the body chamber” (line 14-15) appears to claim the user/human organism which is non-statutory subject matter. It appears that the outflow gas is exhalation gas and is being positively claimed which necessarily requires the human user to be part of the claimed invention. Examiner suggest amending to utilize functional/intended use type language.
Claims 2-3, 5-10, and 12-15 are rejected based on dependency on a rejected claim.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wood (2003/0116163).
Regarding claim 1, Wood discloses a nasal cannula apparatus (see Fig. 1-2 and embodiment of Fig. 13-14 in particular, abstract) which includes a body that defines a body chamber, the body adapted to engage a user between nares and upper lip (see Fig. 13-14, body 102 that defines body chamber as can be seen by airflow arrows, see para. 0060; Fig. 1 shows how the body is adapted to engage user between nares and upper lip); a pair of nasal cannula in cooperation with the body with each of the pair adapted to engage occlusively a naris in order to communicate fluidly between the naris and the body chamber via the nasal cannula (see Fig. 13-14, pair of nasal cannula 44, see abstract and para. 0061 which discloses sealing/occlusive connection of nasal cannula); an inflow port in fluid communication with the body chamber (see Fig. 13-14, inflow port 104, para. 0060); an inflow valve disposed within the body chamber in cooperation with the inflow port to control communication of respiratory gas through the inflow port into the body chamber to be inhaled via the pair of nasal cannula (see Fig. 13 showing inhalation state, inflow valve 112, see para. 0060); an outflow port in fluid communication with the body chamber to communicate an outflow gas from the body chamber, the outflow gas having been exhaled into the body chamber via the pair of nasal cannula (see Fig. 14 showing exhalation state, outflow port 106, see para. 0060); and wherein the inflow valve allows respiratory gas communication through the inflow port into the body chamber during inhalation and blocks respiratory gas communication through the inflow port into the body chamber during exhalation (see Fig. 13-14 showing inhalation and exhalation states, respectively, para. 0060-0063, the inflow valve 112 being a one-way valve provides for such flow).
Regarding claim 2, the Wood device further includes an outflow valve disposed within the body chamber in cooperation with the outflow port to control fluid communication through the outflow port (see Fig. 14 showing the exhalation state, outflow valve 114, see para. 114).
Regarding claim 3, the Wood device’s outflow valve blocks fluid communication through the outflow port during inhalation and allows fluid communication through the outflow port during exhalation (see Fig. 13-14 showing inhalation and exhalation states, respectively, para. 0060-0063, the outflow valve 114 being a one-way valve provides for such flow).
Regarding claim 16, the use of the Wood device includes a method of respiratory therapy (see Fig. 1-2 and embodiment of Fig. 13-14 in particular, abstract) which includes attaching a body to the user generally between an upper lip and external nares with a pair of nasal cannula occlusively engaged with the nares of the user, the pair of nasal cannula being in fluid communication with a body chamber defined by the body (see Fig. 13-14, body 102 that defines body chamber as can be seen by airflow arrows, see para. 0060; Fig. 1 shows how the body engages user between external nares and upper lip; see Fig. 13-14, pair of nasal cannula 44, see abstract and para. 0061 which discloses sealing/occlusive connection of nasal cannula); decreasing a chamber pressure within the body chamber to less than a supply pressure within a supply tube communicating with the body chamber by inhaling respiratory gas from the body chamber through the pair of nasal cannula thereby positioning an inflow valve in an OPEN position flowing respiratory gas from the supply tube into the body chamber and thence via the pair of nasal cannula into the nares (see Fig. 13 showing inhalation state, inflow valve 112 in the OPEN position as shown, see para. 0060-0063; see Fig. 1-2, supply tube 22; inhalation by the user decreases pressure in the chamber); and increasing the chamber pressure within the body chamber to greater than the supply pressure within the supply tube by exhaling an outflow gas through the pair of nasal cannula into the body chamber thereby positioning the valve in a CLOSED position blocking flow of respiratory gas from the supply tube into the body chamber (see Fig. 14 showing exhalation state with valve 112 in the CLOSED position as shown, see para. 0060-0063; exhalation by the user increases the chamber pressure as claimed).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-6, 11-15, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Gupta (2003/0111081).
Regarding claim 4, the Wood device is silent as to further including a sensor in fluid cooperation with the outflow port to detect an attribute of the outflow gas, having been exhaled, communicated through the outflow port; however, Gupta teaches a similar nasal cannula device which includes providing a sensor which fluidly receives exhaled outflow gas via a discharge tube and detects an attribute of the exhaled outflow gas (see Gupta Fig. 1 and 4, para. 0020 and 0026 for example, discharge tube 22 and 24 allows for carbon dioxide sensor 32 to receive the exhaled outflow gas and measure an attribute, i.e. carbon dioxide). Thus 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 Wood device to provide exhaled outflow gas via a discharge tube from the outflow port to a carbon dioxide sensor, as taught by Gupta in order to provide the ability to monitor gas levels of the patient, i.e. carbon dioxide.
Regarding claim 5, the modified Wood device’s sensor is configured to detect the attribute only during exhalation (see Gupta Fig. 1, 4, and para. 0020 and 0026, the sensor 32 is an exhalation carbon dioxide sensor and thus only senses exhalation).
Regarding claim 6, the modified Wood device’s attribute is selected from a group consisting of carbon dioxide, nitric oxide, a ketone, carbon monoxide, and a temperature (see Gupta Fig. 1, 4, and para. 0020 and 0026, the sensor 32 is an exhalation carbon dioxide sensor and thus the attribute is carbon dioxide).
Regarding claim 11, Wood discloses a nasal cannula apparatus (see Fig. 1-2 and embodiment of Fig. 13-14 in particular, abstract) which includes a body that defines a body chamber, the body adapted to engage a user generally above an upper lip (see Fig. 13-14, body 102 that defines body chamber as can be seen by airflow arrows, see para. 0060; Fig. 1 shows how the body is adapted to engage user above the upper lip); a pair of nasal cannula in cooperation with the body with each of the pair adapted to engage occlusively a naris in order to communicate fluidly between the naris and the body chamber via the nasal cannula (see Fig. 13-14, pair of nasal cannula 44, see abstract and para. 0061 which discloses sealing/occlusive connection of nasal cannula); a supply tube in fluid communication with the body chamber to communicate a respiratory gas from a gas source into the body chamber for inhalation via the pair of nasal cannula (see Fig. 1-2, supply tube 22 which communicates with gas source, either 18 or 20, para. 0042); an inflow valve in fluid cooperation with the supply tube and the body chamber in to control communication of respiratory gas from the supply tube into the body chamber to be inhaled via the pair of nasal cannula (see Fig. 13 showing inhalation state, inflow valve 112, see para. 0060); and wherein the inflow valve allows respiratory gas communication from the supply tube into the body chamber during inhalation and blocks respiratory gas communication from the supply tube into the body chamber during exhalation (see Fig. 13-14 showing inhalation and exhalation states, respectively, para. 0060-0063, the inflow valve 112 being a one-way valve provides for such flow). Wood is silent as to including a discharge tube in fluid communication with the body chamber to communicate an outflow gas from the body chamber, the outflow gas having been exhaled into to the body chamber via the nasal cannula; however, Gupta teaches a similar nasal cannula device which includes providing a sensor which fluidly receives exhaled outflow gas via a discharge tube and detects an attribute of the exhaled outflow gas (see Gupta Fig. 1 and 4, para. 0020 and 0026 for example, discharge tube 22 and 24 allows for carbon dioxide sensor 32 to receive the exhaled outflow gas and measure an attribute, i.e. carbon dioxide). Thus 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 Wood method to provide exhaled outflow gas via a discharge tube from the outflow port to a carbon dioxide sensor, as taught by Gupta in order to provide the ability to monitor gas levels of the patient, i.e. carbon dioxide.
Regarding claim 12, the modified Wood device further includes an outflow valve in fluid cooperation with the discharge tube and the body chamber to control fluid communication between the discharge tube and the body chamber (see Wood Fig. 13-14, para. 0060, outflow valve 114 which controls fluid communication to discharge tube 22 and 24 of Gupta as applied in the combination above).
Regarding claim 13, the modified Wood device’s outflow valve blocks fluid communication between the discharge tube and the body chamber during inhalation and allows fluid communication from the body chamber into the discharge tube during exhalation (see Wood Fig. 13-14 showing inhalation and exhalation states, respectively, and para. 0060, outflow valve 114 blocking and allowing flow to discharge tube 22 and 24 of Gupta as applied in the combination above).
Regarding claim 14, the modified Wood device further includes a sensor in fluid cooperation with the discharge tube to detect an attribute of the outflow gas (see Gupta Fig. 1 and 4, para. 0020 and 0026 for example, discharge tube 22 and 24 allows for carbon dioxide sensor 32 to receive the exhaled outflow gas and measure an attribute, i.e. carbon dioxide).
Regarding claim 15, the modified Wood device’s sensor is configured to detect the attribute only during exhalation (see Gupta Fig. 1, 4, and para. 0020 and 0026, the sensor 32 is an exhalation carbon dioxide sensor and thus only senses exhalation).
Regarding claim 17, the Wood method includes positioning an outflow valve in a CLOSED position by decreasing the chamber pressure to less than a discharge pressure by inhaling respiratory gas from the body chamber through the cannula and the CLOSED position of the outflow valve blocking fluid communication to the body chamber via the outflow port (see Fig. 13 showing the inhalation state, para. 0060, outflow valve 114 being in the CLOSED position to block fluid communication due to inhalation which causes decrease in chamber pressure). The Wood method is silent as to the outflow valve blocking fluid communication from body chamber to a discharge tube communicating therewith; however, Gupta teaches a similar nasal cannula device which includes providing a sensor which fluidly receives exhaled outflow gas via a discharge tube and detects an attribute of the exhaled outflow gas (see Gupta Fig. 1 and 4, para. 0020 and 0026 for example, discharge tube 22 and 24 allows for carbon dioxide sensor 32 to receive the exhaled outflow gas and measure an attribute, i.e. carbon dioxide). Thus 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 Wood method to provide exhaled outflow gas via a discharge tube from the outflow port to a carbon dioxide sensor, as taught by Gupta in order to provide the ability to monitor gas levels of the patient, i.e. carbon dioxide.
Regarding claim 18, the Wood method includes positioning an outflow valve in an OPEN position by increasing chamber pressure greater than discharge pressure by exhaling outflow gas through the cannula and body chamber, the outflow valve in the OPEN position communicating outflow gas from the body chamber to outside the body chamber (see Fig. 14 showing the exhalation state with outflow valve 114 in an OPEN position allowing flow from the body chamber, user exhalation causing the increase in chamber pressure). The Wood method is silent as to the outflow valve discharging exhaled outflow gas from body chamber to a discharge tube communicating therewith; however, Gupta teaches a similar nasal cannula device which includes providing a sensor which fluidly receives exhaled outflow gas via a discharge tube and detects an attribute of the exhaled outflow gas (see Gupta Fig. 1 and 4, para. 0020 and 0026 for example, discharge tube 22 and 24 allows for carbon dioxide sensor 32 to receive the exhaled outflow gas and measure an attribute, i.e. carbon dioxide). Thus 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 Wood method to provide exhaled outflow gas via a discharge tube from the outflow port to a carbon dioxide sensor, as taught by Gupta in order to provide the ability to monitor gas levels of the patient, i.e. carbon dioxide.
Regarding claim 19, the Wood method is silent as to including the step of detecting an attribute of the outflow gas using a sensor in fluid cooperation with the outflow gas; however, Gupta teaches a similar nasal cannula device which includes providing a sensor which fluidly receives exhaled outflow gas via a discharge tube and detects an attribute of the exhaled outflow gas (see Gupta Fig. 1 and 4, para. 0020 and 0026 for example, discharge tube 22 and 24 allows for carbon dioxide sensor 32 to receive the exhaled outflow gas and measure an attribute, i.e. carbon dioxide). Thus 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 Wood method to provide exhaled outflow gas via a discharge tube from the outflow port to a carbon dioxide sensor, as taught by Gupta in order to provide the ability to monitor gas levels of the patient, i.e. carbon dioxide.
Regarding claim 20, the Wood method’s attribute is selected from a group consisting of carbon dioxide, nitric oxide, a ketone, carbon monoxide, and a temperature (see Gupta Fig. 1, 4, and para. 0020 and 0026, the sensor 32 is an exhalation carbon dioxide sensor and thus the attribute is carbon dioxide).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood.
Regarding claim 7, the Wood device discloses a filter in fluid communication with an outflow port to filter the outflow fluid (see Wood embodiment in Fig. 11, 15, 17-18, para. 0059, 0067) and 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 Wood device embodiment of Fig. 13-14 to include a filter to filter outflow fluid in order to provide this filtering or retaining of heat/moisture from exhaled air (Wood para. 0059).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Tero (2011/0284001).
Regarding claim 8, the Wood device is silent as to further including a PEEP valve in fluid communication with the outflow port to maintain a chamber pressure within the body chamber above a baseline; however, Tero teaches a similar nasal cannula device which includes a PEEP valve in fluid communication with outflow port to maintain a chamber pressure above baseline (see Tero Fig. 1, para. 0032, 0040). Thus 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 Wood device to include a PEEP valve, as taught by Tero, in order with positive end expiratory pressure in a commonly used CPAP therapy.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Love (2023/0347096).
Regarding claim 9, the Wood device is silent as to further including an anti-asphyxiation valve in communication with the body chamber to communicate ambient air when chamber pressure falls below a trigger pressure; however, Love teaches a breathing apparatus in the form of a nasal cannula with an anti-asphyxiation valve as claimed (see Love para. 0162-0163). Thus 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 Wood device to include an anti-asphyxiation valve, as taught by Love, in order to provide a safety device to ensure user receives respiratory gas (Love para. 0164).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Graves (5,271,391).
Regarding claim 10, the Wood device is silent as to a bag defining a bag reservoir in fluid communication with the inflow port to communicate the respiratory gas from the reservoir into the body chamber during inhalation; however, Graves discloses a similar nasal cannula device which includes a bag with a bag reservoir to supply inhalation gas to the cannula (see Graves Fig. 1 and col. 3 ln. 46-60, bag 22 with reservoir). Thus 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 Wood device to include a bag with bag reservoir for inhalation gas, as taught by Graves, in order to provide an accumulation chamber for inhalation of respiratory gas on demand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Martin (2015/0000658), Swanson (2009/0173350), McKinnon et al. (2012/0060845), Curti et al. (2002/0053346), Bowe et al. (5,335,656) disclose nasal cannula systems similar to the claimed/disclosed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
