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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 365(c) is acknowledged.
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 7-8 and 16-18 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 7, “a second aerosol sensor located outside of the mask” is confusing because the claim is directed towards a “mask”. It is unclear if the second aerosol sensor is part of the mask or separate from the mask entirely. During examination, the claim interpretation is the second sensor can be attached to the mask or elsewhere outside the mask.
Claim 16 is rejected for the same reasoning as for claim 7 above.
Claims 8, 17, and 18 are rejected based on their dependency from a rejected claim.
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)(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.
Claims 1-7, 9-16, and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20210330922 to Boston.
Regarding Claim 1, Boston teaches a mask for a patient for reducing exposure of aerosol particles emitted from the patient to other individuals (par. 0003, 0007, Figures 1-4 mask is worn by the patient to protect healthcare workers from airborne pathogens), the mask comprising:
an inner chamber configured to enclose a nose and a mouth of the patient (as shown in Figure 4, the mask encloses a nose and mouth of the patient; the chamber encircling the nose and mouth is considered as the inner chamber); and
a negative pressure chamber fluidly connected to the inner chamber (the space immediately underneath the ports 64, 66, 68, 94, 96 is considered as the negative pressure chamber) and having an outer opening and a suction opening (outer openings 94, 96, suction opening 64), the outer opening covered by a seal (cap 92 seals the openings 94, 96 using gasket seal 99 and also port seals 106, 108, par. 0038-0039) and the suction opening configured to couple to a suction device for removing the aerosol particles located within the inner chamber and the negative pressure chamber (suction opening 64 connects to tubing 70 which provides negative pressure to remove airborne pathogens including aerosol particles, par. 0033).
Regarding Claim 2, Boston further teaches wherein the seal is configured to be cut or opened to form a device opening providing access to the nose of the patient, the device opening receiving a medical device and forming a seal around the medical device (sealing valves 106, 108, provide device access through the ports, par. 0039).
Regarding Claim 3, Boston further teaches wherein the medical device is an endoscope (instrument 98, Figure 2; endoscope, laryngoscope, bronchoscope, esophagoscope, par. 0037).
Regarding Claim 4, Boston further teaches an outer wall (the side of the mask 50 that faces away from the patient) defining:
a posterior opening for surrounding the nose and the mouth of the patient (periphery of the mask 52 shown in Figure 4);
the suction opening of the negative pressure chamber (suction opening port 64, Figure 4);
the outer opening of the negative pressure chamber (ports 94, 96 shown in Figure 2), and
a filter opening configured to receive and house a filter for filtering air moving between the inner chamber and outside of the mask (port 68, shown in Figures 1-4, houses a filter 84, par. 0035).
Regarding Claim 5, Boston further teaches an inner wall defining the negative pressure chamber (inner side of mask 50 that faces the patient).
Regarding Claim 6, Boston further teaches a first aerosol sensor located at the suction opening and configured to detect the aerosol particles being removed by the suction device (the suction port/opening includes a sensor 74 for detection of aerosol particles indicative of pathogens, par. 0033, 0068).
Regarding Claim 7, Boston further teaches a second aerosol sensor located outside of the mask and configured to detect the aerosol particles escaping the negative pressure chamber (exhaled air sensor, par. 0068).
Regarding Claim 9, Boston teaches a mask for a patient to be worn during a medical examination to mitigate exposure of aerosol particles emitted from the patient into an examination room (par. 0003, 0007, Figures 1-4 mask is worn by the patient to protect healthcare workers from airborne pathogens), the mask comprising:
a negative pressure chamber (the space immediately underneath the ports 64, 66, 68, 94, 96 is considered as the negative pressure chamber) having an outer opening and a suction opening (outer openings 94, 96, suction opening 64; an additional outer opening 170, Figure 5), the suction opening configured to couple to a suction device for removing the aerosol particles located within the negative pressure chamber (suction opening 64 connects to tubing 70 which provides negative pressure to remove airborne pathogens including aerosol particles, par. 0033); and
a seal covering the outer opening having a device opening providing access to a nose of the patient (cap 92 seals the openings 94, 96 using gasket seal 99 and also port seals 106, 108, par. 0038-0039; additional opening 170 is sealed via membrane 180, Figure 6), the device opening receiving a medical device and forming a seal around the medical device (sealing valves 106, 108, provide device access through the ports, par. 0039, for instrument 98, Figure 2; endoscope, laryngoscope, bronchoscope, esophagoscope, par. 0037; additional opening 170 provides access for endotracheal tubes, par. 0046).
Regarding Claim 10, Boston further teaches wherein the device opening is cut with a sharp instrument prior to receiving the medical device (aperture 170 is cut, par. 0045 or is cut in a self-healing membrane, par. 0053).
Regarding Claim 11, Boston further teaches an inner chamber fluidly connected to the negative pressure chamber and configured to enclose the nose and a mouth of the patient (as shown in Figure 4, the mask encloses a nose and mouth of the patient; the chamber encircling the nose and mouth is considered as the inner chamber).
Regarding Claim 12, Boston further teaches wherein the medical device is an endoscope (endoscope, laryngoscope, bronchoscope, esophagoscope, par. 0037).
Regarding Claim 13, Boston further teaches an outer wall defining:
a posterior opening for surrounding the nose and the mouth of the patient (periphery of the mask 52 shown in Figure 4);
the suction opening of the negative pressure chamber (suction opening port 64, Figure 4);
the outer opening of the negative pressure chamber (ports 94, 96 shown in Figure 2), and
a filter opening configured to receive and house a filter for filtering air moving between the inner chamber and outside of the mask (port 68, shown in Figures 1-4, houses a filter 84, par. 0035).
Regarding Claim 14, Boston further teaches an inner wall defining the negative pressure chamber (inner side of mask 50 that faces the patient).
Regarding Claim 15, Boston further teaches a first aerosol sensor located at the suction opening and configured to detect the aerosol particles being removed by the suction device (the suction port/opening includes a sensor 74 for detection of aerosol particles indicative of pathogens, par. 0033, 0068).
Regarding Claim 16, Boston further teaches a second aerosol sensor located outside of the mask and configured to detect the aerosol particles escaping the negative pressure chamber (exhaled air sensor, par. 0068).
Regarding Claim 19, Boston further teaches the assembled device in Figure 4, which implicitly requires the steps claimed of covering the patient with a mask, connecting the suction device 70, opening the seal 106, and inserting a medical device 98 (e.g. endoscope). The details of the device used can be found in the rejections of claims 1 and 9 above.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 8, 17, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210330922 to Boston in view of US 20200269076 to Farmer.
Regarding Claims 8 and 17, Boston does not teach wherein the first aerosol sensor and the second aerosol sensor use light scattering to detect the aerosol particles. Boston is silent as to the mode of detection the sensor utilizes and only teaches the sensor is “commercially available” (par. 0033).
Farmer teaches aerosol sensors in a face mask, wherein the aerosol sensors use light scattering to detect the aerosol particles (light scattering measuring chamber 32, Figure 1; par. 0037).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide light scattering sensors in the system of Boston as taught by Farmer to be commercially available sensors for the purpose of detecting aerosols leaking from face masks (Table 1 of Farmer).
Claim 18, Boston does not teach wherein the first aerosol sensor and the second aerosol sensor simultaneously detecting the aerosol particles indicate that the aerosol particles have escaped into the examination room.
However, Farmer teaches aerosol sensors in a face mask, wherein the aerosol sensors are placed in the path of the exhaled air (sensor 1, inside mask, Figure 12C) and outside the mask (sensor 2 outside mask, Figure 12C) in order to compare the simultaneously measured values to determine mask fit, i.e. if the mask is leaking the aerosol particles into the examination room or not (Fit factor, Figure 12C).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to use the aerosol sensors of Boston to simultaneously take measurements and compare the measurements to determine if the aerosol particles have escaped into the examination room, as taught by Farmer, to indicate the fit (i.e. leakage) of the mask.
Claim 20 is rejected for the same reasoning as for claim 18 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20240042153 to Powell, US 20230330379 to Forzani, US 20230211098 to Lisco, US20230181398 to Leyden, US 20230142819 to Turer, US 20230032878 to Kota, US 20220257887 to Brady teach a face mask and/or face chamber with negative pressure for reducing aerosols from leaking from the mask. US 20220023573 to Resto, US 20220015973 to Klaftenegger teach reconfigurable and sealed ports in face masks. US 11358014 to Farmer, US 4914957 to Dougherty teach sensors to compare the inside air to the outside air to determine a mask fit.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799