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 .
Specification
The disclosure is objected to because of the following informalities:
¶0032 has one instance which reads “nose once” but should instead read “nose cone”
Appropriate correction is required.
Claim Objections
Claim(s) 2, 10 and 12-14 is/are objected to because of the following informalities:
Claim 2, Ln. 2 & 3 each recite “the mask” which should read “the medical mask apparatus” for consistency with claim 1
Claim 10, Ln. 1-2 recites “N95 of HEPA air filtration” which should read “N95 or HEPA air filtration”
Claim 10, Ln. 2 twice recites “the mask” which should read “the medical mask” for consistency with claim 8
Claim 12, Ln. 1 recites “the mask” which should read “the medical mask” for consistency with claim 8
Claim 13, Ln. 2 recites “an endoscopic instrument” which should read “the endoscope” for consistency with claim 8
Claim 14, Ln. 1 recites “the mask” which should read “the medical mask” for consistency with claim 8
Appropriate correction is required.
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.
Claim(s) 1-7 and 18 is/are rejected under 35 U.S.C. 101 because in general, if a claimed element of the device is positively recited so that the human body, or a part thereof, is also positively recited, then the claim is deemed to be directed towards or encompassing a human organism. In this case, claim 1 recites the limitation “a mask material conforming to a patient's face along a sealing surface.” Therefore, claim 1 contains subject matter that is unpatentable (i.e. “conforming to a patient's face” positively recites the patient’s face). It is suggested that the claim be amended to read “a mask material configured to conform to a patient's face along a sealing surface.”
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 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) 8-9 and 13-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by George et al. (WO 2021/214448 A1).
Regarding claim 8, George discloses a method of providing a sterile environment in a medical exam room for an endoscopy in a patient's nose or mouth (e.g. Fig. 5; Pg. 8-9), the method comprising: applying a medical mask to the patient (Fig. 4), wherein the medical mask comprises: a mask material (Fig. 4 #12) conforming to the patient's face along a sealing surface (Pg. 4, Ln. 15-20 – conforms to contours), and a valve (Figs. 4-5 #34; Pg. 5-6) providing an opening (Fig. 5 #34 opened to receive #70) capable of passing an endoscope (Fig. 5 #70; Pg. 8-9) through and into the patient's nose or mouth (Fig. 5; Pg. 8-9); and inserting an endoscope through the valve of the medical mask (Fig. 5 #70; Pg. 8-9). It is noted that the “valve” of the claim could alternately be read as access device 24 based upon how the disclosed valve does not have a self-closing ability (e.g. valve 230 of the instant invention includes a small hole which cannot self-close).
Regarding claim 9, George discloses performing the endoscopy (Fig. 5; Pg. 8-9); and removing, after the endoscopy, the medical mask (the mask will eventually be removed from patient).
Regarding claim 13, George discloses the valve is flexible to expand and allow the endoscope or other instrument to pass through (Figs. 4-6; Pg. 8-9).
Regarding claim 14, George discloses the medical mask comprises a nose cone (Figs. 4-6 #30; Pg. 5-6) and a cap (Figs. 4-6 #32; Pg. 5-6), and wherein at least one of the nose cone or the cap comprises comprise
Regarding claim 15, George discloses the valve comprises .
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over George et al. (WO 2021/214448 A1) in view of Ugbeye (U.S. Pub. 2022/0000575).
Regarding claim 10, George discloses the mask material provides air filtration between a patient side of the medical mask to an examination room side of the medical mask (Pg. 1, Ln. 7-13).
George is silent as to whether the mask material provides N95 or HEPA air filtration.
However, George teaches the mask as of common surgical mask material for the purpose of infection control (Pg. 1, Ln. 7-13). Ugbeye teaches a face mask and teaches N95 rated masks are a common form of mask worn to protect against micro particles, such as viruses (¶0108).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in George the mask material provides N95 air filtration based upon the commonly recognized design of surgical mask material for the purpose of infection and virus control as complying with N95 requirements in view of Ugbeye.
Regarding claim 11, George is silent as to whether the mask material comprises woven polypropylene or polyethylene.
Ugbeye teaches a face mask and teaches polypropylene as a common filtering material for face mask, particularly for N95 rated masks (¶¶0153, 0156, 0186, 0200).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in George the mask material comprises woven polypropylene based upon the use of polypropylene as a common filtering material for face mask, particularly for N95 rated masks in view of Ugbeye. One of ordinary skill in the art would have obviously expected the polypropylene to be woven in the mask material based upon this common form of manufacturing in N95 medical masks.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over George et al. (WO 2021/214448 A1) in view of Tirotta (U.S. Patent 5431158.
Regarding claim 16, George fails to disclose a malleable nose bridge is attached to the mask material to cause the mask material to conform to the shape of a nose bridge of the patient.
Tirotta teaches an endoscopy mask (Fig. 1) including a malleable nose bridge (#22; Col. 5, Ln. 56-66) attached to a material of the mask to cause the mask material to conform to the shape of a nose bridge of a patient. Tirotta teaches a malleable nose bridge as providing the benefit of reinforcing the mask while providing a secured fit to the patient’s nasal bridge (Col. 5, Ln. 56-66).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in George a malleable nose bridge is attached to the mask material to cause the mask material to conform to the shape of a nose bridge of the patient in order to provide the benefit of reinforcing the mask while providing a secured fit to the patient’s nasal bridge in view of Tirotta.
Regarding claim 17, George teaches the invention as modified above and Tirotta as incorporated therein further teaches the malleable nose bridge comprises a metal (Col. 5, Ln. 56-66 – aluminum).
Allowable Subject Matter
Claim(s) 1-7 and 18 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Claim 12 is allowed over the prior art. The claim is solely objected to based upon the above claim objection.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the prior art fails to teach or suggest a medical mask apparatus including all elements and functionality recited by the instant claim. Of particular note the claim recites a nose cone with a conically shaped first end and a cylindrically shaped second end; the claim separately recites the nose cone and the cap, with a portion of the mask material is captured at an interface between the nose cone and the cap; a valve in the cap, wherein the valve is flexible to expand and allow a medical instrument to pass through the valve.
The closest prior art to the instant claim is George et al. (WO 2021/214448 A1) which teaches a face mask to receive an endoscope (Fig. 5; Pg. 8-9). In George the structure which is “flexible to expand and allow a medical instrument to pass” would best be read as flexible closure 34 (e.g. Figs. 4-6). However, flexible closure 34 is only considered by George to be provided on an interior of the face mask (e.g. Figs. 4-5, 8-10, 13-14 & 17-19). The claim, however, recites the valve as “in the cap.” Thus, George could only read on the instant claim if inner member 30 were to be read as the cap. But that would mean that outer member 32 would need to be read as the nose cone which would not be accurate because of the requirement of the claim on the shaping of the two ends of the nose cone.
Thus, while George teaches a face mask closely relatable to the requirements of the instant claim there is not found to be a preponderance of the evidence that one having ordinary skill in the art at the time of the effective filing of the invention would have considered it prima facie obvious to have rearranged parts in George in such a manner as to have arrived at the instantly claimed invention without improper hindsight reasoning.
As a matter of claim interpretation it is noted that the phrasing “through the mask material” is understood to mean that the mask material is an interface for the engaging of the cap and the nose cone and not that the cap passes through the mask material.
Regarding claim 12, the claim is found allowable over the prior art for the same general reasons as discussed above in regard to claim 1.
As a matter of claim interpretation it is noted that the phrasing “through the mask material” is understood to mean that the mask material is an interface for the engaging of the cap and the nose cone and not that the cap passes through the mask material.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Regarding claim 8 further attention is particularly drawn to Xie (CN 201586310 U; Fig. 3) and Wang et al. (CN 210992441 A; Fig. 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785