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 .
Response to Amendment
The Amendment filed 09 Jul 2026 has been entered. Claims 1-20 are pending in the application. Claims 1-10 and 16-20 have been withdrawn.
Election/Restrictions
Claims 1-10 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups I & III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09 Jul 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 23 (Figs. 11-13). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 11-15 is/are objected to because of the following informalities:
Claim 11 begins with “The” which should instead read “A”
Claim 11, Ln. 3 recites “air” which should read “the air” following after Ln. 2
Claim 11, Ln. 6 recites “air” which should read “the air” following after Ln. 2
Claim 11, Ln. 7 recites “air” which should read “the air” following after Ln. 2
Claim 12, Ln. 3 recites “face of a patient” which should read “the face of the patient” following after claim 11
Claim 12, Ln. 4 recites “air” which should read “the air” following after claim 11
Claim 15, Ln. 1-2 recites “and lower surface” which should read “and a lower surface” for clarity
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.
Claim(s) 13-14 is/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 pre-AIA the applicant regards as the invention.
Claim 13 recites the limitation “the face mask further comprises a lower jaw-lifting member for lifting the jaw of the patient” which deems the claim indefinite. The face mask has not been positively recited in either claim 11 or claim 12. The instant claim only recites limitations related to the face mask but fails to expressly positively recite the face mask. It is thus unclear whether the face mask is to be understood as positively recited by the claim. If the face mask is not being positively claimed then the claim would be subject to a rejection under 35 U.S.C. 112(d) as not further meaningfully limiting the claim upon which it depends. Thus, the instant claim appears to need to positively recite the face mask. It is suggested to specify the face mask as “connected to” the coupling of the breathing connector. This can be added in any of claims 11-13. For the purposes of examination the claim will be interpreted as positively reciting the face mask.
Claim 14 recites the limitation “the dome member is made of a plastic material” which deems the claim indefinite. The face mask has not been positively recited in either claim 11 or claim 12. The instant claim only recites limitations related to the face mask but fails to expressly positively recite the face mask. It is thus unclear whether the face mask is to be understood as positively recited by the claim. If the face mask is not being positively claimed then the claim would be subject to a rejection under 35 U.S.C. 112(d) as not further meaningfully limiting the claim upon which it depends. Thus, the instant claim appears to need to positively recite the face mask. It is suggested to specify the face mask as “connected to” the coupling of the breathing connector. This can be added in any of claims 11-12 and 14. For the purposes of examination the claim will be interpreted as positively reciting the face mask.
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) 11-12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garth et al. (EP 0421007 A1).
Regarding claim 11, Garth discloses a bag-valve mask resuscitator (Figs. 5-6; Col. 4-7) comprising; a) a compressible bag (Fig. 5 #41; Col. 6-7 – flexible material which is manually squeezed) that can be manually squeezed to deliver air to a patient; b) a first end (near end in view of Fig. 5 including #46) having an inlet valve (Fig. 5 #46; Col. 6, Ln. 50-55, similar to Fig. 1 #36 – Col. 5, Ln. 5-8) through which the air is delivered to the bag; c) a second opposing end (opposite end out of view of Fig. 5); and d) a breathing connector (Figs. 5-6 #47, similar to Fig. 1 #33; Col. 6, Ln. 44-48 & Col. 5, Ln. 49 – Col. 6, Ln. 6) that is centered between the first and second ends of the bag (Fig. 5 #47 is centered) through which the air is delivered to the patient; wherein the breathing connector has a coupling for connection to a face mask (Figs. 1 & 5 connect to mask 34) that is placed on the patient and an exhaust outlet (Fig. 2 #71; Col. 5, Ln. 55 – Col. 6, Ln. 6) so that the air is allowed to flow from the bag and into the patient and exhaled air from the patient is directed into the exhaust outlet. It is noted that the compressible bag is not required by the claim to have any particular shape.
Regarding claim 12, Garth discloses the face mask comprises a dome member (Fig. 5 – mask is domed), the dome member having a deformable lower rim for forming a seal between the dome and face of the patient such that the dome forms an enclosed cavity (Col. 8, Ln. 14-17) and an upper air connector port (Fig. 1 top end of mask is a connector) for delivering the air to the enclosed cavity. It is noted that the face mask is not read as positively recited by the claim.
Regarding claim 14, Garth discloses the dome member is made of a plastic material (Col. 1, Ln. 22-24; Col. 6, Ln. 10-14 – common plastic mask).
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garth et al. (EP 0421007 A1) in view of Navarijo (U.S. Pub. 2016/0101252).
Regarding claim 15, Garth discloses the bag has an upper surface and a lower surface (Figs. 5-6), the breathing connector being fastened to the lower surface (Figs. 5-6).
Garth fails to disclose a handle being fastened to the upper surface.
Navarijo teaches a bag valve mask resuscitator (Fig. 3; ¶0043) and teaches a handle is commonly found on reservoir bags to serve as a positioning guide for the hand of a user (¶0043).
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 Garth a handle being fastened to the upper surface in order to provide the benefit of serving as a positioning guide for the hand of a user, as is known to be commonly found on reservoir bags in the art, in view of Navarijo.
Allowable Subject Matter
Claim 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 13, Garth fails to teach or suggest the face mask further comprises a lower jaw-lifting member for lifting the jaw of the patient. It is noted that based upon the 35 U.S.C. 112(b) rejection and interpretation of the claim above the face mask is read as positively recited by the claim.
The mask 34 of Garth is only an already commercially available mask and has no consideration of a part to interact with the patient’s lower jaw. One of ordinary skill in the art would not have been motivated to have used a specialized resuscitation face mask in Garth of the type presently claimed without improper hindsight reasoning.
It is noted that the arrangement recited in claim 11 is generally unexpected in the prior art. Weingart et al. (U.S. Pub. 2022/0273897) is an example of a more common bag-valve mask resuscitator design where air/gas only travel from an inlet and one end to an outlet at an opposite end. Claim 11 instead recites its interface between the bag and the face mask as occurring in a middle of the bag. One of ordinary skill in the art would not have considered it prima facie obvious to have modified a standard bag-valve mask resuscitator in order to have the arrangement recited in claim 11.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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