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
This Office Action is in response to a preliminary amendment filed on 9/25/2024. As directed by the preliminary amendment, claims 8-100 were canceled, claims 1 and 4-7 were amended, and no new claims were added. Thus, claims 1-7 are pending for this application.
Claim Objections
Claim 5 is objected to because of the following informalities:
In claim 5 lines 2-3, “201/min to 1501/min or 201/min to 801/min for adult patients, and l/min to 301/min” should be changed to --20 L/min to 150 L/min or 20 L/min to 80 L/min for adult patients, and 1 L/min to 30 L/min-- in order to correct the typographical error.
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 1-7 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 phrase “at least one first member and/or second member” in line 5 is unclear whether the “at least one” is directed to (i.e. if a second member is chosen when “or” is used, is there at least one second member or does the at least one only correspond to the first member, i.e. more than one first members can be present but not more than one second members).
Furthermore, the phrase “forming at least one aperture” is unclear whether the first, second, or both members are able to form at least one aperture (i.e. if both a first and second member are chosen, do they each include at least one aperture, or does at least one aperture occur regardless of which and how many of which first and second members are chosen? And is the “at least one” tied to the “at least one” of the “at least one first member and/or second member”, i.e. is there a 1:1 ratio?).
Claim 1 recites the limitation "the ambient environment" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 2, the phrase “the at least one first member is arranged to deflect or move bi-directionally relatively the second member” in lines 1-2 is unclear as claim 1 recites “at least one first member and/or second member”, meaning the second member may not be required of the claim, therefore in a case where only a first member is present the claim is unclear because there is no second member.
The remaining claims are rejected due to dependence on a rejected base 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.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kavermann (US 2017/0049982).
Regarding claim 1, as best understood, Kavermann discloses (Figs. 14-20) a tracheostomy guard for a patient interface, comprising:
a first portion (first end 1) arranged to connect to a patient interface (i.e. tracheal tube, paragraph [0142]) in fluid communication with the first portion, in use,
a second portion (comprising body 3 and portion 10) in fluid communication with the first portion, comprising at least one first member (portion 10) and/or second member (body 3) forming at least one aperture (apertures 155,156) in fluid communication with the ambient environment,
wherein the aperture has a size variable in response to a force applied to at least part of the second portion, in use (see Figs. 19-20 and paragraph [0167]-[0168]).
Regarding claim 2, Kavermann discloses wherein the at least one first member is arranged to deflect or move bi-directionally relatively the second member in response to the force applied (paragraphs [0167]-[0168]).
Regarding claim 3, Kavermann discloses wherein the size of the aperture relates to a cross-sectional dimension of the aperture (see Figs. 19-20 and paragraph [0167]-[0168]).
Claim(s) 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fuller (US 2019/0290876).
Regarding claim 1, Fuller discloses (Figs. 9-12B) tracheostomy guard for a patient interface, comprising:
a first portion (portion of casing 131 from left side to left side of seal, including the spring 132) arranged to connect to a patient interface (comprising outer and inner canula 101,110)) in fluid communication with the first portion, in use,
a second portion (portion of casing 131 including seal 133, air channel 134, and the chamber formed between seal 133 and valve, see Fig. 12A) in fluid communication with the first portion, comprising at least one first member (portion of casing between the seal and the valve) forming at least one aperture (aperture formed between valve and seal 133) in fluid communication with the ambient environment,
wherein the aperture has a size variable in response to a force applied to at least part of the second portion, in use (see Figs. 12a-12b and paragraph [0016]).
Regarding claim 4, Fuller disclose the force applied is associated with a gases flow rate of gases in the tracheostomy guard (see Figs. 12-12b and paragraph [0016]).
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.
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.
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.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fuller (US 2019/0290876).
Regarding claim 5, Fuller discloses a gases flow rate associated with the force, but does not disclose the gases flow rate relates to a high flow rate of 20 1/min to 150 1/min or 20 1/min to 80 1/min for adult patients, and 1 l/min to 30 1/min for neonatal or paediatric patients. However, outside evidence of criticality, one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to try to high flow rate of 20 1/min to 150 1/min or 20 1/min to 80 1/min for adult patients, and 1 l/min to 30 1/min for neonatal or paediatric patients for the purpose of providing optimal flow therapy to a user based on their age and body condition, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 1 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over an alternative embodiment of Kavermann (US 2017/0049982) in view of Wu (CN 108310487).
Regarding claim 1, Kavermann discloses (Fig. 1-12), as best understood, a tracheostomy guard for a patient interface, comprising:
a first portion (first end 1) arranged to connect to a patient interface (i.e. tracheal tube, paragraph [0142]) in fluid communication with the first portion, in use,
a second portion (comprising body 3 and portion 10) in fluid communication with the first portion, comprising at least one first member (portion 10) and/or second member (body 3) forming at least one aperture (aperture 15) in fluid communication with the ambient environment.
Kavermann does not disclose wherein the aperture has a size variable in response to a force applied to at least part of the second portion, in use.
However, Wu teaches (Figs. 1-3) a sputum removal system comprising an aperture (aperture of right side of t-shape connector 9 having valve 92) that has a size variable in reseponse to a force applied to at least part of the second portion in use (valve 92 opens when sputum compresses spring to let sputum fall into collection tank 10, page 2 paragraph 5 and page 4 paragraph 2).
Therefore, 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 aperture of Kavermann to have a size variable in response to a force applied to at least a part of the second portion in use, as taught by Wu, for the purpose of preventing backflow of sputum to a user which could otherwise cause injury to a user.
Regarding claim 6, modified Kavermann discloses wherein the variable size of the aperture is configured to allow for sputum release therethrough in response to the force applied, in use (page 4 paragraph 2 Wu).
Regarding claim 7, modified Kavermann discloses wherein the force applied to the second portion in use is due at least part to a weight of sputum present in the second portion (weight of sputum at least in part opens valve 92, page 2 paragraph 4 Wu).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pinel (US 2009/0025717) discloses a mucus trap having a valve.
Maitz (US 5,062,835) discloses a mucus trap having a valve structure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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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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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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