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 3/1/2024. As directed by the preliminary amendment, no claims were canceled, claim 7 was amended, and no new claims were added. Thus, claims 1-10 are pending for this application.
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 1-10 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 claims 1-2, the phrase “the nasal plug” is unclear whether what follows applies to only one of the two nasal plugs or both nasal plugs (two nasal plugs are claimed but the claim appears to then be directed to one of the nasal plugs?).
Regarding claim 1, the phrase “the base is provided in the insertion portion” in lines 7-8 is unclear as the term “in” conventionally is defined to mean that one element is interior of another, however this does not appear to be the case shown in Fig. 1-2, and further made unclear by the fact that the two components are claimed in claim 1 to be “integrally formed”.
Regarding claims 3 and 10, the phrase "can" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
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 and 3-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (CN 104853794).
Regarding claim 1, as best understood, Zhang discloses (Fig. 1-2 and 5) a nose vent plug, comprising
a base (body 17) and
two nasal plugs (first nasal cannula system 12 and second nasal cannula system 34) symmetrically provided on the base (see Fig. 1), and inner edges of the two nasal plugs forming a gap (gap between prongs shown in Fig. 1-2) for embedding a nasal septum,
wherein the nasal plug comprises
an insertion portion (top rim of plugs, see Fig. 1) for inserting into a nasal cavity to deliver air flow and a pressing portion (rounded portion of prongs below rim, see Fig. 1) for pressing against a nostril to block the nasal cavity (see Fig. 4), a bottom end of the pressing portion is integrally formed on the base (attached to and thus integrally formed, see Fig. 5), the insertion portion is integrally formed on a top end of the pressing portion (attached to and thus integrally formed, see Fig. 5), and
an air hole (chamber 60) running through the pressing portion (see Fig. 5) and the base is provided in the insertion portion (see Fig. 5).
Regarding claim 3, as best understood, Zhang discloses a fitting edge (edge of bridge part 38 of base 17 between the prongs 12,34) is provided on a labial side of the base (see Fig. 1) to fit with a nasolabial fold so that the base can cover the nostril when the inserting portion is fully inserted into the nostril (see Fig. 2).
Regarding claim 4, Zhang discloses inner edge lines of the two nasal plugs are gradually approached from top to bottom so that the gap is in a convergent shape (see convergent shape in Fig. 1).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 104853794).
Regarding claim 2, Zhang discloses wherein an upper portion of the nasal plug is the insertion portion (top rim of plug, see Fig. 1), middle and lower portions of the nasal plug is the pressing portion (rounded portion of prongs below rim, see Fig. 1) whose outer diameter is larger than that of the insertion portion (see Fig. 1), but does not disclose a range of an angle α between a tangent line at each point on an outer contour line of the pressing portion and a horizontal line is 20°< α <80°. 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 an angle range 20°< α <80° for the purpose of optimizing user fit and comfort when using the device, 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) 5-6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 104853794) in view of Kwok (US 2008/0289633).
Regarding claim 5, Zhang discloses a material of the nose vent plug, but does not disclose this material is medical silica gel or rubber silica gel.
However, Kwok teaches (Fig. 16B) a nasal vent plug made of rubber silica gel (paragraph [0104] and [0129] Kwok).
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 material of the nasal plug of Zhang to be medical silica gel or rubber silica gel, as taught by Kwok, for the purpose of providing prongs that are adjustable or deformable to perfectly fit and seal to the patient's nares (paragraph [0129] Kwok).
Regarding claim 6, Zhang discloses nose vent plugs, but does not disclose wherein the nose vent plug integrally comprises: an external air bag, and a filling medium which is filled in the external air bag; and wherein the filling medium is gas, liquid or gel.
However, Kwok teaches (Fig. 16B) nose prongs that integrally comprise and external air bag (body of prong that is filled with gel, paragraph [0129]) and a filling medium which is filled in the external air bag (gel, paragraph [0129]); and wherein the filling medium is gas, liquid or gel (gel, paragraph [0129]).
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 prongs of Zhang to integrally comprise: an external air bag, and a filling medium which is filled in the external air bag; and wherein the filling medium is gas, liquid or gel, as taught by Kwok, for the purpose of providing prongs that are adjustable or deformable to perfectly fit and seal to the patient's nares (paragraph [0129] Kwok).
Claim(s) 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 104853794) in view of Bornholdt (US 2018/0036505).
Regarding claim 7, Zhang discloses a nasal mask for anesthesia, comprising the nose vent plug of claim 1 and an insertion pipe (conduit 20) wherein the nose vent plug is fitted on the insertion pipe through the air hole (see Fig. 5), but does not disclose a nasal mask main body, wherein a connecting pipe is provided in the nasal mask main body, the insertion pipe connected to the connecting pipe is provided on the nasal mask main body.
However, Bornholdt teaches a nasal mask main body (frame 120) and a base (seal housing 141, paragraph [0164]) wherein a connecting pipe (inspiratory conduit 3 connected to inlet 123 of frame 120) is provided in the nasal mask main body (see Figs. 1-2). Regarding the limitation, “the insertion pipe connected to the connecting pipe is provided on the nasal mask main body”, because the insertion pipe is attached to the base which is attached to the nasal mask main body, the insertion pipe is also provided on the nasal mask main body.
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 nasal mask of Zhang to include nasal mask main body, wherein a connecting pipe is provided in the nasal mask main body, the insertion pipe connected to the connecting pipe is provided on the nasal mask main body, as taught by Bornholdt, for the purpose of providing a supporting frame and associated connections so that the system can be adjustably secured to head of user while in use.
Regarding claim 8, modified Zhang discloses wherein the nasal mask main body integrally is in a shape of a triangular frame (“triangular”, paragraph [0162] Bornholdt) hollowed out in the middle (see hollow portion in center in Fig. 3 Bornholdt) and fits cheeks of face around the nose (see Fig. 26 Bornholdt), the nasal mask main body comprises a vent portion (inlet 123 Bornholdt) and a fixing portion (connection portions 121 Bornholdt) symmetrically connected to both ends of the vent portion (see Fig. 3 Bornholdt), and the connecting pipe is provided in the vent portion (see paragraph [0162] and Fig. 1 Bornholdt).
Regarding claim 9, modified Zhang discloses wherein an external connecting pipe (see tubing connected to gas supply 15 in Fig. 1 and paragraph [0159] Bornholdt) for connecting an external air supply device is connected to the connecting pipe (see Fig. 1 and paragraph [0159] Bornholdt).
Regarding claim 10, modified Zhang discloses wherein fixing straps (straps 162 Bornholdt) that can be engaged with each other (via clip 167, paragraph [0165] Bornholdt) are respectively provided on the fixing portion (see Fig. 4 and paragraph [0165] Bornholdt).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gunaratnam (US 6,439,230) discloses a mask with nasal ports.
Peacock (US 2017/0151409) discloses a mask system with similar structure as that of claim 1.
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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