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 .
Information Disclosure Statement
The Examiner notes that an ISR was issued on 8/23/2024 in the PCT application that claims priority to this application, but no information disclosure regarding the ISR or the documents cited therein has been made in this application.
Claim Objections
Claims 4, 6, 7, 10-12, 16 and [18] are objected to because of the following informalities:
The claim following claim 17 is not numbered; for purposes of examination, it will be numbered claim 18, and Applicant should amend it to be numbered as such
Claims 4, 10 and 16 should be amended to read “wherein each of the plurality…is elongated” for clarity and grammatical correctness
Regarding claims 6, 12 and 18, the claims should read “silicone” because it is understood that the nasal interface is intended to utilize the pliable, elastic material that is silicone, rather than the brittle, crystalline element that is silicon
Claim 7, the last line should read “the inhalation member
Claim 11, line 1 should read “The method of claim 7”
Appropriate correction is required.
Claim Interpretation
In light of the instant disclosure, e.g. instant Figs. 2-3 where, although the opening 140 is angled toward the left, the vertical/longitudinal axis still extends through the opening 140, “the opening is offset from a longitudinal axis” in claims 2, 8 and 14, is understood to mean that “the opening is not perpendicular/is angled with regards to a longitudinal axis.”
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 1-18 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 claims 1, 7 and 13 (and thus their dependent claims), the claims recite the phrase “of a bead shape,” which is indefinite, because beads come in every shape, e.g. round, cube, star, tubular, etc., such that it is unclear which, of all the possible shapes, is intended. As best understood, for purposes of examination, in view of upper portion 180 as depicted in the instant Figures, “of a bead shaped” is understood to mean “bulbous.”
Claim 10 recites the limitation "the plurality of ventilation cutouts" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, claim 10 will be considered to depend from claim 9, which provides the requisite antecedent basis.
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, 3-5, 7, 9-11, 13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davenport et al. (US 2008/0051674 A1; hereinafter “Davenport”).
Regarding claims 1, 7 and 13, Davenport discloses/infers a method for providing oxygen to an infant or a kid (nasal cannula…used to convey respiratory gases…oxygen assistant therapy…[for] very small children or infants, para [0068]), the method comprising:
providing a nasal cannula (nasal cannula 12) (Figs. 1 and 9, 9A-C) comprising:
a reservoir tube (left auxiliary line 14 OR lines 14+line 16, which constitute a bifurcated tube) (Fig. 1); and
a first inhalation member (left supply line 26) that extends from the reservoir tube and is configured to fit into a nostril of a patient (Figs. 1 and 9B-C), the first inhalation member has a proximal end (to the left in Figs. 1 and 9) and a distal end (at the top in Figs. 1 and 9) (see Fig. 9 modified, below), the proximal end is integral with the reservoir tube (supply arms 26 are respectively connectable to one of the auxiliary respiratory gas supply lines 14…by…adhesive bonding, ultrasonic welding, para [0062]), the distal end has an opening (gas discharge outlet 32) (Figs. 9, 9A-C) (para [0063]), the inhalation member is hollow and in fluid communication with the reservoir tube (Figs. 1, 9 and 9A-C; para [0060]), the first inhalation member comprises:
a lower portion of a tapered profile (see Fig. 1 modified, below), the lower portion tapers from a bottom (proximal end) towards a neck of the first inhalation member (see Fig. 1 modified, below), and
an upper portion extends between the opening and the neck (see Fig. 1 modified, below), the upper portion is, as best understood, of a bead shape/bulbous (see Fig. 1 modified, below); and
inserting the first inhalation member into the nostril of the patient, wherein the upper portion of the inhalation member anchors into the nostril securing the nasal cannula (Figs. 1 and 9B-C; head 72 is sized to facilitate retention of the nasal cannula within a nostril 71 of a patient, para [0068]).
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Regarding claims 3, 9 and 15, Davenport discloses the nasal cannula of claim 1, method of claim 7, and inhalation member of claim 13, wherein the first inhalation member further comprises: a plurality of ventilation cutouts (channels, grooves, slots, troughs or flutes 74) (para [0082]; wherein “cutout” is a product-by-process limitation that results in a channel/groove/slot/trough, such that Davenport anticipates the claimed product) in a wall of the first inhalation member (Figs. 9 and 9A).
Regarding claims 4, 10 and 16, Davenport discloses the nasal cannula of claim 3, method of claim [9], and inhalation member of claim 15, wherein [each of] the plurality of ventilation cutouts [is] elongated and extends along a longitudinal axis (longitudinal axis A) of the first inhalation member (Fig. 9; para [0082]).
Regarding claims 5 and 11, Davenport discloses the nasal cannula of claim 1, and method [of] claim 7, wherein the nasal cannula further comprises: a second inhalation member (right supply line 26) (Figs. 1 and 9) that extends from the reservoir tube (when considered as lines 14+line 16) (Fig. 1) and is spaced apart from the first inhalation member (Fig. 9), the second inhalation member is identical to the first inhalation member (Figs. 9 and 9A).
Regarding claim 17, Davenport discloses the inhalation member of claim 13, wherein the inhalation member is configured to couple to a reservoir tube of the nasal cannula (Fig. 9 in view of Fig. 1; para [0082]).
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.
Claim(s) 2, 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Davenport in view of Hudson (US 2,735,432; hereinafter “Hudson”).
Regarding claims 2, 8 and 14, Davenport discloses the nasal cannula of claim 1, method of claim 7, and inhalation member of claim 13, wherein Davenport further teaches wherein an upper nasal prong opening is offset from a longitudinal axis of the first inhalation member (Fig. 4), but Davenport does not disclose this arrangement in combination with the embodiment of Fig. 9. However, Hudson teaches that it was known in the nasal cannula art before the effective filing date of the claimed invention to include wherein an upper nasal prong opening is offset from a longitudinal axis of the first inhalation member (Figs. 3-5) to ensure that oxygen is directed into the nasal passages leading into the pharynx rather than up into the posterior portions of the nostril (col. 1, lines 28-35). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the embodiment of Davenport Fig. 9 to include wherein the opening is offset from a longitudinal axis of the first inhalation member as taught by Davenport and Hudson, in order to provide the predictable result of guiding the oxygen supply along the natural contours of the nasal passage directly into the pharynx (Hudson col. 1 and col. 3, lines 52-61).
Claim(s) 6, 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Davenport in view of Hernandez (US 2006/0266361 A1; hereinafter “Hernandez”).
Regarding claims 6, 12 and 18, Davenport discloses the nasal cannula of claim 1, method of claim 7, and inhalation member of claim 13, but Davenport is silent regarding wherein the first inhalation member is made of silicon[e]. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Hernandez teaches that it was known in the nasal cannula art before the effective filing date of the claimed invention to include wherein the first inhalation member (nasal insert 26) (Fig. 3) is made of silicone (cannula may be made out of…silicon, para [0046]), such that it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Davenport to include wherein the first inhalation member is made of silicone as taught by Hernandez, in order to utilize a standard material in the art to provide a flexible, user-friendly interface for wearer comfort and/or washability.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references that could be used to reject at least claim 13 under 35 USC 102: Archouniani et al. (US 2019/0070441 A1); Childers (US 4,327,719); Chuang et al. (US 2015/0238785 A1); Frank et al. (US 2020/0261752 A1); Han et al. (US 2008/0295846 A1); Caldwell (US 2,693,800); Lei (US 2020/0061324 A1). Additional references teaching a bulbous upper portion of an inhalation member for anchoring a nasal cannula: Fontaine (US 2022/0031541 A1); McAuley (US 2003/0094178 A1); Zimmerman (US 4,273,124). Additional reference teaching a neck in a nasal cannula inhalation member: Chou et al. (US 2020/0023153 A1). Additional references teaching ventilation cutouts for nasal cannula inhalation members: Foley et al. (US 9,730,830 B2); Gadsby et al. (WO 2022/050852 A1); Santin et al. (US 2006/0085027 A1). Additional reference teaching bulbous nasal inserts specifically for use with infants: Ackerman et al. (US 4,774,946; Fig. 3). Reference teaching use of nasal filter mounts as cannula mounts: Ellis (US 6,561,188 B1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785