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 the amendment filed 5/13/26. Claims 12, 22 and 31 have been amended, claims 1-11 have been cancelled and new claim 33 has been added. Therefore, claims 12-33 are presently pending in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Claim 12 recites “wherein each of the two prongs is positioned in the at least one localized reduction in cross-sectional area” however, due to the language “at least one localized reduction in cross-sectional area” the claim allows for two annular ridges that span both prongs, which must be shown or the features canceled from the claims. Claim 17 is rejected for the same reason.
Further, the “wherein an entire width of the first prong is positioned within one of the at least one localized reduction in cross-sectional area and an entire width of the second prong is positioned within another of the at least one localized reduction in cross-sectional area” in claim 22 must be shown or the features canceled from the claims.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 recites “wherein each of the two prongs is positioned in the at least one localized reduction in cross-sectional area” however, due to the language “at least one localized reduction in cross-sectional area” the claim allows for two annular ridges that span both prongs, and it is unclear how two annular ridges can each span the two prongs. Figure 6 of applicant’s drawings show a single annular ridge that spans the two prongs and it is unclear how a second annular ridge could also span the two prongs. Claim 17 is rejected for the same reasons.
Claim 22 recites “wherein an entire width of the first prong is positioned within one of the at least one localized reduction in cross-sectional area and an entire width of the second prong is positioned within another of the at least one localized reduction in cross-sectional area” however this language is not found in the original disclosure.
Any remaining claims are rejected as being dependent on a rejected base claim.
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 12-22 and 24-28 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.
Claim 12 recites “and is spaced…” however it is unclear what structure this language is referring back to.
Claims 24-28 recite “the annular ridge” however it is unclear which annular ridge from claim 22 applicant is referring back to.
Any remaining claims are rejected as being dependent on a rejected base claim.
Claim Rejections - 35 USC § 102
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.
Claims 12-16, 19-26, 28-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kooij et al. (2011/0067704).
Regarding claim 12, in fig. 34 Kooij discloses a nasal cannula (structure in fig. 34), comprising: a central body portion 1005 comprising a cavity (defined by a hollow interior of 1005) and an inlet at an end of the central body portion (an inlet is shown to be at a first end at a left-hand side 1007 of the central body portion), wherein each of a first end 1007 of the cavity and a second end 1009 of the cavity has a diameter that is the same (Fig. 34); a first prong (left 1010) and a second prong (right 1010) extending from the central body portion (Fig. 34); the first prong and the second prong are sized and being able to flush carbon dioxide from nares of a user (the first prong and the second prong are sized to insert into the nares [0155], such that the prongs are able to flush carbon dioxide from nares of the user), at least one localized reduction in cross-sectional area downstream of the inlet and formed by an annular ridge extending into the cavity (see annotated Fig. 34 directly below), a cross-sectional shape of the ridge is asymmetrical (along a longitudinal plane due to the rounded projection between the prongs, Fig. 34), at least a portion of the annular ridge being configured to be positioned between the two prongs (see Annotated fig. 34 below), the annular ridge comprising a peak (the ridge extending further into the cavity between the two prongs) forming a maximum reduction in cross-sectional area within the central body portion; the at least one localized reduction in cross-sectional area being configured to cause a pressure drop whereby a decreased gas flow rate results downstream of the at least one localized reduction in cross-sectional area (the localized reduction in cross-sectional area acts as a throttle); and wherein each of the two prongs is positioned in the at least one localized reduction in cross-sectional area (Annotated fig. 34 directly below) and is spaced a distance away from the peak of the annular ridge (the two prongs are spaced to the left and the right of the peak and further the distal ends of the two prongs are spaced a distance from the peak).
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Regarding claim 13, Kooij discloses that the inlet is configured to receive a flow of gases from an inlet tube (1100, abstract).
Regarding claim 14, Kooij discloses that the annular ridge comprises a curved leading edge (Annotated 34 above, extending from 1007).
Regarding claim 15, Kooij discloses that the annular ridge comprises a tapered leading edge or a tapered trailing edge (both the leading and trailing edges on either ends of the ridge taper).
Regarding claim 16, Kooij discloses that the annular ridge comprises one or more convergent or divergent sections (both the leading and trailing edges on either ends of the ridge taper and therefore converge).
Regarding claim 19, Kooij discloses that a width of the annular ridge varies (see Annotated fig. 34 above).
Regarding claim 20, Kooij discloses lateral portions (614, fig. 41-42).
Regarding claim 21, Kooij discloses headgear straps (602, Fig. 41) configured to connect to the lateral portions (Fig. 41-42).
Regarding claim 22, in fig. 34 Kooij discloses a nasal cannula (structure in fig. 34), comprising: a central body portion 1005 comprising a cavity (defined by a hollow interior of 1005) and an inlet at an end of the central body portion (an inlet is shown to be at a first end at a left-hand side 1007 of the central body portion), wherein each of a first end 1007 of the cavity and a second end 1009 of the cavity has a diameter that is the same (Fig. 34); a first prong (left 1010) and a second prong (right 1010) extending from the central body portion (Fig. 34); the first prong and the second prong are sized and being able to flush carbon dioxide from nares of a user (the first prong and the second prong are sized to insert into the nares [0155], such that the prongs are able to flush carbon dioxide from nares of the user), the cavity defining a flow direction (left to right) that is aligned with a longitudinal axis in an area that contains and extends between the first prong and the second prong (Fig. 34), at least one localized reduction in cross-sectional area downstream of the inlet and formed by an annular ridge extending into the cavity (see highlighted annular ridges called “one” and “another” localized reduction in cross-sectional area in annotated fig. 34 below), wherein the at least one localized reduction in cross-sectional area is able to cause a pressure drop whereby a decreased gas flow rate results downstream of the at least one localized reduction in cross-sectional area (based on its cross-sectional reducing structure), wherein an entire width of the first prong is positioned within one of the at least one localized reduction in cross-sectional area (Annotated Fig. 34 below) and an entire width of the second prong is positioned within another of the at least one localized reduction in cross-sectional area (Annotated Fig. 34 below).
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Regarding claim 23, Kooij discloses that the inlet is configured to receive a flow of gases from an inlet tube (1100, abstract).
Regarding claim 24, Kooij discloses that a center of the annular ridge is positioned closer to the first prong (1010 closer to 1007) than the second prong (the “one localized reduction in cross-sectional area” annular ridge is closer to the first prong), the first prong positioned closer to the inlet than the second prong (Annotated fig. 34 above).
Regarding claim 25, Kooij discloses that a center of the annular ridge is positioned closer to the second prong (1010 closer to 1009) than the first prong (the “another localized reduction in cross-sectional area” annular ridge is closer to the second prong), the second prong positioned further from the inlet of the central body portion than the first prong (Annotated fig. 34 above).
Regarding claim 26, Kooij discloses that a cross-sectional shape of the annular ridge comprises a rounded projection (the rounded projection at the distal ends of each annular ridge that extends outwards closest to 1007 and 1009, respectively, Fig. 34).
Regarding claim 28, Kooij discloses that a cross-sectional shape of the annular ridge is asymmetrical (along a longitudinal plane due toa portion of the rounded projection between the prongs, Fig. 34).
Regarding claim 29, Kooij discloses lateral portions (614, fig. 41-42).
Regarding claim 30, Kooij discloses headgear straps (602, Fig. 41) configured to connect to the lateral portions (Fig. 41-42).
Regarding claim 31, in fig. 34 Kooij discloses a nasal cannula (structure in fig. 34), comprising: a central body portion 1005 comprising a cavity (defined by a hollow interior of 1005) and an inlet at an end of the central body portion (an inlet is shown to be at a first end at a left-hand side 1007 of the central body portion), wherein each of a first end 1007 of the cavity and a second end 1009 of the cavity has a diameter that is the same (Fig. 34); a first prong (left 1010) and a second prong (right 1010) extending from the central body portion (Fig. 34); the first prong and the second prong are sized and being able to flush carbon dioxide from nares of a user (the first prong and the second prong are sized to insert into the nares [0155], such that the prongs are able to flush carbon dioxide from nares of the user), a single ridge (ridge extending down between the first and second prongs) positioned between the first prong and the second prong (Fig. 34), the single ridge extending from an interior surface of the central body portion (Fig. 34); wherein the single ridge comprises the only ridge positioned between the first prong and the second prong (Fig. 34); at least one localized reduction in cross-sectional area downstream of the inlet and formed by the single ridge extending into the cavity (the single ridge, fig. 34), and the at least one localized reduction in cross-sectional area being configured to cause a pressure drop whereby a decreased gas flow rate results downstream of the at least one localized reduction in cross-sectional area (the localized reduction in cross-sectional area acts as a throttle, Fig. 34).
Regarding claim 32, Kooij discloses that the inlet is configured to receive a flow of gases from an inlet tube (1100, abstract).
Regarding claim 33, Kooij discloses that the first prong and the second prong are positioned a distance from an apex of any single ridge (the first and second prongs are spaced a distance to the left and right of the apex of the single ridge and further the distal ends of the first and second prongs are spaced a distance from the apex of the single ridge).
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.
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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kooij, as applied to claim 12 above.
Regarding claim 18, Kooij is silent regarding that the annular ridge is off-centered relative to the two prongs. However, it would have been an obvious matter of design choice to modify the two prongs to be slightly off-centered from the annular ridge, since such a modification would have involved a mere change in the form or shape of a component and it appears that such a change would perform equally as well as delivering a pressure drop to the user. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Kooij, as applied to claim 22 above, and further in view of Tero (2015/0083123).
Regarding claim 27, the modified Kooij is silent regarding a cross-sectional shape of the annular ridge comprises a squared or triangular projection. However, in figures 12 Tero teaches that a cannula that has a squared cross-section [0056]. 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 Kooij’s annular ridge (not including the notch between the prongs) with a squared annular ridge, as taught by Tero, for the purpose of providing an alternate cross-sectional shape having the predictable results of reducing a cross-sectional area of a cavity.
Response to Arguments
Applicant’s arguments filed 5/13/26, with respect to the rejection of claim 22 under Kooij et al. (2011/0067704) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Kooij et al. (2011/0067704).
Applicant’s arguments filed 5/13/26, with respect to the rejection of claims 12 and 31 under Wondka (2009/0183739) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Kooij et al. (2011/0067704).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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