DETAILED ACTION
This action is in response to the Response to Election/Restriction filed 3/9/2026. Currently, claims 1-24 are pending in the application.
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 .
Election/Restrictions
Applicant’s election without traverse of Species 11, Figures 16A-16F (corresponding to claims 1-4, 7-10, 12, 16, 19, 22 and 23) in the reply filed on 3/9/2026 is acknowledged.
Claims 5, 6, 11, 13-15, 17, 18, 20, 21 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/9/2026.
Claim 16 is withdrawn as being drawn to a non-elected species. Claim 16 recites “at least one stopper.” Applicant’s disclosure does not teach a stopper associated with elected Species 11, Figures 16A-16F. Rather, Applicant’s disclosure teaches stopper 2003 in Figure 4A, corresponding to non-elected Species 2. Further, Applicant’s disclosure teaches stopper 3003 in Figure 6A, corresponding to non-elected Species 3. Claim 16, therefore, is withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “for treating breathing problem” in line 1 of the claim should be amended to recite ---for treating a breathing problem---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), all recitations of “the nasal passage” should be amended to recite ---the user’s nasal passage---. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the slit vent” in line 2 of the claim should be amended to recite ---the at least one slit vent---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a multiple of slit vents” in line 2 of the claim should be amended to recite ---multiple of said at least one slit vent---. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “each of the nasal dilator” in line 2 of the claim should be amended to recite ---each of the two nasal dilators---. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “one-way flow resistance unit” in claims 1-4, 19 and 23.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant’s specification teaches the following corresponding structure(s) as performing the claimed function: a one-way flow resistance valve and a valve seat.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 10 is 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 10 recites the limitation "the neighboring slit vents" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the 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.
Claim(s) 1, 4 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nussbaum (US 2016/0051397 A1).
Regarding claim 1, Nussbaum teaches in Figures 1-8, [0074], [0076] and [0078]
a hollow nasal dilator body (elongated tubular housings 21; shown in Figures 4 and 5 to be hollow; [0078] teaches “the housings 21 are tubular shaped and formed with robust, through internal passages 61 (FIG. 5);” [0076] teaches “a pair of elongated tubular housings 21 to be inserted in the patient's nasal passages as shown in FIG. 8 to be frictionally held therein;” capable of dilating a user’s nostrils when inserted therein, depending on the size of the user’s nostrils) having a first end opening (top end opening of elongated tubular housing 21, as shown in Figure 1) and a second end opening (bottom end opening of elongated tubular housing 21, as shown in Figure 1) opposing the first end opening (top end opening of elongated tubular housing 21, as shown in Figure 1), wherein the hollow nasal dilator body (elongated tubular housings 21) longitudinally extends from (as shown in Figure 1) the first end opening (top end opening of elongated tubular housing 21, as shown in Figure 1) to the second end opening (bottom end opening of elongated tubular housing 21, as shown in Figure 1) and being adapted for insertion into a user's nostril (as shown in Figure 8; [0076] teaches “a pair of elongated tubular housings 21 to be inserted in the patient's nasal passages as shown in FIG. 8 to be frictionally held therein”) with the second end opening (bottom end opening of elongated tubular housing 21, as shown in Figure 1) placed within the user's nasal passage (as shown in Figure 8) so that the hollow nasal dilator body (elongated tubular housings 21) supports and dilates the nasal passage ([0076] teaches “a pair of elongated tubular housings 21 to be inserted in the patient's nasal passages as shown in FIG. 8 to be frictionally held therein;” capable of dilating a user’s nostrils when inserted therein, depending on the size of the user’s nostrils); and
a one-way flow resistance unit (rim device 23, flexible membrane 27, proximally facing circular valve seat 31; [0074] teaches “when the patient inhales the diametrically opposite sections of the membrane 27 will be raised proximally off the seat 31 for the patient to inhale ambient air and, upon expiration, the membrane 27 will be driven distally to engage the peripheral edges with the seat 31 to positively block expiration of spent air”) assembled to (as shown in Figures 1, 4 and 5; [0074] teaches “elongated tubular housings 21 capped at the distal end by a relatively rigid rim device 23 supported distended radially by means of radial ribs 25 and carrying a flexible membrane 27 centrally from a mounting post 29” and “the rim device 23 forms a proximally facing circular valve seat 31”) the hollow nasal dilator body (elongated tubular housings 21) and in proximity to (as shown in Figures 1, 4 and 5) the first end opening (top end opening of elongated tubular housing 21, as shown in Figure 1) and away from (as shown in Figures 1, 4 and 5) the second end opening (bottom end opening of elongated tubular housing 21, as shown in Figure 1), wherein the one-way flow resistance unit (rim device 23, flexible membrane 27, proximally facing circular valve seat 31) creates an exhalation flow resistance higher than an inhalation flow resistance such that an expiratory positive airway pressure is generated within the nasal passage ([0074] teaches “when the patient inhales the diametrically opposite sections of the membrane 27 will be raised proximally off the seat 31 for the patient to inhale ambient air and, upon expiration, the membrane 27 will be driven distally to engage the peripheral edges with the seat 31 to positively block expiration of spent air”).
Regarding claim 4, Nussbaum teaches the apparatus of claim 1. Nussbaum teaches in Figure 4 and [0074] that the one-way flow resistance unit (rim device 23, flexible membrane 27, proximally facing circular valve seat 31; [0074] teaches “when the patient inhales the diametrically opposite sections of the membrane 27 will be raised proximally off the seat 31 for the patient to inhale ambient air and, upon expiration, the membrane 27 will be driven distally to engage the peripheral edges with the seat 31 to positively block expiration of spent air”) comprises a one-way flow resistance valve (flexible membrane 27; [0074] teaches “when the patient inhales the diametrically opposite sections of the membrane 27 will be raised proximally off the seat 31 for the patient to inhale ambient air and, upon expiration, the membrane 27 will be driven distally to engage the peripheral edges with the seat 31 to positively block expiration of spent air”) and a valve seat (proximally facing circular valve seat 31), the one-way flow resistance valve (flexible membrane 27) is fastened in (as shown in Figure 4; [0074] teaches “a relatively rigid rim device 23 supported distended radially by means of radial ribs 25 and carrying a flexible membrane 27 centrally from a mounting post 29” and “the rim device 23 forms a proximally facing circular valve seat 31”) the valve seat (proximally facing circular valve seat 31), and the valve seat (proximally facing circular valve seat 31) is assembled to (as shown in Figure 4; [0074] teaches “elongated tubular housings 21 capped at the distal end by a relatively rigid rim device 23” and “the rim device 23 forms a proximally facing circular valve seat 31”) the hollow nasal dilator body (elongated tubular housings 21).
Regarding claim 22, Nussbaum teaches the nasal dilator of claim 1 (see the rejection of claim 1 above). Nussbaum teaches in Figures 6-8, [0074] and [0076] two nasal dilators as claimed in claim 1 (as shown in Figures 6-8; [0074] teaches “a pair of nasal tube devices”) and a jointing piece (connector tab device 41) connected between the two nasal dilators (as shown in Figures 6-8; [0074] teaches “a pair of nasal tube devices;” [0076] teaches “the housings are connected together by means of an adjustable nose strap device, generally designated 41”).
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.
Claim(s) 2, 3, 12 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nussbaum (US 2016/0051397 A1) in view of COLLAZO (US 2021/0170132 A1).
Regarding claim 2, Nussbaum teaches the apparatus of claim 1. Nussbaum does not teach that the one-way flow resistance unit is removable and interchangeable from the nasal dilator.
However, COLLAZO teaches in Figures 2A-2E, [0017], [0027] and [0036] an analogous device wherein the one-way flow resistance unit (flange 206, valve 210/212, inlet aperture cover 216; [0027] teaches “the valve may allow air to pass through the nasal insert during inhalation, but may also work to prevent air from passing through the nasal insert during exhalation” and “the valve may serve to resist flow (i.e. increase resistance) in one direction”) is removable and interchangeable from ([0027] teaches “the valve may be replaceable;” [0036] teaches “the respiratory interface may have different attachable/removable valves”) the nasal dilator (nasal insert 100; [0017] teaches “the nasal insert 100 may have a generally oval shape to facilitate conforming to the shape of the patient's nostril;” capable of dilating a user’s nostrils when inserted therein, depending on the size of the user’s nostrils).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the one-way flow resistance unit of Nussbaum to be removable and interchangeable from the nasal dilator as taught by COLLAZO because this element is known to enable the nasal dilator to “be offered with different methods for adjusting the back pressure generated by the device,” which provides adjustability such that a patient can have “some time to adapt to breathing using a respiratory interface with a valve,” as COLLAZO teaches in [0036].
Regarding claim 3, Nussbaum teaches the apparatus of claim 1. Nussbaum does not teach that the one-way flow resistance unit is able to adjust a ratio of the exhalation flow resistance to the inhalation flow resistance.
However, COLLAZO teaches in Figures 2A-2E, [0027] and [0036] an analogous device wherein the one-way flow resistance unit (flange 206, valve 210/212, inlet aperture cover 216; [0027] teaches “the valve may allow air to pass through the nasal insert during inhalation, but may also work to prevent air from passing through the nasal insert during exhalation” and “the valve may serve to resist flow (i.e. increase resistance) in one direction”) is able to adjust a ratio of the exhalation flow resistance to the inhalation flow resistance ([0036] teaches “the respiratory interface may be offered with different methods for adjusting the back pressure generated by the device,” “the respiratory interface may have different attachable/removable valves with different resistance values or performance,” “the respiratory interface may have an adjustable or variable valve,” “an adjustable valve or adjustable bleed port may be adjusted manually or electronically,” “an adjustable valve or adjustable bleed port may self-adjust based on the respiratory interface sensing flow or pressure or may adjust based on a predetermined program” and “an adjustable valve or adjustable bleed port may adjust based on a ramp time or the number of hours the respiratory interface is used”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the one-way flow resistance unit of Nussbaum to be able to adjust a ratio of the exhalation flow resistance to the inhalation flow resistance as taught by COLLAZO because this element is known to enable the nasal dilator to “be offered with different methods for adjusting the back pressure generated by the device,” which provides adjustability such that a patient can have “some time to adapt to breathing using a respiratory interface with a valve,” as COLLAZO teaches in [0036].
Regarding claim 12, Nussbaum teaches the apparatus of claim 1. Nussbaum does not teach that the hollow nasal dilator body has at least one lateral vent in proximity to the first end opening.
However, COLLAZO teaches in Figures 1A and 1B and [0018]an analogous device wherein the hollow nasal dilator body (hollow body 102; [0018] teaches “in use, nasal insert can function to open the nasal passage”) has at least one lateral vent (at least one weight-reducing structure 108; [0018] teaches “the weight reducing structures 108 can include indentations or apertures, such as slots, perforations, and like openings”) in proximity to (as shown in Figures 1A and 1B) the first end opening (inlet aperture 104).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the hollow nasal dilator body of Nussbaum to have at least one lateral vent in proximity to the first end opening as taught by COLLAZO because this element is known to “function to reduce the weight or structure of the nasal insert,” as COLLAZO teaches in [0018].
Regarding claim 23, Nussbaum teaches the apparatus of claim 22. Nussbaum does not teach that the one-way flow resistance unit of each of the nasal dilator is able to adjust a ratio of the exhalation flow resistance to the inhalation flow resistance.
However, COLLAZO teaches in Figures 2A-2E, [0021], [0027] and [0036] an analogous device wherein the one-way flow resistance unit (flange 206, valve 210/212, inlet aperture cover 216; [0027] teaches “the valve may allow air to pass through the nasal insert during inhalation, but may also work to prevent air from passing through the nasal insert during exhalation” and “the valve may serve to resist flow (i.e. increase resistance) in one direction”) of each of the nasal dilator (nasal inserts 202; [0021] teaches “a respiratory interface 200 having a pair of nasal inserts 202”) is able to adjust a ratio of the exhalation flow resistance to the inhalation flow resistance ([0036] teaches “the respiratory interface may be offered with different methods for adjusting the back pressure generated by the device,” “the respiratory interface may have different attachable/removable valves with different resistance values or performance,” “the respiratory interface may have an adjustable or variable valve,” “an adjustable valve or adjustable bleed port may be adjusted manually or electronically,” “an adjustable valve or adjustable bleed port may self-adjust based on the respiratory interface sensing flow or pressure or may adjust based on a predetermined program” and “an adjustable valve or adjustable bleed port may adjust based on a ramp time or the number of hours the respiratory interface is used”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the one-way flow resistance unit of each of the nasal dilator of Nussbaum to be able to adjust a ratio of the exhalation flow resistance to the inhalation flow resistance as taught by COLLAZO because this element is known to enable the nasal dilator to “be offered with different methods for adjusting the back pressure generated by the device,” which provides adjustability such that a patient can have “some time to adapt to breathing using a respiratory interface with a valve,” as COLLAZO teaches in [0036].
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nussbaum (US 2016/0051397 A1) in view of Doshi et al. (US 2009/0145441 A1).
Regarding claims 7-10, Nussbaum teaches the apparatus of claims 1 and 4. Nussbaum does not teach that the one-way flow resistance valve has at least one slit vent in a radial direction; wherein the one-way flow resistance valve has a cut between the slit vent and a periphery of the one-way flow resistance valve; wherein the one-way flow resistance valve has a multiple of slit vents spaced from each other and arranged along at least one radial direction; and wherein the one-way flow resistance valve has a cut between at least one pair of the neighboring slit vents.
However, Doshi et al. teaches in Figures 2A and 2B, [0013], [0076] and [0085] an analogous device wherein the one-way flow resistance valve (flap valve 207; [0013] teaches “flap valve airflow resistors;” [0076] teaches “the airflow resistor may be a flap valve;” [0085] teaches “all of the nasal devices described herein also include an airflow resistor” and “in general, the airflow resistor opesn in one direction (during inhalation) and is closed during exhalation”) has at least one slit vent (as defined in the annotated copy of Figure 2B provided below) in a radial direction (as shown in Figure 2B); wherein the one-way flow resistance valve (flap valve 207) has a cut (as defined in the annotated copy of Figure 2B provided below) between (as shown in the annotated copy of Figure 2B provided below) the slit vent (as defined in the annotated copy of Figure 2B provided below) and a periphery (perimeter edge) of the one-way flow resistance valve (flap valve 207); wherein the one-way flow resistance valve (flap valve 207) has a multiple of slit vents (as defined in the annotated copy of Figure 2B provided below) spaced from each other and arranged along at least one radial direction (as shown in the annotated copy of Figure 2B provided below); and wherein the one-way flow resistance valve (flap valve 207) has a cut (as defined in the annotated copy of Figure 2B provided below) between at least one pair of (as shown in the annotated copy of Figure 2B provided below) the neighboring slit vents (as defined in the annotated copy of Figure 2B provided below).
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It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the one-way flow resistance valve of Nussbaum to provide that the one-way flow resistance valve has at least one slit vent in a radial direction; wherein the one-way flow resistance valve has a cut between the slit vent and a periphery of the one-way flow resistance valve; wherein the one-way flow resistance valve has a multiple of slit vents spaced from each other and arranged along at least one radial direction; and wherein the one-way flow resistance valve has a cut between at least one pair of the neighboring slit vents as taught by Doshi et al. because this element is known in the art to be an alternate configuration to provide an “appropriate airflow resistor” that is “particularly useful,” as Doshi et al. teaches in [0013] and [0066].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nussbaum (US 2016/0051397 A1) in view of Ferdinand et al. (US 2009/0308398 A1).
Regarding claim 19, Nussbaum teaches the apparatus of claim 1. Nussbaum does not teach that the one-way flow resistance unit is provided with an individual color code based on its individual flow resistance.
However, Ferdinand et al. teaches in [0110-0111] an analogous device wherein the one-way flow resistance unit is provided with an individual color code based on its individual flow resistance ([0110] teaches “any of the adjustable resistance nasal devices described herein may include one or more indicators configured to indicate the resistance of the device,” “in particular, the devices may include one or more indicators that indicate the expiratory resistance (e.g., the resistance to exhalation)” and “the indicator is a color indicator;” [0111] teaches “the tabs (adhesively removable resistance modifying members 3301 and 3303) may be color coded or may be otherwise labeled (e.g., alphanumerically) with an indicator of the expiratory resistance”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the one-way flow resistance unit of Ferdinand et al. to be provided with an individual color code based on its individual flow resistance as taught by Ferdinand et al. because this element is known to “indicate the expiratory resistance (e.g., the resistance to exhalation)” to the user such that the user can identify a particular one-way flow resistance unit, as Ferdinand et al. teaches in [0110].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 3/18/2026