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
The Amendment filed 08 Jun 2026 has been entered. Claims 59 and 61-79 are pending in the application with claim 60 canceled. Claims 59, 62-68, 70-76 and 79 are currently amended. Claims 75-79 remain withdrawn. Applicant’s amendment to the Claims have overcome most, but not every, objection and 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 06 Feb 2026. The remaining issues are restated below.
Claim 59 is no longer interpreted as invoking 35 U.S.C. 112(f) following the amendment to claim 59 and its specifying of the moisture reducing device as specifically being “positioned at or on an external surface of the nasal cannula interface,” which imparts a certain structural definition to the moisture reducing device which was not present in prior claim 59.
The prior 35 U.S.C. 102(a)(1) rejections are withdrawn as requested (Pg. 11-15) based on the amendment to the claims.
Response to Arguments
Applicant's arguments filed 08 Jun 2026 have been fully considered but they are not fully persuasive.
Regarding the second 35 U.S.C. 112(b) rejection of claim 67 applicant asserts the claim has been amended to overcome the rejection (Pg. 8). However, it is respectfully submitted that the indefinite language “or other structure” still remains in claim 67. Claim 67 thus remains rejected under 35 U.S.C. 112(b).
Regarding the 35 U.S.C. 112(b) rejection of claim 72 applicant asserts the claim has been amended to overcome the rejection (Pg. 9). However, it is respectfully submitted that while the preamble of the claim has been amended the particular limitation at issue still remains indefinite as its language has not been amended in accordance with the amended preamble (see below 35 U.S.C. 112(b) rejection). Claim 72 thus remains rejected under 35 U.S.C. 112(b).
Regarding the 35 U.S.C. 112(f) interpretation of the claims applicant argues the limitation “moisture reducing device” does not satisfy all three prongs of the analysis in MPEP 2181 (Pg. 10-11).
It is initially noted that claim 59 has been amended to specify the moisture reducing device as specifically being “positioned at or on an external surface of the nasal cannula interface.” That new language imparts a certain structural definition to the moisture reducing device which was not present in prior claim 59. Thus, amended claim 59 is not read as invoking 35 U.S.C. 112(f).
However, claim 72 still includes the language “moisture reducing device” and is understood to refer to a different moisture reducing device from that of claim 59. Regarding the three prongs of MPEP 2181, the language “moisture reducing device” in claim 72 1) includes the nonce term “device”, 2) is recited with the functional language “moisture reducing”, and 3) fails to recite any structure for performing the claimed function. The limitation “moisture reducing device” is thus still read as invoking 35 U.S.C. 112(f).
Applicant’s arguments, see Pg. 9, filed 08 Jun 2026, with respect to claim 73 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of claim 73 has been withdrawn. Applicant has clearly indicated the porous material of claim 73 is to be understood as in addition to the moisture reducing device of claim 59.
Applicant’s arguments with respect to claim(s) 59 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner concurs with applicant’s assertion that amended claim 59 patentably distinguishes over the prior art of record in the preceding Office action (Pg. 11-15). The prior 35 U.S.C. 102(a)(1) rejections have thus been withdrawn.
Claim Objections
Claim(s) 72 and 74 is/are objected to because of the following informalities:
Claim 72, Ln. 3-4 recites “a moisture reducer and/or moisture reducing device” which should read “a moisture reducer and/or a second moisture reducing device” to clearly distinguish from the moisture reducing device of claim 59
Claim 74, Ln. 1-2 recites “A nasal cannula system comprising the nasal interface of Claim 63” which should read “The nasal cannula system of Claim 63” following after the amendment to claim 63
Claim 74, Ln. 2 recites “prong(s)” which should read “non-sealing prong(s)” for consistency with claim 59
Appropriate correction is required.
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.
Claim(s) 62 and 69-71 is/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 claim(s) 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 62 recites the limitation “the moisture reducing device is on, at, or in the at least one non-sealing nasal prong.” Claim 59 has previously recited the moisture reducing device as “positioned at or on an external surface of the nasal cannula interface.” Thus, the final portion of the “or” clause of the instant claim requires the moisture reducing device to be located both “at or on an external surface of the nasal cannula interface” (claim 59) and “in the at least one non-sealing nasal prong” (claim 62). There is lack of sufficient written description support for a moisture reducing device located both externally of the nasal cannula interface while simultaneously internally of the at least one non-sealing nasal prong. The instant claim appears to be improperly mixing and matching limitations from different embodiments not disclosed as suitably combinable together. There is thus lack of sufficient written description support in the application as originally filed for the full scope of the instant claim, with particular attention to the final portion of the “or” clause of the claim.
Claim 69 recites the limitation “the moisture reducing device comprises a heater.” Claim 59 has previously recited the moisture reducing device as “positioned at or on an external surface of the nasal cannula interface.” Thus, the instant claim requires the moisture reducing device to be located both “at or on an external surface of the nasal cannula interface” (claim 59) and to have the form of a heater (claim 69). There is lack of sufficient written description support for a moisture reducing device located both externally of the nasal cannula interface while simultaneously having the form of a heater. The only disclosed heater is in the form of a heating wire 1119 which is not reasonably “positioned at or on an external surface of the nasal cannula interface,” as required by claim 59. The instant claim appears to be improperly mixing and matching limitations from different embodiments not disclosed as suitably combinable together. There is thus lack of sufficient written description support in the application as originally filed for the claiming of the moisture reducing device as a heater which is positioned at or on an external surface of the nasal cannula interface.
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(s) 67-68 and 72 is/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 pre-AIA the applicant regards as the invention.
Claim 67 recites the limitation “the moisture flow formation comprises a channel, microstructure, capillary of other structure configured to wick moisture from a nare of the patient” which deems the claim indefinite. The terminology “other structure” is inappropriately broad and fails to properly define the metes and bounds of the limitation. It is suggested to either define in the claim what “other structure(s)” is/are intended or to delete the terminology of “other structure.”
Claim 72 recites the limitation “the nasal cannula interface further comprises one or more conduits” in Ln. 2-3 which deems the claim indefinite. The specification of the instant application makes a clear distinction between a nasal cannula interface and any conduits which connect to the nasal cannula interface. While the claim has been amended to be drawn to a nasal cannula system the present limitation has not been amended to identify the one or more conduits as a separate part of the system from the nasal cannula interface. The claim is thus indefinite as it attempts to recited the one or more conduits as part of the nasal cannula interface when the one or more conduits instead appear to be better understood as a separate part of the nasal cannula system from the nasal cannula device. For the purposes of examination the limitation will be interpreted as reading “the nasal cannula system comprises one or more conduits.”
Claim Interpretation - 35 USC § 112(f)
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: “moisture reducing device” in claim 72.
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.
The corresponding structure for the “moisture reducing device” is best understood from the specification as at least: wicking material 1117 (¶0356 of the PGPub copy of the instant application) or heater wire 1119 (¶0357 of the PGPub copy of the instant application).
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 § 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 59 and 61-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe et al. (U.S. Pub. 2008/0190436).
Regarding claim 59, Jaffe discloses a nasal cannula interface (Fig. 33; ¶¶0204-0207; see also Fig. 29) for a respiratory support system configured to deliver a flow of gases (¶¶0206-0207), the nasal cannula interface comprising: an inlet (Fig. 33 inlet required to receive “oxygen”; ¶¶0196, 0206-0207; see also Fig. 29) to receive the flow of gases; at least one nasal prong (Fig. 33 #346; ¶0205) configured to receive the flow of gases from the inlet, and to be received in, and to deliver the gases to a nare of a patient (¶¶0204-0205 – “nostril interface” will be received in a nare), at least one gases flow path for the flow of gases being provided from the inlet and through the at least one nasal prong (Fig. 33; ¶¶0205-0207); wherein the nasal cannula interface further comprises a moisture reducing device configured to remove moisture from, or reduce moisture in, the nare of the patient (Fig. 33 #348, ¶0207). Moisture exchanger 348 is capable of reducing moisture in the nare of the patient based upon its ability to absorb moisture which might otherwise be trapped in the nare (¶0207); and wherein the moisture reducing device is positioned at or on an external surface of the nasal cannula interface (Fig. 33; ¶0207).
Jaffe is silent as to whether the at least one nasal prong is non-sealing.
However, one of ordinary skill in the art would have noticed that while Jaffe mentions the concept of sealing many times in its disclosure that none of those teachings of sealing are in relation to a positioning of a nasal prong relative to a user’s nares. Rather, all teachings of sealing in Jaffe are only relation to a sealing between components of the system of Jaffe. Further, the illustration of Fig. 22, while being a different embodiment, clearly shows an intent by Jaffe to provide a non-sealing nasal prong. And finally, the context of the invention of Jaffe is supplemental oxygen delivery (¶¶0003, 0095). One of ordinary skill in the art would have obviously recognized that supplemental oxygen delivery is typically performed with a non-sealing nasal cannula such that the strong flow of oxygen does not become harmful to the user and/or causes drying of the user’s airways, a problem addressed by the embodiment of Fig. 33 in Jaffe (¶0207).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Jaffe the at least one nasal prong is non-sealing based upon how there is no teaching or suggestion in Jaffe of a sealing nasal prong as well as how the context of supplemental oxygen delivery in Jaffe would have obviously led one of ordinary skill in the art to have expected the common use of a non-sealing nasal prong.
Regarding claim 61, Jaffe further teaches the moisture reducing device comprises one or more hydrophilic, moisture absorbent (¶0207), and/or wicking material.
Regarding claim 62, Jaffe further teaches the moisture reducing device is on, at (Fig. 33; ¶0207), or in the at least one non-sealing nasal prong.
Regarding claim 63, Jaffe further teaches a nasal cannula system wherein the moisture reducing device is provided on
Regarding claim 64, Jaffe further teaches the nasal cannula interface comprises a body of the moisture reducing device (Fig. 33 #348), the body being mounted on the at least one non-sealing nasal prong (Fig. 33).
Regarding claim 65, Jaffe further teaches the moisture reducing device is provided at or on an external surface of the at least one nasal prong (Fig. 33; ¶0207).
Regarding claim 66, Jaffe further teaches the moisture reducing device may comprise a moisture flow formation (Fig. 33 #348). The language “moisture flow formation” has no particular structural connotation. Moisture exchanger 348 is readable as a moisture flow formation based upon how it absorbs moisture from a user’s nare (¶0207).
Regarding claim 67, Jaffe further teaches the moisture flow formation may comprise a channel, microstructure, capillary or other structure (Fig. 33 #348; ¶0207), configured to wick moisture from a nare of the patient. Moisture exchanger 348 is readable as a structure to wick moisture based upon how it absorbs moisture from a user’s nare (¶0207).
Regarding claim 68, Jaffe further teaches the moisture flow formation is configured to direct or funnel moisture from the nare of the patient to the moisture reducing device (¶0207 – the absorbing of moisture by moisture exchanger 348 direts moisture).
Claim(s) 72-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe et al. (U.S. Pub. 2008/0190436) in view of Boucher et al. (U.S. Pub. 2014/0158127).
Regarding claim 72, Jaffe fails to teach one or more conduits comprising a moisture reducer and/or moisture reducing device.
Boucher teaches a nasal cannula system (e.g. Fig. 1; ¶0100) comprising a conduit (Fig. 1 conduits; ¶0105) with which a nasal cannula interface is in fluid communication, the one or more conduits comprising a heater (¶0192). A heater reads on one possible embodiment of the disclosed moisture reducing device of the one or more conduits. Boucher teaches a heater in the conduit as providing the benefit of reducing condensation (¶0192).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Jaffe one or more conduits comprising a moisture reducing device in the form of a heater in order to provide the benefit of reducing condensation in view of Boucher.
Regarding claim 73, Jaffe fails to teach the nasal cannula interface comprises a porous material to absorb moisture.
Boucher teaches a nasal cannula (Figs. 33 & 35; ¶¶0180, 0182) including a porous material to absorb moisture (Figs. 33 & 35; ¶¶0180, 0182 – listed absorbent materials are porous, e.g. cotton). Boucher teaches cotton as being one exemplary absorbent material for use inside a nasal cannula to wick away rainout droplets (¶¶0180, 0182).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Jaffe the nasal cannula interface comprises a porous material to absorb moisture in order to provide the benefit of locating an absorbent material inside a nasal cannula to wick away rainout droplets in view of Boucher.
Regarding claim 74, Jaffe fails to teach the cannula manifold, non-sealing prong(s) and/or gases inlet conduit comprise thermally conductive plastic.
Boucher teaches a nasal cannula (e.g. Figs. 1-35) including a cannula manifold and prong(s) made from such plastics as polydimethylsiloxane, neoprene, polystyrene, polybutenes (¶0193). One of ordinary skill in the art would have obviously recognized those types of plastics as all being thermally conductive to a certain degree. It is noted that the claim does not specify a degree to which the plastic is thermally conductive. Boucher thus teaches that commonly used nasal cannula plastics are thermally conductive.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Jaffe the cannula manifold and/or prong(s) comprise thermally conductive plastic based upon an obvious design choice of common plastic materials for a nasal cannula to include polydimethylsiloxane, neoprene, polystyrene, polybutenes, which are each thermally conductive to a certain degree in view of Boucher.
Allowable Subject Matter
Claim(s) 69-71 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 69, Jaffe fails to teach or suggest a heater at the nasal prong operable as a moisture reducing device and being positioned at or on an external surface of a nasal cannula interface. While the previously cited prior art indicates the known use of a heating at a nasal cannula there is not found to be any teaching or suggestion of a heater specifically at or on an external surface of a nasal cannula interface. Note is made of the above 35 U.S.C. 112(a) rejection of the instant claim.
Other prior art readable on claim 59 include the previously cited: Tiep et al. (U.S. Patent 4535767; Figs. 1 & 3-4 #34 readable as an externally located moisture reducing device), Payton et al. (U.S. Patent 4736741; Figs. 1-7 #30 readable as an externally located moisture reducing device), and Lewis et al. (U.S. Pub. 2007/0175473; Fig. 4 #423 readable as an externally located moisture reducing device). However, none of these further prior art teach or suggest a heater specifically at or on an external surface of a nasal cannula interface.
It is thus found that one having ordinary skill in the art would not have considered it prima facie obvious in view of the prior art to have provided a heater at or on an external surface of a nasal cannula interface without improper hindsight reasoning.
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 JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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