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 .
Election/Restrictions
Claims 75-79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 22 Dec 2025.
Applicant's election with traverse of Group I (claims 59-74) and Species A in the reply filed on 22 Dec 2025 is acknowledged. The traversal is on the ground(s) that there would be no search burden (Pg. 5-6). This is not found persuasive because the concept of “search burden” cited by applicant only applies to applications filed under 35 U.S.C. 111(a) (see MPEP 801). As the present application has been filed under 35 U.S.C. 371 the restriction/election requirement instead follows the unity of invention principles set forth in MPEP 1850.
The requirement is still deemed proper and is therefore made FINAL.
Upon review the prior species portion of the election/restriction requirement from 23 Sep 2025 is fully withdrawn. It is found that the previously indicated Species A-C all address the same technical feature of moisture reduction in a nasal cannula interface and thus should be examined together. The previously indicated Species D, while distinct from Species A-C, is solely directed toward nonelected Group II, thus rendering the species portion of the election/restriction requirement moot.
Claim Objections
Claim(s) 63, 65 and 73-74 is/are objected to because of the following informalities:
Claim 63, Ln. 2 recites “gases inlet conduit” which should read “a gases inlet conduit”
Claim 65 should add a comma to the end of its preamble
Claim 73 should add a comma to the end of its preamble
Claim 74, Ln. 2 recites “gases inlet conduit manifold” which should read “gases inlet conduit” for consistency with claim 63
Appropriate correction is required.
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(s) 62-68 and 70-74 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 62 recites the limitation “the moisture reducing device may be on, at, or in the at least one nasal prong” which deems the claim indefinite. The use of the optional language “may be” leaves it indefinite whether the claim is positively reciting anything. The language should be changed to not leave the full claim as optional. For the purposes of examination the limitation will be interpreted as reading “the moisture reducing device is on, at, or in the at least one nasal prong”.
Claim 63 recites the limitation “a gases inlet conduit connected to the cannula manifold” which deems the claim indefinite. The scope of the claimed subject matter is unclear due to inconsistencies between the language of the claim preamble and certain portions of the body of the claim. The preamble of claim 63 sets forth the subcombination of a nasal cannula interface. However, line 2-3 of the claim recites “a gases inlet conduit connected to the cannula manifold” which sets forth a positive relationship between the nasal cannula interface and the gases inlet conduit, and thus the claim appears to claim the combination a nasal cannula system. It is noted that the specification of the instant application makes a clear distinction between a nasal cannula interface and an inspiratory conduit which connects to the nasal cannula interface. Applicant needs to amend the language of the claim to be consistent either as a combination or subcombination claim. Further, it is not evidently clear that the moisture reducing device of claim 59 could be accurately read as only in the gases inlet conduit while satisfactorily performing the function of the moisture reducing device recited in claim 59 as “remov[ing] moisture from, or reduc[ing] moisture in, the nare of the patient” since the gases inlet conduit is relatively far from the nare of the patient. For the purposes of examination the portion of the claim referring to the gases inlet conduit will not be considered since the gases inlet conduit is not accurately part of the nasal cannula interface as disclosed. The same issue also appears in claim 74.
Claim 64 recites the limitation “the nasal cannula interface may comprise a body of the moisture reducing device” which deems the claim indefinite. The use of the optional language “may comprise” leaves it indefinite whether the claim is positively reciting anything. The language should be changed to not leave the full claim as optional. For the purposes of examination the limitation will be interpreted as reading “the nasal cannula interface comprises a body of the moisture reducing device”.
Claim 65 recites the limitation “the moisture reducing device may be provided at or on an external surface of the at least one nasal prong” which deems the claim indefinite. The use of the optional language “may be” leaves it indefinite whether the claim is positively reciting anything. The language should be changed to not leave the full claim as optional. For the purposes of examination the limitation will be interpreted as reading “the moisture reducing device is provided at or on an external surface of the at least one nasal prong”.
Claim 66 recites the limitation “the moisture reducing device may comprise a moisture flow formation” which deems the claim indefinite. The use of the optional language “may comprise” leaves it indefinite whether the claim is positively reciting anything. The language should be changed to not leave the full claim as optional. For the purposes of examination the limitation will be interpreted as reading “the moisture reducing device comprises a moisture flow formation”.
Claim 67 recites the limitation “the moisture flow formation may comprise a channel, microstructure, capillary or other structure” which deems the claim indefinite. The use of the optional language “may comprise” leaves it indefinite whether the claim is positively reciting anything. The language should be changed to not leave the full claim as optional. For the purposes of examination the limitation will be interpreted as reading “the moisture flow formation comprises a channel, microstructure, capillary or other structure”.
Claim 67 recites the limitation “the moisture flow formation may comprise … [an] other structure” 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 structures” are intended or to delete the limitation.
Claim 68 recites the limitation “the moisture flow formation is configured to direct or funnel moisture to the moisture reducing device” which deems the claim indefinite. Claim 66 has recited the moisture flow formation as part of the moisture reducing device. The claim thus essentially defines the moisture reducing device as directing or funneling moisture to itself, which is confusing and unclear.
Claim 70 recites the limitation “the heater may be provided on the at least one nasal prong” which deems the claim indefinite. The use of the optional language “may be” leaves it indefinite whether the claim is positively reciting anything. The language should be changed to not leave the full claim as optional. For the purposes of examination the limitation will be interpreted as reading “the heater is provided on the at least one nasal prong”.
Claim 72 recites the limitation “the nasal cannula interface further comprises one or more conduits” which deems the claim indefinite. The scope of the claimed subject matter is unclear due to inconsistencies between the language of the claim preamble and certain portions of the body of the claim. The preamble of claim 72 sets forth the subcombination of a nasal cannula interface. However, line 1-2 of the claim recites “the nasal cannula interface further comprises one or more conduits” which sets forth a positive relationship between the nasal cannula interface and the one or more conduits, and thus the claim appears to claim the combination a nasal cannula system. It is noted that 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. Applicant needs to amend the language of the claim to be consistent either as a combination or subcombination claim. For the purposes of examination the claim will be interpreted as a combination of a nasal cannula system including both a nasal cannula interface and the recited one or more conduits.
Claim 73 recites the limitation “a porous material to absorb moisture” which deems the claim indefinite. The limitation “moisture reducing device” in claim 59 has been interpreted as invoking 35 U.S.C. 112(f). Certain of structures disclosed as possible option for the moisture reducing device are made of porous material. There is thus confusion in the instant claim as to whether the porous material of the instant claim is intended to further define the moisture reducing device of claim 59 or is intended as a fully separate structure in addition to the moisture reducing device of claim 59. For the purposes of examination both options will be considered, but applicant is requested to clarify the intent in the claim language.
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 configured to remove moisture from, or reduce moisture in, the nare of the patient” in claim 59 and “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” of both claims 59 and 72 is best understood from the specification as at least: one or more hydrophilic, moisture absorbent and/or wicking devices (¶¶0069-0070), a moisture flow formation comprising a channel, microstructure, capillary or other structure, configured to wick moisture from the patient's nare(s) (¶¶0077-0078), or a heater (¶0079) (¶0083 – indicates the above moisture reducers may also be included on a conduit).
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 § 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 59-64, 66-69 and 72-74 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boucher et al. (U.S. Pub. 2014/0158127).
Regarding claim 59, Boucher discloses a nasal cannula interface (e.g. Figs. 31 & 33-35; ¶¶0176-0178, 0180-0185) for a respiratory support system configured to deliver a flow of gases, the nasal cannula interface comprising: an inlet (Figs. 31 & 33-35 left side entry) to receive the flow of gases; at least one nasal prong (Figs. 31 & 33-35 upward projections) 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, at least one gases flow path for the flow of gases being provided from the inlet and through the at least one nasal prong (Figs. 31 & 33-35 – internal to each cannula); 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. 31 #21590, ¶0176; Fig. 33 #23590, ¶0180, Fig. 34 wicking material internal to #24584a-b, ¶0181; Fig. 35 #25590, ¶0182; or ¶0185 – micro heater embedded in a side wall of the cannula). It is noted that the above citations represent various possible readings from Boucher on the “moisture reducing device” of the instant claim.
Regarding claim 60, Boucher discloses the moisture reducing device is configured to be in the at least one gases flow path (Figs. 31 & 33-35).
Regarding claim 61, Boucher discloses the moisture reducing device comprises one or more hydrophilic, moisture absorbent, and/or wicking material (Figs. 33-35; ¶¶0180-0182). The instant claim does not invoke 35 U.S.C. 112(f).
Regarding claim 62, Boucher discloses the moisture reducing device is on, at, or in the at least one nasal prong (Figs. 33-34; ¶¶0180-0181).
Regarding claim 63, Boucher discloses the moisture reducing device is provided on a cannula manifold (Figs. 33 & 35), the at least one nasal prong (Figs. 33-34),
Regarding claim 64, Boucher discloses the nasal cannula interface comprises a body of the moisture reducing device (Fig. 33 #23590), the body being mounted on the at least one nasal prong. The claim does not specify a shape and/or form which the body must take.
Regarding claim 66, Boucher discloses the moisture reducing device may comprise a moisture flow formation (Fig. 31 #21590; ¶0176). The instant claim does not invoke 35 U.S.C. 112(f).
Regarding claim 67, Boucher discloses the moisture flow formation may comprise a channel (Fig. 31 #21590; ¶0176)
Regarding claim 68, Boucher discloses the moisture flow formation is configured to direct or funnel moisture to the moisture reducing device (Fig. 31 #21590; ¶0176 – each groove 21590 will direct moisture further down itself).
Regarding claim 69, Boucher discloses the moisture reducing device comprises a heater (¶0185 – micro heater embedded in a side wall). The instant claim does not invoke 35 U.S.C. 112(f).
Regarding claim 72, Boucher discloses the nasal cannula interface further comprises one or more conduits (Fig. 1 conduits; ¶0105) with which the nasal cannula interface is in fluid communication, the one or more conduits comprising a moisture reducer and/or moisture reducing device (¶0192 – heater).
Regarding claim 73, Boucher discloses a porous material to absorb moisture (Figs. 33 & 35; ¶¶0180, 0182 – listed absorbent materials are porous, e.g. cotton).
Regarding claim 74, Boucher discloses the cannula manifold, prong(s) .
Claim(s) 59-66 and 73 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Acharya (U.S. Pub. 2008/0314391).
Regarding claim 59, Acharya discloses a nasal cannula interface (Fig. 4; ¶0176-0012) for a respiratory support system configured to deliver a flow of gases, the nasal cannula interface comprising: an inlet (Figs. 2 & 4 side inlets receiving gas as shown in Fig. 2; ¶0012) to receive the flow of gases; at least one nasal prong (Fig. 4 #14, 19 below “porous layer”; ¶0013) 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, at least one gases flow path for the flow of gases being provided from the inlet and through the at least one nasal prong (Figs. 2 & 4); 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. 4 #15, 18; ¶¶0013-0014 – porous layer). The “porous layer” of Acharya is read as at least a functional equivalent of the disclosed moisture reducing device as one option for the disclosed moisture reducing device is a porous material which absorbs moisture (e.g. ¶00269).
Regarding claim 60, Acharya discloses the moisture reducing device is configured to be in the at least one gases flow path (Figs. 2 & 4).
Regarding claim 61, Acharya discloses the moisture reducing device comprises one or more
Regarding claim 62, Acharya discloses the moisture reducing device is on, at, or in the at least one nasal prong (Fig. 4; ¶0013-0014).
Regarding claim 63, Acharya discloses the moisture reducing device is provided on
Regarding claim 64, Acharya discloses the nasal cannula interface comprises a body of the moisture reducing device (Fig. 4 #15, 18; ¶¶0013-0014), the body being mounted on the at least one nasal prong.
Regarding claim 65, Acharya discloses the moisture reducing device is provided at or on an external surface of the at least one nasal prong (Fig. 4).
Regarding claim 66, Acharya discloses the moisture reducing device may comprise a moisture flow formation (Fig. 4 #15, 18; ¶¶0013-0014). The instant claim does not invoke 35 U.S.C. 112(f). A porous layer constitutes a flow formation under broadest reasonable interpretation.
Regarding claim 73, Acharya discloses a porous material to absorb moisture (Fig. 4 #15, 18; ¶¶0013-0014).
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) 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acharya (U.S. Pub. 2008/0314391) in view of Boucher et al. (U.S. Pub. 2014/0158127).
Regarding claim 74, Acharya is silent as to whether the cannula manifold, 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 Acharya 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) 70-71 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd 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 70, Boucher fails to teach or suggest the heater is provided on the at least one nasal prong. There is no consideration in Boucher of a heater at the nasal prong.
Other prior art which teach heating at a nasal cannula include: Schobel et al. (U.S. Pub. 2007/0283957; Fig. 1 #8), Kooij et al. (U.S. Pub. 2011/0067704; Fig. 33#1102), Ratto et al. (U.S. Pub. 2012/0304992; ¶0031), Rybicki et al. (U.S. Pub. 2015/0343167; Fig. 1 #160; ¶¶0023-0024) and Klenner et al. (U.S. Pub. 2016/0030696; Figs. 45J-45Q; ¶0669). In none of those prior art is a heater provided specifically at the nasal prong. Conversely, Schobel teaches an expectation in the art would be to insulate a heating wire away from the prongs to shield a user from possible danger of the heating wire (¶¶0014, 0038). Thus, one of ordinary skill in the art would have avoided placement of a heating wire at the nasal prong to protect the patient from possible harm.
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 the heater on the at least one nasal prong without improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Beyond the list of prior art presented in the discussion of claim 70 above, regarding claim 59 further attention is specifically drawn Jaffe et al. (U.S. Pub. 2008/0190436; Figs. 32-33), Opperman et al. (U.S. Pub. 2013/0333705; Fig. 2), Matsubara et al. (U.S. Pub. 2016/0051787; Figs. 1 & 6-7) and Xu et al. (U.S. Pub. 2024/0157079; Figs. 2-5).
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