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 preliminary amendment filed on 03/02/2026. As directed by the amendment, claims 2-45 and 54 were canceled, claims 1, 46, and 58 were amended, and no claims were newly added. Thus, claims 1, 46-53, and 55-60 are presently pending in this application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig. 13 reference character “122” is not mentioned in the specification.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “160” has been used to designate both “gas permeable body 160” (specification paragraph [0071]) and “cover 160” (specification paragraph [0074]).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "140" and "160" have both been used to designate “gas permeable body” (specification paragraphs [0071, 0074]).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. Abstract lines 1, 2, and 4 use the legal phraseology “comprising” or “comprises”, which should be avoided.
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:
“at least one gas permeable body” of claim 1 line 8
Corresponding structure is [0031] “an open cell foam or mesh, porous or fibre filter materials such as those formed from plastics, fabrics, fibres, fibreglass, synthetic polymer fibres, fabrics e.g. polypropylene fabric; foams (expanded polyethylene, polyurethane, silicone, rubber, etc) and the like”
“at least one nasal element” of claim 46 line 3
Corresponding structure is [0030] “at least one nasal element (such as a nasal prong)”
“a plurality of physical structures” of claim 46 line 4
Corresponding structure is [0026] “one or more of the physical structures comprise filaments or whiskers”, [0027] “one or more of the physical structures comprise fins or pleats”
“an associated securement device” of claim 58 lines 1-2
Corresponding structure is [0011] “The securement device may comprise one or more of, for example, a headgear, head strap, ties, elastic, adhesive dermal pad or the like. In some embodiments, the securement device may comprise a cap/skull cap type headgear”
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.
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 58 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.
Regarding claim 58 line 2, the term “a patient’s face” is unclear as to if a patient is the same or different patient claimed in line 1 of claim 46.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 46-48, 50-53, and 55-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tiep et al. (US 4,535,767; hereinafter “Tiep”).
Regarding claim 46, Tiep discloses a patient interface for delivery of gas to a patient (apparatus 10), the patient interface comprising:
at least one nasal element configured to direct gas into a nare of the patient (cannula 32);
a plurality of physical structures on an external surface of the at least one nasal element (radially projecting fins 34);
wherein the plurality of physical structures are configured to intercept and/or slow aerosols in expiratory gases from the nare (Fig. 3 shows cross section of cannula 32 surrounded by fins 34; fins 34 inside the nares would block at least some expiratory flow and slow or intercept aerosols. Fins 34 would also be a physical barrier to slow all expiratory respiration)
and wherein the plurality of physical structures are provided in a staggered arrangement along a longitudinal length on the external surface of the at least one nasal element (Fig. 3 fins 34 are staggered around the circumference of cannula 32 and fins 34 extend along a longitudinal length on the external surface of cannula 32).
Regarding claim 47, Tiep discloses the plurality of physical structures are configured to reduce line of sight into the nare when in use (Fig. 3 cross section of cannula 32 with fins 34 would be inside the nare, fins 34 would block line of sight around physical placement of fins 34 in the nare).
Regarding claim 48, Tiep discloses the plurality of physical structures extend substantially radially from the external surface of the at least one nasal element (radially projecting fins 34 projecting radially off of cannula 32 exterior), the at least one nasal element comprises one or two nasal elements (cannula 32 has two projections going into each nare).
Regarding claim 50, Tiep discloses more than one of the plurality of physical structures have a shape or configuration that reduces line of sight into the nare when in use, to intercept and/or slow aerosols in the expiratory gases (Fig. 3 shows cross section of cannula 32 surrounded by fins 34; fins 34 inside the nares would block at least some expiratory flow and slow or intercept aerosols. Fins 34 would also be a physical barrier to slow all expiratory respiration).
Regarding claim 51, Tiep discloses more than one of the plurality of physical structures have a cross-sectional shape that is rectangular (cross section of fins 34 would be rectangular, see view in Fig. 3 from the top).
Regarding claim 52, Tiep discloses one or more of the plurality of physical structures has at least one end attached to the at least one nasal element (cannula 32 and fins 34 share the same base end).
Regarding claim 53, Tiep discloses one or more of the plurality of physical structures is flexible at the at least one end attached to the at least one nasal element (Col. 4 liens 5-8 “fins 34 will normally be small enough in dimension as to be capable of adequate flexure so as to minimize any discomfort to a patient”).
Regarding claim 55, Tiep discloses the plurality of physical structures are arranged in rows along a length of the at least one nasal element (along the side length of cannula 32, the fins 34 are arranged in rows from the side perspective).
Regarding claim 56, Tiep discloses the plurality of physical structures are arranged equidistant in the rows and offset from any of the plurality of physical structures in adjacent rows (Each fin 34 is separated and equidistant from each other, see top view from Fig. 3).
Regarding claim 57, Tiep discloses the patient interface is a non-sealing patient interface (Col. 3 lines 60-668 and Col. 4 lines 1-3… cannula 32 is prevented from blocking air flow around them using fins 34, spacing the cannula away from fully blocking, or sealing the nostrils. Also, fins 34 are used to avoid section 16 from fitting against the face blocking air flow).
Regarding claim 58, Tiep discloses an associated securement device configured to retain the patient interface on a patient's face in use (Col. 3 lines 41-46 small holders 30 fit behind the ears of the patient to hold tubes 22 against patient’s head and face).
Regarding claim 59, Tiep discloses an inspiratory conduit adapted to connect to a gases source for delivering a gases flow to the patient. (Col. 3 lines 38-41 tubes 22 connect to common line 26, which connects to the supply tank for delivering oxygen).
Regarding claim 60, Tiep discloses a manifold providing a gas inflow path to the at least one nasal element (center section 16 and receptacle 12 take influx of gas from tubes 22 before delivering via cannula 32), the at least one nasal element comprises one or two nasal elements (cannula 32 has two projections going into each nare).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Brambilla et al. (US 2012/0325218; hereinafter “Brambilla”) in view of Tiep et al. (US 4,535,767; hereinafter “Tiep”).
Regarding claim 1, Brambilla discloses a patient interface for delivery of gas to a patient (see Brambilla ventilation mask 10a, a variant on mask 10), the patient interface comprising:
at least one inspiratory element for directing a flow of gas to a patient airway (see Brambilla cushion 14 for nares intaking gas from gas delivery lumens 32, 34), each inspiratory element comprising at least one inspiratory lumen through which said flow of gas is directed (see Brambilla gas delivery lumens 32, 34);
at least one expiratory element comprising an expiratory gas flow path for directing expiratory gases from the patient (see Brambilla exhalation valve 12); and
at least one gas permeable body in the expiratory gas flow path (see Brambilla HME 104; positioned in chamber 22 and [0072] “able to capture humidity and heat from exhaled flow for the next breath”);
wherein the at least one gas permeable body is configured such that expiratory gases in the expiratory gas flow path are directed through the at least one gas permeable body before exiting the patient interface (see Brambilla [0072] HME 104 in Fig. 10 is positioned between patient expiration and exhaust valve 12).
Brambilla is silent as to a plurality of physical structures on an external surface of the at least one inspiratory element or an external surface of the at least one expiratory element;
and wherein the plurality of physical structures are provided in a staggered arrangement along a longitudinal length on the external surface of the at least one inspiratory element or the external surface of the at least one expiratory element.
However, Tiep teaches a plurality of physical structures on an external surface of the at least one inspiratory element (see Tiep radially projecting fins 34 on external surface of each cannula nare tube 32);
and wherein the plurality of physical structures are provided in a staggered arrangement along a longitudinal length on the external surface of the at least one inspiratory element (see Tiep Fig. 3 fins 34 are staggered around the circumference of cannula 32 and fins 34 extend along a longitudinal length on the external surface of cannula 32). 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 the inspiratory elements, or nasal cannula, of Brambilla with the nasal cannula comprising physical structures on the external surface as taught by Tiep so as to avoid blocking air flow inside the nostrils by spacing the cannula inspiratory elements from fitting too tightly in the nare (see Tiep Col. 3 lines 60-68).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Tiep as applied to claim 46 above, and further in view of Michel et al. (US 2014/0239634; hereinafter “Michel”).
Regarding claim 49, Tiep is silent as to the plurality of physical structures consist of, or comprise a portion that is, oriented at an acute angle relative to the external surface of the at least one nasal element in a direction of insertion into the nare. However, Michel teaches the plurality of physical structures consist of, or comprise a portion that is, oriented at an acute angle relative to the external surface of the at least one nasal element in a direction of insertion into the nare (see Michel [0003] devices for inserting into one or more biological spaces, can be used for an oxygen nasal cannula. Then, Fig. 3B and Fig. 7 shows projecting members 20/40 at an acute angle relative to a longitudinal axis in a direction of insertion into the nare.). 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 the physical structures of fins of Tiep with the angle of the physical structure as taught by Michel so as to direct the flow of gas in a variable direction according to a patient’s needed therapy.
Even if Tiep or modified Tiep fails to disclose the plurality of physical structures consist of, or comprise a portion that is, oriented at an acute angle relative to the external surface of the at least one nasal element in a direction of insertion into the nare, it would have been an obvious matter of design choice to modify the fins 34 of Tiep to be oriented at an acute angle as is claimed, since such a modification would have involved a mere change in the form or shape of a component. 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).
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Applicant argues, on pages 6-7 of the remarks, that the drawing objection to reference character “122” is incorrect because “as the present application does not include a Figure 15”. However, Examiner updated the objection to say “Figure 13”, since that is where the reference character “122” is in the drawings. The objection still stands for the Fig. 13 since the reference character objected to is “122”.
Applicant argues, on page 7 of the remarks, that the objections to the specification are improper. Regarding the abstract, Examiner disagrees that the objection should be withdrawn as the language still uses legal phraseology, as indicated in the objection above. Regarding the specification reference characters, the objection has been moved from the specification to the drawing objections in order to provide more clarity on the reasoning behind the issues. Thus, both specification and drawing objections remain outstanding.
Applicant argues, on pages 8-9 of the remarks, that the interpretations under 112(f) are improper because the additional language provided additional structure to each placeholder term. However, Examiner disagrees and each cited claim limitation to provide structure to the term includes “configured to” language, which is not a corresponding structure but rather a function. Examiner has included corresponding structure to the interpretation in the 112(f) section above. Thus, the interpretations still stand.
Applicant' s arguments, on pages 9-10 of the remarks, with respect to claim 1 have been considered but are moot because the new ground of rejection does not solely rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues, on pages 10-11 of the remarks, that Tiep does not teach the newly added limitation of “wherein the plurality of physical structures are provided in a staggered arrangement along a longitudinal length on the external surface of the at least one nasal element” in claim 46. However, Examiner disagrees because the claim limitation as written is still disclosed by Tiep, see the rejection to claim 46 above. Tiep discloses fins 34 which are provided staggered across the circumference of cannula 32, and provided along a longitudinal length of the entire cannula 32 length. Thus, the physical structures are provided both as staggered and along the longitudinal length. A more specific wording of the limitation is recommended as compared to the present claim amended language. Therefore, the rejection still stands.
Applicant argues, on pages 11-12, that “Michel contemplates integral members 20 that are lined up along a length of a base 16,” citing Figs. 2 and 3B of Michel. However, Examiner disagrees that Michel only teaches members 20 along a base 16. Michel comprises access device 10A,B inserted to an opening 31, such as a nasal opening in use with an oxygen nasal cannula (see Michel [0003]). As shown in Fig. 3A and 7, there are more than one projecting members 20/40 intended to line up along the longitudinal length of access device 10A,B. As the invention of Tiep includes cannula 32 with fins 34 to correctly space the cannula within the nostril and avoid full nasal blockage, the spacing device of Michel is able to create space within the nare as a “space access device”, relied upon to teach the projecting members at an angle as is required by Claim 49. Thus, the rejection still stands.
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 GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
Prosecution Insights