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 .
Preliminary Amendment
This office action is responsive to the preliminary amendment filed on 7/21/26. As directed by the amendment: no claims have been amended, claim 20 has been canceled, and no new claims have been added. Thus, claims 1-19 are presently pending in the application.
Election/Restrictions
Claim 19 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 7/21/26.
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:
“a sterilization system configured to sterilize the first filter” in claim 7 (corresponding structure is UV light sources [0075]).
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 Objections
Claim 8 is objected to because of the following informalities:
Claim 8 recites “of breathing circuit” suggested to be changed to --of the breathing circuit-- for grammatical reasons. 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.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 14 and line 15, claim 4 line 1 and claim 5 line 1 recite “the valve,” however it is unclear which valve of the at least one valve applicant is referring to. The language is suggested to be changed to --the at least one valve--.
Any remaining claims are rejected as being dependent on a rejected base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “an inspiratory limb that carries breathing gases from a medical ventilator towards a patient; an expiratory limb that carries expiratory gases from the patient towards the medical ventilator” suggested to be changed to -- an inspiratory limb that is configured to carry [[carries]] breathing gases from a medical ventilator towards a patient; an expiratory limb that is configured to carry [[carries]] expiratory gases from the patient towards the medical ventilator-- in order to avoid claiming the patient.
Any remaining claims are rejected as being dependent on a rejected base claim.
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 1-3, 5-6, 8, 10, 12-15 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orth et al. (2021/0023325).
Regarding claim 1, in fig. 2 and 11 Orth discloses a ventilation system (see fig. 2), comprising: an inspiratory limb 41 that carries breathing gases from a medical ventilator 10 towards a patient 18; an expiratory limb 21 that carries expiratory gases from the patient towards the medical ventilator (Fig. 2); and a dual-channel expiratory filtration system 300 coupled (fluidically coupled) to the expiratory limb (Fig. 2) and configured to receive unfiltered expiratory gases carried by the expiratory limb (Fig. 2), the dual-channel expiratory filtration system comprising: an inlet 302 that receives the unfiltered expiratory gases from the expiratory limb; a first channel 322, pneumatically coupled to the inlet (Fig. 11), including a first filter 326 that filters the unfiltered expiratory gases to form filtered expiratory gases; a second channel 324, pneumatically coupled to the inlet (Fig. 11), including a second filter 328 that filters the unfiltered expiratory gases to form filtered expiratory gases; at least one valve (304 and 306), wherein when the valve 304 is in a first state (opened), the unfiltered expiratory gases from the inlet flow through the first channel (Fig. 11 [0103]), and when the valve 304 is in a second state (closed), the unfiltered expiratory gases from the inlet flow through the second channel [0103]; and an outlet 334, pneumatically coupled to the first channel and the second channel (Fig. 11), that carries the filtered expiratory gases towards the ventilator (Fig. 2 and 11).
Regarding claim 2, in fig. 11 Orth discloses that the at least one valve includes a first valve 304 positioned in the first channel and a second valve 306 positioned in the second channel.
Regarding claim 3, Orth discloses that the at least one valve is a rotatable valve (304 is rotatable) that is: coupled to the inlet (Fig. 11); selectively coupled to the first channel when the rotatable valve is in the first state (open, fig. 11 [0103]); and selectively coupled to the second channel when the rotatable valve is in the second state (closed [0103]).
Regarding claim 5, Orth discloses that the valve is configured to be controlled manually by a clinician (due to handle 314 [0103]).
Regarding claim 6, Orth discloses that a first check valve (338 [0108] is a replacement for 330) in a first post-filter segment of the first channel; and a second check valve (338 [0108] is a replacement for 332) in a second post-filter segment of the second channel.
Regarding claim 8, in fig. 2 and 11 Orth discloses a method for filtering expiratory gases while maintaining pressure in a breathing circuit [0103], the method comprising: receiving an unfiltered expiratory gas flow through a first filter 326 positioned in an expiratory limb (21 through 74) of breathing circuit; receiving a selection to change the unfiltered expiratory gases to flow through a second filter 328 positioned in the expiratory limb of the breathing circuit (by closing first valve 304 and opening second valve 306 [0103-0106]); and subsequent to receiving the selection, receiving the unfiltered expiratory gas flow through the second filter [0103-0106], but not the first filter [0103], while maintaining pressure in the breathing circuit [0103].
Regarding claim 10, Orth discloses receiving a selection to change the unfiltered expiratory gases to flow through the first filter positioned in the expiratory limb of the breathing circuit (open first valve 304 [0103]); and receiving the unfiltered expiratory gas flow through the first filter 326, but not the second filter (328, Fig. 11, second valve 306 is closed), while maintaining pressure in the breathing circuit (Fig. 11).
Regarding claim 12, Orth discloses that the first filter 326 is positioned in a first channel 322 of a filtration system in the expiratory limb (Fig. 2 and 11), and the second filter 328 is positioned in a second channel 324 of the filtration system (Fig. 2 and 11).
Regarding claim 13, in fig. 2 and 11 Orth discloses a method for replacing expiratory filters of a ventilation system without breaking a breathing circuit [0107], the method comprising: opening a first channel 322 and closing a second channel 324 such that expiratory gases flow through a first filter 326 coupled to the first channel [0103]; closing the first channel and opening the second channel such that the expiratory gases flow through a second filter 328 coupled to the second channel [0105]; and while the expiratory gases are flowing through the second channel, replacing filter media of the first filter while maintaining pressure in the breathing circuit [0107].
Regarding claim 14, Orth discloses that the first channel 322 and the second channel 324 are both coupled to an inlet 302 and an outlet 334 (Fig. 11).
Regarding claim 15, Orth discloses that subsequent to replacing the filter media of the first filter: reopening the first channel and reclosing the second channel such that the expiratory gases flow through first channel and the first filter [0103-0107]; and while the expiratory gases are flowing through the first channel, replacing filter media of the second filter [0107].
Regarding claim 17, Orth discloses that opening the first channel 322 and closing the second channel 324 comprises rotating a rotatable valve (valve 304 is rotatable, fig. 11 [0103]).
Regarding claim 18, Orth discloses that opening the second channel 324 and closing the first channel 322 comprises rotating the rotatable valve (valve 304 is rotatable, fig. 11 [0103]).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Orth, as applied to claim 1 above, in further view of Huey (2022/0100213).
Regarding claim 4, Orth discloses that the valve 304 may be any other form of valve may be used that functions to stop and permit flow therethrough [0105], but is silent regarding that the valve is controlled by the ventilator. However, Huey teaches a valve 100 that is either controlled manually or by a ventilator [0052-0053]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orth’s manual valve with a valve controlled by the ventilator, as taught by Huey, for the purpose of providing an alternate valve having the predictable results of allowing and disallowing flow.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Orth, as applied to claim 1 above, in further view of Gamache et al. (2023/0142973).
Regarding claim 7, Orth discloses removing the first filter and cleaning it, but is silent regarding a sterilization system configured to sterilize the first filter. However, Gamache teaches a sterilization system configured to sterilize the first filter (UV treatment of the filter [0670][0549]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orth’s filter with the addition of a sterilization system, as taught by Gamache, for the purpose of cleaning the filter for extended use.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Orth, as applied to claim 8 above, in further view of Gamache et al. (2023/0142973).
Regarding claim 9, Orth discloses removing the first filter and cleaning it, but is silent regarding that while the unfiltered expiratory gas flow is received through the second filter, sterilizing the first filter. However, Gamache teaches a sterilization system configured to sterilize a filter while remaining within the system (UV treatment of the filter during filtration, therefore the UV treatment occurs while the unfiltered expiratory gas flow is received through the second filter and through the first filter [0670][0549] further “The filtration unit can also remain at its operational location although not in use by the user, and be subjected to cleaning and decontamination prior to being ready for re-use by the user”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orth’s first filter with the addition of a sterilization system, as taught by Gamache, for the purpose of cleaning the filter for extended use.
Regarding claim 11, Orth discloses removing the first filter and cleaning it, but is silent regarding that while the unfiltered expiratory gas flow is received through the first filter, sterilizing the second filter. However, Gamache teaches a sterilization system configured to sterilize a filter while remaining within the system (UV treatment of the filter during filtration, therefore the UV treatment occurs while the unfiltered expiratory gas flow is received through the second filter and through the first filter [0670][0549] further “The filtration unit can also remain at its operational location although not in use by the user, and be subjected to cleaning and decontamination prior to being ready for re-use by the user”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orth’s second filter with the addition of a sterilization system, as taught by Gamache, for the purpose of cleaning the filter for extended use.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Orth, as applied to claim 13 above, in further view of Gamache et al. (2023/0142973).
Regarding claim 16, Orth discloses removing the first filter and cleaning it, but is silent regarding that subsequent to closing the first channel and opening the second channel, and prior to replacing the filter media of the first filter, sterilizing the first filter. However, Gamache teaches a sterilization system configured to sterilize a filter while remaining within the system (UV treatment of the filter during filtration, therefore the UV treatment occurs while the unfiltered expiratory gas flow is received through the second filter and through the first filter [0670][0549] further “The filtration unit can also remain at its operational location although not in use by the user, and be subjected to cleaning and decontamination prior to being ready for re-use by the user” which allows the filter to be sterilized prior to eventual replacement). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orth’s first filter with the addition of a sterilization system, as taught by Gamache, for the purpose of cleaning the filter for extended use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Boulanger et al. (2022/0401686) directed towards a manual and electrical valve, Studer et al. (2021/0330996) directed wards a dual-channel system with two filters and two valves, Orr (2005/0247316) directed towards a bypass valve and Paydar et al. (6,648,947) directed towards a method and apparatus for replacing a filter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy 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.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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