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 .
Claim Objections
Claim 1 and 15-16 is objected to because of the following informalities:
In claim 16, line 5, “patent” should read patient”
Appropriate correction is required.
Applicant is advised that should claim 13 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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:
“vacuum source” in claims 1 and 33, equivalent structure found on page 4, lines 29-33. Therefore, the interpretation of “vacuum source” is best understood as a vacuum with a container configured to hold and filter air, a vacuum line, and equivalents thereof.
“treatment source” in claims 1 and 33, equivalent structure found on page 5, lines 6-19 and page 6, lines 3-17. Therefore, the interpretation of “treatment source” is best understood as an ultraviolet light, an oxidant generator such as ozone generators and ion generators, an infrared heater, microwave generator, and equivalents thereof. Claims 11 and 13 are noted as reciting structure for performing the claimed function, and is therefore not subject to this interpretation.
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 § 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.
Claim(s) 1-16, 25-26 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Breegi (WO 2018144809).
Regarding claim 1, Breegi teaches a system for treating an environment (para. 004, “a system for controlling the microenvironment of a contained space”), the system comprising:
an enclosure configured to fit over at least a head of a patient (Abstract, infant incubator apparatus 10; Figs 4A and 5; para. 0020), the enclosure including:
a framework sized and shaped to fit over at least the head of the patient (Fig. 2A, collapsible frame 12 including articulated arms (23, 25) and support arms 24; paragraphs 0053 and 0057); and
a fluid impermeable barrier disposed on the framework (para. 0058, disposable housing/canopy 14; paragraphs. 0018 and 0025), the fluid impermeable barrier including an outer surface and an inner surface defining an interior region facing the patient (paragraphs 0022, 0059, and 0074; para. 0061, “contained space 16”);
a vacuum source fluidly connected to the interior region via the fluid impermeable barrier (para. 00104, “vacuum device”); and
a treatment source (paragraphs 0019, 0026 0076) fluidly connected to one or more of the vacuum source or the fluid impermeable barrier (para. 0026, “UV light source”), the treatment source being configured to treat air from the interior region (para. 0014, “UV light source, e.g., for use in…sterilization of the air”).
Regarding claim 2, Breegi teaches the system according to claim 1 as stated above wherein the enclosure has a domed shape (Figs. 3, 4A and 5; para. 0075).
Regarding claim 3, Breegi teaches the system according to claim 1 as stated above wherein the framework includes a metal frame (para. 0057).
Regarding claim 4, Breegi teaches the system according to claim 1 as stated above wherein the framework includes one or more inflatable members (paragraphs 0066-0067 where the housing/canopy, which is disposed on the collapsible frame, includes inflatable elements).
Regarding claim 5, Breegi teaches the system according to claim 1 as stated above wherein the framework is foldable (Abstract, “collapsible frame 12”; Fig. 2A).
Regarding claim 6, Breegi teaches the system according to claim 1 as stated above wherein the fluid impermeable barrier includes a transparent polymer (para. 0025).
Regarding claim 7, Breegi teaches the system according to claim 1 as stated above further comprising one or more access ports disposed in the fluid impermeable barrier (para. 0077, “hand ports/sleeves 29”).
Regarding claim 8, Breegi teaches the system according to claim 1 as stated above wherein the enclosure is sized and shaped to fit around at least a portion of an operation table or chair (para. 0068, where the housing base 50 can be configured to insert and enclose a mattress 68; Fig. 9, the disposal enclosure 14 is on a mattress coupled to a table/bed).
Regarding claim 9, Breegi teaches the system according to claim 1 as stated above wherein the enclosure includes an upper portion (Fig. 3, hub A 21 and hub B 22), a lower portion (Fig. 3, base 50), and a reusable connection between the upper portion and the lower portion (Fig. 3, patient access door 36 comprising an air-lock closing system; para. 0065).
Regarding claim 10, Breegi teaches the system according to claim 9 as stated above wherein the reusable connection includes a zipper (para. 0065; Fig. 6, patient access door 36).
Regarding claim 11, Breegi teaches the system according to claim 1 as stated above wherein the treatment source includes one or more of an oxidant source or a UV-light source (paragraphs 0019-0020).
Regarding claim 12, Breegi teaches the system according to claim 1 as stated above wherein the vacuum source is fluidly coupled to the interior region via a collection conduit and the treatment source is fluidly coupled to the collection conduit and configured to treat air passing therethrough (paragraphs 0012, 0019, and 0078, where via the control system module, the ultraviolet emitting and vacuum devices are in communication with each other through various inlet and outlet ports).
Regarding claim 13, Breegi teaches the system according to claim 1 as stated above wherein the treatment source is fluidly coupled to the interior region via an input conduit and the treatment source includes an oxidant generator configured to input oxidants into the interior region (paragraphs 0019-0020, “ozonizer”; paragraphs 0090-0091).
Regarding claim 14, Breegi teaches the system according to claim 1 as stated above wherein the treatment source is fluidly coupled to the interior region via an input conduit and the treatment source includes an oxidant generator configured to input oxidants into the interior region (paragraphs 0019-0020, “ozonizer”; paragraphs 0090-0091).
Regarding claim 15, Breegi teaches the system according to claim 1 as stated above further comprising a controller operably coupled to the vacuum source and the treatment source, the controller being configured to control application of vacuum in the interior region and application of treatment from the treatment source (paragraphs 0080-0091, “control system module”; para. 00104, “the control system module can comprise a vacuum device”).
Regarding claim 16, Breegi teaches a method of treating expired air (Abstract; paragraphs 00103-00106), the method comprising:
covering at least the face of a patient with an enclosure configured to retain air expired from the patient in an interior region thereof (para. 0072; Figs. 7 and 9);
placing the interior region under negative pressure (para. 00104);
receiving expired air from the patient within the interior region (para 00104, “air circulation systems”); and
treating the expired air to neutralize one or more contaminants therein (para. 0091 where air is introduced from an ozone generator into the contained space).
Regarding claim 25, Breegi teaches the method according to claim 16 as stated above wherein treating the expired air to neutralize one or more contaminants therein includes inputting ozone into the interior region (para. 0020; para. 0090, “sterilizer for example, an ozonizer”).
Regarding claim 26, Breegi teaches the method according to claim 16 as stated above wherein treating the expire air to neutralize one or more contaminants therein includes irradiating the interior region with ultraviolet radiation at a wavelength selected to neutralize one or more of bacteria, viruses, or fungi (paragraphs 0020, 0076, 0090, “UV germicidal irradiation”).
Regarding claim 33, Breegi teaches a system for treating an environment (para. 004, “a system for controlling the microenvironment of a contained space”), the system comprising:
an enclosure configured to fit over at least a head of a patient (Abstract, infant incubator apparatus 10; Figs 4A and 5; para. 0020) and at least a portion of an operation table or chair (para. 0068, where the housing base 50 can be configured to insert and enclose a mattress 68; Fig. 9, the disposal enclosure 14 is on a mattress coupled to a table/bed), the enclosure including:
a framework sized and shaped to fit over at least the head of the patient (Fig. 2A, collapsible frame 12 including articulated arms (23, 25) and support arms 24; paragraphs 0053 and 0057); and
a fluid impermeable barrier disposed on the framework (para. 0058, disposable housing/canopy 14; paragraphs. 0018 and 0025), the fluid impermeable barrier including an outer surface and an inner surface defining an interior region facing the patient (paragraphs 0022, 0059, and 0074; para. 0061, “contained space 16”); and
one or more access ports disposed on the fluid impermeable barrier (Fig. 6, hand ports/sleeves 29), the one or more access ports being configured to resealably allow access to the interior region from outside of the fluid impermeable barrier (para. 0077);
a vacuum source fluidly connected to the interior region via the fluid impermeable barrier (para. 00104, “vacuum device”); and
a treatment source (paragraphs 0019, 0026 0076) fluidly connected to one or more of the vacuum source or the fluid impermeable barrier (para. 0026, “UV light source”), the treatment source being configured to treat air from the interior region (para. 0014, “UV light source, e.g., for use in…sterilization of the air”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breegi, further in view of Glazman (US 2007/0113842).
Regarding to claim 27, Breegi teaches the method according to claim 26 as stated above. Breegi fails to teach wherein the wavelength is between 100 nm and 320 nm.
Glazman teaches an analogous enclosure with circulating treated air to protect against pathogens wherein the wavelength (of ultraviolet radiation) is between 100 nm and 320 nm (para. 0030).
Therefore, it would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention, to have combined the method of Breegi with the specified ultraviolet radiation wavelength of Glazman. Regulating the wavelength of the ultraviolet radiation provides the enclosure with a steady flux of radiation, as such, the radiation is evenly and safety applied to the circulated air within the interior space (Glazman, paragraphs 0023-0039).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Maloney (US 8,298,130) teaches a contamination detainment unit with at least one access port but fails to disclose a vacuum source. Conn (US 6,367,476) discloses a medical canopy, disposed a on support stand, that provides a sterile environment for an occupant. Gauger et al. (US 6,321,764) teaches a collapsible isolation apparatus comprising suction lines, a transparent cover, and a flexible base. Cooper et al. (US 11,752,050) teaches a portable and inflatable patient isolation chamber and stretcher system that contains a plurality of access ports. Bui (US 10,905,839) teaches a domed enclosure designed to support bimanual airway intervention coupled to a vacuum device and ultraviolet lights. Petersen et al. (WO 2018/232371) teaches a lower body negative pressure device intended to create a sealed environment. Cubillos et al. (2020) teaches a portable negative air flow isolation chamber that provides a physical barrier during aerosol-generating procedures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROGAN R LANDEEN whose telephone number is (571)272-1390. The examiner can normally be reached Monday - Friday 8:00am - 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791