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 the amendment filed 2/9/2026. As directed by the amendment, claims 1 and 2 have been amended, and claims 12 and 13 have been added. As such, claims 1, 2, 4, 5, 7, 8, 10, 12 and 13 are pending in the instant application.
Applicant has amended claim 1 to be supported by the specification as originally filed; the rejection under 35 USC 112(a)/first paragraph is withdrawn.
Applicant has amended the claims to clarify the claimed subject matter; the previous rejections under 35 USC 112(b)/second paragraph are withdrawn.
Claim 2 still does not further limit claim 1; the rejection under 35 USC 112(d)/fourth paragraph is updated below.
Response to Arguments
Applicant's arguments filed 2/9/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 5 of Remarks that “even if [modifying the axial-flow humidifier of Salmon with the plural, parallel-arranged cylindrical wicks of Batista] were proper, the resulting combination would still fail to teach or suggest the specific, relative angular orientation of the humidification means now claimed,” asserting that “Salmon nor Batista, nor any other reference of record, provides and teaching, suggestion, or motivation for arrange a plurality of humidification means at e.g., a specific 90-degree angle relative to one another within a gas flow path, as now set forth in claim 12.”
The Examiner disagrees that the prior art of record does not teach or suggest the contested limitation. Batista para [0130] explicitly teaches: “two…pairs of apertures… rotated by any suitable amount, such as 90 degrees, about the longitudinal axis of the hollow shaft portion relative the longitudinal axis of one or more of the other heater and wick assemblies” (emphasis added). Previously-cited Cox (US 4,064,203; Fig. 2) also teaches two substantially cylindrical humidification means extending across a gas flow path and arranged at 90˚ to one another. Therefore, the prior art of record does indeed teach and suggest a plurality of humidification means at e.g., a specific 90-degree angle relative to one another within a gas flow path, as now set forth in claim 12.
Applicant argues on page 5 of Remarks that “[t]he Examiner’s combination rests on the flawed premise that arranging elements is a simple design choice.” The Examiner disagrees with this characterization of the previous rejection. The previous claim set did not recite any particular spatial arrangement of the substantially cylindrical humidification means, such that no “simple design choice” was previously asserted. Moreover, the motivation to arrive at the newly-claimed, evenly-staggered arrangement would have been obvious to an artisan in light of the teachings of Batista as well as the general knowledge in the gas humidification art before the effective filing date of the claimed invention as discussed in the updated rejection below, because an even staggering of elements would provide the predictable result of maximally exposing more surface areas directly to incoming (non-humidified) gas, which would predictably provide increased and/or more efficient evaporation due to basic physics/fluid dynamics.
Applicant argues on page 5 of Remarks that “the claimed arrangement…is not an arbitrary choice but a specific, engineered configuration disclosed as “optimum” for an n-element system…achieves a particular technical result on the gas flow dynamics, ensuring uniform humidification across the elements,” asserting that an artisan would “have had not only to combine the disparate teachings of Salmon and Batista to create a cross-flow system (which itself lacks motivation), but would also have had to know to arrange the resulting elements at a specific angle…is impermissible hindsight.”
The Examiner disagrees with these arguments for a number of reasons. First, the Examiner disagrees that the teachings of Salmon and Batista are “disparate.” They are both concerned with the evaporation of fluid from prismatic humification means that extend perpendicular to a flow path that is encircled by a fluid reservoir for feeding said humidification means. Second, the Examiner fails to see how a creating “a cross-flow system” lacks motivation. Salmon explicitly discloses a prismatic humification means that extends perpendicular to a flow path, i.e. as best understood, “a cross-flow system,” and Batista teaches a similar arrangement of prismatic humification means, which includes a plurality of specifically-cylindrical humification means. The motivation to combine Salmon and Batista comes from expressly from Batista as well as the general knowledge in the art/basic physics regarding the effects of increased surface area on evaporative output, as discussed in the rejections maintained below. Third, in response to applicant's argument that the claimed arrangement “achieves a particular technical result on the gas flow dynamics, ensuring uniform humidification across the elements,” the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Staggering/offsetting prismatic evaporative elements that extend across a gas flow path was common in the field of fluid evaporation before the effective filing date of the claimed invention, see e.g. previously-cited Cox or previously-cited Lawson (US 4,738,805), as well as Akita et al. (US 2005/0252982 A1; Fig. 7, paras [0111-112]), Wallach et al. (US 2,386,826; Fig. 2, col. lines 56-60), or Savage (US 3,898,922; Fig. 2, col. 2, lines 24-28). Staggering of substantially cylindrical humidification means that extend radially across a gas flow path is explicitly taught by Batista para [0130], with an even staggering (i.e. staggering at an angle of 180/n) being obvious in order to provide the predictable results discussed in the updated rejection of claim 1 below. If this arrangement also “ensur[es] uniform humification across the elements” as asserted by Applicant, then that is a result that flows from the suggestion of the prior art and cannot be the basis for patentability. Fourth, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Evenly spacing staggered humidification means to maximize the surface area directly exposed to drier incoming gas to enhance evaporation would have been obvious to an artisan before the effective filing date of the claimed invention in view of Batista’s teaching thereof that any suitable angle/staggering can be utilized (Batista para [0130]) and in view of the general knowledge in the art/basic physics regarding the effects of surface area on evaporative output, i.e. more exposed surface area = more evaporation [see e.g. previously-cited Lawson col. 4, lines 4-8] and the drier the gas contacting a humidification means, the greater the ability for that gas to uptake humidity. Therefore, the rejections in view of the prior art are maintained/updated below.
Claim Objections
Claims 7 and 8 are objected to because of the following informalities:
Claim 7, line 2 should read “includes”
Claim 8, line 1 should not have the “t” in “to” struck through
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 already recites the plurality of substantially cylindrical humidification means made of an absorbent material including a cotton tamponade, which, as an inherent property of absorbent cotton, is a material which can transport liquid by the capillary effect, such that claim 2 is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
“Humidifying the first absorbent humidification means” in amended claim 1 is understood in light of page 6 the instant specification to mean supplying liquid to the first absorbent humidification means that is subsequently used to humidify gas.
“An angle of α = 180˚:n” in claim 1 is understood in light of the instant specification, see page 6, first full paragraph, to mean the angle equals 180 divided by n.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: cylindrical humidification means in claim 1, because the absorbent material being positioned in the flow path such that gas flows through it is considered sufficient structure to provide the function of humidification.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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) 1, 2, 4, 5, 7, 8, 10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Salmon et al. (US 2017/0007798 A1; hereinafter “Salmon”) in view of Blackhurst et al. (US 2004/0102731 A1; hereinafter “Blackhurst”), Batista (US 2017/0340011 A1), Milewicz (US 6,010,118; hereinafter “Milewicz”) and Harrington (US 2016/017555 A1; hereinafter “Harrington”).
Regarding claims 1 and 12, Salmon discloses a device for gas humidification (gas humidification system 512) (Figs. 5A-D) that is fully capable of being used in laparoscopy as nothing would prevent this intended use, e.g. by fluidly connecting humidifier outlet 518 to a laparoscopic instrument (see e.g. Blackhurst Fig. 1, para [0055], as evidence of this feasibility), for connecting to a gas supply device (via fluidly connecting humidifier inlet 516 to e.g. a flow generator 201, see Salmon Figs. 2A-B), including
a water reservoir (housing 561 provides or contains a reservoir for containing water, para [0117]) in a chamber (Figs. 5B-C) with first absorbent humidification means (mass of absorbent material 547) (Fig. 5C; housing 561 provides or contains a reservoir for containing…the second mass of absorbent material 547, para [0117]),
wherein the water reservoir with the first absorbent humidification means is disposed concentrically around a gas flow path (through conduit 563) through the chamber (Figs. 5B-C; mass of absorbent material 547 may be in the form of a cylindrical sheet…housing 561 may fully circumscribe the conduit 563…an annular space or recess is formed by the housing 561 around conduit 563 for receiving the second mass of absorbent material 547, para [0117]),
wherein the chamber includes a gas inlet (inlet 516) and a gas outlet (outlet 518),
wherein the gas inlet is configured to be connected directly or through an optional tube (tube 229) to the gas supply device (Fig. 5A in view of Figs. 2A-B and para [0116]), and wherein the gas outlet leads to a gas tube (e.g. conduit 222) through which gas can be supplied to a patient (Fig. 5A in view of Figs. 2A-B and para [0116]; with Blackhurst Fig. 1 as evidence that heated delivery conduits such as that of Salmon were known to be/obvious to be connectable to laparoscopic instruments before the effective filing date of the claimed invention, in order to provide the predictable result of supplying heated, humidified gas during a laparoscopy, and see see also Milewicz Fig. 1 and abstract, which teaches a heated tube 12 for heating gas exiting a humidifier 10 for use in laparoscopy),
prismatic humidification means (mass of absorbent material 534) made of a second absorbent material (the first mass of absorbent material 534 and the second mass of absorbent material 547 may be separate masses, para [0117]) that includes a tamponade (Figs. 5B-C; paras [0111] and [0117]; where the material extending into the passageway/material 534 is depicted/described as a rectangular plug/pad/mass of absorbent material with heating element 513 imbedded therein and thus comprehends a tamponade), which are disposed orthogonally to gas flow (Figs. 5B-C), so that the gas flow is configured to be supplied through outer surfaces of the one or more prismatic humidification means (Figs. 5B-C; para [0117]),
wherein the prismatic humidification means made of a second absorbent material has at least one end surface in contact with the water reservoir, and wherein the prismatic body is positioned in the gas flow path (Figs. 5B-C; physical, fluid, and/or other forms of communication between the first mass of absorbent material 534 and the second mass of absorbent material 534…the first mass of absorbent material 534 may have tendrils or roots that protrude into the second mass of absorbent material 547, para [0117]).
Salmon does not explicitly recite the construction material for the humidification system 512, such that Salmon is silent regarding wherein the chamber is specifically a plastic chamber. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Batista demonstrates that it was well known in the fluid vaporization art/to solve the problem of forming a vaporization chamber before the effective filing date of the claimed invention for a vaporization chamber (cartridge 500) with a concentrically disposed reservoir (storage portion 506) and cylindrical absorbent vaporization means (capillary wick 504 and/or capillary material 506) (Figs. 4-6A) to be plastic (para [0096]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the chamber of Salmon to be a plastic chamber as taught by Batista, in order to provide the predictable result of using a robust, cheap and/or easily sourced and/or formed housing material.
Modified Salmon is silent regarding wherein the plastic chamber contains a stub having a septum connected therewith for humidifying the first absorbent humidification means. However, Milewicz demonstrates that it was well known in the medical humidifier art before the effective filing date of the claimed invention for a humidification chamber (comprising humidification chamber 10 with ends 16/17 and fitting 19) (Figs. 1-2) comprising a concentric absorbent humidification means (layer of gauze 23) to contain a stub (side port 20) having a septum (elastomeric seal) (Fig. 2) connected therewith for humidifying the absorbent humidification means (side port 20 has an elastomeric seal through which a hypodermic needle may be inserted to enable extra water to be added if required, col. 3, lines 54-65). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Salmon to include wherein the plastic chamber contains a stub having a septum connected therewith for humidifying the first absorbent humidification means as taught by Milewicz, in order to utilize a well-known access/refill means to provide the predictable result of being able to refill the device during use (i.e. the housing sections of Salmon are connected) with minimal disruption/mess, e.g. via syringe (Milewicz col. 3, lines 61-65).
Salmon further discloses/teaches wherein the first absorbent humidification means include a humidification material selected from the group consisting of a cotton wadding and a sponge (mass of absorbent material…placed in reservoir…may comprise natural or artificial sponge, para [0113]), because it would have been reasonably inferred that the absorbent materials in Salmon Figs. 5A-D are the same absorbent materials as described for the other embodiments, and also because it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, such that it would have been obvious to an artisan before the effective filing date of the claimed invention for the absorbent material 547 in the reservoir of the embodiment of Salmon Fig. 5C to be the same material as that taught for the reservoir of Salmon Fig. 3C, in order to utilize a known material to provide the predictable result of a suitable absorbent material (i.e. able to temporarily uptake/hold fluid) within the reservoir of Salmon Fig. 5C. Note: Bastista also teaches the use of a sponge for temporarily holding vaporizable material (paras [0063] and [0071-72]), and see also Milewicz, col. 2, line 23 and col. 4, line 21, which teaches that cotton wadding was another a material known to artisans before the effective filing date of the claimed invention to be suitable for providing humidification means and thus obvious to use as the absorbent material within the reservoir of Fig. 5C of Salmon in order to predictably serve the absorbent functionality disclosed by Salmon.
Modified Salmon is silent regarding the humidification means made of the second absorbent material comprising a plurality of substantially cylindrical humidification means, such that the gas flow is supplied through outer barrel surfaces thereof and each have at least one cylindrical end surface is in contact with the water reservoir and the other cylindrical end surface or the cylinder barrel is positioned in the gas flow, the plurality of substantially cylindrical humidification means including a number n of substantially cylindrical humidification means, wherein the n substantially cylindrical humidification means are disclosed at an angle of α = 180˚:n with respect to one another, including wherein the n substantially cylindrical humidification means includes two tamponades at 90˚ with respect to one another. However, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B, a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, rearranging parts of an invention involves only routine skill in the art, see MPEP 2144.04.VI.C, and Batista demonstrates that it was well known in the fluid vaporization art/to solve the problem of providing absorbent vaporizing means within a gas flow path before the effective filing date of the claimed invention to include a plurality of substantially cylindrical humidification means (wick assemblies 100) (Figs. 1A-B and 4; para [0084]), such that the gas flow is supplied through outer barrel surfaces thereof and each has at least one cylindrical end surface (the top and/or bottom end surface in Fig. 7B) is in contact with the fluid reservoir (storage portion 506) (para [0136]) and the cylinder barrel (the body of the wick assembly 100) is positioned in the gas flow (Fig. 7B; para [0136]), the plurality of substantially cylindrical humidification means including a number n of substantially cylindrical humidification means (Fig. 6A and para [0130], which teaches n=2: “two…pairs of apertures [where each pair supports a wick assembly/cylindrical humidification means]”), wherein the n substantially cylindrical humidification means are disclosed at an angle of α = 180˚:n with respect to one another, including wherein the n substantially cylindrical humidification means includes two tamponades at 90˚ with respect to one another (the longitudinal axis of one or more of the heater and wick assemblies is rotated by any suitable amount, such as 90 degrees, about the longitudinal axis of the hollow shaft portion relative the longitudinal axis of one or more of the other heater and wick assemblies, para [0130]), where n=2 and 90˚ relative rotation teaches angle of α = 180˚:n, wherein the n substantially cylindrical humidification means includes two tamponades at 90˚ with respect to one another. Therefore, it would have been obvious to an artisan before the filing date of the claimed invention to duplicate the prismatic humidification means of Salmon and for them to be substantially cylindrical such that the gas flow is supplied through outer barrel surfaces thereof and each has at least one cylindrical end surface is in contact with the water reservoir and the cylinder barrel is positioned in the gas flow and staggered from each other as taught by Batista, with the staggering being at an angle of α = 180˚:n with respect to one another (as both obvious to try out of finite staggering options given the radial positioning of the prismatic humidification means of Salmon and Batista and as obvious in order to evenly space radial staggered elements to achieve the predictable results below), including wherein the n substantially cylindrical humidification means includes two tamponades at 90˚ with respect to one another as taught by Batista, in order to provide the predictable results of increased surface area (by providing more than one prismatic humidification means) for increased vaporization/humidification output using a standard prismatic shape (cylinder) with increased surface area per cross-sectional volume (as compared to a rectangular prism) for increased evaporation therefrom, and evenly staggering the substantially cylindrical humidification means, i.e. at an angle of α = 180˚:n, in order to predictably maximize direct/unimpeded exposure of each substantially cylindrical humidification means to non-humified flow of gas through the gas flow path by evenly radially spacing it from the others and minimize the ability of gas to flow past the substantially cylindrical humidification means without flowing around/through a substantially cylindrical humidification means (by virtue of evenly-spaced/staggered spokes) for enhanced efficiency.
Salmon further discloses/teaches that the second absorbent material includes, as best understood, a cotton tamponade (mass…may comprise…cotton felt…may extend at least partially into the reservoir…at least partially into the gas passageway, para [0110]), because it would have been reasonably inferred that the absorbent materials in Salmon Figs. 5A-D are the same absorbent materials as described for the other embodiments, and also because it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, such that it would have been obvious to an artisan before the effective filing date of the claimed invention for the absorbent material 534 that extends partially into reservoir and across the gas passage in Salmon Fig. 5C to be the same as that taught for the similarly arranged absorbent material 334 of Salmon Fig. 3C, in order to utilize a known material to provide the predictable result of a suitable absorbent material (i.e. able to wick and release fluid) within the gas passageway of Salmon Fig. 5C. Note: see also Milewicz, col. 4, line 21, which teaches that cotton was known to artisans before the effective filing date of the claimed invention to be suitable for providing humidification means and thus obvious to use as the absorbent material within the passageway of Fig. 5C of Salmon in order to predictably serve the wicking/evaporative functionality disclosed/taught by Salmon.
Modified Salmon is silent regarding the plurality of substantially cylindrical humidification means including a number of substantially cylindrical humidification means sufficient to allow a gas volume flow of 20-50 l/min. However, Harrington demonstrates that it was well known in the respiratory/medical humidifier art before the effective filing date of the claimed invention to allow a gas volume flow of 20-50 l/min (flow rates ranging from 20 L/min to 50 L/min, para [0456]) in the presence of humification means that extend across the gas passage (e.g. Fig. 9J/15A). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to size the device of modified Salmon such that it is sufficient to allow a gas volume flow of 20-50 l/min as taught by Harrington [while utilizing the multiple cylindrical humidification means taught by modified Salmon above], in order to predictably utilize the device of modified Salmon in standard respiratory and medical humidifier applications, e.g. the delivery of humidified respiratory gas at therapeutic pressures (Harrington para [0456]).
Regarding claim 2, Salmon in view of Blackhurst, Batista, Milewicz and Harrington teaches the device of claim 1, wherein modified Salmon further discloses/teaches wherein the plurality of substantially cylindrical humidification means is made from a material, which can transport liquid by the capillary effect, see the cotton tamponade material discussed above regarding claim 1, where absorbent cotton is inherently/by definition a material which can transport liquid by the capillary effect, and wherein Salmon reinforces the need for wicking/capillary effect (wicking material, Salmon paras [0111] and [0113] in view of paras [0117-118]), such that it would have been reasonably inferred or would have been obvious to an artisan before the filing date of the claimed invention for the absorbent materials in Salmon Figs. 5A-D to be the same wicking materials as described for the other embodiments, in order to predictably provide for the fluid transfer from the mass of absorbent material 547 to the mass of absorbent material 534 described by Salmon paras [0117-118].
Regarding claim 4, Salmon in view of Blackhurst, Batista, Milewicz and Harrington teaches the device of claim 1, wherein modified Salmon further discloses wherein the gas tube is configured to be heated (conduit 222 may comprise a heater 230, Salmon para [0109]) at the gas outlet of the plastic chamber (Salmon Fig. 5A in view of Figs. 2A-B and as evidenced by Blackhurst Fig. 1 as discussed above regarding claim 1, i.e. that the heated tube of Salmon Figs. 2A-B would have been obvious to use in conjunction with the humidifier of Fig. 5A-D (as taught by Salmon para [0116]) for ensuring that the gas remains warm/humidified when delivered for respiratory therapy or laparoscopy, and see also Milewicz Fig. 1 and abstract, which also teaches a heated tube 12 for heating gas exiting a humidifier 10 for use in laparoscopy).
Regarding claim 5, Salmon in view of Blackhurst, Batista, Milewicz and Harrington teaches the device of claim 1, wherein Salmon further teaches temperature sensors (para [0108]) and the humidifier in contact with a relevant sensor (para [0116]), but Salmon does not explicitly recite wherein a temperature probe is in the gas tube. However, Blackhurst demonstrates that it was well known in the art of heated, humidified gas delivery tubes before the effective filing date of the claimed invention to include wherein a temperature probe (temperature sensor 11/sensor 50) is in the gas tube (Fig. 1; para [0061]/Fig. 8; para [0077]). Therefore, it would have been obvious to an artisan before the filing date of the claimed invention for modified Salmon to include wherein a temperature probe is in the gas tube as taught by Blackhurst, in order to provide the predictable result of a feedback means for controlling the humidifier and/or a means for ensuring that the humidified gases are exiting the humidifier/being delivered to the patient at the desired temperature (Blackhurst, paras [0065]/[0077]).
Regarding claim 7, Salmon in view of Blackhurst, Batista, Milewicz and Harrington teaches the device of claim 1, wherein optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Batista further educates modified Salmon to include wherein the plurality of substantially cylindrical humidification means include[s] two to five substantially cylindrical humidification means (Salmon Figs. 5B-C in view of Batista Fig. 6A and para [0130], which teaches 2, 3, 4 or 5 heater/wick assemblies), in order to provide the predictable result of a suitable number of evenly staggered humidification means for efficiently providing a desired degree of humidification.
Regarding claim 8, Salmon in view of Blackhurst, Batista, Milewicz and Harrington teaches the device of claim 7, wherein modified Salmon further teaches wherein the two to five substantially cylindrical humidification means and/or the first humidification means are heated ([a] heating element may be located within, on, around or near the first absorbent material…a heating element may be located within, on, around or near the second absorbent material, Salmon para [0084]; see also heating element 513, Salmon Figs. 5B-C, paras [0117-118]; and Batista Figs. 1A and 4-6B and paras [0084] and [0107]).
Regarding claim 10, Salmon in view of Blackhurst, Batista, Milewicz and Harrington teaches the device of claim 1, wherein modified Salmon further discloses/teaches wherein the gas tube is heated by a heating wire (heater 230) (para [0116] in view of Figs. 2A-B; heater may comprise one or more resistive wires located in, on, or around the…conduit, para [0106]), because it would have been reasonably inferred or would have been obvious to an artisan before the filing date of the claimed invention for the heater in all of the embodiments of Salmon to comprise the same wire material, in order to provide the predictable result of a heated conduit using standard heating means; and see also Milewicz, which teaches a heater wire 7 through tube 12 in Fig. 1.
Regarding claim 13, Salmon in view of Blackhurst, Batista, Milewicz and Harrington teaches the device of claim 1, wherein Batista further educates modified Salmon to include wherein the n substantially cylindrical humidification means includes three tamponades at 60° with respect to one another (Salmon Figs. 5B-C in view of Batista Fig. 6A and para [0130], which teaches 3 heater/wick assemblies), in view of the obviousness of even staggering discussed above regarding claim 1, in order to provide the predictable result of a suitable number of evenly staggered humidification means for efficiently providing a desired degree of humidification.
Conclusion
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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