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 8/18/2026. As directed by the amendment, claims 1, 2, 7 and 8 have been amended. Claims 1, 2, 4, 5, 7, 8, 10, 12 and 13 are pending in the instant application.
Applicant has amended the claims to address minor informalities; the previous objections to the claims are withdrawn.
Applicant has amended the claims such that claim 2 further limits claim 1; the rejection of the claims under 35 USC 112(d)/fourth paragraph is withdrawn.
Response to Arguments
Applicant's arguments filed 8/18/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues on page 5 of Remarks that “[t]he cited combination does not teach or suggest the claimed device as a whole, and the Office Action does not provide an adequate reason why a person of ordinary skill would have modified Salmon to arrive at this particular combination of structure, arrangement and individual heating.”
The Examiner disagrees. Salmon teaches individual heating means (heating element 513) “in, on or near” (emphasis added) the prismatic absorbent material 534 that spans the gas flow path (Salmon Figs. 5B-C; para [0117]). Both Batista and Milewicz demonstrate that wrapping a heating wire around (individual) cylinders of absorbent material was a well-known arrangement for placing a heating element on an absorbent material to aid in vaporizing a fluid therefrom, see the updated rejection below, and see also previously-cited Duque et al. (US 2018/0177240 A1; Fig. 1), Imamura et al. (US 6,175,687 B1; Figs. 1-2), Koeth (US 2015/0196323 A1; Fig. 2b), Potter et al. (US 2021/0093006 A1; Fig. 3), and Rosser (US 2018/0177236 A1; Fig. 2), which further demonstrate this common configuration. Therefore, the prior art already of record teaches and suggests the claimed device as discussed in the updated rejection below, for the obvious reason of utilizing a known arrangement (absorbent cylinders individually wrapped with heating wire) to predictably provide the heated vaporization functionality disclosed by Salmon.
Regarding claim 1, Applicant argues that “the heating arrangement identified by the Examiner in Salmon is materially different from the newly claimed arrangement… Salmon employs a central heating structure.”
The Examiner respectfully notes that while Salmon Figs. 5B-C depict a central heating structure, Salmon para [0117] explicitly discloses/teaches that the heating means 513 may be “in, on or near” (emphasis added) the prismatic absorbent material 534. As such, Salmon is not limited to the depicted central heating means of Figs. 5B-C. Since heating means on a prismatic absorbent structure were well-known in the art before the effective filing date of the claimed invention to be provided by wrapping a wire around a cylindrical absorbent structure, as taught by previously-applied Batista as well as previously-applied Milewicz (and as demonstrated by the myriad other references above), the Examiner asserts it would have been obvious to an artisan before the effective filing date of the claimed invention to include this well-known configuration in Salmon in order to predictably provide the heated vaporization functionality of Salmon as discussed in the updated rejections below.
Regarding claim 1, Applicant argues on page 5 of Remarks that “Salmon does not disclose the newly added individual-heating limitation.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed above and in the updated rejections below, Salmon discloses/ teaches an absorbent prism that spans a gas flow path with a heating element thereon, and Batista teaches the use of multiple absorbent cylinders that span a gas flow path with a heating wire wrapped around each (and Milewicz also teaches wrapping a wire around an absorbent cylinder), such that the combination of references predictably arrives at the claimed invention as discussed in the updated rejections below.
Regarding claim 1, Applicant argues on page 5 of Remarks that Batista is concerned with “an aerosol-generating system rather than a laparoscopic medical-gas humidifier” and that “[i]ts disclosed heater/wick structures are designed from vaporization…under operating conditions that are materially different from the high-flow medical-gas environment of the present claims,” asserting that “[t]he fact that Batista discloses a heater associated with a capillary body does not, without more, provide a reason to reconfigure Salmon…so that each member of the claimed plurality of n substantially cylindrical humidification means is individually wrapped by a respective heating wire in the claimed angular configuration and gas-flow path.”
The Examiner fails to see what “more” would be required. Salmon discloses discloses/teaches an absorbent prism that spans a gas flow path with a heating element thereon, which is suitable/obvious to be used as a laparoscopic medical-gas humidifier as evidenced/taught by Blackhurst and Harrington, and Batista teaches the use of multiple, angularly-spaced absorbent cylinders that span a gas flow path with a heating wire wrapped around each (and Milewicz also teaches wrapping a wire around an absorbent cylinder). The combination only requires the selection of a known prismatic shape (cylinder), utilizing a common heating arrangement (wrapped wire), and duplication of parts with regards to Salmon, which would not require much “reconfigur[ing]” and which would look exactly like the arrangement of Batista, and which would produce predictable results as discussed above and in the update rejections below, for the obvious purpose of providing sufficient/a desired vaporization capacity.
Regarding claim 1, Applicant argues on pages 5-6 of Remarks that “[t]he amended configuration is not merely the use of a known heater for its conventional purpose…provide[s] localized heat transfer at the gas-contacting structures and permit[s] the humidification system to respond to the claimed high gas-volume flow…cited references do not identify this integrated arrangement as a solution to a problem in Salmon, nor does the Office Action explain why a skilled artisan would have selected and combined the cited features in this particular manner.”
The Examiner fails to see how the amended configuration is not the use of a known heater for its conventional purpose. Absorbent cylinders spanning a gas flow path and individually wrapped with heating wire serve the same purpose in modified Salmon as they do in Batista (and any of the other previously-cited prior art references mentioned above): to heat fluid wicked into the absorbent structures in order to encourage vaporized fluid into the gas flow path. An artisan looking at Batista (and Milewicz) would have readily identified the claimed arrangement as taught by Batista (and Milewicz) as a solution to providing the heated vaporization in Salmon, and the Office Action did (and does) explain why an artisan would have selected and combined these features, as discussed above and in the updated rejection below, namely, to utilize a known arrangement (absorbent cylinders individually wrapped with heating wire) to predictably provide the heated vaporization functionality of Salmon. Since modified Salmon teaches all the claimed limitations as discussed in the updated rejections below, it is configured to perform as asserted by Applicant on pages 5-6 of Remarks.
Regarding claim 1, Applicant argues on page 6 of Remarks that “the operating context of Batista weighs against the proposed modification…different fluid, flow conditions, and intended uses make it insufficient merely to identify isolated structural similarities,” asserting that “[a] reasoned obviousness analysis must explain why the skilled artisan would have transferred Batista’s heating arrangement into Salmon’s laparoscopic gas humidifier, and further, would have done so in the specific individually wrapped, angularly arranged plurality now required by claim 1.”
The Examiner disagrees that the operating context of Batista “weighs against” the proposed combination. The heating-wire-wrapped absorbent elements of Batista (and Milewicz) perform the same functionality as the absorbent material with heating element thereon of Salmon, namely, they all encourage vaporized fluid into a gas flow path. While the scale of Batista may be smaller than Salmon, that of Milewicz is not, and the rejection is not based on a bodily incorporation of the wrapped absorbent elements of Batista and/or Milewicz into Salmon, rather, the rejection is based on a nominal change in shape, utilizing a common heating arrangement, and duplication of parts with regards to Salmon. There is nothing in Salmon, Batista or Milewicz that would preclude the proposed modifications, and Applicant has provided no objective evidence that the combination would be unachievable by an artisan or would not produce the predicted results discussed in the updated rejections below. Therefore, the amended claims remain rejected in view of the prior art.
Regarding claim 1, Applicant argues on page 6 of Remarks that “Blackhurst, Milewicz, and Harrington…do not cure the foregoing deficiency concerning the newly added requirement that each of the n substantially cylindrical humidification means be individually wrapped by a respectively heating wire.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed above and in the updated rejection below, Milewicz does teach wrapping a cylindrical humidification means with a heating wire, such that the combination of references does teach the contested limitation as discussed in the updated rejections below.
Regarding claim 1, Applicant argues on page 6 of Remarks that “[a]lthough the number of references in a combination is not itself determinative, the rejection must still provide an articulated technical reason for selecting and integrating their disparate teachings in the manner claimed…the present rejection does not do so without using Applicant's disclosure as a roadmap.”
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). The Examiner asserts that the present rejection relies solely on the teachings of the prior art and the knowledge of an artisan before the effective filing date of the claimed invention. The modification of Salmon to arrive at the invention of claim 1 only requires a nominal change in shape of the prismatic absorbent material, utilizing common heating and water injection arrangements, known materials, and duplication of parts, all of which are explicitly taught by the prior art and were known in the art before the effective filing date of the claimed invention to serve the purposes for which they are claimed, such that their combination provides the predictable results discussed in the updated rejection below, without any need to rely on the instant disclosure.
No separate arguments are made with regards to the dependent claims.
The rejections of the dependent claims are maintained below.
Claim Objections
Claim 1 is objected to because of the following informalities:
The last line of claim 1 recites “wire (11)”, where it is noted that no other element numbers are present in the claims, such that Applicant may wish to amend claim 1 to read “wire
Appropriate correction is required.
Claim Interpretation
“Humidifying the first absorbent humidification means” in claim 1, lines 4-5, 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: the first absorbent humidification means and cylindrical humidification means in claim 1, because absorbent materials being positioned to direct water from a reservoir into a flow path such that gas flows through/around wetted material 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, 2 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 which can transport liquid by the capillary effect, includes 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]), 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]), 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 (cotton) to provide the predictable result of a suitable absorbent material (i.e. able to wick fluid from the reservoir and provide the fluid to the gas flow path) within the gas passageway of Salmon Fig. 5C, 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]. 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]).
Modified Salmon further teaches wherein each of the n substantially cylindrical humidification means is individually provided with a respective heating element (heating element 513) (Salmon Figs. 5B-C; para 0117]), wherein Salmon further teaches that the heating element can be in the mass 534 as depicted in Salmon Figs. 5B-C or on the mass 534, Salmon see para [0117], and Batista and Milewicz demonstrate that it was well known in the fluid vaporization art before the effective filing date of the claimed invention for a heating element to be provided on a cylindrical absorbent mass by virtue of cylindrical absorbent mass(es) being individually wrapped by a respective heating wire (Batista Figs. 1A and 6A, para [0107-109]; Milewicz Fig. 2, col. 4, lines 16-18). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Salmon to include wherein each of the n substantially cylindrical humidification means is individually wrapped a respective heating wire as taught by Salmon in view of Batista and/or Milewicz, in order to provide the predictable result of a suitably arranged heating element (wrapped wire) to provide the heating function disclosed by Salmon.
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 configured to be 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], in view of Batista Figs. 1A and 6B, paras [0084] and [0107-109], and/or Milewicz Fig. Fig. 2, col. 4, lines 16-18 as discussed above regarding claim 1).
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
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 KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, Tu-Th 8a-2p, F 7:30-11:30a ET.
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, Brandy Lee can be reached at 571-270-7410. 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.
/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
Prosecution Insights