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 9/3/2025. As directed by the amendment, claim 1 has been amended. Claims 1-6, 8-10, 13, 16, 17, 19, 20, 22, 25, 26, 28, 30 and 31 are pending in the instant application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, namely, Tang teaches the newly added limitations regarding, as best understood, a molding material disposed over/around all of a heater element except the electrical contacts thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 8-10, 13, 16, 17, 19, 20, 22, 25, 26, 28, 30 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 (and thus its dependent claims), it is unclear in claim 1 whether “disposed over the entire PCB” (emphasis added) means only (an entirety of) an upper side/surface of the PCB is covered by the molding material, because “over” could be considered directional, OR whether the claim requires all of the sides/surfaces of the PCB to be overlaid with the molding material. As best understood, from e.g. para [0296] of the instant specification, “full coverage” equates to “encapsulation,” such that the latter interpretation will be applied for purposes of examination.
Further regarding claim 1 (and thus its dependent claims), the claim requires the PCB to “have…a plurality of electrical contacts” and for “the entire PCB” (which thus includes the plurality of electrical contacts) to have a molding material disposed over it, i.e. the molding material is disposed over the electrical contacts per the understanding above, but then the claim recites “wherein the plurality of electrical contacts are not encapsulated by the molding material,” wherein it is unclear how the entire PCB, including the electrical contacts, can be covered/encapsulated by the molding material, yet the electrical contacts, as part of the PCB, are not encapsulated by the molding material. As best understood, for purposes of examination and as supported by e.g. original claim 25, claim 1 will be considered to read “a molding material encapsulating the entire PCB, except that
Claim 25 recites the limitation "the at least one electrical contact" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 22 and 25 are 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, as best understood, is now narrower than claim 22, and claim 1 has been amended to recite limitations narrower than that of claim 25, such that claims 22 and 25 are no longer 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 8-10, 13, 16, 17, 19, 20, 22, 25, 26, 28, 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (WO 2016/036260 A1; hereinafter “Burgess”) in view of Tang et al. (WO 2012/171072 A1; hereinafter “Tang”), Takahashi (JP 2013-206582 A1; hereinafter “Takahashi,” wherein the citations below refer to the translation provided with the Office Action mailed on 4/15/2024), Shibue (JP 2004-301766 A; hereinafter “Shibue,” where the citations below refer to the translation provided with the Office Action mailed 10/18/2024), and Pape (Chapter 29 Adhesion Promoters: Silane Coupling Agents. Applied Plastics Engineering Handbook, 2011, p 503-517; hereinafter “Pape”).
Regarding claims 1, 22 and 25, Burgess discloses/suggests a respiratory humidification apparatus (Figs. 1A and 3E) comprising:
a gas flow passage (gasses channel 102/gasses flow path 338) having an internal area (Fig. 1A/3B), the gas flow passage having an inlet (to the left in Fig. 1A/gasses inlet 331) configured to receive gases into the internal area of the gas flow passage and an outlet (gasses outlet 127/ configured to allow gases to pass out of the internal area of the gas flow passage (Fig. 1A/3B; paras [0089]/[0184]);
a heater (heating element 114/314/400) (Figs. 4A-C; heating element 400 maybe be used as the heating device 314…[as] the heating device 114, para [0189]) having a heating surface (facing up in Fig. 1A; facing up and/or down in Fig. 3D), the heater disposed between the inlet and the outlet of the gas flow passage and configured to heat a humidification liquid received by the heating surface to humidify gases flowing through the gas flow passage (Fig. 1A/3B; paras [0089]/[0184]), the heater comprising:
a printed circuit board (PCB) (printed circuit board 401) with heating tracks (resistive tracks 411) that are in thermal communication with the internal area of the gas flow passage (Fig. 1A/3B/4B; paras [0189-190] in view of paras [0089]/[0184]), the PCB having a contact region comprising a plurality of electrical contacts (electrical contacts 452 and/or 457) (Fig. 4B; paras [0191] and [0195]);
a molding material (over-molded wicking surface) disposed over at least a portion of the PCB (wicking surface…provided by an over-molding on the printed circuit board 401, para [0190], see also paras [0010], [0018], [0020], [0027], [0036-38], [0097] and [0174]); and
a metering arrangement (metering arrangement 110) comprising a humidification inlet (inlet 116/outlets of channels 318) (Fig. 1A/Fig. 3C) capable of delivering the humidification liquid (fluid 104) (para [0090]) from a reservoir (reservoir 106) to the heating surface of the heater (heating element 114/314) (Figs. 1A/3C-D; paras [0090-100] and [0186]; wherein it would have been inferred and/or obvious to an artisan before the effective filing date of the claimed invention for the embodiment of Figs. 3A-F to include the same metering arrangement as described for the other embodiments, in order to predictably meter water to the heater the embodiment of Figs. 3A-F for controlled humidification), the metering arrangement configured to meter the humidification liquid to the heating surface of the heater (Figs. 1A/3C-D; paras [0090] and [0186]); and
the respiratory humidification apparatus configured to provide humidified gases to a patient (abstract).
Burgess is silent regarding, as best understood, the molding material disposed over/encapsulating the entire PCB, [except that] the plurality of electrical contacts are not encapsulated by the molding material. However, Tang teaches that it was known in the respiratory humidifier art before the effective filing date of the claimed invention for a molding material (overmolded outer protective coatings 1192 and 1193) to be disposed over/encapsulate the entire heater (comprising support substrate 1190 and heating element 1174), [except that] the plurality of electrical contacts (contact portion/conductors 1295) are not encapsulated by the molding material (Figs. 9-1 and 9-2; paras [0099] and [00113]) [and see also Shibue, cited below, which further demonstrates the known/obvious practice before the effective fling date of the claimed invention of covering/encapsulating heating tracks (with film 14) while leaving the electrical contacts (terminals 15,16) thereof uncovered, see Shibue Fig. 1]. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modified Burgess to include, as best understood, the molding material disposed over/encapsulating the entire PCB, except that the plurality of electrical contacts are not encapsulated by the molding material as taught by Tang [and further evidenced by Shibue], in order to provide the predictable results of the majority of the PCB/heater being encapsulated to keep water/moisture from directly contacting the elements thereof to prevent corrosion, fouling and/or short circuiting thereof, while still allowing direct electrical contact to be made by associated terminals for supplying power to the heating tracks and/or power and/or data transfer to the sensors and/or associated heating tube via the electrical contacts (Burgess paras [0190-191] and [0195] and Tang paras [0099] and [00113]).
Modified Burgess is silent regarding a bonding layer comprising a silicon-containing linker, the bonding layer coupling at least a portion of the molding material to the PCB, wherein a surface of a portion of the PCB coupled to the molding material has been plasma treated. However, Takahashi demonstrates that it was well known in the art of over-molded thermal electronic elements (e.g. PTC thermistor 7/conductive wire 5 in Fig. 2) to include a bonding layer comprising a silicon (silicon-based adhesive material, fifth full para on page 3), the bonding layer coupling at least a portion of the molding material (overmold structure 9) to the underlying structure (PTC thermistor 7/conductive wire 5), wherein a surface of a portion of the underlying structure coupled to the molding material has been plasma treated (conductive wire 5 may be subjected to…plasma treatment, fourth full para on page 4), Shibue demonstrates that it was well known in the art of over-molded electronic elements (e.g. electrodes 12, 13 on substrate 11 in Fig. 1) to include a bonding layer (adhesive layer) comprising a silicon-containing linker (silane coupling agent) (an adhesive layer between the insulating substrate and the electrodes 12 and 13 and the moisture-sensitive film 14 for improving the adhesiveness there of…an acrylic silane coupling agent, para [0105]), the bonding layer coupling at least a portion of the overlying material (film 14) to the underlying substrate (insulating substrate 11) (paras [0105] and [0108]), wherein a surface of a portion of the underlying substrate coupled to the molding material has been plasma treated (insulating substrate 11…is prepared…modifying the surface state of the insulating substrate 11 and improving the adhesion to the moisture-sensitive film 14…a plasma treatment…an adhesive layer…formed on the surface of the insulating substrate 11, para [0108]), and Pape demonstrates that selecting an adhesion promoter/silicon coupling agent such that the bonding laver comprises a silicon-containing linker formed through a reaction between one or more of an epoxy ring, amine, succinic anhydride, methoxyl or ethoxyl moiety and one or more of a carboxyl, amine, epoxy ring, succinic anhydride or reactive silanol moiety (sections 29.2.1-2, 29.3.2-3, 29.5 and Table 29.1/7) would have been obvious to an artisan before the effective filing date of the claimed invention through routine experimentation in order to arrive at a suitable bonding promoter depending on the particular thermoplastic material selected for the bonding layer (Burgess para [0190]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Burgess to include a bonding layer comprising a silicon-containing linker, the bonding layer coupling at least a portion of the molding material to the PCB, wherein a surface of a portion of the PCB coupled to the molding material has been plasma treated and wherein the bonding laver comprises a silicon-containing linker formed through a reaction between one or more of an epoxy ring, amine, succinic anhydride, methoxyl or ethoxyl moiety and one or more of a carboxyl, amine, epoxy ring, succinic anhydride or reactive silanol moiety as taught by Takahashi, Shibue and Pape, in order to enhance/ reinforce/ensure connectivity between the PCB and the wicking layer of Burgess to predictably prevent/avoid delamination thereof and potential leakage therebetween (Takahashi, fourth full para on page 1; Pape beginning of section 29.4) and/or to predictably ensure that thermal connection between the PCB heating element and the wicking layer is maintained throughout use, using well-known, electronic-compatible bonding materials with standard silicon coupling agent bonding moieties as adhesion promoters that are particularly suited to hot, humid conditions [i.e. the conditions expected in a humidifier] (Pape section 29.4: “[s]ilane coupling agents…prevent debonding at the interface, even in hot, humid environments,” see also section 29.1 and the end of section 29.3.1) and established means for pretreating surfaces for enhanced connection to such adhesive material (see also Pape section 29.1, which reinforces the well-known use of plasma treatment to enhance bonding between two surfaces).
Regarding claim 2, Burgess in view of Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the PCB spans a portion of the gas flow passage from the internal area to an external area that is external to the gas flow passage (Burgess Fig. 4B in view of Fig. 3D, where the contact region 451 comprising contacts 452 is external to the gas flow passage, i.e. where connector 351 is located), a portion of the PCB exposed in the external area (contact region 451 is exposed to connector 351) (para [0195]) and a portion of the PCB being in thermal communication with the internal area of the gas flow passage (the majority portion of the PCB that is positioned within the flow passage, see Burgess Fig. 3D).
Regarding claim 3, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the PCB comprises one or more electrical components (comprising sensors and/or tracks 411, see Burgess paras [0025], [0122-124], [0190-191], [0194-195]) configured to receive, transmit, and/or process information about conditions of the respiratory humidification apparatus and/or the gas flow passage (Burgess paras [0025], [0122-124], [0191], [0194]).
Regarding claim 4, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the PCB comprises one or more temperature sensors (thermistors 421) in thermal communication with the internal area of the gas flow passage (Burgess Fig. 4A in view of Figs. 1A/3D; para [0194]).
Regarding claim 5, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the PCB comprises two or more temperature sensors (thermistors 421) and wherein at least one of the two or more temperature sensors is configured to measure a temperature of the heating surface (Burgess Fig. 4A; para [0194]).
Regarding claim 6, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the PCB comprises a sensor (e.g. thermistors 421) configured to detect whether the heating surface is wetted by the humidification liquid in at least one region (Fig. 4A; Burgess para [0194] in view of paras [0031], [0035], [0122-123]).
Regarding claim 8, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further suggests/teaches wherein the PCB comprises one or more sensor, the one or more sensor comprising a pressure sensor, a flow sensor, and/or a humidity sensor, wherein the one or more sensor is configured to detect a parameter of gases in the gas flow passage (pressure sensor may be positioned at…the heater surface, Burgess para [0047]; the heating surface may have a flow sensor, Burgess para [0025]; which suggests/teaches said sensors being comprised by the PCB that forms the heating surface, in order to provide the sensors on a component of the heating surface in order to capture the most accurate surface conditions).
Regarding claim 9, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the PCB comprises a fluid level sensor and/or a liquid sensor (e.g. thermistors 421) (Burgess Fig. 4A; para [0194] in view of paras [0031], [0035], [0122-123]).
Regarding claim 10, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the heating tracks of the PCB are in thermal communication with the internal area of the gas flow passage (Burgess Fig. 4B in view of Figs. 1A/3D).
Regarding claim 13, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 3, wherein Burgess further discloses/suggests wherein the molding material (over-molded wicking surface) covers at least one sensor and/or one or more of the one or more electrical components of the PCB and the molding material separating the at least one sensor and/or one or more of the one or more electrical components from direct exposure to the internal area of the gas flow passage (Burgess Figs. 1A/3D in view of Figs. 4A-B; paras [0190-191]; wherein it would have been obvious to an artisan before the effective filing date of the claimed invention that the overmolded wicking material covers/separates the electrical tracks and sensors of the PCB from exposure to the internal area of the gas flow passage, in order to ensure that water is evenly distributed across the entirety of the PCB for maximum heating area and in order to keep water/moisture from directly contacting the electrical tracks and sensors of the PCB to prevent corrosion, fouling and/or short circuiting thereof).
Regarding claim 16, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the respiratory humidification apparatus comprises a humidification liquid pre-heater (the system may also comprise pre-heating the water flow…water pre-heater, Burgess para [0168]).
Regarding claim 17, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the respiratory humidification apparatus comprises a humidification liquid flow controller (water flow controller configured to control a flow rate of water delivered to the heating surface, Burgess paras [0047] and [0090-96]).
Regarding claim 19, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein respiratory humidification apparatus comprises a gas pre-heater (gas pre-heater, Burgess paras [0016] and [0200]).
Regarding claim 20, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein the molding material comprises a thermoplastic material or a thermosetting material (over-molding may be a thermoplastic material, Burgess para [0037]; [wicking surface] substrates such as silicone, Burgess para [0206]).
Regarding claim 26, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein a portion of the molding material comprises micro-channels and/or surface structures (Burgess paras [0015], [0018], [0190-193]).
Regarding claim 28, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses wherein a portion of the molding material is configured to receive the humidification liquid and retain it so that it can be heated by the heating tracks (Burgess paras [0015], [0018], [0030], [0036], [0190-193], [0203-208]; e.g. where liquid is retained in the portions comprising channels).
Regarding claim 30, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein Burgess further discloses/suggests wherein the molding material is hydrophilic or hydrophobic (paras [0030], [0204-206]; over-molding may be a thermoplastic material, Burgess para [0037]; [wicking surface] substrates such as silicone, Burgess para [0206]; where thermoplastics/silicone are traditionally hydrophobic).
Regarding claim 31, Burgess in view of Tang, Takahashi, Shibue and Pape teaches the respiratory humidification apparatus of claim 1, wherein modified Burgess further discloses wherein the bonding layer chemically couples the molding material to the portion of the PCB (see discussion of claim 1 above, where silicone adhesives and silane coupling agents work through chemical reactions).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching coverage of heating elements except for the electrical contacts thereof: previously-cited Bayer (US 2015/0030317; Fig. 6); previously-cited Row (US 2010/0147299 A1; Figs. 6a-6c); Reinstadtler (US 2007/0125376 A1; Fig.3).
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-Th 7:30a-4:30p, F 7:30a-11:30a ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785