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
The Amendment filed 27 Jan 2026 has been entered. Claims 1, 7, 10, 12, 14, 18-19, 21-22, 31, 33-40 and 74-76 are pending in the application with claims 2, 4 and 45 canceled. Claims 1, 14 and 35-36 are currently amended with claims 75-76 newly added. Applicant’s amendment to the Claims have overcome each and every 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 27 Aug 2025.
The prior 35 U.S.C. 102(a)(1) rejections are withdrawn as requested based upon the amendment to the claims (Pg. 6-7).
Response to Arguments
Applicant's arguments filed 27 Jan 2026 have been fully considered but they are not fully persuasive.
Examiner concurs with applicant’s assertion that amended claim 1 is not anticipated by either Rummery et al. (U.S. Pub. 2017/0252529) (Pg. 6-7) or Sims et al. (U.S. Pub. 2013/0152931).
Regarding amended claim 1, and its relation to former claim 4, applicant argues that the drawings of Rummery are not enough for an obviousness rejection and cites to MPEP 2125 (Pg. 7-8).
It is respectfully noted that a primary concern in MPEP 2125 is whether exact dimensions are being attempted to be cited from the reference. In amended claim 1 the “dimension” being cited as obvious from Rummery is in fact a relatively broad range of possible comparative values between span length and depth. Claim 1 is not concerned with exact measures, but instead only with relative proportions. What MPEP 2125(II) does note is a holding of the courts that the desirability of certain measures can be obviously arrived at in light of a reference’s overall disclosure even when its drawings are lacking exact measures.
When comparing Fig. 2-3 to Fig. 2-4 in Rummery one of ordinary skill in the art would have obviously concluded the placement of outer laminate 234-1 on textile 220-1 above support structure 240-1 would create an external corrugated depth for the conduit 200-1 which is meaningfully less than an external corrugated depth of the conduit 200 in Fig. 2-3. Further, recognizing that element 240-1 is termed a “support structure” one of ordinary skill in the art would have expected support structure 240-1 to have a meaningful height in order to suitably perform its function of providing support. Thus, the illustration of Fig. 2-4 of Rummery, when taken into consideration with the overall disclosure of Rummery, suitably suggests a span length of at least double a depth along that span length (see annotated Fig. 2-4 below).
PNG
media_image1.png
522
741
media_image1.png
Greyscale
Annotated Rummery Fig. 2-4
If applicant wishes to continue in this argument in regard to claim 1 they are requested to provide a detailed explanation about why Fig. 2-4 of Rummery would be expected to instead result in a ratio outside of the claimed range.
In the interests of compact prosecution note is made of several prior art which provide particular dimensions of respiratory corrugated conduits which would be suitable evidence to corroborate the obviousness findings against claims 1 and 74: Row et al. (U.S. Pub. 2010/0116272; rib with height of 1-2 mm, pitch of 4.5 to 5.5 mm (¶0059), usable with either 15 mm or 22 mm tubing (¶0063)), Kaye et al. (U.S. Pub. 2014/0053939; rib with height of 1.70 mm (¶0073), ribs with pitch of 3.0 to 9.0 mm (¶0075)) and Maurer (U.S. Pub. 2018/0296787; rib with height of 0.5 to 2.5 mm and pitch of 3 to 7 mm, overall tube internal diameter of 15 mm (¶0142)).
Applicant notes that the obviousness rejection of claim 74 is improper for the same general reasons as argued in regard to claim 1 (Pg. 8). Again, the range recited in claim 74 is particularly broad and Rummery is still found suitable for rendering the claim prima facie obvious for similar reasons to those discussed above in regard to claim 1.
If applicant wishes to continue in this argument in regard to claim 74 they are requested to provide a detailed explanation about why Figs. 2-3 and 2-5 of Rummery would be expected to instead result in a relative value for the depth outside of the claimed range.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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, 7, 10, 12, 14, 18-19, 21-22, 34-37, 39 and 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rummery et al. (U.S. Pub. 2017/0252529).
Regarding claim 1, Rummery discloses a respiratory conduit (Fig. 2-4; ¶¶0055-0075) comprising: a hollow tube (Fig. 2-4 #220-1, 230-1) having an inlet (Fig. 2-1 one #202), an outlet (Fig. 2-1 other #202), and a longitudinal axis (Fig. 2-1 along #200), and the hollow tube defining a fluid flow path (internal to Figs. 2-4), wherein, along at least a length of the hollow tube, an outer surface of the hollow tube comprises alternate ridges and grooves (Fig. 2-4 along exterior of #220-1); and a sheath (Fig. 2-4 #234-1) surrounding at least a portion of the length of the hollow tube, the sheath comprising alternate attachment portions contacting the ridges of the hollow tube (Fig. 2-4), the sheath further comprising bridging portions that extend across the grooves of the hollow tube (Fig. 2-4 #234-1 extends longitudinally), wherein each of the bridging portions has a span length being a distance in a longitudinal direction between adjacent attachment portions, wherein each of the bridging portions comprises a depth being a maximum distance in a radial direction between a point on the bridging portion and a point on one of the adjoining attachment portions (Fig. 2-4 #234-1 extends downward radially over troughs); wherein the depth of each of the bridging portions is greater than zero (Fig. 2-4 #234-1 extends downward radially over troughs).
Rummery fails to explicitly disclose a ratio of the span length to the depth is in a range from 2:0.1 and 2:1 inclusive of the endpoints.
However, in Fig. 2-4 of Rummery the depth is limited in each groove as outer laminate 234-1 lays over top of support structure 240-1 (instead of underneath the support structure in Figs. 2-3 and 2-5). While it is recognized that Fig. 2-4 cannot be assumed to be drawn to scale, one of ordinary skill in the art viewing Fig. 2-4 would have obviously expected for the defined span length dimension between adjacent ridges to be between two and twenty times the depth defined in Fig. 2-4 based upon the limited depth of the outer laminate 234-1 in that embodiment relative to Figs. 2-3 and 2-5 caused by the placement of the outer laminate 234-1 over top of the support structure 240-1. Further, recognizing that element 240-1 is termed a “support structure” one of ordinary skill in the art would have expected support structure 240-1 to have a meaningful height in order to suitably perform its function of providing support. Thus, the illustration of Fig. 2-4 of Rummery, when taken into consideration with the overall disclosure of Rummery, suitably suggests a span length of at least double a depth along that span length.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Rummery a ratio of the span length to the depth is in a range from 2:0.1 and 2:1 inclusive of the endpoints based upon the obviously suggested relative dimensions in Fig. 2-4, when compared to Figs. 2-3 and 2-5, that the defined span length dimension between adjacent ridges will obviously be between two and twenty times the depth as caused by the placement of the outer laminate 234-1 over top of the support structure 240-1 in the embodiment of Fig. 2-4.
Regarding claim 7, Rummery discloses the respiratory conduit, in a rest state, is not extended, flexed or compressed (e.g. ¶¶0062-0065).
Regarding claim 10, Rummery fails to explicitly disclose the sheath has a yield strain of at least 45% in the longitudinal direction.
However, Rummery discloses an intent for the textile 220 to be able to be able to readily stretch in a lengthwise direction (¶¶0061, 0075). Rummery thus suggests as obvious an intent to provide a material which easily stretches in the longitudinal direction, with such a material thus obviously being designed with a significant yield strain in the longitudinal direction. It is noted the claim has not recited any particular material as providing the claimed yield strain.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Rummery the sheath has a yield strain of at least 45% in the longitudinal direction in order to provide the benefit of specifying a material property, i.e. yield strain, suitable to perform the desire to Rummery to provide a material which easily stretches in the longitudinal direction.
Regarding claim 12, Rummery discloses each of the bridging portions extends across the respective groove in a spaced apart relationship such that an outer surface of the respective groove and an inner surface of the respective bridging portion define a cavity (Fig. 2-4 cavity between #234-1 and #220-1).
Regarding claim 14, Rummery discloses a point on each of the bridging portions where the depth is maximum is a middle point between adjacent ridges (Fig. 2-4 #234-1).
Regarding claim 18, Rummery discloses the bridging portions are substantially arcuate (Fig. 2-4 #234-1).
Regarding claim 19, Rummery discloses a minimum diameter of each of the bridging portions is less than a minimum diameter of the attachment portions, such that the bridging portions extend inward from the attachment portions (Fig. 2-4 #234-1).
Regarding claim 21, Rummery discloses the sheath is tightly fitted to the hollow tube such that the attachment portions contact an outer surface of at least a portion of the ridges and at least partially adopt a profile of the ridges (Fig. 2-4 #234-1).
Regarding claim 22, Rummery discloses the attachment portions are attached or bonded to the hollow tube at the ridges (¶0065 – textile and inner laminate attached; ¶0073 – textile and outer laminate attached).
Regarding claim 34, Rummery is silent as to whether the sheath is transparent.
However, Rummery teaches the outer laminate layer 234-1 can be made from such materials as polyurethane, silicone, and nylon (¶0073). One of ordinary skill in the art would have obviously recognized that those materials are commonly made to be transparent when used in both medical and tubing applications.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Rummery the sheath is transparent based upon an obvious design choice when selecting amongst the different possible materials taught by Rummery for outer laminate layer 234-1 to have made the material transparent as is known to be commonly done in both medical and tubing applications.
Regarding claim 35, Rummery further suggests as obvious the ratio of the span length to the depth is selected to minimize outwards buckling of the sheath (¶0073 – e.g. structural integrity). The claimed limitations amount to an intended use and design consideration and are given limited patentable weight (see MPEP 2114).
Regarding claim 36, Rummery further suggests as obvious the ratio of the span length to the depth is selected to enable low level disinfection of an exterior surface of the sheath (¶0073 – impermeable materials are capable of being disinfected). The claimed limitations amount to an intended use and design consideration and are given limited patentable weight (see MPEP 2114).
Regarding claim 37, Rummery discloses the hollow tube is corrugated (Fig. 2-4 #220-1, 230-1).
Regarding claim 39, Rummery discloses the ridges and the grooves are helical (¶¶0060, 0062).
Regarding claim 74, Rummery discloses a respiratory conduit (either of Figs. 2-3 & 2-5; ¶¶0055-0075) comprising: a hollow tube (Fig. 2-3 #230 or Fig. 2-5 #220-2, 230-2) having an inlet (Fig. 2-1 one #202), an outlet (Fig. 2-1 other #202), and a longitudinal axis (Fig. 2-1 along #200), the hollow tube defining a fluid flow path (internal to either of Figs. 2-3 & 2-5), wherein, along at least a length of the hollow tube, an outer surface of the hollow tube comprises alternate ridges and grooves (Fig. 2-3 along exterior of #230 or Fig. 2-5 along exterior of #220-2), the ridges having an outer diameter; a sheath (Fig. 2-3 #220 or Fig. 2-5 #234-2) surrounding at least a portion of the length of the hollow tube, the sheath comprising alternate attachment portions (at peaks) and bridging portions (between peaks), wherein the attachment portions contact the ridges of the hollow tube (either of Figs. 2-3 & 2-5), wherein the bridging portions extend across the grooves of the hollow tube (either of Figs. 2-3 & 2-5), wherein each of the bridging portions has a depth being a maximum distance in a radial direction between a point on the bridging portion and a point on an adjoining attachment portion (from peak to trough). It is noted that claim does not preclude the bridging portion from contacting the hollow tube.
Rummery is silent as to whether the depth of each of the bridging portions is between about 2% and about 15% of the outer diameter of the ridges.
However, the depth in Rummery in Fig. 2-3 is the vertical difference between a peak of inner laminate 230 and a trough of textile 220 (and in Fig. 2-5 is the vertical difference between a peak of textile 220-2 and a trough of outer laminate 234-2). That dimension generally corresponds to the corrugation depth seen in Figs. 2-1 and 2-2. One of ordinary skill in the art of corrugated respiratory conduits would have considered it prima facie obvious for the corrugation depth seen in Figs. 2-1 and 2-2, and thus Figs. 2-3 and 2-5, to be between about 2% and about 15% of the outer diameter of the layer immediately under the uppermost layer of the air delivery conduit 200 as the corrugations have a meaningful depth (e.g. at least 2%) but not a significantly high depth which would impede operation (e.g. not more than 15%).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Rummery the depth of each of the bridging portions is between about 2% and about 15% of the outer diameter of the ridges based upon how one of ordinary skill in the art would expected to have arrived at a corrugation depth within that range based upon the overall disclosure in relation to Figs. 2-1 to 2-3 & 2-5 of Rummery and in recognition of the common depth dimensions for corrugations on respiratory conduits.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rummery et al. (U.S. Pub. 2017/0252529) in view of Huddart et al. (U.S. Patent 5640951).
Regarding claim 31, Rummery is silent as to whether the sheath has a substantially uniform wall thickness in a rest state of between about 100 microns and about 250 microns.
Huddart teaches a respiratory conduit (Fig. 2) including a sheath (Fig. 2 #30; Col. 4, Ln. 1-17), the sheath having a wall thickness of between about 100 microns and about 150 microns (Col. 4, Ln. 13-17). Huddart teaches this thickness as effective for an outer insulating sheath (Col. 4, Ln. 1-17 & Col. 8, Ln. 7-13).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Rummery the sheath, as the outer laminate of Rummery, has a substantially uniform wall thickness in a rest state of between about 100 microns and about 250 microns in order to provide the benefit of selecting a sheath thickness recognized in the art as effective for an outer insulating sheath in view of Huddart.
Claim(s) 33, 38 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rummery et al. (U.S. Pub. 2017/0252529) in view of Huddart et al. (U.S. Patent 5640951).
Regarding claim 33, Rummery fails to disclose the sheath and/or the hollow tube comprises a low-density polyethylene (LDPE).
Sims teaches a breathing tube (e.g. Fig. 1) and teaches LDPE as one particularly preferred material for manufacturing of medical tubing (¶0127).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Rummery the sheath and/or the hollow tube comprises a low-density polyethylene (LDPE) in order to provide the benefit of selecting LDPE as a particular material known to be preferred for manufacturing of medical tubing in view of Sims.
Regarding claim 38, Rummery fails to explicitly disclose the ridges and the grooves comprise a series of annular ridges and grooves.
Sims teaches a breathing tube (e.g. Fig. 1) and teaches ridges and grooves comprising a series of annular ridges and grooves (¶0125). Sims teaches a configuration which includes annular corrugations which transition to a helical corrugation and teaches a benefit of retaining the qualities of helical corrugations while improving the seal with the annular corrugations (¶0125).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Rummery the ridges and the grooves comprise a series of annular ridges and grooves in order to provide the benefit of combing the advantages of both annular corrugations (e.g. better sealing) and helical corrugations (e.g. better bending) into the conduit in view of Sims.
Regarding claim 40, Rummery teaches the invention as modified above and Sims as incorporated therein further teaches the hollow tube is formed from one or more spirally wound components (¶0125).
Allowable Subject Matter
Claim(s) 75-76 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 75, Rummery fails to teach or suggest the cavity is empty. Rather, Fig. 2-4 of Rummery clearly includes support structure 240-1 within the cavity. One of ordinary skill in the art would not have sought to remove support structure 240-1 from that embodiment of Rummery. And even if support structure 240-1 were to be removed the result would be akin to Figs. 2-3 and 2-5 where the depth would appear to be too great to meet the requirements of claim 1.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 76, Rummery fails to teach or suggest the hollow tube further comprises one or more heating wires. Rummery has no consideration of heating its conduit. And even if it were attempted to add a heating wire to Rummery it is not clear how that would impact the conduit of Rummery and whether the particular embodiment of Fig. 2-4 would be suitable to operate with a heating wire.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
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 JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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, Kendra Carter can be reached at (571) 272-9034. 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.
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785