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 6/16/2026. As directed by the amendment, claims 26-28 and 30-36 have been amended, claim 29 has been cancelled, and claims 37 and 38 have been added. As such, claims 26-28 and 30-38 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Applicant has amended the claims to address minor informalities; the previous objections to the claims are withdrawn.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 claim 26 to clarify the claimed subject matter therein and cancelled claim 29; the previous rejections of the claims under 35 USC 112(b)/second paragraph are withdrawn.
Response to Arguments
Applicant's arguments filed 6/16/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 7 of Remarks that they traverse and do not agree with the objection to the priority.
Applicant does not clearly point to where they believe the prior-filed applications disclose or support the instantly claimed ranges/endpoints for pitch and axial width recited in instant claim 26; as such, the priority determination discussed on page 2 of the Office Action mailed 12/16/2025 stands.
Applicant argues on page 11 of Remarks that “the Office Action has failed to demonstrate why a person of ordinary skill in the art would be motivated to combine the teachings of O’Connor with either Goff or Forrester.”
The Examiner disagrees. Pages 7-8 and 10-11 of the Office Action mailed 12/16/2025 clearly explain the motivations to combine the teachings of Goff and Forrester with the base reference of O’Connor, namely, in order to provide the predictable results of a smoothed inner path for airflow (as taught by Goff para [0035]) while optimizing pitch/width within known ranges to achieve a maximum-extendable-length tube (thus providing the most versatility) where the arc length is still protectively situated within the confines of the adjacent reinforcing coils even when the tube is fully bent, so the inwardly-biased portions are not exposed to rubbing or other engagements that can cause wear and failure (as taught by Forrester para [0061]), and so that the inwardly-biased portions do not obstruct a desired flow of breathing gas through the tube (as taught by Forrester para [0062]). Therefore, sufficient motivation has been provided from the prior art itself; the art rejections are maintained below.
Applicant argues on page 11 of Remarks that “the Office Action improperly relies on Richitelli – a non-analogous prior art – as a secondary reference.”
In response to applicant's argument that Richitelli is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this
case, Richitelli is both in the field of applicant’s endeavor (spirally reinforced tubes for
delivering gases) as well as reasonably pertinent to the particular problem with which
the applicant was concerned (how to construct a spirally reinforced tube for delivering
gases). Therefore, Richitelli is analogous art.
Applicant argues on pages 12-13 of Remarks that “O’Connor emphasizes the importance of tailoring the specific characteristics of the tube with their specific applications… a person of ordinary skill in the art would understand the specific characteristics of a medical tube is tied to the specific procedure and application it is designed for… a person of ordinary skill in the art would not be motivated to combine O’Connor with Goff or Forrester as the structure and design of the medical tubes in Goff and Forrester are specific to [] applications… fundamentally different to that of O’Connor.”
The Examiner thanks Applicant for acknowledging that an artisan would have been familiar with optimizing medical tube characteristics, and maintains that selecting a shape known to be suitable for spirally wound reinforcing members in medical tubes (as taught by Goff) and finding optimal values for the pitch/drape disclosed by O’Connor would have been a matter of routine experimentation within known ranges, particularly under the guidance of Forrester regarding the avoidance of inward extension beyond the spirally wound reinforcing member even in a bent configuration. The Examiner fails to see how the applications of Goff and Forrester are “fundamentally different to that of O’Connor,” seeing as all three references are directed to tubes for suppling respiratory gas, or how O’Connor would be rendered unsuitable for its disclosed application in light of the modifications discussed below, as it would still be a spirally-reinforced tube for delivering respiratory gases. As such, the art rejections are maintained below.
Applicant argues on pages 14-15 of Remarks that Goff “teaches away from [the corrugated hose/approach of] O’Connor” because “these tubes exhibit a poor response to torsion…the hose of Goff has an outer layer “without the ridges of the prior art hoses” and has a structural element that is “free of connection to the sealing element over a majority of the hose,” and that “[t]he entire design of the hose of Goff is intended to address the shortcomings of a corrugated hose.”
The Examiner respectfully notes that Goff is not relied on for a teaching of corrugation or sealing, and the relevant teachings of Goff—i.e. a particular shape and axial width for a spirally wound reinforcing member—are independent of any corrugation or sealing present (or absent) in Goff. Nowhere in Goff is it taught that D-shaped spiral reinforcement is unsuitable for use in corrugated tubing, and Applicant’s arguments regarding a “teaching away” with regards to corrugation or sealing are not germane to the rejection, because they are unrelated to the solution taught by Goff regarding shape selection and sizing of a spirally-wound reinforcing member. Moreover, it is noted that Forrester (Fig. 4) also teaches a D-shape, as does previously-cited Smith (Fig. 8), and sizing is obvious optimization in light of O’Connor and the teachings of Forrester; Goff was applied simply because it included an actual axial width dimension along with its D-shape, thus providing extra evidence to support the finding of obviousness.
Applicant argues on page 15 of Remarks that “combining Goff with O’Connor would render O’Connor unsatisfactory for its intended purpose.”
The Examiner disagrees. The Examiner fails to see how selecting a particular (known) shape and axial width dimension for the reinforcing member of O’Connor (as taught by Goff) would render the tube of O’Connor unsatisfactory for its intended purpose, as it would still function as a spirally-reinforced tube for delivering respiratory gases.
Applicant argues on page 15 of Remarks that “the Examiner disregards that the structural element of Goff is significantly wider than that of O’Connor…cannot merely pick select bits and pieces of multiple reference while ignoring the references’ substantial teachings and requirements that teach away from combination with each other…no way to incorporate Goff’s teaching of a smooth, non-corrugated, and disconnected hose into O’Connor”.
The Examiner respectfully notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The longitudinal width of the reinforcing member Goff has not been “disregarded;” it is simply not relevant to the rejection, which is not a bodily incorporation of Goff. The instant claims do not recite a longitudinal width requirement for the reinforcing member, and the Examiner asserts that an artisan would have had no difficulty appropriately sizing a D-shaped reinforcing element within the constraints of O’Connor and within the known ranges taught by O’Connor and Goff to ensure the predictable results discussed in the rejections maintained below. Moreover, there is no requirement that all of the teachings of a secondary reference be incorporated in a base reference. Therefore, while Goff may include additional teachings regarding smoothness and disconnection, these teachings have no bearing on the shape or size of the reinforcing member taught by Goff. There clearly is a way to incorporate Goff’s teaching of a D-shaped reinforcing member into O’Connor by simply reshaping and resizing it as appropriate, and the Examiner notes that, although not relevant to the rejection, there is also a way to incorporate Goff’s other teachings into O’Connor without “rendering it unsatisfactory for its intended purposes,” because even if the tube of O’Connor were made “smooth, non-corrugated, and disconnected” as alleged by Applicant, it would still function as a spirally-reinforced respiratory gas delivery hose, since this is the same function as the tube of Goff.
Applicant argues on pages 17-18 of Remarks that “Forrester teaches away from O’Connor” because Forrester “teaches away from a medical hose manufactured by extruding a thin layer of material over adjacent coils of a helix [such as disclosed by O’Connor]…[t]he annealing process taught in Forrester is intended to address the shortcomings of medical hoses manufactured by extruding a thin layer of material over reinforcing coils.”
The Examiner again notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Also, there is no requirement that all of the teachings of a secondary reference be incorporated in a base reference. The teachings of Forrester regarding annealing have no bearing on the shape of the reinforcing member or inward extension of the tube wall taught by Forrester, and it is noted that O’Connor is further modified in view of Richitelli not to have a thin layer of material extruded over reinforcing coils. The Examiner further notes that the claimed arrangement of D-shaped helically wound reinforcing member and overlapping wrapping was already known in the respiratory tubing art before the effective filing date of the claimed invention, see e.g. previously-cited Smith Fig. 8, such that an artisan would have had no issue incorporating Forrester’s teaching of a D-shaped reinforcing member with limited inner wall extension into modified O’Connor by simply reshaping and resizing the reinforcing member as appropriate.
Applicant argues on page 19 of Remarks that the web portions of Forrester are “not draped.”
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). The film between the windings of the base reference of O’Connor are draped, see O’Connor Fig. 3D, i.e. Forrester is not needed for a teaching in this regard, and an artisan would have had no issue with applying the teachings of Forrester regarding the avoidance of inward extension beyond the spirally wound reinforcing member (particularly in a bent configuration) to this drape of O’Connor as discussed in the rejections maintained below, see e.g. previously-cited Aketo as evidence that this had already been done/was known to be achievable before the effective filing date of the claimed invention.
Applicant argues on pages 21-22 of Remarks that Richitelli is not analogous art because a) “[m]edical tubing must meet certain standards and certifications that hair dryer tubing (i.e., as taught in Richitelli) does not need to meet” and “medical tubing has a meaning in the art…is a unique field with special requirements,” and b) “Richitelli was not seeking to improve the robustness of the conduit…[or] seeking to provide crush-resistant medical tube that resists damage in use….the overlapped region is less protective than it could be specifically because of the tapering.” In response to applicant's argument that Richitelli is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Rebuttal to a): Applicant’s narrow construal the field of endeavor to only “medical” tubing is not convincing. While the intended use of the claimed tube may be within the medical area, the field of endeavor of the instant apparatus claims is spirally reinforced tubes, because intended use carries limited weight in apparatus claims, and "medical" as recited in the instant preambles does not have any specific meaning as an adjective for a tube, because contrary to Applicant’s assertions, any tube can be used in a medical setting and thus constitute a "medical tube.” Indeed, the disclosed features are equally pertinent to spirally wound tubing for any number of applications, and there is nothing in the claimed invention that would preclude its use in other applications, or that recites specific requirements not found in other applications. Therefore, Richitelli is in the field of endeavor of the claimed invention because it is concerned with a spirally reinforced tube the same as the instant claims.
Rebuttal to b): Applicant’s narrow construal of the problem being solved is also unconvincing. There is nothing in the claimed invention that excludes Richitelli’s tapering, and the problem faced by both Applicant and Richitelli is “how to create a robust, crush-resistant tube, particularly one with a spirally reinforcing member.” Contrary to Applicant’s assertions, Richitelli is concerned with providing robustness and crush resistance, as this was its entire reason for providing a spirally wound reinforcing member and overlapping material on the crests thereof. [The Examiner also notes that e.g. previously-cited Smith is further evidence regarding this well-known solution to robust crush-resistance.]
Therefore, Richitelli is both in the field of applicant’s endeavor (spirally reinforced tubes for delivering gases) as well as reasonably pertinent to the particular problem with which the applicant was concerned (how to construct a robust, crust-resistant/spirally reinforced tube for delivering gases), such that Richitelli is analogous art.
Claim Objections
Claim 27 is objected to because of the following informalities:
In claim 27, either the comma in line 3 should be reinstated, or the comma removed from line 4, in order to either fully offset, or not offset, the phrase “when…strain”
Appropriate correction is required.
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.
Claim 37 is 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 37, it is unclear what is meant by “a drape…is configured to allow more…to be exposed to ambient air to increase a rate at which moisture is lost.” First, is “a drape” in claim 37 the same or different than the inward draping recited in claim 26? Second, “more” and “increased” relative to what? A non-draped tube? A non-breathable tube? A differently-draped tube? Para [0058] of the instant specification appears to be the only part of the spec concerned “more” surface exposure and “greater” amount of moisture loss, stating: “In some embodiments, wherein the elongate film 210 comprises a breathable material, this can allow more of the breathable surface of the elongate film 210 to be exposed to the ambient environment such that a greater amount of moisture can be lost from the elongate film 210” (emphasis added). As such, as best understood, it is the use of a breathable material in a draped tube provides the newly-claimed functionality, as compared to a non-breathable material and/or a non-draped tube. Since claim 26 already recites a breathable, draped film, the limitations/functionality of claim 37 are understood to be inherently provided by the structure of claim 26.
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, 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.
Claims 26-28 and 32-38 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor et al. (US 2014/0000626 A1; hereinafter “O’Connor”) in view of Goff et al. (US 2018/0021535 A1; hereinafter “Goff”), Forrester (US 2014/0130931 A1; hereinafter “Forrester”) and Richitelli et al. (US 3,323,553; hereinafter “Richitelli”).
Regarding claim 26, O’Connor discloses a medical tube (medical tube 100) (Figs. 1 and 3D) configured to transport heated and humidified gases in a respiratory system (paras [0003], [0007], [0503], [0542]), the medical tube configured to extend between a respiratory component and a patient interface (e.g. Fig. 12 in view of paras [0003], [0007], [0503], [0542]), the medical tube comprising:
a spirally wound reinforcing member (internal form 110) (paras [0473-475]; internal form may be fabricated by spirally winding, para [0540]) extending between a first end and a second end of the medical tube (Figs. 3D and 12; para [0543]), the spirally wound reinforcing member having a pitch when the medical tube is not subject to deformational strain between 1.8 mm and 3.0 mm plus or minus 10% (the internal form is a helically wound element having a pitch between adjacent turns of…about 2mm, or…about 1.9, or…about 1.8, or…about 1.7, para [0077]);
a breathable film (tubular body 102) (Fig. 3D; tubular body formed from…a breathable thermoplastic polyurethane, para [0491]; where a thin, flexible plastic comprehends a film), the breathable film being permeable to moisture vapor but substantially impermeable to liquid moisture and a flow of gases as material properties of the breathable materials disclosed by O’Connor e.g. paras [0491-492] and [0495], the breathable film being bonded with the spirally wound reinforcing member (the tubular body…bonded to at least a part of the internal form, para [0020]; see also e.g. para [0483]);
the breathable film and the inner portion of the spirally wound reinforcing member together defining a lumen (lumen 107) between the first end and the second end (Figs. 3D and 12; para [0470]), the breathable film draping inwardly toward the lumen in a gap region defined between adjacent turns of the spirally wound reinforcing member (Fig. 3D), a width of the breathable film between adjacent turns of the spirally wound reinforcing member defining an arc length (Fig. 3D).
O’Connor is silent regarding the spirally wound reinforcing member comprising a D-shaped cross-section, the D-shaped cross-section being defined by a flatter portion and a rounder portion, the rounder portion being positioned outside of the flatter portion, the D-shaped cross-section comprising an axial width that is between 0.8 mm and 1.5 mm plus or minus 10%. However, a change in size/shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A&B, 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 Goff teaches that it was well known in the reinforced tube art before the effective filing date of the claimed invention for a reinforced tube to include a spirally wound reinforcing member (spiral structural element 10) with a pitch between 1-10 mm (para [0031]) and comprising a D-shaped cross section (Fig. 6E), the D-shaped cross-section being defined by a flatter portion and a rounder portion, the rounder portion being positioned outside of the flatter portion (Fig. 6E; para [0035]), the D-shaped cross-section comprising an axial width that is between 0.8 mm and 1.5 mm plus or minus 10% (about 0.5-2 mm, para [0031]), with Forrester Fig. 4 reinforcing that D-shaped spiral reinforcement was well known in the respiratory reinforced tube art before the effective filing date of the claimed invention. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tube of O’Connor to include the spirally wound reinforcing member comprising a D-shaped cross-section, the D-shaped cross-section being defined by a flatter portion and a rounder portion, the rounder portion being positioned outside of the flatter portion, the D-shaped cross-section comprising an axial width that is between 0.8 mm and 1.5 mm plus or minus 10% as taught by Goff and Forrester (and in view optimizing pitch/width within known ranges to achieve the structural arrangement/functionality taught by Forrester below), in order to provide the predictable result of a smoothed inner path for airflow (Goff para [0035]), as well as the predictable result of maximizing length extension while preventing protrusion into the lumen when the tube is bent as discussed below.
Modified O’Connor is silent regarding the breathable film comprising a first edge and a second edge and being spirally wound around an outside of the spirally wound reinforcing member such that the breathable film overlaps itself with the first edge being on a second side of the rounder portion of the spirally wound reinforcing member and the second edge being on a first side of the rounder portion of the spirally wound reinforcing member, the breathable film being bonded with itself. However, this was a well-known process for producing spirally-reinforced tubing before the effective filing date of the claimed invention, as demonstrated by Richitelli, which teaches the film (strip 13) comprising a first edge (edge 22) and a second edge (edge 29) (Fig. 2) and being spirally wound around an outside of the spirally wound reinforcing member (helix 10 with coating 11) such that the film overlaps itself with the first edge being on a second side (left side) of the round portion of the spirally wound reinforcing member and the second edge being on a first side (right side) of the round portion of the spirally wound reinforcing member, the breathable film being bonded with the spirally would reinforcing member and itself (Figs. 1-3; wire helix 10 is provided with a continuous wall covering 12 by being helically wrapped about with a single covering strip 13…covering 12 formed by the strip is bonded to the coating 11 on the wire helix 10, col. 2, lines 29-35; wherein bonding between the overlapped ends is inferred because otherwise the adjacent spirals of the strip would not hold together when the tube is extended and/or the tube would leak and/or flaps would form at the overlapped areas that would catch debris and/or snag). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to form the tube of modified O’Connor by using the well-known method taught by Richitelli, i.e. wherein the breathable film comprising a first edge and a second edge and being spirally wound around an outside of the spirally wound reinforcing member such that the breathable film overlaps itself with [the] first edge being on a second side of the rounder portion of the spirally wound reinforcing member and the second edge being on a first side of the rounder portion of the spirally wound reinforcing member, the breathable film being bonded with itself, in order to use a standard method to produce the expected result of a spirally-reinforced tube, particularly one that is thin-walled and highly flexible and well adapted to being transparent (Richitelli col. 1), which would have been obviously desirable given the medical setting of O’Connor, where light weight and flexibility is necessarily for patient comfort, since the tube is suspended from the face/head, and where transparency allows for detection of condensation build up or flow obstructions, while also providing a buffer at the reinforcing member where it is most vulnerable to wear (Richitelli col. 2, lines 4-15), in order to predictably provide a more durable tube.
While O’Connor further discloses ranges for the pitch, reinforcing member diameter, film thickness and corrugation depth that are fully capable of providing an arc length as claimed (see O’Connor paras [0510-511] and [0520-521] and the discussion provided on pages 6-7 of the Office Action mailed 11/18/2019 in parent application 15/514,221), modified O’Connor does not explicitly teach intentionally arriving at the arc length being sufficient to allow the breathable film to drape inwardly as much as possible between adjacent turns of the spirally wound reinforcing member while not protruding inwardly beyond the spirally wound reinforcing member when the medical tube is fully bent (e.g. in the depiction in O’Connor Fig. 3D, the diameter of the reinforcement member would not be large enough to keep the depicted arc length from protruding into the lumen past the innermost surface of the reinforcement member when the tube is fully bent). However, Forrester teaches that it was known in the art of reinforced breathing tubing before the effective filing date of the claimed invention to ensure that the arc length (the length of the radially inwardly extending portions 230 that define reverse folds 250) (Fig. 9) of an inwardly-biased film profile between adjacent windings (reinforcing coils 210) of a spirally wrapped reinforcing member (helix 220; e.g. paras [0045], [0051] and [0064-66]) is sufficient to allow the breathable film to drape between adjacent turns of the spirally wound reinforcing member while not protruding inwardly beyond the spirally wound reinforcing member when the medical tube is fully bent/when the windings of the reinforcing member make (indirect) contact with one another/are fully compressed (Fig. 9; ensuring that the folds 250…are located at a radial distance from the centerline of the hose 200 that is farther than are the inner diameters of the reinforcing coil 210 from the centerline, paras [0061-62]), by providing the reinforcing member with a cross-section comprising an axial width that is large enough relative to the pitch and arc length to keep the arc length from protruding into the lumen past the innermost surface of the reinforcement member when the tube is bent (Figs. 9-10). Forrester also demonstrates that it was well known in the art of reinforced breathing tubing before the effective filing date of the claimed invention that arc length is directly tied to (i.e. a known result-effective variable) the fully extended length of the tube (para [0063]). It would have been obvious to an artisan before the effective filing date of the claimed invention to modify the diameter/width (and/or the pitch) of the reinforcement of modified O’Connor to be within the claimed ranges, i.e. in or around those of O’Connor and Goff (particularly in view of the diameter/width needing to be larger than that disclosed by O’Connor as discussed above), and to provide an arc length sufficient to allow the breathable film to drape as much as possible between adjacent turns of the spirally wound reinforcing member while not protruding inwardly beyond the spirally wound reinforcing member when the medical tube is fully bent as taught by Forrester, in order to provide the expected result of a maximum-extendable-length tube (thus providing the most versatility) where the arc length is still protectively situated within the confines of the adjacent reinforcing coils even when the tube is fully bent, so the inwardly-biased portions are not exposed to rubbing or other engagements that can cause wear and failure (Forrester para [0061]), and so that the inwardly-biased portions do not obstruct a desired flow of breathing gas through the tube (Forrester para [0062]).
Regarding claim 27, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 26, but modified O’Connor is silent wherein an average radial distance from a lowest point of the breathable film to a bottom of the spirally wound reinforcing member when the medical tube is not subject to deformational strain, is less than 0.2 mm. However, it has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art, see MPEP 2144.05.II.A, such that given the relative dimensions of the lowest point of the film and reinforcing member depicted in Forrester Fig. 9 in view of the dimensions disclosed by O’Connor and Goff and rendered obvious through routine experimentation as discussed above (see O’Connor paras [0507-521], Goff para [0031] and the claim 26 discussion above), it would have been obvious to an artisan before the effective filing date of the claimed invention to arrive at the instant range through routine experimentation in order to provide a suitably crush resistant tube (i.e. thick enough reinforcement) that balances the need for extension while still protecting the film (Forrester para [0051] and paras [0062-63]).
Regarding claim 28, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 27, wherein O’Connor further discloses wherein the spirally wound reinforcing member is configured to lean sideways in response to a force applied normal to an axial length of the medical tube (since the reinforcing member is spirally wound as discussed above, and the film is a thin, flexible thermoplastic material as discussed above, the reinforcing member of modified O’Connor is configured to perform as claimed because when a force normal to an axial length is applied, the windings will lean in the direction of their winding because they are angled with respect to said force and will thus distribute the force along the angle).
Regarding claim 32, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 26, wherein the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, see MPEP 2113, such that modified O’Connor anticipates wherein the spirally wound reinforcing member is an extruded member because this process produces the same reinforcing member as disclosed/taught by modified O’Connor. Moreover, Forrester teaches that it was known in the respiratory reinforced tube art before the effective filing date of the claimed invention for a spirally wound reinforcing member (coils 110 of helix 120) to be an extruded member (the materials that form the coils 110 of the helix 120…to be extruded, para [0021]; see also paras [0051] and [0065-66]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to manufacture the tube of modified O’Connor such that the spirally wound reinforcing member is an extruded member as taught by Forrester, in order to utilize a well-known process to predictably provide the reinforcing member.
Regarding claim 33, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 32, wherein the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, see MPEP 2113. Moreover, O’Connor further discloses wherein the breathable film is extruded (e.g. para [0048]), such that modified O’Connor anticipates wherein the breathable film is extruded because this process produces the same film as disclosed/taught by modified O’Connor, and in order to utilize a well-known process to predictably provide the film.
Regarding claim 34, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 33, wherein O’Connor further discloses wherein the spirally wound reinforcing member provides rigidity or structural support to the breathable film (Fig. 3D; per the definition of “reinforcing” and see also e.g. para [0033]: “the internal form is supportive or supporting of the lumen within the tube so formed”; and para [0483]).
Regarding claim 35, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 26, wherein O’Connor further discloses wherein the breathable film comprises a thermoplastic elastomer, a thermoplastic polyurethane (TPU), or a thermoplastic polyester (tubular body is…thermoplastic elastomer(s)…thermoplastic polyurethane…thermoplastic polyester, paras [0491-492]).
Regarding claim 36, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 35, wherein O’Connor further discloses wherein the spirally wound reinforcing member comprises the TPU (tubular body formed from…a breathable thermoplastic polyurethane, para [0491]).
Regarding claim 37, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 26, wherein, as best understood, O’Connor further discloses wherein a drape of the breathable film is configured to allow more of the breathable film to be exposed to ambient air to increase a rate at which moisture is lost in use, by virtue of the film being breathable and draped, see O’Connor Fig. 3D and claim 1 discussion above in view of the 112b discussion above.
Regarding claim 38, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 26, wherein O’Connor, Goff and Richitelli all further disclose/teach wherein the (breathable) film positioned between adjacent turns of the spirally wound reinforcing member is spaced a distance from itself when the (medical tube) is in a neutral position (O’Connor Fig. 3D; Goff Fig. 6E; Richitelli Fig. 1), in order to provide the predictable result of allowing a user to estimate the length of tube needed for a given purpose without manipulation of the tube and/or that allows the use of the extended length of the tube without the need for continuously-applied axial force.
Claim(s) 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor in view of Goff, Forrester and Richitelli as applied to claim 26 above, and further in view of Susumu (GB 2370336 A; hereinafter “Susumu”).
Regarding claims 30 and 31, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube of claim 26, but modified O’Connor is silent regarding wherein the spirally wound reinforcing member is hollow and comprises a cavity configured to hold or transport a fluid. However, Susumu teaches that it was known in the reinforced tube art before the effective filing date of the claimed invention for a reinforced tube to include wherein the (D-shaped) spirally wound reinforcing member (e.g. hollow member 21) is hollow and thus comprises a cavity configured to hold or transport a fluid (Figs. 5-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for modified O’Connor to include wherein the spirally wound reinforcing member is hollow and comprises a cavity configured to hold or transport a fluid (e.g. air/gas) as taught by Susumu, in order to provide the expected result of a lower weight tube (Susumu page 3, lines 8-10) for enhanced consumer experience (i.e. less weight on the face).
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.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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