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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 62/054,588 and 62/198,038, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional applications do not disclose the instantly claimed ranges/endpoints for pitch and axial width recited in instant claim 26. Therefore, the earliest priority date for the instant claims is that of the PCT application, that is, 9/24/2015.
Response to Arguments
This office action is in response to the preliminary amendment filed 2/15/2024. As directed by the amendment, claims 1-25 have been cancelled, and claims 26-36 have been added. As such, claims 26-36 are pending in the instant application.
Claim Objections
Claims 26-36 are objected to because of the following informalities:
Claim 26, lines 5-6 would more clearly avoid the appearance of an improper method step in an apparatus claim if they were to read “a pitch
Claim 26, lines 15-16 should read “the first edge” because they are clearly referring to that of line 12
Claim 26, line 25 should read “to drape inwardly” for clarity
The preambles of claims 27-36 should read “The medical tube” for clearer antecedent basis
Claim 27, line 3 would more clearly avoid the appearance of an improper method step in an apparatus claim if it were to read “
Claim 28, line 2 should read “member is configured to lean sideways” to make it clearer that the intended result flows from the structure rather than a method of using
Claim 35, line 2 should read “a thermoplastic polyurethane (TPU),” to clarify the acronym used in claim 36
Claim 36, line 2 should read “the TPU” because it is understood to be referring to that of claim 35
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.
Claims 26-36 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 26 (and thus its dependent claims), the terms “highly permeable” and “bulk flow” in claim 26 is a relative term which renders the claim indefinite. The terms “highly” and “bulk” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degrees, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination, prior art that teaches standard breathable film (i.e. film that allows vapor to pass therethrough but not liquid) will be considered to read on the instant limitation.
Regarding claim 29, the claim reads as a method step (a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite, see MPEP 2173.05(p).II), and one which is dependent on an indefinite degree of force being applied. For purposes of examination, any spirally-reinforced tube is capable of performing as claimed, per the standard functionality of spirally-reinforced tubing, i.e. spiral reinforcement of tubing provides at least some degree of crush-resistance.
Claim Interpretation
Regarding claim 26, in light of the instant specification (e.g. Fig. 3I and paras [0063-66] and [0069]), an arc length that is “sufficient to allow the breathable film to drape as much as possible…while not protruding inwardly beyond the spirally would reinforcing member when the medical tube is fully bent” is one where the lowest point of the arc that extends toward the lumen, when adjacent windings of the reinforcing member are compressed together so as to be (indirectly) touching, is approximately level with the innermost extent of adjacent windings.
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 26-29 and 32-36 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 that is measured when the medical tube is not subject to deformational strain, the pitch being 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, as best understood, highly permeable to moisture vapor but substantially impermeable to liquid moisture and a bulk 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 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 as claimed in 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, measured 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 as claimed in claim 27, wherein O’Connor further discloses wherein the spirally wound reinforcing member will 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 29, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube as claimed in claim 28, wherein O’Connor further discloses wherein the medical tube does not fully collapse such that a gases flow can be maintained while the force is applied (para [0481]; wherein the tube of modified O’Connor is configured to perform as claimed because it provides crush resistance, i.e. maintains some degree of opening through the tube when a force normal to an axial length [i.e. crushing] is applied).
Regarding claim 32, O’Connor in view of Goff, Forrester and Richitelli teaches the medical tube as claimed in 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 as claimed in 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 as claimed in 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 as claimed in claim 26, wherein O’Connor further discloses wherein the breathable film comprises a thermoplastic elastomer, a thermoplastic polyurethane, 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 as claimed in 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]).
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 as claimed in 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional reference teaching a D-shaped-spirally-reinforced, breathable-material-spirally-wrapped respiratory tube: Smith et al. (US 2002/0002976 A1; Fig. 8, paras [0033] and [0035]). Additional reference teaching the obviousness of D-shaped spiral reinforcement for tubing: Forrester (US 2010/0215351 A1). Additional references regarding spiral-wrapped tubing construction: Arney et al. (US 6,152,186); Carlson (US 5,848,223); Forrester et al. (US 2014/0332108 A1); Kanao (US 2008/0202621 A1). Additional references regarding breathable tubing: Cheung et al. (US 2015/0048530 A1); Herron, Jr. (US 2009/0025724 A1); Hurmez et al. (US 2013/0098360 A1). Additional reference teaching the optimization of parameters to ensure that tubing drape does not extend past spiral enforcement: Aketo et al. (JP H11344166). Additional references regarding hollow spiral reinforcement of tubes: Kahn (US 3,047,026); Kanao (WO 2009/072516 A1).
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