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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed 11/21/2025. As directed by the amendment, claims 1-12 and 19 have been amended, previously-presented claim 21 has been cancelled and another claim 21 [see claim numbering objection below] has been added. As such, claims 1-15, 17-20 and [22] are pending in the instant application.
Applicant has amended the claims to address the first minor informality indicated on page 6 of the Office Action mailed 5/21/2025, but did not correct the second objection; the objections to the claims are updated below, where any objection not maintained below has been withdrawn
Applicant has not filed a terminal disclaimer to obviate the double patenting rejections; the double patenting rejections are updated below.
Response to Arguments
Applicant's arguments filed 11/21/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
On page 8 of Remarks, Applicant asserts that the Office Action “misinterprets Smith as teaching a ribbon of laser being continuously spirally wound” (emphasis Applicant’s) because Fig. 1 of Smith illustrates the proximal end 16 “away from the junction for the fluid pathway for the balloon” and “to interpret the cited passage of Smith as teaching a resistant material being continuously positioned along the entire length of the tube…is inconsistent and impossible…because the conduit for the balloon 26 would interfere with the winding.”
The Examiner disagrees that Smith has been “misinterpreted”. Smith explicitly states, “A ribbon of laser reflective material 30 is spirally wound on the conduit portion 28 from the proximal end 16 to the distal end 20 to constitute the tube member 12 with a flexible metallic sheath” (col. 4, lines 7-10, emphasis added), “install the cuff 24 after the laser reflective material and the protective cover 40 are installed” (col. 4, lines 64-66, and col. 3, lines 67-68 explicitly state, “A flexible cuff 24 is provided on the tube member 12 near the distal end portion 20” (emphasis added). Therefore, Smith clearly anticipates the reflective material extending to the distal end, beyond the flexible cuff. Applicant has provided no evidence or logical underpinning as to why it would be “impossible” for the overlappingly-wrapped (i.e. continuously arranged) strip of Smith to extend under the cuff as claimed. Applicant asserts that the branch at the proximal end would preclude wrapping in the location of the branch (which, it is noted, is not the contested location); however, winding the strip of Smith to accommodate the conduit for the balloon could be easily accomplished by winding the strip above and below the branch, and it is emphasized that this would have no effect on the winding of the strip along the distal portion of the tube, i.e. under the cuff as claimed, as there is no branch in the distal portion. Therefore, the Examiner maintains that Smith anticipates the instant limitation regarding the resistant member positioned radially inside at least a portion of the expandable cuff. However, in the interest of compact prosecution, Shapiro has been added in the alternative in the updated rejections below, as an even more explicit teaching of the known practice of positioning a resistant member positioned radially inside at least a portion of the expandable cuff well before the effective filing date of the claimed invention, since Shapiro includes a cross-section (Fig. 5) through the cuff thereof, which explicitly depicts resistant member 11a as positioned radially inside the cuff (cuff 12 with cover 19), in order to support the obviousness of the resistant member of Smith extending underneath the cuff thereof in the event that this arrangement is deemed not disclosed by Smith.
On pages 8-9 of Remarks, Applicant alleges “what can only be reasonably interpreted as the laser reflective material 30 is illustrated with shading [in Smith Fig. 1]…clearly illustrated terminating well before the proximal end 16 and at the cuff 24.”
The Examiner disagrees with Applicant’s unsubstantiated assertions on two points. First, Smith makes no indication as what the shading in Fig. 1 might represent; it could just as easily be coloration for depth indication, such that Applicant’s speculation that it represents the laser reflective material is not the “only” reasonable interpretation. Second, even if the shading were taken to represent the laser reflective material, Applicant’s arguments, in as far as they apply to the contested claim language regarding the resistant member being positioned radially inside at least a portion of the cuff, are still unconvincing because there is no indication in Smith that the shading does not continue under the cuff. As discussed above and maintained in the rejection below, Smith Figs. 1-3 combined with col. 4, lines 7-10 indicate that the overlappingly, helically-wrapped resistant member extends the length of the tube from one end to the other and thus underneath a subsequently attached cuff which is positioned between said ends. Moreover, this argument is moot with regards to the alternative rejection in view of Shapiro, which expressly teaches a resistant member extending underneath a cuff.
On page 9 of Remarks, Applicant argues that “Fig. 3 is a fragmentary perspective of the embodiment of Smith, and not intended in any way to suggest the laser reflective portion extends the entire length of the tube member 12….the proximal end 16 distal end 20 are not even annotated inf [sic] Fig. 3 of Smith,” which Applicant asserts is “further assurance that the Office Action’s interpretation of Smith is inconsistent with the actual disclosure.” The Examiner respectfully notes that Fig. 3 is presented in combination with Smith col. 4, lines 7-10, which explicitly states that the “ribbon of laser reflective material 30 is spirally wound…from the proximal end 16 to the distal end 20.” Fig. 1 shows the proximal end at the top and the distal end at the bottom, below the cuff; these features need not be shown in Fig. 3, because Fig. 3 is just demonstrating how the ribbon is wound. As such, the Office’s interpretation is consistent the disclosure of Smith. Moreover, this argument is moot with regards to the alternative rejection in view of Shapiro.
On page 10 of Remarks, Applicant argues that Smith’s disclosure of a different embodiment--where the laser reflective material is applied after the cuff—means that “the laser reflective material cannot extend to the distal end over the flexible cuff, which would render the cuff useless” (emphasis added) and that “the only reasonable interpretation of Smith is that the wrapping…described as starting at the proximal portion…and being wrapped towards [note: Smith col. 4, lines 7-9, recites “to” not just “towards”] the distal portion…not intended to suggest that the reflective material was wrapped continuously between the proximal and distal end.”
The Examiner respectfully notes that the rejection was based on Smith’s disclosure of an embodiment where the cuff is applied after the laser reflective material. In this embodiment, it is entirely reasonably to treat the disclosure of Smith stating that the laser reflective material is wrapped from end to end at face value, because in this case, the laser reflective material would already be in place such that it extends under the cuff, not “over the cuff.” Moreover, this argument is moot with regards to the alternative rejection in view of Shapiro, which expressly teaches a resistant member extending underneath a cuff.
On page 10 of Remarks, Applicant acknowledges that Smith discloses wherein the cuff can be installed after the laser reflective material, but asserts that “this does not suggest that the cuff is installed OVER the laser reflective material, and it would be inconsistent with the specification and Figures of Smith to interpret it this way.”
The Examiner disagrees. Smith explicitly states, “A ribbon of laser reflective material 30 is spirally wound on the conduit portion 28 from the proximal end 16 to the distal end 20 to constitute the tube member 12 with a flexible metallic sheath” (col. 4, lines 7-10, emphasis added), and col. 3, lines 67-68 explicitly state, “A flexible cuff 24 is provided on the tube member 12 near the distal end portion 20” (emphasis added). Therefore, there is nothing inconsistent with interpreting Smith at face value, as Smith clearly intends the reflective material to extend to the distal end, beyond the location of the later-installed flexible cuff. Moreover, this argument is moot with regards to the alternative rejection in view of Shapiro, which expressly teaches a cuff installed over a resistant member.
On page 11 of Remarks, Applicant argues that Patel discloses coextruded layers and thus “fails to teach or suggest “an inflation lumen [that] passes…through the [helically wrapped] resistant member.””
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 base reference of Smith (and alternatively in view of Shapiro) already discloses(/teaches) an uninterrupted, helically wrapped resistant member underneath a cuff. The nature of the layers of Patel are not germane to the rejection. Patel educates Smith to extend an inflation lumen through all of the exterior layers of a tube that are underneath a cuff, i.e. the resistant member and sleeve of Smith/Smith in view of Sharpiro; therefore, the rejections in view of Patel are maintained/updated below.
On pages 11 and 12 of Remarks, Applicant makes no additional substantive arguments with regards to the dependent claims.
On page 12 of Remarks, regarding claim 19, Applicant argues that “Smith fails to teach extending the resistant member past an inflation lumen and Patel requires precise co-extrusion to multiple layers to properly seal.” 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 base reference of Smith (and alternatively in view of Shapiro) already discloses(/teaches) an uninterrupted, helically wrapped resistant member underneath the entire extent of a cuff, with Coleman educating Smith to include two cuffs located in the same region, such that the combination teaches the uninterrupted, helically wrapped resistant member underneath both cuffs. The nature of the layers of Patel are not germane to the rejection. Patel educates modified Smith to extend an inflation lumen through all of the exterior layers of a tube that are underneath each cuff, i.e. the resistant member and sleeve of Smith/Smith in view of Sharpiro; therefore, the combination of references arrives at the claimed invention as discussed in the rejection maintained below.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 21 been renumbered 22.
Claims 1 and 12 are objected to because of the following informalities:
Claim 1, line 6, and claim 12, lines 8 and 10, should not have a comma after “wherein” (three instances)
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 9 of U.S. Patent No. 11,628,264 B2. Although the claims at issue are not identical, patented claims 8 and 9 recite the same limitations/encompass the same subject matter as instant claims 19 and 20 (along with additional limitations), respectively, because one of the patented inflation lumen passageways being fluidly coupled to one of the patented cuffs through the patented second hole, which is aligned with the patented first hole that is cut through the resistant member, per patented claim 8, infers that at least one of the patented inflation lumen passageways passes through the resistant member via the patented first hole.
Claims 1-9, 12-15, 17, 18 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6 and 7 of U.S. Patent No. 11,628,264 B2 in view of Smith et al. (US 5,139,019; hereinafter “Smith”) and Patel (US 4,335,732; hereinafter “Patel”), OR, in the alternative in view of Smith, Shapiro et al. (US 5,027,812; hereinafter “Shapiro”) and Patel.
Regarding instant claims 1, 6-8, 12 and 22, patented claim 1 recites all of the instant limitations, except that patented claim 1 is silent regarding wherein the resistant member is helically wrapped, formed of/comprises a metallic material/aluminum (which inherently resists penetration by a laser) and is positioned radially inside at least a portion of the expandable cuff (although this latter limitation is recited in patented claim 5). However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Smith teaches that it was known in the laser-resistant endotracheal tube (ET) art before the effective filing date of the claimed invention for an overlappingly, helically-wrapped resistant member formed of/comprising a metallic material/aluminum to extend along the length of an ET from one end of an ET to the other and thus underneath a subsequently attached cuff, as discussed in the updated art rejection below, Shapiro, supplied in the alternative as an even more explicit teaching for compact prosecution, teaches that it was known in the laser-resistant ET art before the effective filing date of the claimed invention for a resistant member (metal conduit 11A) formed of/comprising a metallic material/aluminum (col. 4, lines 3-5) to be positioned radially inside at least a portion of the expandable cuff (inflatable cuff 12) (Figs. 1 and 5), and Patel teaches that it was known in the ET art before the effective filing date of the claimed invention for an inflation lumen (inflation lumen 20) (Fig. 2) to pass from a tube (shaft 25) to an expandable cuff (balloon 18) though all layers (outer lamination 26 and core 27) under the cuff that extend between the inflation lumen and the cuff (Figs. 2 and 2a; col. 5, lines 212-25), i.e. via hole 32, such that it would have been obvious to an artisan before the effective filing date of the claimed invention for patented claim 1 to include the absent limitations as taught by Smith, Shapiro and Patel, in order to provide the predictable results of a continuous/uninterrupted resistant member, formed from a standard material (aluminum) and using a standard method (overlapping helical winding), that provides laser resistance along the entirety of the ET (including under the cuff) to thereby protect the entire length of the ET, as well as to e.g. provide a versatile production method that allows pre-manufacturing of resistant tubing that can be subsequently modified with cuff(s) as desired, and to provide a standard means (inflation lumen that extends through all the layers of the ET wall, i.e. including the continuously wrapped material and sleeve, under the cuff to connect the cuff to an internal inflation lumen) to inflate the patented cuff in a low profile way (i.e. using an internal inflation lumen). Instant claims 2-5, 13-15, 17 and 18 are obvious over patented claims 2-4, 6 and 7 when the patented claim 1 is modified as discussed above because patented claims 2-4, 6 and 7 recite the same limitations as instant claims 2-5, 13-15, 17 and 18 (along with additional limitations), with patented claim 4 inferring that the inflation lumens are not fluidly coupled to one another as recited by instant claim 5 in order to provide the independent inflation recited by patented claim 4. Regarding instant claim 9, patented claim 6 infers that the sleeve is positioned radially outside of the resistant member in order to exert the patented compression, and this positioning is also taught by Smith Fig. 4, but modified patent claim 1 is silent regarding the sleeve extending at least the length of the resistant member. However, Smith teaches that the sleeve 40 extends from the proximal end to the distal end, the same as the resistant member, and that the function of a smooth sleeve is to cover the wrapped resistant member so as to space the resistant member from the patient (col. 2, lines 46-48 and col. 4, lines 31-32 and 50-61), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified patented claim 1 to further include the absent limitations as taught by Smith, in order to provide a radially external sleeve that is coextensive with the resistant member to provide the predictable results of ensuring the stability of, and providing smoothness to, the resistant member along its entire length.
Claims 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,628,264 B2 in view of Smith, Shapiro and Patel as discussed above, and further in view of Field (WO 2020/025912 A1; hereinafter “Field”). Regarding instant claim 10, modified patented claim 1 is silent regarding adhesive applied to the proximal and distal end of the resistant member and the sleeve to couple the resistant member and the sleeve to the ET. However, Field teaches/suggests that it was known in the ET art before the effective filing date of the claimed invention, when providing a smooth outer surface that extends at least the length of the underlying, non-smooth portion/layer (portion 23) (Fig. 1), to utilize adhesive to bond an overlying layer/sleeve to the ET (Fig. 1; page 6, lines 1-3 and the second half of the second full para), inferred to include the ends of the sleeve, such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified patented claim 1 to include adhesive applied to the proximal and distal end of the resistant member and the sleeve to couple the resistant member and the sleeve to the ET as taught/suggested by Field, in order to provide the predictable results of robustly securing the patented sleeve and resistant member to the patented ET using standard means (adhesive) and in a way that prevents delamination of the layers during use, particularly at the ends thereof, which could otherwise cause irritation to a patient if the ends peel up and/or seepage between the layers. Regarding instant claim 11, modified patented claim 1 is silent regarding the sleeve being formed of silicone. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Field demonstrates that it was well known in the ET art before the effective filing date of the claimed invention for a smooth outer sleeve (sleeve 30) (Fig. 1) to be formed of silicone (page 6, first full para in view of page 5, second full para). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the patented sleeve to be formed of silicone, in order to provide the predictable result of a smooth outer material that is highly flexible, very compatible with patient tissue and autoclavable (Field page 5, second full para).
Claim Rejections - 35 USC § 112
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.
Claim 8 is 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 has been amended to recite that the resistant member is (helically) wrapped around a portion of the tube; therefore, claim 8 is 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 Interpretation
Regarding new claim 22, “comprising” is considered to be broader than “formed from” in claim 7, which is considered similarly to “composed of,” see MPEP 2111.03.IV., such that claim 22 is not considered to be a duplicate claim.
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, 6-9, 12, 17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 5,139,019; hereinafter “Smith”) in view of Patel (US 4,335,723; hereinafter “Patel”), OR, in the alternative, over Smith in view of Shapiro et al. (US 5,027,813; hereinafter “Shapiro”) and Patel.
Regarding claims 1 and 8, Smith discloses a tube (endotracheal device 10) (Figs. 1-6) for delivering fluid (abstract), comprising:
a tube (flexible conduit portion 28) extending between a first opening (inlet opening 14) and a second opening (outlet opening 18) (Fig. 1);
an expandable cuff (cuff 24) formed on a distal end of the tube (Fig. 1; col. 3, line 67-col. 4, line 3);
a resistant member (spirally wound laser reflective material 30) helically wrapped around a portion of the tube (Figs. 2-6; col. 4, lines 7-9, where the resistant member is said to extend the full length of the ET, i.e. from the proximal end 16 to the distal end 20); and
a sleeve (protective covering 40) formed around the resistant member (Figs. 2-6);
wherein, the sleeve presents a substantially smooth outer surface (a smooth flexible protective covering surrounds the laser reflective material so as to provide a smooth conformal exterior surface for the tube member, col. 2, lines 46-48);
wherein the resistant member is positioned radially inside of at least a portion of the first cuff (Figs. 1 and 3; col. 4, lines 7-9 and lines 64-66, where the laser reflective material is said to be (continuously overlappingly) wrapped from the proximal end 16 to the distal end 20 and the cuff installed afterward, i.e. positioned between the proximal end and the distal end and thus over a region of the continuous wrapping, thus the reflective material extends under/radially inside the cuff).
While Smith is considered to disclose wherein the resistant member is positioned radially inside of at least a portion of the first cuff as discussed above, for purposes of compact prosecution, Shapiro is included in the alternative, as an even more explicit teaching that it was known in the laser resistant ET art before the effective filing date of the claimed invention to include wherein the resistant member (metal conduit 11A) is positioned radially inside of at least a portion of the first cuff (inflatable cuff 12) (Figs. 1 and 5). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Smith to include wherein the resistant member is positioned radially inside of at least a portion of the first cuff as taught by Shapiro, in order to provide the predictable results of a continuous resistant member that provides laser resistance along the entirety of the ET (including under the cuff) to thereby protect the entire length of the ET, as well as to e.g. provide a versatile production method that allows pre-manufacturing of resistant tubing that can be subsequently modified with cuff(s) as desired.
While (modified) Smith discloses/teaches wherein the resistant member extends continuously under the cuff as discussed above, (modified) Smith is silent regarding wherein an inflation lumen passes from the tube to the expandable cuff through the resistant member. However, Patel teaches that it was known in the endotracheal tube art before the effective filing date of the claimed invention for an inflation lumen (inflation lumen 20) (Fig. 2) to pass from a tube (shaft 25) to an expandable cuff (balloon 18) though multiple layers (outer lamination 26 and core 27) that extend under the cuff (Figs. 2 and 2a; col. 5, lines 212-25), i.e. via hole 32, such that it would have been obvious to an artisan before the effective filing date of the claimed invention for (modified) Smith to include wherein an inflation lumen passes from the tube to the expandable cuff through the resistant member as taught by Patel, in order to provide a standard means (i.e. an inflation line embedded in the tube 12 of Smith) by which to inflate the cuff (with continuous underlying resistant member) of Smith/Smith in view of Shapiro, i.e. by providing a hole from the embedded lumen through the overlying tube material, the laser reflective material 30 and protective cover 40 and into the cuff.
Regarding claim 6, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the tube of claim 1, wherein Smith further discloses and Shapiro further teaches further wherein the resistant member is formed from a material that resists penetration by a laser (Smith Figs. 5-6; col. 4, lines 14-15 and col. 5, lines 20-24; Shapiro abstract).
Regarding claim 7, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the tube of claim 6, wherein Smith further discloses and Shapiro further teaches further wherein the resistant member is formed of an aluminum material (laser reflective material 30 is formed of aluminum, Smith col. 4, lines 14-15; Shapiro abstract).
Regarding claim 9, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the tube of claim 8, wherein (modified) Smith further discloses/teaches further wherein the sleeve is positioned radially outside of the resistant member and extends at least the length of the resistant member (Smith Figs. 1 and 3, col. 4, lines 28-32 in view of lines 7-9, where both the sleeve and the resistant member are said extend the full length of the ET from the proximal end 16 to the distal end 20, and see the teachings of Shapiro Figs. 1, 4 and 5, col. 4, lines 1-3, regarding a resistant member which is sheathed/sleeved the entire length thereof), particularly since Smith teaches that the function of the smooth sleeve is to cover the wrapped resistant member so as to provide stability and space the resistant member from the patient (col. 2, lines 46-48 and col. 4, lines 31-32 and 50-61), such that it would have been obvious to an artisan before the effective filing date of the claimed invention to ensure that the sleeve of modified) Smith extends at least the length of the resistant member as taught by Smith and Shapiro, in order to provide a sleeve that is coextensive with the resistant member to provide the predictable results of ensuring the stability of, and providing smoothness to, the resistant member along its entire length.
Regarding claim 12, Smith discloses an endotracheal tube assembly (endotracheal device 10/60) (Figs. 1 and 3/8), comprising:
an airway tube (flexible conduit portion 28) forming a fluid channel (main fluid passage 22) from a first opening (inlet opening 14) to a second opening (outlet opening 18) and defining a tube wall (Figs. 1 and 4/9; col. 3, lines 61-66);
a resistant member (laser reflective material 30/62) formed of a metallic material (Smith col. 4, lines 10-15) and positioned around a portion of the airway tube (Figs. 2-12);
a sleeve (protective covering 40/68) formed around the resistant member (Figs. 2-12); and
a first cuff (cuff 24) formed along the airway tube proximate to the second opening (18) (Fig. 1);
wherein the sleeve is formed of a single material (e.g. PTFE, col. 4, lines 28-34) having a substantially smooth outer surface (a smooth flexible protective covering surrounds the laser reflective material so as to provide a smooth conformal exterior surface for the tube member, col. 2, lines 46-48);
wherein the resistant member is positioned radially inside of at least a portion of the first cuff (Figs. 1 and 3; col. 4, lines 7-9 and lines 64-66, where the laser reflective material is said to be (continuously overlappingly) wrapped from the proximal end 18 to the distal end 20 and the cuff installed afterward, i.e. positioned between the proximal end and the distal end and thus over a region of the continuous wrapping, thus the reflective material extends under/radially inside the cuff).
While Smith is considered to disclose wherein the resistant member is positioned radially inside of at least a portion of the first cuff as discussed above, for purposes of compact prosecution, Shapiro is included in the alternative, as an even more explicit teaching that it was known in the laser resistant ET art before the effective filing date of the claimed invention to include wherein the resistant member (metal conduit 11A) is positioned radially inside of at least a portion of the first cuff (inflatable cuff 12) (Figs. 1 and 5). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Smith to include wherein the resistant member is positioned radially inside of at least a portion of the first cuff as taught by Shapiro, in order to provide the predictable results of a continuous resistant member that provides laser resistance along the entirety of the ET (including under the cuff) to thereby protect the entire length of the ET, as well as to e.g. provide a versatile production method that allows pre-manufacturing of resistant tubing that can be subsequently modified with cuff(s) as desired.
While (modified) Smith discloses/teaches wherein the resistant member extends continuously under the cuff as discussed above, (modified) Smith is silent regarding wherein an inflation lumen passes from the airway tube to the expandable cuff through the resistant member. However, Patel teaches that it was known in the endotracheal tube art before the effective filing date of the claimed invention for an inflation lumen (inflation lumen 20) (Fig. 2) to pass from a airway tube (shaft 25) to an expandable cuff (balloon 18) though multiple layers (outer lamination 26 and core 27) that extend under the cuff (Figs. 2 and 2a; col. 5, lines 212-25), i.e. via hole 32, such that it would have been obvious to an artisan before the effective filing date of the claimed invention for (modified) Smith to include wherein an inflation lumen passes from the airway tube to the expandable cuff through the resistant member as taught by Patel, in order to provide a standard means (i.e. an inflation line embedded in the tube 12 of Smith) by which to inflate the cuff (with continuous underlying resistant member) of Smith/Smith in view of Shapiro, i.e. by providing a hole from the embedded lumen through the overlying tube material, the laser reflective material 30 and protective cover 40 and into the cuff.
Regarding claim 17, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the endotracheal tube assembly of claim 12, wherein Smith further discloses further wherein the resistant member is wrapped around the airway tube (Fig. 2; col. 4, lines 7-10) and the sleeve radially compresses the resistant member towards the airway tube (Figs. 3-4/8-9 and 13 in view of col. 2, lines 63-65, col. 4, lines 48-53 and col. 5, lines 18-20, where the sleeve is described as being stretched during assembly and in a stressed state while on the conduit, wherein such a stretched/stressed state will exert a compressive force on the resistant member towards the airway tube because the stretched sleeve is positioned radially outside of the resistant member and the airway tube).
Regarding claim 22, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the tube for delivering fluid of claim 1, wherein Smith further discloses and Shapiro further teaches wherein the resistant member comprises aluminum (Smith col. 4, lines 14-15; Shapiro abstract).
Claim(s) 2-5, 13-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel, OR Smith in view of Shapiro and Patel as applied to claims 1 and 12 above, and further in view of Coleman et al. (US 4,834,087; hereinafter “Coleman”).
Regarding claim 2, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the tube of claim 1, but modified Smith is silent regarding a second expandable cuff formed at the distal end of the tube. However, Coleman demonstrates that it was well known in the endotracheal tube (ET) art before the effective filing date of the claimed invention for a laser-resistant ET (endotracheal tube 10) (Fig. 1; abstract) to include a first expandable cuff (liquid-inflatable barrier cuff 22) and a second expandable cuff (liquid-inflatable elastomeric sealing cuff 20) formed at the distal end of the tube (Fig. 1; col. 4, lines 28-42). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Smith to include a second expandable cuff formed at the distal end of the tube as taught by Coleman, in order to provide the predictable result of redundant and/or more finely tailorable sealing at the distal end of the ET.
Regarding claim 3, Smith in view of Patel and Coleman OR Smith in view of Shapiro, Patel and Coleman teaches the tube of claim 2, wherein Smith further discloses a first inflation lumen (inflation lumen) (not shown), that is fluidly coupleable to the expandable cuff (Fig. 1; col. 4, lines 1-3), and Patel further educates modified Smith to include the first inflation lumen being partially formed within a wall of the tube as discussed above regarding claim 1. Additionally, Coleman demonstrates that it was well known in the endotracheal tube (ET) art before the effective filing date of the claimed invention for the first inflation line (first inflation lumen 28) of an ET to be partially formed within a wall of the tube (Figs. 2-3). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Smith to include the first inflation lumen being partially formed within a wall of the tube as taught by Patel and Coleman, in order to provide the predictable result of a standard inflation lumen configuration, particularly one that does not affect air flow through the ET or alter the outer surface of the ET.
Regarding claim 4, Smith in view of Patel and Coleman OR Smith in view of Shapiro and Coleman teaches the tube of claim 3, wherein Coleman further educates modified Smith to include a second inflation lumen (second inflation lumen 36) that is fluidly coupleable to the second expandable cuff, the second inflation lumen being partially formed within the wall of the tube (Coleman Figs. 2-3; col. 5, lines 23-30), in order to provide the predictable result of a known means by which to inflate the second cuff discussed above regarding claim 2, which provides the same benefits as discussed above regarding claim 3.
Regarding claim 5, Smith in view of Patel and Coleman OR Smith in view of Shapiro and Coleman teaches the tube of claim 4, wherein Coleman further educates modified Smith to include wherein the first inflation lumen and the second inflation lumen are not fluidly coupled to one another in the wall of the tube (Coleman Figs. 2-3), in order to provide the predictable result of allowing independent inflation of the cuffs to tailor the sealing as discussed above regarding claim 2.
Regarding claim 13, Smith in view of Patel OR Smith in view of Shapiro teaches the endotracheal tube assembly of claim 12, but modified Smith is silent regarding a second cuff formed along the airway adjacent to the first cuff. However, Coleman demonstrates that it was well known in the endotracheal tube (ET) art before the effective filing date of the claimed invention for a laser-resistant ET (endotracheal tube 10) (Fig. 1; abstract) to include a first expandable cuff (liquid-inflatable barrier cuff 22) and a second expandable cuff (liquid-inflatable elastomeric sealing cuff 20) formed along the airway adjacent to the first cuff (Fig. 1; col. 4, lines 28-42). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Smith to include a second cuff formed along the airway adjacent to the first cuff as taught by Coleman, in order to provide the predictable result of redundant and/or more finely tailorable sealing at the distal end of the ET.
Regarding claim 14, Smith in view of Patel and Coleman OR Smith in view of Shapiro and Coleman teaches the endotracheal tube assembly of claim 13, wherein Smith further discloses a first inflation lumen (inflation lumen) (not shown), fluidly coupled to the first cuff (Figs. 1-2; (Fig. 1; col. 4, lines 1-3), and Patel further educates modified Smith to include wherein the first inflation lumen is defined at least partially within the tube wall as discussed above regarding claim 12, and Coleman further demonstrates that it was well known in the endotracheal tube (ET) art before the effective filing date of the claimed invention for the first inflation line (first inflation lumen 28) of an ET to be defined at least partially within the tube wall (Figs. 2-3), and Coleman further educates modified Smith to include a second inflation lumen (second inflation lumen 36) defined at least partially within the tube wall and fluidly coupled to the second cuff (Coleman Figs. 2-3; col. 5, lines 23-30). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Smith to include the first inflation lumen defined at least partially within the tube wall and a second inflation lumen defined at least partially within the tube wall and fluidly coupled to the second cuff as taught by Patel and Coleman, in order to provide the predictable result of a standard inflation lumen configuration, particularly one that does not affect air flow through the ET or alter the outer surface of the ET, and in order to provide the predictable result of using the same means by which to inflate the second cuff discussed above regarding claim 13.
Regarding claim 15, Smith in view of Patel and Coleman OR Smith in view of Shapiro and Coleman teaches the endotracheal tube assembly of claim 14, wherein Coleman further educates modified Smith to include wherein the first cuff and second cuff are inflatable independent of one another (Coleman Figs. 2-3), in order to provide the predictable result of allowing independent inflation of the cuffs to tailor the sealing as discussed above regarding claim 13.
Regarding claim 19, Smith discloses a method for manufacturing an endotracheal tube (Figs. 2 and 13), comprising:
forming an airway tube (flexible conduit portion 28) with an inflation lumen passageway (inflation lumen) (not shown) (Fig. 1; col. 4, lines 1-3);
winding a resistant member (laser reflective material 30) around an outer portion of the airway tube (Fig. 2; col. 4, lines 7-10);
expanding a sleeve and positioning a sleeve (protective covering 40) around the resistant member (Figs. 3-4 and 13; covering 40 may be stretched [i.e. expanded] over…the conduit, col. 4, lines 28-32 and 48-52);
allowing the sleeve to contract to thereby compress the resistant member against the airway tube (Figs. 3-4 and 13 in view of col. 2, lines 63-65, col. 4, lines 48-53 and col. 5, lines 18-20, where the sleeve is described as being stretched during assembly and in a stressed state while on the conduit, wherein such a stretched/stressed state will exert a compressive force on the resistant member towards the airway tube because the stretched sleeve is positioned radially outside of the resistant member and the airway tube); and
coupling a proximal cuff (flexible cuff 24) to the airway tube (Fig. 1; col. 3, lines 67-68) and fluidly coupling the inflation lumen passageway to the proximal cuff (Fig. 1; col. 3, line 86-col. 4, lines 1-3, wherein, for the cuff to be inflated via the inflation lumen, the two must be fluidly coupled).
Smith is silent regarding coupling a distal cuff and forming the airway tube with at least two inflation lumen passageways defined in a wall of the airway tube, and fluidly coupling the proximal and distal cuffs to a different one of the two inflation lumen passageways. However, Coleman demonstrates that these elements/ configurations were well known in the endotracheal tube (ET) art before the effective filing date of the claimed invention as discussed above regarding claims 2-5/13-15. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the method of Smith to include coupling a distal cuff and forming the airway tube with at least two inflation lumen passageways defined in a wall of the airway tube, and fluidly coupling the proximal and distal cuffs to a different one of the two inflation lumen passageways as taught by Coleman, in order to provide the predictable results of redundant and/or more finely tailorable sealing (by allowing independent inflation of the cuffs) at the distal end of the ET, and a standard inflation lumen configuration, particularly one that does not affect air flow through the ET or alter the outer surface of the ET.
While modified Smith further teaches wherein the resistant member is positioned radially inside of the cuffs (Smith Figs. 1 and 3; col. 4, lines 7-9 and lines 64-66, where the laser reflective material is said to be (continuously overlappingly) wrapped from the proximal end 16 to the distal end 20 and the cuff installed afterward, i.e. positioned between the proximal end and the distal end and thus over a region of the continuous wrapping, such that the reflective material would extend under/radially inside both the cuffs of modified Smith because they would both be positioned between the proximal and distal ends of the tube), and where Shapiro is included in the alternative for purposes of compact prosecution, as an even more explicit teaching that it was known in the laser resistant ET art before the effective filing date of the claimed invention to include wherein the resistant member (metal conduit 11A) is positioned radially inside of at least a portion of the first cuff (inflatable cuff 12) (Figs. 1 and 5), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for Smith to include wherein the resistant member is positioned radially inside of at least a portion of the first cuff as taught by Shapiro, in order to provide the predictable results of a continuous resistant member that provides laser resistance along the entirety of the ET (including under the cuff) to thereby protect the entire length of the ET, as well as to e.g. provide a versatile production method that allows pre-manufacturing of resistant tubing that can be subsequently modified with cuff(s) as desired, modified Smith is silent regarding wherein at least one of the two inflation lumen passageways passes through the resistant member. However, Patel teaches that it was known in the endotracheal tube art before the effective filing date of the claimed invention for an inflation lumen (inflation lumen 20) (Fig. 2) to be embedded in a tube (shaft 25) and fluidly connected to an expandable cuff (balloon 18) by passing through multiple layers (outer lamination 26 and core 27) that extend under the cuff (Figs. 2 and 2a; col. 5, lines 212-25), i.e. via hole 32, such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Smith to include wherein at least one of the two inflation lumen passageways passes through the resistant member as taught by Patel, in order to provide standard means (i.e. inflation line(s) embedded in the tube 12 of modified Smith that are directly connected to the cuff(s) by a hole underlying the cuff(s)) by which to inflate the cuff(s) (with underlying resistant member) of modified Smith, i.e. by providing a hole from the embedded lumen(s) through the overlying tube material, laser reflective material 30 and protective cover 40 and into the cuff(s).
Claim(s) 10, 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel, OR Smith in view of Shapiro and Patel as applied to claims 1 and 17 above, and further in view of Field (WO 2020/025912; hereinafter “Field”).
Regarding claim 10, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the tube of claim 1, but modified Smith is silent regarding wherein adhesive is applied to the proximal and distal end of the resistant member and the sleeve to couple the resistant member and the sleeve to the tube. However, Field teaches/suggests that it was known in the endotracheal tube (ET) art before the effective filing date of the claimed invention to utilize adhesive applied to an end of a sleeve (sleeve 30) to couple the sleeve to the underlying tube (portion 23) (Fig. 1; page 6, lines 1-3 and the second half of the second full para), inferred to include at the ends of the sleeve. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Smith to include adhesive applied to the proximal and distal end of the resistant member and the sleeve to couple the resistant member and the sleeve to the tube as taught/suggested by Field, in order to provide the predictable results of securing the resistant member and sleeve to the ET using standard means (adhesive) and in a way that prevents delamination of the layers during use, particularly at the ends thereof, which could otherwise cause irritation to a patient if the distal end peels up and/or allow fluids to become trapped between the layers and exit from the distal or proximal end, which could contaminate the lungs and/or the area around the patient.
Regarding claim 11, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the tube of claim 1, but modified Smith is silent regarding wherein the sleeve is formed of silicone. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Field demonstrates that it was well known in the endotracheal tube (ET) art before the effective filing date of the claimed invention for a smooth outer sleeve (sleeve 30) (Fig. 1) to be formed of silicone (page 6, first full para in view of page 5, second full para). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the sleeve of modified Smith to be formed of silicone as taught by Field, in order to provide the predictable result of a smooth outer material that is highly flexible, very compatible with patient tissue and autoclavable (Field page 5, second full para).
Regarding claim 18, Smith in view of Patel OR Smith in view of Shapiro and Patel teaches the endotracheal tube assembly of claim 17, but modified Smith is silent regarding wherein the resistant member and the sleeve are adhesively coupled to the airway tube at a proximal and distal end of the resistant member and the sleeve. However, Field teaches/suggests that it was known in the endotracheal tube (ET) art before the effective filing date of the claimed invention to utilize adhesive at an end of a sleeve (sleeve 30) to adhesively couple the sleeve to the underlying tube (portion 23) (Fig. 1; page 6, lines 1-3 and the second half of the second full para), inferred to include at the ends of the sleeve. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Smith to include wherein the resistant material and the sleeve are adhesively coupled to the airway tube at a proximal and a distal end of the resistant member and the sleeve as taught/suggested by Field, in order to provide the predictable results of securing resistant member and sleeve to the ET using standard means (adhesive) and in a way that prevents delamination of the layers during use, particularly at the ends thereof, which could otherwise cause irritation to a patient if the distal end peels up and/or allow fluids to become trapped between the layers and exit from the distal or proximal end, which could contaminate the lungs and/or the area around the patient.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel and Coleman, OR Smith in view of Shapiro, Patel and Coleman as applied to claim 19 above, and further in view of Field.
Regarding claim 20, Smith in view of Patel and Coleman OR Smith in view of Shapiro, Patel and Coleman teaches the method of claim 19, but modified Smith is silent regarding further comprising applying adhesive to a proximal and distal end of both the sleeve and resistant member to thereby adhesively couple the sleeve and resistant member to the airway tube. However, Field teaches/suggests that it was known in the endotracheal tube (ET) art before the effective filing date of the claimed invention to apply adhesive to an end of a sleeve (sleeve 30) to adhesively couple the sleeve to the underlying tube (portion 23) (Fig. 1; page 6, lines 1-3 and the second half of the second full para), inferred to include at the ends of the sleeve. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the method of modified Smith to include applying adhesive to a proximal and distal end of both the sleeve and resistant member to thereby adhesively couple the sleeve and resistant member to the airway tube as taught/suggested by Field, in order to provide the predictable results of securing resistant member and sleeve to the ET using standard means (adhesive) and in a way that prevents delamination of the layers during use, particularly at the ends thereof, which could otherwise cause irritation to a patient if the distal end peels up and/or allow fluids to become trapped between the layers and exit from the distal or proximal end, which could contaminate the lungs and/or the area around the patient.
Conclusion
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785