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 .
Claim Objections
Claim(s) 1-20 is/are objected to because of the following informalities:
Claims 1-5 & 8 variously recite “the/said projections” and “the/said internal projections.” As the initial limitation in Ln. 3 of claim 1 reads “one or more internal projections” all subsequent limitations should read “the/said one or more internal projections” for consistency with claim 1 and to clearly identify that the claim is not positively required multiple internal projections. Note, however, that the limitation on Ln. 3 of claim 2 should not read “the one or more internal projections” because Ln. 2 of claim 2 has positively recited “ribs” in plural which means claim 2 must have more than one internal projection.
Claim 7, Ln. 4 recites “the projection” which should read “the internal projection” for consistency
Claims 8, 10 & 12 each recite “the ET tube” which should read “the endotracheal tube” for consistency with claim 1
Claim 9, Ln. 1 recites “the one or more projections” which should read “the one or more internal projections” for consistency with claim 1
Claim 10, Ln. 2 recites “a distal tip portion” which should read “the distal tip portion” following after claim 1
Claim 15, Ln. 2 recites “a distal end” which should read “the distal end” following after claim 1
Claim 18, Ln. 1 recites “an ET tube” which should read “the endotracheal tube” for consistency with claim 1
Claim 18, Ln. 2 recites “an endotracheal tube” which should read “the endotracheal tube” for consistency with claim 1
Claim 19 begins “The intubation system of claim 18” while all other claims use the language “according to claim XX.” It is suggested to amend the claim to read “The intubation system according to claim 18.”
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(s) 7 and 11-12 is/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 pre-AIA the applicant regards as the invention.
Claim 7 recites the limitation “the tube” in Ln. 1which deems the claim indefinite. Claim 1 has recited two different tubes which leads to confusion as to which tube is being herein referred to. For the purposes of examination the limitation will be interpreted as reading “the endotracheal tube.”
Claim 11 recites the limitations “the main tube body” in Ln. 2 and “the device” in Ln. 3. There is insufficient antecedent basis for the limitations in the claim. It appears the claim is intending to refer to the main body portion recited in claim 10. Thus, for the purposes of examination the claim will be read as dependent on claim 10 and the limitations will be respectively interpreted as reading “the main body portion” and “the endotracheal tube.”
Claim 12 recites the limitation “the device” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “the endotracheal tube.”
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “control mechanism” in claim 19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the “control mechanism” is best understood from the specification as at least: actuator 107 (¶0105; Fig. 1).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-6, 8 and 12-16 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/200,741 in view of Agdanowski (U.S. Patent 4488548). Reference claim 11 includes all limitations of instant claim 1 with the exception of the specificity that the [one or more] internal projections are tapered in at least one direction.
Agdanowski teaches an endotracheal tube (Figs. 1-2 #14; Col. 2, Ln. 65-68) comprising one or more internal projections (Figs. 2-3 #58; Col. 3, Ln. 62 – Col. 4, Ln. 10), said one or more internal projections projecting radially inwardly (Figs. 2-3 #58 radially inward from #36) from an internal wall surface (Figs. 2-3 #36) of a distal tip portion of the endotracheal tube (Fig. 2 #58 at distal tip portion of the tube), wherein the one or more internal projections are tapered in at least one direction (Fig. 2 – longitudinal tapering at opposite ends or Fig. 3 rounded upper tip; Col. 6, Ln. 40-47 – inclined to serve as ramp). Agdanowski teaches a tapering of the internal projections as providing the benefit of supplying a ramp to guide an inner catheter into proper position (Col. 6, Ln. 40-47).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in reference claim 11 the [one or more] internal projections are tapered in at least one direction in order to provide the benefit of supplying a ramp to guide an inner catheter into proper position in view of Agdanowski.
A further mapping of dependent claims is as follows:
Instant claims 2-6 vs. Agdanowski (see 35 U.S.C. 102(a)(1) rejection of claims 2-6 below)
Instant claim 8 as obvious in view of Agdanowski (see 35 U.S.C. 103 rejection of claim 8 below)
Instant claims 12-14 as obvious in view of Agdanowski (see 35 U.S.C. 103 rejection of claims 12-14 below). Note also the obviousness versus instant claims 12-14 rendered by the helically wound, meshed or braided reinforcement structure recited in reference claim 1.
Instant claim 15 vs. Agdanowski (see 35 U.S.C. 102(a)(1) rejection of claim 15 below)
Instant claim 16 vs. limitations in reference claim 1
This is a provisional nonstatutory double patenting rejection.
Claim(s) 17 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/200,741 in view of Agdanowski (U.S. Patent 4488548) and further in view of O’Neil et al. (U.S. Pub. 2010/0313896). Reference claim 11 is silent as to whether the endotracheal tube comprises a material having a Shore A Hardness in a range of from 60 to 75.
Agdanowski does disclose a material of the endotracheal tube can include polyvinyl chloride (Col. 3, Ln. 11-17). O’Neil teaches an endotracheal tube (Fig. 1; ¶0031) which can be made from a material such as polyvinyl chloride (¶¶0033-0034) and have a Shore A Hardness of 70 (¶0044). O’Neil teaches the claimed Shore A Hardness is a common and expected value for an endotracheal tube material (¶¶0033-0034, 0044).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in reference claim 11 the endotracheal tube comprises a material having a Shore A Hardness in a range of from 60 to 75 based upon a common use of polyvinyl chloride having Shore A Hardness within the claimed range when making an endotracheal tube in view of O’Neil.
Claim(s) 18-20 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/200,741 in view of Agdanowski (U.S. Patent 4488548) and further in view of Poormand (U.S. Pub. 2020/0297957). Reference claim 11 is silent as to a stylet for guiding the endotracheal tube during intubation.
Poormand teaches an intubation kit (Figs. 9-11) including a stylet (Figs. 1a-1b; ¶¶0045, 0063-0065) for guiding an endotracheal tube (Figs. 9-11 #101; ¶0063-0065) during intubation. Poormand teaches a stylet as providing the benefit of assisting a clinician during patient intubation (¶¶0006-0007, 0063-0065).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in reference claim 11 a stylet for guiding the endotracheal tube during intubation in order to provide the benefit of assisting a clinician during patient intubation in view of Poormand.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agdanowski (U.S. Patent 4488548).
Regarding claim 1, Agdanowski discloses an endotracheal tube (Figs. 1-2 #14; Col. 2, Ln. 65-68) having a body (Fig. 2 body of #14) comprising a flexible hollow tube (Fig. 2 #24; Col. 3, Ln. 4-7) with a distal end for insertion into a patient's trachea during intubation (Figs. 1-2 #16), and an opposite proximal end (Fig. 1 end outside of patient’s mouth); wherein the endotracheal tube comprises one or more internal projections (Figs. 2-3 #58; Col. 3, Ln. 62 – Col. 4, Ln. 10), said one or more internal projections projecting radially inwardly (Figs. 2-3 #58 radially inward from #36) from an internal wall surface (Figs. 2-3 #36) of a distal tip portion of the endotracheal tube (Fig. 2 #58 at distal tip portion of the tube), wherein the one or more internal projections are tapered in at least one direction (Fig. 2 – longitudinal tapering at opposite ends or Fig. 3 rounded upper tip; Col. 6, Ln. 40-47 – inclined to serve as ramp). Meanings of the phrase “projecting radially inwardly” and the term “tapered” are discussed in ¶¶0014-0015 of the instant specification.
Regarding claim 2, Agdanowski discloses the one or more internal projections comprise elongate ribs (Fig. 2 #58 are elongated) having an extension direction which is substantially parallel to a longitudinal axis of the endotracheal tube (Fig. 2), and wherein the one or more internal projections are tapered along said extension direction (Fig. 2; Col. 6, Ln. 40-47 – inclined to serve as ramp).
Regarding claim 3, Agdanowski discloses the one or more internal projections are tapered such that a proximal portion of the one or more internal projections has a lower height than a distal portion of the one or more internal projections (Fig. 2 virtually no height at proximal end of #58 while some height before distal end of #58). It is noted that the claimed “proximal portion” and “distal portion” only require the reading of an individually selectable part of the internal projections. The claim is not understood to imply that another distal portion of the internal projection could not have the same lower height as the claimed proximal portion.
Regarding claim 4, Agdanowski discloses the one or more internal projections comprise a first portion (Fig. 2 rightward portion of #58 tapered downward to the right) which is tapered in a first direction, and a second portion (Fig. 2 leftward portion of #58 tapered downward to the left or Fig. 3 #58 tapered at its upper tip) which is tapered in a second direction, different to the first direction.
Regarding claim 5, Agdanowski discloses the one or more internal projections are integrally formed with the internal wall surface (Figs. 2-3; Col. 3, Ln. 62-68).
Regarding claim 6, Agdanowski discloses at least one internal projection is located along the axis of the longest longitudinal dimension of the distal tip portion (Fig. 2). It is noted that the “internal projection” of the instant claim is clearly understood to refer back to claim 1.
Regarding claim 15, Agdanowski discloses the endotracheal tube further comprises an inflatable cuff (Fig. 2 #26; Col. 3, Ln. 4-8) provided at or near the distal end of the endotracheal tube.
Claim(s) 1, 3, 5-6, 9-10 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeLuccia et al. (U.S. Patent 4502482).
Regarding claim 1, DeLuccia discloses an endotracheal tube (Figs. 10-12 #110; Col. 7-8) having a body (Fig. 10 body of #110) comprising a flexible hollow tube (e.g. Fig. 1; inherently flexible to allow positioning within trachea) with a distal end for insertion into a patient's trachea during intubation (Fig. 10 right end), and an opposite proximal end (Fig. 1 end outside of patient’s mouth); wherein the endotracheal tube comprises one or more internal projections (Fig. 12 #142; Col. 7, Ln. 68 – Col. 8, Ln. 31), said one or more internal projections projecting radially inwardly (Fig. 12 #142 are radially inward from main material of #122) from an internal wall surface (Fig. 12 inner wall of #122) of a distal tip portion of the endotracheal tube (Fig. 12), wherein the one or more internal projections are tapered in at least one direction (Fig. 12 ramped tapering of #142). Meanings of the phrase “projecting radially inwardly” and the term “tapered” are discussed in ¶¶0014-0015 of the instant specification. It is noted that the instant disclosure indicates the endotracheal tube’s body need not be a single piece of material (e.g. instant claim 10).
Regarding claim 3, DeLuccia discloses the one or more internal projections are tapered such that a proximal portion of the one or more internal projections has a lower height than a distal portion of the one or more internal projections (Fig. 12 left side leading toward #142 is shorter than peak height at #142).
Regarding claim 5, DeLuccia discloses the one or more internal projections are integrally formed with the internal wall surface (Fig. 12 #142 integral with #122).
Regarding claim 6, DeLuccia discloses at least one internal projection is located along the axis of the longest longitudinal dimension of the distal tip portion (Fig. 12). It is noted that the “internal projection” of the instant claim is clearly understood to refer back to claim 1.
Regarding claim 9, DeLuccia discloses the one or more internal projections comprise a shoulder portion (Fig. 13 portion of #142 shown engaging #144) comprising an axially facing detent surface.
Regarding claim 10, DeLuccia discloses the endotracheal tube body comprises a main body portion (Figs. 10 & 12 #112) and the distal tip portion (Figs. 10 & 12 #122), said portions being provided as separate components (Fig. 10)
Regarding claim 15, DeLuccia discloses the endotracheal tube further comprises an inflatable cuff (Fig. 1 #26; Col. 8, Ln. 38-40) provided at or near the distal end of the endotracheal tube.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 8 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agdanowski (U.S. Patent 4488548).
Regarding claim 8, Agdanowski discloses the size of the one or more internal projection(s) is selected to restrict the maximum dimension of a central lumen of the endotracheal tube in at least one direction (Figs. 2-3 – restricted dimension between #58).
Agdanowski is silent as to whether said maximum dimension of the restricted portion of the lumen being in a range of from 4 mm to 7 mm.
It is noted that the claim does not require the restricted portion to be located in any singular position of the central lumen. It is thus considered that Agdanowski teaches and illustrates spacers 58 as inclined with a ramp design (Fig. 2; Col. 6, Ln. 40-47). Thus, the amount of the central lumen restricted by spacers 58 varies directly with the height of spacers 58 at any single cross-sectional position along the ramp. Agdanowski further teaches an adult endotracheal tube may commonly have an inner diameter of 7.5 mm (Col. 6, Ln. 64-65). Additionally, one of ordinary skill in the art would recognize that endotracheal tubes may be provided in a variety of larger or smaller diameter sizes based upon the size of the patient being treated. Taking together the inner diameter expressly discussed by Agdanowski along with the variable size of restriction along the ramped structure of spacers 58 one of ordinary skill in the art would have considered it prima facie obvious that at least at some portion along the ramped structure of spacers 58 a cross-sectional measure between opposed spacers 58 would have measured a distance of between 4 mm and 7 mm. The instant claim thus fails to patentably distinguish over Agdanowski.
Regarding claim 12, Agdanowski is silent as to whether the endotracheal tube is configured such that the distal tip portion of the endotracheal tube resists buckling at applied axial loads of 20 N or more.
It is however noted that one of ordinary skill in the art would obviously expect an endotracheal tube having a larger diameter to present greater wall thickness and thus greater resistance to buckling. Agdanowski illustrates in Fig. 3 six equally, circumferentially placed spacers 58 at the distal tip. One of ordinary skill in the art would obviously expect the spacers 58 to increase the resistance to buckling in that location. Thus, one of ordinary skill in the art would have expected the distal tip of Agdanowski to have presented a greater resistance to buckling than in the remainder of tube 14. The specific value recited by the instant claim for the buckling resistance is not found to be of such an increased magnitude over the expected buckling of a common endotracheal tube such that the increased resistance created by spacers 58 would not be expected to render the claimed resistance a result-effective variable obviously expected to be found during ordinary experimentation and optimization of the endotracheal tube of Agdanowski. The instant claim thus fails to patentably distinguish over Agdanowski.
Regarding claim 13, Agdanowski is silent as to whether the endotracheal tube is configured to bend at an applied torque of 1 Nm or less
However, Agdanowski clearly intends a suitable flexibility for tube 14 in order to allow ease of intubation into a patient (e.g. Fig. 1). The specific value recited by the instant claim for the bending torque is not found to be of such a reduced magnitude over the expected flexibility of a common endotracheal tube such that the claimed bending torque would not be expected to be found as a result-effective variable obviously arrived at during ordinary experimentation and optimization of the endotracheal tube of Agdanowski. The instant claim thus fails to patentably distinguish over Agdanowski.
Regarding claim 14, Agdanowski is silent as to whether the endotracheal tube is configured to resist collapse at an applied pressure up to and including 300 cmH2O.
However, one of ordinary skill would have recognized the danger to a patient’s life of an endotracheal tube which may collapse during use. The specific value recited by the instant claim for the resistance to collapse is not found to be of such an increased magnitude over the expected collapse resistance design of a common endotracheal tube such that the increased resistance created by spacers 58, or merely inherent to the material of tube 14, would not be expected to render the claimed resistance to collapse a result-effective variable obviously expected to be found during ordinary experimentation and optimization of the endotracheal tube of Agdanowski. The instant claim thus fails to patentably distinguish over Agdanowski.
Claim(s) 8 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeLuccia et al. (U.S. Patent 4502482).
Regarding claim 8, DeLuccia discloses the size of the one or more internal projection(s) is selected to restrict the maximum dimension of a central lumen of the endotracheal tube in at least one direction (Fig. 12 – restricted dimension between #142).
DeLuccia is silent as to whether said maximum dimension of the restricted portion of the lumen being in a range of from 4 mm to 7 mm.
It is noted that the claim does not require the restricted portion to be located in any singular position of the central lumen. It is thus considered that DeLuccia teaches an illustrates protuberances 142 as inclined with a ramp design (Fig. 12). Thus, the amount of the central lumen restricted by protuberances 142 varies directly with the height of protuberances 142 at any single cross-sectional position along the ramp. DeLuccia further teaches endotracheal tubes are known to be provided having an inner diameter in a range of 4 mm to 12 mm and that the introducer will have an internal diameter of 3 mm to 12 mm (Col. 10, Ln. 38-49). Taking together the inner diameters discussed by DeLuccia along with the variable size of restriction along the ramped structure of protuberances 142one of ordinary skill in the art would have considered it prima facie obvious that at least at some portion along the ramped structure of protuberances 142a cross-sectional measure between opposed protuberances 142 would have measured a distance of between 4 mm and 7 mm. The instant claim thus fails to patentably distinguish over DeLuccia.
Regarding claim 13, DeLuccia is silent as to whether the endotracheal tube is configured to bend at an applied torque of 1 Nm or less
However, DeLuccia clearly intends a suitable flexibility for tube 112 in order to allow ease of intubation into a patient (e.g. Fig. 5). The specific value recited by the instant claim for the bending torque is not found to be of such a reduced magnitude over the expected flexibility of a common endotracheal tube such that the claimed bending torque would not be expected to be found as a result-effective variable obviously arrived at during ordinary experimentation and optimization of the endotracheal tube of DeLuccia. The instant claim thus fails to patentably distinguish over DeLuccia.
Regarding claim 14, DeLuccia is silent as to whether the endotracheal tube is configured to resist collapse at an applied pressure up to and including 300 cmH2O.
However, one of ordinary skill would have recognized the danger to a patient’s life of an endotracheal tube which may collapse during use. The specific value recited by the instant claim for the resistance to collapse is not found to be of such an increased magnitude over the expected collapse resistance design of a common endotracheal tube such that the material of tube 112 would not be expected to render the claimed resistance to collapse a result-effective variable obviously expected to be found during ordinary experimentation and optimization of the endotracheal tube of DeLuccia. The instant claim thus fails to patentably distinguish over DeLuccia.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agdanowski (U.S. Patent 4488548) in view of Shimamura et al. (U.S. Patent 4737153).
Regarding claim 16, Agdanowski discloses the endotracheal tube body comprises a polymeric material (Col. 3, Ln. 11-17).
Agdanowski fails to disclose the endotracheal tube body comprising a helically wound, meshed or braided reinforcement structure embedded therein, the helically wound, meshed or braided reinforcement structure being formed from one or more filaments.
Shimamura teaches an endotracheal tube (Fig. 1) comprising a helically wound reinforcement structure (Figs. 1 & 10 #6; Col. 3, Ln. 53 – Col. 4, Ln. 4) embedded therein, the helically wound reinforcement structure being formed from one or more filaments (Fig. 10 #6; Col. 4, Ln. 2-4). Shimamura teaches a reinforcement structure as providing the benefit of improving tube flexibility while reducing strain on end parts (Col. 2, Ln. 10-19).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Agdanowski the endotracheal tube body comprising a helically wound reinforcement structure embedded therein, the helically wound reinforcement structure being formed from one or more filaments in order to provide the benefit of improving tube flexibility while reducing strain on end parts in view of Shimamura.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeLuccia et al. (U.S. Patent 4502482) in view of Shimamura et al. (U.S. Patent 4737153).
Regarding claim 16, DeLuccia discloses the endotracheal tube body comprises a polymeric material (Col. 5, Ln. 58-62).
DeLuccia fails to disclose the endotracheal tube body comprising a helically wound, meshed or braided reinforcement structure embedded therein, the helically wound, meshed or braided reinforcement structure being formed from one or more filaments.
Shimamura teaches an endotracheal tube (Fig. 1) comprising a helically wound reinforcement structure (Figs. 1 & 10 #6; Col. 3, Ln. 53 – Col. 4, Ln. 4) embedded therein, the helically wound reinforcement structure being formed from one or more filaments (Fig. 10 #6; Col. 4, Ln. 2-4). Shimamura teaches a reinforcement structure as providing the benefit of improving tube flexibility while reducing strain on end parts (Col. 2, Ln. 10-19).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in DeLuccia the endotracheal tube body comprising a helically wound reinforcement structure embedded therein, the helically wound reinforcement structure being formed from one or more filaments in order to provide the benefit of improving tube flexibility while reducing strain on end parts in view of Shimamura.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agdanowski (U.S. Patent 4488548) in view of O’Neil et al. (U.S. Pub. 2010/0313896).
Regarding claim 17, Agdanowski is silent as to whether the endotracheal tube comprises a material having a Shore A Hardness in a range of from 60 to 75.
Agdanowski does disclose a material of the endotracheal tube can include polyvinyl chloride (Col. 3, Ln. 11-17). O’Neil teaches an endotracheal tube (Fig. 1; ¶0031) which can be made from a material such as polyvinyl chloride (¶¶0033-0034) and have a Shore A Hardness of 70 (¶0044). O’Neil teaches the claimed Shore A Hardness is a common and expected value for an endotracheal tube material (¶¶0033-0034, 0044).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Agdanowski the endotracheal tube comprises a material having a Shore A Hardness in a range of from 60 to 75 based upon a common use of polyvinyl chloride having Shore A Hardness within the claimed range when making an endotracheal tube in view of O’Neil.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeLuccia et al. (U.S. Patent 4502482) in view of O’Neil et al. (U.S. Pub. 2010/0313896).
Regarding claim 17, DeLuccia is silent as to whether the endotracheal tube comprises a material having a Shore A Hardness in a range of from 60 to 75.
DeLuccia does disclose a material of the endotracheal tube can include polyvinyl (Col. 6, Ln. 1-10). O’Neil teaches an endotracheal tube (Fig. 1; ¶0031) which can be made from a material such as polyvinyl chloride (¶¶0033-0034) and have a Shore A Hardness of 70 (¶0044). O’Neil teaches the claimed Shore A Hardness is a common and expected value for an endotracheal tube material (¶¶0033-0034, 0044).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in DeLuccia the endotracheal tube comprises a material having a Shore A Hardness in a range of from 60 to 75 based upon a common use of polymer materials having Shore A Hardness within the claimed range when making an endotracheal tube in view of O’Neil.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agdanowski (U.S. Patent 4488548) in view of Poormand (U.S. Pub. 2020/0297957).
Regarding claim 18, Agdanowski discloses an intubation system comprising an endotracheal tube according to claim 1 (see above).
Agdanowski fails to disclose a stylet for guiding the endotracheal tube during intubation.
Poormand teaches an intubation kit (Figs. 9-11) including a stylet (Figs. 1a-1b; ¶¶0045, 0063-0065) for guiding an endotracheal tube (Figs. 9-11 #101; ¶0063-0065) during intubation. Poormand teaches a stylet as providing the benefit of assisting a clinician during patient intubation (¶¶0006-0007, 0063-0065).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Agdanowski a stylet for guiding the endotracheal tube during intubation in order to provide the benefit of assisting a clinician during patient intubation in view of Poormand.
Regarding claim 19, Agdanowski teaches the invention as modified above and Poormand as incorporated therein further teaches the stylet comprises a body having a pivotable tip located at a distal end of the body (Poormand – Figs. 2a-2b; ¶0046), the pivotable tip moveable about a pivot point in two opposing directions from the longitudinal axis of the distal end of the stylet body (Poormand – Figs. 2a-2b; ¶0046), and a control mechanism (Poormand – Fig. 2a #7; ¶0045) for controlling the pivot angle of the pivotable tip.
Regarding claim 20, Agdanowski teaches the invention as modified above and Poormand as incorporated therein further teaches each of the endotracheal tube and the stylet comprise a connector configured for respective engagement with one another to attach the stylet to the endotracheal tube (Poormand – Fig. 9; ¶0063).
Allowable Subject Matter
Claim(s) 7 and 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, Agdanowski and DeLuccia each fail to teach or suggest the endotracheal tube comprises a plurality of internal projections, and wherein one projection has a maximum height that is larger than the maximum height of one or more other of the plurality of projections, optionally wherein the projection having the largest maximum height is a projection located along the axis of the longest longitudinal dimension of the distal tip portion. It is initially noted that the “internal projections” of the instant claim are clearly understood to refer back to claim 1. The “optionally” portion of the claim is not read as positively recited.
There is no reason to expect that spacers 58 in Agdanowski would be provided with different heights from each other. Similarly, there is no reason to expect that protuberances 142 in DeLuccia would be provided with different heights from each other.
It is noted that claim 1 has recited several particular limitations which considerably narrow the scope of available prior art (e.g. “internal projections projecting radially inwardly from an internal wall surface of a distal tip portion of the endotracheal tube” with particular attention to the terms “radially,” “inwardly,” and “distal tip” and “the internal projections are tapered”).
The common expectation in the art would be of matching heights when using projections in multiple, as in Agdanowski and DeLuccia. It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 11, DeLuccia fails to teach or suggest the endotracheal tube is configured such that the main tube body buckles at a lower applied axial load than the distal tip portion of the endotracheal tube. It is initially noted that based on the 35 U.S.C. 112(b) rejection of the claim the instant claim has been interpreted as dependent on claim 10. Claim 10 is particularly narrow in scope, beyond the requirements of claim 1 discussed immediately above in regard to claim 7, because of its recitation of the endotracheal tube body as formed of two separate components. The general expectation in the art is for an endotracheal tube body to be made as a singular structure and not as two separate components.
In DeLuccia the bevelled end portion 122 is designed to readily collapse so that it can be retracted when no longer required (e.g. Fig. 13; Col. 8, Ln. 16-31). Based upon the desired collapsibility of bevelled end portion 122 one of ordinary skill in the art would have expected bevelled end portion 122 to be less resistant to buckling than tube 112, which is a reversal of what is required by the instant claim.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785