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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “adjustable flange further comprises a protrusion configured for fitting around part of said patient’s nose” (claim 19) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification fails to include any discussion of the adjustable flange comprising a protrusion configured for fitting around part of said patient’s nose.
Claim Objections
Claim(s) 8-10, 17-21 and 26-27 is/are objected to because of the following informalities:
Claim 8, Ln. 2 recites “said first distal opening” which should read “said first opening” following after claim 1
Claim 9, Ln. 2 recites “said first distal opening” which should read “said first opening” following after claim 1
Claim 10, Ln. 2-3 recites “the first circular cross-section of said tubular body” which should read “a first circular cross-section of said flexible tubular body”
Claim 17, Ln. 2 recites “the interface with said tubular body” which should read “an interface with said flexible tubular body”
Claim 18, Ln. 2-3 recites “said tubular body” which should read “said flexible tubular body”
Claim 19, Ln. 2 recites “a patient’s nose” which should read “said patient’s nose” following after claim 1
Claim 20 needs a comma at the end of its preamble
Claim 20, Ln. 2 recites “said tubular body” which should read “said flexible tubular body”
Claim 20, Ln. 2 recites “said first distal opening” which should read “said first opening” following after claim 1
Claim 21, Ln. 1 recites “said at least one securing strap” which should read “said at least one securement strap” for consistency with claim 14
Claim 26 needs a comma at the end of its preamble
Claim 27, Ln. 3 recites “a patient with said securement strap” which should read “the patient with said at least one securement strap” following after claim 1 and for consistency with claim 14
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) 13, 20 and 25 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 13 recites the limitation “means for controlling slidable friction along said proximal segment of said flexible tubular body” in Ln. 2 which deems the claim indefinite. The flange 50 in the disclosure of the invention is only specifically shown and discussed as sliding along the distal portion of the flexible tubular body (e.g. in Figs. 1 & 7 #50 is below #14). Additionally, claim 12 has recited the adjustable flange as “configured to slidably translate along said distal segment”. It is thus unclear why the instant claim refers to the proximal segment instead of the distal segment. It appears that confusion may be a typographical error. For the purposes of examination the limitation will be interpreted as reading “means for controlling slidable friction along said distal segment of said flexible tubular body”.
Claim 20 recites the limitation “the first segment” 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 distal segment” based at least upon the discussion of indicators in ¶0048 of the PGPub copy of the instant application.
Claim 25 recites the limitation “the proximal segment” in Ln. 1. There is insufficient antecedent basis for this limitation in the claim. The proper antecedent basis is found in claim 6. The instant claim should either be made ultimately dependent on claim 6 or be amended to include the limitations of claim 6.
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 (claim 13) 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.
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 “means for controlling slidable friction along said proximal segment of said flexible tubular body” is best understood from the specification as at least: twist-lock features, friction lock features, embossments, squeeze-temporary shape change features, and tapered interface areas (¶0021 of the PGPub copy of the instant application).
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (U.S. Pub. 2004/0099273) in view of Guyuron et al. (U.S. Pub. 2012/0080037).
Regarding claim 1, Wright discloses a nasopharyngeal airway device (Figs. 1-3C; ¶0016) comprising: a tubular body (Figs. 1-2 #12; ¶0016) extending between a first distal end (Figs. 1-2 bottom of #12) and a second proximal end (Figs. 1-2 top of #12), said first distal end configured for placement in a patient’s pharynx via insertion through a nostril (Figs. 3A-3C) and said second proximal end configured to extend outside said patient’s nose (Figs. 3A-3C); a first opening (Fig. 1 #16; ¶0016) at the first distal end of said tubular body, said first opening being offset from a longitudinal center of said tubular body at said first distal end (Fig. 1; ¶0016 – bevel shaped); a second opening (Fig. 3A top of #12) at the second proximal end of said tubular body, said second opening being orthogonal to the longitudinal center of said tubular body at said second proximal end (Figs. 1-3C).
Wright is silent as to whether the tubular body is flexible.
Guyuron teaches a nasopharyngeal airway device (Fig. 2 #10; ¶0031) including a body (Fig. 2 #18) formed of a flexible material (¶0031). Guyuron teaches a flexible body material as providing the benefit of facilitating the insertion of the nasopharyngeal airway into a patient’s nose and through the nasal passage by allowing the nasopharyngeal airway to bend and flex as may be necessary to navigate through the internal anatomy of the patient's nasal passage (¶0031).
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 Wright the tubular body is flexible in order to provide the benefit of facilitating the insertion of the nasopharyngeal airway into a patient’s nose and through the nasal passage by allowing the nasopharyngeal airway to bend and flex as may be necessary to navigate through the internal anatomy of the patient's nasal passage in view of Guyuron.
Regarding claim 2, Wright teaches the invention as modified above and further suggests as obvious said flexible tubular body is formed with a shape-memory curvature between the first distal end and second proximal end (Wright – Fig. 2, Guyuron – Fig. 2; intends curved shape), and the first opening at the first distal end of said flexible tubular body is offset toward an interior of said curvature (Wright – Figs. 1-2).
Regarding claim 3, Wright teaches the invention as modified above and further suggests as obvious said flexible tubular body has an annular cross-section at the first distal end circumscribing a circular interior, and the first opening is an oblong having an area greater than the circular interior (Wright – Figs. 2-3B). The illustrated opening 16 in Wright is obviously suggestive of being larger than the annular cross-section of distal end 18.
Regarding claim 4, Wright teaches the invention as modified above and further teaches said flexible tubular body has a rounded distal wall section adjoining the first opening (Wright – Fig. 1 – rounded adjacent #16).
Regarding claim 5, Wright teaches the invention as modified above and further teaches said flexible tubular body has an annular cross-section at the second proximal end circumscribing a circular interior, and the second opening is circular with an area
Regarding claim 6, Wright teaches the invention as modified above and further teaches said flexible tubular body is stepped along its length between the first distal end and the second proximal end resulting in a distal segment having a smaller diameter than a proximal segment (Figs. 1-2). The trumpet 12 has a widest diameter which steps down to a main, smaller diameter as the tube moves distally.
Regarding claim 7, Wright teaches the invention as modified above and together with Guyuron further teaches a plurality of radially-oriented openings (Guyuron – Fig. 2 #30, 30; ¶0036) along the distal segment of said flexible tubular body. While Wright only teaches a single opening 20 (Fig. 1; ¶0016) Guyuron teaches as obvious adding a further side opening (Fig. 2 #30, 30; ¶0036). Note also holes 50 in Figs. 10-11 of Guyuron (¶¶0052-0054).
Regarding claim 8, Wright teaches the invention as modified above and together with Guyuron further teaches said plurality of radially-oriented openings are spaced longitudinally from said first opening (Wright – location of #20 in Fig. 1; Guyuron – location of #30 in Fig. 2). Note also holes 50 in Figs. 10-11 of Guyuron (¶¶0052-0054).
Regarding claim 9, Wright teaches the invention as modified above and together with Guyuron further teaches said plurality of radially-oriented openings are spaced circumferentially about said first opening (Wright – location of #20 in Fig. 1; Guyuron – location of #30 in Fig. 2). Note also holes 50 in Figs. 10-11 of Guyuron (¶¶0052-0054).
Regarding claim 10, Wright teaches the invention as modified above and further suggests as obvious said plurality of radially-oriented openings each have a diameter less than or equal to a diameter of a first circular cross-section of said flexible tubular body (Figs. 1-2 #20 only has a limited opening size relative to the tube diameter). Note also holes 50 in Figs. 10-11 of Guyuron (¶¶0052-0054).
Regarding claim 11, Wright teaches the invention as modified above and further teaches said second proximal end of the flexible tubular body is configured for attachment to an existing adjunct airway device (Figs. 1-2 & 3C).
Claim(s) 12-13, 16, 18-20, 22 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (U.S. Pub. 2004/0099273) in view of Guyuron et al. (U.S. Pub. 2012/0080037) and further in view of Barodka (U.S. Pub. 2010/0300450).
Regarding claim 12, Wright teaches the invention as modified above but fails to teach an adjustable flange configured to slidably translate along said distal segment of said flexible tubular body.
Barodka teaches a nasopharyngeal airway device (Figs. 1-3 #10; ¶0019) including an adjustable flange (Fig. 1 #26; ¶0020) configured to slidably translate along a portion of the device. The adjustable flange 26 of Barodka is located distally of connector portion 22 which creates a stepped diameter along device 10 from a maximum diameter at connector portion 22 to a smaller diameter along a main portion of airway tube 12 (e.g. Figs. 1-2). Barodka teaches an adjustable flange as providing the benefit of being moveably disposed along the tube to help stabilize and hold the device in place at the patient's nostril (¶0020).
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 substituted in the modified Wright, in place of the trumpet design, an adjustable flange configured to slidably translate along said distal segment of said flexible tubular body in order to provide the benefit of supply a moveable flange disposed along the tubular body to help stabilize and hold the device in place at the patient's nostril in view of Barodka. One of ordinary skill in the art would have obviously recognized the benefit of the adjustability of the adjustable flange of Barodka over the static trumpet design of Wright.
Regarding claim 13, Wright teaches the invention as modified above and Barodka further suggests as obvious said adjustable flange includes means for controlling slidable friction along said proximal segment of said flexible tubular body (Figs. 1-2; ¶0020). The disclosed “means for controlling slidable friction” as noted above covers a wide range of possibilities. The adjustable annular flange 26 of Barodka will obviously have some mechanism to control its sliding, with even a friction fit being readable as at least a functional equivalent of the broadly disclosed “means” of the claim.
Regarding claim 16, Wright teaches the invention as modified above and Barodka further suggests as obvious said distal segment of said flexible tubular body comprises at least one adjustment indicator (¶0023 – indicator markings) configured to index a position of said adjustable flange.
Regarding claim 18, Wright teaches the invention as modified above and Barodka further teaches said adjustable flange further comprises at least one gripping extension (Figs. 1-2 surface of #26 readable as a gripping extension) that is laterally or axially oriented with respect to said flexible tubular body.
Regarding claim 19, Wright teaches the invention as modified above and Barodka further teaches said adjustable flange further comprises a protrusion configured for fitting around part of said patient’s nose (Barodka – Fig. 3 shows #26 protruding around an entrance to the patient’s nose).
Regarding claim 20, Wright teaches the invention as modified above but fails to teach at least one indicator along the distal segment of said flexible tubular body to index orientation of said first opening.
Barodka teaches nasopharyngeal airway device (Figs. 1-3 #10; ¶0019) including indicator markings to index depth of insertion (¶0023). Barodka teaches indicator markings as providing the benefit of ensuring correct placement of the device within a patient’s airway (¶0023).
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 the modified Wright at least one indicator along the distal segment of said flexible tubular body to index orientation of said first opening in order to provide the benefit of ensuring correct placement of the device within a patient’s airway in view of Barodka.
Regarding claim 22, Wright teaches the invention as modified above and Barodka further teaches said adjustable flange comprises at least one lateral extension (Figs. 1-2 surface of #26 readable as a lateral extension).
Regarding claim 26, Wright teaches the invention as modified above but fails to teach an external flange extending radially from said flexible tubular body.
Barodka teaches nasopharyngeal airway device (Figs. 1-3 #10; ¶0019) including an external flange (Fig. 1 #26; ¶0020) extending radially from the device. Barodka teaches an external flange as providing the benefit of being moveably disposed along the tube to help stabilize and hold the device in place at the patient's nostril (¶0020).
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 substituted in Wright, in place of the trumpet design, an external flange extending radially from said flexible tubular body in order to provide the benefit of supply a moveable flange disposed along the tubular body to help stabilize and hold the device in place at the patient's nostril in view of Barodka. One of ordinary skill in the art would have obviously recognized the benefit of the adjustability of the adjustable flange of Barodka over the static trumpet design of Wright.
Claim(s) 14 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (U.S. Pub. 2004/0099273) in view of Guyuron et al. (U.S. Pub. 2012/0080037) and further in view of Barodka (U.S. Pub. 2010/0300450) and further in view of Thompson et al. (U.S. Pub. 2013/0338521).
Regarding claim 14, Wright teaches the invention as modified above but fails to teach said adjustable flange includes at least one securement strap.
Thompson teaches a nasal tube device (e.g. Fig. 5A) including a flange (Fig. 5A #104; ¶0064) includes at least one securement strap (Fig. 5A #510; ¶0064). Thompson teaches a securing strap as providing the benefit of holding the nasal tube device in place and secured to the patient (¶0064).
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 the modified Wright said adjustable flange includes at least one securement strap in order to provide the benefit of holding the nasal tube device in place and secured to the patient in view of Thompson.
Regarding claim 21, Wright teaches the invention as modified above and Thompson further teaches said at least one securement strap is an elastic loop (Fig. 5A; ¶¶0055-0056).
Claim(s) 14-15, 17, 21 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (U.S. Pub. 2004/0099273) in view of Guyuron et al. (U.S. Pub. 2012/0080037) and further in view of Barodka (U.S. Pub. 2010/0300450) and further in view of Byatt (U.S. Pub. 2008/0149107).
Regarding claim 14, Wright teaches the invention as modified above but fails to teach said adjustable flange includes at least one securement strap.
Byatt teaches a tracheotomy tube device (Figs. 1-4; ¶0015) including an adjustable flange (#20; ¶0016) including at least one securement strap (Fig. 3 connectable to #57; ¶0016). Thompson teaches a securing strap as providing the benefit of holding the tube in place on the patient during use (¶0016). Byatt is read as analogous art as it addresses the same problem of securing an airway tube to a patient.
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 the modified Wright said adjustable flange includes at least one securement strap in order to provide the benefit of holding the tube in place on the patient during use in view of Byatt.
Regarding claim 15, Wright teaches the invention as modified above but fails to teach said adjustable flange includes at least one depressed region configured to promote a sturdy grip.
Byatt teaches a tracheotomy tube device (Figs. 1-4; ¶0015) including an adjustable flange (#20; ¶0016) including a depressed region (Figs. 2 & 4 ends of #24, 25 near #1; ¶0017) configured to promote a sturdy grip. Thompson teaches a depressed region as providing the benefit of allowing alternation between an unlocked condition and a locked condition for the flange (¶0017). Byatt is read as analogous art as it addresses the same problem of securing an airway tube to a patient.
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 the modified Wright said adjustable flange includes at least one depressed region configured to promote a sturdy grip in order to provide the benefit of allowing alternation between an unlocked condition and a locked condition for the flange in view of Byatt.
Regarding claim 17, Wright teaches the invention as modified above but fails to teach said adjustable flange further comprises protrusions at an interface with said flexible tubular body.
Byatt teaches a tracheotomy tube device (Figs. 1-4; ¶0015) including an adjustable flange (#20; ¶0016) including protrusions (Figs. 2 & 4 ends of #24, 25 near #1; ¶0017) at an interface with said flexible tubular body. Thompson teaches protrusions as providing the benefit of allowing alternation between an unlocked condition and a locked condition for the flange (¶0017). Byatt is read as analogous art as it addresses the same problem of securing an airway tube to a patient.
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 the modified Wright said adjustable flange further comprises protrusions at an interface with said flexible tubular body in order to provide the benefit of allowing alternation between an unlocked condition and a locked condition for the flange in view of Byatt.
Regarding claim 21, Wright teaches the invention as modified above and Byatt further suggests as obvious said at least one securement strap is an elastic loop. One of ordinary skill in the art of airway tubes would obviously have expected a securing strap to be elastic in order to conform to the differently sized anatomy of different patients.
Regarding claim 27, Wright teaches the invention as modified above and Byatt further teaches at least one notch in said adjustable flange configured to allow the adjustable flange to pinch said flexible tubular body when secured to a patient with said securement strap (Fig. 4 pinching of #24, 25 against #1; ¶0017).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (U.S. Pub. 2004/0099273) in view of Guyuron et al. (U.S. Pub. 2012/0080037) and further in view of Gingles et al. (U.S. Pub. 2005/0103332).
Regarding claim 23, Wright teaches the invention as modified above and further teaches a rounded distal wall section adjoining the first opening (Wright – Fig. 1 – rounded adjacent #16)
Wright is silent as to said rounded distal wall section having a reduced wall thickness relative to adjoining wall sections to promote atraumatic insertion.
Gingles teaches an airway catheter (Fig. 6; ¶0034) including a gradually decreasing thickness from proximal portion 72 to distal portion 76 (¶0034). Gingles teaches a least thickness provided at the distal end as having the same benefit as using a lowest durometer material at the distal end (¶0034) and teaches the benefit of using a lowest durometer material at the distal end as being to reduce trauma to the airway during insertion (¶0024).
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 the modified Wright said rounded distal wall section having a reduced wall thickness relative to adjoining wall sections to promote atraumatic insertion in order to provide the benefit of using a least thickness at the distal end to reduce trauma to the airway during insertion in view of Gingles.
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (U.S. Pub. 2004/0099273) in view of Guyuron et al. (U.S. Pub. 2012/0080037) and further in view of Sasaki (U.S. Pub. 2021/0169678).
Regarding claim 24, Wright teaches the invention as modified above but is silent as to whether said flexible tubular body is transparent or translucent.
Sasaki teaches a nasopharyngeal airway device (Fig. 1 #1; ¶0022) and teaches the device as formed of transparent synthetic resin (¶0022, claim 10). Sasaki teaches transparent material as an obvious design choice when seeking to specify a soft synthetic material for use in a patient’s airway(¶0022, claim 10).
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 the modified Wright said flexible tubular body is transparent based upon an obvious design choice when selecting a particular material in Wright to use a soft synthetic material which is transparent in view of Sasaki.
Regarding claim 25, Wright teaches the invention as modified above and Sasaki further suggests as obvious the proximal segment of said flexible tubular body is transparent or translucent (claim 10 – entire tube transparent).
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. Regarding claim 1 further attention is particularly drawn to: Barodka (U.S. Pub. 2010/0300450; Fig. 3), Guyuron et al. (U.S. Pub. 2012/0080037; Fig. 2) and Plott et al. (U.S. Pub. 2022/0378598; Figs. 1A-1B).
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.
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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.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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