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 .
This action is in response to the filing on 10/30/2025. Since the previous filing, claims 1, 3 has been amended, claim 25 has been added and no claims have been cancelled. Thus, claims 1-14, 16-19 and 21-25 are pending in the application.
In regards to the previous 103 Rejections, Applicant has amended to overcome these rejections and they are therefore withdrawn with new rejections entered below.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-5, 9-10, 12-14, 16-19 and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loewen (US 2019/0388635) in view of Cant (GB 2504581) and Lucchina (US 2022/0152329).
In regards to claim 1, Loewen discloses a medical device, comprising: anon-steerable ventilation tube introducer (bougie 500); the ventilation tube introducer having a shaft having a longitudinal axis (paragraph 7, see Annotated Fig 5); the shaft having two shaft members provided by a shaft proximal member (tube 520) and a shaft distal member (distal portion 514); a proximal terminal end of the introducer provided by the shaft proximal member and a distal terminal end of the introducer provided by the shaft distal member (see Annotated Fig 5); the shaft proximal member and the shaft distal member are joined to each other (paragraph 34 line 17-20); the shaft distal member is without an internal passageway (distal portion 514 a solid, paragraph 33 line 14-16); the shaft distal member includes a dowel; the shaft proximal member includes a dowel receptacle; and the dowel is disposed in the dowel receptacle (projection 534, paragraph 34 line 17-20).
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Annotated Fig 5
Loewen does not disclose wherein the shaft proximal member is formed of plastic and the shaft distal member is formed of an elastomer having a hardness which is lower than a hardness of the plastic of the shaft proximal member, the shaft distal member is a single monolithic piece having a conical surface which continuously tapers from distally adjacent the shaft proximal member to proximally adjacent the bulbous tip.
However, Cant teaches a bougie wherein the shaft proximal member is formed of plastic (page 6 line 8-9) and the shaft distal member is formed of an elastomer (page 5 line 19) having a hardness which is lower than a hardness of the plastic of the shaft proximal member (tip 10 formed of flexible material while bougie body 26 formed of semi-rigid plastic, page 5 line 19 and page 6 line 8-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein the shaft proximal member is formed of plastic and the shaft distal member is formed of an elastomer having a hardness which is lower than a hardness of the plastic of the shaft proximal member as taught by Cant as this would aid in avoiding causing the patient injury when the device is inserted or removed and one would be motivated to select these materials because Cant provides teaching that is known to provide a similar device section out of these type of materials and shape (Cant: page 3 line 2-4 and 16-17). One skilled in the art would reasonably expect that these materials and shape would allow the device to function in a similar manner.
Further, Lucchina teaches wherein: the distal shaft member is a single monolithic piece (joints between sections may be simple transverse grooves rather than full separations, paragraph 254-256, sheath 200 overmoulded to segments, paragraph 209) having a conical surface which continuously tapers from distally adjacent the shaft proximal member (body 11) to proximally adjacent the bulbous tip (distal portion 12 with sheath 200 smoothly tapers to ball end 210, Fig 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein the distal shaft member is a single monolithic piece having a conical surface which continuously tapers from distally adjacent the shaft proximal member to proximally adjacent the bulbous tip as taught by Lucchina as this would form an atraumatic end for the safety of the patient (Lucchina: paragraph 73).
In regards to claim 2, Loewen in view of Cant and Lucchina teaches the device of claim 1.
Loewen does not disclose wherein: the shaft distal member has a bulbous tip which forms the distal terminal end of the introducer.
However, Lucchina teaches wherein: the shaft distal member has a bulbous tip which forms the terminal end of the introducer (ball end 210, paragraph 218, Fig 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the shaft distal member has a bulbous tip which forms the terminal end of the introducer as taught by Lucchina as this would form an atraumatic end for the safety of the patient (Lucchina: paragraph 73).
In regards to claim 3, Loewen in view of Cant and Lucchina teaches the device of claim 2.
Loewen does not disclose wherein: the conical surface is provided by a conical region which has an outer diameter adjacent the shaft proximal member in a range of 3 mm to 6 mm, and an outer diameter adjacent the bulbous tip of 1 mm to 4 mm; and the conical region has a length of 5 mm to 25 mm.
However, Cant teaches a conical region (tip 10) with a length of 5 mm to 25 mm (page 5 line 12-15).
Further, Lucchina teaches wherein: the conical surface is provided by a conical region which has an outer diameter adjacent the shaft proximal member in a range of 3 mm to 6 mm (first segment 112 with sheathe 200 adjacent body 11 has diameter equal to 11, paragraph 121, being between 3 and 4 mm, paragraph 136), and an outer diameter adjacent the bulbous tip of 1 mm to 4 mm (sheath around final segment 125 approximately 2.8 mm, paragraph 212).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the conical region has an outer diameter adjacent the shaft proximal member in a range of 3 mm to 6 mm, and an outer diameter adjacent the bulbous tip of 1 mm to 4 mm; and the conical region has a length of 5 mm to 25 mm in view of Cant and Lucchina as these are commonly used dimensions so as to safely fit the device into a patient.
In regards to claim 4, Loewen in view of Cant and Lucchina teaches the device of claim 2 and Lucchina further teaches wherein: the bulbous tip is spherical (ball end 210, Fig 3) and has a diameter in a range of 2 mm to 5 mm (paragraph 217).
In regards to claim 5, Loewen in view of Cant and Lucchina teaches the device of claim 1 and Loewen further discloses wherein: the shaft proximal member has a distal end region having an outer diameter; the shaft distal member has a proximal end region having an outer diameter; and the outer diameter of the distal end region of the shaft proximal member and the outer diameter of the proximal end region of the shaft distal member are substantially equal (paragraph 34 line 1-3, Fig 5).
In regards to claim 9, Loewen in view of Cant and Lucchina teaches the device of claim 1 and Cant further teaches the elastomer has a Shore A durometer hardness, as measured by ASTM D2240-15 (2021), in a range of 20-80 Shore A durometer hardness (page 5 line 19-21).
Loewen does not disclose wherein: the plastic has a Shore D durometer hardness, as measured by ASTM D2240-15 (2021), in a range of 55 to 70 Shore D durometer hardness.
However, Lucchina teaches wherein: the plastic has a Shore D durometer hardness, as measured by ASTM D2240-15 (2021), in a range of 55 to 70 Shore D durometer hardness (paragraph 142).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the plastic has a Shore D durometer hardness, as measured by ASTM D2240-15 (2021), in a range of 55 to 70 Shore D durometer hardness as taught by Lucchina as this is a known material property to provide the structure needed to safely and effectively use to the device.
In regards to claim 10, Loewen in view of Cant and Lucchina teaches the device of claim 9 and Cant further teaches wherein: the elastomer has a Shore A durometer hardness, as measured by ASTM D2240-15 (2021), in a range of 25-70 Shore A durometer hardness (page 5 line 19-21).
In regards to claim 12, Loewen in view of Cant and Lucchina teaches the device of claim 1.
Loewen does not disclose wherein: the plastic shaft has a longitudinal length in a range of 50 to 73 centimeters; and the plastic shaft has an outer diameter in a range of 3 to 6 millimeters.
However, Lucchina teaches wherein: the plastic shaft has a longitudinal length in a range of 50 to 73 centimeters (paragraph 4 and paragraph 126); and the plastic shaft has an outer diameter in a range of 3 to 6 millimeters (paragraph 136).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the plastic shaft has a longitudinal length in a range of 50 to 73 centimeters; and the plastic shaft has an outer diameter in a range of 3 to 6 millimeters as taught by Lucchina as this a commonly used length to ensure the device may be fully and safely inserted to the correct position.
In regards to claim 13, Loewen in view of Cant and Lucchina teaches the device of claim 1 and Cant further discloses wherein: the elastomer of the shaft distal member is polyurethane (page 6 line 21-22).
In regards to claim 14, Loewen in view of Cant and Lucchina teaches the device of claim 1 and the combination further teaches wherein: the shaft proximal member and the shaft distal member are bonded to each other (Loewen: paragraph 34 line 17-21; Cant: page 6 line 18 an 21-22 and page 10 line 4-6).
In regards to claim 16, Loewen in view of Cant and Lucchina teaches the device of claim 1 and the combination further teaches wherein: the dowel of the shaft distal member and the dowel receptacle of the shaft proximal member are bonded to each other (Loewen: paragraph 34 line 17-21; Cant: page 6 line 18 and 21-22 and page 10 line 4-6, Fig 4 and 5).
In regards to claim 17, Loewen in view of Cant and Lucchina teaches the device of claim 16 and Cant further teaches wherein: the dowel receptacle of the shaft proximal member includes a plurality of ridges to grip the shaft distal member and/or a plurality of recesses to grip the shaft distal member (splines 16 fit into grooves of body 26, page 10 line 4-6).
In regards to claim 18, Loewen in view of Cant and Lucchina teaches the device of claim 1 and Loewen further discloses wherein: the dowel receptacle of the shaft proximal member is provided by a lumen of the shaft proximal member (paragraph 34 line 17-21, Fig 5).
In regards to claim 19, Loewen in view of Cant and Lucchina teaches the device of claim 1.
Loewen does not disclose wherein: the shaft proximal member and the shaft distal member have different colors.
However, Cant teaches wherein: the shaft proximal member and the shaft distal member have different colors (page 5 line 24 – page 6 line 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the shaft proximal member and the shaft distal member have different colors as taught by Cant as this would make the end easier to see while inserting (Cant: page 5 line 24-25).
In regards to claim 21, Loewen in view of Cant and Lucchina teaches the device of claim 1.
Loewen does not disclose wherein: the dowel of the shaft distal member and the dowel receptacle of the shaft proximal member are friction fit to each other.
However, Cant teaches wherein: the dowel of the shaft distal member and the dowel receptacle of the shaft proximal member are friction fit to each other (page 6 line 181 and 21-22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the dowel of the shaft distal member and the dowel receptacle of the shaft proximal member are friction fit to each other as taught by Cant as this is a known method of attaching adjacent components securely to one another.
In regards to claim 22, Loewen in view of Cant and Lucchina teaches the device of claim 1 and Loewen further discloses wherein: the dowel of the shaft distal member and the dowel receptacle of the shaft proximal member are positively mechanically engaged to each other (paragraph 34 line 17-21).
In regards to claim 23, Loewen in view of Cant and Lucchina teaches the device of claim 1.
Loewen does not disclose wherein: the shaft proximal member and the shaft distal member are friction fit to each other.
However, Cant teaches wherein: the shaft proximal member and the shaft distal member are friction fit to each other (page 6 line 18-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the shaft proximal member and the shaft distal member are friction fit to each other as this is a known means of attachment between components.
In regards to claim 24, Loewen in view of Cant and Lucchina teaches the device of claim 1.
Loewen does not disclose wherein: the shaft proximal member and the shaft distal member are positively mechanically engaged to each other.
However, Cant teaches wherein: the shaft proximal member and the shaft distal member are positively mechanically engaged to each other (page 6 line 18-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the shaft proximal member and the shaft distal member are positively mechanically engaged to each other as this is a known means of attachment between components.
In regards to claim 25, Loewen in view of Cant and Lucchina teaches the device of claim 1.
Loewen does not disclose wherein: the single monolithic piece is a single injection molded piece.
However, Lucchina teaches forming the piece via injection molding (paragraph 39 and 41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the single monolithic piece is a single injection molded piece as taught by Lucchina as even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEM 2113 I).
Claim(s) 6-8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loewen (US 2019/0388635) in view of Cant (GB 2504581) and Lucchina (US 2022/0152329) as applied above and in further view of Talbot (GB 2507474).
In regards to claim 6, Loewen in view of Cant and Lucchina teaches the device of claim 1 and Loewen further discloses wherein the shaft has a shaft proximal segment and a shaft distal segment (see Annotated Fig 5); the shaft proximal segment arranged along the longitudinal axis (see Annotated Fig 5); and the shaft distal segment arranged at an angle relative to the longitudinal axis (see Annotated Fig 5).
Loewen does not disclose wherein the angle is in a range of 140 degrees to 170 degrees.
However, Talbot teaches wherein the angle is in a range of 140 degrees to 170 degrees (angle N is approximately 40 degrees providing a complimentary angle on 140 degrees, page 5 line 10-11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein the angle is in a range of 140 degrees to 170 degrees as taught by Talbot as this would provide an angle at which the device may be more easily inserted into the patient.
In regard to claim 7, Loewen in view of Cant, Lucchina and Talbot teaches the device of claim 6 and Loewen further discloses wherein the shaft distal segment is formed by the shaft proximal member and the shaft distal member (see Annotated Fig 5, interpreting Shaft Proximal Member as including the bend section of 514 as indicated by
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In regards to claim 8, Loewen in view of Cant, Lucchina and Talbot teaches the device of claim 6 and Loewen further discloses wherein the shaft distal segment is formed only by the shaft distal member (see Annotated Fig 5, interpreting Shaft Proximal Member as excluding the bend section of 514).
In regards to claim 11, Loewen in view of Cant and Lucchina teaches the device of claim 1.
Loewen does not disclose wherein: the plastic of the shaft proximal member is polyethylene.
However, Talbot teaches wherein: the plastic of the shaft proximal member is polyethylene (page 3 line 10-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Loewen wherein: the plastic of the shaft proximal member is polyethylene as taught by Talbot as this is a known material for such devices.
Response to Arguments
In regards to the arguments concerning the independent claim, these arguments are in regards to the amendments made to the claims and are addressed in the new rejections entered above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on (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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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785