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 .
Status of Claims
This office action is responsive to the appeal filed on 02/12/2026. Claims 1-17 are presently pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6, 8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kofoed (US 5789660 A), in view of Cline (RU 2678035 C2).
Regarding claim 1, Kofoed discloses an airway adapter (FIG. 1-5 Airway adapter 20) forming a part of a breathing circuit (FIG. 4 and 5 “M”, “F”, and Airway adapter 20) connected to a test subject (Set forth in [Column 6 lines 23-25]), the airway adapter comprising:
a first cylindrical portion (FIG. 1 and 4 Second portion 26) that forms a male terminal fitted into a female member (FIG. 4 and 5 “F”) forming another part of the breathing circuit;
a second cylindrical portion (FIG. 1 and 4 First portion 24) that forms a female terminal compartmentalizing a fitting portion (FIG. 1 Center section 32) into which a male member (FIG. 4 and 5 “M”) forming another part of the breathing circuit is fitted;
an airway forming portion (FIG. 1 Flow passage 34) that is disposed in an internal space compartmentalized by the first cylindrical portion and that forms an airway communicating with the fitting portion;
wherein the first cylindrical portion has a first proximal end portion that is nearer to the second cylindrical portion (As shown in the annotated FIG. 4 below).
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Kofoed does not explicitly disclose a first sealing member that is disposed on an outer circumferential surface of the first cylindrical portion and that has higher flexibility than the first cylindrical portion, and wherein the first proximal end portion is nearer to the second cylindrical portion than the first sealing member.
However, Cline teaches a sealing member (Cline: FIG. 9B Sealing ring 314b) that is disposed on an outer circumferential surface of a first cylindrical portion (Cline: FIG. 9B Housing 308) and that has higher flexibility than the first cylindrical portion (Cline: FIG. 9B Sealing ring 314b can be made of silicone, rubber, or another elastomer as set forth in [0067]), the sealing member (Cline: FIG. 9B Sealing ring 314b) disposed at a position nearer to the first distal end portion than to the first proximal end portion.
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Kofoed and Cline are both considered to be analogous to the claimed invention because they are in the same field of medical connection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Cline and include a sealing member (Cline: FIG. 9B Sealing ring 314b) that is disposed on an outer circumferential surface of a first cylindrical portion (Cline: FIG. 9B Housing 308) and that has higher flexibility than the first cylindrical portion (Cline: FIG. 9B Sealing ring 314b can be made of silicone, rubber, or another elastomer as set forth in [0067]), the sealing member (Cline: FIG. 9B Sealing ring 314b) disposed at a position nearer to the first distal end portion than to the first proximal end portion. The sealing member (Cline: FIG. 9B Sealing ring 314b) disposed at a position nearer to the first distal end portion than to the first proximal end portion would mean that in Kofoed as modified by Cline the first proximal end portion would be nearer to the second cylindrical portion than the first sealing member. Doing so would ensure the desired parts of the apparatus properly engage and form a complete seal (Cline: Set forth in [0067]).
Kofoed as modified fails to explicitly disclose, wherein in a case where the first cylindrical portion is fitted into the female member, the first sealing member is brought into contact with an inner circumferential surface of the female member such that a gap is formed between the outer circumferential surface of the first cylindrical portion and the inner circumferential surface of the female member in at least a part of a section between the first sealing member and the first proximal end portion.
However, with the presence of a sealing member, there would be gaps on both sides of any present sealing member given that the sealing member and the inner circumferential surface would meet before the inner and outer circumferential surfaces, meaning a gap on either side would be present. With a gap present on both sides of the sealing member, there would be, according to the limitation, a gap between the outer circumferential surface of the first cylindrical portion and the inner circumferential surface of the female member in at least a part of a section between the first sealing member and the first proximal end portion.
Regarding claim 2, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kofoed as modified by Cline further teaches the airway adapter, wherein the first sealing member (Cline: FIG. 9B Sealing ring 314b) has a ring shape extending in a circumferential direction of the first cylindrical portion (Cline: FIG. 9B Sealing ring 314b is extending from housing 308).
Regarding claim 3, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kofoed as modified by Cline further teaches the airway adapter (FIG. 1-5 Airway adapter 20), wherein the first cylindrical portion (FIG. 1 and 4 Second portion 26) has a first distal end portion that is farther from the second cylindrical portion (As shown in annotated FIG. 4 below), than the first sealing member (Cline: FIG. 9B Sealing ring 314b which is located on the first cylindrical portion as modified above);
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and the first sealing (Cline: FIG. 9B Sealing rings 314a 314b) disposed at a position nearer to the first distal end portion than to the first proximal end portion (As shown in the annotated figure below and as modified above in claim 1).
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Regarding claim 6, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kofoed does not explicitly disclose wherein the first sealing member includes a plurality of sealing members that are arrayed along a direction in which the male terminal is fitted into the female member.
However, Cline teaches a plurality of sealing members (Cline: FIG. 9B Sealing rings 314a and 314b) that are arrayed along a direction in which the male terminal (Cline: FIG. 9B Housing 308) is fitted into the female member.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Cline and include a plurality of sealing members (Cline: FIG. 9B Sealing rings 314a and 314b) that are arrayed along a direction in which the male terminal (Cline: FIG. 9B Housing 308) is fitted into the female member. It is obvious in the art that including more rings would improve the seal provided by the sealing member.
Regarding claim 8, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kofoed as modified by Cline further teaches the airway adapter, wherein the first sealing member (Cline: FIG. 9B Sealing rings 314a and 314b) protrudes in a radial direction of the first cylindrical portion from the outer circumferential surface of the first cylindrical portion, and has a surface inclined along a direction in which the male terminal is fitted into the female member (Cline: As shown in the annotated figure below).
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Regarding claim 17, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kofoed further discloses the airway adapter, further comprising: a support portion (FIG. 2 Monitoring portion 28) that is disposed between the first cylindrical portion (FIG. 4 Second tubular portion 24) and the second cylindrical portion (FIG. 4 First tubular portion 26), and on which a sensor for detecting gas in the airway is mounted (As set forth in [Column 6 Lines 45-48]).
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kofoed (US 5789660 A), in view of Cline (RU 2678035 C2) as applied to claim 1 and claim 6, in further view of Gordon (US 20150105752 A1).
Regarding claim 5, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kofoed further discloses the airway adapter wherein the first cylindrical portion has a first distal end portion that is farther from the second cylindrical portion (As shown in the annotated FIG. 4 below), than the first sealing member (Cline: FIG. 9B Sealing ring 314b which is located on the first cylindrical portion as modified above);
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and a dimension in a radial direction of the first cylindrical portion is smaller in value at the first distal end portion than at the first proximal end portion (Bores of first portion 24 and second portion 26 are tapered as set forth in [Column 7 lines 57-59] indicating that the first cylindrical portion will be smaller at the distal end then it is at the proximal end).
Additionally, Gordan teaches wherein a dimension in a radial direction of a cylindrical portion is smaller in value at a distal end portion than at a proximal end portion (Gordan: FIG. 2 Adapter tool 100 as set forth in [0016] and shown in the figure to be tapered in nature, wherein the radial dimension is smaller in value at a distal end portion than at a proximal end portion).
Kofoed and Gordan are both considered to be analogous to the claimed invention because they are in the same field of medical connection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Gordan and include the tapered nature of the male member of the adapter, wherein a dimension in a radial direction of a cylindrical portion is smaller in value at a distal end portion than at a proximal end portion (Gordan: FIG. 2 Adapter tool 100 as set forth in [0016] and shown in the figure to be tapered in nature, wherein the radial dimension is smaller in value at a distal end portion than at a proximal end portion). Doing so would further enable the device to act as a universal adapter for use with a variety of connection parts (Gordan: As set forth in [0016]).
Regarding claim 7, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 6 above.
Kofoed does not explicitly disclose the airway adapter according, wherein the first sealing members consist of at least two first sealing members having different protrusion heights from the outer circumferential surface; and one of the first sealing members that has a larger protrusion height is disposed at a position where an interval between an inner circumferential surface of the female member and the outer circumferential surface is larger when the first cylindrical portion is fitted into the female member.
However, Gordan teaches wherein a dimension in a radial direction of a cylindrical portion is smaller in value at a distal end portion than at a proximal end portion (Gordan: FIG. 2 Adapter tool 100 as set forth in [0016] and shown in the figure to be tapered in nature, wherein the radial dimension is smaller in value at a distal end portion than at a proximal end portion).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Gordan and include the tapered nature of the male member of the adapter, wherein a dimension in a radial direction of a cylindrical portion is smaller in value at a distal end portion than at a proximal end portion (Gordan: FIG. 2 Adapter tool 100 as set forth in [0016] and shown in the figure to be tapered in nature, wherein the radial dimension is smaller in value at a distal end portion than at a proximal end portion). Doing so would further enable the device to act as a universal adapter for use with a variety of connection parts (Gordan: As set forth in [0016]).
Further, it would be obvious to someone skilled in the art that if the first cylindrical portion is tapered (Bores of first portion 24 and second portion 26 are tapered as set forth in [Column 7 lines 57-59] indicating that the first cylindrical portion will be smaller at the distal end then it is at the proximal end, and as set forth above as modified by Gordon), the first sealing members consisting of at least two first sealing members, would have to have different protrusion heights from the outer circumferential surface (FIG. 4 Outside of second portion 26); and one of the first sealing members would have to have a larger protrusion height disposed at a position where an interval between an inner circumferential surface of the female member (FIG. 4 inside “F”) and the outer circumferential surface is larger when the first cylindrical portion is fitted into the female member. Doing so would mean that the sealing members are able to correctly provide a gas-tight seal since they will be able to engage properly with the inner circumferential surface of the female member.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kofoed (US 5789660 A) in view of Cline (RU 2678035 C2) as applied to claim 1, in further view of Phillips (WO 2019105597 A1).
Regarding claim 4, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kofoed further discloses the airway adapter (FIG. 1-5 Airway adapter 20), wherein the first cylindrical portion (FIG. 1 and 4 Second portion 26) has a first distal end portion that is farther from the second cylindrical portion (As shown in annotated FIG. 4 below) than the sealing member (Cline: FIG. 9B Sealing ring 314b which is located on the first cylindrical portion as modified above);
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Kofoed as modified does not explicitly disclose the first sealing member is disposed at a position nearer to the first proximal end portion than to the first distal end portion.
However, Philips teaches the first sealing member (Phillips: FIG. 3 Sealing ring 45) is disposed at a position nearer to the first proximal end portion than to the first distal end portion (Phillips: Shown in annotated FIG. 3 below).
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Kofoed and Philips are both considered to be analogous to the claimed invention because they are in the same field of medical connection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Phillips and include the first sealing member (Phillips: FIG. 3 Sealing ring 45) is disposed at a position nearer to the first proximal end portion than to the first distal end portion. Doing so would ensure the desired parts of the apparatus properly engage and seal (Philips: As set forth in [0065]).
Claim 9, 10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kofoed (US 5789660 A) in view of Cline (RU 2678035 C2) as applied to claim 1, in further view of Brudenell (WO 2021009511 A1).
Regarding claim 9, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kofoed as modified further discloses wherein the second cylindrical portion has a second proximal end portion (As shown in the annotated figure below).
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Kofoed does not explicitly disclose the airway adapter, further comprising: a second sealing member that is disposed on an inner circumferential surface of the second cylindrical portion in the fitting portion, and that has higher flexibility than the second cylindrical portion and wherein the second proximal end portion is nearer to the first cylindrical portion than the second sealing member.
However, Brudenell teaches a second sealing member (Brudenell: FIG. 3 Sealing ring 302) that is disposed on an inner circumferential surface of the second cylindrical portion (Brudenell: FIG. 3 Half 301b) in the fitting portion (Brudenell: FIG. 3 Inside of half 301b), and that has higher flexibility than the second cylindrical portion (Brudenell: FIG. 3 Sealing ring 302 may be formed of rubber as set forth on [Page 11 Lines 30-31]).
Kofoed and Brudenell are both considered to be analogous to the claimed invention because they are in the same field of medical connection devices involving gas. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Brudenell and include a second sealing member (Brudenell: FIG. 3 Sealing ring 302) that is disposed on an inner circumferential surface of the second cylindrical portion (Brudenell: FIG. 3 Half 301b) in the fitting portion (Brudenell: FIG. 3 Inside of half 301b), and that has higher flexibility than the second cylindrical portion (Brudenell: FIG. 3 Sealing ring 302 may be formed of rubber as set forth on [Page 11 Lines 30-31]). The second sealing member (Brudenell: FIG. 3 Sealing ring 302) being disposed on an inner circumferential surface of the second cylindrical portion would mean that the second proximal end portion is nearer to the first cylindrical portion than the second sealing member. Doing so would ensure a gas tight seal between the two components (Brudenell: As set forth on [Page 11 Lines 28-31]).
Kofoed as modified fails to explicitly disclose, wherein in a case where the male member is fitted into the fitting portion, the second sealing member is brought into contact with an outer circumferential surface of the male member such that a gap is formed between the inner circumferential surface of the second cylindrical portion and the outer circumferential surface of the male member in at least a part of a section between the second sealing member and the second proximal end portion.
However, with the presence of a sealing member, there would be gaps on both sides of any present sealing member given that the sealing member and the inner circumferential surface would meet before the inner and outer circumferential surfaces, meaning a gap on either side would be present. With a gap present on both sides of the sealing member, there would be, according to the limitation, a gap formed between the inner circumferential surface of the second cylindrical portion and the outer circumferential surface of the male member in at least a part of a section between the second sealing member and the second proximal end portion when the second sealing member is brought into contact with an outer circumferential surface of the male member.
Regarding claim 10, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Kofoed as modified by Brudenell further teaches the airway adapter, wherein the second sealing member (Brudenell: FIG. 3 Sealing ring 302) has a ring shape that extends in a circumferential direction of the second cylindrical portion (Brudenell: FIG. 3 Sealing ring 302 is extending from half 301b).
Regarding claim 12, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Kofoed as modified further discloses the airway adapter (FIG. 1-5 Airway adapter 20), wherein the fitting portion has a second distal end portion (As shown in the annotated FIG. 4 below) that is farther from the first cylindrical portion than the second sealing member (Brudenell: FIG. 3 Sealing ring 302 being disposed on the inner circumferential surface of the second cylindrical portion);
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Kofoed as modified does not explicitly the second sealing member is disposed at a position nearer to the second proximal end portion than to the second distal end portion.
However, Brudenell teaches the second sealing member (Brudenell: FIG. 3 Sealing ring 302) is disposed at a position nearer to the second proximal end portion than to the second distal end portion (Brudenell: As shown in the annotated figure below).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Brudenell and include the second sealing member (Brudenell: FIG. 3 Sealing ring 302) is disposed at a position nearer to the second proximal end portion than to the second distal end portion (Brudenell: As shown in the annotated figure). Doing so would ensure the desired parts of the apparatus properly engage and seal (Brudenell: As set forth on [Page 11 Lines 28-31]).
Regarding claim 13, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Kofoed further discloses the airway adapter, wherein the second cylindrical portion has a second proximal end portion that is nearer to the first cylindrical portion, and a second distal end portion (As shown in the annotated FIG. 4 below) that is farther from the first cylindrical portion than the second sealing member (Brudenell: FIG. 3 Sealing ring 302 being disposed on the inner circumferential surface of the second cylindrical portion);
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Kofoed does not explicitly disclose a dimension of the fitting portion in the radial direction of the second cylindrical portion is smaller in value at the second proximal end portion than at the second distal end portion.
However, Brudenell teaches a dimension of the fitting portion (Brudenell: FIG. 3 inside Half 301b) in the radial direction of the second cylindrical portion (Brudenell: FIG. 3 Half 301b) is smaller in value at the second proximal end portion than at the second distal end portion (Brudenell: As shown in the annotated figure below).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Brudenell and include a dimension of the fitting portion (Brudenell: FIG. 3 inside Half 301b) in the radial direction of the second cylindrical portion (Brudenell: FIG. 3 Half 301b) is smaller in value at the second proximal end portion than at the second distal end portion (Brudenell: As shown in the annotated figure). Doing so would allow for a male member to be easily coupled to the female terminal end of the second cylindrical portion.
Regarding claim 14, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Kofoed as modified does not explicitly disclose wherein the second sealing member includes a plurality of sealing members that are arrayed along a direction in which the male member is fitted.
However, Cline teaches a plurality of sealing members (Cline: FIG. 9B Sealing rings 314a and 314b).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Cline and include a plurality of sealing members (Cline: FIG. 9B Sealing rings 314a and 314b). It is obvious in the art that including more rings would improve the seal provided by the sealing member.
Regarding claim 15, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 14 above.
Kofoed as modified by Brudenell and Cline teaches the airway adapter, wherein the second sealing member consisting of at least two second sealing members (Cline: FIG. 9B Sealing rings 314a and 314b).
Kofoed as modified does not explicitly disclose wherein the sealing members having different protrusion heights from the inner circumferential surface; and one of the second sealing members that has a larger protrusion height is disposed at a position where an interval between an outer circumferential surface of the male member and the inner circumferential surface is larger when the male member is fitted into the fitting portion.
However, it would be obvious to someone skilled in the art that if the fitting portion (Brudenell: FIG. 3 inside Half 301b) in the radial direction of the second cylindrical portion (Brudenell: FIG. 3 Half 301b) is smaller in value at the second proximal end portion than at the second distal end portion (Brudenell: As shown in the annotated figure below),
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the second sealing members consisting of at least two second sealing members would have to have different protrusion heights from the inner circumferential surface (FIG. 4 Inside first portion 24); and one of the second sealing members would have to have a larger protrusion height disposed at the position where an interval between an outer circumferential surface of the male member (FIG. 4 Outside “M”) and the inner circumferential surface is larger when the male member is fitted into the fitting portion. Doing so would mean that the sealing members are able to correctly provide a gas-tight seal since they will be able to engage properly with the outer circumferential surface of the male member.
Regarding claim 16, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Kofoed as modified by Brudenell further teaches the airway adapter wherein the second sealing member (Brudenell: Sealing ring 302) protrudes in a radial direction of the first cylindrical portion from an inner circumferential surface of the second cylindrical portion (Brudenell: As shown in the annotated figure below) and has an inclined surface extending along a direction in which the male member is fitted (Brudenell: As shown in the annotated figure below).
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Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kofoed (US 5789660 A), in view of Cline (RU 2678035 C2), in further view of Brudenell (WO 2021009511 A1) as applied to claim 9, in further view of Chiu (US 20140378950 A1).
Regarding claim 11, Kofoed as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Kofoed further discloses the airway adapter (FIG. 1-5 Airway adapter 20), wherein the fitting portion has a second distal end portion (As shown in the annotated FIG. 4 below) that is farther from the first cylindrical portion than the second sealing member (Brudenell: FIG. 3 Sealing ring 302 being disposed on the inner circumferential surface of the second cylindrical portion).
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Kofoed as modified does not explicitly disclose the second sealing member is disposed at a position nearer to the second distal end portion than to the second proximal end portion.
However, Chiu further teaches the second sealing member (Chiu: FIG. 4 Sealing member 4) is disposed at a position nearer to the second distal end portion than to the second proximal end portion (Chiu: As shown in the annotated figure below).
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Kofoed and Chiu are both considered to be analogous to the claimed invention because they are in the same field of connectors for medical use. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kofoed to incorporate the teaching of Chiu and include the second sealing member (Chiu: FIG. 4 Sealing member 4) is disposed at a position nearer to the second distal end portion than to the second proximal end portion (Chiu: As shown in the annotated figure). Doing so would Doing so would ensure the desired parts of the apparatus properly engage and seal (Chiu: As set forth in [0023]).
Response to Arguments
Applicant’s arguments, see pages 1-5, filed 02/12/2026, with respect to the rejections of independent claim 1 under 35 U.S.C. 103 as being unpatentable over Kofoed (US 5789660 A), in view of Cline (RU 2678035 C2) and Gordon (US 20150105752 A1) and all dependent claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made for independent claim 1 under 35 U.S.C. 103 as being unpatentable over Kofoed (US 5789660 A) in view of Cline (RU 2678035 C2), and dependent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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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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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights