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 .
Response to Amendment
The Amendment filed on 12/4/2025 has been entered. Claims 1-9 and 11-20 remain pending in the application. Claim 21 is new.
Applicants amendments to the abstract have overcome the abstract objections previously set forth in the Non-final Office Action mailed 9/30/2025.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 9/30/2025.
Applicants amendments to the claims have failed to overcome all of the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 9/30/2025. Specifically, the rejection of claim 19 under 35 U.S.C. 112 has not been overcome.
Examiner notes Applicant did not properly underline all new amendments made to the claims. All amendments must be properly indicated. See 37 CFR 1.121, section (c)(2).
In claim 2, line 3 “the[[a]]” should have stated “the[[a]]” to indicate the term “the” was added.
In claim 3, line 4 “first channel and the second channel” should have stated “first channel and the second channel” to indicate the term “channel” and “the” was added.
In claim 3, line 5 “first channel and the second channel” should have stated “first channel and the second channel” to indicate the term “channel” and “the” was added.
In claim 7, line 3 “the[[an]]” should have stated “the[[an]]” to indicate the term “the” was added.
In claim 11, line 5 “the first position and the second position” should have stated “the first position and the second position” to indicate the terms “position” and “the” were added.
In claim 11, line 6 “first opening of the housing” should have stated “first opening of the housing” to indicate “of the housing” was added.
In claim 12, line 2 “comprises comprises
In claim 12, line 2 “the inner surface of the housing” should have stated “the inner surface of the housing” to indicate “of the housing” was added.
In claim 15, line 3 “a[[the]]” should have stated “a[[the]]” to indicate the term “a” was added.
In claim 20, line 4 “the[[a]]” should have stated “the[[a]]” to indicate the term “the” was added.
Examiner notes although these amendments are not underlined, they are entered.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 13 recites “the finger”. Line 7 and 8 refer to the finger as the flexible finger. Examiner suggests replacing “the finger” in line 13 of claim 1 with “the flexible finger” to put the claim in clearer form and clearly refer to the flexible finger of line 7.
Line 17-18 recites “the finger”. Line 7 and 8 refer to the finger as the flexible finger. Examiner suggests replacing “the finger” in line 17-18 of claim 1 with “the flexible finger” to put the claim in clearer form and clearly refer to the flexible finger of line 7.
Claim 17 objected to because of the following informalities:
Line 20 recites “the finger”. Line 11 and 12 refer to the finger as the flexible finger. Examiner suggests replacing “the finger” in line 20 of claim 17 with “the flexible finger” to put the claim in clearer form and clearly refer to the flexible finger of line 11.
Line 24 recites “the finger”. Line 11 and 12 refer to the finger as the flexible finger. Examiner suggests replacing “the finger” in line 24 of claim 17 with “the flexible finger” to put the claim in clearer form and clearly refer to the flexible finger of line 11.
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.
Claims 1-9 and 11-21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 1,
Line 6-7 recites “at least one channel that extends through the first end of the inner body to form a flexible finger between the at least one channel”. It is unclear what is meant by this. It is unclear how the at least one channel can form a flexible finger as a channel is an opening. Based on the disclosure it appears the coupling sleeve forms the flexible finger and that there is at least one channel located next to the flexible finger. For examination purposes Examiner construes “at least one channel that extends through the first end of the inner body to form a flexible finger between the at least one channel” to require the coupling sleeve to form a flexible finger and have at least one channel located next to the flexible finger.
Examiner notes claims 2-9 and 11-16 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 3,
Line 3-6 recites “a first portion of the coupling sleeve between the first channel and the second channel forms a first flexible finger, and a second portion of the coupling sleeve between the first channel and the second channel forms a second flexible finger”. Claim 3 depends on claim 1. Claim 1 requires a flexible finger. It is unclear if the first flexible finger and second flexible finger are in addition to the flexible finger of claim 1 i.e. three flexible fingers are required or if the flexible finger of claim 1 is the same as the first flexible finger. For examination purposes Examiner construes the flexible finger of claim 1 and the first flexible finger to be the same flexible finger. Examiner suggests replacing “a first flexible finger” in claim 3 with “the flexible finger”.
In regard to claim 4,
Line 2 recites “a first end of the inner body”. Claim 4 depends on claim 1. Claim 1 introduces “a first end of the inner body”. It is unclear if the first end of the inner body in claim 4 is the same as the first end of the inner body of claim 1 or if the first end of the inner body of claim 4 is a different additional end to the first end of the inner body of claim 1. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a first end of the inner body” in line 2 of claim 4 with “the first end of the inner body”.
In regard to claim 11,
Line 4 recites “a first end of the inner body”. Claim 11 depends on claim 1. Claim 1 introduces “a first end of the inner body”. It is unclear if the first end of the inner body in claim 11 is the same as the first end of the inner body of claim 1 or if the first end of the inner body of claim 11 is a different additional end to the first end of the inner body of claim 1. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a first end of the inner body” in line 4 of claim 11 with “the first end of the inner body”.
In regard to claim 15,
Line 1-2 recites “a first end of the inner body”. Claim 15 depends on claim 1. Claim 1 introduces “a first end of the inner body”. It is unclear if the first end of the inner body in claim 15 is the same as the first end of the inner body of claim 1 or if the first end of the inner body of claim 15 is a different additional end to the first end of the inner body of claim 1. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a first end of the inner body” in line 1-2 of claim 15 with “the first end of the inner body”.
In regard to claim 17,
Line 10-11 recites “at least one channel that extends through the first end of the inner body to form a flexible finger between the at least one channel”. It is unclear what is meant by this. It is unclear how the at least one channel can form a flexible finger as a channel is an opening. Based on the disclosure it appears the coupling sleeve/wall forms the flexible finger and that there is at least one channel located next to the flexible finger in the wall/coupling sleeve. For examination purposes Examiner construes “at least one channel that extends through the first end of the inner body to form a flexible finger between the at least one channel” to require the coupling sleeve/wall to form a flexible finger and have at least one channel located next to the flexible finger.
Examiner notes claims 18 and 21 are similarly rejected by virtue of their dependency on claim 17.
In regard to claim 19,
Line 6-7 recites “the first end of the inner body”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if the first end of the inner body is intended to refer to a first end of the inner body or the first end of the housing. For examination purposes Examiner construes “the first end of the inner body” to be “a first end of the inner body”. Examiner suggests replacing “the first end of the inner body” in line 6-7 of claim 19 with “a first end of the inner body”.
Line 6-7 recites “at least one channel that extends through the first end of the inner body to form a flexible finger between the at least one channel”. It is unclear what is meant by this. It is unclear how the at least one channel can form a flexible finger as a channel is an opening. Based on the disclosure it appears the coupling sleeve/wall forms the flexible finger and that there is at least one channel located next to the flexible finger in the wall/coupling sleeve. For examination purposes Examiner construes “at least one channel that extends through the first end of the inner body to form a flexible finger between the at least one channel” to require the coupling sleeve/wall to form a flexible finger and have at least one channel located next to the flexible finger.
Line 16-18 recites “in a second position of the inner body, the second end of the housing is moved away from a second end of the inner body”. It is unclear if claim 19 is intending to claim that the second position is the position in which the housing has been moved/is away from the second end of the inner body or if in the second position the housing can be moved/is moved away from the second end of the inner body to another position. Based on the disclosure and figure 9 for example, the second position appears to be the position in which the second end of the housing is away from the second end of the inner body. Examiner suggests replacing “in a second position of the inner body, the second end of the housing is moved away from a second end of the inner body” in line 16-18 of claim 19 with “in a second position of the inner body, the second end of the housing is away from a second end of the inner body”.
Examiner notes claim 20 is similarly rejected by virtue of its dependency on claim 19.
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 (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 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.
Claims 1-3, 11-12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheffer (U.S. PG publication 20130167841).
In regard to claim 1,
Sheffer discloses a coupling device (see figure 4 and 5, item 66: wherein the coupling device is construed as the entire device in figure 4 and 5 not including item 28 or 42; Examiner notes as disclosed in paragraph [0037] item 78 and 70 have threads) for medical tubing (figure 5, item 42 and 28), the coupling device comprising:
a housing (figure 4, item 70) having an inner surface forming a cavity (see figure 4), a first opening into the cavity (opening of item 70 closest to item 74), and a second opening (opening of item 70 furthest from item 74) into the cavity; and
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an inner body (see figure 4 above) having a fluid passage (see figure 4 above), extending through the inner body (see figure 4 above), and a coupling sleeve (see figure 4 above) at a first end of the inner body (see figure 4 above), the coupling sleeve comprising at least one channel (see channels between item 72) that extends through the first end of the inner body to form a flexible finger (see 112 rejection above for claim interpretation; figure 4, item 72; paragraph [0035]) between the at least one channel, and a thread (thread disclosed in paragraph [0037] on item 78) that extends along the flexible finger (paragraph [0037]; see item 78 which is a portion of the flexible finger 72), wherein the inner body is positioned within the cavity of the housing with the coupling sleeve extending toward the first opening of the housing (see figure 5) such that the housing and the inner body are movable relative to each other (see figure 4 and 5; paragraph [0035]-[0036]);
wherein, in a first position (see position of inner body shown in figure 5 relative to the housing) of the inner body, biasing of at least a portion of the coupling sleeve comprising the finger in a direction that is radially outward is configured to be resisted by engagement of the coupling sleeve with the housing (paragraph [0036]); and wherein, in a second position (see position of inner body shown in figure 4 relative to the housing) of the inner body, the coupling sleeve has been moved through the first opening of the housing (see figure 4) in a direction that is away from the second opening of the housing such that at least the portion of the coupling sleeve comprising the finger can be biased radially outward (see figure 4 and paragraph [0035]; see also figure 11).
In regard to claim 2,
Sheffer discloses the coupling device of Claim 1, wherein the at least one channel (see channels between each finger 72 shown in figure 4. Examiner notes multiple channels are present) extends from the first end of the inner body toward a second end of the inner body (see figure 4).
In regard to claim 3,
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Sheffer discloses the coupling device of Claim 1, wherein the at least one channel comprises a first channel and a second channel (see figure 4; Examiner notes four channels are present, and the first channel and second channel are construed as the channels which the first flexible finger and second flexible finger are between), wherein the second channel is spaced apart from the first channel (see figure 4), and where a first portion of the coupling sleeve between the first channel and the second channel forms a first flexible finger (item 72; paragraph [0035]), and a second portion of the coupling sleeve between the first channel and the second channel forms a second flexible finger (item 72; paragraph [0035]).
In regard to claim 11,
Sheffer discloses the coupling device of Claim 1, wherein the first opening of the housing comprises a first cross-sectional width (see figure 5), and an outer surface of the coupling sleeve comprises a second cross-sectional width (see figure 5), and wherein the first cross-sectional width is equal to or greater than the second cross-sectional width (see figure 5), such that, a first end of the inner body is longitudinally movable between the first position and the second position through the first opening of the housing (see figure 5 and figure 4; see figure 11).
In regard to claim 12,
Sheffer discloses the coupling device of Claim 1, wherein the housing comprises a ledge (threads on locking sleeve 70 as disclosed in paragraph [0037] form a ledge) that extends radially inward from the inner surface of the housing into the cavity (paragraph [0037]; see figure 4 wherein the threads are located on the inner surface to engage with the threads of item 78).
In regard to claim 15,
Sheffer discloses the coupling device of Claim 1, wherein a distance from a first end of the inner body to a second end of the inner body is greater than a distance from a first end of the housing to a distal end of the cavity (see figure 4 and 5).
Claims 1-2, 4, 11, 13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poncon (U.S. PG publication 20140142553).
In regard to claim 1,
Poncon discloses a coupling device (see all of figure 5A not including item 60 or 61) for medical tubing (Examiner notes for medical tubing is a functional limitation. The coupling device is fully capable of being used with medical tubing comprising a luer lock connector 60 as supported by figure 5A and paragraph [0003]-[0004]; Examiner notes the medical tubing is not positively required by the claim), the coupling device comprising:
a housing (figure 5A item 40; Examiner notes the housing can alternatively be considered as item 40 and item 10 collectively) having an inner surface (see inner surface of item 40) forming a cavity (see figure 5A, item 40), a first opening into the cavity (see figure 5A), and a second opening into the cavity (see figure 5A); and
an inner body (figure 5A, item 30; Examiner notes the inner body can alternatively be considered as item 30 and item 20 collectively) having a fluid passage (see figure 5A), extending through the inner body (see figure 5A), and a coupling sleeve (see coupling sleeve formed by both items 34 in figure 5A) at a first end of the inner body (see figure 5A), the coupling sleeve comprising at least one channel (see figure 2 wherein a channel is present between fingers 34) that extends through the first end of the inner body to form a flexible finger (figure 2 and 5A, item 34; Examiner notes the finger can be flexed as shown in figure 5B) between the at least one channel (see figure 2), and a thread (figure 2, item 37) that extends along the flexible finger (see figure 2), wherein the inner body is positioned within the cavity of the housing (see figure 5A and 5B) with the coupling sleeve extending toward the first opening of the housing such that the housing and the inner body are movable relative to each other (see position in figure 5A compared to figure 5B);
wherein, in a first position of the inner body (see position shown in figure 5A), biasing of at least a portion of the coupling sleeve comprising the finger in a direction that is radially outward is configured to be resisted by engagement of the coupling sleeve with the housing (see figure 5A; paragraph [0056]); and wherein, in a second position of the inner body (see position shown in figure 5B), the coupling sleeve has been moved through the first opening of the housing in a direction that is away from the second opening of the housing such that at least the portion of the coupling sleeve comprising the finger can be biased radially outward (see figure 5B; paragraph [0055] and [0057]).
In regard to claim 2,
Poncon discloses the coupling device of Claim 1, wherein the at least one channel extends from the first end of the inner body toward a second end of the inner body (see figure 2).
In regard to claim 4,
It is noted for the rejection of claim 4 the inner body is construed as item 20 and 30.
Poncon discloses the coupling device of Claim 1, wherein the inner body comprises a luer tip (figure 5A, item 20) that extends within the coupling sleeve (see figure 5A), toward a first end of the inner body (see figure 5A).
In regard to claim 11,
Poncon discloses the coupling device of Claim 1, wherein the first opening of the housing comprises a first cross-sectional width (see figure 5A), and an outer surface of the coupling sleeve comprises a second cross-sectional width (see figure 5A), and wherein the first cross-sectional width is equal to or greater than the second cross-sectional width (see figure 5A), such that, a first end of the inner body is longitudinally movable between the first position and the second position through the first opening of the housing (see figure 5B compared to figure 5A).
In regard to claim 13,
It is noted for the rejection of claim 13 the housing is construed as item 10 and 40.
Poncon discloses the coupling device of Claim 1, wherein the housing comprises a tubing channel (see tubing channel formed by item 10) that extends through a second end of the housing (see figure 5B wherein the second end of item 40 forms a second end of the housing) and intersects the second opening (see figure 5B).
In regard to claim 15,
Poncon discloses the coupling device of Claim 1, wherein a distance from a first end of the inner body to a second end of the inner body is greater than a distance from a first end of the housing to a distal end of the cavity (see figure 5A).
In regard to claim 16,
Poncon discloses the coupling device of Claim 1, further comprising a cap (figure 1 and 5B, item 13) coupled to a first end of the housing (see figure 5B wherein the first end of the housing is formed by item 40 and the portion of item 10 which item 40 surrounds), the cap forming at least a portion of the first opening of the housing (see figure 5B).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sheffer (U.S. PG publication 20130167841) further in view of Gish (U.S. PG publication 20190381306).
In regard to claim 5,
Sheffer discloses the coupling device of Claim 1.
Sheffer fails to disclose further comprising a biasing element positioned between a first end of the housing and the inner body.
Gish teaches further comprising a biasing element (spring 220 in figure 2A; see figure 2A where two springs are present) positioned between a first end of the housing (figure 2A, item 108) and the inner body (figure 2A, item 102).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Sheffer to include a biasing element between item 68 and 70 of Sheffer therefore resulting in further comprising a biasing element positioned between a first end of the housing and the inner body, as taught by Gish, for the purpose of preventing inadvertent use of the coupling device (paragraph [0025] of Gish).
In regard to claim 6,
Sheffer in view of Gish teaches the coupling device of Claim 5, wherein the biasing element comprises a spring (see item 220 of Gish) configured to direct the inner body toward the first position (see figure 5 of Sheffer and figure 2A of Gish).
Claims 17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sheffer (U.S. PG publication 20130167841) further in view of Gish (U.S. PG publication 20190381306) further in view of Thomas (U.S. PG publication 20160067435).
In regard to claim 17,
Sheffer discloses a coupling device assembly (see all of figure 4 and 5; Examiner notes as disclosed in paragraph [0037] item 78 and 70 have threads) comprising:
a housing (figure 4, item 70) having a first end (end of item 70 closest to item 74), a second end (end of item 70 furthest from item 74), and an inner surface forming a cavity (see figure 4 and 5), wherein the first end comprises a first opening into the cavity, and the second end comprises a second opening into the cavity (see figure 4 and 5);
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an inner body (see figure 4 above) having a first end portion (see figure 4 above), a second end portion (see figure 4 above), a fluid passage extending through the first end portion and the second end portion of the inner body (see figure 4), the first end portion comprising a coupling sleeve (see figure 4 above) formed by a wall having an inner surface that extends around a longitudinal axis defined by the fluid passage to form a recess extending from a first end of the inner body toward the second end portion (see figure 4 above), the wall comprising at least one channel (see channels formed between item 72) that extends through the first end of the inner body to form a flexible finger (figure 4, item 72; paragraph [0035]) between the at least one channel (see figure 4), and a thread (thread disclosed in paragraph [0037] on item 78) that extends along the flexible finger (paragraph [0037]), wherein the inner body is positioned within the cavity of the housing such that the housing and the inner body are movable relative to each other (see figure 4 and 5; paragraph [0035]-[0036]);
a tubing (figure 5, item 42), wherein an end portion of the tubing is coupled to the fluid passage of the inner body (see figure 4 and 5).
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wherein, in a first position (see position of inner body shown in figure 5 relative to the housing) of the inner body, the first end of the inner body is longitudinally aligned with the first end of the housing (see figure 5 above) such that biasing of at least a portion of the wall comprising the finger away from the longitudinal axis is configured to be resisted by the housing (paragraph [0036]), and in a second position of the inner body (see position of inner body shown in figure 4 relative to the housing), the second end of the housing is away from the second end portion of the inner body such that the first end of the inner body is longitudinally spaced apart from the first end of the housing and at least the portion of the wall comprising the finger can be biased away from the longitudinal axis (see figure 4 and paragraph [0035]; see also figure 11).
Sheffer fails to disclose a biasing element positioned between the first end of the housing and the inner body; and a tubing extending through the second opening of the housing and into the cavity.
Gish teaches a biasing element (spring 220 in figure 2A; see figure 2A where two springs are present) positioned between the first end of the housing (figure 2A, item 108) and the inner body (figure 2A, item 102).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Sheffer to include a biasing element between item 68 and 70 of Sheffer therefore resulting in a biasing element positioned between the first end of the housing and the inner body, as taught by Gish, for the purpose of preventing inadvertent use of the coupling device (paragraph [0025] of Gish).
Sheffer in view of Gish fails to disclose a tubing extending through the second opening of the housing and into the cavity.
Thomas teaches a tubing (figure 2 and 8, item 15 and 12) extending through the second opening of the housing (opening of item 81 that item 15 is received within; see figure 8) and into the cavity (see figure 8).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify tubing 42, connection 40 and bore 44 of Sheffer and the coupling device assembly of Sheffer in view of Gish to include an adaptor 15 of Thomas and an opening sized to receive the adaptor 15 to result in a tubing extending through the second opening of the housing and into the cavity, as taught by Thomas, for the purpose of forming an air tight seal (paragraph [0037] of Thomas).
In regard to claim 19,
Sheffer discloses a method for providing a coupling device (see figure 4 and 5, item 66: wherein the coupling device is construed as the entire device in figure 4 and 5 not including item 28 or 42; Examiner notes as disclosed in paragraph [0037] item 78 and 70 have threads) for medical tubing (figure 5, item 42), the method comprising:
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inserting an inner body (see figure 4 above) into a cavity of a housing (figure 4, item 70) such that the housing and the inner body are movable relative to each other (see figure 4, 5, and 11; paragraph [0035]-[0036]), and a coupling sleeve (see figure 4 above) defined by a proximal portion of the inner body extends through a first opening at a first end of the housing (see figure 4 and 5), the coupling sleeve comprising at least one channel (see channels between fingers 72 in figure 4) that extends through the first end of the inner body to form a flexible finger (figure 4, item 72; paragraph [0035]) between the at least one channel (see figure 4), and a thread (thread disclosed in paragraph [0037] on item 78) that extends along the flexible finger (paragraph [0037]);
inserting the medical tubing (figure 5, item 42) and coupling the tubing to a fluid passage extending through the inner body (see figure 4 above);
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wherein, in a first position (see position of inner body shown in figure 5 relative to the housing) of the inner body, the first end of the inner body is longitudinally aligned with the first end of the housing (see figure 5 above) such that biasing of at least a portion of the coupling sleeve comprising the finger away from a longitudinal axis of the fluid passage of the inner body is resisted by the housing (paragraph [0036]), and in a second position (see position of inner body shown in figure 4 relative to the housing) of the inner body, the second end of the housing is moved away from a second end of the inner body such that the first end of the inner body is longitudinally spaced apart from the first end of the housing and at least the portion of the coupling sleeve comprising the finger can be biased away from the longitudinal axis (see figure 4 and paragraph [0035]; see also figure 11).
Sheffer fails to disclose inserting a biasing element into the housing such that the biasing element is positioned between the first end of the housing and the inner body; and inserting the medical tubing through a second opening at a second end of the housing.
Gish teaches inserting a biasing element (spring 220 in figure 2A; see figure 2A where two springs are present) into the housing such that the biasing element is positioned between the first end of the housing (figure 2A, item 108) and the inner body (figure 2A, item 102).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Sheffer to include a biasing element between item 68 and 70 of Sheffer therefore resulting in inserting a biasing element into the housing such that the biasing element is positioned between the first end of the housing and the inner body, as taught by Gish, for the purpose of preventing inadvertent use of the coupling device (paragraph [0025] of Gish).
Sheffer in view of Gish fails to disclose inserting the medical tubing through a second opening at a second end of the housing.
Thomas teaches inserting the medical tubing (figure 2 and 8, item 15 and 12) through a second opening at a second end of the housing (opening of item 81 that item 15 is received within; see figure 8).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify tubing 42, bore 44, and connection 40 of Sheffer and the coupling device assembly of Sheffer in view of Gish to include an adaptor 15 of Thomas and an opening sized to receive the adaptor 15 to result in inserting the medical tubing through a second opening at a second end of the housing, as taught by Thomas, for the purpose of forming an air tight seal (paragraph [0037] of Thomas).
In regard to claim 20,
Sheffer in view of Gish in view of Thomas teaches the method of Claim 19 wherein, when the inner body is in the second position and a mating connector (figure 4 and 5, item 28 of Sheffer), coupled to the coupling sleeve, is moved in a direction away from the first end of the inner body, engagement of the mating connector with the coupling sleeve directs at least the portion of the coupling sleeve away from the longitudinal axis (paragraph [0035] and [0007] of Sheffer).
In regard to claim 21,
Sheffer in view of Gish in view of Thomas teaches the coupling device assembly of Claim 17, wherein another portion of the tubing is coupled to the second opening of the housing (see analysis of claim 17 above, figure 4 of Sheffer, and figure 2 and 8 of Thomas; Examiner notes another portion of the tubing is coupled to the second opening of the housing indirectly via the end portion of the tubing; Additionally as shown in figure 8 of Thomas the very end/end poriton of item 15 of the tube is coupled to the second opening and another portion of item 15 is also coupled to the second opening of the housing).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Poncon (U.S. PG publication 20140142553) further in view of Peters (U.S. Patent no 6217564).
In regard to claim 7,
Poncon discloses the coupling device of Claim 1.
Poncon fails to disclose wherein the inner body comprises a spline that extends from an outer surface of the inner body, in a direction that is radially outward away from the outer surface of the inner body.
Peters teaches wherein the inner body (figure 4, item 22 and 7), comprises a spline (figure 4, item 28; Examiner notes spline 28 is received within groove 27 of the housing) that extends from an outer surface of the inner body (see figure 4), in a direction that is radially outward away from the outer surface of the inner body (see figure 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify item 30 of Poncon to include a spline that extends from an outer surface of the inner body, in a direction that is radially outward away from the outer surface of the inner body and to also modify item 40 of Poncon to include a groove to receive the spline, as taught by Peters, for the purpose of effectively keying together two components to enable longitudinal displacement without rotation (column 4, line 50-65 of Peters).
In regard to claim 8,
Poncon in view of Peters teaches the coupling device of Claim 7, wherein the spline is configured to be positioned within a groove (see figure 4, item 27 of Peters and analysis of claim 7 above) extending along the inner surface of the housing such that the housing and the inner body are rotationally coupled (see analysis of claim 7 above).
In regard to claim 9,
Poncon in view of Peters teaches the coupling device of Claim 8, wherein the housing and the inner body are movable, relative to each other, along a length of the groove (see analysis of claim 7 and 8 above and column 4, line 50-65 of Peters.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Poncon (U.S. PG publication 20140142553).
It is noted for the rejection of claim 14 the housing is construed as item 10 and 40.
Poncon discloses the coupling device of Claim 13.
Poncon fails to disclose wherein at least a portion of the tubing channel comprises a cross-sectional width that is greater than a cross-sectional width of the second opening.
It would have been an obvious matter of design choice to modify Poncon to include wherein at least a portion of the tubing channel comprises a cross-sectional width that is greater than a cross-sectional width of the second opening since applicant has not disclosed that having wherein at least a portion of the tubing channel comprises a cross-sectional width that is greater than a cross-sectional width of the second opening solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein at least a portion of the tubing channel comprises a cross-sectional width that is greater than a cross-sectional width of the second opening, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Allowable Subject Matter
Claim 18 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:
In regard to claim 18,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the coupling device assembly of Claim 17, wherein, when the inner body is in the first position, a length of the tubing between a second end of the inner body and a distal end of the cavity, adjacent to the second end of the housing, is longer than a distance between the second end of the inner body and the distal end of the cavity.
As shown in figure 5 of Sheffer, a length of the tubing 42 between a second end of the inner body and a distal end of the cavity, adjacent to the second end of the housing, is not longer than a distance between the second end of the inner body and the distal end of the cavity. Paragraph [0057] of the instant disclosure further provides a benefit for this specific arrangement and states that “Because the length L1 of the tubing 16 within the cavity 118 is longer than the distance D1 between the inner body 150 and the distal end of cavity 118, movement of the inner body 150 away from the second end 114 of the housing may not be resisted by the tubing 16”. The subject matter of wherein, when the inner body is in the first position, a length of the tubing between a second end of the inner body and a distal end of the cavity, adjacent to the second end of the housing, is longer than a distance between the second end of the inner body and the distal end of the cavity, in combination with all other limitations of claim 17, could not be found nor was suggested elsewhere in the prior art of record. Accordingly, claim 18 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.
Response to Arguments
Applicant's arguments filed 12/4/2025 in regard to the rejections under 35 U.S.C. 112 have been fully considered but they are not persuasive. Claim 19 was not amended to address the issues regarding the limitation “is moved away”. Additionally, no specific arguments were provided regarding the rejection of claim 19 under 35 U.S.C. 112. Accordingly, the rejection under 35 U.S.C. 112 remains.
Applicant’s arguments with respect to Peters (U.S. Patent no 6217564) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 12/4/2025 in regard to Sheffer (U.S. PG publication 20130167841) have been fully considered but they are not persuasive. Applicant argues Sheffer fails to disclose at least, the features of the "coupling sleeve comprising at least one channel that extends through the first end of the inner body to form a flexible finger between the at least one channel, and a thread that extends along the flexible finger," and the features in which "in a first position of the inner body, biasing of at least a portion of the coupling sleeve comprising the finger in a direction that is radially outward is configured to be resisted by engagement of the coupling sleeve with the housing," and "in a second position of the inner body, the coupling sleeve has been moved through the first opening of the housing in a direction that is away from the second opening of the housing such that at least the portion of the coupling sleeve comprising the finger can be biased radially outward." No specific arguments have been included regarding why Applicant believes Sheffer fails to disclose the limitations above. As detailed above, item 72 is a flexible finger that includes a thread as supported by paragraph [0037]. Sheffer also discloses wherein, in a first position (see position of inner body shown in figure 5 relative to the housing) of the inner body, biasing of at least a portion of the coupling sleeve comprising the finger in a direction that is radially outward is configured to be resisted by engagement of the coupling sleeve with the housing (paragraph [0036]); and wherein, in a second position (see position of inner body shown in figure 4 relative to the housing) of the inner body, the coupling sleeve has been moved through the first opening of the housing (see figure 4) in a direction that is away from the second opening of the housing such that at least the portion of the coupling sleeve comprising the finger can be biased radially outward (see figure 4 and paragraph [0035]; see also figure 11). By moving the housing, the coupling sleeve is moved through the first opening of the housing in a direction that is away from the second opening of the housing such that at least the portion of the coupling sleeve comprising the finger can be biased radially outward. Claim 1 does not require the housing to be fixed in position and the inner body to move. Claim 1 also further does not define how the coupling sleeve has been moved through the first opening of the housing in a direction that is away from the second opening of the housing such that at least the portion of the coupling sleeve comprising the finger can be biased radially outward.
Applicant argues that the claims dependent on claim 1, independent claim 17, independent claim 19, the claims dependent on claim 17, and the claims dependent on claim 19 are allowable for similar reasons. See response to arguments 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.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785