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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 03/30/26 has been entered.
Election/Restrictions
Claims 6-11 and 14-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/18/25.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/30/26 and 04/15/26 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Amendment
The amendment filed 11/13/25 has been entered. Claims 1 and 16 have been amended. Claims 2, 4-5, and 17 are cancelled. Claims 6-11 and 14-15 remain withdrawn. Claims 3, 12-13 are in the original/ previously presented form. Thus, claims 1, 3, 12-13, and 16 remain pending in the application. There were no objections or 112 rejections previously set forth in the Notice of Allowance mailed 12/30/25. Therefore, there are no objections or 112 rejections withstanding.
Claim Objections
Claims 1, 3, and 16 are objected to because of the following informalities:
Claim 1 line 17 reads “the sealing pin has a fixing element at the end opposite the bounding element” and should likely read “the sealing pin has a fixing element at [[the]] an end opposite the bounding element” to provide proper antecedent basis for “end” of the sealing pin which has not yet been introduced in the claim
Claim 3 lines 1-2 read “wherein at its outer side” and should likely read “wherein at [[its]] an outer side” to provide proper antecedent basis for the outer side of the sealing pin which has yet to be introduced in the claim language
Claim 16 lines 10-11 read “of the base body at the lumen side” and should likely read “of the base body at [[the]] a lumen side” to provide proper antecedent basis for lumen side that has yet to be introduced in the claim language
Appropriate correction is required.
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.
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 1, 3, 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez et al. (U.S. Patent No. 8,758,306), hereinafter Lopez, in view of Connell et al. (U.S. PGPUB No. 2005/0197646), hereinafter Connell.
Regarding claim 1, Lopez discloses a first connector part (see FIG. 4) comprising:
an elongate base body (body from proximal end 22 to distal end 24, see col 8 lines 26-38) with a lumen for conducting a fluid (see FIG. 7);
a first threaded portion (26) that is arranged at an outer side (threads visible on outside surface and therefore on an “outer” side) of the base body and that enables a releasable connection of the first connector part (20) to a correspondingly matched second connector part (such as a male end of a standard luer connector, see col 8 lines 39-52);
a sealing pin (seal 60 disposed over base member, see ‘Modified FIG. 4’ below and col 12 lines 25-50)
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that has a lumen arranged in the lumen of the elongate base body so that fluid is capable of flowing through and/or around the sealing pin and the lumen of the elongate base body (see col 11 lines 25-51: seal 60 of sealing pin fitted inside lumen of body 20 for allowing fluid flow such as shown in FIG. 7); and
a second coupling portion (38) that is arranged at an inner side (38 on inside circumference of connector 20) of the elongate base body at a lumen side (internal surface forming lumen) and that enables a releasable connection of the first connector part (20) to the sealing pin (seal 60 disposed over base member) that is correspondingly matched to the second coupling portion (38, see col 10 lines 17-37 and col 17 lines 47-59: 38 mates with 96 of base member of sealing pin), wherein
the sealing pin (seal 60 disposed over base member) furthermore has a bounding element (112) that restricts a rotation of the sealing pin to one direction (see col 9 line 66- col. 10 line 16: 112 engages 40 to prevent rotation between components and thus restricts rotation to only the coupling direction and prevents/restricts rotation in a decoupling direction), and
the sealing pin (seal 60 disposed over base member) has a fixing element (92, see col 15 line 60- col. 16 line 17: 92 can have cylindrical cross-section, as shown by Applicant in the current Application FIG. 4a) at the end opposite (as seen in FIG. 4) the bounding element (112), wherein the sealing pin (seal 60 disposed over base member) is capable of being releasably or non-releasably fixed to a closure element via a latched connection and/or via an undercut (cylindrical cross-section of 92 is capable of being releasably/ non-releasably fixed to a “closure element” via a latched connection in as much as is disclosed by Applicant in the current Application such as [0058] & [0064]).
Lopez further discloses that the second coupling portion correspondingly matched to the sealing pin can be substituted by many other attachment methods (see col 10 lines 17-37), such as snap, interference, press-fit features or “any other suitable coupling features or methods” (see col 17 lines 47-59).
Lopez is silent to the second coupling portion being specifically a second “threaded” portion and “the thread pitch of the first threaded portion differs from the thread pitch of the second threaded portion”.
However, Connell teaches a first connector part (14, see FIG. 5) comprising an elongate base body; a first threaded portion (24, see ‘Modified FIG. 5’ below, FIG. 7 and [0092]: outer thread 24)
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arranged at an outer side (on outside circumference) of the base body (14); a sealing pin (60 & 18, see [0115]); a second threaded portion (22) that is arranged at an inner side (inside circumference) of the elongate base body at a lumen side (see ‘Modified FIG. 5’ above, FIG. 7 and [0091-0092]: inner thread 22) and that enables a releasable connection of the first connector part (14) to the sealing pin (60&18) that is correspondingly matched to the second threaded portion (see [0091-0092] and [0114-0115]), wherein the thread pitch of the first threaded portion (24) differs from (see [0092]: desired thread pitch can be varied for both threaded portions 24/22) the thread pitch of the second threaded portion (22).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the second coupling portion disclosed in Lopez to be specifically a second threaded coupling portion as taught by Connell for the purpose of enabling any corresponding second coupling member/device to connect at the internal threads (see [0091-0092]), thus achieving the second coupling portion being specifically a second “threaded” portion. Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a snap fit flange coupling mechanism disclosed in Lopez) for another known element (a threaded coupling mechanism taught in Connell) in the art to obtain the predictable result of coupling two structures of a connector together (see MPEP § 2143.I.B).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thread pitch of the first and second threaded portions taught by Lopez in view of Connell to differ as taught by Connell for the purpose of achieving a desired range of travel or relative movement between components (see [0092]), thus achieving “the thread pitch of the first threaded portion differs from the thread pitch of the second threaded portion”.
Regarding claim 3, the modified system of Lopez teaches the first connector part in accordance with claim 1, and Lopez further discloses wherein, at its outer side (96 disposed on outer circumference of base portion of sealing pin, see FIG. 4), the sealing pin (seal 60 disposed over base member) has a coupling portion (96) that is adapted to enter into coupled engagement (see col 10 lines 17-37 and col 17 lines 47-59: 38 mates with 96 of base member of sealing pin) with the second coupling portion (38) of the first connector (20).
Lopez further discloses that the second coupling portion correspondingly matched to the sealing pin can be substituted by many other attachment methods (see col 10 lines 17-37), such as snap, interference, press-fit features or “any other suitable coupling features or methods” (see col 17 lines 47-59).
Lopez is silent to specifically a threaded coupling such that the sealing pin has a “threaded” portion that is adapted to enter into “threaded” engagement with the second “threaded” portion of the first connector.
However, Connell teaches a first connector part (14, see FIG. 5) comprising an elongate base body; a first threaded portion (24, see ‘Modified FIG. 5’ below, FIG. 7 and [0092]: outer thread 24)
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arranged at an outer side (on outside circumference) of the base body (14); a sealing pin (60 & 18, see [0115]); a second threaded portion (22) that is arranged at an inner side (inside circumference) of the elongate base body at a lumen side (see ‘Modified FIG. 5’ above, FIG. 7 and [0091-0092]: inner thread 22) and that enables a releasable connection of the first connector part (14) to the sealing pin (60&18) that is correspondingly matched to the second threaded portion (see [0091-0092] and [0114-0115]), wherein the thread pitch of the first threaded portion (24) differs from (see [0092]: desired thread pitch can be varied for both threaded portions 24/22) the thread pitch of the second threaded portion (22), wherein, at its outer side (outside circumference of 60), the sealing pin (60&18) has a threaded portion (threads 64 seen best in FIG. 4. See also [0113-0114]) that is adapted to enter into threaded engagement with (see [0113-0114]) the second threaded portion (22) of the first connector (14).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the snap-fit coupling of the sealing pin disclosed in Lopez with the threaded coupling as taught by Connell. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a snap fit flange coupling mechanism disclosed in Lopez) for another known element (a threaded coupling mechanism taught in Connell) in the art to obtain the predictable result of coupling two structures of a connector together (see MPEP § 2143.I.B), thus achieving the sealing pin has a “threaded” portion that is adapted to enter into “threaded” engagement with the second “threaded” portion of the first connector.
Regarding claim 12, the modified system of Lopez teaches the first connector part in accordance with claim 1, and Lopez further discloses wherein the first connector part is in total or in part an element of a connection between a blood treatment apparatus (see FIG. 1 and col 6 line 66- col 7 line 25).
Lopez is silent to wherein the first connector part is in total or in part an element of a connection between a blood treatment apparatus “and a disposable article”.
However, Connell teaches a first connector part (14, see FIG. 5), wherein the first connector part (14) is in total or in part an element of a connection between a blood treatment apparatus (see [0081]: i.e. a blood treatment apparatus performing dialysis) and a disposable article (see [0112-0114] and [0120-0122]: disposable fluid bags).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the first connector part connected to a blood treatment apparatus disclosed in Lopez to connect between a blood treatment apparatus and a disposable article as taught by Connell for the purpose of maintaining a sterile connection at the connector when multiple fluid reservoirs need to be delivered to the patient over time (see [0120-0122]), thus achieving wherein the first connector part is in total or in part an element of a connection between a blood treatment apparatus “and a disposable article”.
Regarding claim 13, the modified system of Lopez teaches the first connector part in accordance with claim 1, and Lopez further discloses wherein the first connector part (14 comprising body 20, see FIG. 4 & 2A) is in fluid communication with a tube (212, see FIG. 1 and col 6 line 66- col. 7 line 15) or in fluid communication with a dialyzer.
Regarding claim 16, Lopez discloses a first connector part (see FIG. 4) comprising:
an elongate base body (body from proximal end 22 to distal end 24, see col 8 lines 26-38) with a lumen for conducting a fluid (see FIG. 7);
a first threaded portion (26) that is arranged at an outer side (threads visible on outside surface and therefore on an “outer” side) of the base body and that enables a releasable connection of the first connector part (20) to a correspondingly matched second connector part (such as a male end of a standard luer connector, see col 8 lines 39-52);
a sealing pin (seal 60 disposed over base member, see ‘Modified FIG. 4’ below and col 12 lines 25-50)
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that has a lumen arranged in the lumen of the elongate base body so that fluid is capable of flowing through and/or around the sealing pin and the lumen of the elongate base body (see col 11 lines 25-51: seal 60 of sealing pin fitted inside lumen of body 20 for allowing fluid flow such as shown in FIG. 7); and
a second coupling portion (38) that is arranged at an inner side (38 on inside circumference of connector 20) of the base body at the lumen side (internal surface forming lumen) and that enables a releasable connection of the first connector part (20) to the sealing pin (seal 60 disposed over base member) that is correspondingly matched to the second coupling portion (38, see col 10 lines 17-37 and col 17 lines 47-59: 38 mates with 96 of base member of sealing pin), and
the sealing pin (seal 60 disposed over base member) furthermore has a bounding element (112) in the form of a toothed block (see FIG. 4), that restricts a rotation of the sealing pin to one direction (see col 9 line 66- col. 10 line 16: 112 engages 40 to prevent rotation between components and thus restricts rotation to only the coupling direction and prevents/restricts rotation in a decoupling direction).
Lopez further discloses that the second coupling portion correspondingly matched to the sealing pin can be substituted by many other attachment methods (see col 10 lines 17-37), such as snap, interference, press-fit features or “any other suitable coupling features or methods” (see col 17 lines 47-59).
Lopez is silent to the second coupling portion being specifically a second “threaded” portion and “wherein the thread pitch of the first threaded portion differs from the thread pitch of the second threaded portion”.
However, Connell teaches a first connector part (14, see FIG. 5) comprising an elongate base body; a first threaded portion (24, see ‘Modified FIG. 5’ below, FIG. 7 and [0092]: outer thread 24)
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arranged at an outer side (on outside circumference) of the base body (14); a sealing pin (60 & 18, see [0115]); a second threaded portion (22) that is arranged at an inner side (inside circumference) of the elongate base body at a lumen side (see ‘Modified FIG. 5’ above, FIG. 7 and [0091-0092]: inner thread 22) and that enables a releasable connection of the first connector part (14) to the sealing pin (60&18) that is correspondingly matched to the second threaded portion (see [0091-0092] and [0114-0115]), wherein the thread pitch of the first threaded portion (24) differs from (see [0092]: desired thread pitch can be varied for both threaded portions 24/22) the thread pitch of the second threaded portion (22).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the second coupling portion disclosed in Lopez to be specifically a second threaded coupling portion as taught by Connell for the purpose of enabling any corresponding second coupling member/device to connect at the internal threads (see [0091-0092]), thus achieving the second coupling portion being specifically a second “threaded” portion. Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a snap fit flange coupling mechanism disclosed in Lopez) for another known element (a threaded coupling mechanism taught in Connell) in the art to obtain the predictable result of coupling two structures of a connector together (see MPEP § 2143.I.B).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thread pitch of the first and second threaded portions taught by Lopez in view of Connell to differ as taught by Connell for the purpose of achieving a desired range of travel or relative movement between components (see [0092]), thus achieving “the thread pitch of the first threaded portion differs from the thread pitch of the second threaded portion”.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 12, 13 (see remarks filed 11/13/25) 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stroup (U.S. PGPUB No. 2011/0048540) teaches several embodiments of connectors including sealing pins, toothed blocks, and threaded connections that are relevant to the current disclosure (see at least FIG. 7B)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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