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 .
Claim Objections
Claim 16 is objected to because of the following informalities: a duplicated comma in line 3 should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 is 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.
Claim 6 recites “…removing the cap from the base element such that a heat shrink band is retained on the base element.”. It is not clear if the heat shrink band is to be retained on the base element subsequent to cap removal and if so it is unclear if a heat shrink band would be retained in its entirety and unbroken, or if the heat shrink band is retained on the base element prior to cap removal. For purposes of examination, this is interpreted such that a heat shrink band is retained on the base element prior to cap removal. Claim 7 is rejected at least because it depends from claim 6.
Claim Rejections - 35 USC § 102
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 5, 8, 11-16 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Connell et al. (Connell) US 2003/0153865 A1.
Regarding claim 5, Connell discloses a method for retaining a cap (cap 12, P0068) on a base element (tip protector 42) for a medical connector (shell 36, P0083), comprising: obtaining the base element (tip protector 42) containing a finger retainer (ring 44, P0087) on a distal end of the base element, a hole extending through the finger retainer (hole, see annotated Fig. 1A below), and a recess at a proximal end of the base element (recess, see annotated Fig. 1A below); attaching the base element to a distal end of the cap (Fig. 1A), the cap including a partially enclosed interior space (interior volume, see annotated Fig. 7 below) and a proximal end; and securing the cap to the base element at a distal end of the cap (Fig. 1A).
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Regarding claim 8, Connell discloses the method of claim 5 further comprising removing the cap from the base element (Connell, Fig. 2) to prevent installation onto the base element to prevent reuse of the cap (Connell teaches the claimed structure and therefore is fully capable of preventing installation onto the base element to prevent reuse of the cap).
Regarding claim 11, Connell discloses a base element (tip protector 42) for use with a cap (cap 12, P0068) for a medical connector (shell 36, P0083), the base element comprising: a finger support portion (ring 44, P0087) having a hole (hole, see annotated Fig. 1A below) therethrough that is sized and configured to receive a finger of a user (the hole is fully capable of receiving a finger of a user because it is a ring); and a cap support portion (cap support portion, see annotated Fig. 2 below) coupled with the finger support portion and extending away from an outside surface of the finger support portion (outside surface of the finger support portion, see annotated Fig. 2 below), the cap support portion being configured to removably couple with the cap for the medical connector (Fig. 2); wherein: the cap support portion comprises an annular wall (annular wall, see annotated Fig. 1A below) and a space that is surrounded by the annular wall (space, see annotated Fig. 1A below); and the space is configured to receive at least a portion of the cap (elongate member, see annotated Fig. 1A below) in the space when the cap is secured to the base element (see annotated Fig. 1A below).
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Regarding claim 12, Connell discloses the base element of claim 11, further comprising one or more side extensions (side extension, see annotated Fig. 2 above) extending away from the outside surface of the finger support portion, the one or more side extensions configured to enable the user to exert a greater torque force on the base element by pressing on the one or more side extensions with fingers of a user (the one or more side extensions are fully capable of enabling the user to exert a greater torque force on the base element by pressing on the one or more side extensions with fingers of a user because of the additional structure provided by the side extension for gripping).
Regarding claim 13, Connell discloses the base element of claim 12, wherein the one or more side extensions have a rounded or triangular shape (triangular shape, see annotated Fig. 2 above).
Regarding claim 14, Connell discloses the base element of claim 11, wherein the annular wall of the cap support portion comprises an outwardly facing surface (outwardly facing surface of the annular wall of the cap support, see annotated Fig. 1A below) configured to engage with an inner surface of a sealing flange of the cap positioned at a distal end the cap (inner surface of a sealing flange of the cap, see annotated Fig. 1A above, engaging as claimed).
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Regarding claim 15, Connell discloses the base element of claim 11, wherein the space surrounded by the annular wall includes a radially inward facing surface (radially inward facing surface, see annotated Fig. 1A below) and a bottom surface (bottom surface, see annotated Fig. 1A below), the space being configured to receive at least a distal end of an elongate member of the cap (elongate member, see annotated Fig. 1A above) within the space when the cap is coupled with the base element (Fig. 1A).
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Regarding claim 16, Connell discloses the base element of claim 11, wherein the cap support portion of the base element comprises an annular flange (annular flange, see annotated Fig. 1A below, which is the proximal end annular wall) extending outwardly from an outside surface of the annular wall (outside surface of annular wall, see annotated Fig. 1A below) of the cap support portion,, wherein an upper flange surface (upper flange surface, see annotated Fig. 1A below) is configured to engage a distal end of a sealing flange (seal 18, P0071) of the cap.
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Regarding claim 19, Connell discloses the base element of claim 11, wherein an axial centerline of the hole of the finger support portion is perpendicular to an axial centerline of the space surrounded by the annular wall (see below, wherein an axial centerline of the hole would extend perpendicular from Fig. 1A).
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Regarding claim 20, Connell discloses the base element of claim 11, wherein the cap is a peritoneal dialysis cap (connectors for use in peritoneal dialysis, P0001).
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Connell in view of Thiagarajan et al. (Thiagarajan) US 2016/0287758 A1.
Regarding claim 1, Connell discloses a capping system (connector 10 as shown in Fig. 1A) for a medical connector (shell 36, P0083), comprising: a base element (tip protector 42) comprising: a finger retainer (ring 44, P0087) on a distal end of the base element (see annotated Fig. 1A below for distal and proximal directions), the finger retainer including a hole extending through the finger retainer (hole, see annotated Fig. 1A below); and a recess positioned on a proximal end of the base element and above the finger retainer (recess, see annotated Fig. 1A below); and a cap (cap 12, P0068) comprising: a body (body 14, P0070) having a closed proximal end (proximal end closed by septum 30, P0080) and a distal end (distal end of cap, see annotated Fig. 1A below); an interior volume (interior volume, see annotated Fig. 7 below) within the body; an elongate member (elongate member, see annotated Fig. 1A below) extending from the closed proximal end of the body axially through at least a portion of the interior volume surrounding the elongate member to a distal end of the elongate member (distal end of the elongate member, see annotated Fig. 1A below); and threads (external threads 24, P0077) for securing the cap to the medical connector (shell 36, P0083); wherein at least a portion of the proximal end of the base element is configured to be secured to the distal end of the cap (Fig. 1A).
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Connell teaches use of a disinfectant 20 P0072, but does not teach the elongate member comprising an antimicrobial.
However, Thiagarajan teaches antimicrobial catheter assemblies comprising an antimicrobial (copper, P0026).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the elongate member of Connell with an antimicrobial for the purpose of preventing microbial colonization along regions of the fluid path defined by the surfaces of elongate member to reduce the incidence of infection, Thiagarajan P0026
Regarding claim 2, Connell in view of Thiagarajan teaches the capping system of claim 1, wherein the recess is configured to receive at least a portion of the distal end of the elongate member (Connell, shown in annotated Fig. 1A above).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Connell in view of Thiagarajan in view of Godin et al. (Godin) US 2019/0275313 A1.
Regarding claim 3, Connell in view of Thiagarajan teaches the capping system of claim 1.
Connell in view of Thiagarajan does not teach wherein the cap comprises a heat shrink band at the distal end of the cap providing a barrier to the interior volume.
However, Godin teaches tamper evident features including shrink bands made via a heat shrink process, P0002.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the connector 10 as shown in Fig. 1A of Connell with a heat shrink band as claimed connecting the tip protector 42 to the shell 36 of Connell for the purpose of providing tamper evidence indicative of safety and/or sterility, Godin P0002.
Regarding claim 4, Connell in view of Thiagarajan in view of Godin teaches the capping system of claim 3, wherein the cap is secured to the base element by the heat shrink band to prevent detachment of the cap from the base element (the heat shrink band provides further securement to prevent detachment of the cap from the tip protector).
Claims 6-7 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Connell in view of Godin.
Regarding claim 6, Connell discloses the method of claim 5, further comprising removing the cap from the base element (Fig. 2).
Connell does not teach the method such that a heat shrink band is retained on the base element.
However, Godin teaches tamper evident features including shrink bands made via a heat shrink process, P0002.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the connector 10 as shown in Fig. 1A of Connell with a heat shrink band as claimed connecting the tip protector 42 to the shell 36 of Connell for the purpose of providing tamper evidence indicative of safety and/or sterility, Godin P0002.
Regarding claim 7, Connell in view of Godin teaches the method of claim 6, wherein the heat shrink band is configured to prevent reinstallation onto the base element (the heat shrink band is fully capable of preventing reinstallation onto the base element by providing the user with a visual indication that sterility is no longer ensured).
Regarding claim 17, Connell discloses the base element of claim 11.
Connell does not teach the base element further comprising a sealing band positioned on an outer surface of the base element at a proximal end thereof, the sealing band configured to retain the cap and inhibit detachment of the cap from the base element prior to use.
However, Godin teaches tamper evident features including a sealing band (shrink bands made via a heat shrink process, P0002).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the connector 10 as shown in Fig. 1A of Connell with a sealing band as claimed connecting the tip protector 42 to the shell 36 of Connell for the purpose of providing tamper evidence indicative of safety and/or sterility, Godin P0002, wherein the sealing bank is fully capable of retaining the cap and inhibiting detachment of the cap from the base element prior to use.
Regarding claim 18, Connell in view of Godin teaches the base element of claim 17, wherein the sealing band is configured to prevent re-installation of the cap onto the base element to prevent reuse of the cap (the sealing band is fully capable of preventing re-installation of the cap onto the base element to prevent reuse of the cap since the sealing band is broken when the cap is removed to inform the user as noted above).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Connell.
Regarding claim 9, Connell discloses the method of claim 5.
Connell does not explicitly teach the method further comprising placing the base element on a finger of a user through the hole.
However, Connell describes the tip protector 42 defining a ring 44.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Connell because Connell teaches a ring which is defined as a circlet worn on a finger (see attached definition).
Regarding claim 10, Connell teaches the method of claim 9, wherein the base element comprises one or more side extensions (Connell, side extension, see annotated Fig. 2 below) configured to allow the user to exert a greater torque force on the base element by restricting a rotation of the base element placed on the finger (the side extension of Connell is fully capable of allowing a user to exert a greater torque force on the base element by restricting a rotation of the base element placed on the finger because of the additional structure provided by the side extension for gripping).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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