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
Claims 1, 4, 6-9, 12-17, and 20 are objected to because of the following informalities:
-Claim 1, line 1: please correct the semicolon to a colon
-Claim 4, line 3: please correct “the nub” to “the nub portion”
-Claim 6, line 1: please correct “the seat” to “the cannula seat”
-Claim 7, line 1: please correct “the seat” to “the cannula seat”
-Claim 7, line 1: please correct “the portion” to “a portion”
-Claim 8, line 1: please correct “the septum housing” to “the housing”
-Claim 8, line 2: please correct “each ear” to “each ear of the set of ears”
-Claim 8, line 3: please correct “the ears” to “each ear of the set of ears”
-Claim 9, line 1: please correct “the septum housing” to “the housing”
-Claim 12, line 2: please correct the semicolon to a colon
-Claim 12, line 12: please correct “the exterior surface” to “an exterior surface”
-Claim 13, line 1: please correct “cannula subassembly” to “subcutaneous access assembly”
-Claim 14, line 1: please correct “cannula subassembly” to “subcutaneous access assembly”
-Claim 15, line 1: please correct “cannula subassembly” to “subcutaneous access assembly”
-Claim 16, line 1: please correct “cannula subassembly” to “subcutaneous access assembly”
-Claim 16, line 1: please correct “a list” to “the group”
-Claim 16, line 2: please correct “the portion” to “a portion”
-Claim 17, line 4: please correct “enlarge” to “enlarged”
-Claim 20, line 1: please correct “a list” to “the group”
-Claim 20, line 2: please correct “the portion” to “a portion”
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 16 and 18-20 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.
Claim 16 recites the limitation “wherein the seat is selected from a list consisting of a raised region surrounding the passage and a receptacle recessed into the portion of the end wall surrounding the passage”. Claim 12, from which claim 16 depends, establishes that the seat is a structure of the housing (see claim 12, lines 6-7), the housing also includes an aperture (see claim 12, line 3), and that the passage is a structure of the cannula (see claim 12, line 7). It appears that claim 16 is similar to claims 6-7 which are dependent upon claim 1. However the term “the passage” in claims 1 and 6-7 is equivalent to the term “the aperture” in claims 12 and 16. Therefore, it is unclear whether Applicant intends for the claim to recite “wherein the seat is selected from a list consisting of a raised region surrounding the passage and a receptacle recessed into the portion of the end wall surrounding the passage” as is currently written, or whether the claim should instead read “wherein the seat is selected from a list consisting of a raised region surrounding the aperture and a receptacle recessed into the portion of the end wall surrounding the aperture”. For examination purposes, the Examiner interprets this limitation in claim 16 as “wherein the seat is selected from a list consisting of a raised region surrounding the aperture and a receptacle recessed into the portion of the end wall surrounding the aperture”.
Claim 18 recites the limitation “the projection”. There is a lack of antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the projection” as “a projection of the enlarged region”.
Claim 19 recites the limitations “the flange” and “the axis of elongation”. There is a lack of antecedent basis for these limitations in the claim. For examination purposes, the Examiner interprets “the flange” as “a flange of the enlarged region” and the Examiner interprets “the axis of elongation” as “an axis of elongation of the cannula”.
Claim 20 recites the limitation “wherein the seat is selected from a list consisting of a raised region surrounding the passage and a receptacle recessed into the portion of the end wall surrounding the passage”. Claim 17, from which claim 20 depends, establishes that the seat is a structure of the housing (see claim 17, lines 4-5), the housing also includes at least one aperture of the end wall (see claim 17, line 2), and that the passage is a structure of the cannula (see claim 17, lines 5-6). It appears that claim 20 is similar to claims 6-7 which are dependent upon claim 1. However the term “the passage” in claims 1 and 6-7 is equivalent to the term “the at least one aperture of the end wall” in claims 17 and 20. Therefore, it is unclear whether Applicant intends for the claim to recite “wherein the seat is selected from a list consisting of a raised region surrounding the passage and a receptacle recessed into the portion of the end wall surrounding the passage” as is currently written, or whether the claim should instead read “wherein the seat is selected from a list consisting of a raised region surrounding the at least one aperture of the end wall and a receptacle recessed into the portion of the end wall surrounding the at least one aperture of the end wall”. For examination purposes, the Examiner interprets this limitation in claim 20 as “wherein the seat is selected from a list consisting of a raised region surrounding the at least one aperture of the end wall and a receptacle recessed into the portion of the end wall surrounding the at least one aperture of the end wall”.
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, 5-8, and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cote et al. (US 2005/0101932 A1, hereinafter referred to as “Cote ‘932”).
Regarding claim 1, Cote ‘932 discloses a cannula subassembly (site 100, see Figs. 1-20) for coupling to a patient care assembly base (set 200, see Figs. 21-42) (see Figs. 43-50, par. [0164], [0167]-[0168]) comprising:
a cannula (cannula 130) having an outlet (opening at end 134) at a first end (end 134) and an enlarged region (flange portion 136) at a second end (end 132), the enlarged region (flange portion 136) including a sharp guide (tapered portion 138) continuous with a lumen (central bore 142) of the cannula (cannula 130) and an exterior surface (exterior surface of flange portion 136) (see Figs 6 and 12-14, par. [0138]-[0139], [0165]);
a housing (member 120) separate from the cannula (cannula 130) including an end wall (tapered bottom surfaces 125) with a passage (central passage through tapered bottom surfaces 125) therethrough surrounded by a cannula seat (portion of tapered bottom surfaces 125 which seats the flange portion 136), the housing (member 120) having a sidewall (cylindrical sidewall of member 120) extending from the end wall (tapered bottom surfaces 125) with at least one delivery sharp passage (apertures 123) therein (see Figs. 1-11, par. [0136]-[0137], [0139], [0169]);
a septum (diaphragm 150) disposed within the housing (member 120) and forming a fluid tight seal at least against the exterior surface (exterior surface of flange portion 136) (see Fig. 6, par. [0134], [0143]-[0144]); and
a retention clip (retaining member fitted over member 120, see par. [0146]) coupled to the housing (member 120) and capturing the septum (diaphragm 150) at least partially within the housing (member 120) (see par. [0146]).
Regarding claim 2, Cote ‘932 discloses the cannula subassembly of claim 1, wherein the exterior surface (exterior surface of flange portion 136) includes a frusto-conic portion (tapered bottom side 140) and a straight walled portion (straight walled portion of exterior surface of flange portion 136 above/proximal to tapered bottom side 140, see Figs. 12-14), the straight walled portion (straight walled portion of exterior surface of flange portion 136 above/proximal to tapered bottom side 140, see Figs. 12-14) being substantially parallel to an axis of extension of the cannula (cannula 130) (see Figs. 12-14, par. [0138]).
Regarding claim 3, Cote ‘932 discloses the cannula subassembly of claim 1, wherein the exterior surface (exterior surface of flange portion 136) is straight walled and extends substantially parallel to an axis of extension of the cannula (cannula 130) (see Figs. 12-14, par. [0138], flange portion 136 includes a straight walled portion above/proximal to tapered bottom side 140 which is substantially parallel to the axis of extension of the cannula 130).
Regarding claim 5, Cote ‘932 discloses the cannula subassembly of claim 1, wherein the enlarged region (flange portion 136) of the cannula (cannula 130) includes a flange (tapered bottom side 140) disposed at an end of the enlarged region (flange portion 136) most proximate the outlet (opening at end 134) (see Figs. 12-14, par. [0138]).
Regarding claim 6, Cote ‘932 discloses the cannula subassembly of claim 1, wherein the seat (portion of tapered bottom surfaces 125 which seats the flange portion 136) is a raised region surrounding the passage (central passage through tapered bottom surfaces 125) (see Figs. 6-6A, par. [0139], the portion of tapered bottom surfaces 125 which seats the flange portion 136 is tapered downward such that it is raised relative to the central opening through it).
Regarding claim 7, Cote ‘932 discloses the cannula subassembly of claim 1, wherein the seat (portion of tapered bottom surfaces 125 which seats the flange portion 136) is a receptacle recessed into the portion of the end wall (tapered bottom surfaces 125) surrounding the passage (central passage through tapered bottom surfaces 125) (see Figs. 6-6A, par. [0139], the portion of tapered bottom surfaces 125 which seats the flange portion 136 is tapered downward such that the lower portion of tapered bottom surfaces 125 is recessed relative to the upper portion of tapered bottom surfaces 125).
Regarding claim 8, Cote ‘932 discloses the cannula subassembly of claim 1, wherein the septum housing (member 120) includes a set of ears (two of surfaces 124 which are diametrically opposite each other can be considered ears, see annotated Fig. 1 below) projecting outwardly from the sidewall (cylindrical sidewall of member 120) and each ear (two of surfaces 124 which are diametrically opposite each other can be considered ears, see annotated Fig. 1 below) includes a set of wedge bodies (two of surfaces 124 on opposite faces of each ear, see annotated Fig. 1 below) disposed on opposing faces of the ears (two of surfaces 124 which are diametrically opposite each other can be considered ears, see annotated Fig. 1 below).
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Annotated Fig. 1
Regarding claim 12, Cote ‘932 discloses a subcutaneous access assembly (site 100, see Figs. 1-20) for coupling to a medical device base (set 200, see Figs. 21-42) attached to a patient (see Figs. 43-50, par. [0164], [0167]-[0168]) comprising:
a housing (member 120) including an end wall (tapered bottom surfaces 125) with an aperture (central passage through tapered bottom surfaces 125) therethrough, the housing (member 120) having a sidewall (cylindrical sidewall of member 120) extending from the end wall (tapered bottom surfaces 125) with at least one delivery sharp passage (apertures 123) therein (see Figs. 1-11, par. [0136]-[0137], [0139], [0169]);
a molded cannula (cannula 130, note: the limitation “a molded cannula” is considered a product-by-process limitation which is limited to the structure “a cannula” rather than the method of production “molded”, see MPEP 2113) extending through the aperture (central passage through tapered bottom surfaces 125), the cannula (cannula 130) having an outlet (opening at end 134) at a first end (end 134) and an enlarged region (flange portion 136) at a second end (end 132), the enlarged region (flange portion 136) disposed on a seat (portion of tapered bottom surfaces 125 which seats the flange portion 136) within the housing (member 120), there being a passage (central bore 142) through the cannula (cannula 130) extending along an axis of elongation of the cannula (cannula 130), at least a portion of the passage (central bore 142) in the enlarged region (flange portion 136) having a cross-sectional area greater than that at the first end (end 134) (see Figs 6 and 12-14, par. [0138]-[0139], [0165]);
a retainer (retaining member fitted over member 120, see par. [0146]) coupled to the housing (member 120) (see par. [0146]); and
a septum (diaphragm 150) captured within the housing (member 120) by the retainer (retaining member fitted over member 120, see par. [0146]) and forming a fluid tight seal at least against a portion of the exterior surface (exterior surface of flange portion 136) of the enlarged region (flange portion 136) (see Figs. 6-6A, par. [0134], [0143]-[0144]).
Regarding claim 13, Cote ‘932 discloses the cannula subassembly of claim 12, wherein the enlarged region (flange portion 136) includes a flange (tapered bottom side 140) and a projection (portion of flange portion 136 above/proximal to tapered bottom side 140, see Figs. 12-14) raised off a side of the flange (tapered bottom side 140) opposite the outlet (opening at end 134), the projection (portion of flange portion 136 above/proximal to tapered bottom side 140, see Figs. 12-14) surrounding the passage (central bore 142) (see Figs. 6-6A and 12-14, par. [0138]).
Regarding claim 14, Cote ‘932 discloses the cannula subassembly of claim 13, wherein the projection (portion of flange portion 136 above/proximal to tapered bottom side 140, see Figs. 12-14) at least partially defines the portion of the exterior surface (exterior surface of flange portion 136) of the enlarged region (flange portion 136) (see Figs. 6-6A and 12-14, par. [0138]).
Regarding claim 15, Cote ‘932 discloses the cannula subassembly of claim 13, wherein the flange (tapered bottom side 140) extends outwardly with respect to the axis of elongation (see Figs. 12-14).
Regarding claim 16, Cote ‘932 discloses the cannula subassembly of claim 13, wherein the seat (portion of tapered bottom surfaces 125 which seats the flange portion 136) is selected from a list consisting of a raised region surrounding the passage (central bore 142) (see Figs. 6-6A, par. [0139], the portion of tapered bottom surfaces 125 which seats the flange portion 136 is tapered downward such that it includes raised/higher portions) and a receptacle recessed into the portion of the end wall (tapered bottom surfaces 125) surrounding the passage (central bore 142) (see Figs. 6-6A, par. [0139], the portion of tapered bottom surfaces 125 which seats the flange portion 136 is tapered downward such that the lower portion of tapered bottom surfaces 125 is recessed relative to the upper portion of tapered bottom surfaces 125).
Regarding claim 17, Cote ‘932 discloses a cannula assembly (site 100, see Figs. 1-20) for coupling to a portion of a patient care assembly (set 200, see Figs. 21-42) (see Figs. 43-50, par. [0164], [0167]-[0168]) comprising:
a housing (member 120) including an end wall (tapered bottom surfaces 125) and a side wall (cylindrical sidewall of member 120) each including at least one aperture (central passage through tapered bottom surfaces 125 and apertures 123) (see Figs. 1-11, par. [0136]-[0137], [0139], [0169]);
a molded cannula (cannula 130, note: the limitation “a molded cannula” is considered a product-by-process limitation which is limited to the structure “a cannula” rather than the method of production “molded”, see MPEP 2113) separate from the housing (member 120) and having a portion extending through one of the at least one aperture (central passage through tapered bottom surfaces 125) of the end wall (tapered bottom surfaces 125), the cannula (cannula 130) including an enlarged region (flange portion 136) disposed at least partially within the housing (member 120) on a seat (portion of tapered bottom surfaces 125 which seats the flange portion 136) of the housing (member 120), there being a passage (central bore 142) extending through the cannula (cannula 130) having a cross-sectional area which is largest in a portion of the enlarged region (flange portion 136) and smallest at an outlet (opening at end 134) of the cannula (cannula 130) (see Figs 6 and 12-14, par. [0138]-[0139], [0165]); and
a septum (diaphragm 150) captured within the housing (member 120) in compression against a portion of an exterior surface (exterior surface of flange portion 136) of the enlarged region (flange portion 136) of the septum (diaphragm 150) establishing a fluid tight seal against the portion of the exterior surface (exterior surface of flange portion 136) (see Figs. 6-6A, par. [0134], [0143]-[0144]).
Regarding claim 18, Cote ‘932 discloses the cannula subassembly of claim 17, wherein the projection (portion of flange portion 136 above/proximal to tapered bottom side 140, see Figs. 12-14) at least partially defines the portion of the exterior surface (exterior surface of flange portion 136) of the enlarged region (flange portion 136) (see Figs. 6-6A and 12-14, par. [0138]).
Regarding claim 19, Cote ‘932 discloses the cannula subassembly of claim 17, wherein the flange (tapered bottom side 140) extends outwardly with respect to the axis of elongation (see Figs. 12-14).
Regarding claim 20, Cote ‘932 discloses the cannula subassembly of claim 17, wherein the seat (portion of tapered bottom surfaces 125 which seats the flange portion 136) is selected from a list consisting of a raised region surrounding the passage (central bore 142) (see Figs. 6-6A, par. [0139], the portion of tapered bottom surfaces 125 which seats the flange portion 136 is tapered downward such that it includes raised/higher portions) and a receptacle recessed into the portion of the end wall (tapered bottom surfaces 125) surrounding the passage (central bore 142) (see Figs. 6-6A, par. [0139], the portion of tapered bottom surfaces 125 which seats the flange portion 136 is tapered downward such that the lower portion of tapered bottom surfaces 125 is recessed relative to the upper portion of tapered bottom surfaces 125).
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.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Cote et al. (US 2005/0101932 A1, hereinafter referred to as “Cote ‘932”), as applied to claim 1 above, in view of Cote et al. (US 2019/0151567 A1, hereinafter referred to as “Cote ‘567”).
Regarding claim 4, Cote ‘932 discloses the cannula subassembly of claim 1. While Cote ‘932 teaches a retention clip (retaining member fitted over member 120, see par. [0146]), Cote ‘932 fails to expressly show or describe the structure of the retainer. Specifically, Cote ‘932 fails to state wherein the retention clip includes a channel therethrough, a nub portion of the septum extending through the channel and the channel exerting a compressive force against the nub.
Cote ‘567 teaches a cannula subassembly (see Figs. 6A-K) wherein the retention clip (site cap 187) includes a channel therethrough (see Figs. 6A-E, site cap 187 includes a central channel which receives upper protrusion 195 of septum 190), a nub portion (upper protrusion 195) of the septum (septum 190) extending through the channel (see Figs. 6A-E, site cap 187 includes a central channel which receives upper protrusion 195 of septum 190) and the channel (see Figs. 6A-E, site cap 187 includes a central channel which receives upper protrusion 195 of septum 190) exerting a compressive force against the nub (upper protrusion 195) (see Figs. 6A-K, par. [0064]-[0065]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula subassembly of Cote ‘932 to include wherein the retention clip includes a channel therethrough, a nub portion of the septum extending through the channel and the channel exerting a compressive force against the nub, as taught by Cote ‘567, in order to serve as the structure of the retention clip which securely locks the septum within the housing (see Cote ‘567 par. [0064]).
Regarding claim 9, Cote ‘932 discloses the cannula subassembly of claim 1. However, Cote ‘932 fails to expressly state wherein the septum housing includes a set of protuberances configured to compress the septum.
Cote ‘567 teaches a cannula subassembly (see Figs. 6A-K) wherein the septum housing (central hub 181) includes a set of protuberances (see Figs. 6A, 6E, 6H, par. [0064], septum 190 includes a U-shaped slanted portion 192 and the interior wall of central hub 181 is correspondingly shaped to receive and seal against septum 190 and portion 192 such that central hub 181 would have two protuberances which form the corresponding U-shape of central hub 181) configured to compress the septum (septum 190) (see Figs. 6A-K, par. [0064]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula subassembly of Cote ‘932 to include wherein the septum housing includes a set of protuberances configured to compress the septum, as taught by Cote ‘567, in order to shape the housing and septum to allow for the cannula to be inserted at various angles (see Cote ‘567 par. [0064], [0066]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Cote et al. (US 2005/0101932 A1, hereinafter referred to as “Cote ‘932”), as applied to claim 1 above, in view of Sonderegger (US 2014/0039453 A1).
Regarding claim 10, Cote ‘932 discloses the cannula subassembly of claim 1. However Cote ‘932 fails to state wherein the cannula subassembly further comprises at least one additional septum.
Sonderegger teaches a cannula subassembly (see Figs. 1-4) wherein the cannula subassembly (see Figs. 1-4) further comprises at least one additional septum (see Figs. 2-4, par. [0027]-[0030] and [0032]-[0033]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula subassembly of Cote ‘932 to include wherein the cannula subassembly further comprises at least one additional septum, as taught by Sonderegger, in order to allow a blunt delivery member through the least one delivery sharp passage in the sidewall of the housing and between the two septa rather than requiring a sharp needle to penetrate and cause damage to the single septa to form a fluid communication (see Sonderegger par. [0032]-[0033]).
Regarding claim 11, Cote ‘932 discloses the cannula subassembly of claim 1. However Cote ‘932 fails to state wherein the septum has at least one additional septum nested therein.
Sonderegger teaches a cannula subassembly (see Figs. 1-4) wherein the septum (septum 90) has at least one additional septum (septum 80) nested therein (see Figs. 2-4, par. [0027]-[0030] and [0032]-[0033], septum 90 is ring-shaped whereas septum 80 has an upper wall such that septum 80 is partially within the wall of septum 90).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula subassembly of Cote ‘932 to include wherein the septum has at least one additional septum nested therein, as taught by Sonderegger, in order to allow a blunt delivery member through the least one delivery sharp passage in the sidewall of the housing and between the two septa rather than requiring a sharp needle to penetrate and cause damage to the single septa to form a fluid communication (see Sonderegger par. [0032]-[0033]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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