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, 7-8, 11-14, and 16-20 are objected to because of the following informalities:
-Claim 1, lines 4-5: please correct “an on a seat” to “and on a seat”
-Claim 1, line 6: please correct “the exterior surface” to “an exterior surface”
-Claim 7, line 3: please correct “the nub” to “the nub portion”
-Claim 8, line 1: please correct “list” to “group”
-Claim 8, line 2: please correct “of establishing” to “of: establishing”
-Claim 8, line 4: please add a comma after “cannula”
-Claim 11, line 4: please correct “the housing” to “the septum housing”
-Claim 11, lines 4-5: please correct “the housing” to “the septum housing”
-Claim 11, line 6: please correct “the housing” to “the septum housing”
-Claim 12, lines 2-3: please correct “the housing” to “the septum housing”
-Claim 13, lines 1-2: please correct “the housing” to “the septum housing”
-Claim 13, line 3: please correct “the nub” to “the nub portion”
-Claim 14, line 1: please correct “list” to “group”
-Claim 14, line 3: please add a comma after “seat”
-Claim 14, line 4: please correct “the housing” to “the septum housing”
-Claim 16, line 3: please correct “the housing” to “the cannula subassembly housing”
-Claim 16, line 4: please correct “the housing” to “the cannula subassembly housing”
-Claim 16, line 5: please correct “the housing” to “the cannula subassembly housing”
-Claim 16, line 7: please correct “the housing” to “the cannula subassembly housing”
-Claim 17, lines 2-3: please correct “the housing” to “the cannula subassembly housing”
-Claim 18, lines 1-2: please correct “the housing” to “the cannula subassembly housing”
-Claim 18, line 3: please correct “the nub” to “the nub portion”
-Claim 19, line 1: please correct “list” to “group”
-Claim 19, line 3: please add a comma after “seat”
-Claim 19, line 4: please correct “the housing” to “the cannula subassembly housing”
-Claim 20, line 1: please correct “list” to “group”
-Claim 20, lines 1-2: please correct “of establishing” to “of: establishing”
-Claim 20, line 4: please add a comma after “cannula”
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.
Claim 5 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 5 recites the limitation “wherein positioning the cannula comprises locating a portion of the enlarged region on a raised projection…”. Claim 1, from which claim 5 depends, previously recites “compressing a septum against a portion of the exterior surface of the enlarged region”. In other words, a portion of the enlarged region is introduced in both claim 1 and claim 5. It is unclear whether the portion introduced in claim 5 should be considered the same portion introduced in claim 1. For examination purposes, the Examiner interprets that the portions introduced in claim 1 and 5 are not the same. The Examiner interprets “a portion” in claim 5 as “another portion”.
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 1-5, 8, 10-11, 14-16, and 19-20 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 method for assembling a cannula subassembly (site 100, see Figs. 1-20), the method comprising:
providing a housing (member 120) (see Fig. 8, par. [0136]);
positioning 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) such that a part of a first portion of the cannula (cannula 130) is external to the housing (member 120) (see Fig. 6) and an enlarged region (flange portion 136) at an end (first end 132) of the cannula (cannula 130) is disposed within the housing (member 120) and on a seat (bottom surfaces 125) of the housing (member 120) (see Figs 6 and 12-14, par. [0138]-[0139]);
compressing a septum (diaphragm 150) against a portion of the exterior surface of the enlarged region (flange portion 136) and forming a fluid tight seal between at least the septum (diaphragm 150) and the enlarged region (flange portion 136) (see Fig. 6, par. [0134], [0143]-[0144]); and
capturing the septum (diaphragm 150) at least partially within the housing (member 120) by coupling a retainer (retaining member fitted over member 120, see par. [0146]) to the housing (member 120) (see par. [0146]).
Regarding claim 2, Cote ‘932 discloses the method of claim 1, wherein capturing the septum (diaphragm 150) comprises retaining a surface (outer periphery 160) of the septum (diaphragm 150) against an end wall (interior cavity wall of member 120, see Fig. 6, par. [0143]) of the housing (member 120) (see Figs. 6 and 15-17, par. [0143], [0146]).
Regarding claim 3, Cote ‘932 discloses the method of claim 2, wherein the end wall (interior cavity wall of member 120, see Fig. 6, par. [0143]) includes a passage (cavity 121) therethrough and positioning the cannula (cannula 130) comprises passing the first portion of the cannula (cannula 130) at least partially through the passage (cavity 121) (see Figs. 6 and 8-11, par. [0137], [0139]).
Regarding claim 4, Cote ‘932 discloses the method of claim 1, wherein positioning the cannula (cannula 130) comprises locating the enlarged region (flange portion 136) at least partially within a depression which at least partially defines the seat (bottom surfaces 125) (see Fig. 6, par. [0139], the inner walls of housing member 120 including bottom surfaces 125 form a depressed seat for receiving the flange portion 136 of cannula 130).
Regarding claim 5, Cote ‘932 discloses the method of claim 1, wherein positioning the cannula (cannula 130) comprises locating a portion of the enlarged region (flange portion 136) on a raised projection (see Fig. 6, bottom surfaces 125 are tapered such that the upper portion of bottom surfaces are raised/project upward compared to the lowermost portion of bottom surfaces 125) surrounding an aperture (central aperture defined within bottom surfaces 125 which cannula 130 partially passes through) in the housing (member 120) through which the first portion of the cannula (cannula 130) extends, the raised projection (see Fig. 6, bottom surfaces 125 are tapered such that the upper portion of bottom surfaces are raised/project upward compared to the lowermost portion of bottom surfaces 125) at least partially defining the seat (bottom surfaces 125) (see Fig. 6, par. [0139], [0143]).
Regarding claim 8, Cote ‘932 discloses the method of claim 1, wherein compressing the septum (diaphragm 150) comprises one of the list consisting of establishing a fluid seal against a straight walled portion (portion of flange portion 136 above bottom taper 140) of the enlarged region (flange portion 136) which is raised from a flange (bottom taper 140) of the enlarged region (flange portion 136) and extends in a direction parallel to an axis of elongation of the cannula (cannula 130) and establishing a fluid seal at least against a straight walled portion (portion of flange portion 136 above bottom taper 140) of the enlarged region (flange portion 136) that extends parallel to the axis of elongation of the cannula (cannula 130) (see Fig. 6, par. [0138], [0143]-[0144]).
Regarding claim 10, Cote ‘932 discloses the method of claim 1, wherein the method further comprises coupling the cannula subassembly (site 100, see Figs. 1-20) within a patient care assembly base (set 200, see Figs. 21-42) (see Figs. 43-50, par. [0164], [0167]-[0168]).
Regarding claim 11, Cote ‘932 discloses a method for assembling a patient care assembly (see Figs. 1-50, site 100 of Figs. 1-20 and set 200 of Figs. 21-42 form an assembly as shown in Figs. 43-50), the method comprising:
providing a septum housing (member 120) (see Fig. 8, par. [0136]);
positioning 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) such that a part of a first portion of the cannula (cannula 130) is external to the housing (member 120) (see Fig. 6) and an enlarged region (flange portion 136) at an end (first end 132) of the cannula (cannula 130) is disposed on a seat (bottom surfaces 125) within the housing (member 120) (see Figs 6 and 12-14, par. [0138]-[0139]);
capturing a septum (diaphragm 150) at least partially within the housing (member 120) and compressed against an exterior surface of the enlarged region (flange portion 136) so as to form a fluid tight seal (see Fig. 6, par. [0134], [0143]-[0144]);
coupling the septum housing (member 120) in place within a receptacle (aperture 270) of the patient care assembly (see Figs. 1, 21, 43, and 49-50, par. [0164], [0167]-[0168]).
Regarding claim 14, Cote ‘932 discloses the method of claim 11, wherein positioning the cannula (cannula 130) comprises one of the list consisting of: locating the enlarged region (flange portion 136) at least partially within a depression which at least partially defines the seat (bottom surfaces 125) (see Fig. 6, par. [0139], the inner walls of housing member 120 including bottom surfaces 125 form a depressed seat for receiving the flange portion 136 of cannula 130) and locating a portion of the enlarged region (flange 136) on a raised projection (see Fig. 6, bottom surfaces 125 are tapered such that the upper portion of bottom surfaces are raised/project upward compared to the lowermost portion of bottom surfaces 125) surrounding an aperture (central aperture defined within bottom surfaces 125 which cannula 130 partially passes through) in the housing (member 120) through which the first portion of the cannula (cannula 130) extends, the raised projection (see Fig. 6, bottom surfaces 125 are tapered such that the upper portion of bottom surfaces are raised/project upward compared to the lowermost portion of bottom surfaces 125) at least partially defining the seat (bottom surfaces 125) (see Fig. 6, par. [0139], [0143]).
Regarding claim 15, Cote ‘932 discloses the method of claim 11, wherein capturing the septum (diaphragm 150) comprises establishing a fluid seal at least against a straight walled portion (portion of flange portion 136 above bottom taper 140) of the enlarged region (flange portion 136) that extends parallel to an axis of elongation of the cannula (cannula 130) (see Fig. 6, par. [0138], [0143]-[0144]).
Regarding claim 16, Cote ‘932 discloses a method for assembling a patient care assembly (see Figs. 1-50, site 100 of Figs. 1-20 and set 200 of Figs. 21-42 form an assembly as shown in Figs. 43-50), the method comprising:
positioning 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) within a cannula subassembly housing (member 120) with a part of a first portion of the cannula (cannula 130) external to the housing (member 120) (see Fig. 6) and an enlarged region (flange portion 136) at an end (first end 132) of the cannula (cannula 130) disposed on a seat (bottom surfaces 125) within the housing (member 120) (see Figs 6, 8, and 12-14, par. [0136] and [0138]-[0139]);
capturing a septum (diaphragm 150) at least partially within the housing (member 120) and compressed against an exterior surface of the enlarged region (flange portion 136) so as to form a fluid tight seal (see Fig. 6, par. [0134], [0143]-[0144]);
coupling the housing (member 120) in place within a receptacle (aperture 270) of the patient care assembly (see Figs. 1, 21, 43, and 49-50, par. [0164], [0167]-[0168]).
Regarding claim 19, Cote ‘932 discloses the method of claim 16, wherein positioning the cannula (cannula 130) comprises one of the list consisting of: locating the enlarged region (flange portion 136) at least partially within a depression which at least partially defines the seat (bottom surfaces 125) (see Fig. 6, par. [0139], the inner walls of housing member 120 including bottom surfaces 125 form a depressed seat for receiving the flange portion 136 of cannula 130) and locating a portion of the enlarged region (flange 136) on a raised projection (see Fig. 6, bottom surfaces 125 are tapered such that the upper portion of bottom surfaces are raised/project upward compared to the lowermost portion of bottom surfaces 125) surrounding an aperture (central aperture defined within bottom surfaces 125 which cannula 130 partially passes through) in the housing (member 120) through which the first portion of the cannula (cannula 130) extends, the raised projection (see Fig. 6, bottom surfaces 125 are tapered such that the upper portion of bottom surfaces are raised/project upward compared to the lowermost portion of bottom surfaces 125) at least partially defining the seat (bottom surfaces 125) (see Fig. 6, par. [0139], [0143]).
Regarding claim 20, Cote ‘932 discloses the method of claim 16, wherein capturing the septum (diaphragm 150) comprises one of the list consisting of establishing a fluid seal against a straight walled portion (portion of flange portion 136 above bottom taper 140) of the enlarged region (flange portion 136) which is raised from a flange (bottom taper 140) of the enlarged region (flange portion 136) and extends in a direction parallel to an axis of elongation of the cannula (cannula 130) and establishing a fluid seal at least against a straight walled portion (portion of flange portion 136 above bottom taper 140) of the enlarged region (flange portion 136) that extends parallel to the axis of elongation of the cannula (cannula 130) (see Fig. 6, par. [0138], [0143]-[0144]).
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 6-7, 9, 12-13, and 17-18 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 claims 1, 11, and 16 above, in view of Cote et al. (US 2019/0151567 A1, hereinafter referred to as “Cote ‘567”).
Regarding claim 6, Cote ‘932 discloses the method of claim 1. While Cote ‘932 teaches a retainer (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 capturing the septum comprises engaging at least one retaining finger of the retainer into a cooperating receiving feature of the housing.
Cote ‘567 teaches a method for assembling a cannula subassembly (see Figs. 6A-K) wherein capturing the septum (septum 190) comprises engaging at least one retaining finger (outward flared portions of site cap 187, see Fig. 6B) of the retainer (site cap 187) into a cooperating receiving feature (inner walls of central hub 181) of the housing (central hub 181) (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 method of Cote ‘932 to include wherein capturing the septum comprises engaging at least one retaining finger of the retainer into a cooperating receiving feature of the housing, as taught by Cote ‘567, in order to serve as the structure of the retaining member which securely locks the septum within the housing (see Cote ‘567 par. [0064]).
Regarding claim 7, Cote ‘932 discloses the method of claim 1. While Cote ‘932 teaches a retainer (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 capturing the septum comprises receiving a nub portion of the septum at least partially within a channel extending through the retainer and exerting a compressive force on the nub with a sidewall of the channel.
Cote ‘567 teaches a method for assembling a cannula subassembly (see Figs. 6A-K) wherein capturing the septum (septum 190) comprises receiving a nub portion (upper protrusion 195) of the septum (septum 190) at least partially within a channel (central opening of site cap 187) extending through the retainer (site cap 187) and exerting a compressive force on the nub (upper protrusion 195) with a sidewall of the channel (central opening of site cap 187) (see Figs. 6A-K, par. [0064]-[0065], upper protrusion 195 is snugly held within site cap 187).
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 method of Cote ‘932 to include wherein capturing the septum comprises receiving a nub portion of the septum at least partially within a channel extending through the retainer and exerting a compressive force on the nub with a sidewall of the channel, as taught by Cote ‘567, in order to serve as the structure of the retaining member which securely locks the septum within the housing (see Cote ‘567 par. [0064]).
Regarding claim 9, Cote ‘932 discloses the method of claim 1. However, Cote ‘932 fails to expressly state wherein compressing the septum comprises exerting a compressive force against the septum with a number of protuberances defined on the inner wall of the housing.
Cote ‘567 teaches a method for assembling a cannula subassembly (see Figs. 6A-K) wherein compressing the septum (septum 190) comprises exerting a compressive force against the septum (septum 190) with a number 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) defined on the inner wall (inner surface 189) of the housing (central hub 181) (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 method of Cote ‘932 to include wherein compressing the septum comprises exerting a compressive force against the septum with a number of protuberances defined on the inner wall of the housing, 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]).
Regarding claim 12, Cote ‘932 discloses the method of claim 11. However, Cote ‘932 fails to expressly state wherein capturing the septum comprises exerting a compressive force against the septum with a number of protuberances defined on the inner wall of the housing.
Cote ‘567 teaches a method for assembling a patient care assembly (see Figs. 6A-K) wherein capturing the septum (septum 190) comprises exerting a compressive force against the septum (septum 190) with a number 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) defined on the inner wall (inner surface 189) of the housing (central hub 181) (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 method of Cote ‘932 to include wherein capturing the septum comprises exerting a compressive force against the septum with a number of protuberances defined on the inner wall of the housing, 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]).
Regarding claim 13, Cote ‘932 discloses the method of claim 11, wherein capturing the septum (diaphragm 150) comprises coupling a retainer (retaining member fitted over member 120, see par. [0146]) to the housing (member 120) (see par. [0146]).
While Cote ‘932 teaches a retainer (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 capturing the septum comprises receiving a nub portion of the septum at least partially within a channel extending through the retainer, the channel exerting a compressive force on the nub.
Cote ‘567 teaches a method for assembling a patient care assembly (see Figs. 6A-K) wherein capturing the septum (septum 190) comprises receiving a nub portion (upper protrusion 195) of the septum (septum 190) at least partially within a channel (central opening of site cap 187) extending through the retainer (site cap 187), the channel (central opening of site cap 187) exerting a compressive force on the nub (upper protrusion 195) (see Figs. 6A-K, par. [0064]-[0065], upper protrusion 195 is snugly held within site cap 187).
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 method of Cote ‘932 to include wherein capturing the septum comprises receiving a nub portion of the septum at least partially within a channel extending through the retainer, the channel exerting a compressive force on the nub, as taught by Cote ‘567, in order to serve as the structure of the retaining member which securely locks the septum within the housing (see Cote ‘567 par. [0064]).
Regarding claim 17, Cote ‘932 discloses the method of claim 16. However, Cote ‘932 fails to expressly state wherein capturing the septum comprises exerting a compressive force against the septum with a number of protuberances defined on the inner wall of the housing.
Cote ‘567 teaches a method for assembling a patient care assembly (see Figs. 6A-K) wherein capturing the septum (septum 190) comprises exerting a compressive force against the septum (septum 190) with a number 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) defined on the inner wall (inner surface 189) of the housing (central hub 181) (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 method of Cote ‘932 to include wherein capturing the septum comprises exerting a compressive force against the septum with a number of protuberances defined on the inner wall of the housing, 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]).
Regarding claim 18, Cote ‘932 discloses the method of claim 16, wherein capturing the septum (diaphragm 150) comprises coupling a retainer (retaining member fitted over member 120, see par. [0146]) to the housing (member 120) (see par. [0146]).
While Cote ‘932 teaches a retainer (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 capturing the septum comprises receiving a nub portion of the septum at least partially within a channel extending through the retainer, the channel exerting a compressive force on the nub.
Cote ‘567 teaches a method for assembling a patient care assembly (see Figs. 6A-K) wherein capturing the septum (septum 190) comprises receiving a nub portion (upper protrusion 195) of the septum (septum 190) at least partially within a channel (central opening of site cap 187) extending through the retainer (site cap 187), the channel (central opening of site cap 187) exerting a compressive force on the nub (upper protrusion 195) (see Figs. 6A-K, par. [0064]-[0065], upper protrusion 195 is snugly held within site cap 187).
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 method of Cote ‘932 to include wherein capturing the septum comprises receiving a nub portion of the septum at least partially within a channel extending through the retainer, the channel exerting a compressive force on the nub, as taught by Cote ‘567, in order to serve as the structure of the retaining member which securely locks the septum within the housing (see Cote ‘567 par. [0064]).
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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