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 .
Election/Restrictions
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/31/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitations is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 16 is objected to because of the following informalities:
in claim 16, line 3: “a” should be inserted before “connector septum”.
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 1-2 and 4-18 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 1 recites “drainage liquid flowing through the drainage tube flows through the connector from the inlet port to the outlet port” in lines 6-7, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claims 2 and 4-18 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “drainage liquid” in line 3, but it is not clear if this recitation is the same as, related to, or different from “drainage liquid” in claim 1, line 6. If they are the same, “drainage liquid” in claim 2 should be “the drainage liquid”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claims 4-5 are rejected by virtue of their dependence from claim 1.
Claim 7 recites “drainage liquid” in line 2, but it is not clear if this recitation is the same as, related to, or different from “drainage liquid” in claim 1, line 6. If they are the same, “drainage liquid” in claim 7 should be “the drainage liquid”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 9 recites “the cap valve” in line 1 in which there is insufficient antecedent basis for this limitation in the claims. Also, it is not clear what relation this cap valve has with the other structural features of the claimed system.
Claim 9 recites “drainage liquid” in line 2 and “drainage liquid” in line 5, but it is not clear if these recitations are the same as, related to, or different from each other or “drainage liquid” in claim 1, line 6. If they are all the same, “drainage liquid” in claim 9, line 2 and in claim 9, line 5 should be “the drainage liquid”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 10 recites “a portion of the sampling system” in line 1, but it is not clear if this recitation is the same as, related to, or different from any element recited in claim 1. The relationship between the recitation of claim 10 and the elements of claim 1 should be made clear.
Claims 11-12 are rejected by virtue of their dependence from claim 10.
Claim 11 recites “the connector septum” in line 1 and “the connector valve” in line 2 in which there are insufficient antecedent bases for these limitations in the claims. Also, it is not clear what relation the connector septum or the connector valve have with the other structural features of the claimed system.
Claim 12 is rejected by virtue of its dependence from claim 11.
Claim 13 recites “the cap valve” in line 1 in which there is insufficient antecedent basis for this limitation in the claims. Also, it is not clear what relation this cap valve has with the other structural features of the claimed system.
Claims 14-17 are rejected by virtue of their dependence from claim 13.
Claim 14 recites “the open state” in line 3 and “the closed state” in line 4 in which there are insufficient antecedent bases for these limitations in the claims.
Claim 15 is rejected by virtue of its dependence from claim 14.
Claim 18 recites “liquid” in line 1, but it is not clear if this recitation is the same as, related to, or different from “drainage liquid” in claim 1, line 6. If they are the same, “liquid” in claim 18 should be “a drainage liquid”. If they are different, their relationship should be made clear.
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 1-2 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipate by CN 104107464 (Ding). Citations to Ding will refer to the machine English translation that accompanies this Office Action.
With respect to claim 1, Ding teaches a drainage liquid sampling system, comprising:
a connector couplable with a drainage tube (the drainage tube 1 of Ding) of a drainage system, the connector defining an inlet port (the element A of the below annotated FIG. 1 of Ding), an outlet port (the switch 11 of Ding), and a sample port (the element B of the below annotated FIG. 1 of Ding), wherein: the inlet port, the outlet port, and the sample port are in fluid communication with each other (the switch 11 and the elements A and B of the below annotated FIG. 1 of Ding are in fluid communication with each other), and drainage liquid flowing through the drainage tube flows through the connector from the inlet port to the outlet port (pages 1-3 of Ding); and
a sample container (the sampling bag 3 of Ding) couplable with the sample port.
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Annotated FIG. 1 of Ding
With respect to claim 2, Ding teaches that the connector comprises a connector valve (the control valve 4 of Ding) disposed in line with the sample port (the element A of the below annotated FIG. 1 of Ding), the connector valve selectively configurable between an open state and a closed state, wherein drainage liquid is: permitted to enter through the sample port when the connector valve is in the open state (FIG. 2 of Ding), and prevented from exiting through the sample port when the connector valve is in the closed state (FIG. 1 of Ding).
With respect to claim 18, Ding teaches a drainage system for draining a liquid from a patient, comprising: a drainage tube (the drainage tube 1 of Ding) configured to couple with a drainage catheter at a distal end of the drainage tube; a collection container coupled to the drainage tube at a proximal end of the drainage tube (the urine-collecting bag 2 of Ding); and the sampling system of claim 1 (see the rejection of claim 1), the sampling system connected in line with the drainage tube (FIGS. 1-2 of Ding show this configuration).
Claims 1-2, 4, 6-9, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipate by U.S. Patent Application Publication No. 2012/0055271 (McElroy).
With respect to claim 1, McElroy teaches a drainage liquid sampling system, comprising:
a connector (the bladder 150, the inlet end 114,the port 142, and the outlet end 116 of McElroy) couplable with a drainage tube (the catheter of McElroy; paragraph 0038 of McElroy) of a drainage system, the connector defining an inlet port (the inlet end 114 of McElroy), an outlet port (the outlet end 116 of McElroy), and a sample port (the port 142 of McElroy), wherein: the inlet port, the outlet port, and the sample port are in fluid communication with each other (the inlet end 114, the outlet end 116, and the port 142 of McElroy are in fluid communication with each other), and drainage liquid flowing through the drainage tube flows through the connector from the inlet port to the outlet port (paragraphs 0038-0043 of McElroy); and
a sample container (the syringe 50 of McElroy) couplable with the sample port.
With respect to claim 2, McElroy teaches that the connector comprises a connector valve (the bladder 150 of McElroy) disposed in line with the sample port (the port 142 of McElroy), the connector valve selectively configurable between an open state and a closed state, wherein drainage liquid is: permitted to enter through the sample port when the connector valve is in the open state (paragraphs 0038-0042 and FIGS. 9-10 of McElroy), and prevented from exiting through the sample port when the connector valve is in the closed state (paragraphs 0038 and 0043 of McElroy).
With respect to claim 4, McElroy teaches that the connector valve (the bladder 150 of McElroy) comprises a connector septum (the inner bladder segment 157 of McElroy) disposed across the sample port.
With respect to claim 6, McElroy teaches a cap (the bezel 120 of McElroy) couplable with the sample container (the syringe 50 of McElroy), the cap configured to sealably couple with an open end of the sample container (paragraph 0035 of McElroy).
According to a first interpretation, with respect to claim 7, McElroy teaches that the cap (the bezel 120 of McElroy) comprises a cap valve (the bladder stem 154 of McElroy) selectively configurable between an open state (paragraphs 0038-0042 and FIGS. 9-10 of McElroy) and a closed state (paragraphs 0038 and 0043 of McElroy), wherein drainage liquid is: permitted to enter into the sample container when the cap valve is in the open state (paragraphs 0038-0042 and FIGS. 9-10 of McElroy), and prevented from exiting the sample container when the cap valve is in the closed state (paragraphs 0038 and 0043 of McElroy).
According to a first interpretation, with respect to claim 8, McElroy teaches that the cap (the bezel 120 of McElroy) is configured to couple with the connector (the bladder 150, the inlet end 114,the port 142, and the outlet end 116 of McElroy).
According to a second interpretation, with respect to claim 7, McElroy teaches that the cap (the guide 52 of McElroy) comprises a cap valve (the tip 50a of McElroy) selectively configurable between an open state (paragraphs 0038-0042 and FIGS. 9-10 of McElroy) and a closed state (paragraphs 0038 and 0043 of McElroy), wherein drainage liquid is: permitted to enter into the sample container when the cap valve is in the open state (paragraphs 0038-0042 and FIGS. 9-10 of McElroy), and prevented from exiting the sample container when the cap valve is in the closed state (paragraphs 0038 and 0043 of McElroy).
According to a second interpretation, with respect to claim 8, McElroy teaches that the cap (the guide 52 of McElroy) is configured to couple with the connector (the bladder 150, the inlet end 114,the port 142, and the outlet end 116 of McElroy).
According to a second interpretation, with respect to claim 9, McElroy teaches that the cap valve (the tip 50a of McElroy) is configured to automatically: permit drainage liquid to enter the sample container upon coupling of the cap with the connector (paragraphs 0038-0042 and FIGS. 9-10 of McElroy), and prevent drainage liquid from exiting the sample container upon decoupling of the cap from the connector (paragraphs 0038 and 0043 of McElroy).
With respect to claim 18, McElroy teaches a drainage system for draining a liquid from a patient, comprising: a drainage tube (the catheter of McElroy; paragraph 0038 of McElroy) configured to couple with a drainage catheter at a distal end of the drainage tube; a collection container coupled to the drainage tube at a proximal end of the drainage tube (the collection bag 20 of McElroy); and the sampling system of claim 1 (see the rejection of claim 1), the sampling system connected in line with the drainage tube (FIGS. 1-2 and paragraphs 0038-0043 of McElroy).
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 1, 2, 4, 6-8, 13-14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104107464 (Ding), in view of U.S. Patent Application Publication No. 2008/0132876 (Felt). Citations to Ding will refer to the machine English translation that accompanies this Office Action.
Ding teaches a control valve 4 couplable with a drainage tube (the drainage tube 1 of Ding) and a sampling bag 3 (FIG. 2 of Ding). There are fluid connections between the control valve 4 and the sampling bag 3, between the control valve 4 and the urine-collecting bag 2, and between the control valve 4 and the drainage tube 4 of Ding shown schematically as boxes. Felt shows a male-female connection (100, 200) used for fluid connection (abstract; FIGS. 1A-1B and 2-3; paragraphs 0008 and 0045 of Felt). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the fluid connectors of Felt as the fluid connections between the control valve 4 and the sampling bag 3, between the control valve 4 and the urine-collecting bag 2, and between the control valve 4 and the drainage tube 4 of Ding so as to maintain sterility.
With respect to claim 1, the combination teaches or suggests a drainage liquid sampling system, comprising:
a connector (the control valve 4 of Ding and the female connections 200 of Felt) couplable with a drainage tube (the drainage tube 1 of Ding) of a drainage system, the connector defining an inlet port (the female connection 200 of Felt between the control valve 4 and the drainage tube 4 of Ding), an outlet port (the female connection 200 of Felt between the control valve 4 and the urine-collecting bag 2 of Ding), and a sample port (the female connection 200 of Felt between the control valve 4 and the sampling bag 3), wherein: the inlet port, the outlet port, and the sample port are in fluid communication with each other (the fluid connections 200 of Felt between the control valve 4 and the sampling bag 3, between the control valve 4 and the urine-collecting bag 2, and between the control valve 4 and the drainage tube 4 of Ding are in fluid communication with each other), and drainage liquid flowing through the drainage tube flows through the connector from the inlet port to the outlet port (pages 1-3 of Ding); and
a sample container (the sampling bag 3 of Ding) couplable with the sample port.
With respect to claim 2, the combination teaches or suggests that the connector (the control valve 4 of Ding and the female connections 200 of Felt) comprises a connector valve (the membrane 600 of Felt) disposed in line with the sample port, the connector valve selectively configurable between an open state and a closed state, wherein drainage liquid is: permitted to enter through the sample port when the connector valve is in the open state (FIG. 2 of Ding with FIG. 3 of Felt), and prevented from exiting through the sample port when the connector valve is in the closed state (FIG. 1 of Ding with FIG. 2 of Felt).
With respect to claim 4, the combination teaches or suggests that the connector valve comprises a connector septum (the membrane 600 of Felt) disposed across the sample port.
With respect to claim 6, the combination teaches or suggests a cap (the male connector element 100 of Felt) couplable with the sample container (the sampling bag 3 of Ding), the cap configured to sealably couple with an open end of the sample container (FIG. 1A and paragraph 0021 of Felt).
With respect to claim 7, the combination teaches or suggests that the cap (the male connector element 100 of Felt) comprises a cap valve (the membrane 500 of Felt) selectively configurable between an open state and a closed state, wherein drainage liquid is: permitted to enter into the sample container when the cap valve is in the open state (FIG. 3 of Felt), and prevented from exiting the sample container when the cap valve is in the closed state (FIG. 2 of Felt).
With respect to claim 8, the combination teaches or suggests that the cap (the male connector element 100 of Felt) is configured to couple with the connector (the control valve 4 of Ding and the female connections of Felt).
With respect to claim 13, the combination teaches or suggests that the cap valve (the membrane 500 of Felt) comprises a cap septum (the membrane 500 of Felt) disposed across an opening at a distal end of the cap (the male connector element 100 of Felt).
With respect to claim 14, the combination teaches or suggests that the cap septum (the membrane 500 of Felt) is deflectable, wherein the cap valve is in: the open state when the cap septum is in a deflected state (FIG. 3 of Felt), and the closed state when the cap septum is in a non-deflected state (FIG. 2 of Felt).
With respect to claim 16, the combination teaches or suggests that: the cap (the male connector element 100 of Felt) comprises a protrusion (the male luer taper 120 of Felt) disposed within the opening of the cap, and the protrusion is configured to deflect the cap septum (the membrane 500 of Felt) and connector septum (the membrane 600 of Felt) upon coupling of the cap with the connector (FIG. 3 of Felt).
With respect to claim 18, the combination teaches or suggests a drainage system for draining a liquid from a patient, comprising: a drainage tube (the drainage tube 1 of Ding) configured to couple with a drainage catheter at a distal end of the drainage tube; a collection container coupled to the drainage tube at a proximal end of the drainage tube (the urine-collecting bag 2 of Ding); and the sampling system of claim 1 (see the rejection of claim 1), the sampling system connected in line with the drainage tube (FIGS. 1-2 of Ding show this configuration).
Claims 1-2, 4, 6-8, 13-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104107464 (Ding), in view of U.S. Patent Application Publication No. 2005/0090805 (Shaw). Citations to Ding will refer to the machine English translation that accompanies this Office Action.
Ding teaches a control valve 4 couplable with a drainage tube (the drainage tube 1 of Ding) and a sampling bag 3 (FIG. 2 of Ding). There are fluid connections between the control valve 4 and the sampling bag 3, between the control valve 4 and the urine-collecting bag 2, and between the control valve 4 and the drainage tube 4 of Ding shown schematically as boxes. Shaw shows a male-female connection (102, 104) used for fluid connection (abstract; FIGS. 2 and 5; paragraphs 0031-0039 of Shaw). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the fluid connectors of Shaw as the fluid connections between the control valve 4 and the sampling bag 3, between the control valve 4 and the urine-collecting bag 2, and between the control valve 4 and the drainage tube 4 of Ding so as to prevent containments and prevent leakage.
With respect to claim 1, the combination teaches or suggests a drainage liquid sampling system, comprising:
a connector (the control valve 4 of Ding and the male connections 104 of Shaw) couplable with a drainage tube (the drainage tube 1 of Ding) of a drainage system, the connector defining an inlet port (the male connection 104 of Shaw between the control valve 4 and the drainage tube 4 of Ding), an outlet port (the male connection 104 of Shaw between the control valve 4 and the urine-collecting bag 2 of Ding), and a sample port (the male connection 104 of Shaw between the control valve 4 and the sampling bag 3), wherein: the inlet port, the outlet port, and the sample port are in fluid communication with each other (the fluid connections 104 of Shaw between the control valve 4 and the sampling bag 3, between the control valve 4 and the urine-collecting bag 2, and between the control valve 4 and the drainage tube 4 of Ding are in fluid communication with each other), and drainage liquid flowing through the drainage tube flows through the connector from the inlet port to the outlet port (pages 1-3 of Ding); and
a sample container (the sampling bag 3 of Ding) couplable with the sample port.
With respect to claim 2, the combination teaches or suggests that the connector (the control valve 4 of Ding and the male connections 104 of Shaw) comprises a connector valve (the penetration tube 202 of Shaw) disposed in line with the sample port, the connector valve selectively configurable between an open state and a closed state, wherein drainage liquid is: permitted to enter through the sample port when the connector valve is in the open state (FIG. 2 of Ding with FIG. 5 of Shaw), and prevented from exiting through the sample port when the connector valve is in the closed state (FIG. 1 of Ding with FIG. 2 of Shaw).
With respect to claim 4, the combination teaches or suggests that the connector valve comprises a connector septum (the male septum 323 of Shaw) disposed across the sample port.
With respect to claim 6, the combination teaches or suggests a cap (the female connection 102 of Shaw) couplable with the sample container (the sampling bag 3 of Ding), the cap configured to sealably couple with an open end of the sample container (FIG. 2 and paragraphs 0034 and 0047-0048 of Shaw).
With respect to claim 7, the combination teaches or suggests that the cap (the female connection 102 of Shaw) comprises a cap valve (the stopple 310 of Shaw) selectively configurable between an open state and a closed state, wherein drainage liquid is: permitted to enter into the sample container when the cap valve is in the open state (FIG. 5 of Shaw), and prevented from exiting the sample container when the cap valve is in the closed state (FIG. 2 of Shaw).
With respect to claim 8, the combination teaches or suggests that the cap (the female connection 102 of Shaw) is configured to couple with the connector (the control valve 4 of Ding and the male connections 104 of Shaw).
With respect to claim 13, the combination teaches or suggests that the cap valve (the stopple 310 of Shaw) comprises a cap septum (the female septum 313 of Shaw) disposed across an opening at a distal end of the cap (the female connection 102 of Shaw).
With respect to claim 14, the combination teaches or suggests that the cap septum (the female septum 313 of Shaw) is deflectable, wherein the cap valve is in: the open state when the cap septum is in a deflected state (FIG. 5 of Felt), and the closed state when the cap septum is in a non-deflected state (FIGS. 2 and 4A of Shaw).
With respect to claim 15, the combination teaches or suggests that the cap septum (the female septum 313 of Shaw) comprises a cap slit (the slit 314 of Shaw) extending through the cap septum, the cap slit configurable between an open condition and a closed condition, wherein the cap slit is in: the open condition when the cap septum is in the deflected state (FIG. 5 of Felt), and the closed condition when the cap septum is in the non-deflected state (FIGS. 2 and 4A of Shaw).
With respect to claim 16, the combination teaches or suggests that: the cap (the female connection 102 of Shaw) comprises a protrusion (the luer body 106 of Shaw) disposed within the opening of the cap (the female connection 102 of Shaw), and the protrusion is configured to deflect the cap septum (the female septum 313 of Shaw) and connector septum (the male septum 323 of Shaw) upon coupling of the cap with the connector (FIG. 5 of Felt).
With respect to claim 18, the combination teaches or suggests a drainage system for draining a liquid from a patient, comprising: a drainage tube (the drainage tube 1 of Ding) configured to couple with a drainage catheter at a distal end of the drainage tube; a collection container coupled to the drainage tube at a proximal end of the drainage tube (the urine-collecting bag 2 of Ding); and the sampling system of claim 1 (see the rejection of claim 1), the sampling system connected in line with the drainage tube (FIGS. 1-2 of Ding show this configuration).
Claims 5, 10-11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104107464 (Ding),in view of U.S. Patent Application Publication No. 2005/0090805 (Shaw), and further in view of U.S. Patent Application Publication No. 2017/0312114 (Glithero). Citations to Ding will refer to the machine English translation that accompanies this Office Action.
The combination teaches or suggests a drainage liquid sampling system. Glithero teaches that any portion of such a drainage system may be coated to substantially prevent microbes from growing thereon by using any suitable antimicrobial coating (paragraph 0057 of Glithero). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a suitable antimicrobial coating on any portion of the drainage system of the combination since it substantially prevent microbes from growing thereon.
With respect to claim 5, the combination teaches that the connector septum (the male septum 323 of Shaw) comprises an anti-microbial coating (the coating suggested by Glithero).
With respect to claim 10, the combination teaches or suggests that at least a portion of the sampling system comprises an anti-microbial coating (the coating suggested by Glithero).
With respect to claim 11, the combination teaches or suggests that the connector septum (the male septum 323 of Shaw) is deflectable, wherein the connector valve (the penetration tube 202 of Shaw) is in: the open state when the connector septum is in a deflected state (FIG. 2 of Ding with FIG. 5 of Shaw), and the closed state when the connector septum is in a non-deflected state (FIG. 1 of Ding with FIG. 2 of Shaw).
With respect to claim 17, the combination teaches or suggests that the cap septum (the female septum 313 of Shaw) comprises an anti-microbial coating (the coating suggested by Glithero).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over CN 104107464 (Ding), in view of U.S. Patent Application Publication No. 2005/0090805 (Shaw), and further in view of U.S. Patent Application Publication No. 2017/0312114 (Glithero), and further in view of U.S. Patent No. 4,197,848 (Garrett). Citations to Ding will refer to the machine English translation that accompanies this Office Action.
The combination teaches or suggests that the connector septum (the male septum 323 of Shaw) comprises a connector hole 324 through which the penetration tube 202 extends through (paragraph 0046-0047 of Shaw). Garrett teaches that a slit 56 is another type of suitable passageway that seals (col. 5, lines 1-20 of Garrett). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a slit in place of the connector hole 324 of Shaw since it is a simple substitute of one known element for another to obtain predictable results.
With respect to claim 12, the combination teaches or suggests that the connector septum (the male septum 323 of Shaw) comprises a connector slit (the slit suggested by Garrett) extending through the connector septum, the connector slit configurable between an open condition and a closed condition, wherein the connector slit is in: the open condition when the connector septum is in the deflected state (FIG. 2 of Ding with FIG. 5 of Shaw), and the closed condition when the connector septum is in the non-deflected state (FIG. 1 of Ding with FIG. 2 of Shaw).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over CN 104107464 (Ding), in view of U.S. Patent Application Publication No. 2005/0090805 (Shaw), and further in view of U.S. Patent Application Publication No. 2017/0312114 (Glithero), and further in view of ES 2329577 (Raybuck). Citations to Ding and Raybuck will refer to the machine English translations that accompany this Office Action.
The combination teaches or suggests that the connector septum (the male septum 323 of Shaw) comprises a connector hole 324 through which the penetration tube 202 extends through (paragraph 0046-0047 of Shaw). Raybuck teaches that a slit 102 is another type of suitable passageway that seals (pages 11-13 of Raybuck). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a slit in place of the connector hole 324 of Shaw since it is a simple substitute of one known element for another to obtain predictable results.
With respect to claim 12, the combination teaches or suggests that the connector septum (the male septum 323 of Shaw) comprises a connector slit (the slit suggested by Raybuck) extending through the connector septum, the connector slit configurable between an open condition and a closed condition, wherein the connector slit is in: the open condition when the connector septum is in the deflected state (FIG. 2 of Ding with FIG. 5 of Shaw), and the closed condition when the connector septum is in the non-deflected state (FIG. 1 of Ding with FIG. 2 of Shaw).
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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