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 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.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ray et al. (US 20250172472 A1).
Regarding Claims 7-9, Ray discloses an imaging slide ("imaging section 115" [0028]; FIG. 1A) configured to receive a flow of a liquid ("translucent bodily fluid passes through the flow chamber 102"[0032]; FIG. 1A), the imaging slide comprising:
a channel configured to receive the flow of the liquid ("flow chamber 102 having an entry port 105, an exit port 110, and an imaging section 115 in flow communication with the entry port 105 and the exit port 110" [0028]; FIG. 1A);
an imaging window that at least partially defines the channel ("light has passed through the flow chamber 102" [0030]; FIG. 2); and
an inlet ("entry port 105" [0029]; FIG. 1A), wherein the inlet is configured to allow a catheter or a sample tube of a medical drain bag to be coupled to the imaging slide ("flow chamber 102 may be configured to attach to and to be detached from a catheter 117 (e.g., a urine catheter) at the entry port 105" [0029]; FIG. 1A);
wherein the imaging window is optically clear ("light has passed through the flow chamber 102" [0030]; FIG. 2), wherein the imaging slide is configured to be imaged by an imaging system ("LFI system 100" [0028]; FIG. 1A), wherein the imaging system comprises an illumination device ("illumination source 120" [0030]) and an imaging device ("optical sensor 125" [0030]), and wherein the imaging system is configured to receive the imaging slide between the illumination device and the imaging device (see FIG. 1A); and
a protective film that is placed over the imaging window ("quartz/UV-transparent coverslips may be used" [0052]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordano (US 20080254471 A1) in view of Huang (US 20140315303 A1).
Regarding Claim 1, Bordano discloses a medical drain bag ("drain bag 160" [0044]; FIG. 2) comprising:
a main body that defines a reservoir, the main body configured to hold a liquid within the reservoir ("dimensioned to accommodate any portions of the original volume of wash, sample or storage solution from the tissue/collection container" [0044]); and
a plurality of ports that are each in fluid communication with the reservoir ("plurality of ports" [0015]; FIG. 2), wherein the plurality of ports comprise:
an input port ("access opening or lip 12" [0045]; FIG. 2);
a syringe port ("septum syringe port" [0014]) that is configured to allow the liquid to flow from the reservoir and to a syringe; and
a sample port ("sampling hub 120" [0049]) that is configured to allow the liquid to flow from the reservoir and to an imaging slide (NOTE: any sampling port that can freely dispense fluid reads on this claim).
Bordano fails to specify the input port is configured to be coupled to a catheter and receive the liquid through the catheter. However, Huang teaches an apparatus for the processing of biological sample comprising an input port (“inlet (Port 1)” [0174]; FIG. 3A) configured to be coupled to a catheter and receive the liquid through the catheter ("sample was injected into Chamber 1 from Port 1 using a syringe with a catheter tip" [0243]; FIG. 3A). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Bordano to incorporate the teachings of Huang to suitably introduce the fluid sample to be processed into the system ([0032]).
Regarding Claim 2, Bordano discloses the medical drain bag comprises a plurality of tubes that are each coupled to the main body (see FIG. 2), a syringe tube ("septum syringe port" [0014]) that is coupled to the syringe port ("tubing 40 may function as a transfer hub by inclusion of one or more ports such as septum syringe port 47" [0044]; FIG. 1); and a sample tube that is coupled to the sample port ("Connector 45 disposed on tubing 40 may function as a transfer hub by inclusion of one or more ports" [0044]). Bordano fails to specify the plurality of tubes comprise: an input tube that is coupled to the input port. However, Huang teaches the plurality of tubes comprise: an input tube that is coupled to the input port ("chamber comprises an inlet (Port 1)" [0174]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Bordano to incorporate the teachings of Huang to suitably introduce the fluid sample to be processed into the system ([0032]).
Regarding Claim 3, Bordano discloses the main body has a rounded rectangle shape that defines four edges, and wherein each of the plurality of tubes are coupled proximate to the same edge of the main body (see FIG. 2).
Regarding Claim 4, Bordano fails to specify the main body has a rounded rectangle shape that defines a first edge that is opposite to a second edge, the input tube and the syringe tube are coupled proximate to the first edge of the main body, and the sample tube is coupled proximate to the second edge of the main body. However, Huang teaches the main body has a rounded rectangle shape that defines a first edge that is opposite to a second edge, the input tube and the syringe tube are coupled proximate to the first edge of the main body, and the sample tube is coupled proximate to the second edge of the main body ([0181]; FIG. 3A). ]). Therefore, it would have been obvious to modify Bordano to suitably control the flow of the fluid ([0193]).
Regarding Claim 5, Bordano discloses a safety clamp coupled to the input tube, the syringe tube, or the sample tube ("tubing can be clamped off by a clamp such as Roberts clamp 90" [0047]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordano/Huang in view of Ray et al. (US 20250172472 A1).
Regarding Claim 6, Bordano/Huang fails to specify the liquid is a peritoneal dialysis effluent. However, Ray teaches an analysis system for a translucent bodily fluid (Abstract) wherein the liquid is a peritoneal dialysis effluent ([0109]). Therefore, it would have been obvious to modify Bordano/Huang to suitably monitor dialysis effluent ([0109]).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ray et al. (US 20250172472 A1) in view of Tsinberg et al. (US 20070161051 A1).
Regarding Claims 10-11, Ray fails to specify the protective film comprises a tab that extends beyond a periphery of a main body of the imaging slide; the protective film wraps around an edge of a main body of the imaging slide such that the protective film is placed over opposing sides of the imaging slide. However, Tsinberg teaches a microflow slide comprising “a body wherein a flow path is provided having an inlet and an outlet” ([0010]) wherein the protective film ("polymeric wrap 43" [0033]; FIG. 10) comprises a tab that extends beyond a periphery of a main body of the imaging slide (see FIG. 10); the protective film wraps around an edge of a main body of the imaging slide such that the protective film is placed over opposing sides of the imaging slide (see FIG. 7). Therefore, it would have been obvious to modify Ray to suitably assure “fluidtight sealing between the bottom surface of the body and the top surface of the plate” ([0010]).
Claim(s) 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordano (US 20080254471 A1) in view of Huang (US 20140315303 A1) and further in view of Ray et al. (US 20250172472 A1).
Regarding Claim 12, Bordano discloses a medical drain bag ("drain bag 160" [0044]; FIG. 2) comprising:
a main body that defines a reservoir, the main body configured to hold a liquid within the reservoir ("dimensioned to accommodate any portions of the original volume of wash, sample or storage solution from the tissue/collection container" [0044]); and
a plurality of ports that are each in fluid communication with the reservoir ("plurality of ports" [0015]; FIG. 2), wherein the plurality of ports comprise:
an input port ("access opening or lip 12" [0045]; FIG. 2);
a syringe port ("septum syringe port" [0014]) that is configured to allow the liquid to flow from the reservoir and to a syringe; and
a sample port ("sampling hub 120" [0049]) that is configured to allow the liquid to flow from the reservoir and to an imaging slide (NOTE: any sampling port that can freely dispense fluid reads on this claim).
Bordano fails to specify the input port is configured to be coupled to a catheter and receive the liquid through the catheter. However, Huang teaches an apparatus for the processing of biological sample comprising an input port (“inlet (Port 1)” [0174]; FIG. 3A) configured to be coupled to a catheter and receive the liquid through the catheter ("sample was injected into Chamber 1 from Port 1 using a syringe with a catheter tip" [0243]; FIG. 3A). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Bordano to incorporate the teachings of Huang to suitably introduce the fluid sample to be processed into the system ([0032]).
Bordano/Huang fails to specify the imaging slide comprises: a channel configured to receive the liquid; an imaging window that at least partially defines the channel; and an inlet, wherein the inlet is coupled to the sample port. However, Ray teaches the imaging slide comprises: a channel configured to receive the liquid ("flow chamber 102 having an entry port 105, an exit port 110, and an imaging section 115 in flow communication with the entry port 105 and the exit port 110" [0028]; FIG. 1A);
an imaging window that at least partially defines the channel ("light has passed through the flow chamber 102" [0030]; FIG. 2); and an inlet ("entry port 105" [0029]; FIG. 1A), wherein the inlet is coupled to the sample port ("flow chamber 102 may be configured to attach to and to be detached from a catheter 117 (e.g., a urine catheter) at the entry port 105" [0029]; FIG. 1A).
Therefore, it would have been obvious to modify Bordano/Huang to suitably perform “analysis of translucent bodily fluids” ([0009]).
Regarding Claim 13, Bordano discloses the medical drain bag comprises a plurality of tubes that are each coupled to the main body (see FIG. 2), a syringe tube ("septum syringe port" [0014]) that is coupled to the syringe port ("tubing 40 may function as a transfer hub by inclusion of one or more ports such as septum syringe port 47" [0044]; FIG. 1); and a sample tube that is coupled to the sample port ("Connector 45 disposed on tubing 40 may function as a transfer hub by inclusion of one or more ports" [0044]). Bordano fails to specify the plurality of tubes comprise: an input tube that is coupled to the input port. However, Huang teaches the plurality of tubes comprise: an input tube that is coupled to the input port ("chamber comprises an inlet (Port 1)" [0174]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Bordano to incorporate the teachings of Huang to suitably introduce the fluid sample to be processed into the system ([0032]).
Regarding Claim 14, Bordano discloses the main body has a rounded rectangle shape that defines four edges, and wherein each of the plurality of tubes are coupled proximate to the same edge of the main body (see FIG. 2).
Regarding Claim 15, Bordano fails to specify the main body has a rounded rectangle shape that defines a first edge that is opposite to a second edge, the input tube and the syringe tube are coupled proximate to the first edge of the main body, and the sample tube is coupled proximate to the second edge of the main body. However, Huang teaches the main body has a rounded rectangle shape that defines a first edge that is opposite to a second edge, the input tube and the syringe tube are coupled proximate to the first edge of the main body, and the sample tube is coupled proximate to the second edge of the main body ([0181]; FIG. 3A). ]). Therefore, it would have been obvious to modify Bordano to suitably control the flow of the fluid ([0193]).
Regarding Claim 16, Bordano discloses a safety clamp coupled to the input tube, the syringe tube, or the sample tube ("tubing can be clamped off by a clamp such as Roberts clamp 90" [0047]).
Regarding Claims 17-18, Bordano fails to specify the claimed features. However, Ray teaches an analysis system for a translucent bodily fluid (Abstract) wherein the imaging window is optically clear ("light has passed through the flow chamber 102" [0030]; FIG. 2), wherein the imaging slide is configured to be imaged by an imaging system ("LFI system 100" [0028]; FIG. 1A), wherein the imaging system comprises an illumination device ("illumination source 120" [0030]) and an imaging device ("optical sensor 125" [0030]), and wherein the imaging system is configured to receive the imaging slide between the illumination device and the imaging device (see FIG. 1A); and
a protective film that is placed over the imaging window ("quartz/UV-transparent coverslips may be used" [0052]).
Therefore, it would have been obvious to modify Bordano/Huang to suitably monitor dialysis effluent ([0109]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordano/Huang/Ray and further in view of Tsinberg et al. (US 20070161051 A1).
Regarding Claims 19-20, Bordano/Huang/Ray fails to specify the claimed features. However, Tsinberg teaches a microflow slide comprising “a body wherein a flow path is provided having an inlet and an outlet” ([0010]) wherein the protective film ("polymeric wrap 43" [0033]; FIG. 10) comprises a tab that extends beyond a periphery of a main body of the imaging slide (see FIG. 10); the protective film wraps around an edge of a main body of the imaging slide such that the protective film is placed over opposing sides of the imaging slide (see FIG. 7). Therefore, it would have been obvious to modify Ray to suitably assure “fluidtight sealing between the bottom surface of the body and the top surface of the plate” ([0010]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights