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 1-20 are objected to because of the following informalities:
All instances where applicant has written “-“ between words in claims should be removed for clarity in claims 1-20. Below is an example of one instance from claim 1:
“and/or detect biochemical- and/or physiological- changes” should be “and/or detect biochemical and/or physiological changes”
All instances where applicant means to write that a word can be plural should be corrected with parenthesis. Below is an example of one instance from claim 1:
“the target tissue/s” should be “the target tissue(s)”.
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 15 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 15 recites the limitation "the controller module”. There is insufficient antecedent basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear as to which earlier recited element (if any) the limitations reference. For the purposes of examination, the limitations are interpreted as not referring to any earlier recited elements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 10-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skinner (US 20210016074 A1).
With respect to claim 1, Skinner discloses a medical system (see paragraph 0004-0006), comprising:
one or more catheters each comprising at least one lumen, configured to be inserted, via an endovascular invasive (EVI) device, into one or more venous vasculatures, and positioned in proximity to one or more target tissues (see paragraph 0040-0045 and 0068: implantable venous access ports comprising a catheter with lumens that are positioned in proximity to target tissue);
one or more sensors configured to be integrated with at least one of the catheters distal-end, and configured to monitor and/or detect biochemical- and/or physiological- changes in a venous fluid, at least partially originated from the target tissue/s (see paragraph 0047, 0089 and 0104: sensor microassembly is placed within a vein of a patient where the sensors are located on the outside of the catheter to detect various elements in the blood as it flows such as red blood cells 168, platelets 170, white blood cells 172, and/or other circulating components 174 such as DNA, proteins, cancer cells and/or the like), and
an implant port, configured to be connected to the proximal-end of the catheter/s, for communication therebetween (see paragraph 0040, 0047 and 0104-0105: catheter #190 begins at port #164 proximally for communication); the port comprising:
one or more reservoirs, each having an access-element, and each configured to be in fluid communication with at least one of the catheters (see paragraph 0047, 0085: The port 164 may include a septum 166 where a needle or other injection device is inserted for administering fluids, e.g., medicines or drugs. It may be noted that the septum 166 is self-healing meaning that when an injection device is inserted and subsequently removed, upon removal, the septum seals itself such that liquid does not leak from the port 164 into the subcutaneous pocket 214);
a data-storage module, configured to communicate with the sensor/s and to store the monitored- and/or detected- data derived therefrom (see paragraph 0073, 0104-0107: control module #138 includes memory #142 to store data where #138 is coupled to sensor microassembly #162 via catheter #190); and
a wireless receiver- and/or transmitter- module, configured for wireless communication between the data-storage module and a controller (see paragraph 0045, 0073-0075: wireless communications interface #148 which receives and transmits data between control module #138 and memory #142).
With respect to claim 2, all limitations of claim 1 apply in which Skinner further discloses
wherein the access-element is configured to enable exterior fluid communication with its associated reservoir and therefore with the reservoir's associated catheter/s (see paragraph 0003, 0068 and 0085: IVAP device is surgically implanted by a physician with the catheter extending into superior vena cava or right atrium and can perform various functions with fluid communication), for at least one of:
flushing the associated catheter/s' -lumen/s and/or -sensor/s;
providing a therapeutic and/or diagnostic infusion, via the associated catheter/s (see paragraph 0068: The IVAP device 102 is configured to perform various functions such as, but not limited to: administration of antibiotics, chemotherapy agents, or other IV drugs; administration of fluids, nutrients, or blood products; and/or blood collection, analysis, quantification, and/or the like).; and
obtaining aspiration sample/s, via the associated catheter/s (see paragraph 0068: The IVAP device 102 is configured to perform various functions such as, but not limited to: administration of antibiotics, chemotherapy agents, or other IV drugs; administration of fluids, nutrients, or blood products; and/or blood collection, analysis, quantification, and/or the like).
With respect to claim 10, all limitations of claim 1 apply in which Skinner further discloses wherein the implant port is a subcutaneous port, configured to be implanted under skin (see paragraph 0040 and 0105: subcutaneous port implanted under skin).
With respect to claim 11, all limitations of claim 10 apply in which Skinner further discloses wherein the access-element comprises a septum, configured to enable fluid to be injected to- and/or to be drawn from- the reservoir, via a needle (see paragraph 0047 and 0085: self-sealing septum where needle or other injection device is inserted for administering fluids).
With respect to claim 12, all limitations of claim 1 apply in which Skinner further discloses wherein the port further comprises at least one power source (see paragraph 0047: power source).
With respect to claim 13, all limitations of claim 12 apply in which Skinner further discloses wherein at least one of the power sources is a wireless rechargeable battery (see paragraph 0082-0083: rechargeable battery with inductive charging).
With respect to claim 14, all limitations of claim 1 apply in which Skinner further discloses wherein the port comprises a controller module, configured communicate via the receiver- and/or transmitter- module with other controllers (see paragraph 0045 and 0073-0074: onboard processor and telemetry communicate with remote computing device).
With respect to claim 15, all limitations of claim 1 apply in which Skinner further discloses wherein the controller module is configured to receive the monitored and/or detected data derived from the at least one sensor, to process and analyze their data and produce medical recommendations and/or conclusions (see paragraph 0065-0066 and 0074: central server #110 at any time via an authenticated computing device can obtain valuable information about a patients vitals and make therapeutic adjustments as needed).
With respect to claim 16, all limitations of claim 1 apply in which Skinner further discloses wherein at least one of the following holds true:
the target tissue is a tumor and wherein the sensors/s are configured to monitor biochemical and/or physiological changes in a fluid stream at least partially originated from the tumor (see paragraph 0089: the sensor microassembly 162 depicted in FIG. 1B is placed directly in the bloodstream for measuring various elements in the blood as it flows 188 through the superior vena cava 128 and for transmitting the measured information back to the control module 138. For example, the sensors may be configured to detect and measure various circulating elements in the bloodstream such as red blood cells 168, platelets 170, white blood cells 172, and/or other circulating components 174 such as DNA, proteins, cancer cells and/or the like);
the controller further comprises visual internal control means, configured to provide spectroscopic control reference to the sensor/s;
at least two sensors are geometrically arranged in a staggered way, configured to deduce spatial and spatiotemporal information regarding biochemical and/or physiological signals, found in proximity to the device;
at least one sensor is an optical sensor configured to detect cell residues characteristic of cell death; cells are at least one of: membrane blebs, nucleic acids, DNA or RNA fragments, exosomes, nucleic fragments, structural proteins, mitochondrial proteins or other cellular debris, biochemical signals and any combination thereof;
at least one sensor is of an optical type selected from a UV-VIS spectrometer, NIR spectrometer, FTIR spectrometer, led, optical fiber and any combination thereof;
at least one sensor is configured to detect the second harmonic generation signature of Collagen;
at least one sensor is a chemical sensor configured to detect inorganic and/or organic ions; and
at least one sensor is a biological sensor configured to detect cell residues characteristic of cell death.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Skinner in view of Shelton (US 20080306466 A1).
With respect to claim 3, all limitations of claim 1 apply in which Skinner does not specifically disclose wherein the port further comprises one or more pumps, configured to draw and/or push fluid between the reservoir/s and it's/their associated catheter/s.
Shelton teaches one or more pumps configured to push fluid between a reservoir and catheter (see paragraph 0004, 0019-0025: implanted pump pushes reservoir fluid through catheter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skinner with the teachings of Shelton to have added one or more pumps because it would have resulted in the predictable result of pushing fluid through a catheter to check for catheter patency, sampling CSF, injecting contrast dye into the patient and/or catheter, removing medication from the catheter prior to dye injection, injecting additional medication, and/or removing pharmaceuticals or other fluids that are causing an allergic or otherwise undesirable biologic reaction (Shelton: see [0025]).
With respect to claim 4, all limitations of claim 3 apply in which Shelton further teaches wherein the pump is configured to control the fluid communication between the reservoir and it's/their associated catheter/s (see paragraph 0004, 0019-0025: controller regulated pumping controls flow along the route).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Skinner in view of John (US 20150018758 A1).
With respect to claim 5, all limitations of claim 1 apply in which Skinner discloses positioning a catheter at a target cavity and at a right atrium (see paragraph 0003, 0068 and 0085: IVAP device is surgically implanted by a physician with the catheter extending into superior vena cava or right atrium and can perform various functions with fluid communication) however does not disclose wherein the port comprises a single said reservoir: configured to be connected with and in fluid communication with at least two of the catheters, and wherein: a first said catheter is configured to be positioned in proximity to the target tissue; and a second said catheter is configured to be positioned in proximity to a right atrium; such that an influence of a treatment provided to the target tissue, via the second catheter, is monitored and/or detected via the first catheter.
John teaches a single said reservoir: configured to be connected with and in fluid communication with at least two of the catheters (see paragraph 0025: one or more catheters in fluid communication with a single chamber), and wherein: a first said catheter (see paragraph 0070-0072: flow controller #20a); and a second said catheter (see paragraph 0070-0072: flow controller #20b); such that an influence of a treatment provided to the target tissue, via the second catheter, is monitored and/or detected via the first catheter (see paragraph 0101-0105: shared reservoir routing where each is monitored).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skinner with the teachings of John to have two catheter because it would have resulted in the predictable result , these flow controllers are used to divert fluid in order to provide a simple mechanism for adjusting the rate of drug flow, rather than to halt flow, to send fluids to different catheter hubs thereby allowing different reservoirs to send fluid to different catheter hubs, and to isolate different fluids (John: see [0070]).
With respect to claim 6, all limitations of claim 5 apply in which John further teaches wherein each of the catheters comprises at least one blocking element, configured block its associated lumen/s, thereby configured to enable at least one of: blocking the lumen/s of the first catheter, when pushing and/or drawing fluid via the second catheter (see paragraph 0129: The catheter 80 has a distal end which here contains a cap or flow control system 84 connected to the first distal end of the lumen 82a and the second distal end of the lumen 82b for connection to the target site of the patient); blocking the lumen/s of the second catheter, when pushing and/or drawing fluid via the first catheter; and blocking the lumen/s of both the first- and second- catheters, to enable cleansing of the reservoir.
Claims 7-9 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Skinner in view of Arepally (US 20200108239 A1).
With respect to claim 7, all limitations of claim 1 apply in which Skinner does not disclose wherein each of said reservoir/s is configured to be connected with- and in fluid communication with- only one of said catheters.
Arepally teaches each of said reservoir/s is configured to be connected with- and in fluid communication with- only one of said catheters (see paragraph 0079-0080: each separate reservoir connects to their respective catheter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skinner with the teachings of Arepally to have two catheters each in fluid communication with its own separate reservoir because it would have resulted in the predictable result of having each catheter be implanted in different areas and the fluid delivered via each catheter is separated (Arepally: see [0080]) to treat and/or test different areas.
With respect to claim 8, all limitations of claim 7 apply in which Arepally further teaches wherein the port comprises at least two said reservoirs (see paragraph 0079-0080: two reservoirs), and wherein:
at first said reservoir is configured to be connected to a first said catheter, configured to be positioned in proximity to the target tissue (see paragraph 0080: second catheter is implanted within target vessel); and
a second said reservoir is configured to be connected to a second said catheter, configured to be positioned in proximity to a right atrium (see paragraph 0080: first catheter implanted within right atrium);
such that an influence of a treatment provided to the target tissue, via the second catheter, is monitored and/or detected via the first catheter (see paragraph 0080-0083).
With respect to claim 9, all limitations of claim 8 apply in which Arepally further teaches wherein each of the access-elements is differently marked, configured to enable a caregiver an identification of its associated catheter (see paragraph 0049: different physical/tactile port features to identify paths).
With respect to claim 17, Skinner discloses a medical method (see paragraph 0004-0006) comprising the steps of:
inserting at least one diagnostic-catheter, via an endovascular invasive (EVI) device, comprising at least one lumen and at least one integrated sensor, into a venous vasculature, such that the sensor/s is/are placed at a proximity to a target tissue (see paragraph 0045-0047 and 0068: implantable venous access ports comprising a catheter with lumens that are positioned in proximity to target tissue);
implanting a subcutaneous port (see paragraph 0040 and 0105: implanting a subcutaneous port), comprising
one or more reservoirs, each reservoir having an access-element (see paragraph 0047, 0085: The port 164 may include a septum 166 where a needle or other injection device is inserted for administering fluids, e.g., medicines or drugs. It may be noted that the septum 166 is self-healing meaning that when an injection device is inserted and subsequently removed, upon removal, the septum seals itself such that liquid does not leak from the port 164 into the subcutaneous pocket 214);
a data-storage module, configured for communicating with the sensor/s and to storing the monitored- and/or detected- data derived therefrom (see paragraph 0073, 0104-0107: control module #138 includes memory #142 to store data where #138 is coupled to sensor microassembly #162 via catheter #190);
a wireless receiver- and/or transmitter- module, configured for wireless communication between the data-storage module and a controller (see paragraph 0045, 0073-0075: wireless communications interface #148 which receives and transmits data between control module #138 and memory #142);
connecting the reservoir/s to the proximal-end of the inserted diagnostic- catheter/s for communication therebetween (see paragraph 0040 and 0047: connecting reservoir to catheter);
monitoring biochemical and/or physiological venous fluid at least partially originated from the target tissue, via the sensor/s, and detecting biochemical and/or physiological changes in the venous fluid (see paragraph 0089: the sensor microassembly 162 depicted in FIG. 1B is placed directly in the bloodstream for measuring various elements in the blood as it flows 188 through the superior vena cava 128 and for transmitting the measured information back to the control module 138. For example, the sensors may be configured to detect and measure various circulating elements in the bloodstream such as red blood cells 168, platelets 170, white blood cells 172, and/or other circulating components 174 such as DNA, proteins, cancer cells and/or the like), and
analyzing the monitored and/or the detected data using the controller, for producing medical recommendations and/or conclusions (see paragraph 0065-0066 and 0074: central server #110 at any time via an authenticated computing device can obtain valuable information about a patients vitals and make therapeutic adjustments as needed).
Skinner does not specifically disclose each reservoir to a different catheter.
Arepally teaches two different reservoirs connecting to their own respective catheters (see paragraph 0079-0080: each separate reservoir connects to their respective catheter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skinner with the teachings of Arepally to have two catheters each in fluid communication with its own separate reservoir because it would have resulted in the predictable result of having each catheter be implanted in different areas and the fluid delivered via each catheter is separated (Arepally: see [0080]) to treat and/or test different areas.
With respect to claim 18, all limitations of claim 17 apply in which Skinner further discloses further comprising at least one of:" drawing fluid for external analysis, via diagnostic-catheter and a first reservoir; (see paragraph 0003 and 0068: drawing blood for external analysis)" infusing designated substance/s having an effect on the fluid surrounding the at least one sensor, via diagnostic-catheter and a first reservoir; and" removing and/or replacing sensor/s integrated on diagnostic-catheter, via an EVI device.
With respect to claim 19, all limitations of claim 17 apply in which Arepally further teaches further comprising at least one of the steps of:
inserting a therapeutic-catheter, via an EVI device, such that its distal-end is in proximity to a right atrium, and connecting a second- and different- reservoir of the subcutaneous port to a proximal-end of the inserted therapeutic-catheter, for communication therebetween (see paragraph 0079-0081: systemic path has a separate port reservoir and atrial location); and
infusing the right atrium with a systematic therapeutic treatment via the therapeutic-catheter and the second reservoir, and monitoring and/or detecting an influence of the provided therapeutic treatment for a target tissue, via the diagnostic catheter
With respect to claim 20, all limitations of claim 17 apply in which Skinner further teaches wherein the steps of monitoring, detecting and analyzing of the venous fluid are provided in real-time, while the target tissue is infused (see paragraph 0045 and 0130: continuous sensing in real time).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
