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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 606 (Figs. 6A-6C). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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 1, 4, 5, 7, 22, 24, 26, 27, 29, 31, and 80-85 are rejected under 35 U.S.C. 103 as being unpatentable over Hochareon (US 2012/0302995) in view of Myrick et al (US 2018/0207592).
Regarding claim 1, Hochareon discloses:
A catheter (220; Fig. 11A) configured to be inserted into a vasculature of a patient (Abstract), wherein the catheter (220) comprises: a catheter body (220), a first lumen (2) extending through the catheter body (220), wherein the first lumen (2) is configured to be in fluid communication with the vasculature of the patient (Fig. 11A) when the catheter (220) is inserted into the vasculature of the patient (Fig. 11A), and the first lumen (2) is configured to perform at least one of receiving a sample of blood from the vasculature of the patient (¶0087 – “receiving venous drainage flow”) or measuring a parameter of blood of the patient; one or more second lumens (1) extending through the catheter body, wherein the one or more second lumens are configured to receive a gas enriched liquid from a gas enriched liquid source (¶0062, ¶0090 – oxygenated perfusate); wherein the catheter body (220) is configured to position the one or more second lumens (1) such that the stream of the gas enriched liquid intersect and mix with the blood of the patient in a region beyond an end of the catheter body (220) and beyond the first lumen (2) (Fig. 11A).
Hochareon is silent regarding “two or more capillaries extending from the catheter body and coupled to the one or more second lumens,” “wherein each of the two or more capillaries are in fluid communication with the one or more second lumens and are in fluid communication with the vasculature of the patient when the catheter is inserted into the vasculature of the patient,” “wherein each of the two or more capillaries are configured to receive the gas enriched liquid from the one or more second lumens and to simultaneously dispense respective streams of the gas enriched liquid directly into the vasculature of the patient,” and “wherein the catheter body is configured to position the two or more capillaries at one or more predetermined angles relative to one another.”
However, Myrick teaches a catheter (500; Fig. 2A) comprising a plurality of capillaries (10, 11; Fig. 2B) that are in fluid communication with a lumen (40; Fig. 5A) configured to receive a gas enriched liquid from a gas enriched liquid source (¶0028) and the vasculature of the patient in order to mix gas-enriched liquid with the bodily liquid (¶0028). Myrick further teaches that the capillaries (10, 11) are configured to receive the gas enriched liquid and simultaneously dispense the streams of liquid directly into the vasculature of the patient at a predetermined angle (α; Fig. 1). Myrick teaches that this arrangement forms an efficient mixing zone while minimizing or eliminating clinically significant bubbles during gas enrichment in the vessel (¶0037, 0038). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to have modified the device of Hochareon to incorporate the capillaries of Myrick in order to provide sufficient structure to minimize or eliminate clinically significant bubbles during gas enrichment in the vessel, as recognized by Myrick.
Regarding claim 4, Hochareon in view of Myrick discloses:
The catheter of claim 1, further comprising a pressure sensor (¶0071 – pressure sensor) disposed within the first lumen (2; ¶0071 – sensor can be disposed in line 66 in Fig. 3, which is equivalent to the venous drainage line 2 of Fig. 11A), wherein the pressure sensor is configured to obtain one or more pressure measurements (¶0071).
Regarding claim 5, Hochareon in view of Myrick discloses:
The catheter of claim 1, wherein the parameter of the blood of the patient is at least one of: a partial pressure of oxygen of the blood of the patient, SO2 of the blood of the patient, a pressure of the blood of the patient (¶0071, 0094, 0097 – pressure in the system is taken into consideration, using a pressure sensor), a flow rate of the of the blood of the patient, or a temperature of the of the blood of the patient (¶0071, 0094, 0097 – temperature of the perfusion flow manages temperature of the blood).
Regarding claim 7, Hochareon in view of Myrick discloses:
The catheter of claim 1, wherein the catheter (220) comprises: a third lumen (3) extending through the catheter body (220), wherein the third lumen (220) is configured to be in fluid communication with the vasculature of the patient (Fig. 11A) when the catheter (220) is inserted into the vasculature of the patient (the third lumen 3 is fully capable of performing at least one of receiving an additional sample of the blood of the patient from the vasculature of the patient and or measuring an additional parameter of the blood of the patient, such as by monitoring the temperature within line 3 to ensure the temperature of the excess flow is as required).
Regarding claim 22, Hochareon in view of Myrick discloses:
The catheter of claim 1, further comprising one or more sensors (¶0094), wherein the one or more sensors are configured such that the one or more sensors are in fluid communication with the vasculature of the patient when the catheter (220) is inserted into the vasculature of the patient (¶0071 – sensor can be disposed in line 66 in Fig. 3, which is equivalent to the venous drainage line 2 of Fig. 11A, putting it in fluid communication with the patient vessel).
Regarding claim 24, Hochareon in view of Myrick discloses:
The catheter of claim 1, further comprising a self-centering device (230; balloon 230 is fully capable of centering the catheter body 220 within the vasculature of the patient).
Regarding claim 26, Hochareon discloses:
A system (Fig. 11A) comprising: a catheter body (220), a first lumen (2) extending through the catheter body (220), wherein the first lumen (2) is configured to be in fluid communication with the vasculature of the patient (Fig. 11A) when the catheter (220) is inserted into the vasculature of the patient (Fig. 11A), and the first lumen (2) is configured to perform at least one of receiving a sample of blood from the vasculature of the patient (¶0087 – “receiving venous drainage flow”) or measuring a parameter of blood of the patient; one or more second lumens (1) extending through the catheter body, wherein the one or more second lumens are configured to receive a gas enriched liquid from a gas enriched liquid source (¶0062 – oxygenated perfusate); wherein the catheter body (220) is configured to position the one or more second lumens (1) such that the stream of the gas enriched liquid intersect and mix with the blood of the patient in a region beyond an end of the catheter body (220) and beyond the first lumen (2) (Fig. 11A); and a fluid dispensing device (310; Fig. 15) in fluid communication with the one or more second lumens (1) (¶0107), wherein the fluid dispensing device (310) comprises one or more pumps (318) configured to provide the gas enriched liquid to the one or more second lumens (1) (¶0114).
Hochareon is silent regarding “two or more capillaries extending from the catheter body and coupled to the one or more second lumens,” “wherein each of the two or more capillaries are in fluid communication with the one or more second lumens and are in fluid communication with the vasculature of the patient when the catheter is inserted into the vasculature of the patient,” “wherein each of the two or more capillaries are configured to receive the gas enriched liquid from the one or more second lumens and to simultaneously dispense respective streams of the gas enriched liquid directly into the vasculature of the patient,” and “wherein the catheter body is configured to position the two or more capillaries at one or more predetermined angles relative to one another.”
However, Myrick teaches a catheter (500; Fig. 2A) comprising a plurality of capillaries (10, 11; Fig. 2B) that are in fluid communication with a lumen (40; Fig. 5A) configured to receive a gas enriched liquid from a gas enriched liquid source (¶0028) and the vasculature of the patient in order to mix gas-enriched liquid with the bodily liquid (¶0028). Myrick further teaches that the capillaries (10, 11) are configured to receive the gas enriched liquid and simultaneously dispense the streams of liquid directly into the vasculature of the patient at a predetermined angle (α; Fig. 1). Myrick teaches that this arrangement forms an efficient mixing zone while minimizing or eliminating clinically significant bubbles during gas enrichment in the vessel (¶0037, 0038). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to have modified the device of Hochareon to incorporate the capillaries of Myrick in order to provide sufficient structure to minimize or eliminate clinically significant bubbles during gas enrichment in the vessel, as recognized by Myrick.
Regarding claim 27, Hochareon in view of Myrick discloses:
The system of claim 26, further comprising one or more connectors (connection in diagram of Fig. 15 is a connector) configured to couple the one or more second lumens (1) to one or more respective dispensing ports (end of pump 318) of the fluid dispensing device (310).
Regarding claim 29, Hochareon in view of Myrick discloses:
The system of claim 26, wherein the gas enriched liquid comprises one or more of oxygen (¶0062 - oxygen), ozone, inert gas, nitrogen, nitrous oxide, carbon dioxide, or air.
Regarding claim 31, Hochareon discloses:
A system (Fig. 11A) comprising: a catheter body (220), a first lumen (2) extending through the catheter body (220), wherein the first lumen (2) is configured to be in fluid communication with the vasculature of the patient (Fig. 11A) when the catheter (220) is inserted into the vasculature of the patient (Fig. 11A), and the first lumen (2) is configured to perform at least one of receiving a sample of blood from the vasculature of the patient (¶0087 – “receiving venous drainage flow”) or measuring a parameter of blood of the patient; one or more second lumens (1) extending through the catheter body, wherein the one or more second lumens are configured to receive a gas enriched liquid from a gas enriched liquid source (¶0062 – oxygenated perfusate); wherein the catheter body (220) is configured to position the one or more second lumens (1) such that the stream of the gas enriched liquid intersect and mix with the blood of the patient in a region beyond an end of the catheter body (220) and beyond the first lumen (2) (Fig. 11A); and a blood sampling device (320; Fig. 16) in fluid communication with the first lumen (2), wherein the blood sampling device (320) is configured to withdraw the sample of the blood of the patient from the vasculature of the patient through the first lumen (2) (¶0099).
Hochareon is silent regarding “two or more capillaries extending from the catheter body and coupled to the one or more second lumens,” “wherein each of the two or more capillaries are in fluid communication with the one or more second lumens and are in fluid communication with the vasculature of the patient when the catheter is inserted into the vasculature of the patient,” “wherein each of the two or more capillaries are configured to receive the gas enriched liquid from the one or more second lumens and to simultaneously dispense respective streams of the gas enriched liquid directly into the vasculature of the patient,” and “wherein the catheter body is configured to position the two or more capillaries at one or more predetermined angles relative to one another.”
However, Myrick teaches a catheter (500; Fig. 2A) comprising a plurality of capillaries (10, 11; Fig. 2B) that are in fluid communication with a lumen (40; Fig. 5A) configured to receive a gas enriched liquid from a gas enriched liquid source (¶0028) and the vasculature of the patient in order to mix gas-enriched liquid with the bodily liquid (¶0028). Myrick further teaches that the capillaries (10, 11) are configured to receive the gas enriched liquid and simultaneously dispense the streams of liquid directly into the vasculature of the patient at a predetermined angle (α; Fig. 1). Myrick teaches that this arrangement forms an efficient mixing zone while minimizing or eliminating clinically significant bubbles during gas enrichment in the vessel (¶0037, 0038). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to have modified the device of Hochareon to incorporate the capillaries of Myrick in order to provide sufficient structure to minimize or eliminate clinically significant bubbles during gas enrichment in the vessel, as recognized by Myrick.
Regarding claim 80, Hochareon in view of Myrick discloses:
The system of claim 26, further comprising a pressure sensor (¶0071 – pressure sensor) disposed within the first lumen (2; ¶0071 – sensor can be disposed in line 66 in Fig. 3, which is equivalent to the venous drainage line 2 of Fig. 11A), wherein the pressure sensor is configured to obtain one or more pressure measurements (¶0071).
Regarding claim 81, Hochareon in view of Myrick discloses:
The system of claim 26, wherein the parameter of the blood of the patient is at least one of: a partial pressure of oxygen of the blood of the patient, SO2 of the blood of the patient, a pressure of the blood of the patient (¶0071, 0094, 0097 – pressure in the system is taken into consideration, using a pressure sensor), a flow rate of the of the blood of the patient, or a temperature of the of the blood of the patient (¶0071, 0094, 0097 – temperature of the perfusion flow manages temperature of the blood).
Regarding claim 82, Hochareon in view of Myrick discloses:
The system of claim 26, wherein the catheter (220) comprises: a third lumen (3) extending through the catheter body (220), wherein the third lumen (220) is configured to be in fluid communication with the vasculature of the patient (Fig. 11A) when the catheter (220) is inserted into the vasculature of the patient (the third lumen 3 is fully capable of performing at least one of receiving an additional sample of the blood of the patient from the vasculature of the patient and or measuring an additional parameter of the blood of the patient, such as by monitoring the temperature within line 3 to ensure the temperature of the excess flow is as required).
Regarding claim 83, Hochareon in view of Myrick discloses:
The catheter of claim 26, further comprising one or more sensors (¶0094), wherein the one or more sensors are configured such that the one or more sensors are in fluid communication with the vasculature of the patient when the catheter (220) is inserted into the vasculature of the patient (¶0071 – sensor can be disposed in line 66 in Fig. 3, which is equivalent to the venous drainage line 2 of Fig. 11A, putting it in fluid communication with the patient vessel).
Regarding claim 84, Hochareon in view of Myrick discloses:
The catheter of claim 31, wherein the parameter of the blood of the patient is at least one of: a partial pressure of oxygen of the blood of the patient, SO2 of the blood of the patient, a pressure of the blood of the patient (¶0071, 0094, 0097 – pressure in the system is taken into consideration, using a pressure sensor), a flow rate of the of the blood of the patient, or a temperature of the of the blood of the patient (¶0071, 0094, 0097 – temperature of the perfusion flow manages temperature of the blood).
Regarding claim 85, Hochareon in view of Myrick discloses:
The catheter of claim 31, further comprising one or more sensors (¶0094), wherein the one or more sensors are configured such that the one or more sensors are in fluid communication with the vasculature of the patient when the catheter (220) is inserted into the vasculature of the patient (¶0071 – sensor can be disposed in line 66 in Fig. 3, which is equivalent to the venous drainage line 2 of Fig. 11A, putting it in fluid communication with the patient vessel).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon in view of Myrick further in view of Dabrowiak et al (US 2013/0079859).
Regarding claim 19, Hochareon in view of Myrick discloses the catheter of claim 1 but is silent regarding “wherein at least one capillary comprises a fiducial marking.” However, Dabrowiak teaches a catheter (Abstract), thus being in the same field of endeavor, that uses a marker band on its distal portion (¶0044). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to have modified the capillaries of Myrick to incorporate the marker of Dabrowiak in order to provide sufficient structure to visualize the device within the patient.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon in view of Myrick further in view of Salzman et al (US 5423320).
Regarding claim 23, Hochareon in view of Myrick discloses the catheter of claim 22 but is silent regarding “wherein at least one of the one or more sensors is an oxygen partial pressure (pO2) sensor.” However, Salzman teaches a catheter (Abstract), thus being in the same field of endeavor, with an oxygen partial pressure sensor (Col. 6:12-20) in order to measure the partial pressure at the location within the patient during the therapy (Col. 6:12-20). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to have modified the device of Hochareon to incorporate the partial pressure sensor of Salzman in order to provide sufficient structure to monitor the oxygenation at the therapy site during use of the device, as recognized by Salzman.
Allowable Subject Matter
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783