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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 and all dependents thereof 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 5 recites the limitation "the oxygen concentration adjustment unit" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-4, 8-10, 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kassab (US 2010/0222637 A1).
With regard to claim 1, Kassab discloses A treatment device (Fig. 1 and 4) of a cerebrovascular disorder ([0048]) comprising: a main body (Fig. 1, element 10) including an injection unit (14/20, [0054] injection fluid exits out of the distal end 14 and pores 20), the injection unit configured to be inserted into a living body ([0054]) and to inject a fluid into the living body (oxygenated arterial blood is delivered back into the normal flow of venous blood, [0054]); oxygen concentration measurement units (24, [0057], sensors 24 can be used to measure oxygen saturation) configured to be disposed at two or more locations in the living body (Fig. 1 shows three sensors 24 placed longitudinal along the distal end portion and thus are located at different locations in the body as they are placed along a longitudinal direction); and a flow rate adjustment unit (Fig. 4 shows the full system including the main body 10 which is connected to a remote module that controls the flow rate of the fluid entering into the main body, [0087]) configured to adjust a flow rate of the fluid to be injected by the injection unit ([0087]).
With regard to claim 2, Kassab discloses wherein the flow rate adjustment unit is configured to adjust the flow rate of the fluid to be injected by the injection unit according to oxygen concentrations at the two or more locations in the living body measured by the oxygen concentration measurement units ([0087]-[0089], remote control unit 270 uses the data collected from sensor 24 and can analyze the data to automatically adjust the volume of fluid injected into or withdrawn to maintain the arterial blood pressure and flow rate within the acceptable pre-programmed parameters [0089]).
With regard to claim 3, Kassab discloses wherein the flow rate adjustment unit (270) is configured to decrease the flow rate or to stop a supply of the fluid to be injected by the injection unit if one of the oxygen concentrations at the two or more locations in the living body measured by the oxygen concentration measurement units exceeds a predetermined upper limit value ([0087]-[0089], remote control unit 270 uses the data collected from sensor 24 and can analyze the data to automatically adjust the volume of fluid injected into or withdrawn to maintain the arterial blood pressure and flow rate within the acceptable pre-programmed parameters [0089], claim uses the language “configured to” implying functional language thus the flow rate adjustment unit must only be capable of decreasing flow rate if a predetermine upper limit value is reached. Because 270 can control flow rate based on the sensor readings, it would be capable of performing the recited claim function).
With regard to claim 4, wherein the flow rate adjustment unit is configured to adjust the flow rate of the fluid to be injected by the injection unit such that the oxygen concentrations at the two or more locations in the living body measured by the oxygen concentration measurement units are between the predetermined upper limit value and a predetermined lower limit value after the flow rate of the fluid to be injected by the injection unit is decreased or the supply is stopped (“configured to” language implies functional language only the structure of the flow rate adjustment unit must be taught and simply capable of performing the recited function. Because the flow rate adjustment unit 270 is designed to take the data from the oxygen concentration sensors 24 and thus adjust flow rate and other parameters including keeping blood flow within a specific pressure, the flow rate adjustment unit would be capable of performing the recited function).
With regard to claim 8, Kassab discloses further comprising: a pressure measurement unit ([0057], one or more sensors can be used including a pressure measurement sensor. Thus one of the sensors can be used to measure pressure and can be considered the pressure measurement unit) disposed in a flow path of the main body (located at the distal end, as shown in Fig. 1), and wherein the flow rate adjustment unit (270) is configured to adjust the flow rate of the fluid to be injected by the injection unit or the flow rate of the fluid to be discharged by a discharge unit according to a pressure in the living body measured by the pressure measurement unit ([0087]-[0089], remote control unit 270 uses the data collected from sensors 24 and can analyze the data to automatically adjust the volume of fluid injected into or withdrawn to maintain the arterial blood pressure and flow rate within the acceptable pre-programmed parameters [0089]).
With regard to claim 9, Kassab discloses wherein the injection unit (14/20) of the main body is located at a distal end portion of the main body (see Fig. 1).
With regard to claim 10, Kassab discloses wherein the main body (10) includes a discharge unit in a middle portion of the main body (pores 20 are located along the distal and middle portion of the main body there one of the pores can be considered a discharge unit and the other of the pores can be considered part of the injection unit as described in claim 1).
With regard to claim 17, Kassab discloses A treatment device (Fig. 1 and 4) of a cerebrovascular disorder ([0048]) comprising: a main body (10) including an injection unit (14), the injection unit is configured to be inserted into a living body ([0054]) and to inject a fluid and a discharge unit (20, [0054]) configured to discharge the fluid ([0054]); a pressure measurement unit (24) disposed in a flow path of the main body (see Fig. 1); a flow rate adjustment unit (270) configured to adjust a flow rate of the fluid to be injected by the injection unit or a flow rate of the fluid to be discharged by the discharge unit ([0054]); and wherein the flow rate adjustment unit is configured to adjust the flow rate of the fluid to be injected by the injection unit or the flow rate of the fluid to be discharged by the discharge unit according to a pressure in the living body measured by the pressure measurement unit ([0079]-[0087], remote module 270 controls fluid that can fill the chamber which then flows into the main body to be perfused out through discharge unit 20).
With regard to claim 18, Kassab discloses wherein flow adjustment unit (270) is configured to maintain the pressure in the living body within a predetermined range as measured by the pressure measurement unit [0085], [0072], [0073]. Also see [0090], [0091]).
With regard to claim 19, Kassab discloses wherein the flow rate adjustment unit (270) is configured to adjust a circulation amount of the fluid based on a pressure value measured by the pressure measurement unit, the pressure value being between a preset upper limit value and a preset lower limit value ([0087]-[0089], remote control unit 270 uses the data collected from sensors 24 and can analyze the data to automatically adjust the volume of fluid injected into or withdrawn to maintain the arterial blood pressure and flow rate within the acceptable pre-programmed parameters [0089]. Also see [0090]. [0091]).
With regard to claim 20, Kassab discloses A treatment device (Fig. 1 and 4) of a cerebrovascular disorder ([0048]) comprising: a main body (Fig. 1, element 10) including an injection unit (14/20, [0054] injection fluid exits out of the distal end 14 and pores 20), the injection unit configured to be inserted into a living body ([0054]) and to inject a fluid into the living body (oxygenated arterial blood is delivered back into the normal flow of venous blood, [0054]); oxygen concentration measurement unit (24, [0057], sensors 24 can be used to measure oxygen saturation) configured to be disposed at two or more locations in the living body (Fig. 1 shows three sensors 24 placed longitudinal along the distal end portion and thus are located at different locations in the body as they are placed along a longitudinal direction); and a flow rate adjustment unit (Fig. 4 shows the full system including the main body 10 which is connected to a remote module that controls the flow rate of the fluid entering into the main body, [0087]) configured to adjust a flow rate of the fluid to be injected by the injection unit ([0087]), wherein the flow rate adjustment unit (270) is configured to decrease the flow rate or to stop a supply of the fluid to be injected by the injection unit if one of the oxygen concentrations at the two or more locations in the living body measured by the oxygen concentration measurement units exceeds a predetermined upper limit value ([0087]-[0089], remote control unit 270 uses the data collected from sensor 24 and can analyze the data to automatically adjust the volume of fluid injected into or withdrawn to maintain the arterial blood pressure and flow rate within the acceptable pre-programmed parameters [0089], claim uses the language “configured to” implying functional language thus the flow rate adjustment unit must only be capable of decreasing flow rate if a predetermine upper limit value is reached. Because 270 can control flow rate based on the sensor readings, it would be capable of performing the recited claim function).
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.
Claim(s) 5-7, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab (US 2010/0222637 A1) in view Osterholm (US 4,686, 085).
With regard to claim 5, Kassab discloses the claimed invention except for an oxygen concentration adjustment unit.
Osterholm teaches a cerebral drug treatment system (fig. 1) also including sensors for sensing a bodily function (shown in output monitor 34) which delivers diagnostic fluid to the brain (at 20). Osterholm further includes a flow rate adjustment unit (18) and further teaches an oxygen concentration adjustment unit (16 and 36) that is configured to adjust the oxygen concentration at the fluid to be injected by the injection unit (20a)(Col 15, lines 6-24) according to oxygen concentrations at the two or more locations in the living body measured by the oxygen concentration measurement units (Col 13, lines 34-Col 14, line 13, fluid directly from the brain is pulled for sampling including the oxygen concentration, which in turn continuously provides information on the tissue in the brain itself thus considered to be monitoring oxygen concentrations at locations in the living body, this information is then send to the oxygen co monitor and control unit 36 which controls the oxygenation of the new diagnostic fluid to be delivered at 16).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device of Kassab to also include an oxygen concentration adjustment unit as taught by Osterholm for the purpose of maintaining proper oxygen levels within the fluid to be delivered such that an alarm can be sounded if oxygen falls outside proper levels (Col 15, lines 6-24).
With regard to claim 6, Kassab discloses the claimed invention except for the oxygen concentration adjustment unit.
Osterholm teaches wherein the oxygen concentration adjustment unit is configured to decrease the oxygen concentration of the fluid to be injected by the injection unit when one of the oxygen concentrations at the two or more locations in the living body measured by the oxygen concentration measurement units exceeds a predetermined upper limit value (Col 15, line 6-24; Col 13, lines 34- Col 14, line 13; the oxygen concentration adjustment unit is taught by the prior art and would be configured to decrease oxygen concentration based on specific predetermined limits as it is capable to adjust oxygen concentrations based on data received from sensors in the body).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device of Kassab to also include an oxygen concentration adjustment unit as taught by Osterholm for the purpose of maintaining proper oxygen levels within the fluid to be delivered such that an alarm can be sounded if oxygen falls outside proper levels (Col 15, lines 6-24).
With regard to claim 7, Kassab discloses the claimed invention except for the oxygen adjustment unit.
Osterholm teaches wherein after the oxygen concentration adjustment unit is configured to decrease the oxygen concentration of the fluid to be injected by the injection unit (col 15, lines 6-24), the oxygen concentration adjustment unit configured to adjust the oxygen concentration of the fluid to be injected by the injection unit such that the oxygen concentrations at the two or more locations in the living body measured by the oxygen concentration measurement units are between the predetermined upper limit value and a predetermined lower limit value (Col 15, line 6-24; Col 13, lines 34- Col 14, line 13; the oxygen concentration adjustment unit is taught by the prior art and would be configured to adjust oxygen concentration based on specific predetermined limits as it is capable to adjust oxygen concentrations based on data received from sensors in the body).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device of Kassab to also include an oxygen concentration adjustment unit as taught by Osterholm for the purpose of maintaining proper oxygen levels within the fluid to be delivered such that an alarm can be sounded if oxygen falls outside proper levels (Col 15, lines 6-24).
With regard to claim 16, Kassab discloses the claimed invention except for the specific fluid being delivered.
Osterholm teaches wherein the fluid is a hyperoxygenated artificial cerebrospinal fluid (col 15, line 25-end).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device of Kassab to deliver hyperoxygenated artificial cerebrospinal fluid as taught by Osterholm for the purpose of preserving the tissues and cells which would not do well if exposed to large volumes of non-physiologic ionic solutions (Col 15, lines 25-end).
Claim(s) 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab (US 2010/0222637 A1) in view of Thomas (US 2012/0191069 A1).
With regard to claim 11 and 12, Kassab discloses the claimed invention except for branched proximal portion.
Claim 11: Thomas teaches a cerebral catheter similar to Kassab (Fig. 4) and further teaches wherein a proximal end portion of the main body (22) branches into an inlet tube (56) and an outlet tube (62).
Claim 12: Thomas teaches wherein the inlet tube (56) includes an inlet portion (at 58) at a proximal end portion of the inlet tube, and the outlet tube (62) includes an outlet portion (at 64) at a proximal end portion of the outlet tube.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device of Kassab with the branched proximal portion as taught by Thomas for the purpose of separating fluid taken from the body with fluid being delivered back to the body ([0032]).
With regard to claim 13, Kassab discloses further comprising: a discharge unit (Fig. 4, element 220) configured to discharge the fluid (from fluid source 280), and wherein a flow rate of the fluid to be discharged by the discharge unit is adjusted by the flow rate adjustment unit ([0081]).
With regard to claim 14, Kassab discloses Kassab discloses the claimed invention except for the branched proximal portion with an inlet portion and outlet portion.
Thomas teaches wherein the inlet portion (58) and the injection unit (through 32) communicate with each other, and the outlet portion (64) and the discharge unit (40) communicate with each other by lumens extending along a longitudinal direction of the main body (see Fig. 4 main body 22).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device of Kassab with the branched proximal portion as taught by Thomas for the purpose of separating fluid taken from the body with fluid being delivered back to the body ([0032]).
With regard to claim 15, Kassab discloses the claimed invention except for a discharge drive unit.
Thomas teaches further comprising: a discharge drive unit (pump 50 which draws CSF from the body via portals 40 [0032]) configured to suction a cerebrospinal fluid in a spinal canal of the living body from the discharge unit ([0032]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device of Kassab with the discharge drive unit as taught by Thomas for the purpose of pulling native CSF for treatment and re-delivery into the body ([0032]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783