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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-22, drawn to a method for improving, repairing, or preventing impairment of brain function, classified in A61M 2202/0225.
II. Claim 23-27, drawn to a device for applying pressure to one or more neck veins, classified in A61H 2201/1609.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the method can be performed with another product, such as supplying CO2 with a gas delivery system and perform compression by hand.
During a telephone conversation with Michale Beck on 3/2/2026 a provisional election was made without traverse to prosecute the invention of I, claims 1-22. Affirmation of this election must be made by applicant in replying to this Office action. Claim 23-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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)(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.
Claim(s) 1, 2, 4-7, 9-12 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Schroeder (US20190262212), hereafter Schroeder.
Regarding Claim 1, Schroeder discloses a method for improving, repairing or preventing impairment of brain function in a subject (par. 0014, “methods of assisting biofluid movement in a subject, e.g., in the brain or cardiovascular system…”) by facilitating cerebral blood (par. 0035, “The resulting increase in PP contributes to both the increased supply of nutrient-rich blood to the neurons”, higher PP and increased blood supply to neurons facilitates cerebral blood flow) and cerebral spinal fluid flow (par. 0035, “The present invention also has the potential to improve ISF/CSF material exchange, improve the movement of CSF to the veins, improve movement of lymph, and the improve movement of blood in the veins”), comprising increasing blood flow away from the brain (par. 0035, “the improve movement of blood in the veins”) distal to the dysfunctional valve”; the prior art discloses applying pressure to help poor blood removal from the brain) and down the spinal cord and interstitial spaces through the Glymphatic Pathways (par. 0105, “the role of arterial pulsation as a driving force for CSF/ISF exchange and transport to the veins is generally emerging as a common thread, as is the notion that inadequate glymphatic function can lead to NCD. Consequently, any deviation from normal arterial pulsation could have implications for proper glymphatic function”, the prior art applies pulsation which improves blood and waste removal through the glymphatic pathways; par. 0135, “cerebrovascular pulsation produces fluid movement in the perivascular spaces of the brain (Iliff et al., 2013b) and spinal cord”).
Regarding Claim 2, Schroeder discloses the method of claim 1, further comprising increasing one or both of the intracranial pressure and the intracranial blood volume, to increase blood flow away from the brain (par. 0094, “constricted internal jugular veins are associated with (a) increased blood volume in the brain (Kitano et al., 1964—although the procedure they used also compressed the carotid arteries); (b) increased intracranial pressure in a variety of patient populations”; the prior art specifically discloses applying pressure to jugular veins which increases intracranial pressure and volume).
Regarding Claim 4, Schroeder discloses the method of claim 2, wherein the step of increasing one or both of the intracranial pressure and the intracranial blood volume is achieved by applying pressure to one or more neck veins (par. 0028, “FIGS. 3A-3B presents side views for one general method of applying stimulation to both the carotid artery and jugular vein (FIG. 3A), or exclusively to either the carotid artery or jugular vein independently (FIG. 3B)”; par. 0094 discloses pressure to jugular veins increases intracranial pressure).
Regarding Claim 5, Schroeder discloses the method of claim 4, wherein the one or more neck veins includes at least one internal jugular vein or at least one external jugular vein (par. 0028, , “FIGS. 3A-3B presents side views for one general method of applying stimulation to both the carotid artery and jugular vein (FIG. 3A), or exclusively to either the carotid artery or jugular vein independently (FIG. 3B)”).
Regarding Claim 6, Schroeder discloses the method of claims 4, wherein pressure applied to the one or more neck veins is about 10 mm Hg to about 100 mm Hg (par. 0014, “apply an appropriate series of pulses to a target for an appropriate duration… about 0.1, 0.5, 1.0, 5.0, 10, 15, to 20 kPa”; 5kPa approximately equals to 37.5 mm Hg, the prior art is within the claimed range).
Regarding Claim 7, Schroeder discloses the method of claim 4, wherein the pressure applied to one or more neck veins is applied intermittently in a plurality of cycles (par. 0056, “external pressure applied to that vein (serving as an artificial valve), which is periodically released so that blood can pass freely at critical times”), wherein each cycle is characterized as having an on-time having a first neck vein pressure and an off-time having a second neck vein pressure (Examiner Notes: See par. 0056, the prior art discloses the pressure being applied periodically, by applying pressure to the vein for a set time period and close at other times; therefore, the prior art inherently includes a first neck vein pressure during an on time where pressure is being applied, and a second neck vein pressure during an off time where the pressure is released), wherein the first neck vein pressure is greater than the second neck vein pressure (Examiner Notes: par. 0056, the first neck vein pressure is when the pressure is being applied, the second neck vein pressure is when the pressure is released/zero pressure, therefore the first neck vein pressure is inherently greater than the second neck vein pressure).
Regarding Claim 9, Schroeder discloses the method of claim 7, wherein the off-time has a duration of one second to one hour (par. 0075, “the external force is applied only once every 5 heart beats, every 10 beats, every 5 minutes, every half hour, etc.”, the prior art discloses pressure being applied every 5 minutes, meaning the off time is 5 minutes which is within the claimed range; furthermore, par. 0039 discloses the duration/timing is adjustable).
Regarding Claim 10, Schroeder discloses the method of claim 7, wherein the first neck vein pressure is 10-100 mm Hg (par. 0014, “In certain aspects the pressure can be at most, at least, or about 0.1, 0.5, 1.0, 5.0, 10, 15, to 20 kPa”; in case of the pressure is about 5 kPa, the prior art is within the claimed range).
Regarding Claim 11, Schroeder discloses the method of claim 7, wherein the second neck vein pressure is 0-50 mm Hg (par. 0056, “…periodically released so that blood can pass freely at critical times”; when the pressure is released, the second neck vein pressure is zero, therefore it is within the claimed range).
Regarding Claim 12, Schroeder discloses the method of claim 7, wherein the first neck vein pressure is at least 20 mm Hg greater than the second neck vein pressure (par. 0014, par. 0056, in case where the first neck vein pressure is 5 kPa and second neck vein pressure is 0, the prior art is within the claimed range).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder, in view of Smith (US8985120), hereafter Smith.
Regarding Claim 3, Schroeder discloses the method of claim 2, but is silent on wherein the step of increasing one or both of the intracranial pressure and the intracranial blood volume is achieved by administering changes to inspired CO2 levels of the subject by using exogenous or endogenous CO2.
However, Smith taches a method of increasing intracranial pressure and blood volume (col. 5 line 61 – col. 6 line 1), wherein the step of increasing one or both of the intracranial pressure and the intracranial blood volume is achieved by administering changes to inspired CO2 levels of the subject by using exogenous or endogenous CO2 (col. 5 line 61 – col 6 line 1, “The method of controlling pCO.sub.2 in a patient at a predetermined desired level can be provided comprising a breathing circuit/mask which is capable of increasing the CO.sub.2 to enable an increase in cerebral blood flow and resultant cerebral blood pressure. With increased cerebral blood flow, cerebral blood velocity, and intracranial pressure there remains less space for intracranial tissues to move in relation to each other”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known method of Schroeder, with the method of Smith, to optimize the healing environment of the brain tissue itself by reducing the systemic inflammatory response and maximizing flow of oxygen rich hemoglobin as taught by Smith (col. 6, line 16-19).
Claim(s) 8, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder, in view of Smith (US20140343599), hereafter Dsmith.
Regarding Claim 8, Schroeder discloses the method of claim 7, wherein the duration of on-time can be adjusted as needed (par. 0039), but does not specifically disclose wherein the on-time has a duration of one second to one hour.
However, Dsmith teaches a method for preventing impairment of brain function (Abstract, “…to reduce the risk of traumatic brain injury and injuries to the spinal column”), comprising of applying pressure to jugular veins to increase intracranial volume/pressure (Abstract, “applying pressure to at least one jugular vein.. Reducing blood outflow from the cranial cavity increases intracranial volume and/or pressure of the cerebrospinal fluid”), wherein the pressure is being applied for 15 minutes (par. 0067, Fig. 10 shows the pressure being applied for a 15 minutes period then removed).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the on-time of Schroeder to 15 minutes as applicant appears to have placed no criticality on the claimed range (See applicant’s disclosure, par. 0023) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 13, Schroeder discloses the method of claim 7, wherein the duration of each cycle can be adjusted as needed (par. 0039), and that the off-time can be 5 minutes (par. 0075), but does not specifically disclose wherein each cycle has a duration of five seconds to two hours.
However, Dsmith teaches a method for preventing impairment of brain function (Abstract, “…to reduce the risk of traumatic brain injury and injuries to the spinal column”), comprising of applying pressure to jugular veins to increase intracranial volume/pressure (Abstract, “applying pressure to at least one jugular vein.. Reducing blood outflow from the cranial cavity increases intracranial volume and/or pressure of the cerebrospinal fluid”), wherein the pressure is being applied for 15 minutes (par. 0067, Fig. 10 shows the pressure being applied for a 15 minutes period then removed).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the duration of each cycle of Schroeder, to 20 minutes (15 minutes on-time, 5 minutes off-time) as applicant appears to have placed no criticality on the claimed range (See applicant’s disclosure, par. 0023) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 14-16, 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder, in view of Wennen et al. (US11311450), hereafter Wennen.
Regarding Claim 14, Schroeder discloses the method of claim 4, wherein the pressure applied can have various pattern (par. 0043), but does not specifically disclose that the pressure applied to one or more neck veins is applied alternately to one or more veins on one side of the neck and then to one or more veins on the other side of the neck.
However, Wennen teaches a method for providing pressure to neck veins of a user (Fig. 11, col. 12, line 35-55), wherein the pressure applied to one or more neck veins is applied alternately to one or more veins on one side of the neck and then to one or more veins on the other side of the neck (col. 12, line 35-55, “Each of the first and second neck garment portions may be configurable or controllable to apply pressure to the right and left sides of the neck… Specifically, the pressure applying regions of first and second neck garment portions may be controllable or configurable to apply pressure alternately during a therapy cycle of a therapy period (e.g., first neck garment portion then second neck garment portion then first neck garment portion and so on)”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known method of Schroeder, with the method of Wennen, to have the pressure applied in an alternative pattern, to avoid the chances of an individual passing out as taught by Wennen (col. 12, line 35-55).
Regarding Claim 15, Schroeder discloses a method for improving, repairing or preventing impairment of brain function in a subject (par. 0014, “methods of assisting biofluid movement in a subject, e.g., in the brain or cardiovascular system…”) by facilitating cerebral blood (par. 0035, “The resulting increase in PP contributes to both the increased supply of nutrient-rich blood to the neurons”, higher PP and increased blood supply to neurons facilitates cerebral blood flow) and cerebral spinal fluid flow (par. 0035, “The present invention also has the potential to improve ISF/CSF material exchange, improve the movement of CSF to the veins, improve movement of lymph, and the improve movement of blood in the veins”), by increasing blood flow away from the brain (par. 0035, “the improve movement of blood in the veins”) distal to the dysfunctional valve”; the prior art discloses applying pressure to help poor blood removal from the brain) and down the spinal cord and interstitial spaces through the Glymphatic Pathways (par. 0105, “the role of arterial pulsation as a driving force for CSF/ISF exchange and transport to the veins is generally emerging as a common thread, as is the notion that inadequate glymphatic function can lead to NCD. Consequently, any deviation from normal arterial pulsation could have implications for proper glymphatic function”, the prior art applies pulsation which improves blood and waste removal through the glymphatic pathways; par. 0135, “cerebrovascular pulsation produces fluid movement in the perivascular spaces of the brain (Iliff et al., 2013b) and spinal cord”), comprising applying pressure to one or more neck veins on each side of the subject’s neck (par. 0028, “FIGS. 3A-3B presents side views for one general method of applying stimulation to both the carotid artery and jugular vein (FIG. 3A), or exclusively to either the carotid artery or jugular vein independently (FIG. 3B)”; par. 0094 discloses pressure to jugular veins increases intracranial pressure).
Schroeder further discloses wherein the pressure applied can have various pattern (par. 0043), but does not specifically disclose that the pressure applied alternately to one or more veins on one side of the neck and then to one or more veins on the other side of the neck.
However, Wennen teaches a method for providing pressure to neck veins of a user (Fig. 11, col. 12, line 35-55), wherein the pressure applied alternately to one or more veins on one side of the neck and then to one or more veins on the other side of the neck (col. 12, line 35-55, “Each of the first and second neck garment portions may be configurable or controllable to apply pressure to the right and left sides of the neck… Specifically, the pressure applying regions of first and second neck garment portions may be controllable or configurable to apply pressure alternately during a therapy cycle of a therapy period (e.g., first neck garment portion then second neck garment portion then first neck garment portion and so on)”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known method of Schroeder, with the method of Wennen, to have the pressure applied in an alternative pattern, to avoid the chances of an individual passing out as taught by Wennen (col. 12, line 35-55).
Regarding Claim 16, the modified Schroeder discloses the method of 15, wherein the pressure is applied intermittently in a plurality of cycles (Schroeder, par. 0056, “external pressure applied to that vein (serving as an artificial valve), which is periodically released so that blood can pass freely at critical times”), wherein each cycle is characterized as having an on-time having a first neck vein pressure and an off-time having a second neck vein pressure (Examiner Notes: See Schroeder, par. 0056, the prior art discloses the pressure being applied periodically, by applying pressure to the vein for a set time period and close at other times; therefore, the prior art inherently includes a first neck vein pressure during an on time where pressure is being applied, and a second neck vein pressure during an off time where the pressure is released), wherein the first neck vein pressure is greater than the second neck vein pressure (Examiner Notes: Schroeder, par. 0056, the first neck vein pressure is when the pressure is being applied, the second neck vein pressure is when the pressure is released/zero pressure, therefore the first neck vein pressure is inherently greater than the second neck vein pressure).
Regarding Claim 18, the modified Schroeder discloses the method of claim 16, wherein the off-time has a duration of one second to one hour (Schroeder, par. 0075, “the external force is applied only once every 5 heart beats, every 10 beats, every 5 minutes, every half hour, etc.”, the prior art discloses pressure being applied every 5 minutes, meaning the off time is 5 minutes which is within the claimed range; furthermore, par. 0039 discloses the duration/timing is adjustable).
Regarding Claim 19, the modified Schroeder discloses the method of claim 16, wherein the first neck vein pressure is 10-100 mm Hg (Schroeder, par. 0014, “In certain aspects the pressure can be at most, at least, or about 0.1, 0.5, 1.0, 5.0, 10, 15, to 20 kPa”; in case of the pressure is about 5 kPa, the prior art is within the claimed range).
Regarding Claim 20, the modified Schroeder discloses the method of claim 16, wherein the second neck vein pressure is 0-50 mm Hg (Schroeder, par. 0056, “…periodically released so that blood can pass freely at critical times”; when the pressure is released, the second neck vein pressure is zero, therefore it is within the claimed range).
Regarding Claim 21, the modified Schroeder discloses the method of claim 16, wherein the first neck vein pressure is at least 20 mm Hg greater than the second neck vein pressure (Schroeder, par. 0014, par. 0056, in case where the first neck vein pressure is 5 kPa and second neck vein pressure is 0, the prior art is within the claimed range).
Claim(s) 17, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder, in view of Wennen, further in view of Dsmith.
Regarding Claim 17, the modified Schroeder discloses the method of claim 16, wherein the duration of on-time can be adjusted as needed (Schroeder, par. 0039), but does not specifically disclose wherein the on-time has a duration of one second to one hour.
However, Dsmith teaches a method for preventing impairment of brain function (Abstract, “…to reduce the risk of traumatic brain injury and injuries to the spinal column”), comprising of applying pressure to jugular veins to increase intracranial volume/pressure (Abstract, “applying pressure to at least one jugular vein.. Reducing blood outflow from the cranial cavity increases intracranial volume and/or pressure of the cerebrospinal fluid”), wherein the pressure is being applied for 15 minutes (par. 0067, Fig. 10 shows the pressure being applied for a 15 minutes period then removed).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the on-time of Schroeder to 15 minutes as applicant appears to have placed no criticality on the claimed range (See applicant’s disclosure, par. 0023) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 22, the modified Schroeder discloses the method of claim 16, wherein the duration of each cycle can be adjusted as needed (Schroeder, par. 0039), and that the off-time can be 5 minutes (par. 0075), but does not specifically disclose wherein each cycle has a duration of five seconds to two hours.
However, Dsmith teaches a method for preventing impairment of brain function (Abstract, “…to reduce the risk of traumatic brain injury and injuries to the spinal column”), comprising of applying pressure to jugular veins to increase intracranial volume/pressure (Abstract, “applying pressure to at least one jugular vein.. Reducing blood outflow from the cranial cavity increases intracranial volume and/or pressure of the cerebrospinal fluid”), wherein the pressure is being applied for 15 minutes (par. 0067, Fig. 10 shows the pressure being applied for a 15 minutes period then removed).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the duration of each cycle of Schroeder, to 20 minutes (15 minutes on-time, 5 minutes off-time) as applicant appears to have placed no criticality on the claimed range (See applicant’s disclosure, par. 0023) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785