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
Applicant’s election without traverse of Species A in the reply filed on 6/15/2025 is acknowledged.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/3/2026 has been entered.
Response to Amendments
The Amendment filed 2/3/2026 has been entered. Claims 1-2, 4-7, 14, 16, 18-19, 22, 25, and 27 were amended, claims 3, 8-9, 11-13, 15, 24, 26, 29, 32, and 34-35 were canceled, and claims 36-43 were new. Thus, claims 1-2, 4-7, 10, 14, 16-23, 25, 27-28, 30-31, 33, and 36-43 are pending in the application.
Claim Objections
Claim 43 is objected to because of the following informalities: claim 43 recites “the subject a movement” in line 3, and is suggested to read --the subject in a movement-- in order to be grammatically correct. 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.
Claims 2, 5-7, 19-21, 40-41, and 43 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.
Regarding claim 2, the limitation “a backrest” in line 2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a backrest” in claim 1. For the purposes of examination, they will be interpreted as the same limitation.
Regarding claim 5, the limitations “a headrest” in line 2 and “a head” in line 2 are confusing, as it is unclear whether these limitations are meant to be the same as or different from “a headrest” and “a head” in claim 1, respectively. For the purposes of examination, they will be interpreted as the same respective limitations.
Regarding claim 6, the limitations “a backrest” in line 2 and “a headrest” in line 2 are confusing, as it is unclear whether these limitations are meant to be the same as or different from “a backrest” and “a headrest” in claim 1, respectively. For the purposes of examination, they will be interpreted as the same respective limitations.
Claim 19 recites the limitation "the spinal column" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 41, the limitation “a spinal column” in line 2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “the spinal column” in claim 19. For the purposes of examination, they will be interpreted as the same limitation.
Regarding claim 43, the limitation “two outside of the multiple cerebrospinal fluid pumps” in line 2 is confusing, as it is unclear as to what is meant by this limitation. According to the Examiner’s best understanding of the Applicant’s invention, this limitation is being interpreted as two more cerebrospinal fluid pumps of the multiple cerebrospinal fluid pumps which are outside of the one cerebrospinal fluid pump of multiple cerebrospinal fluid pumps.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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.
Claims 10, 17, and 38-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Badger (US 2,672,860).
Regarding claim 10, Badger discloses an apparatus (massaging device) (col. 1 lines 1-3) comprising:
a pump configured in a pumping state to oscillate between a first position and a second position to change dynamics of a cerebrospinal fluid (CSF) system of a subject as compared to the dynamics of the CSF in a non-pumping state (when in a pumping state, the hydraulic mechanism with oil in cylinder 31 that acts upon a piston 39 is a pump; the pump then moves the connected piston rod 62’ and a massaging element 43-50 up and down against a user’s spine to thereby change its CSF dynamics; when not in a pumping state, the mechanism would be off, and so no massage would be occurring) (Figs. 1-2, 4-6; col. 1 lines 45-53; col. 4 lines 36-43; col. 5 lines 22-29);
a lumbar flexure device configured to provide pressure to a spinal column of the subject in a supine position, wherein in a home position the lumbar flexure device is configured to touch the subject in the first position and in a span of a length from the home position along a linear actuation axis the lumbar flexure device is configured to apply pressure to the spinal column in the second position (one of the massaging elements 43-50 which are configured to provide a massage pressure to the subject’s spine while the subject is supine; the massaging elements 43-50 start in a down position from the weight of the user, thus the massaging elements 43-50 contact the user’s spine when down, and then move up linearly in a stroke length of the piston rod 62’ to apply the massage pressure) (Figs. 1-2, 4-6; col. 1 lines 35-53; col. 4 lines 27-50); and
a controller configured to control the pumping state between the first position and the second position (prime mover 11, belt 52, gear box 53, shaft 54, switch 55, and rotor 28 used to move the pistons up and down for the massage; additionally, a control panel 7 with knob 66’ can be rotated to control the amount of pressure that each individual massaging element exerts) (Figs. 3, 5-6; col. 3 lines 5-6; col. 4 lines 18-35, 51-75).
Regarding claim 17, Badger discloses the lumbar flexure device further comprising: a shaft (one of the piston rods 62’) (Figs. 1-2, 4-6; col. 4 lines 27-50); and a pressure pad coupled to the shaft, wherein the pump is configured to move the pressure pad back and forth in an axial direction (another of the massaging element 43-50, all of which are connected to a respective piston rods 62’; the pump then axially moves the connected piston rod 62’ and its massaging element 43-50 up and down against a user’s spine) (Figs. 1-2, 4-6; col. 1 lines 45-53; col. 4 lines 27-50).
Regarding claim 38, Badger discloses further comprising: an extension positioned between the shaft and the pressure pad (bracket 73, rod 75, spring 76, bracket 77, and/or weight 78 are positioned between a piston rod 62’ and a respective massaging element 43-50) (Figs. 4-6, 13-15; col. 5 lines 40-59).
Regarding claim 39, Badger discloses wherein the extension is one of multiple extensions of different lengths configured to be positioned between the shaft and the pressure pad (bracket 73, rod 75, spring 76, bracket 77, and/or weight 78 positioned between a piston rod 62’ and a respective massaging element 43-50 are of different lengths) (Figs. 4-6, 13-15; col. 5 lines 40-59).
Claims 18 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartman et al. (US 2013/0085531 A1).
Regarding claim 18, Hartman discloses an apparatus (apparatus for treating a body part) (abstract) comprising:
a headrest configured to support a head of a subject in a supine position (support 7 for supporting the patient’s head while supine) (Figs. 1-8; para. [0045]);
a backrest configured to support a back of the subject in the supine position (second support 9 for supporting the patient’s back while supine) (Figs. 1-8; para. [0045]), wherein the backrest is coupled to the headrest to rotate about a rotation axis (support 7 is coupled to second support 9 via the manipulator 11; support 7 rotates about an axis relative to the second support 9) (Figs. 1-8; para. [0009]; paras. [0045-0046]; para. [0048]; para. [0070]);
a pump configured for an oscillation of the headrest configured to rotate between a posterior extension from a neutral position and an anterior flexion from a neutral position in a pumping state to change dynamics of a cerebrospinal fluid (CSF) system of a subject as compared to the dynamics of the CSF in a non-pumping state wherein the neutral position is at a transition from the flexion to the extension of the headrest (The Applicant’s specification para. [0048] explains that a pump is a mechanism configured to alternatingly provide and release pressure on the spinal column to allow it to flex then move back to an unpressured position, and this process causes a change in CSF fluid dynamics. Hartman discloses a mechanism including a platform 17, linear actuators 19, and hinges 21 which is able to rotatably maneuver the support 7 for the patient’s head. The movement can include sagittal flexion about an angle theta forwards and backwards, thereby flexing and extending the head from a neutral position. Thus, Hartman would be able to function as claimed to pump and change the dynamics of CSF as compared to a non-pumping state, as Hartman is capable of flexing the cervical spine and then extending it.) (Figs. 1-5; para. [0046]; para. [0048]); and
a control system configured to control the oscillation of the pump between the posterior extension and the anterior flexion (controller 27 controls the actuators 19 to maneuver the support 7 between flexion and extension by angle theta) (Figs. 1-5; para. [0046]; para. [0048]).
Regarding claim 22, Hartman discloses wherein the pump is configured to provide anterior flexion and posterior extension from 10 to 40 degrees from the neutral position of the headrest (support 7 can be rotated by an angle theta of -70 to 70 degrees; with 0 degrees being a neutral position, flexion would be a positive angle forwards and extension would be a negative angle backwards) (Figs. 2A-2C; para. [0052]).
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.
Claims 1-2, 5, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Badger in view of Hartman.
Regarding claim 1, Badger discloses an apparatus (massaging device) (col. 1 lines 1-3) comprising:
a pump configured in a pumping state to change dynamics of a cerebrospinal fluid (CSF) system of a subject as compared to the dynamics of the CSF in a non-pumping state (when in a pumping state, the hydraulic mechanism with oil in cylinder 31 that acts upon a piston 39 to move it, which then moves the connected piston rod 62’ and a massaging element 43-50 against a user’s spine to thereby change its CSF dynamics; when not in a pumping state, the mechanism would be off, and so no massage would be occurring) (Figs. 1-2, 4-6; col. 1 lines 45-53; col. 4 lines 36-43; col. 5 lines 22-29), wherein the pump is configured to provide an anterior flexion and a posterior extension of a spinal column of the subject (when the massaging element is moved up against subject’s spine, it would flex the spine anteriorly; when the massaging element is moved back down, the spine would extend posteriorly) (Fig. 1; col. 1 lines 35-53; col. 4 lines 36-43);
a support configured to support the subject in a supine position, wherein the support comprises: a backrest configured to support a back of the subject (the surface of the table upon which the subject lies supine on their back) (Fig. 1); and
a control system configured to control the pumping state in an oscillation between the anterior flexion and the posterior extension of the spinal column of the subject (prime mover 11, belt 52, gear box 53, shaft 54, switch 55, and rotor 28 used to move the pistons up and down for the massage; additionally, a control panel 7 with knob 66’ can be rotated to control the amount of pressure that each individual massaging element exerts) (Figs. 3, 5-6; col. 3 lines 5-6; col. 4 lines 18-35, 51-75).
Badger does not disclose a headrest configured to support a head of the subject, wherein the headrest is configured to rotate with respect to the backrest about a rotation axis.
However, Hartman teaches an apparatus for manipulating a body part (Hartman; abstract) including a headrest configured to support a head of the subject, wherein the headrest is configured to rotate with respect to the backrest about a rotation axis (mechanism including a platform 17, linear actuators 19, and hinges 21 which is able to rotatably maneuver the support 7 for the patient’s head and/or neck, and thus affect their cervical spine) (Hartman; Figs. 1-5; para. [0046]; para. [0048]; para. [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Badger table to include a headrest configured to support a head of the subject, wherein the headrest is configured to rotate with respect to the backrest about a rotation axis, as taught by Hartman, for the purpose of providing a means to apply dynamic physiotherapy to the head, neck, and/or shoulders (Hartman; para. [0001]).
Regarding claim 2, as best understood, the modified Badger teaches wherein the support comprises a backrest configured to support the back of the subject (the surface of the table upon which the subject lies supine on their back) (Badger; Fig. 1), further comprising: an aperture in the backrest; and a moveable pad configured to extend through the aperture to pump the CSF system (opening 6 in the table through which the massaging elements 43-50 extend up to massage the subject) (Badger; Figs. 1-2; col. 1 lines 35-53; col. 2 line 55; col. 3 lines 1-5; col. 4 lines 36-43).
Regarding claim 5, as best understood, the modified Badger teaches wherein the support comprises a headrest configured to support a head of the subject and the spinal column is characterized as a cervical region, the pump is configured to provide flexion and extension from 10 to 40 degrees from a neutral position of a spine of the subject, wherein the headrest is configured to transition the cervical region from the flexion to the extension in the neutral position and the flexion is movement anteriorly and the extension is movement posteriorly (mechanism including a platform 17, linear actuators 19, and hinges 21 which is able to rotatably maneuver the support 7 for the patient’s head and/or neck, and thus affect their cervical spine; the movement can include sagittal flexion about an angle theta of -70 to 70 degrees forwards and backwards, thereby flexing and extending the head from a neutral position; with 0 degrees being a neutral position, flexion would be a positive angle forwards and extension would be a negative angle backwards) (Hartman; Figs. 1-5; para. [0046]; para. [0048]; para. [0052]).
Regarding claim 36, the modified Badger teaches wherein the pump is configured to be positioned in the aperture of the backrest (opening 6 in the table inside of which is the hydraulic mechanism with a cylinder 31, piston 39, and piston rod 62’ for one of the massaging elements 43-50) (Badger; Figs. 1-2; col. 1 lines 35-53; col. 2 line 55; col. 3 lines 1-5; col. 4 lines 36-43).
Regarding claim 37, the modified Badger teaches wherein the pump is one of a plurality of pumps configured to be positioned in the aperture of the backrest (opening 6 in the table inside of which has multiple cylinders 31, pistons 39, and piston rods 62’, one for each massaging element 43-50) (Badger; Figs. 1-2, 4-6; col. 1 lines 35-53; col. 2 line 55; col. 3 lines 1-5; col. 4 lines 36-43).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Badger in view of Hartman as applied to claim 1 above, and further in view of Herman et al. (US 2013/0274800 A1).
Regarding claim 4, the modified Badger teaches the invention as previously claimed, but is silent on wherein the pump is configured to have a length of a stroke of 1 to 5 cm for an extension configured to apply pressure to the subject and a retraction of a pressure pad.
However, Herman teaches a spinal column correction device (Herman; abstract) wherein a height of the lumbar curve portion is about 5.588 cm, which is close to the claimed 1 to 5 cm (lumbar curve portion 46 has a height of about 2.2 inches or about 5.588 cm; please note the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality) (Herman; Figs. 3-4, 15-20; para. [0016]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Badger stroke to be 1 to 5 cm, as taught by Herman and the MPEP, for the purpose of providing a specific stroke length to for the device to act on the user’s lumbar region to correct a user’s lumbar spinal column, and thereby help to provide back pain relief (Herman; para. [0047]).
With this modification, the modified Badger would thus teach wherein the pump is configured to have a length of a stroke of 1 to 5 cm for an extension configured to apply pressure to the subject and a retraction of a pressure pad (Badger pump mechanism would vertically move one of the massage elements 43-50 from a retracted position at 0 cm to an extended position of about 5.588 cm as taught by Herman, which is close to the claimed non-critical range) (Badger, Fig. 1, col. 1 lines 35-53, col. 4 lines 36-43; Herman, Figs. 3-4, 15-20, para. [0016]; MPEP 2144.05(I)).
Regarding claim 6, as best understood, the modified Badger teaches wherein the pump is characterized as a first pump (Badger hydraulic mechanism with a cylinder 31, piston 39, and piston rod 62’ for one of the massaging elements 43-50 as the first pump) (Badger; Figs. 1-2, 4-6; col. 1 lines 45-53; col. 4 lines 36-43) and the support comprises a backrest (the surface of the table upon which the subject lies supine on their back) (Badger; Fig. 1) and a headrest (support 7 for the patient’s head and/or neck) (Hartman; Figs. 1-5), further comprising: the backrest configured to support the back of the subject in the supine position (the surface of the table upon which the subject lies supine on their back) (Badger; Fig. 1); an opening in the backrest, the first pump positioned in the opening (hole in the table inside of which is the hydraulic mechanism with of a cylinder 31, piston 39, and piston rod 62’) (Badger; Figs. 1-2; col. 1 lines 35-53; col. 4 lines 36-43), wherein the first pump is configured to move anteriorly and retract posteriorly with a stroke length of 1 to 5 cm (Badger pump mechanism would vertically move one of the massage elements 43-50 from a retracted position at 0 cm to an extended position of about 5.588 cm as taught by Herman, which is close to the claimed non-critical range) (Badger, Fig. 1, col. 1 lines 35-53, col. 4 lines 36-43; Herman, Figs. 3-4, 15-20, para. [0016]; MPEP 2144.05(I)); the headrest configured to support the head of the subject in the supine position (support 7 for the patient’s head and/or neck when the patient is supine) (Hartman; Figs. 1-5); and a second pump configured to move the headrest in relation to the backrest wherein the second pump is configured to move the headrest 10 to 40 degrees in flexion anteriorly from a neutral position and 10 to 40 degrees in extension posteriorly from the neutral position (the second pump being the mechanism including a platform 17, linear actuators 19, and hinges 21 which is able to rotatably maneuver the support 7 for the patient’s head and/or neck, and thus affect their cervical spine; the movement can include sagittal flexion about an angle theta of -70 to 70 degrees forwards and backwards, thereby flexing and extending the head from a neutral position; with 0 degrees being a neutral position, flexion would be a positive angle forwards and extension would be a negative angle backwards) (Hartman; Figs. 1-5; para. [0046]; para. [0048]; para. [0052]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Badger in view of Hartman and Herman as applied to claim 6 above, and further in view of Clarke et al. (US 5,423,862).
Regarding claim 7, the modified Badger teaches the invention as previously claimed, but does not teach wherein the first pump is configured to move anteriorly and simultaneously the second pump is configured to move the headrest in flexion anteriorly, and the first pump is configured to retract posteriorly and simultaneously the second pump is configured to move the headrest in extension posteriorly.
However, Clarke teaches an orthopedic treatment apparatus (Clarke; abstract) wherein the first pump is configured to move anteriorly and simultaneously the second pump is configured to move the headrest in flexion anteriorly, and the first pump is configured to retract posteriorly and simultaneously the second pump is configured to move the headrest in extension posteriorly (the vertical cyclical motion of the platform 15 for flexion and extension of the lumbar region can be simultaneous with the vertical cyclical rotation of a head supporting portion for cervical flexion and extension, wherein each has their own mechanism for movement) (Clarke; Figs. 1-5; col. 3, lines 32-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Badger pumps such that the first pump is configured to move anteriorly and simultaneously the second pump is configured to move the headrest in flexion anteriorly, and the first pump is configured to retract posteriorly and simultaneously the second pump is configured to move the headrest in extension posteriorly, as taught by Clarke, for the purpose of enabling the device to treat a patient’s spinal column with a compound motion at specific regions (Clarke; col. 5, lines 18-35).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Badger in as applied to claim 10 above, and further in view of Herman.
Regarding claim 14, Badger discloses the invention as previously claimed, but is silent on wherein the pump is configured to move from 1 to 5 cm in an anterior direction.
However, Herman teaches a spinal column correction device (Herman; abstract) wherein a height of the lumbar curve portion is about 5.588 cm, which is close to the claimed 1 to 5 cm (lumbar curve portion 46 has a height of about 2.2 inches or about 5.588 cm; please note the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality) (Herman; Figs. 3-4, 15-20; para. [0016]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Badger stroke to be 1 to 5 cm, as taught by Herman and the MPEP, for the purpose of providing a specific stroke length to for the device to act on the user’s lumbar region to correct a user’s lumbar spinal column, and thereby help to provide back pain relief (Herman; para. [0047]).
With this modification, the modified Badger would thus teach wherein the pump is configured to move from 1 to 5 cm in an anterior direction (Badger pump mechanism would vertically move one of the massage elements 43-50 from a retracted position at 0 cm to an extended anterior position of about 5.588 cm as taught by Herman, which is close to the claimed non-critical range) (Badger, Fig. 1, col. 1 lines 35-53, col. 4 lines 36-43; Herman, Figs. 3-4, 15-20, para. [0016]; MPEP 2144.05(I)).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Badger in as applied to claim 10 above, and further in view of Sarti et al. (see attached “Response of the Flexion–Relaxation Phenomenon Relative to the Lumbar Motion to Load and Speed” article).
Regarding claim 16, Badger discloses the invention as previously claimed, including wherein a cycle time of the pump from the first position to the second position and back to the first position is configured to take between 10 and 15 seconds (the stoke of each piston in the cycle consumes approximately 15 seconds) (Badger; col. 7 lines 9-20), but is silent on an upward movement away from the home position of the lumbar flexure device configured to be 35% to 45% of the cycle time and a downward movement back to the home position configured to be 55% to 65% of the cycle time.
However, Sarti teaches a method of spinal trunk flexion-extension (Sarti; page E 421, left column, “Objective” section) including flexion for a duration of 3 to 8 seconds and extension for a duration of 3 to 8 seconds (trunk flexion and extension took 8 seconds each for the slow series, and 3 seconds each for the fast series) (Sarti; Fig. 2; page E 422, right column, third paragraph), which thus teaches 50% of the cycle time is for both flexion and extension. Moreover, the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality, and 50% is close to the claimed non-critical values of 35% to 45% and 55% to 65% of the cycle time.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Badger apparatus such that it provides flexion for a duration of 3 to 8 seconds and extension for a duration of 3 to 8 seconds, as taught by Sarti, for the purpose of providing a specific suitable time for a patient to experience spinal flexion and extension.
With this modification, the modified Badger would thus teach an upward movement away from the home position of the lumbar flexure device configured to be 35% to 45% of the cycle time and a downward movement back to the home position configured to be 55% to 65% of the cycle time (the modified Badger massaging elements 43-50 would by moved by the piston rod 62’ and pump mechanism upwards to provide spine flexion for half the cycle and back down for the other half of the cycle to provide spine extension as taught by Sarti; please note the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality; when both the flexion and extension times are the same, they will each constitute 50% of a cycle, which is close to the claimed non-critical values) (Badger, Figs. 1-2 and 4-6, col. 1 lines 35-53, col. 4 lines 27-50; Sarti, Fig. 2, page E 422, right column, third paragraph; MPEP 2144.05(I)).
Claims 19-20 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman as applied to claim 18 above, and further in view of Badger.
Regarding claim 19, as best understood, Hartman discloses the invention as previously claimed, but does not disclose further comprising: a moveable pad configured to apply pressure to a thoracolumbar region of the spinal column of the subject to pump the CSF system.
However, Badger teaches a massaging device (Badger; col. 1 lines 1-3) including a moveable pad configured to apply pressure to a thoracolumbar region of the spinal column of the subject to pump the CSF system (one of the massaging elements 43-50 that extends up to massage the subject’s spine at the thoracolumbar region and thereby pump the CSF system) (Badger; Figs. 1-2, 4-6; col. 1 lines 35-53; col. 4 lines 27-43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hartman second support to include a moveable pad configured to apply pressure to a thoracolumbar region of the spinal column of the subject to pump the CSF system, as taught by Badger, for the purpose of enabling the apparatus to provide a means for massaging the spine of a patient with massaging elements that fit the natural curve of the spine and which can adjust the pressure exerted by each massaging element (Badger; col. 1 lines 21-29, 45-53).
Regarding claim 20, the modified Hartman teaches wherein the moveable pad is configured to move in a direction perpendicular to a plane of the backrest (the massaging elements 43-50 would move up axially in a stroke in a direction perpendicular to the plane of the table’s surface) (Badger; Figs. 1-2, 4-6; col. 1 lines 35-53; col. 4 lines 27-43; col. 5 lines 40-46).
Regarding claim 40, the modified Hartman teaches further comprising: an aperture in the backrest, wherein the moveable pad is configured to extend through the aperture to pump the CSF system (opening 6 in the table through which the massaging elements 43-50 extend up to massage the subject) (Badger; Figs. 1-2; col. 1 lines 35-53; col. 2 line 55; col. 3 lines 1-5; col. 4 lines 36-43).
Regarding claim 41, as best understood, the modified Hartman teaches wherein the moveable pad is one of multiple moveable pads configured to move a spinal column of the subject in an anterior direction in different amounts (there are multiple massaging elements 43-50 configured to extend up to massage the subject; only one massaging element 43-50 applies pressure to the subject at a time; also, the amount of pressure exerted from each massaging element 43-50 can be individually adjusted, and so they can be different from each other) (Badger; Figs. 1-2, 4-6; col. 1 lines 25-29; col. 4 lines 7-62).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hartman in view of Badger as applied to claim 20 above, and further in view of Herman.
Regarding claim 21, the modified Hartman teaches the invention as previously claimed, but does not teach wherein the moveable pad is configured to have a stroke length from 1 to 5 cm.
However, Herman teaches a spinal column correction device (Herman; abstract) wherein a height of the lumbar curve portion is about 5.588 cm, which is close to the claimed 1 to 5 cm (lumbar curve portion 46 has a height of about 2.2 inches or about 5.588 cm; please note the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality) (Herman; Figs. 3-4, 15-20; para. [0016]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hartman apparatus’s moveable pad stroke to be 1 to 5 cm, as taught by Herman and the MPEP, for the purpose of providing a specific stroke length to for the device to act on the user’s lumbar region to correct a user’s lumbar spinal column, and thereby help to provide back pain relief (Herman; para. [0047]).
With this modification, the modified Hartman would thus teach the moveable pad is configured to have a stroke length from 1 to 5 cm (Badger pump mechanism would vertically move one of the massage elements 43-50 from a retracted position at 0 cm to an extended position of about 5.588 cm as taught by Herman, which is close to the claimed non-critical range) (Badger, Fig. 1, col. 1 lines 35-53, col. 4 lines 36-43; Herman, Figs. 3-4, 15-20, para. [0016]; MPEP 2144.05(I)).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hartman as applied to claim 18 above, and further in view of Sarti.
Regarding claim 23, Hartman discloses the invention as previously claimed, but does not disclose wherein the extension of the headrest away from the home position is configured to be 35% to 45% of a cycle time of the oscillation and the flexion of the headrest back to the home position will take 55% to 65% of the cycle time of the oscillation.
However, Sarti teaches a method of spinal trunk flexion-extension (Sarti; page E 421, left column, “Objective” section) including flexion for 50% of a cycle time and extension for 50% of the cycle time (trunk flexion and extension took 8 seconds each for the slow series, and 3 seconds each for the fast series, thus both being 50% of the cycle time; please note the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality, and 50% is close to the claimed ranges of 35% to 45% and 55% to 65%) (Sarti; Fig. 2; page E 422, right column, third paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hartman apparatus such that it provides flexion for 35% to 45% of a cycle time and extension for 55% to 65% of the cycle time, as taught by Sarti and the MPEP, for the purpose of providing a specific suitable time for a patient to experience spinal flexion and extension.
With this modification, the modified Hartman would thus teach wherein the extension of the headrest away from the home position is configured to be 35% to 45% of a cycle time of the oscillation and the flexion of the headrest back to the home position will take 55% to 65% of the cycle time of the oscillation (the modified Hartman manipulator 11 mechanism including a platform 17, linear actuators 19, and hinges 21 able to rotatably maneuver the support 7 for the patient’s head for sagittal flexion about an angle theta forwards and backwards, thereby flexing and extending the head from a neutral position; the sagittal flexion upwards would be for half the cycle and the sagittal extension downwards would be the other half of the cycle as taught by Sarti; please note the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality; when both the flexion and extension times are the same, they will each constitute 50% of a cycle, which is close to the claimed non-critical values) (Hartman, Figs. 1-5, para. [0046], para. [0048]; Sarti, Fig. 2, page E 422, right column, third paragraph; MPEP 2144.05(I)).
Claims 25, 27-28, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Badger in view of Hartman and Clarke.
Regarding claim 25, Badger discloses an apparatus (massaging device) (col. 1 lines 1-3) comprising:
a frame (lower body of table 2 and/or frame 99) (Figs. 1-5; col. 2 lines 48-51; col. 7 lines 21-31);
a first support coupled to the frame (lower body of table 2 and/or frame 99 are both coupled to the top surface of table 2) (Figs. 1-5; col. 2 lines 48-51; col. 7 lines 21-31), the first support configured to support a body of the subject in a supine position (the top surface of the table 2 upon which the subject lies supine on their back) (Fig. 1);
a cerebrospinal fluid pump attached to the frame, the cerebrospinal fluid pump configured to move with respect to the support along a linear actuation axis between a retracted position and an extended position (the hydraulic mechanism with oil in cylinder 31 acts upon a piston 39 to move it, which then linearly moves along an axis the connected piston rod 62’ and a massaging element 43-50 up and down with respect to the lower body of table 2 and/or frame 99 against a user’s spine to thereby change its CSF dynamics) (Figs. 1-6; col. 1 lines 45-53; col. 4 lines 18-58);
a control system configured to control an oscillation of a movement between a first position to a second position of the cerebrospinal fluid pump (prime mover 11, belt 52, gear box 53, shaft 54, switch 55, and rotor 28 used to move the pump pistons up and down for the massage; additionally, a control panel 7 with knob 66’ can be rotated to control the amount of pressure that each individual massaging element exerts) (Figs. 3, 5-6; col. 3 lines 5-6; col. 4 lines 18-35, 51-75).
Badger does not disclose a second support coupled to the frame, the second support configured to support a head of the subject in the supine position and to rotate with respect to the first support about a rotation axis.
However, Hartman teaches an apparatus for manipulating a body part (Hartman; abstract) including a second support coupled to the frame, the second support configured to support a head of the subject in the supine position and to rotate with respect to the first support about a rotation axis (support 7 is coupled to second support 9 via the manipulator 11; manipulator 11 mechanism including a platform 17, linear actuators 19, and hinges 21 which is able to rotatably maneuver the support 7 for the supine patient’s head and/or neck about an axis, and thus affect their cervical spine) (Hartman; Figs. 1-5; para. [0009]; paras. [0045-0046]; para. [0048]; para. [0052]; para. [0070]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Badger device to include a second support coupled to the frame, the second support configured to support a head of the subject in the supine position and to rotate with respect to the first support about a rotation axis, as taught by Hartman, for the purpose of providing a means to apply dynamic physiotherapy to the head, neck, and/or shoulders (Hartman; para. [0001]).
Badger does not disclose the control system is configured to simultaneously control an oscillation of a movement between a first position to a second position of the cerebrospinal fluid pump and a rotation from a first position to a second position of the second support, wherein the rotation is between posterior extension and anterior flexion.
However, Clarke teaches an orthopedic treatment apparatus (Clarke; abstract) including the control system configured to simultaneously control an oscillation of a movement between a first position to a second position of the cerebrospinal fluid pump and a rotation from a first position to a second position of the second support, wherein the rotation is between posterior extension and anterior flexion (control 25 controls the movements of the platforms; the vertical cyclical motion of the platform 15 for flexion and extension of the lumbar region can be simultaneous with the vertical cyclical rotation of a head supporting portion for cervical flexion and extension, wherein each has their own mechanism for movement) (Clarke; Figs. 1-5; col. 3, lines 11-18, 32-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Badger control system such that the control system is configured to simultaneously control an oscillation of a movement between a first position to a second position of the cerebrospinal fluid pump and a rotation from a first position to a second position of the second support, wherein the rotation is between posterior extension and anterior flexion, as taught by Clarke, for the purpose of enabling the device to treat a patient’s spinal column with a compound motion at specific regions (Clarke; col. 5, lines 18-35).
Regarding claim 27, the modified Badger teaches wherein the rotation axis is oriented orthogonal to the actuation axis (the Hartman rotation axis for the support 7 would be orthogonal to the linear axis for the vertical movement of the Badger massaging elements 43-50 with the hydraulic pump mechanism) (Badger; Figs. 1-2, 4-6, col. 1 lines 35-53, col. 4 lines 36-43; Hartman, Figs. 1-5, para. [0046], para. [0048], para. [0052]).
Regarding claim 28, the modified Badger teaches comprising: a first orientation wherein the cerebrospinal fluid pump is in the retracted position and the second support is oriented at a first angle to the first support; and a second orientation wherein the cerebrospinal fluid pump is in an intermediate position and the second support is oriented at a second angle to the first support, the second angle being greater than the first angle (considering the simultaneous flexion/extension movements taught by Clarke, when the modified Badger massaging element 43-50 with its respective cylinder 31, piston 39, and piston rod 62’ is retracted down, the Badger table 2/Hartman support 7 would be oriented at an angle of about 0 degrees; when the modified Badger massaging element 43-50 with its respective cylinder 31, piston 39, and piston rod 62’ is moved up, the rotating Hartman support 7 would be oriented at an angle greater than 0 degrees) (Badger, Figs. 1-6, col. 1 lines 25-29 and 35-53, col. 4 lines 7-62; Hartman, Figs. 1-5, para. [0046], para. [0048], para. [0052]; Clarke, Figs. 1-5, col. 3 lines 11-18, 32-50).
Regarding claim 42, the modified Badger teaches wherein the cerebrospinal fluid pump is one of multiple cerebrospinal fluid pumps configured to move a spinal column of a subject in an anterior direction (there are multiple cylinders 31, pistons 39, and piston rods 62’, one for each massaging element 43-50, used to message the subject’s spinal column by moving upwards to apply pressure, and thereby moving the spinal column up in an anterior direction) (Badger; Figs. 1-2, 4-6; col. 1 lines 35-53; col. 2 line 55; col. 3 lines 1-5; col. 4 lines 36-43).
Regarding claim 43, as best understood, the modified Badger teaches wherein the one of the multiple cerebrospinal fluid pumps in the middle of two outside of the multiple cerebrospinal fluid pumps is configured move to the spinal column of the subject a movement that that is larger than the two outside of the multiple cerebrospinal fluid pumps (one of the massaging element 43-50 with its respective cylinder 31, piston 39, and piston rod 62’ can be in the middle of others; only one massaging element 43-50 moves to apply a pressure to the subject at a time, and so the one applying pressure is moving the spinal column in a movement greater than the others; additionally or alternatively, the amount of pressure exerted from each massaging element 43-50 can be individually adjusted by adjusting the amount of distance they can move, and so some can be greater than others) (Badger; Figs. 1-2, 4-6; col. 1 lines 25-29, 35-53; col. 4 lines 7-62).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Badger in view of Hartman and Clarke as applied to claim 25 above, and further in view of Sarti.
Regarding claim 30, the modified Badger teaches wherein the cerebrospinal fluid pump is configured to oscillate between an upward movement away from a home position that is configured to be 35% to 45% of a cycle time and a downward movement back to the home position that is configured to be 55% to 65% of the cycle time.
However, Sarti teaches a method of spinal trunk flexion-extension (Sarti; page E 421, left column, “Objective” section) including flexion for 50% of a cycle time and extension for 50% of the cycle time (trunk flexion and extension took 8 seconds each for the slow series, and 3 seconds each for the fast series, thus both being 50% of the cycle time; please note the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality, and 50% is close to the claimed ranges of 35% to 45% and 55% to 65%) (Sarti; Fig. 2; page E 422, right column, third paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Badger apparatus such that it provides flexion for 35% to 45% of a cycle time and extension for 55% to 65% of the cycle time, as taught by Sarti and the MPEP, for the purpose of providing a specific suitable time for a patient to experience spinal flexion and extension.
With this modification, the modified Badger would thus teach wherein the cerebrospinal fluid pump is configured to oscillate between an upward movement away from a home position that is configured to be 35% to 45% of a cycle time and a downward movement back to the home position that is configured to be 55% to 65% of the cycle time (the modified Badger massaging elements 43-50 would by moved by the piston rod 62’ and pump mechanism upwards to provide spine flexion for half the cycle and back down for the other half of the cycle to provide spine extension as taught by Sarti; please note the MPEP 2144.05(I) explains that prior art teaching a range close to a claimed range is obvious without any showing of unexpected results or criticality; when both the flexion and extension times are the same, they will each constitute 50% of a cycle, which is close to the claimed non-critical values) (Badger, Figs. 1-2 and 4-6, col. 1 lines 35-53, col. 4 lines 27-50; Sarti, Fig. 2, page E 422, right column, third paragraph; MPEP 2144.05(I)).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Badger in view of Hartman as applied to claim 1 above, and further in view of Pilates Encyclopedia (see “How Your Breath Moves Your Spine” article attached).
Regarding claim 31, the modified Badger teaches the invention as previously claimed, but does not teach wherein the oscillation of the pump is configured to gait a breathing pattern of the subject with the flexion and extension of the subject.
However, Pilates Encyclopedia teaches a method of flexing and extending the spine (Pilates Encyclopedia; page 2, first paragraph) wherein the method is configured to gait a breathing pattern of the subject with the flexion and extension of the subject (inhalation naturally extends the spine while exhalation naturally flexes the spine) (Pilates Encyclopedia; page 2, first paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Badger oscillation of the pump such that it is configured to gait a breathing pattern of the subject with the flexion and extension of the subject, as taught by Pilates Encyclopedia, for the purpose of using the natural tendency to help a patient perform a desired flexion and/or extension movement (Pilates Encyclopedia; page 2, first paragraph).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Badger in as applied to claim 10 above, and further in view of Hartman and Clarke.
Regarding claim 33, Badger discloses the invention as previously claimed, but does not disclose further comprising: a cervical flexure device configured to move the cervical region of the spinal column about a rotation axis anteriorly in flexion 10 to 40 degrees from a neutral position to a flexion position and posteriorly in extension 10 to 40 degrees from the neutral position to an extension position, wherein the controller is configured to simultaneously move the lumbar flexure device the span of the length back to the home position and rotate the cervical flexure device anteriorly from the extension position to the flexion position for the second position and simultaneously move the lumbar flexure device from the home position the span of the length and rotate the cervical flexure device posteriorly from the flexion position to the extension position for the first position.
However, Hartman teaches an apparatus for manipulating a body part (Hartman; abstract) including a cervical flexure device configured to move the cervical region of the spinal column about a rotation axis anteriorly in flexion 10 to 40 degrees from a neutral position to a flexion position and posteriorly in extension 10 to 40 degrees from the neutral position to an extension position (mechanism including a platform 17, linear actuators 19, and hinges 21 which is able to rotatably maneuver the support 7 for the patient’s head and/or neck relative to second support 9, and thus affect their cervical spine; the movement can include sagittal flexion about an angle theta of -70 to 70 degrees forwards and backwards, thereby flexing and extending the head from a neutral position; with 0 degrees being a neutral position, flexion would be a positive angle forwards and extension would be a negative angle backwards) (Hartman; Figs. 1-5; para. [0046]; para. [0048]; para. [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Badger device to include a cervical flexure device configured to move the cervical region of the spinal column about a rotation axis anteriorly in flexion 10 to 40 degrees from a neutral position to a flexion position and posteriorly in extension 10 to 40 degrees from the neutral position to an extension position, as taught by Hartman, for the purpose of providing a means to apply dynamic physiotherapy to the head, neck, and/or shoulders (Hartman; para. [0001]).
However, Clarke teaches an orthopedic treatment apparatus (Clarke; abstract) wherein the controller is configured to simultaneously move the lumbar flexure device the span of the length back to the home position and rotate the cervical flexure device anteriorly from the extension position to the flexion position for the second position and simultaneously move the lumbar flexure device from the home position the span of the length and rotate the cervical flexure device posteriorly from the flexion position to the extension position for the first position (the vertical cyclical motion of the platform 15 for flexion and extension of the lumbar region of a length can be performed simultaneously or alternately with the vertical cyclical rotation of a head supporting portion for cervical flexion and extension, wherein each has their own mechanism for movement) (Clarke; Figs. 1-5; col. 3, lines 32-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Badger controller to be configured to simultaneously move the lumbar flexure device the span of the length back to the home position and rotate the cervical flexure device anteriorly from the extension position to the flexion position for the second position and simultaneously move the lumbar flexure device from the home position the span of the length and rotate the cervical flexure device posteriorly from the flexion position to the extension position for the first position, as taught by Clarke, for the purpose of enabling the device to treat a patient’s spinal column with a compound motion at specific regions (Clarke; col. 5, lines 18-35).
Double Patenting
Claims 1-2, 10, 14, 17-19, and 40 of this application are patentably indistinct from claims 34, 37-38, 41, and 48 of copending Application No. 18/124,388. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 10, 14, 17-19, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 37-38, 41, and 48 of copending Application No. 18/124,388, hereinafter ‘388, in view of Splane.
Regarding claim 1, ‘388 discloses an apparatus comprising: a pump configured in a pumping state to change dynamics of a cerebrospinal fluid (CSF) system of a subject as compared to the dynamics of the CSF in a non-pumping state, wherein the pump is configured to provide an anterior flexion and a posterior extension of a spinal column of the subject (a pump adjacent to the CSF system of a subject, and which oscillates to change a cervical curvature of the spine; an oscillation would have back and forth movements, and so would provide flexion and extension; when not oscillating, the pump would not be affecting the CSF fluid dynamics) (‘388; claims 41, 48); a support configured to support the subject in a supine position, wherein the support comprises: a backrest configured to support a back of the subject (a back rest configured to support the back of the subject, which would thereby support the subject when supine) (‘388; claim 48), and a headrest configured to support a head of the subject, wherein the headrest is configured to rotate with respect to the backrest about a rotation axis (a headrest to support a head of the subject, and which is rotated by the oscillating pump) (‘388; claim 41); and a control system configured to control the pumping state in an oscillation between the anterior flexion and the posterior extension of the spinal column of the subject (pump oscillates to change the cervical spinal curvature, and so there must be a means to control the pump to perform the oscillation) (‘388; claim 41).
Alternatively, if ‘388 is not seen as definitively disclosing a control system configured to control the pumping state, Splane teaches a passive motion treatment apparatus (Splane; abstract) including a control system configured to control the pumping state (control unit 28 for operating the mechanisms to move a subject’s body parts) (Splane; para. [0048]; para. [0080]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘388 apparatus to include a control system configured to control the pumping state, as taught by Splane, for the purpose of providing a smooth controlled movement of a body support unit (Splane; para. [0080]).
Regarding claim 2, the modified ‘388 teaches wherein the support comprises a backrest configured to support the back of the subject, further comprising: an aperture in the backrest; and a moveable pad configured to extend through the aperture to pump the CSF system (a back rest configured to support a back of the subject has an aperture from which the pressure pad is extended to change the lumbar curvature of the spinal column) (‘388; claim 48).
Regarding claim 10, ‘388 discloses an apparatus comprising: a pump configured in a pumping state to oscillate between a first position and a second position to change dynamics of a cerebrospinal fluid (CSF) system of a subject as compared to the dynamics of the CSF in a non-pumping state (pump oscillates to change the lumbar curvature of a spinal column of a subject, which would thereby flex and extend the lumbar curvature and change the dynamics of the CSF; as there is an oscillation of the pump, there would be at least two positions for the pump which it moves between) (‘388; claims 33-34); a lumbar flexure device configured to provide pressure to a spinal column of the subject in a supine position, wherein in a home position the lumbar flexure device is configured to touch the subject in the first position and in a span of a length from the home position along a linear actuation axis the lumbar flexure device is configured to apply pressure to the spinal column in the second position (pump oscillates the pressure pad, which is used to change the lumbar curvature when supporting a patient’s back, between at least two positions; because of the pump oscillation moving the pressure pad, one position would be a home position in which the pressure pad is fully retracted to provide a minimum pressure to the lumbar region and another position would be when the pressure pad is extended a length by the pump to apply a maximum pressure to the lumbar region) (‘388; claims 33-34) and a controller configured to control the pumping state between the first position and the second position (pump oscillates between positions, and so there must be a means to control the pump to perform the oscillation) (‘388; claims 33-34).
Alternatively, if ‘388 is not seen as definitively disclosing a controller configured to control the pumping state, Splane teaches a passive motion treatment apparatus (Splane; abstract) including a controller configured to control the pumping state (control unit 28 for operating the mechanisms to move a subject’s body parts) (Splane; para. [0048]; para. [0080]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘388 apparatus to include a controller configured to control the pumping state, as taught by Splane, for the purpose of providing a smooth controlled movement of a body support unit (Splane; para. [0080]).
Regarding claim 14, the modified ‘388 teaches wherein the pump is configured to move from 1 to 5 cm in an anterior direction (‘388; claim 37).
Regarding claim 17, the modified ‘388 teaches the lumbar flexure device further comprising: a shaft; and a pressure pad coupled to the shaft, wherein the pump is configured to move the pressure pad back and forth in an axial direction (pressure pad has a stroke length, and so is implied to have a shaft on the pump to axially move the pressure pad the stroke length distance) (‘388; claims 37-38).
Regarding claim 18, ‘388 discloses an apparatus comprising: a headrest configured to support a head of a subject in a supine position (a headrest for supporting a head of the subject) (‘388; claim 41); a backrest configured to support a back of the subject in the supine position (a back rest for supporting a back of the subject) (‘388; claim 48), wherein the backrest is coupled to the headrest to rotate about a rotation axis (a pump is oscillated to rotate the headrest, and so the headrest would move about a rotation axis) (‘388; claim 41); a pump configured for an oscillation of the headrest configured to rotate between a posterior extension from a neutral position and an anterior flexion from a neutral position in a pumping state to change dynamics of a cerebrospinal fluid (CSF) system of a subject as compared to the dynamics of the CSF in a non-pumping state wherein the neutral position is at a transition from the flexion to the extension of the headrest (a pump is oscillated to rotate the headrest; as there is a back and forth oscillation of the pump, there would be an anterior position, a posterior position, and a middle neutral/non-pumping position between them, through which the pump cycles to change the cervical curvature of the spinal column) (‘388; claims 41, 48); and a control system configured to control the oscillation of the pump between the posterior extension and the anterior flexion (pump oscillates to change the cervical spinal curvature, and so there must be a means to control the pump to perform the oscillation) (‘388; claim 41).
Alternatively, if ‘388 is not seen as definitively disclosing a control system configured to control the pumping state, Splane teaches a passive motion treatment apparatus (Splane; abstract) including a control system configured to control the pumping state (control unit 28 for operating the mechanisms to move a subject’s body parts) (Splane; para. [0048]; para. [0080]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘388 apparatus to include a control system configured to control the pumping state, as taught by Splane, for the purpose of providing a smooth controlled movement of a body support unit (Splane; para. [0080]).
Regarding claim 19, the modified ‘388 teaches further comprising: a moveable pad configured to apply pressure to a thoracolumbar region of the spinal column of the subject to pump the CSF system (a pressure pad is moved by a second pump to change the lumbar curvature of the spinal column) (‘388; claim 48).
Regarding claim 40, the modified ‘388 teaches further comprising: an aperture in the backrest, wherein the moveable pad is configured to extend through the aperture to pump the CSF system (a back rest has an aperture from which the pressure pad is extended to change the lumbar curvature of the spinal column) (‘388; claim 48).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/3/2025 have been fully considered but they are not persuasive.
On page 11 in the “Claim Objections” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the claim objections of the previous office action. The Examiner agrees, and has thus withdrawn those claim objections. However, the newly amended claims raise a new claim objection as detailed above.
On pages 11-12 in the “Claim Rejections - Double Patenting” section of the Applicant’s remarks, the Applicant mentions that any discussion of double patenting issues will be addressed when the claims are allowed, and as such no arguments are currently being set forth. As such, there remain double patenting rejections of the claims as detailed above.
On page 12 in the “Claim Rejections - 35 U.S.C. 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those rejections. However, the newly amended claims raise new 35 U.S.C. 112(b) rejections as detailed above.
Applicant’s arguments on pages 15-18 in the Applicant’s remarks with respect to the Greissing and Splane references have been considered but are moot in view of new grounds of rejection with new additional Badger reference being used in the current rejection as discussed above.
On page 16 in the first paragraph and page 17 in the second paragraph of the Applicant’s remarks, the Applicant argues that Hartman does not disclose the headrest is configured to rotate with respect to the backrest about a rotation axis as recited in claim 1, because the Hartman apparatus can also provide translational motion when performing sagittal flexion. However, the Examiner respectfully disagrees. Firstly, the Applicant’s claimed invention does not preclude the headrest from being able to move translationally as well as rotationally. Secondly, Hartman para. [0054] recites, “the manipulator 11 may maneuver the body part 5 in a volume spanned by the combination of translation and rotation range of motion”, para. [0009] recites, “…manipulator providing controlled positioning of the support in six degrees of freedom (three mutually perpendicular directions of translation (X, Y, Z) and three degrees of rotation about the directions of translation (roll, pitch, yaw)) allows performing complex motions and trajectories with the support. A solid angle spanned by plane angles (.theta., .phi., .rho.) in mutually perpendicular directions of approx. (45.degree., 45.degree., 45.degree.) allows access to the range of motion of the head of a normal, healthy and pain-free human…”, and para. [0048] recites, “sagittal flexion and coronal tilt involve both rotation and translation”. Thus, the Hartman manipulator 11 is capable of performing rotation. In particular, the Hartman manipulator 11 would be able to rotate or tilt the support 7 about an axis to achieve an angle theta with respect to the second support 9 for sagittal flexion, and so involve rotation (Hartman; Figs. 1-5; para. [0046]; para. [0048]; para. [0052]). Thus, the current prior art can still be used to teach the invention as currently claimed.
On page 17 in the second paragraph of the Applicant’s remarks, the Applicant argues that Hartman does not disclose wherein the backrest is coupled to the headrest to rotate about a rotation axis as recited in claim 18, as Hartman discloses translational motion when treating flexion. However, the Examiner respectfully disagrees. As previously explained above, Hartman can use both translation and rotation motions to achieve the angle theta for sagittal flexion and so can be used to teach the Applicant’s claimed invention, as the Applicant’s claimed invention does not preclude the headrest from being able to move translationally. Moreover, Hartman para. [0045] recites, “a manipulator 11 is connected to the support 7 for supporting and maneuvering the support 7” and para. [0070] recites, “the manipulator 11 is placed in a desired position, possibly connected to a coupling on the treatment space floor and/or attached to the second support 9”. Thus, the support 7 can be coupled to second support 9 via the manipulator 11. Thus, the current prior art can still be used to teach the invention as currently claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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