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 Group I, Species corresponding to Figs. 5, 10A-B in the reply filed on 4/15/2026 is acknowledged.
Claim Objections
Claim 31 is objected to because of the following informalities: the limitation “oscillating the headrest is configured to provide flexion” should be “oscillating the headrest to provide flexion…” Claim 32 contains the same defect. 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 22, 31, 41-48 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 22, the limitation “improving CSF dynamics” renders the claim indefinite because its unclear what constitutes an improvement in CSF dynamics. The specification nominally recites the term without explanation and thus its unclear what improvements to CSF dynamics are necessary to anticipate the claim limitation.
Regarding claim 31, the limitation “the pump is characterized as a headrest configured to support a head of the subject” renders the claim indefinite because its unclear how the pump can be characterized as a headrest and previously stated to be positioned adjacent to a CSF system to change the spinal curvature of the subject. Claim 41 contains a similar recitation.
Regarding claim 41, the limitation “a spinal column of the subject” renders the claim indefinite because its unclear whether this is the same as recited in claim 21 or not.
Regarding claim 48, the limitation “the pump is characterized as a first pump, further comprising activating a second pump to extend a pressure pad away from an aperture of a back rest…” renders the claim indefinite because its unclear how many pumps are being claimed. Claim 41 recites a pump for cervical movement but is now dependent on claim 21 which recites a pump for lumbar movement. Its unclear whether the pump claimed in 41 and 21 are the same, whether the second pump is the same as that of claim 21 or not.
Claims dependent thereon are rejected for the same reasons.
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.
(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) 21-24, 29, 33 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cho US 2023/0054542.
Regarding claim 21, Cho discloses a spine exercise equipment, the normal operation of which yields the step of a method comprising: positioning a pump 43, 50, 48 adjacent to the cerebrospinal fluid (CSF) system of a subject; and oscillating the pump configured to cause oscillatory changes in a curvature of a spinal column of the subject, see para. [0032] stating that the rotator 48 causes the frames 42 to undulate in a wave motion, the undulation of which causes oscillatory changes in a curvature of the spine of the subject shown in fig. 3.
Regarding claim 22, Cho discloses the step of affecting in the subject one or more of the following: improving CSF system dynamics; increasing CSF system flux; increasing CSF system flow; changing pressure in the CSF system; increasing hydrostatic pressure of the CSF system; creating peristaltic fluid motion in the CSF system; improving glymphatic clearance; increasing CSF flow in peri-arterial pathways; increasing CSF flow in peri-venous pathways; and increasing flow to a lymphatic system. Cho discloses an apparatus that alters the curvature of the spine in an oscillatory manner as claimed where the oscillations in the curvature would improve and increase CSF system flow and the remaining limitations. The Applicant’s specification states that the increase or improvement in the claims functions is a result of the oscillations in the curvature of the spine. See for example para. [0025]. Since Cho teaches the oscillation of the curvature of the spine, the functions claimed would inherently follow.
Regarding claim 23, Cho discloses treating the subject by one or more of; reducing neuroinflammation; improving a symptom of a stroke, improving a symptom of traumatic brain injury, improving a symptom of neurodegenerative disease; improving posture; and improving a symptom of Alzheimer’s disease. Cho teaches the step of oscillating the curvature of the spine which results in the increase in CSF flux and other functions as claimed. Referring to the Applicant’s specification at para. [0029] for example, the improvement of the symptoms of a stroke are accomplished by changing the curvature of the spinal column and increasing the CSF flow.
Regarding claim 24, Cho discloses increasing one or more of speed, efficacy, or delivery of drugs in one or both of CSF or blood. Cho discloses the CSF pump as claimed where a subject taking medication would yield the steps on increasing the speed, efficacy or deliver of drugs in one or both of CSF or blood.
Regarding claim 29, Cho discloses cycling the pump of a cycle time with a movement away from a home position of the pump that will take about 50% of the cycle time and a movement back to the home position that will take 50% of the cycle time. Referring to fig. 3 for example, the system operates by a motor which makes a revolution to change the position of the asymmetric rotator 48, when a point a rotator is chosen, the system will rotate away from the point for half the time and rotate back to the point the other half of the time.
Regarding claim 33, Cho discloses positioning the pump outside of a body of the subject and oscillating the pump configured to change a lumbar curvature of a spinal column of the subject. See sections 48a, 48b.
Claim(s) 21-24, 29, 31-34, 36, 40, 41, 48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tamura US 3,596,654.
Regarding claim 21, Tamura discloses an apparatus, the normal operation of which yields the method comprising; positioning a pump 26 adjacent to the cerebrospinal fluid (CSF) system of a subject; and oscillating the pump configured to cause oscillatory changes in a curvature of a spinal column of the subject, see col. 2, lines 36-48.
Regarding claims 22-24, referring to the discussion in claims 22-24 of Cho above, Tamura discloses the CSF pump where the normal operation of which would yield the claimed steps.
Regarding claim 29, Tamura discloses cycling the pump of a cycle time with a movement away from a home position of the pump that will take about 50% of the cycle time and a movement back to the home position that will take 50% of the cycle time. Tamura shows the motor 8 cycles the wheel 31 regularly and thus will cycle away and back to a home position equally.
Regarding claim 31, Tamura discloses the pump is characterized as a headrest configured to support a head of the subject, further comprising: oscillating the headrest is configured to provide flexion of the head in a range of 10 to 40 degrees away from a neutral position. Tamura teaches the pump includes a headrest 47 to support the head of the subject as shown in fig. 3, and is oscillated in flexion in the range of 10-40 degrees away from the natural position, as shown in fig 4.
Regarding claim 32, Tamura discloses the pump is characterized as a headrest configured to support a head of the subject, further comprising: oscillating the headrest is configured to provide extension of the head in a range of 10 to 40 degrees away from a neutral position. Tamura teaches the pump includes a headrest 47 to support the head of the subject as shown in fig. 3, and is oscillated in extension in a range of 10-40 degrees from neutral as shown in fig. 4 where the head rest is denoted by the arrow going the opposite direction.
Regarding claim 33, Tamura discloses positioning the pump 26 outside of a body of the subject, see fig. 3, and oscillating the pump configured to change a lumbar curvature of a spinal column of the subject. The pump 26 is positioned at the lumbar curvature of the spinal column.
Regarding claim 34, Tamura discloses activating the pump to extend a pressure pad 26 away from an aperture of a back rest 7 configured to support a back of the subject, and the pressure pad is configured to change the lumbar curvature of the spinal column. See fig. 2 the pad 26 and the pump assembly 25, 28, 31, etc. extend through an aperture in the back rest 7.
Regarding claim 36, Tamura discloses moving the pressure pad between a first position in an aperture of the back rest and a second position extended away from the aperture. The pressure pad 26 oscillated when the wheel 31 is rotated so that the bar 25 reaches a most extended position, i.e. the second position, and a most retracted position, i.e. a first position.
Regarding claim 40, Tamura discloses the pump is characterized as a first pump, further comprising positioning a second pump 49, 48, 40, etc. outside of the body of the subject, see fig. 3, and adjacent to the CSF system of the subject; and oscillating the second pump configured to rotate a headrest 47 configured to support a head of the subject, see fig. 3, wherein rotation of the second pump is configured to change the cervical curvature of the spinal column of the subject, the oscillation of the head rest 47 changes the neck curvature from side to side.
Regarding claim 41, Tamura discloses positioning the pump outside of a body of the subject and adjacent to the cerebrospinal fluid (CSF) system of the subject; supporting a head of the subject on a headrest; and oscillating the pump to rotate the headrest to change a cervical curvature of a spinal column of the subject. Referring to claim 40, Tamura discloses all elements.
Regarding claim 48, Tamura discloses the pump is characterized as a first pump, further comprising: activating a second pump to extend a pressure pad away from an aperture of a back rest configured to support a back of the subject, and the pressure pad is configured to change the lumbar curvature of the spinal column. As best understood, referring to claims 21 and 34, Tamura discloses all elements.
Claim(s) 21, 33-34, 37-38, 41-45 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jang KR 10-1524404.
Regarding claim 21, Jang discloses a method comprising: positioning a pump 171, adjacent to the cerebrospinal fluid (CSF) system of a subject, see fig. with the User U; and oscillating the pump configured to cause oscillatory changes in a curvature of a spinal column of the subject, stating to treat spinal stenosis, the lumbar support 171 is lowered so that the rise and fall are repeated.
Regarding claim 33, Jang discloses positioning the pump 171 outside of a body of the subject and oscillating the pump configured to change a lumbar curvature of a spinal column of the subject, see fig. 1 showing 171 positioned at the lumbar section of the spinal column and claim 21 stating the repeated movement.
Regarding claim 34, Jang discloses activating the pump to extend a pressure pad away from an aperture of a back rest configured to support a back of the subject, and the pressure pad is configured to change the lumbar curvature of the spinal column. The aperture is between the back rests 112, 113 and the pressure pad 171 is extended to change the curvature of the lumbar.
Regarding claims 37-38, Jang discloses the pressure pad stroke length is between 40-60mm.
Regarding claim 41, Jang discloses positioning the pump outside of the body of the subject and adjacent to the cerebrospinal fluid (CSF) system of the subject, see fig. 1, supporting a head of the subject on a headrest 148a, 137; and oscillating the pump to rotate the headrest to change a cervical curvature of a spinal column of the subject, see figs. 6b, 7b, 8a-b showing element 148b moving forward and backward.
Regarding claims 42-45, Jang discloses rotating the pump in an upward/anterior direction to provide a flexion movement to the head of the subject, rotating the pump in a downward/posterior direction to provide an extension movement of the head of the subject, see fig. 3 shown the upward direction of 138, and a downward direction shown in fig. 7b.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 26-28, 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho or Tamura in view of Niederkofler US 2018/0353375.
Regarding claims 26-28, Cho or Tamura discloses all elements but does not state the frequency of oscillations.
Niederkofler teaches a mattress massage system where the frequency of the oscillations can be between 0.1-3Hz, in particular 1 Hz (.33-10 seconds) to produce the desired massage effect. See para. [0013]. At .1 Hz, the cycling of the pump would take 10 seconds, and since the systems of Cho and Tamura are regularly cyclical, the system would move anteriorly and posteriorly for 5 seconds.
It would have been obvious to an ordinary skilled worker to provide a oscillation frequency 0.1-3 Hz in the systems of Cho OR Tamura, as taught by Niederkofler in order to provide a desired massage effect. Id.
Regarding claim 46-47, Tamura, in view of Niederkofler, discloses all elements as discussed in claims 26-28 above.
Regarding claims 37-38, Tamura or Cho discloses all elements but does not expressly state that the pressure stroke is 1-5 cm or 50 mm such that the apparatus is operated to extend the pressure pad a stroke length of 1-5 cm or 50 mm configured to extend the lumbar curvature of the spinal column of the subject. Tamura, Cho, and Niederkofler all teach a similar actuator to produce a similar axial translation but do not discuss the translation distance.
Niederkofler teaches a similar actuator where the pressure pad extends a distance shown in figs. 7B-7C shown at about CF1. The displacement of the massage actuator defines the intensity of the massaging force. See para. [0014]. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In order to properly support a rejection on the basis that an invention is the result of “routine optimization”, the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017) (“Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’”); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) (“[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .”).
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because “obvious to try” is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that “obvious to try” was a valid rationale for an obviousness finding, for example, when there is a “design need” or “market demand” and there are a “finite number” of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 (“The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.”). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. Since Niederkofler teaches the local displacement defines the massaging force, the distance that the actuator displaces is thus a result effective variable that controls the intensity of the massage. Thus, an ordinary skilled worker would have found it obvious to provide a displacement of 50mm to provide a desired massaging force.
Allowable Subject Matter
Claims 25, 30, 35, 39 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 25, the prior art does not teach or disclose lowering brain wave activity of the subject to less than beta frequency.
Regarding claims 30, 35, 39, the prior art does not teach or disclose the asymmetric pump movement as claimed.
The Examiner notes the counterpart opinions filed herein, however the references cited do not appear to disclose the brain wave activity or asymmetric movement of the pump.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
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/GERALD L SUNG/Primary Examiner, Art Unit 3741
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