DETAILED ACTION
This is the initial Office action for non-provisional application 18/498,095 filed October 31, 2023, which claims priority form provisional application 63/381,985 filed November 2, 2022. Claims 1-18, as originally filed, are currently pending.
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 . 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.
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 3-7 and 11-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “said inflatable bladder”; however, since claim 1 previously recites “at least one inflatable bladder”, it is unclear whether or not “said inflatable bladder” is of the “at least one inflatable bladder”. For examination purposes, the limitation “said inflatable bladder” has been interpreted as “said at least one inflatable bladder”.
Claims 4 and 6 each recite the limitations “the thoracic region of the brace” and “the lumbar region of the brace”; however, there is insufficient antecedent basis for these limitations in the claims. For examination purposes, the limitations “the thoracic region of the brace” and “the lumbar region of the brace” have been interpreted as “a thoracic region of the brace” and “a lumbar region of the brace”, respectively.
Claims 5 and 7 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claims 4 and 6.
Claim 11 recites the limitation “said inflatable bladder” in line 8; however, since claim 11 previously recites “at least one inflatable bladder” in line 6, it is unclear whether or not “said inflatable bladder” is of the “at least one inflatable bladder”. For examination purposes, the limitation “said inflatable bladder” has been interpreted as “said at least one inflatable bladder”.
Claims 12-18 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claim 11.
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 1-3, 8, 9, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lou et al. (US 2011/0230806).
Regarding claims 1, 3, 11, and 12, Lou discloses a scoliosis bracing system and a scoliosis treatment method comprising:
a scoliosis brace (Figs. 1D-1E; ¶ 0001) comprising:
an outer shell (orthosis 101) (Figs. 1D-1E & 8B; ¶ 0045); and
a padding layer (neoprene cover 112) disposed on an inner surface of the outer shell (101) (Fig. 8B; ¶ 0053);
an inflatable bladder system comprising:
at least one inflatable bladder (air bladder 100) of predetermined shape and size disposed within the outer shell (101) between the padding layer (112) and the outer shell (101) (Figs. 1C & 8B; ¶ 0043);
the shape, size, and position of the at least one inflatable bladder (100) being effective for applying pressure to a target location on the spine of a patient (¶ 0014).
an air pump (pump 12) in fluid communication with the at least one inflatable bladder (100) (Figs. 4-5; ¶ 0043); and
a pump controller (main controller circuit board 11 with MCU) in communication with the air pump (12) operable for selectively controlling the air pump (12) to inflate and deflate the at least one bladder (100) (Figs. 4-5; ¶ 0038-0039, 0042, & 0063-0065); and
an external control device (external device / main controller personal computer / secondary device) in wireless communication with the inflatable bladder system (¶ 0009, 0046, 0076-0077, & 0079-0080), the external control device comprising a user interface for receiving input and displaying output (¶ 0080).
Lou further discloses that the pump controller (11) has a memory including a table of operating values, wherein the operating values include on and off cycles (start and stop), on and off cycle times, and cycle pressures, and a processor (micro-controller unit) coupled to the memory and the user interface and programmed with executable instructions including an analytics engine which is operable for receiving input from a user to start and stop a timed wear cycle and an operating value, selectively controlling the air pump to cyclically inflate and deflate the bladder according to the operating value during the time wear cycle, operating a feedback loop which continuously monitors pressure of the bladder, selectively controlling the air pump to maintain the predetermined pressure at a constant level based on the feedback loop, continuously recording pressure values during the time wear cycle, and determining an effective wear time (when “quality” and “quantity” parameters are met for compliance) based on changes in the recorded pressure values (¶ 0006, 0009-0011, 0039, 0060-0067, & 0080).
Although Lou teaches that the memory and processor are associated with the pump controller rather than the external control device, Lou further teaches that the external control device can include software to reprogram the pump controller and provide a failsafe mechanism that can reinstate and recover the system in the event that a programming cycle goes awry (¶ 0078-0079).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the scoliosis bracing system taught by Lou such that the external control device includes the memory and processor for the purpose of controlling the programming remotely from the brace. Further, it has been held that rearranging parts of an invention that would not have modified the operation of the device involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 2, Lou discloses a remote server (website or other network endpoint) in wireless communication with the external control device, the remote server comprises a user interface for receiving input and displaying output, a memory including a database of patient date, wherein the patient data includes prescribed operating values, recorded wear date, and bracing scores, a processor coupled to the memory and the user interface, and programmed with executable instructions including an analytics engine which is operable for receiving input from a user to set operating values and retrieve recorded wear data, and displaying output from the database based on the input (¶ 0060 & 0077-0080).
Regarding claims 8, 9, 13, and 14, Lou discloses the invention substantially as claimed, as described above, but fails to teach that the analytics engine is operable for calculating a bracing score based on the effective wear time (analyzing “quality” and “quantity” parameters of wearing the orthosis to assess user compliance) and displaying the bracing score at the conclusion of the timed wear period (the external devices are configured to display data collected by the device including orthosis wear characteristics) (¶ 0003, 0006, 0009, 0060, & 0080).
Claims 4-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lou as applied to claims 1 and 2 above, and in further view of Thibeault (US 2014/0221890).
Regarding claims 4 and 6, Lou discloses that the at least one inflatable bladder (100) can include multiple bladders (¶ 0058) such that there would implicitly be a first inflatable bladder and a second inflatable bladder.
However, Lou fails to teach that the first inflatable bladder is disposed in a thoracic region of the brace and the second inflatable bladder is disposed in a lumbar region of the brace.
Thibeault discloses a scoliosis bracing system comprising a scoliosis brace (back brace 10) and at least one inflatable bladder (one or more inflatable bladders 58) comprising a first inflatable bladder (second bladder 58B) disposed in a thoracic region of the brace (10) and a second inflatable bladder (first bladder 58A) disposed in a lumbar region of the brace (10) (Figs. 3-6; ¶ 0039, 0041, & 0045-0046).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the first and second inflatable bladders of the scoliosis bracing system taught by Lou to be disposed in thoracic and lumbar regions of the brace as taught by Thibeault for the purpose of applying pressure in selected locations to help re-align a user’s spine, wherein the specific location and configuration of the inflatable bladders are based on the conditions of the user’s spine.
Regarding claims 5 and 7, the combination of Lou and Thibeault discloses the invention substantially as claimed, and Thibeault further discloses that the shape of the first and second bladders are intended to conform to the complex shape of the brace and match that of a user’s torso (¶ 0039) and are designed to treat the conditions of the user’s spine (¶ 0041).
Although the combination of Lou and Thibeault fails to expressly teach that the first inflatable bladder is generally parallelogram in shape and the second inflatable bladder is generally tear drop in shape, it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the invention, to modify the first and second inflatable bladders of the scoliosis bracing system taught by the combination of Lou and Thibeault such that the first inflatable bladder is generally parallelogram in shape and the second inflatable bladder is generally tear drop in shape since Applicant has not disclosed that such a shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of effectively applying pressure to the selected locations on the user’s spine. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 10, Lou discloses the invention substantially as claimed, as described above, but fails to teach that the analytics engine is operable for calculating a bracing score based on the effective wear time (analyzing “quality” and “quantity” parameters of wearing the orthosis to assess user compliance) and displaying the bracing score at the conclusion of the timed wear period (the external devices are configured to display data collected by the device including orthosis wear characteristics) (¶ 0003, 0006, 0009, 0060, & 0080).
Allowable Subject Matter
Claims 15-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The closest prior art of record is Lou et al. (US 2011/0230806) as described above with respect to claim 11. However, Lou fails to teach that the operating values included in the memory are increased at predetermined calendar intervals at least partially based on consistent repeated bracing scores over the calendar intervals.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 12/10/2025