DETAILED ACTION
This is the initial Office action for non-provisional application 18/940,764 filed November 7, 2024, which claims priority from provisional application 63/547,987 filed November 9, 2023. Claims 1-20, 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first removably spacer” as recited in claim 5, the “second removable spacer” as recited in claim 10, and “the articulating arm having a proximal end and a distal end with the rib support positioned at the distal end” as recited in claim 18 must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 14, 15, 17, 19, and 20 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 14 recites the limitation “the thoracic bolster”; however, there is insufficient antecedent basis for this limitation in the claim. For examination purposes, the above limitation has been interpreted as “the thoracic bolster assembly” as previously recited in claim 1.
Claims 15 and 17 each recite the limitation “the upper portion”; however, since claim 1 previously recites that both the thoracic bolster assembly and the pelvic bolster assembly each comprise a base with an upper portion, it is unclear which upper portion is being referred to in claims 15 and 17. For examination purposes, the limitation “the upper portion” has been interpreted as “the upper portion of either the thoracic bolster assembly or the pelvic bolster assembly”.
Claim 17 recites the limitation “the pelvic bolster”; however, there is insufficient antecedent basis for this limitation in the claim. For examination purposes, the above limitation has been interpreted as “the pelvic bolster assembly” as previously recited in claim 1.
Claims 19 and 20 each recite the limitation “the articulating arm”; however, there is insufficient antecedent basis for this limitation in the claims. For examination purposes, claims 19 and 20 have been interpreted to depend from claim 18 which previously introduces an articulating arm.
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, 7, 8, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2021/0236369) in view of Nichols et al. (US 2016/0193098).
Regarding claim 1, Lee discloses a patient positioning system (patient positioning system 110) (Figs. 21-22) comprising:
a thoracic bolster assembly (thoracic bolster assembly 130) (Figs. 22-23; ¶ 0093) comprising:
a base (base 135) comprised of a lower portion (lower portion 140) and an upper portion (upper portion 145), the lower portion (140) configured to be removably secured to a pair of rails (rails 115, 120) of a bed frame, the upper portion (145) in rotatable connection with the lower portion (140) to adjust the upper portion (145) in a coronal plane (Figs. 22-23 & 28; ¶ 0094 & 0100); and
a first plurality of patient supports (lateral bolsters 170 having lateral pads 172, thoracic support pad 185) each slidably positionable on the upper portion (145) of the base (135) (Fig. 38; ¶ 0012 & 0118); and
a pelvic bolster assembly (pelvic bolster assembly 125) (Figs. 22-23; ¶ 0093) comprising:
a base (base 135) comprised of a lower portion (lower portion 140) and an upper portion (upper portion 145), the lower portion (140) configured to be removably secured to the pair of rails (rails 115, 120) of the bed frame, the upper portion (145) in rotatable connection with the lower portion (140) to adjust the upper portion (145) in a coronal plane (Figs. 22-23 & 28; ¶ 0094 & 0100); and
a second plurality of patient supports (lateral bolsters 170 having lateral pads 172, pelvic support pad 180) each slidably positionable on the upper portion (145) of the base (135) (Fig. 37; ¶ 0012 & 0118).
However, Lee fails to disclose a top patient support portion pivotably connected to the base and an angular adjustment mechanism in connection with the base and the top patient support portion configured to adjust an angular orientation of the top patient support potion relative to the base, wherein the first and second plurality of patient supports are slidably positionable on the top patient support portion.
Nichols discloses a patient positioning system (traction table) comprising a thoracic bolster assembly (thoracic support portion 300) comprising a base (longitudinal movement subframe 310 + lateral movement subframe 320) comprised of a lower portion (longitudinal movement subframe 310) configured to be secured to a pair of rails (rails 4a, 4b) of a bed frame and an upper portion (lateral movement subframe 320), a top patient support portion (thoracic sagittal pivot subframe 360) pivotably connected to the base (310+320), an angular adjustment mechanism (thoracic longitudinal pivot subframe 350) in connection with the base (310+320) and the top patient support portion (360) to adjust an angular orientation of the top patient support portion (360) relative to the base (310+320), and a plurality of patient supports (securing elements 302a, 302b + brackets 306am 306b) each slidably positionable on the top patient support portion (360) (Figs. 1-2 & 5; ¶ 0035, 0039, 0041, & 0048-0049).
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 patient positioning system taught by Lee to include a top patient support portion pivotably connected to the base and angular adjustment mechanism in connection with the base and the top patient support portion configured to adjust an angular orientation of the top patient support potion relative to the base, wherein the first and second plurality of patient supports are slidably positionable on the top patient support portion as taught by Nichols for the purpose of positioning a thoracic portion of a patient at a desired angle.
Regarding claim 2, the combination of Lee and Nichols discloses the invention substantially as claimed, as described above, and Lee further discloses that the first plurality of patient supports (170, 185) comprises a chest support (thoracic support pad 185) and first and second thoracic paddles (lateral pads 172) (Fig. 38; ¶ 0012 & 0118).
Regarding claim 7, the combination of Lee and Nichols discloses the invention substantially as claimed, as described above, and Lee further discloses that the second plurality of patient supports (170, 180) comprises a chest support (pelvic support pad 180) and first and second thoracic paddles (lateral pads 172) (Fig. 37; ¶ 0012 & 0118).
Regarding claim 8, the combination of Lee and Nichols discloses the invention substantially as claimed, as described above, and Lee further discloses that the pelvic support (180) comprises a pair of pelvic support pads (180a, 180b) separated by a second predetermined distance from each other on the upper portion of the pelvic bolster assembly (125) (Figs. 4 & 37).
Regarding claim 13, the combination of Lee and Nichols discloses the invention substantially as claimed, as described above, and Nichols further discloses a head support (head support portion 200) secured to the thoracic bolster assembly (300) (via frame 2), the head support (200) comprising a base portion (lateral actuator 204) and a support portion (lateral movement subframe 220) in sliding relation to the base portion (204) to accommodate patients of different sizes (Figs. 1-2 & 4; ¶ 0034 & 0041).
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 patient positioning system taught by the combination of Lee and Nichols to include a head support secured to the thoracic bolster assembly and comprising a base portion in sliding relation to a support portion as further taught by Nichols for the purpose of supporting a restraining the patient head.
Regarding claim 14, the combination of Lee and Nichols discloses the invention substantially as claimed, as described above, and Lee further discloses that the lower portion (140) of the base (135) of the thoracic bolster assembly (130) comprises a pair of rail adaptors (brackets 131, 133 + lateral portions of plate 141) for removable engagement with a pair of parallel rails (rails 115, 120) of a support frame, each of the rail adaptors (131, 133 + 141) positioned laterally relative to the patient positioning system (110) (Figs. 22-23, 26a-26b, & 28; ¶ 0096-0097 & 0101).
Regarding claim 15, the combination of Lee and Nichols discloses the invention substantially as claimed, as described above, and Lee further discloses that the upper portion (145) of either the thoracic bolster assembly (130) or the pelvic bolster assembly (125) comprises a pair of supports (inner diameter support 143) pivotally attached to an elongated surface (base plate 114) that extends from a first lateral side to a second lateral side with one support (143) positioned near the first lateral side and the other support (143) positioned near the second lateral side, each support (143) configured to rotationally engage a respective rail adaptor (131, 133 + 141) to allow the elongated surface (114) to rotate in the coronal plane (Figs. 28, 32, & 35-36; ¶ 0104 & 0109).
Regarding claim 16, the combination of Lee and Nichols discloses the invention substantially as claimed, as described above, and Nichols further discloses a second angular adjustment mechanism (cervical longitudinal-transvers pivot subframe 230) configured to adjust an angular orientation of a top patient support potion relative to a base, wherein the second angular adjustment mechanism (230) is positioned toward a lateral side of the patient (slots 234 are positioned laterally) (Fig. 4; ¶ 0044).
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 angular adjustment mechanism of the patient positioning system taught by the combination of Lee and Nichols to positioned toward a lateral side of the patient as further taught by Nichols since 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 17, the combination of Lee and Nichols discloses the invention substantially as claimed, as described above, and Lee further discloses that the lower portion (140) of the base (135) of the pelvic bolster assembly (130) comprises a pair of rail adaptors (brackets 131, 133 + lateral portions of plate 141) for removable engagement with a pair of rails (rails 115, 120) of a bed frame, each of the rail adaptors (131, 133 + 141) positioned laterally relative to the patient positioning system (110), wherein the upper portion (145) of either the thoracic bolster assembly (130) or the pelvic bolster assembly (125) comprises an elongated surface (base plate 114) that extends from a first lateral side to a second lateral side with each lateral side configured to rotationally engage a respective rail adaptor (131, 133 + 141) to allow the elongated surface (114) to rotate in the coronal plane (Figs. 22-23, 26a-26b, 28, 32, & 35-36; ¶ 0096-0097, 0101, 0104, & 0109).
Claims 3-5, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Nichols as applied to claims 1, 2, 7, and 8 above, and in further view of Ebara (US 2022/0040021).
The combination of Lee and Nichols discloses the invention substantially as claimed, as described above, but fails to teach that the chest support comprises a pair of chest pads separated by a first predetermined distance from each other on the top patient support portion of the thoracic bolster assembly, wherein the first predetermined distance is based on a first physiological aspect of a patient, wherein the first predetermined distance is achieved using a first removable spacer configured to be removably secured to the pair of chest pads, wherein the second predetermined distance is based on a second physiological aspect of the patient, and wherein the second predetermined distance is achieved using a second removable spacer configured to be removably secured to the pair of pelvic pads.
Ebara discloses a patient positioning system (supporting device 1) (Figs. 2-3; ¶ 0055) comprising:
a thoracic bolster assembly (chest pressing unit 5) having a first plurality of patient supports (chest-lateral support pads 42, chest-front supports pads 94) which include a pair of chest pads (chest-front supports pads 94) separated by a first predetermined distance from each other on a top patient support portion (base plate 85) of the thoracic bolster assembly (5), wherein the first predetermined distance is based on a first physiological aspect of a patient, wherein the first predetermined distance is achieved using a first removable spacer (slide plates 87) configured to be removably secured to the pair of chest pads (94) (Figs. 8 & 14(a); ¶ 0070-0072 & 0101-0103); and
a pelvic bolster assembly (waist pressing unit 6) having a plurality of patient supports (waist-lateral support pads 167, waist-front support pads 169) which include a pair of pelvic pads (waist-front support pads 169) separated by a second predetermined distance from each other on an upper portion (base plate 168) of the pelvic bolster assembly (6), wherein the second predetermined distance is based on a second physiological aspect of the patient, and wherein the second predetermined distance is achieved using a second removable spacer (slide plates 87) configured to be removably secured to the pair of pelvic pads (169) (Figs. 13-14(a); ¶ 0093, 0099-0100, & 0103).
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 patient positioning system taught by the combination of Lee and Nichols such that the chest support comprises a pair of chest pads separated by a first predetermined distance from each other on the top patient support portion of the thoracic bolster assembly and achieved using a first removable spacer configured to be removably secured to the pair of chest pads, and the second predetermined distance is achieved using a second removable spacer configured to be removably secured to the pair of pelvic pads and taught by Ebara for the purpose of achieving balance to the patient trunk in the left-right direction.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Nichols as applied to claims 1 and 2 above, and in further view of Richardson et al. (US 2019/0281984).
The combination of Lee and Nichols discloses the invention substantially as claimed, as described above, but fails to teach that the chest support further comprises a pair of removable rib extension, each rib extension in sliding engagement with a respective chest pad.
Richardson discloses a patient support (stool 300) comprising a chest support (chest support assembly 304) and a removable rib extension (upper chest support member 324) in sliding engagement with a chest pad (chest support 350) (Figs. 8-10; ¶ 0048-0049).
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 patient positioning system taught by the combination of Lee and Nichols to include a rib extension in sliding engagement with the chest pad as taught by Richardson for the purpose of providing expanded support to a patient’s chest as needed.
Although the combination of Lee / Nichols / Richardson fails to expressly teach that the rib extension includes a pair of rib extension, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the patient support system taught by the combination of Lee / Nichols / Richardson to include a pair of rib extensions since it has been held that mere duplication of the essential working parts of a device has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Nichols as applied to claims 1 and 7 above, in further view of Lim et al. (US 2020/0337923), and in even further view of Amini (US 8,973,188).
The combination of Lee and Nichols discloses the invention substantially as claimed, as described above, but fails to teach that the pelvic support further comprises a pair of removable leg extensions, each leg extension in sliding engagement with a respective pelvic pad, wherein the removable leg extensions are curved downward away from the patient.
Lim (‘923) discloses a patient positioning system (surgical frame 10) comprising a pelvic support (hip and upper leg support mechanism 70) including a pair of leg extensions (leg portions 134, 136) in engagement with a pelvic pad (body portion 132), wherein the leg extensions (134, 136) curve downward away from a patient (Figs. 1A-1B & 2C; ¶ 0048).
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 patient support system taught by the combination of Lee and Nichols such that the pelvic support further comprises a pair of leg extensions in sliding engagement with a respective pelvic pad and are curved downward away from the patient as taught by Lim (‘923) for the purpose of supporting the hips of the patient as well as the upper legs of the patient.
However, the combination of Lee / Nichols / Lim (‘923) fails to teach that the pair of leg extensions are removable and in sliding engagement with the respective pelvic pad.
Amini discloses an analogous pelvic support (pelvic positioning system 100) comprising a pair of removable leg extensions (stirrups 310), each leg extension (310) in sliding engagement with a pelvic pad (base 110) (Figs. 1-7; column 1, lines 40-41; column 6, lines 7-51).
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 pair of removably leg extensions of the patient positioning system taught by the combination of Lee / Nichols / Lim (‘923) to be removable and in sliding engagement with the respective pelvic pad as taught by Amini for the purpose of storing, adjusting, and/or removing the leg extensions as needed.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Nichols as applied to claim 1 above, and in further view of Lim (US 2020/0337929).
The combination of Lee and Nichols discloses the invention substantially as claimed, as described above, but fails to teach an articulating support comprising an articulating arm and a rib support, the articulating arm having a proximal end and a distal end with the rib support positioned at the distal end, wherein the proximal end of the articulating arm is secured to the patient positioning system via a carriage slidably secured to the thoracic bolster assembly or the pelvic bolster assembly.
Lim (‘929) discloses a patient positioning system comprising an articulating support (shoulder hold-down 10) including an articulating arm (locking mechanism 12) and a support (shoulder engaging portion 86), the articulating arm (12) having a proximal end (at leg portion 62) and a distal end (at pivot bracket 200) with the support (86) at the distal end (200), wherein the proximal end (62) of the articulating arm (12) is secured to the patient positioning system via a carriage (leg portion 62) slidably secured to a thoracic bolster assembly (chest support portion 24) (via arm portion 34) (Figs. 1-2; ¶ 0015, 0019, 0024-0026, 0042, & 0044).
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 patient positioning system taught by the combination of Lee and Nichols to include an articulating support comprising an articulating arm and a rib support positioned at a distal end thereof and secured to the patient positioning system via a carriage slidably secured to the thoracic bolster assembly at a proximal end thereof as taught by Lim (‘929) for the purpose of holding a shoulder of a patient and portions of the patient’s back in position relative to the patient positioning system.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Nichols as applied to claim 1 above, in view of Lim (‘929) as applied to claim 18 above, and in further view of Diodato et al. (US 2022/0280367).
The combination of Lee / Nichols / Lim (‘929) discloses the invention substantially as claimed, as described above, but fails to teach that the proximal end of the articulating arm is secured to the patient positioning system via a receiving aperture on the thoracic bolster assembly or the pelvic bolster assembly.
Diodato discloses a patient positioning assembly (patient support apparatus 10) comprising a thoracic bolster assembly (first patient positioner 26), a second bolster assembly (second patient positioner 28), and an arm (post 120) having a proximal end secured to the patient positioning assembly (10) via a receiving aperture (through-holes 110) on the thoracic bolster assembly (26) or the pelvic bolster assembly (28) (Figs. 1-6; ¶ 0045 & 0054).
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 patient positioning system taught by the combination of Lee / Nichols / Lim (‘929) such that the proximal end of the articulating arm is secured to the patient positioning system via a receiving aperture on the thoracic bolster assembly or the pelvic bolster assembly as taught by Diodato for the purpose of selectively positioning the articulating arm relative to the patient based the patient’s size and shape.
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 1/7/2026