DETAILED ACTION
This action is in response to the amendment filed 12/29/2025. Currently, claims 1-13, 15-18, 20-22 and 24-49 are pending in the application. Claims 14, 19 and 23 are cancelled by Applicant. Claims 24-28 are withdrawn and not examined at this point. New claim 49 is added by Applicant.
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 .
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
In response to applicant's argument Huttner teaches away a modification to include the screw-down clamp of Van Neil et al., the examiner asserts that Huttner is not modified to include a screw-down clamp in the rejection(s) below.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the Huttner and Van Neil et al. references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the means for adjusting of Huttner to provide means for adjusting a distance between the device and the support at the lock location while the immobilization device is coupled to the support at the lock location by the means for locking the immobilization device with respect to the support as taught by Van Neil et al. because this element is known to enable the device and the support to be maintained in controlled, “adjustable, spaced relation” to enable adjustment of the spacing between the device and the support as desired, as Van Neil et al. teaches in column 2, lines 54-58.
In response to Applicant’s argument that Van Neil et al. does not teach adjustment while the immobilization device is coupled to the patient anatomy support, the examiner respectfully disagrees. As detailed below Van Neil et al. teaches that adjustment between support member 4 and support panel 6 occurs while support member 4 is coupled to support panel 6 via the locking member 10. More specifically, column 2, lines 53-58 of Van Neil et al. teaches “maintaining” support member 4 and support panel 6 in “adjustable, spaced relation.”
Claim Objections
Claim 49 is objected to because of the following informalities: in order to improve the clarity of the claim(s), all recitations of “plurality of means for locking the immobilization device” should be amended to recite ---plurality of said means for locking the immobilization device---. Appropriate correction is required.
Claim 49 is objected to because of the following informalities: in order to improve the clarity of the claim(s), all recitations of “plurality of means for adjusting” should be amended to recite ---plurality of said means for adjusting---. Appropriate correction is required.
Claim 49 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “means for adjusting a distance” in lines 2-3 of the claim should be amended to recite ---means for adjusting the distance---. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1, 2, 18 and 49 limitation “means for locking” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant’s specification teaches the following structure(s) corresponding to the “means for locking:” a co-located lock and adjuster including a shaft and a plunger.
Claim 1, 9, 18, 40, 41 and 49 limitation “means for adjusting” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant’s specification teaches the following structure(s) corresponding to the “means for adjusting:” a co-located lock and adjuster.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “indexing mechanism” in claims 14 and 40-43.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant’s specification teaches that “bonnet 180 has formed in it grooves 188 that are configured to receive a protrusion 186 formed at the end of the flange 184 (e.g., a spring)” (see [0070] of the publication of the present application), “a cam, step, etc.” (see [0070] of the publication of the present application) or “a spring or cam” (see [0076] of the publication of the present application) corresponds to the claimed indexing mechanism.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 49 is 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 49 recites “further comprising a plurality of means for locking the immobilization device with respect to the patient anatomy support and a plurality of means for adjusting a distance between the immobilization device and the patient anatomy support while the immobilization device is coupled to the patient anatomy support by less than an entirety of the plurality of means for locking the immobilization device with respect to the patient anatomy support.” The meaning of this claim limitation is unclear. For purposes of examination, the examiner will interpret the claim limitation to mean ---further comprising a plurality of means for locking the immobilization device with respect to the patient anatomy support and a plurality of means for adjusting a distance between the immobilization device and the patient anatomy support while the immobilization device is coupled to the patient anatomy support---.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, 9-13, 17, 18, 20-22, 29-41, 43, 48 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huttner (US 2005/0045187), in view of Van Neil et al. (US 3,605,846) and further in view of Yared et al. (US 2011/0071388).
In regards to claims 1 and 40, Huttner teaches in the abstract, Figures 1-6 and 8 and [0029-0031] means for locking (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) with respect to the patient anatomy support (patient restraint board 8) at the lock location (the location at which the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned; Figure 2 teaches a first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 being locked at the location thereof); and means for adjusting a distance between (first cross-piece 4; taught in [0030-0031] and [0037] to be rotated between locked and unlocked positions; when in the unlocked position, the first cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) at the lock location (the location at which the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned; Figures 1 and 2 teach a first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 being locked and unlocked (and thus, adjusted) at the location thereof), wherein the means for locking (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) with respect to the patient anatomy support (patient restraint board 8) at the lock location (the location at which the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned; Figure 2 teaches a first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 being locked at the location thereof) is actuated along an axis ([0029-0031] teaches that the locking pin 1 is movable up or down (along the vertical axis of the locking pin 1) into respective locked and unlocked positions) at the lock location (the location at which the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned) and the means for adjusting (first cross-piece 4) the distance between the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) is actuated about the axis (first cross-piece 4 is taught in [0030-0031] and [0037] and Figure 8 to be rotated about the vertical axis of the locking pin 1 between locked and unlocked positions) along which the means for locking (plurality of locking pins 1/tips 2/split expandable members 3/notched collars 5/holes 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) is actuated.
Huttner does not teach means for adjusting a distance between the immobilization device and the patient anatomy support at the lock location while the immobilization device is coupled to the patient anatomy support at the lock location by the means for locking the immobilization device with respect to the patient anatomy support.
However, Van Neil et al. teaches in Figure 1, column 2, lines 53-58, column 3, lines 3-5 and columns 4-5, lines 74-1 an analogous device (fastening/locking assembly) with means for adjusting (bore 22, screw 80, ribs 86) a distance between (by guiding the threads of screw 80 along the ribs 86 of bore 22 to move support member 4 and support panel 6 toward or away from each other; see column 2, lines 53-58 and columns 4-5, lines 74-1) the device (support member 4) and the support (support panel 6) at the lock location (the location at which locking member 10 is positioned; Figure 1 teaches bore 22/screw 80/ribs 86 and locking member 10 being co-located) while (adjustment between support member 4 and support panel 6 occurs while support member 4 is coupled to support panel 6 via the fastening assembly 2 at the location at which locking member 10 is positioned; column 2, lines 53-58 teaches “maintaining” support member 4 and support panel 6 in “adjustable, spaced relation”) the device (support member 4) is coupled to the support (support panel 6) at the lock location (the location at which locking member 10 is positioned) by the means for locking (locking member 10; column 3, lines 3-5 teaches “locking member 10 coacts with the retainer member 8 to provide a positive attachment of the entire assembly to the panels [4, 6]”) the device (support member 4) with respect to the support (support panel 6).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the means for adjusting of Huttner to provide means for adjusting a distance between the device and the support at the lock location while the immobilization device is coupled to the support at the lock location by the means for locking the immobilization device with respect to the support as taught by Van Neil et al. because this element is known to enable the device and the support to be maintained in controlled, “adjustable, spaced relation” to enable adjustment of the spacing between the device and the support as desired, as Van Neil et al. teaches in column 2, lines 54-58.
Huttner and Van Neil et al. do not teach that the means for adjusting includes an indexing mechanism defining discrete positions, each position of the discrete positions corresponding to a relative distance between the immobilization device and the patient anatomy support; and the indexing mechanism being configured to index rotation of the means for adjusting.
However, Yared et al. teaches in Figures 6-9 and [0112-0114] an analogous device wherein the means for adjusting (adjustment mechanism 1) includes (as taught in [0112]) an indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) defining discrete positions ([0113] teaches “the height adjustment knobs 7 allow the user to deterministically and repeatably set the distance between top tray 5 and bottom tray 4 to discrete distances and maintain parallelism”), each position of the discrete positions corresponding to a relative distance between ([0113] teaches “ball spring plungers 13 ride into the detents 14 in the side of the height adjustment knobs 7 forcing the height adjustment knobs 7 into repeatable and deterministic angular orientations” and “the height adjustment knob rotations are converted to linear motion via threads between the height adjustment knobs 7 and height adjustment nuts 6; thus setting the distance between the top tray 5 and bottom tray 4”) the immobilization device (top tray 5) and the patient anatomy support (bottom tray 4); and the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) being configured to index rotation of ([0113] teaches “ball spring plungers 13 ride into the detents 14 in the side of the height adjustment knobs 7 forcing the height adjustment knobs 7 into repeatable and deterministic angular orientations” and “the height adjustment knob rotations are converted to linear motion via threads between the height adjustment knobs 7 and height adjustment nuts 6; thus setting the distance between the top tray 5 and bottom tray 4”) the means for adjusting (adjustment mechanism 1).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the means for adjusting of Huttner as modified by Van Neil et al. to provide that the means for adjusting includes an indexing mechanism defining discrete positions, each position of the discrete positions corresponding to a relative distance between the immobilization device and the patient anatomy support; and the indexing mechanism being configured to index rotation of the means for adjusting as taught by Yared et al. because this element is known to allow the user to deterministically and repeatably set the distance between the immobilization device and the patient anatomy support to discrete distances, as Yared et al. teaches in [0113].
In regards to claim 2, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claim 1. Huttner teaches in Figure 1 and [0029] that the means for locking (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) with respect to the patient anatomy support (patient restraint board 8) comprises a lock (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) coupleable to (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is shown in Figure 1 to be coupled to the immobilization device via frame 6; hole 7 is shown in Figure 1 to be coupled to patient restraint board 8) at least one of the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) and configured to attach ([0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) to the patient anatomy support (patient restraint board 8).
In regards to claim 3, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1 and 2. Huttner teaches in Figures 1 and 2 and [0029-0031] that the lock (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) includes a plunger (locking pin 1/tip 2) movable along the axis ([0029-0031] teaches that the locking pin 1 is movable up or down (along the vertical axis of the locking pin 1) into respective locked and unlocked positions) between locked and unlocked positions and at least one extension (split expandable member 3) movable radially with respect to the axis when the plunger (locking pin 1/tip 2) is in the locked position ([0030] teaches that the split expandable member 3 expands (which is shown in Figure 2 to be a radial expansion away from the vertical axis of the locking pin 1) on the underside of the frame 6 when the locking pin 1 is locked).
In regards to claim 4, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1-3. Huttner teaches in Figures 2 and 6 and [0030] that the plunger (locking pin 1/tip 2) has a flanged portion (tip 2; shown in Figure 6 to be structured as a projecting rim, or flange) positioned to push ([0030] teaches “this in turn forces the expander at its tip 2 to engage and expand the expandable member 3 on the underside of the frame 6”) the at least one extension (split expandable member 3) radially outward (by expanding the expandable member 3, as shown in Figure 2 and taught in [0030]) when the plunger (locking pin 1/tip 2) is in the locked position (as shown in Figure 2).
In regards to claim 5, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1-4. Huttner teaches in Figure 6 that the plunger (locking pin 1/tip 2) has a tapered portion (as defined in the annotated copy of Figure 6 provided below) adjacent (as shown in Figure 6) the flanged portion (tip 2).
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In regards to claim 6, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1-3. Huttner teaches in Figure 5 that the at least one extension (split expandable member 3) is defined on (shown in Figure 5 to be positioned on) a shaft (as defined in the annotated copy of Figure 5 provided below) within which the plunger (locking pin 1/tip 2) can extend (as shown in Figure 2).
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In regards to claim 7, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1-3 and 6. Huttner teaches in Figure 1 and [0030] the lock (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) further comprising a base (portion of the patient restraint board 8 that includes hole 7) defining a through-hole (hole 7) for accommodating the shaft (as defined in the annotated copy of Figure 5 provided above; hole 7 is shown in Figure 1 to accommodate the shaft) and the plunger (locking pin 1/tip 2; [0030] teaches “a portion of the patient restraint board 8 with its corresponding hole 7 that mates to the locking pin 1”) and configured for coupling the lock (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) to at least one of ([0030] teaches “a portion of the patient restraint board 8 with its corresponding hole 7 that mates to the locking pin 1;” thus, hole 7 functions to attach the locking pin 1 to the patient restraint board 8) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8).
In regards to claim 9, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claim 1. Huttner teaches in Figures 1 and 2, [0030-0031] and [0037] that the means for adjusting (first cross-piece 4) a distance between the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) comprises an adjuster (first cross-piece 4) coupleable to (coupleable to the immobilization device via frame 6) at least one of the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) and configured to selectively adjust the distance between the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy (patient restraint board 8) support while the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) is coupled to (first cross-piece 4 is taught in [0030-0031] and [0037] to be selectively rotated between locked and unlocked positions; when in the unlocked position, the first cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8; the remaining plurality of locking pins 1/tips 2/split expandable members 3/notched collars 5/holes 7 are capable of remaining locked (to connect frame 6 to the patient restraint board 8) when the first cross-piece 4 and its corresponding lock are disengaged) the patient anatomy support (patient restraint board 8).
In regards to claims 10-13, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1 and 9. Huttner does not teach that the adjuster includes a cam surface and a bearing surface, wherein the bearing surface is configured to change the distance between the immobilization device and the patient anatomy support upon relative movement of the cam surface with respect to the immobilization device or the patient anatomy support; wherein the adjuster includes a thread providing the cam surface; wherein the thread of the adjuster is positioned to be engaged by a surface of at least one of the immobilization device, the patient anatomy support, and an element interposed between the immobilization device and the patient anatomy support; the adjuster further comprising a rotator positioned to contact the cam surface and the bearing surface, wherein rotation of the rotator about the axis translates the cam surface or the bearing surface along the axis and adjusts the distance between the immobilization device and the patient anatomy support.
However, Van Neil et al. teaches in Figures 1 and 5, column 2, lines 54-58 and columns 4-5, lines 74-1 an analogous device (fastening/locking assembly) wherein the adjuster (screw 80) includes a cam surface (the grooves of the threads of screw 80; columns 4-5, lines 74-1 teaches “the threads of the screw 80”) and a bearing surface (the projections of the threads of screw 80; columns 4-5, lines 74-1 teaches “the threads of the screw 80”) wherein the bearing surface (the projections of the threads of screw 80; columns 4-5, lines 74-1 teaches “the threads of the screw 80”) is configured to change the distance between (by guiding the threads of screw 80 along the ribs 86 of bore 22 to move support member 4 and support panel 6 toward or away from each other; see column 2, lines 54-58 and columns 4-5, lines 74-1) the device (support member 4) and the support (support panel 6) upon relative movement (up or down) of the cam surface (the grooves of the threads of screw 80) with respect to the device (support member 4) or the support (support panel 6); wherein the adjuster (screw 80) includes a thread (threads of screw 80) providing (forming) the cam surface (the grooves of the threads of screw 80; columns 4-5, lines 74-1 teaches “the threads of the screw 80”); wherein the thread (threads of screw 80) of the adjuster (screw 80) is positioned to be engaged by (as shown in Figure 1) a surface (the surface of ribs 86 of bore 22) of at least one of the immobilization device, the patient anatomy support, and an element (ribs 86) interposed between (as shown in Figure 1) the device (support member 4) and the support (support panel 6); the adjuster (screw 80) further comprising a rotator (bore 22) positioned to contact (via ribs 86, as taught in columns 4-5, lines 74-1) the cam surface (the grooves of the threads of screw 80) and the bearing surface (the projections of the threads of screw 80), wherein rotation of the rotator (bore 22) about the axis (longitudinal axis of bore 22) translates the cam surface (the grooves of the threads of screw 80) or the bearing surface (the projections of the threads of screw 80) along the axis (longitudinal axis of bore 22) and adjusts the distance between (see column 2, lines 54-58) the device (support member 4) and the support (support panel 6).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the adjuster of Huttner as modified by Van Neil et al. and Yared et al. to provide that the adjuster includes a cam surface and a bearing surface, wherein the bearing surface is configured to change the distance between the device and the support upon relative movement of the cam surface with respect to the device or the support; wherein the adjuster includes a thread providing the cam surface; wherein the thread of the adjuster is positioned to be engaged by a surface of at least one of the device, support, and an element interposed between the device and the support; the adjuster further comprising a rotator positioned to contact the cam surface and the bearing surface, wherein rotation of the rotator about the axis translates the cam surface or the bearing surface along the axis and adjusts the distance between the device and the support as taught by Van Neil et al. because this element is known to enable the device and the support to be maintained in controlled, “adjustable, spaced relation” to enable adjustment of the spacing between the device and the support as desired, as Van Neil et al. teaches in column 2, lines 54-58.
In regards to claims 15 and 16, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1, 9, 10 and 13. Huttner and Van Neil et al. do not teach wherein the indexing mechanism includes a groove positioned to indicate when the rotator is aligned with one of the discrete positions; and wherein the indexing mechanism includes an indicator positioned to provide a visual indication of the distance between the immobilization device and the patient anatomy support.
However, Yared et al. teaches in Figures 6-9 and [0113-0114] an analogous device wherein the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) includes a groove (detent 14) positioned to indicate when the rotator (height adjustment knob 7) is aligned with one of the discrete positions ([0113] teaches “ball spring plungers 13 ride into the detents 14 in the side of the height adjustment knobs 7 forcing the height adjustment knobs 7 into repeatable and deterministic angular orientations”); and wherein the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) includes an indicator (height readout 9; see Figure 9) positioned to provide a visual indication (as shown in Figure 9) of the distance between the immobilization device (top tray 5) and the patient anatomy support (bottom tray 4) (see [0114]).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to provide wherein the indexing mechanism includes a groove positioned to indicate when the rotator is aligned with one of the discrete positions; and wherein the indexing mechanism includes an indicator positioned to provide a visual indication of the distance between the immobilization device and the patient anatomy support as taught by Yared et al. because this element is known to allow the user to deterministically and repeatably set the distance between the immobilization device and the patient anatomy support to discrete distances, as Yared et al. teaches in [0113].
In regards to claim 17, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claim 1. Huttner teaches in Figure 1, [0029-0031] and [0037] that the means for adjusting (first cross-piece 4) is configured to selectively adjust the distance between (first cross-piece 4 is taught in [0030-0031] and [0037] to be rotated between locked and unlocked positions; when in the unlocked position, the first cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) after (capable of occurring after) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) is coupled (via the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) to the patient anatomy (patient restraint board 8) support by the means for locking (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7).
Huttner does not teach that the means for adjusting is configured to selectively adjust the distance between the immobilization device and the patient anatomy support while the immobilization device remains coupled to the patient anatomy support by the means for locking.
However, Van Neil et al. teaches in Figure 1, column 2, lines 53-58, column 3, lines 3-5 and columns 4-5, lines 74-1 an analogous device (fastening/locking assembly) wherein the means for adjusting (bore 22, screw 80, ribs 86) is configured to selectively adjust the distance between (by guiding the threads of screw 80 along the ribs 86 of bore 22 to move support member 4 and support panel 6 toward or away from each other; see column 2, lines 53-58 and columns 4-5, lines 74-1) the device (support member 4) and the support (support panel 6) while (adjustment between support member 4 and support panel 6 occurs while support member 4 is coupled to support panel 6 via the locking member 10; column 2, lines 53-58, column 3 teaches “maintaining” support member 4 and support panel 6 in “adjustable, spaced relation”) the device (support member 4) remains coupled to the support (support panel 6) by (column 3, lines 3-5 teaches “locking member 10 coacts with the retainer member 8 to provide a positive attachment of the entire assembly to the panels [4, 6]”) the means for locking (locking member 10; column 3, lines 3-5 teaches “locking member 10 coacts with the retainer member 8 to provide a positive attachment of the entire assembly to the panels [4, 6]”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the means for adjusting of Huttner as modified by Van Neil et al. and Yared et al. to provide that the means for adjusting is configured to selectively adjust the distance between the immobilization device and the patient anatomy support while the immobilization device remains coupled to the patient anatomy support by the means for locking as taught by Van Neil et al. because this element is known to enable the device and the support to be maintained in controlled, “adjustable, spaced relation” to enable adjustment of the spacing between the device and the support as desired, as Van Neil et al. teaches in column 2, lines 54-58.
In regards to claims 18, 20 and 41, Huttner teaches in the abstract, Figures 1-6 and 8 and [0029-0031] an immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”); and an adjustable lock (first locking pin 1/tip 2/split expandable member 3/ first cross-piece 4/notched collar 5/hole 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged;” first cross-piece 4 if taught in [0030-0031] and [0037] to be rotated between locked and unlocked positions; when in the unlocked position, the first cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8) configured to retain the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) in position relative to the anatomy of the patient and the patient anatomy support at a lock location ([0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”), the adjustable lock (first locking pin 1/tip 2/split expandable member 3/ first cross-piece 4/notched collar 5/hole 7) including: means for locking (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) with respect to the patient anatomy support (patient restraint board 8) at the lock location (the location at which the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned; Figure 2 teaches a first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 being locked at the location thereof); and means for adjusting a distance between (first cross-piece 4; taught in [0030-0031] and [0037] to be rotated between locked and unlocked positions; when in the unlocked position, the first cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) at the lock location (the location at which the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned; Figures 1 and 2 teach a first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 being locked and unlocked (and thus, adjusted) at the location thereof), wherein the means for locking (first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) with respect to the patient anatomy support (patient restraint board 8) at the lock location (the location at which the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned; Figure 2 teaches a first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 being locked at the location thereof) is actuated along an axis ([0029-0031] teaches that the locking pin 1 is movable up or down (along the vertical axis of the locking pin 1) into respective locked and unlocked positions) at the lock location (the location at which the first locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned) and the means for adjusting (first cross-piece 4) the distance between the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) is actuated about the axis (first cross-piece 4 is taught in [0030-0031] and [0037] and Figure 8 to be rotated about the vertical axis of the locking pin 1 between locked and unlocked positions) along which the means for locking (plurality of locking pins 1/tips 2/split expandable members 3/notched collars 5/holes 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) is actuated, and wherein the adjustable lock is coupled (via frame 6; the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]”) to the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and is configured to retain ([0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) in position relative to the anatomy of the patient and the patient anatomy support (patient restraint board 8); wherein the patient anatomy support (patient restraint board 8) is another immobilization device (board 8 is taught to be a “patient restraint,” which is understood to restrain and thus, immobilize, at least a portion of the user’s anatomy).
Huttner does not teach means for adjusting a distance between the immobilization device and the patient anatomy support at the lock location while the immobilization device is coupled to the patient anatomy support at the lock location by the means for locking the immobilization device with respect to the patient anatomy support.
However, Van Neil et al. teaches in Figure 1, column 2, lines 53-58, column 3, lines 3-5 and columns 4-5, lines 74-1 an analogous device (fastening/locking assembly) with means for adjusting (bore 22, screw 80, ribs 86) a distance between (by guiding the threads of screw 80 along the ribs 86 of bore 22 to move support member 4 and support panel 6 toward or away from each other; see column 2, lines 53-58 and columns 4-5, lines 74-1) the device (support member 4) and the support (support panel 6) at the lock location (the location at which locking member 10 is positioned; Figure 1 teaches bore 22/screw 80/ribs 86 and locking member 10 being co-located) while (adjustment between support member 4 and support panel 6 occurs while support member 4 is coupled to support panel 6 via the fastening assembly 2 at the location at which locking member 10 is positioned; column 2, lines 53-58, column 3 teaches “maintaining” support member 4 and support panel 6 in “adjustable, spaced relation”) the device (support member 4) is coupled to the support (support panel 6) at the lock location (the location at which locking member 10 is positioned) by the means for locking (locking member 10; column 3, lines 3-5 teaches “locking member 10 coacts with the retainer member 8 to provide a positive attachment of the entire assembly to the panels [4, 6]”) the device (support member 4) with respect to the support (support panel 6).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the means for adjusting of Huttner to provide means for adjusting a distance between the device and the support at the lock location while the immobilization device is coupled to the support at the lock location by the means for locking the immobilization device with respect to the support as taught by Van Neil et al. because this element is known to enable the device and the support to be maintained in controlled, “adjustable, spaced relation” to enable adjustment of the spacing between the device and the support as desired, as Van Neil et al. teaches in column 2, lines 54-58.
Huttner and Van Neil et al. do not teach that the means for adjusting includes an indexing mechanism defining discrete positions, each position of the discrete positions corresponding to a relative distance between the immobilization device and the patient anatomy support; and the indexing mechanism being configured to index rotation of the means for adjusting.
However, Yared et al. teaches in Figures 6-9 and [0112-0114] an analogous device wherein the means for adjusting (adjustment mechanism 1) includes (as taught in [0112]) an indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) defining discrete positions ([0113] teaches “the height adjustment knobs 7 allow the user to deterministically and repeatably set the distance between top tray 5 and bottom tray 4 to discrete distances and maintain parallelism”), each position of the discrete positions corresponding to a relative distance between ([0113] teaches “ball spring plungers 13 ride into the detents 14 in the side of the height adjustment knobs 7 forcing the height adjustment knobs 7 into repeatable and deterministic angular orientations” and “the height adjustment knob rotations are converted to linear motion via threads between the height adjustment knobs 7 and height adjustment nuts 6; thus setting the distance between the top tray 5 and bottom tray 4”) the immobilization device (top tray 5) and the patient anatomy support (bottom tray 4); and the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) being configured to index rotation of ([0113] teaches “ball spring plungers 13 ride into the detents 14 in the side of the height adjustment knobs 7 forcing the height adjustment knobs 7 into repeatable and deterministic angular orientations” and “the height adjustment knob rotations are converted to linear motion via threads between the height adjustment knobs 7 and height adjustment nuts 6; thus setting the distance between the top tray 5 and bottom tray 4”) the means for adjusting (adjustment mechanism 1).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the means for adjusting of Huttner as modified by Van Neil et al. to provide that the means for adjusting includes an indexing mechanism defining discrete positions, each position of the discrete positions corresponding to a relative distance between the immobilization device and the patient anatomy support; and the indexing mechanism being configured to index rotation of the means for adjusting as taught by Yared et al. because this element is known to allow the user to deterministically and repeatably set the distance between the immobilization device and the patient anatomy support to discrete distances, as Yared et al. teaches in [0113].
In regards to claim 21, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 18. Huttner teaches in the abstract and Figure 1 that the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) includes (as taught in the abstract) a frame (frame 6) and a preform (“piece of low-melt thermoplastic material” taught in the abstract) coupled to (taught in the abstract to be “affixed to”) the frame (frame 6), the preform (“piece of low-melt thermoplastic material” taught in the abstract) being formed from a low melting temperature thermoplastic (taught in the abstract to be “low-melt thermoplastic material”) and configured to be formed to the anatomy of the patient (the piece of low-melt thermoplastic material is capable of being formed to the anatomy of the patient), wherein the adjustable lock (see rejection of claim 18 above) is coupled to (as shown in Figure 1) the frame (frame 6) of the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”).
In regards to claim 22, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 18. Huttner teaches in Figures 8 and 9 a plurality of the adjustable lock (plurality of locking pins 1/tips 2/split expandable members 3/notched collars 5/holes 7) coupled to (via frame 6, as shown in Figure 9) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and spaced from one another (as shown in Figure 9), wherein the means for adjusting (cross-pieces 4) the distance between the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) of each of the plurality of the adjustable lock (plurality of locking pins 1/tips 2/split expandable members 3/notched collars 5/holes 7) provides adjustability independent of (inasmuch as each of the first cross-pieces 4 is independently operable, as shown in Figure 8; see also [0027]) other ones of the plurality of the adjustable lock (plurality of locking pins 1/tips 2/split expandable members 3/notched collars 5/holes 7), thereby facilitating adjustment of a fit (by locking or unlocking individual cross-pieces 4) of the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) with respect to one portion of the anatomy of the patient independently from adjusting the fit of other portions of the anatomy of the patient.
In regards to claims 29, 30 and 42, Huttner teaches in the abstract, Figures 1-6 and 8 and [0029-0031] a lock (locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) coupleable to (locking pin 1/tip 2/split expandable member 3/notched collar 5 is shown in Figure 1 to be coupled to the immobilization device via frame 6; hole 7 is shown in Figure 1 to be coupled to patient restraint board 8) at least one of the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) at the lock location (the location at which the locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned) and configured to attach ([0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) to the patient anatomy support (patient restraint board 8) at the lock location (the location at which the locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned), the lock (locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7) including a plunger (locking pin 1/tip 2) movable along an axis (vertical axis of the locking pin 1) at the lock location (the vertical axis of the locking pin 1 is positioned at the location at which the locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned) between locked and unlocked positions ([0029-0031] teaches that the locking pin 1 is movable up or down (along the vertical axis of the locking pin 1) into respective locked and unlocked positions) and at least one extension (split expandable member 3) movable radially with respect to the axis (vertical axis of the locking pin 1) at the lock location (the vertical axis of the locking pin 1 is positioned at the location at which the locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned) when the plunger (locking pin 1/tip 2) is in the locked position ([0030] teaches that the split expandable member 3 expands (which is shown in Figure 2 to be a radial expansion away from the vertical axis of the locking pin 1) on the underside of the frame 6 when the locking pin 1 is locked); and an adjuster (first cross-piece 4; taught in [0030-0031] and [0037] to be rotated between locked and unlocked positions; when in the unlocked position, the first cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8) coupleable to (via frame 6, as shown in Figure 1) at least one of the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) at the lock location (Figure 1 teaches that first cross-piece 4 is positioned at the location at which the locking pin 1/tip 2/split expandable member 3/notched collar 5/hole 7 is positioned).
Huttner does not teach that the adjuster is configured to selectively adjust a distance between the immobilization device and the patient anatomy support at the lock location while the immobilization device is coupled to the patient anatomy support at the lock location; the adjuster including a cam surface and a bearing surface, wherein the bearing surface is configured to change the distance between the immobilization device and the patient anatomy support at the lock location upon relative movement of the cam surface with respect to the immobilization device or the patient anatomy support; the adjuster further comprising a rotator positioned to contact the cam surface and the bearing surface, wherein rotation of the rotator about the axis translates the cam surface or the bearing surface along the axis and adjusts the distance between the immobilization device and the patient anatomy support.
However, Van Neil et al. teaches in Figures 1 and 5, column 2, lines 54-58 and columns 4-5, lines 74-1 an analogous device (fastening/locking assembly) wherein the adjuster (screw 80) is configured to selectively adjust a distance between (by guiding the threads of screw 80 along the ribs 86 of bore 22 to move support member 4 and support panel 6 toward or away from each other; see column 2, lines 53-58 and columns 4-5, lines 74-1) the device (support member 4) and the support (support panel 6) at the lock location (the location at which locking member 10 is positioned; Figure 1 teaches screw 80 and locking member 10 being co-located) while (adjustment between support member 4 and support panel 6 occurs while support member 4 is coupled to support panel 6 via the fastening assembly 2 at the location at which locking member 10 is positioned; column 2, lines 53-58, column 3 teaches “maintaining” support member 4 and support panel 6 in “adjustable, spaced relation”) the device (support member 4) is coupled to the support (support panel 6) at the lock location (the location at which locking member 10 is positioned); the adjuster (screw 80) including a cam surface (the grooves of the threads of screw 80; columns 4-5, lines 74-1 teaches “the threads of the screw 80”) and a bearing surface (the projections of the threads of screw 80; columns 4-5, lines 74-1 teaches “the threads of the screw 80”), wherein the bearing surface (the projections of the threads of screw 80; columns 4-5, lines 74-1 teaches “the threads of the screw 80”) is configured to change the distance between (by guiding the threads of screw 80 along the ribs 86 of bore 22 to move support member 4 and support panel 6 toward or away from each other; see column 2, lines 54-58 and columns 4-5, lines 74-1) the device (support member 4) and the support (support panel 6) at the lock location (the location at which locking member 10 is positioned; Figure 1 teaches screw 80 and locking member 10 being co-located) upon relative movement (up or down) of the cam surface (the grooves of the threads of screw 80) with respect to the device (support member 4) or the support (support panel 6); the adjuster (screw 80) further comprising a rotator (bore 22) positioned to contact (via ribs 86, as taught in columns 4-5, lines 74-1) the cam surface (the grooves of the threads of screw 80) and the bearing surface (the projections of the threads of screw 80), wherein rotation of the rotator (bore 22) about the axis (longitudinal axis of bore 22) translates the cam surface (the grooves of the threads of screw 80) or the bearing (the projections of the threads of screw 80) surface along the axis (longitudinal axis of bore 22) and adjusts the distance between (see column 2, lines 54-58) the device(support member 4) and the support (support panel 6).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the adjuster of Huttner to provide that the adjuster is configured to selectively adjust a distance between the device and the support at the lock location while the device is coupled to the support at the lock location; the adjuster including a cam surface and a bearing surface, wherein the bearing surface is configured to change the distance between the device and the support at the lock location upon relative movement of the cam surface with respect to the device or the support; the adjuster further comprising a rotator positioned to contact the cam surface and the bearing surface, wherein rotation of the rotator about the axis translates the cam surface or the bearing surface along the axis and adjusts the distance between the device and the support as taught by Van Neil et al. because this element is known to enable the device and the support to be maintained in controlled, “adjustable, spaced relation” to enable adjustment of the spacing between the device and the support as desired, as Van Neil et al. teaches in column 2, lines 54-58.
Huttner and Van Neil et al. do not teach that the adjuster includes an indexing mechanism defining discrete positions, each position of the discrete positions corresponding to a relative distance between the immobilization device and the patient anatomy support; and the indexing mechanism being configured to index rotation of the adjuster.
However, Yared et al. teaches in Figures 6-9 and [0112-0114] an analogous device wherein the adjuster (adjustment mechanism 1) includes (as taught in [0112]) an indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) defining discrete positions ([0113] teaches “the height adjustment knobs 7 allow the user to deterministically and repeatably set the distance between top tray 5 and bottom tray 4 to discrete distances and maintain parallelism”), each position of the discrete positions corresponding to a relative distance between ([0113] teaches “ball spring plungers 13 ride into the detents 14 in the side of the height adjustment knobs 7 forcing the height adjustment knobs 7 into repeatable and deterministic angular orientations” and “the height adjustment knob rotations are converted to linear motion via threads between the height adjustment knobs 7 and height adjustment nuts 6; thus setting the distance between the top tray 5 and bottom tray 4”) the immobilization device (top tray 5) and the patient anatomy support (bottom tray 4); and the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) being configured to index rotation of ([0113] teaches “ball spring plungers 13 ride into the detents 14 in the side of the height adjustment knobs 7 forcing the height adjustment knobs 7 into repeatable and deterministic angular orientations” and “the height adjustment knob rotations are converted to linear motion via threads between the height adjustment knobs 7 and height adjustment nuts 6; thus setting the distance between the top tray 5 and bottom tray 4”) the adjuster (adjustment mechanism 1).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the adjuster of Huttner as modified by Van Neil et al. to provide that the adjuster includes an indexing mechanism defining discrete positions, each position of the discrete positions corresponding to a relative distance between the immobilization device and the patient anatomy support; and the indexing mechanism being configured to index rotation of the adjuster as taught by Yared et al. because this element is known to allow the user to deterministically and repeatably set the distance between the immobilization device and the patient anatomy support to discrete distances, as Yared et al. teaches in [0113].
In regards to claims 31 and 43, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claim 1. Huttner and Van Neil et al. do not teach the indexing mechanism comprising a protrusion configured to be received in a groove; and the indexing mechanism further comprising flange from which the protrusion extends such that the protrusion is received in the groove.
However, Yared et al. teaches in Figures 6-9 and [0113] an analogous device wherein the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a protrusion (male thread 15 of height adjustment knob 7; see [0113]) configured to be received in (see Figure 6; [0113] teaches “height adjustment knob 7 contains a male thread 15 that corresponds to female thread 16 defined by height adjustment nut 6”) a groove (female thread 16 defined by height adjustment nut 6); and the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) further comprising flange (vertical column of height adjustment knob 7, shown in Figure 6) from which the protrusion (male thread 15 of height adjustment knob 7; see [0113]) extends (Figure 6 teaches the male thread 15 extending laterally away from the vertical column of height adjustment knob 7) such that the protrusion (male thread 15 of height adjustment knob 7; see [0113]) is received in (as shown in Figure 6; also taught in [0113]) the groove (female thread 16 defined by height adjustment nut 6).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to provide the indexing mechanism comprising a protrusion configured to be received in a groove; and the indexing mechanism further comprising flange from which the protrusion extends such that the protrusion is received in the groove as taught by Yared et al. because this element is known to provide a vertical adjustment mechanism for the indexing mechanism, as Yared et al. teaches in Figures 6-9 and [0113].
In regards to claim 32, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claim 1. Huttner, Van Neil et al. do not teach that the indexing mechanism comprising a cam or a step.
However, Yared et al. teaches in Figures 6-9 and [0113] an analogous device with the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a cam or a step (male thread 15 of height adjustment knob 7; see [0113]).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to comprise a cam or a step as taught by Yared et al. because this element is known to provide a vertical adjustment mechanism for the indexing mechanism, as Yared et al. teaches in Figures 6-9 and [0113].
In regards to claim 33, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claim 1. Huttner and Van Neil et al. do not teach that the indexing mechanism comprising a spring.
However, Yared et al. teaches in Figure 6 and [0112] an analogous device with the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a spring (ball spring plungers 13).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to provide the indexing mechanism comprising a spring as taught by Yared et al. because this element is known to enable “repeatable and deterministic angular orientations” of the indexing mechanism, as Yared et al. teaches in [0113].
In regards to claim 34, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 18. Huttner and Van Neil et al. do not teach the indexing mechanism comprising a protrusion configured to be received in a groove.
However, Yared et al. teaches in Figures 6-9 and [0113] an analogous device wherein the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a protrusion (male thread 15 of height adjustment knob 7; see [0113]) configured to be received in (see Figure 6; [0113] teaches “height adjustment knob 7 contains a male thread 15 that corresponds to female thread 16 defined by height adjustment nut 6”) a groove (female thread 16 defined by height adjustment nut 6).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to provide the indexing mechanism comprising a protrusion configured to be received in a groove as taught by Yared et al. because this element is known to provide a vertical adjustment mechanism for the indexing mechanism, as Yared et al. teaches in Figures 6-9 and [0113].
In regards to claim 35, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 18. Huttner, Van Neil et al. do not teach that the indexing mechanism comprising a cam or a step.
However, Yared et al. teaches in Figures 6-9 and [0113] an analogous device with the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a cam or a step (male thread 15 of height adjustment knob 7; see [0113]).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to comprise a cam or a step as taught by Yared et al. because this element is known to provide a vertical adjustment mechanism for the indexing mechanism, as Yared et al. teaches in Figures 6-9 and [0113].
In regards to claim 36, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 18. Huttner and Van Neil et al. do not teach that the indexing mechanism comprising a spring.
However, Yared et al. teaches in Figure 6 and [0112] an analogous device with the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a spring (ball spring plungers 13).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to provide the indexing mechanism comprising a spring as taught by Yared et al. because this element is known to enable “repeatable and deterministic angular orientations” of the indexing mechanism, as Yared et al. teaches in [0113].
In regards to claim 37, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 29. Huttner and Van Neil et al. do not teach the indexing mechanism comprising a protrusion configured to be received in a groove.
However, Yared et al. teaches in Figures 6-9 and [0113] an analogous device wherein the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a protrusion (male thread 15 of height adjustment knob 7; see [0113]) configured to be received in (see Figure 6; [0113] teaches “height adjustment knob 7 contains a male thread 15 that corresponds to female thread 16 defined by height adjustment nut 6”) a groove (female thread 16 defined by height adjustment nut 6).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to provide the indexing mechanism comprising a protrusion configured to be received in a groove as taught by Yared et al. because this element is known to provide a vertical adjustment mechanism for the indexing mechanism, as Yared et al. teaches in Figures 6-9 and [0113].
In regards to claim 38, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 29. Huttner, Van Neil et al. do not teach that the indexing mechanism comprising a cam or a step.
However, Yared et al. teaches in Figures 6-9 and [0113] an analogous device with the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a cam or a step (male thread 15 of height adjustment knob 7; see [0113]).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to comprise a cam or a step as taught by Yared et al. because this element is known to provide a vertical adjustment mechanism for the indexing mechanism, as Yared et al. teaches in Figures 6-9 and [0113].
In regards to claim 39, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 29. Huttner and Van Neil et al. do not teach that the indexing mechanism comprising a spring.
However, Yared et al. teaches in Figure 6 and [0112] an analogous device with the indexing mechanism (height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4) comprising a spring (ball spring plungers 13).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the indexing mechanism of Huttner as modified by Van Neil et al. and Yared et al. to provide the indexing mechanism comprising a spring as taught by Yared et al. because this element is known to enable “repeatable and deterministic angular orientations” of the indexing mechanism, as Yared et al. teaches in [0113].
In regards to claim 48, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claim 1. Huttner and Van Neil et al. do not teach a numeric indicator configured to provide a visual indication to a user of the adjustable lock corresponding to the distance between the immobilization device and the patient anatomy support at the lock location.
However, Yared et al. teaches in Figure 9 and [0114] an analogous device that includes a numeric indicator (height readouts 9) configured to provide a visual indication (as shown in Figure 9) to a user of the adjustable lock corresponding to the distance between the immobilization device (top tray 5) and the patient anatomy support (bottom tray 4) at the lock location (see [0114]).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the adjustable lock of Huttner as modified by Van Neil et al. and Yared et al. to further include a numeric indicator configured to provide a visual indication to a user of the adjustable lock corresponding to the distance between the immobilization device and the patient anatomy support at the lock location as taught by Yared et al. because this element is known provide a means to “show the relative heights” to inform the user, as Yared et al. teaches in [0113].
In regards to claim 49, Huttner, Van Neil et al. and Yared et al. the apparatus of claim 18. Huttner teaches in Figures 1-6 and 8 a plurality (plurality shown in Figure 8) of means for locking (locking pins 1/tip 2/split expandable members 3/notched collars 5/holes 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) with respect to the patient anatomy support (patient restraint board 8) and a plurality (plurality shown in Figure 8) of means for adjusting a distance between (cross-pieces 4; taught in [0030-0031] and [0037] to be rotated between locked and unlocked positions; when in the unlocked position, each cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) while the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) is coupled to (first cross-piece 4 is taught in [0030-0031] and [0037] to be selectively rotated between locked and unlocked positions; when in the unlocked position, the first cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8; the remaining plurality of locking pins 1/tips 2/split expandable members 3/notched collars 5/holes 7 are capable of remaining locked (to connect frame 6 to the patient restraint board 8) when the first cross-piece 4 and its corresponding lock are disengaged) the patient anatomy support (patient restraint board 8), and wherein each of the plurality of means for locking (locking pins 1/tip 2/split expandable members 3/notched collars 5/holes 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) with respect to the patient anatomy support (patient restraint board 8) is independently actuated along an axis ([0029-0031] teaches that the locking pins 1 are independently movable up or down (along the vertical axis of the respective locking pin 1) into respective locked and unlocked positions), and each of the plurality of means for adjusting the distance between (cross-pieces 4; taught in [0030-0031] and [0037] to be rotated between locked and unlocked positions; when in the unlocked position, each cross-piece 4 is capable of disengaging the frame 6 from the patient restraint board 8 (as shown in Figure 1), to create (and therefore, adjust) a distance between the frame 6 and the patient restraint board 8) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) and the patient anatomy support (patient restraint board 8) is independently (inasmuch as each of the first cross-pieces 4 is independently operable, as shown in Figure 8; see also [0027]) actuated about a respective axis (first cross-piece 4 is taught in [0030-0031] and [0037] and Figure 8 to be rotated about the vertical axis of the locking pin 1 between locked and unlocked positions) along which the plurality of means for locking (locking pins 1/tip 2/split expandable members 3/notched collars 5/holes 7; [0029] teaches “a plurality of these locking mechanisms are arrayed about the periphery of the frame 6 in sufficient number so as to securely lock the frame 6 to the patient restraint board 8 when the locking mechanism has been engaged”) the immobilization device (the abstract teaches a “piece of low-melt thermoplastic material affixed to a rigid, non-thermoplastic frame [6]” “for positioning a patient relative to a patient restraint board during radiation therapy”) are actuated.
Huttner and Van Neil et al. do not teach that each of the plurality of means for adjusting defines the discrete positions, each position of the discrete positions corresponding to a relative distance between the immobilization device and the patient anatomy support.
However, Yared et al. teaches in Figures 1 and 6-9 and [0112-0114] an analogous device wherein each of the plurality of means for adjusting (adjustment mechanisms 1; two such mechanisms are shown in Figure 1; [0112] teaches “the adjustment mechanism 1 in a preferred embodiment includes height adjustment knobs 7, knob bearings 8, retaining rings 10, height readout dials 11, wave springs 12, ball spring plungers 13, height adjustment nuts 6, screws 19, top tray 5 and bottom tray 4”) defines the discrete positions ([0113] teaches “the height adjustment knobs 7 allow the user to deterministically and repeatably set the distance between top tray 5 and bottom tray 4 to discrete distances and maintain parallelism”), each position of the discrete positions corresponding to a relative distance between ([0113] teaches “ball spring plungers 13 ride into the detents 14 in the side of the height adjustment knobs 7 forcing the height adjustment knobs 7 into repeatable and deterministic angular orientations” and “the height adjustment knob rotations are converted to linear motion via threads between the height adjustment knobs 7 and height adjustment nuts 6; thus setting the distance between the top tray 5 and bottom tray 4”) the immobilization device (top tray 5) and the patient anatomy support (bottom tray 4).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify each of the plurality of means for adjusting of Huttner as modified by Van Neil et al. and Yared et al. to define the discrete positions, each position of the discrete positions corresponding to a relative distance between the immobilization device and the patient anatomy support as taught by Yared et al. because this element is known to allow the user to deterministically and repeatably set the distance between the immobilization device and the patient anatomy support to discrete distances, as Yared et al. teaches in [0113].
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huttner (US 2005/0045187), in view of Van Neil et al. (US 3,605,846), in view of Yared et al. (US 2011/0071388) and further in view of Leib et al. (US 5,704,746).
In regards to claim 8, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1-3 and 6. Huttner, Van Neil et al. and Yared et al. do not teach that at least one of the plunger and the shaft are keyed to limit rotation of the plunger relative to the shaft.
However, Leib et al. teaches in Figure 4, column 3, lines 11-13 and column 4, lines 9-13 an analogous device (adjustable fastener/lock) wherein at least one of the plunger (drive pin 16) and the shaft (shank 34) are keyed to limit rotation of the plunger relative to the shaft (column 4, lines 9-13 teaches “notches 22, 20 of drive pin 16 align with ridges 72, 74 of fingers 36, 38 [of shank 34] thereby reducing or preventing rotation of drive pin 16”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify at least one of the plunger and the shaft of Huttner as modified by Van Neil et al. and Yared et al. to be keyed to limit rotation of the plunger relative to the shaft as taught by Leib et al. because this element is known to assure an accurate installation of the plunger through the shaft, as Leib et al. teaches in column 4, lines 9-13.
Claim(s) 44-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huttner (US 2005/0045187), in view of Van Neil et al. (US 3,605,846), in view of Yared et al. (US 2011/0071388) and further in view of Hammer et al. (US 2006/0236449 A1).
In regards to claim 44, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1, 31 and 43. Huttner, Van Neil et al. and Yared et al. do not teach the flange being configured to provide a spring force to push the protrusion into the groove.
However, Hammer et al. teaches in Figures 7 and 8 and [0041-0042] an analogous device with the flange (tubular member 142) being configured to provide a spring force to push the protrusion (spring-loaded plunger 146) into ([0041-0042] teaches “outer tubular member 140 contains a plurality of orifices 144 through which a conventional spring-loaded plunger 146 can be disposed” and “inner tubular member 142 contains a helical slot 148 with detents 150, through which spring loaded plunger 146 can be disposed”) the groove (plurality of orifices 144, detent 150).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Huttner as modified by Van Neil et al. and Yared et al. to provide the flange being configured to provide a spring force to push the protrusion into the groove as taught by Hammer et al. because this element is known to make “fine height adjustments readily attainable,” with a more secure, spring-forced engagement of the protrusion within the groove, as Hammer et al. teaches in [0041-0042].
In regards to claims 45-47, Huttner, Van Neil et al. and Yared et al. teach the apparatus of claims 1 and 31. Huttner, Van Neil et al. and Yared et al. do not teach the protrusion being configured to cause an indication of the discrete position of the adjustable lock; and the indication being an audible indication; and the audible indication being a clicking sound.
However, Hammer et al. teaches in Figures 7 and 8 and [0041-0042] an analogous device with the protrusion (spring-loaded plunger 146) being configured to cause an indication (click sound, caused by “click stop” engagement; see [0042]) of the discrete position of the adjustable lock ([0041-0042]); and the indication being an audible indication; and the audible indication being a clicking sound (click sound, caused by “click stop” engagement; see [0042]).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the adjustable lock of Huttner as modified by Van Neil et al. and Yared et al. to provide the protrusion being configured to cause an indication of the discrete position of the adjustable lock; and the indication being an audible indication; and the audible indication being a clicking sound as taught by Hammer et al. because this element is known to provide the user with an audible alert and confirmation that a change in discrete position occurred, as Hammer et al. teaches in [0041-0042].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 4/21/2026
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