DETAILED ACTION
This action is in response to the amendment filed 12/31/2025. Currently, claims 1-23 are pending in the application. New claims 11-23 are 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 amendment to claim 1 is sufficient to overcome the previous objection to claim 1. Applicant’s amendment to claim 2 is sufficient to overcome the previous objection to claim 2. Applicant’s amendment to claim 8 is sufficient to overcome the previous objection to claim 8.
Applicant’s amendment to claim 1 is sufficient to overcome the previous rejection of claims 1-10 under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive.
Applicant’s arguments rely on language solely recited in preamble recitations in claim(s) 1. When reading the preamble in the context of the entire claim, the recitation “method of immobilizing an anatomy if a patient for treatment” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
In response to Applicants argument that Livingston does not teach that table plate 14 and lower support plate 18 are configured to support the anatomy of the patient, the examiner respectfully disagrees. As shown in Figure 2 of Livingston, the table plate 14 and lower support plate 18 are positioned below the head 48 of the patient 46 such that they support the weight thereof. Further, Applicant should note that Livingston explicit teaches plate 18 being a “support” plate and further, teaches that “lower support plate 18 is supported by the table plate 14” (see column 1, lines 66-67).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Election/Restrictions
Newly submitted claims 20 and 21 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the species of new claims 20 and 21 and the originally presented species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. For instance, the originally presented species includes adjusting a distance, in one or more discrete increments, between the frame and the support by rotating an adjuster coupled to at least one of (i) the frame and (ii) the support, and the species of new claims 20 and 21 includes adjusting a distance, in one or more discrete increments, between the frame and the support at a location using one of plural adjusters coupled to the frame or the support at the location and spaced from another one of the plural adjusters, such that the distance between the frame and the support at the location is adjustable independent of a distance between the frame and the support at the another one of the plural adjusters. In addition, these species are not obvious variants of each other based on the current record.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 20 and 21 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Newly submitted claims 22 and 23 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the species of new claims 22 and 23 and the originally presented species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. For instance, the originally presented species includes the support configured to support the anatomy of the patient; and adjusting a distance, in one or more discrete increments, between the frame and the support by rotating an adjuster coupled to at least one of (i) the frame and (ii) the support, and the species of new claims 22 and 23 includes coupling the frame to the support at plural locations spaced from one another; and adjusting a distance, in one or more discrete increments, between the frame and the support at one of the plural locations using one of plural adjusters at the one of the plural locations, such that the distance between the frame and the support at the one of the plural locations is adjustable independent of a distance between the frame and the support at another one of the plural locations. In addition, these species are not obvious variants of each other based on the current record.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 22 and 23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 11 is objected to because of the following informalities: claim 11 recites “the anatomy of the patient is interposed between the thermoplastic preform and the support to immobilize the patient,” which is a claim limitation lacking proper antecedent basis in the specification. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), all recitations of “the preform” (recited twice) should be amended to recite ---the thermoplastic preform---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 13 recites “at least one of the plural adjusters being coupled to the frame and spaced from another one of the plural adjusters.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach one or more of the adjusters being spaced from one another, as claimed. Rather, Applicant’s original disclosure teaches all of the adjusters (135) being spaced from one another, as shown in at least Figures 3A-3C.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 18 recites “indicating the distance between the frame and the support via one or more audible indicators associated with the adjuster.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach the audible indicator functioning to indicate the distance between the frame and the support, as claimed. Rather, Applicant’s original disclosure explicitly teaches the audible indicator functioning to indicate “that the bonnet 180 has been rotated to a next discrete position” (see [0071] of the publication of the present application).
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 13 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 13 recites “one or more of plural adjusters.” It is unclear if these claimed “adjusters” include, or are distinct from, the “adjuster” previously recited in claim 1 (upon which claim 13 depends).
Claim 19 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 19 recites “wherein the two separate frame sections are not directly connected to one another other than by the preform.” The meaning of this claim limitation is unclear. This recitation indicates that the two separate frame sections are directly connected to one another by the preform. However, the preform being an intermediary structure between the two separate frame sections requires that the frame sections are indirectly connected (and not directly connected as claimed). For purposes of examination, the examiner will interpret this claim limitation to mean ---wherein the two separate frame sections are connected to one another other by the preform---.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-8, 10, 12, 14-17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Livingston (US 6,282,739 B1).
In regards to claim 1, Livingston teaches in Figures 1 and 2, columns 1-2, lines 59-2, column 2, lines 4-25, 36-42 and 46-49 and column 3, lines 11-14
forming, from a frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) coupled to (column 2, lines 17-19 teaches “a uniframe 40 that includes a U-shaped support member 42 and a porous moldable thermoplastic member 44”) a thermoplastic preform (porous moldable thermoplastic member 44), an immobilizer corresponding to the anatomy (head 48) of the patient (patient 46) by:
heating the thermoplastic preform (moldable thermoplastic member 44) to a forming temperature (column 2, lines 36-39 teaches “the moldable member 44 of the uniframe 40 is molded to match the contour of the front portion of the head 48 of the patient 46 by heating the moldable member 44”); and
positioning the thermoplastic preform (porous moldable thermoplastic member 44) relative to the anatomy (head 48) of the patient (patient 46) (column 2, lines 36-42 teaches “the moldable member 44 of the uniframe 40 is molded to match the contour of the front portion of the head 48 of the patient 46 by heating the moldable member 44 and then placing the moldable member onto the surface of the front portion of the head 48 of the patient 46 and then permitting the moldable member 44 to cool and harden”) and relative to (column 2, lines 46-49 teaches “the patient 46 is then positioned face down with the front portion of the head 48 of the patient 46 positioned within and supported by the molded member 44 of the uniframe 40 within the adjustable head rest 10;” Figures 1 and 2 teach porous moldable thermoplastic member 44 being positioned above table plate 14 and lower support plate 18 and thus, positioning of the patient 46 to be supported by the porous moldable thermoplastic member 44 necessarily positions the patient 46 relative to the table plate 14 and lower support plate 18; additionally the table plate 14 and lower support plate 18 are part of the adjustable head rest 10, as taught in column 1, lines 59-62) a support (table plate 14 and lower support plate 18; columns 1-2, lines 63-2 teaches “a plurality of vertical support posts 16a, 16b, 16c, and 16d, are supported by and extend in a vertical direction from the table plate 14,” “a lower support plate 18 is supported by the table plate 14” and “a pair of vertical support posts 20a and 20b and a vertical support member 22 are supported by and extend from the lower support plate 18”), the support (table plate 14 and lower support plate 18) configured to support (as shown in Figure 2) the anatomy (head 48) of the patient (patient 46);
coupling (via lead screw 26, as shown in Figure 1) (column 2, lines 15-20 teaches “swivel clamps 38a, 38b, 38c, and 38d are pivotably connected to the base plate 34 for removably attaching a uniframe 40 that includes a U-shaped support member 42 and a porous moldable thermoplastic member 44 to the base plate 34”) the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) to the support (table plate 14 and lower support plate 18); and
adjusting a distance (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”), in one or more discrete increments (column 3, lines 11-14 teaches “a counter, or other visual indicator, may be added to the upper support 24 in order to provide a visual indication of the [discrete] rotational position of the adjustable lead screw 26”), between the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and the support (table plate 14 and lower support plate 18) by rotating (column 2, lines 9-11 teaches “an adjustment knob 32 is connected to the upper end of the actuating lead screw 26 for permitting a user to rotate the adjusting lead screw;” column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) an adjuster (actuating lead screw 26 and adjustment knob 32) coupled to (column 2, lines 4-9 teaches “an actuating lead screw 26 is rotatably supported by and extends between the lower support plate 18 and the upper support 22” and “a mounting bracket 28 that includes a pair of openings 30a and 30b for receiving the vertical supports, 20a and 20b, respectively is threadedly coupled to the actuating lead screw 26”) at least one of (both of) (i) the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and (ii) the support (table plate 14 and lower support plate 18).
In regards to claim 2, Livingston teaches the method of claim 1. Livingston teaches in column 2, lines 23-25 and column 3, lines 9-11 that the adjusting (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) comprises adjusting a distance between (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and the support (table plate 14 and lower support plate 18) at one (first post 12) of plural adjusters (posts 12; taught in column 3, line 9 to be “adjustable”) independent of (column 3, lines 9-11 teaches “the lengths of the posts 12 may be adjustable thereby permitting the angle of inclination of the head 48 of the patient 46 to be controllably adjusted;” for the user’s head to be angled in use, it is understood that the posts 12 would need to be independently adjustable such that at least two posts 12 have differing lengths) a distance between the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and the support (table plate 14 and lower support plate 18) at another one (second post 12) of the plural adjusters (posts 12; taught in column 3, line 9 to be “adjustable”).
In regards to claim 3, Livingston teaches the method of claim 1. Livingston teaches in column 2, lines 21-25 that the adjusting (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) comprises adjusting the distance between (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and the support (table plate 14 and lower support plate 18) while the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) is coupled to (column 2, lines 21-25 teaches “During operation, the uniframe 40 may be removably connected to the base plate 34 by pivotally adjusting the swivel clamps 38a, 38b, 38c, and 38d. The vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32.”) the support (table plate 14 and lower support plate 18).
In regards to claim 4, Livingston teaches the method of claim 1. Livingston teaches in column 2, lines 21-25 prior to the adjusting step (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”), deactivating (column 2, lines 21-25 teaches “During operation, the uniframe 40 may be removably connected to the base plate 34 by pivotally adjusting the swivel clamps 38a, 38b, 38c, and 38d. The vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32.;” it is clear that in order to connect the uniframe 40 to table plate 14/lower support plate 18 via base plate 34 using swivel clamps 38a, 38b, 38c, and 38d, the uniframe 40 must have been initially uncoupled to table plate 14/lower support plate 18 via base plate 34 by disengaging/deactivating swivel clamps 38a, 38b, 38c, and 38d) a lock (swivel clamps 38a, 38b, 38c, and 38d; column 2, lines 15-20 teaches “swivel clamps 38a, 38b, 38c, and 38d are pivotably connected to the base plate 34 for removably attaching a uniframe 40 that includes a U-shaped support member 42 and a porous moldable thermoplastic member 44 to the base plate 34”) coupled to (column 2, lines 15-20 teaches “swivel clamps 38a, 38b, 38c, and 38d are pivotably connected to the base plate 34”) at least one of (i) the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and (ii) the support (table plate 14 and lower support plate 18) to permit uncoupling of the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) from the support (table plate 14 and lower support plate 18) .
In regards to claim 6, Livingston teaches the method of claim 1. Livingston teaches in Figure 1 and column 2, lines 4-6 that the adjuster (actuating lead screw 26 and adjustment knob 32) is integrated into (as shown in Figure 1; column 2, lines 4-6 teaches “actuating lead screw 26 is rotatably supported by and extends between the lower support plate 18 and the upper support 22”) the support (table plate 14 and lower support plate 18).
In regards to claim 7, Livingston teaches the method of claim 1. Livingston teaches in column 2, lines 9-11 and 23-25 that adjusting (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) comprises rotating a knob (adjustment knob 32) to adjust the distance between (column 2, lines 9-11 teaches “an adjustment knob 32 is connected to the upper end of the actuating lead screw 26 for permitting a user to rotate the adjusting lead screw;” column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and the support (table plate 14 and lower support plate 18).
In regards to claim 8, Livingston teaches the method of claims 1 and 7. Livingston teaches in column 2, lines 6-11 and 23-25 and column 3, lines 11-14 that the adjusting (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) comprises rotating a knob (adjustment knob 32) to slide a stepped sliding member (actuating lead screw 26; column 2, lines 6-9 teaches actuating lead screw 26 being a threaded screw; a threaded screw can be considered “stepped” inasmuch as the thread includes varying vertical heights, or steps; column 2, line 11 teaches rotation, or sliding, of the actuating lead screw 26) to adjust the distance between (column 2, lines 9-11 teaches “an adjustment knob 32 is connected to the upper end of the actuating lead screw 26 for permitting a user to rotate the adjusting lead screw;” column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and the support (table plate 14 and lower support plate 18) between the one or more discrete increments (column 3, lines 11-14 teaches “a counter, or other visual indicator, may be added to the upper support 24 in order to provide a visual indication of the [discrete] rotational position of the adjustable lead screw 26”).
In regards to claim 10, Livingston teaches the method of claim 1. Livingston teaches in column 1, lines 29-36 conducting radiation therapy on (column 1, lines 29-36 “a method of providing radiation therapy to a rear portion of a head of a patient is provided that includes supporting the front portion of the head of the patient within a molded member that matches the contours of the front portion of the head of the patient, adjusting the vertical elevation of the molded member, and deliverying a prescribed amount of radiation to the rear portion of the head of the patient”) the anatomy (head 48) of the patient (patient 46).
In regards to claim 12, Livingston teaches the method of claim 1. further comprising adjusting a distance (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) between the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and a surface of the support (table plate 14 and lower support plate 18) to which the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) is coupled (via lead screw 26, as shown in Figure 1) (column 2, lines 15-20 teaches “swivel clamps 38a, 38b, 38c, and 38d are pivotably connected to the base plate 34 for removably attaching a uniframe 40 that includes a U-shaped support member 42 and a porous moldable thermoplastic member 44 to the base plate 34”).
In regards to claim 14, Livingston teaches the method of claim 1. Livingston teaches in column 2, lines 4-9 and Figure 1 the adjuster (actuating lead screw 26 and adjustment knob 32) is coupled to (column 2, lines 4-9 teaches “an actuating lead screw 26 is rotatably supported by and extends between the lower support plate 18 and the upper support 22;” Figure 1 teaches all elements of the head rest 10 being connected to form a single unit) the support (table plate 14 and lower support plate 18).
In regards to claim 15, Livingston teaches the method of claims 1 and 14. Livingston teaches in column 2, lines 4-9 and Figure 1 that the adjuster (actuating lead screw 26 and adjustment knob 32) is positioned on (column 2, lines 4-9 teaches “an actuating lead screw 26 is rotatably supported by and extends between the lower support plate 18 and the upper support 22;” Figure 1 teaches the actuating lead screw 26 and adjustment knob 32 being supported by, and positioned on top of, the table plate 14 and lower support plate 18) the support (table plate 14 and lower support plate 18).
In regards to claim 16, Livingston teaches the method of claims 1 and 14. Livingston teaches in Figure 1 that the adjuster (actuating lead screw 26 and adjustment knob 32) is integrated into (inasmuch as actuating lead screw is connected to and extends down in toward, as shown in Figure 1) the support (table plate 14 and lower support plate 18).
In regards to claim 17, Livingston teaches the method of claim 1. Livingston teaches in column 2, lines 23-25 and column 3, lines 11-14 that adjusting (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) further comprises rotating the adjuster (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) and indicating the distance between the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and the support (table plate 14 and lower support plate 18) via one or more visual indicators (column 3, lines 11-14 teaches “a counter, or other visual indicator, may be added to the upper support 24 in order to provide a visual indication of the rotational position of the adjustable lead screw 26;” as taught in column 2, lines 23-25, the position of the adjustable lead screw 26 is indicative of the distance between mounting bracket 28/base plate 34/uniframe 40/U-shaped support member 42 and the table plate 14/lower support plate 18) associated with the adjuster (actuating lead screw 26 and adjustment knob 32).
In regards to claim 19, Livingston teaches the method of claim 1. Livingston teaches in Figure 1 that the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) is a split frame comprising two separate frame sections (inasmuch as the two lateral extents of the base plate 34 are separated and spaced from one another, as shown in Figure 1) connected by (as shown in Figure 1) the preform (moldable thermoplastic member 44) and wherein the two separate frame sections (the two lateral extents of the base plate 34) are connected to one another other by (as shown in Figure 1) the preform (moldable thermoplastic member 44).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Livingston (US 6,282,739 B1) in view of Coppens et al. (US 2004/0123388 A1).
In regards to claim 5, Livingston teaches the method of claim 1. Livingston does not teach repeating the coupling and adjusting steps while the anatomy of the patient is supported by the support.
However, Coppens et al. teaches in [0009], [0023] and [0026] an analogous method that includes repeating the coupling (by engaging one or more clips 72 to secure the thermoplastic mesh mask in place, as taught by [0026]) and adjusting steps (see [0023]) while the anatomy (head) of the patient is supported by the support ([0009] teaches “the patient support device of the present invention provides a head, shoulder and torso support and immobilization device that is adaptable to most commercially available treatment tables, is easily adjustable and provides efficient repeatability while allowing 360-degree treatment of the head and neck;” [0026] teaches that “the thermoplastic mesh mask is formed to fit the patient's features and dimensions and is attached to the headrest frame 40 in order to restrict the patient's movement and accurately and repeatably position the patient for treatment” and “the attachment means can be one or more clips 72”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the method of Livingston to include repeating the coupling and adjusting steps while the anatomy of the patient is supported by the support because this element is known “to restrict the patient's movement and accurately and repeatably position the patient for treatment,” as Coppens et al. teaches in [0026].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Livingston (US 6,282,739 B1) in view of Ulfarsson et al. (US 2011/0098722 A1).
In regards to claim 9, Livingston teaches the method of claim 1. Livingston does not teach conducting stereotactic radiosurgery on the anatomy of the patient.
However, Ulfarsson et al. teaches in Figure 1 and [0131] an analogous method that includes conducting stereotactic radiosurgery on the anatomy of the patient ([0131] teaches “stereotactic radiosurgery uses a large dose of radiation to destroy tumor tissue, e.g. in the brain” and “the stereotactic frame 300 is used to aim high-dose radiation beams directly at the tumor inside the patient”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the method of Livingston to include conducting stereotactic radiosurgery on the anatomy of the patient as taught by Ulfarsson et al. because this element is known to use “a large dose of radiation to destroy tumor tissue, e.g. in the brain” and provide that “most nearby tissues are not damaged by this procedure,” which “minimizes the effect of the radiation on the normal brain and reduces the risk of side effects,” as Ulfarsson et al. teaches in [0004] and [0131].
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Livingston (US 6,282,739 B1) in view of De Mooij (US 2015/0047652 A1).
In regards to claim 11, Livingston teaches the method of claim 1. Livingston teaches in Figure 2 and column 2, lines 36-43 positioning the thermoplastic preform (moldable thermoplastic member 44) relative to the anatomy (head 48) of the patient (patient 46) and relative to (as shown in Figure 2; column 2, lines 36-43 teaches “the moldable member 44 of the uniframe 40 is molded to match the contour of the front portion of the head 48 of the patient 46 by heating the moldable member 44 and then placing the moldable member onto the surface of the front portion of the head 48 of the patient 46” and “the adjustable head rest 10 [which includes table plate 14 and lower support plate 18] is then positioned below”) the support (table plate 14 and lower support plate 18).
Livingston does not teach positioning such that the anatomy of the patient is interposed between the thermoplastic preform and the support to immobilize the patient.
However, De Mooij teaches in the abstract, Figure 11 and [0147-0148] an analogous method that includes positioning such that the anatomy (head) of the patient is interposed between (as taught in [0147-0148]) the thermoplastic preform (moldable thermoplastic sheets 11, 11') and the support (flanged support member 3) to immobilize the patient (the abstract teaches the device functioning “for immobilization of a patient body part”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the method of Livingston to include positioning such that the anatomy of the patient is interposed between the thermoplastic preform and the support to immobilize the patient as taught by De Mooij because this element is known to provide more secure immobilization of the entire periphery of the anatomy of the patient.
In regards to claim 13, Livingston teaches the method of claim 1. Livingston does not teach adjusting the distance between the frame and the support by rotating one or more of plural adjusters, at least one of the plural adjusters being coupled to the frame and spaced from another one of the plural adjusters, such that the distance between the frame and the support at the at least one of the plural adjusters is adjustable independent of a distance between the frame and the support at the another one of the plural adjusters.
However, De Mooij teaches in Figures 2 and 4, [0141-0144] an analogous method that includes adjusting the distance between (by connecting or disconnecting the relative structures; see [0143-0144]) the frame (circumferential rim 12’) and the support (circumferential rim 12 and flanged support member 3) by rotating ([0142] teaches the connection means 8’ being screws, which are understood to require rotation to facilitate operation thereof) one or more of plural adjusters (connection means 8’; [0142] teaches “each circumferential rim is provided with 3 to 30, preferably 5 to 25, more preferably 10 to 20 connection means”), at least one of the plural adjusters (connection means 8’) being coupled to (as shown in Figures 2 and 4; [0141] teaches “each a circumferential rim 12, 12' having a number of connection means 8, 8'”) the frame (circumferential rim 12’) and spaced from another one of (as shown in Figures 2 and 4) the plural adjusters (connection means 8’), such that the distance between (formed when the relative structures are connected or disconnect from one another) the frame (circumferential rim 12’) and the support (circumferential rim 12 and flanged support member 3) at the at least one of the plural adjusters (connection means 8’) is adjustable independent of a distance between (inasmuch as the connection means 8’ are taught in [0142] to be independently operable screws) the frame (circumferential rim 12’) and the support a(circumferential rim 12 and flanged support member 3) t the another one of the plural adjusters (connection means 8’).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the method of Livingston to include adjusting the distance between the frame and the support by rotating one or more of plural adjusters, at least one of the plural adjusters being coupled to the frame and spaced from another one of the plural adjusters, such that the distance between the frame and the support at the at least one of the plural adjusters is adjustable independent of a distance between the frame and the support at the another one of the plural adjusters as taught by De Mooij because this element is known to provide versatility in the manner and type of adjustment capable of being achieved.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Livingston (US 6,282,739 B1) in view of Phillips et al. (US 2002/0073487 A1).
In regards to claim 18, Livingston teaches the method of claim 1. Livingston teaches in column 2, lines 23-25 and column 3, lines 11-14 that adjusting (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) further comprises rotating the adjuster (column 2, lines 23-25 teaches “the vertical elevation of the uniframe 40 may then be adjusted by rotating the actuating lead screw 26 using the adjustment knob 32”) and indicating the distance between the frame (mounting bracket 28, base plate 34, uniframe 40, U-shaped support member 42) and the support (table plate 14 and lower support plate 18) via one or more indicators (column 3, lines 11-14 teaches “a counter, or other visual indicator, may be added to the upper support 24 in order to provide a visual indication of the rotational position of the adjustable lead screw 26;” as taught in column 2, lines 23-25, the position of the adjustable lead screw 26 is indicative of the distance between mounting bracket 28/base plate 34/uniframe 40/U-shaped support member 42 and the table plate 14/lower support plate 18) associated with the adjuster (actuating lead screw 26 and adjustment knob 32).
Livingston does not teach the one or more indicators being audible.
However, Phillips et al. teaches in [0073] an analogous method with the one or more indicators being audible ([0073] teaches “an audible sound and/or visual cues may be provided”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the method of Livingston to provide the one or more indicators being audible as taught by Phillips et al. because this element is known in the art to be a suitable alternative for visual indicator(s) that “may be provided to notify the user,” as Phillips et al. teaches in [0073].
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 4/29/2026
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