DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes legal phraseology (i.e. “comprising”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 10-11 and 13-17 are objected to because of the following informalities which require appropriate correction:
In claim 1 line 1: “a patient’s head and neck” should be “a head and neck of a patient”.
In claim 10 line 4: “their ear” should be “an ear” and “their tragus” should be “the tragus”.
In claim 11 line 1: “a patient’s head and neck” should be “a head and neck of a patient”.
In claim 11 line 4: “the patient’s ear” should be “the ear of the patient” and “their tragus” should be “the tragus”.
In claim 11 line 6: “the height” should be “a height”.
In claim 11 line 7: “the patient’s head and neck” should be “the head and neck of a patient”.
In claim 13: “the positioning” should be “positioning”.
In claim 14: “the aligning” should be “aligning”.
In claim 14 line 1: “the patient’s tragus” should be “the tragus of the patient”.
In claim 15: “the positioning” should be “positioning”.
In claim 16: “the aligning” should be “aligning”.
In claim 16 line 1: “the patient’s tragus” should be “the tragus of the patient”.
In claim 17: “the adjusting” should be “adjusting” and “the tilting” should be “tilting”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sexton (WO 2015/127500).
With respect to claim 1, Sexton discloses a headrest for positioning a patient’s head and neck (head positioning device 1 in fig 1, shown in use positioning a patient’s head and neck in fig 7a) the headrest (1) comprising: a base (base plate 10); an actuating block which includes a housing (hydraulic actuating/drive mechanism 80 which includes a housing as shown in figs 5-6; figs 1 and 5; para [0037]) which is mounted on the base (as shown in fig 1) and an elevator which is vertically slidably engaged with the housing and includes a vertical actuating mechanism and a tilt actuating mechanism (hydraulic actuating mechanism preferably includes a user operable handle 85 which extends in the vertical direction from the housing as shown in fig 1 and which is operable to cause elevation of the head plate and tilting of the head plate – para [0013-0014]; elevation and tilting shown in figures 8-10); a first arm and a second arm (arms 30; fig 1) which are attached to the elevator (para [0041]); a platform (head plate 40 – para [0032]) which is hingedly connected to the tilt actuating mechanism (the arms are pivotally attached to the head plate on one end (the pivot attachment is interpreted as being a hinged connection since it permits rotation around a fixed, central axis) and are fixedly attached to the drive rod at the opposite end for pivotal movement therewith upon user operation of the handle such that the head plate is lifted and/or tilted via operation of the actuating mechanism – para [0013-0014]); a first pivot mount and a second pivot mount which are attached to or are part of the platform and are pivotally attached to the first arm and the second arm, respectively (the arms 30 are pivotally attached at a second end to head plate 40; the attachments between the arms and the plate are interpreted as being pivot mounts in order to provide a pivoting attachment between these elements – see para [0032]); and a landmark cushion (support cushion 50) which is mounted on the platform (removably attached to head plate 40 – para [0030]), includes a lateral midline (interpreted as being a midline that extends across the center of cushion 50 in the same direction as the length/longitudinal direction of the base 10 in fig 1) and a distal end (end of cushion 50 on distal end 11 of plate 10 in fig 1) and defines a central aperture (the cushion 50 is generally c-shaped and thus includes an opening or aperture at the center – see fig 1 and para [0016]), wherein the first pivot mount and the second pivot mount are aligned with the lateral midline (as shown in fig 8, the connection/attachment points between arms 30 and plate 40 (which are interpreted as being pivot mounts) are shown being located at the lateral midline of the cushion 50).
With respect to claim 2, Sexton discloses the device as claimed (see rejection of claim 1) and also discloses that the vertical actuating mechanism (handle 85) includes a gear actuator and at least one rack pair comprising a rack and a gear, wherein the gear actuator is in motive relation with the gear, and the rack is disposed on one of the housing or the elevator and the gear is rotatably disposed on the other of the housing or the elevator (as shown in fig 6, the handle 85 includes a gear on the bottom end which inherently must mesh with a rack on the housing structure; the gear is interpreted as being actuated upon moving the handle 85).
With respect to claim 10, Sexton discloses the headrest device as claimed (see rejection of claim 1) and also discloses a method of a patient self-aligning their head in preparation for a treatment (para [0040]), the method comprising: selecting the headrest (it is inherent that the headrest must be selected in order to be used as described in para [0040]) which is located on a treatment table with the patient lying on the treatment table (it is inherent that the headrest is located on a patient treatment table and that the patient lies on the table during use because the positioner is described as being use in laryngoscopy where the patient is induced by an anaesthetist and thus must be lying on a treatment table for the procedure; see para [0040-0041]); and the patient locating their ear in the central aperture such that their tragus is aligned with the first pivot mount and the second pivot mount, the patient thereby self-aligning their head in preparation for the treatment (as shown in figures 7a-10, the patient’s head is positioned within the opening at the center of the cushion with the ear, including the tragus, aligned with the fixed rods that attach the arms 30 to plate 40)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-9 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sexton (WO 2015/127500).
With respect to claim 3, Sexton discloses the device as claimed (see rejection of claim 2) but does not explicitly disclose that the rack is disposed on the elevator and the gear is rotatably mounted on the housing. It would have been obvious, however, to arrange these elements in this manner since rearranging parts of an invention involves only routine skill in the art.
With respect to claim 4, Sexton discloses the device substantially as claimed (see rejection of claim 3) and also discloses that the tilt actuating mechanism includes a tilt actuator and an angle adjustment arm, wherein the tilt actuator is in motive relation with the angle adjustment arm and the angle adjustment arm is hingedly connected to the platform (the arms are pivotally attached to the head plate on one end (the pivot attachment is interpreted as being a hinged connection since it permits rotation around a fixed, central axis) and are fixedly attached to the drive rod at the opposite end for pivotal movement therewith upon user operation of the handle such that the head plate is lifted and/or tilted via operation of the actuating mechanism – para [0013-0014]).
With respect to claim 5, Sexton discloses the device substantially as claimed (see rejection of claim 4) and also discloses that the actuating block (80) further comprises a plurality of rails and sliders, the rails disposed on one of the housing or the elevator and the sliders disposed on the other of the housing or the elevator (para [0037]).
With respect to claim 6, Sexton discloses the device substantially as claimed (see rejection of claim 5) and also discloses that the device further comprises an outer housing which is connected to the elevator and is disposed outside of the housing (housing 81; fig 4-5).
With respect to claim 7, Sexton discloses the device substantially as claimed (see rejection of claim 6) but does not explicitly disclose that the actuating block is distal to a distal end of the landmark cushion. However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have repositioned the actuating block on the device of Sexton so that the actuating block is distal to a distal end of the landmark cushion since rearranging parts of an invention involves only routine skill in the art.
With respect to claim 8, Sexton discloses the device substantially as claimed (see rejection of claim 7) and also discloses that the landmark cushion (support cushion 50) is releasably mounted on the platform (removably attached to head plate 40 – para [0030]).
With respect to claim 9, Sexton discloses the device substantially as claimed (see rejection of claim 8) and also discloses that the platform (40) is U-shaped (as shown in fig 5) and the platform is nested in the base (as shown in fig 7a where the arms are retracted providing a nested configuration as opposed to the extended arrangement shown in figs 8-10).
Sexton does not, however, explicitly disclose that the base is U-shaped, but it would have been an obvious matter of design choice to one skilled in the art, before the effective filing date of the invention, to construct the base of Sexton having a u-shape since applicant has not disclosed that such a design solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a base for a head positioning device.
With respect to claim 11, Sexton discloses the headrest device substantially as claimed (see rejection of claim 4) and also discloses a method of positioning a patient’s head and neck in preparation for a treatment (para [0040]), the method comprising: selecting the headrest (it is inherent that the headrest must be selected in order to be used as described in para [0040]) which is located on a treatment table with the patient lying on the treatment table (it is inherent that the headrest is located on a patient treatment table and that the patient lies on the table during use because the positioner is described as being use in laryngoscopy where the patient is induced by an anaesthetist and thus must be lying on a treatment table for the procedure; see para [0040-0041]); locating the patient’s ear in the central aperture such that their tragus is aligned with the first pivot mount and the second pivot mount, the patient thereby self-aligning their head in preparation for the treatment (as shown in figures 7a-10, the patient’s head is positioned within the opening at the center of the cushion with the ear, including the tragus, aligned with the fixed rods that attach the arms 30 to plate 40)); actuating the gear actuator; and, concomitantly, the gear actuator adjusting the height of the platform and landmark cushion, thereby positioning the patient’s head and neck (para [0041-0043]).
With respect to claim 12, Sexton discloses the method substantially as claimed (see rejection of claim 11) and also discloses actuating the tilt actuator; and, concomitantly, the angle adjustment arm tilting the platform and the landmark cushion (para [0041-0042]).
With respect to claim 13, Sexton discloses the method substantially as claimed (see rejection of claim 11) and also discloses that the positioning is conducted by a practitioner (the anaesthetist performs the elevating and tilting steps in the positioning process as described in para [0041-0042]).
With respect to claim 14, Sexton discloses the method substantially as claimed (see rejection of claim 11) and also discloses that the aligning the patient’s tragus with the first pivot mount and the second pivot mount is conducted by the patient (as described in para [0040], the device is used/operated by placing the device in the initial base position as seen in Figure 7a so a patient's head can comfortably rest in the support cushion 50 and the patient's head 98 is elevated by between 2-4cm and will rest in the coronal plane by default, thereafter, the patient is induced by the anaesthetist – thus, the steps prior to induction, including positioning the head with the ear/tragus aligned with the pivot mounts as shown in fig 7a, are interpreted as being performed by the patient since they are still awake and conscious during that part of the process).
With respect to claim 15, Sexton discloses the method substantially as claimed (see rejection of claim 12) and also discloses that the positioning is conducted by a practitioner (the anaesthetist performs the elevating and tilting steps in the positioning process as described in para [0041-0042]).
With respect to claim 16, Sexton discloses the method substantially as claimed (see rejection of claim 13) and also discloses that the aligning the patient’s tragus with the first pivot mount and the second pivot mount is conducted by the patient (as described in para [0040], the device is used/operated by placing the device in the initial base position as seen in Figure 7a so a patient's head can comfortably rest in the support cushion 50 and the patient's head 98 is elevated by between 2-4cm and will rest in the coronal plane by default, thereafter, the patient is induced by the anaesthetist – thus, the steps prior to induction, including positioning the head with the ear/tragus aligned with the pivot mounts as shown in fig 7a, are interpreted as being performed by the patient since they are still awake and conscious during that part of the process).
With respect to claim 17, Sexton discloses the method substantially as claimed (see rejection of claim 14) and also discloses that the adjusting the height and the tilting of the platform and the landmark cushion are conducted by a practitioner (the anaesthetist performs the elevating and tilting steps in the positioning process as described in para [0041-0042]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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