DETAILED ACTION
In Applicant’s Response filed 4/29/26, Applicant cancelled claims 1-20 and added new claims 21-42. Currently, claims 21-42 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of species 5 in the reply filed on 4/29/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 27-30 and 40 are objected to because of the following informalities which require appropriate correction:
In claim 27, line 1 should be amended to recite: “A combination comprising the helmet of claim 21 with a surgical frame” for improved clarity.
In claim 28 line 1: “claim 7” should be “claim 27”.
In claim 29 line 1: “claim 8” should be “claim 28”.
In claim 30, line 1 should be amended to recite: “A combination comprising the helmet of claim 30 with a surgical frame” for improved clarity.
In claim 40, line 1 should be amended to recite: “A combination comprising the helmet of claim 37 with a surgical frame” for improved clarity.
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) 21, 23-25 and 41-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raffler (US 5012533).
With respect to claim 21, Raffler discloses a helmet for protecting and supporting a head of a patient (protective helmet 1), the helmet (1) comprising:
a posterior portion (back of the head part 4; figs 2, 4, 5) including a first lateral side, a second lateral side and a first upper side (identified in annotated fig 5), a first body portion extending between the first lateral side, the second lateral side, and the first upper side (portion of part 4 that includes openings for straps as shown in fig 5), and the first body portion including an inner surface for positioning adjacent the head of the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7);
a first lateral portion (side part 5; figs 1,5) including a first posterior side and a first anterior side (identified in annotated fig 5), a second body portion extending between the first posterior side and the first anterior side (portion of part 5 that includes the strap as shown in fig 5), and the second body portion including an inner surface for positioning adjacent the head of
the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7), the first lateral portion (5) being hingedly connected to the posterior portion (4) adjacent the first lateral side and the first posterior side (as shown in fig 5; see annotated fig 5; the shell parts are interconnected by a hinged plate – col 1 lines 60-63, col 2 lines 3-5), and being moveable (via the hinged plate) between an open position (flat packing state shown in fig 5) and a closed position relative to the posterior portion (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4);
a second lateral portion (side part 6, figs 1, 4, 5) including a second posterior side and a second anterior side (identified in annotated fig 5), a third body portion extending between the second posterior side and the second anterior side (portion of part 6 that includes the strap as shown in fig 5), and the third body portion including an inner surface for positioning adjacent the head of the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7), the second lateral portion being hingedly connected to the posterior portion adjacent the second lateral side and the second posterior side (as shown in fig 5; see annotated fig 5; the shell parts are interconnected by a hinged plate – col 1 lines 60-63, col 2 lines 3-5), and being moveable (via the hinged plate) between an open position (flat packing state shown in fig 5) and a closed position relative to the posterior portion (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4); and
an anterior portion (forehead part 3; figs 1-3 and 5) including a third lateral side, a fourth lateral side and a second upper side (identified in annotated fig 5), a fourth body portion extending between the third lateral side, the fourth lateral side, and the second upper side (portion of part 3 that includes the strap as shown in fig 5), an opening formed in the fourth body portion (holes 16; fig 5), and the fourth body portion including an inner surface for positioning adjacent the head of the patient, and the anterior portion being hingedly connected to the posterior portion adjacent the first upper side and the second upper side, and being moveable (via the hinged plate) between an open position (flat packing state shown in fig 5) and a closed position (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) relative to the posterior portion, the first lateral portion and the second lateral portion (the shell parts are formed independently of each other and are each attached to the hinged plate on a separate arm as shown in fig 5 – thus, the shell parts are interpreted as being independently movable);
wherein, when the first lateral portion is in the closed position relative to the
posterior portion, when the second lateral portion is in the closed position relative to the
posterior portion, and when the anterior portion is in the closed position relative to the
posterior portion and in the closed positions relative to the first lateral portion and the
second lateral portion, the helmet is assembled (as shown in figs 1-4).
Raffler does not specifically disclose that the helmet is for protecting/supporting the head during surgery, but with regard to this statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over the device of Raffler which is interpreted as being capable of being used during surgery, as claimed, if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Additionally, the law of anticipation does not require that the reference “teach” what the subject patent teaches, but rather it is only necessary that the claims under attack “read on” something in the reference. Kalman v. Kimberly Clark Corp., 218 USPQ 781 (CCPA 1983). Furthermore, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
ANNOTATED FIG 5 :
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With respect to claim 23, Raffler discloses a helmet as claimed (see rejection of claim 21) and Raffler also discloses that the inner surfaces of the posterior portion, the first lateral portion, the second lateral portion, and the anterior portion are each covered with padding to cushion the head of the patient when the helmet is assembled therearound (inner contour of the shell parts can be provided with soft material cushion 23; see col 4 lines 51-54; fig 3).
With respect to claim 24, Raffler discloses a helmet as claimed (see rejection of claim 21) and Raffler also discloses a first hinge attached to the posterior portion and the first lateral portion form a first hinged connection, a second hinge attached to the posterior portion and the second lateral portion form a second hinged connection, and a third hinge attached to the posterior portion and the anterior portion form a third hinged connection (the hinged plate is configured as a cruciform hinged plate, whose center is located in the center parts of the helmet shell and whose arms extend into the individual shell parts – col 2 lines 45-56; the hinged plate provides individual hinged transition areas at each of the shell parts – col 2 lines 3-5).
With respect to claim 25, Raffler discloses a helmet as claimed (see rejection of claim 24) and Raffler also discloses a first latch secured between the posterior portion and the first lateral portion serves to hold the first lateral portion in the closed position relative to the posterior portion (part of strap 13 extends between the shell parts 4 and 5 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32), a second latch secured between the posterior portion and the second lateral portion serves to hold the second lateral portion in the closed position relative to the posterior portion (part of strap 13 extends between the shell parts 4 and 6 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32), and a third latch secured between the posterior portion and the anterior portion serves to hold the anterior portion in the closed position relative to the posterior portion (strap 8 extends between the shell parts 3 and 4 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32).
With respect to claim 41, Raffler discloses a helmet (protective helmet 1) comprising:
a posterior portion (back of the head part 4; figs 2, 4, 5);
a first lateral portion (side part 5; figs 1,5) hingedly connected to the posterior portion (4) (as shown in fig 5; the shell parts are interconnected by a hinged plate – col 1 lines 60-63, col 2 lines 3-5), and being moveable (via the hinged plate) between a first open position (flat packing state shown in fig 5) and a first closed position relative to the posterior portion (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4);
a second lateral portion (side part 6, figs 1, 4, 5) hingedly connected to the posterior portion (as shown in fig 5; the shell parts are interconnected by a hinged plate – col 1 lines 60-63, col 2 lines 3-5), and being moveable (via the hinged plate) between a second open position (flat packing state shown in fig 5) and a second closed position relative to the posterior portion (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4); and
an anterior portion (forehead part 3; figs 1-3 and 5) hingedly connected to the posterior portion (as shown in fig 5; the shell parts are interconnected by a hinged plate – col 1 lines 60-63, col 2 lines 3-5), and being moveable (via the hinged plate) between a third open position (flat packing state shown in fig 5) and a third closed position (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) relative to the posterior portion, and movable between a fourth open position and a fourth closed position relative to the first lateral portion and the second lateral portion (the shell parts are formed independently of each other and are each attached to the hinged plate on a separate arm as shown in fig 5 – thus, the shell parts are interpreted as being independently movable);
wherein the helmet is disassembled when the first lateral portion is in the first open position, the second lateral portion is in the second open position, the anterior portion is in the third open position, and the anterior portion is in the fourth open position (as shown in fig 5), and
wherein the helmet is assembled when the first lateral portion is in the first closed position, the second lateral portion is in the second closed position, the anterior portion is in the third closed position, and the anterior portion is in the fourth closed position (as shown in figs 1-4).
With respect to claim 42, Raffler discloses method comprising:
providing a helmet (protective helmet 1; the helmet inherently is “provided” in order to be used) comprising a posterior portion (back of the head part 4; figs 2, 4, 5), a first lateral portion (side part 5; figs 1,5), a second lateral portion (side part 6, figs 1, 4, 5), and an anterior portion (forehead part 3; figs 1-3 and 5);
coupling the helmet to a head of a patient (as shown in figs 1-4) by pivoting the first lateral portion, the second lateral portion and the anterior portion relative to the posterior portion, and pivoting the anterior portion relative to the first lateral portion and the second lateral portion (the shell parts are interconnected by a hinged plate – col 1 lines 60-63, col 2 lines 3-5; the shell parts are bent or “pivoted” downwards from the flat configuration in fig 5 to correspond to the skull as shown in figs 1-4); and
uncoupling the helmet from the head of the patient by pivoting the first lateral portion, the second lateral portion, and the anterior portion relative to the posterior portion, and pivoting the anterior portion relative to the first lateral portion and the second lateral portion (the shell parts are interconnected by a hinged plate – col 1 lines 60-63, col 2 lines 3-5; the shell parts are configured to bend or pivot between the flat configuration in fig 5 to the configuration shown in figs 1-4 where the parts correspond to the skull; the shell parts are formed independently of each other and are each attached to the hinged plate on a separate arm as shown in fig 5 – thus, the shell parts are interpreted as being independently movable and, thus, are interpreted as also pivoting via the hinged plate between the configuration in figs 1-4 to the configuration in fig 5).
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 22 is rejected under 35 U.S.C. 103 as being unpatentable over Raffler (US 5012533) in view of Mazzei (US 6112333).
With respect to claim 22, Raffler discloses a helmet as claimed (see rejection of claim 21) and Raffler also discloses a method of using the helmet (1) comprising assembling the helmet around the head of the patient (shown assembled on the head in figures 1-4) by placing the posterior portion (4) adjacent a posterior portion of the head of the patient (as shown in fig 4), moving the first lateral portion (5) from the open position (flat state shown in fig 5) to the closed position (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) to position the first lateral portion (5) adjacent a first lateral side of the head of the patient (shown in figs 1, 2 and 4), moving the second lateral portion (6) from the open position (flat state shown in fig 5) to the closed position (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) to position the second lateral portion (6) adjacent a second lateral side of the head of the patient (as shown in figs 1 and 4), and moving the anterior portion (3) from the open positions (flat state shown in fig 5) to the closed positions (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) relative to the posterior portion, the first lateral portion, and the second lateral portion (the shell parts are formed independently of each other and are each attached to the hinged plate on a separate arm as shown in fig 5 – thus, the shell parts are interpreted as being independently movable such that the part 3 moves relative to parts 4, 5 and 6) to position the anterior portion (3) adjacent a face of the patient (shown in figs 1-3) such that a nasal cavity and an oral cavity of the patient are accessible (as shown in fig 1).
Raffler does not, however, disclose that the nasal cavity and oral cavity of the patient are accessible through the opening in the anterior portion.
Mazzei teaches a safety helmet comprising an anterior portion that includes an opening therein configured such that the nasal cavity and oral cavity of the patient are accessible through the opening (the ocular aperture 37 intersects the chin support aperture 39 as shown in figs 1-3, thus providing an opening extending over the nasal cavity area; the chin support aperture allows for viewing and access to the lower mouth area of the face of the patient). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the anterior portion of the device of Raffler to further include an opening configured such that the nasal cavity and oral cavity of the patient are accessible through the opening, like the anterior portion of the Helmet of Mazzei, in order to prevent interference with the user’s breathing.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Raffler (US 5012533) in view of Farquharson (US 4404690).
With respect to claim 26, Raffler discloses a helmet as claimed (see rejection of claim 21) but does not disclose that a first aperture for providing access to a first ear of the patient is formed in the first lateral portion, and a second aperture for providing access to a second ear of the patient is formed in the second lateral portion.
Farquharson teaches a protective helmet that includes left and right side portions that are configured to extend over the sides of the user’s face to beneath the ears and which include an opening 30 provided in each side piece, for the ear (see i.e. fig 7). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the first and second lateral portions of the device of Raffler to be configured to extend further down the sides of the user’s face to beneath the ears, like the sides of the helmet of Farquharson, to provide increased protection to the face and, furthermore, to include a first aperture for providing access to a first ear of the patient formed in the first lateral portion, and a second aperture for providing access to a second ear of the patient formed in the second lateral portion, like the openings 30 in Farquharson, in order to improve comfort and prevent interference with the user’s hearing.
Claims 27-28, 30-35, 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Raffler (US 5012533) in view of Lim et al (US 2019/0000702).
With respect to claim 27, Raffler discloses a helmet as claimed (see rejection of claim 21) but does not disclose the helmet in combination with a surgical frame, wherein the helmet includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion, the adjustable-connection assembly including a first post portion extending outwardly relative to the first lateral portion, and a second post portion rotatably attached to the first post portion; and the surgical frame comprising a support structure, a main beam portion rotatable relative to the support structure, and a helmet-interconnection assembly attached to the main beam portion, the helmet-interconnection assembly extending outwardly from the main beam portion, and including a third post portion and a connector configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof.
Lim, however, teaches a helmet (head support 20) in combination with a surgical frame (surgical frame 10), wherein the helmet (20) includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion (connection between support 20 and the frame 10 shown in figs 4-6 and 9), the adjustable-connection assembly including a first post portion (106) extending outwardly relative to the first lateral portion (shown in figs 4-5, 9), and a second post portion (104) rotatably attached to the first post portion (para [0061]; figs 4-6); and the surgical frame (10) comprising a support structure (14), a main beam portion (12) rotatable relative to the support structure (para [0052]), and a helmet-interconnection assembly attached to the main beam portion (mechanism 110 connecting beam 104 to the frame as shown in figs 9-10), the helmet-interconnection assembly extending outwardly from the main beam portion (shown in figs 9-10), and including a third post portion and a connector (links 112 and 114 coupled via a connector to beam 104) configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof (shown in figs 9-10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the helmet of Raffler in combination with a surgical frame, wherein the helmet includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion, the adjustable-connection assembly including a first post portion extending outwardly relative to the first lateral portion, and a second post portion rotatably attached to the first post portion; and the surgical frame comprising a support structure, a main beam portion rotatable relative to the support structure, and a helmet-interconnection assembly attached to the main beam portion, the helmet-interconnection assembly extending outwardly from the main beam portion, and including a third post portion and a connector configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof, as taught by Lim, in order to assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
With respect to claim 28, Raffler in view of Lim discloses the combination substantially as claimed (see rejection of claim 27) and Lim further teaches that an interconnection is provided between the connector and the second post portion (links 112 and 114 are coupled via a connector to beam 104; there is an interconnection between this connector and the beam 104 as best shown in fig 11) to attach the helmet-interconnection assembly to the adjustable-connection assembly (as shown in figs 9-11), and the interconnection is configured to provide controlled movement of the helmet toward and away from the main beam portion (movement is shown between figs 9-10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the combination of Raffler in view of Lim such that an interconnection is provided between the connector and the second post portion to attach the helmet-interconnection assembly to the adjustable-connection assembly, and the interconnection is configured to provide controlled movement of the helmet toward and away from the main beam portion, as taught by Lim, in order to further assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
With respect to claim 30, Raffler discloses a helmet for protecting and supporting a head of a patient (protective helmet 1), the helmet (1) comprising:
a posterior portion (back of the head part 4; figs 2, 4, 5) including a first lateral side, a second lateral side and a first upper side (identified in annotated fig 5), a first body portion extending between the first lateral side, the second lateral side, and the first upper side (portion of part 4 that includes openings for straps as shown in fig 5), and the first body portion including an inner surface for positioning adjacent the head of the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7);
a first lateral portion (side part 5; figs 1,5) including a first posterior side and a first anterior side (identified in annotated fig 5), a second body portion extending between the first posterior side and the first anterior side (portion of part 5 that includes the strap as shown in fig 5), and the second body portion including an inner surface for positioning adjacent the head of
the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7), the first lateral portion (5) being moveable (the shell parts are interconnected by a hinged plate and moved via the hinged plate – col 1 lines 60-63, col 2 lines 3-5) between an open position (flat packing state shown in fig 5) and a closed position relative to the posterior portion (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4);
a second lateral portion (side part 6, figs 1, 4, 5) including a second posterior side and a second anterior side (identified in annotated fig 5), a third body portion extending between the second posterior side and the second anterior side (portion of part 6 that includes the strap as shown in fig 5), and the third body portion including an inner surface for positioning adjacent the head of the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7), the second lateral portion being moveable (the shell parts are interconnected by a hinged plate and thus movable via the hinged plate – col 1 lines 60-63, col 2 lines 3-5) between an open position (flat packing state shown in fig 5) and a closed position relative to the posterior portion (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4); and
an anterior portion (forehead part 3; figs 1-3 and 5) including a third lateral side, a fourth lateral side and a second upper side (identified in annotated fig 5), a fourth body portion extending between the third lateral side, the fourth lateral side, and the second upper side (portion of part 3 that includes the strap as shown in fig 5), an opening formed in the fourth body portion (holes 16; fig 5), and the fourth body portion including an inner surface for positioning adjacent the head of the patient, and the anterior portion being moveable (the shell parts are interconnected by a hinged plate and thus movable via the hinged plate – col 1 lines 60-63, col 2 lines 3-5) between an open position (flat packing state shown in fig 5) and a closed position (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) relative to the posterior portion, the first lateral portion and the second lateral portion (the shell parts are formed independently of each other and are each attached to the hinged plate on a separate arm as shown in fig 5 – thus, the shell parts are interpreted as being independently movable);
wherein, after the first lateral portion is moved to the closed position relative to the
posterior portion, after the second lateral portion is moved to the closed position relative to the posterior portion, and after the anterior portion is moved to the closed position relative to the posterior portion and moved to the closed positions relative to the first lateral portion and the second lateral portion, the helmet is assembled (as shown in figs 1-4).
Raffler does not specifically disclose that the helmet is for protecting/supporting the head during surgery, but with regard to this statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over the device of Raffler which is interpreted as being capable of being used during surgery, as claimed, if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Additionally, the law of anticipation does not require that the reference “teach” what the subject patent teaches, but rather it is only necessary that the claims under attack “read on” something in the reference. Kalman v. Kimberly Clark Corp., 218 USPQ 781 (CCPA 1983). Furthermore, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
ANNOTATED FIG 5 :
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Raffler does not, however, disclose that the helmet includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion, the adjustable-connection assembly including a post portion rotatably attached relative to the first lateral portion wherein the post portion of the adjustable-connection assembly is attachable to componentry of a moveable portion of a surgical frame to maintain a position of the helmet relative to the moveable portion.
Lim, however, teaches a helmet (head support 20) in combination with a surgical frame (surgical frame 10), wherein the helmet (20) includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion (connection between support 20 and the frame 10 shown in figs 4-6 and 9), the adjustable-connection assembly including a first post portion (106) rotatably attached to the relative to the helmet (para [0061]; figs 4-6); wherein the post portion of the adjustable-connection assembly (106) is attachable to componentry of a moveable portion of a surgical frame (attached to beam 104 which is part of surgical frame 10 which is moveable as shown in figs 9-11) to maintain a position of the helmet relative to the moveable portion (as shown in figs 9-10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the helmet of Raffler in combination with a surgical frame, wherein the helmet includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion, the adjustable-connection assembly including a post portion rotatably attached relative to the first lateral portion wherein the post portion of the adjustable-connection assembly is attachable to componentry of a moveable portion of a surgical frame to maintain a position of the helmet relative to the moveable portion, as taught by Lim, in order to assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
With respect to claim 31, Raffler in view of Lim discloses the helmet substantially as claimed (see rejection of claim 30) and Raffler also discloses that the inner surfaces of the posterior portion, the first lateral portion, the second lateral portion, and the anterior portion are each covered with padding to cushion the head of the patient when the helmet is assembled therearound (inner contour of the shell parts can be provided with soft material cushion 23; see col 4 lines 51-54; fig 3).
With respect to claim 32, Raffler in view of Lim discloses the helmet substantially as claimed (see rejection of claim 30) and Raffler also discloses a first hinge attached to the posterior portion and the first lateral portion form a first hinged connection, a second hinge attached to the posterior portion and the second lateral portion form a second hinged connection, and a third hinge attached to the posterior portion and the anterior portion form a third hinged connection (the hinged plate is configured as a cruciform hinged plate, whose center is located in the center parts of the helmet shell and whose arms extend into the individual shell parts – col 2 lines 45-56; the hinged plate provides individual hinged transition areas at each of the shell parts – col 2 lines 3-5).
With respect to claim 33, Raffler in view of Lim discloses the helmet substantially as claimed (see rejection of claim 32) and Raffler also discloses a first latch secured between the posterior portion and the first lateral portion serves to hold the first lateral portion in the closed position relative to the posterior portion (part of strap 13 extends between the shell parts 4 and 5 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32), a second latch secured between the posterior portion and the second lateral portion serves to hold the second lateral portion in the closed position relative to the posterior portion (part of strap 13 extends between the shell parts 4 and 6 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32), and a third latch secured between the posterior portion and the anterior portion serves to hold the anterior portion in the closed position relative to the posterior portion (strap 8 extends between the shell parts 3 and 4 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32).
With respect to claim 34, Raffler in view of Lim discloses a helmet substantially as claimed (see rejection of claim 30) but does not disclose the helmet in combination with a surgical frame, wherein the helmet includes an adjustable-connection assembly including a second post portion extending outwardly relative to the first lateral portion and the post portion is rotatably attached to and movable along the second post portion; and the surgical frame comprising a support structure, a main beam portion rotatable relative to the support structure, and a helmet-interconnection assembly attached to the main beam portion, the helmet-interconnection assembly extending outwardly from the main beam portion, and including a third post portion and a connector configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof.
Lim, however, teaches a helmet (head support 20) in combination with a surgical frame (surgical frame 10), wherein the helmet (20) includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion (connection between support 20 and the frame 10 shown in figs 4-6 and 9), the adjustable-connection assembly including a first post portion (106) extending outwardly relative to the first lateral portion (shown in figs 4-5, 9), and a second post portion (104) rotatably attached to the first post portion (para [0061]; figs 4-6); and the surgical frame (10) comprising a support structure (14), a main beam portion (12) rotatable relative to the support structure (para [0052]), and a helmet-interconnection assembly attached to the main beam portion (mechanism 110 connecting beam 104 to the frame as shown in figs 9-10), the helmet-interconnection assembly extending outwardly from the main beam portion (shown in figs 9-10), and including a third post portion and a connector (links 112 and 114 coupled via a connector to beam 104) configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof (shown in figs 9-10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the helmet of Raffler in combination with a surgical frame, wherein the helmet includes an adjustable-connection assembly including a second post portion extending outwardly relative to the first lateral portion and the post portion is rotatably attached to and movable along the second post portion; and the surgical frame comprising a support structure, a main beam portion rotatable relative to the support structure, and a helmet-interconnection assembly attached to the main beam portion, the helmet-interconnection assembly extending outwardly from the main beam portion, and including a third post portion and a connector configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof, as taught by Lim, in order to assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
With respect to claim 35, Raffler in view of Lim discloses the combination substantially as claimed (see rejection of claim 34) and Lim further teaches that an interconnection is provided between the connector and the post portion (links 112 and 114 are coupled via a connector to beam 104; there is an interconnection between this connector and the beam 104 as best shown in fig 11) to attach the helmet-interconnection assembly to the adjustable-connection assembly (as shown in figs 9-11), and the interconnection is configured to provide controlled movement of the helmet toward and away from the main beam portion (movement is shown between figs 9-10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the combination of Raffler in view of Lim such that an interconnection is provided between the connector and the post portion to attach the helmet-interconnection assembly to the adjustable-connection assembly, and the interconnection is configured to provide controlled movement of the helmet toward and away from the main beam portion, as taught by Lim, in order to further assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
With respect to claim 37, Raffler discloses a helmet for protecting and supporting a head of a patient (protective helmet 1), the helmet (1) comprising:
a posterior portion (back of the head part 4; figs 2, 4, 5) including a first lateral side, a second lateral side and a first upper side (identified in annotated fig 5), a first body portion extending between the first lateral side, the second lateral side, and the first upper side (portion of part 4 that includes openings for straps as shown in fig 5), and the first body portion including an inner surface for positioning adjacent the head of the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7);
a first lateral portion (side part 5; figs 1,5) including a first posterior side and a first anterior side (identified in annotated fig 5), a second body portion extending between the first posterior side and the first anterior side (portion of part 5 that includes the strap as shown in fig 5), and the second body portion including an inner surface for positioning adjacent the head of
the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7), the first lateral portion (5) being (), and being moveable (as shown in fig 5; see annotated fig 5; the shell parts are interconnected by a hinged plate and thus are movable via the hinged plate – col 1 lines 60-63, col 2 lines 3-5) between an open position (flat packing state shown in fig 5) and a closed position relative to the posterior portion (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4);
a second lateral portion (side part 6, figs 1, 4, 5) including a second posterior side and a second anterior side (identified in annotated fig 5), a third body portion extending between the second posterior side and the second anterior side (portion of part 6 that includes the strap as shown in fig 5), and the third body portion including an inner surface for positioning adjacent the head of the patient (the inner face of the shell parts is adapted to the human skull contour - col 2 lines 6-7), the second lateral portion being moveable (as shown in fig 5; see annotated fig 5; the shell parts are interconnected by a hinged plate and thus are movable via the hinged plate – col 1 lines 60-63, col 2 lines 3-5) between an open position (flat packing state shown in fig 5) and a closed position relative to the posterior portion (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4); and
an anterior portion (forehead part 3; figs 1-3 and 5) including a third lateral side, a fourth lateral side and a second upper side (identified in annotated fig 5), a fourth body portion extending between the third lateral side, the fourth lateral side, and the second upper side (portion of part 3 that includes the strap as shown in fig 5), an opening formed in the fourth body portion (holes 16; fig 5), and the fourth body portion including an inner surface for positioning adjacent the head of the patient, and the anterior portion being moveable (as shown in fig 5; see annotated fig 5; the shell parts are interconnected by a hinged plate and thus are movable via the hinged plate – col 1 lines 60-63, col 2 lines 3-5) between an open position (flat packing state shown in fig 5) and a closed position (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) relative to the posterior portion, the first lateral portion and the second lateral portion (the shell parts are formed independently of each other and are each attached to the hinged plate on a separate arm as shown in fig 5 – thus, the shell parts are interpreted as being independently movable);
wherein, after the first lateral portion is moved to the closed position relative to the
posterior portion, after the second lateral portion is moved to the closed position relative to the posterior portion, and after the anterior portion is moved to the closed position relative to the posterior portion and in the closed positions relative to the first lateral portion and the
second lateral portion, the helmet is assembled (as shown in figs 1-4).
Raffler does not specifically disclose that the helmet is for protecting/supporting the head during surgery, but with regard to this statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over the device of Raffler which is interpreted as being capable of being used during surgery, as claimed, if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Additionally, the law of anticipation does not require that the reference “teach” what the subject patent teaches, but rather it is only necessary that the claims under attack “read on” something in the reference. Kalman v. Kimberly Clark Corp., 218 USPQ 781 (CCPA 1983). Furthermore, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
ANNOTATED FIG 5 :
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Raffler does not, however, disclose that the helmet includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion, the adjustable-connection assembly including a post portion rotatably attached relative to the first lateral portion wherein the post portion of the adjustable-connection assembly is attachable to componentry of a moveable portion of a surgical frame to maintain a position of the helmet relative to the moveable portion.
Lim, however, teaches a helmet (head support 20) in combination with a surgical frame (surgical frame 10), wherein the helmet (20) includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion (connection between support 20 and the frame 10 shown in figs 4-6 and 9), the adjustable-connection assembly including a first post portion (106) rotatably attached to the relative to the helmet (para [0061]; figs 4-6); wherein the post portion of the adjustable-connection assembly (106) is attachable to componentry of a moveable portion of a surgical frame (attached to beam 104 which is part of surgical frame 10 which is moveable as shown in figs 9-11) to maintain a position of the helmet relative to the moveable portion (as shown in figs 9-10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the helmet of Raffler in combination with a surgical frame, wherein the helmet includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion, the adjustable-connection assembly including a post portion rotatably attached relative to the first lateral portion wherein the post portion of the adjustable-connection assembly is attachable to componentry of a moveable portion of a surgical frame to maintain a position of the helmet relative to the moveable portion, as taught by Lim, in order to assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
With respect to claim 38, Raffler in view of Lim discloses a helmet substantially as claimed (see rejection of claim 37) and Raffler also discloses a first hinge attached to the posterior portion and the first lateral portion form a first hinged connection, a second hinge attached to the posterior portion and the second lateral portion form a second hinged connection, and a third hinge attached to the posterior portion and the anterior portion form a third hinged connection (the hinged plate is configured as a cruciform hinged plate, whose center is located in the center parts of the helmet shell and whose arms extend into the individual shell parts – col 2 lines 45-56; the hinged plate provides individual hinged transition areas at each of the shell parts – col 2 lines 3-5).
With respect to claim 39, Raffler in view of Lim discloses a helmet substantially as claimed (see rejection of claim 38) and Raffler also discloses a first latch secured between the posterior portion and the first lateral portion serves to hold the first lateral portion in the closed position relative to the posterior portion (part of strap 13 extends between the shell parts 4 and 5 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32), a second latch secured between the posterior portion and the second lateral portion serves to hold the second lateral portion in the closed position relative to the posterior portion (part of strap 13 extends between the shell parts 4 and 6 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32), and a third latch secured between the posterior portion and the anterior portion serves to hold the anterior portion in the closed position relative to the posterior portion (strap 8 extends between the shell parts 3 and 4 and inherently will hold the parts in the closed position on the head when the strap is tightened – see col 4 lines 6-32).
With respect to claim 40, Raffler in view of Lim discloses a helmet substantially as claimed (see rejection of claim 37) but does not disclose the helmet in combination with a surgical frame, the surgical frame comprising a support structure, a main beam portion rotatable relative to the support structure, and a helmet-interconnection assembly attached to the main beam portion, the helmet-interconnection assembly extending outwardly from the main beam portion, and including a third post portion and a connector configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof wherein an interconnection is provided between the connector and the second post portion to attach the helmet-interconnection assembly to the adjustable-connection assembly, and the interconnection is configured to provide controlled movement of the helmet toward and away from the main beam portion.
Lim, however, teaches a helmet (head support 20) in combination with a surgical frame (surgical frame 10), wherein the helmet (20) includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion (connection between support 20 and the frame 10 shown in figs 4-6 and 9), the adjustable-connection assembly including a first post portion (106) extending outwardly relative to the first lateral portion (shown in figs 4-5, 9), and a second post portion (104) rotatably attached to the first post portion (para [0061]; figs 4-6); and the surgical frame (10) comprising a support structure (14), a main beam portion (12) rotatable relative to the support structure (para [0052]), and a helmet-interconnection assembly attached to the main beam portion (mechanism 110 connecting beam 104 to the frame as shown in figs 9-10), the helmet-interconnection assembly extending outwardly from the main beam portion (shown in figs 9-10), and including a third post portion and a connector (links 112 and 114 coupled via a connector to beam 104) configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof (shown in figs 9-10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the helmet of Raffler in combination with a surgical frame, wherein the helmet includes an adjustable-connection assembly attached to an exterior portion of the first lateral portion, the adjustable-connection assembly including a first post portion extending outwardly relative to the first lateral portion, and a second post portion rotatably attached to the first post portion; and the surgical frame comprising a support structure, a main beam portion rotatable relative to the support structure, and a helmet-interconnection assembly attached to the main beam portion, the helmet-interconnection assembly extending outwardly from the main beam portion, and including a third post portion and a connector configured to interconnect with the second post portion to maintain a position of the helmet relative to the main beam portion during rotation thereof, as taught by Lim, in order to assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
Lim further teaches that an interconnection is provided between the connector and the second post portion (links 112 and 114 are coupled via a connector to beam 104; there is an interconnection between this connector and the beam 104 as best shown in fig 11) to attach the helmet-interconnection assembly to the adjustable-connection assembly (as shown in figs 9-11), and the interconnection is configured to provide controlled movement of the helmet toward and away from the main beam portion (movement is shown between figs 9-10). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the combination of Raffler in view of Lim such that an interconnection is provided between the connector and the second post portion to attach the helmet-interconnection assembly to the adjustable-connection assembly, and the interconnection is configured to provide controlled movement of the helmet toward and away from the main beam portion, as taught by Lim, in order to further assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
Claims 29 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Raffler (US 5012533) in view of Lim et al (US 2019/0000702) and further in view of Mazzei (US 6112333).
With respect to claims 29 and 36, Raffler in view of Lim discloses the combination substantially as claimed (see rejection of claims 28 and 35) and Raffler also discloses a method of using the helmet (1) comprising assembling the helmet around the head of the patient (shown assembled on the head in figures 1-4) by placing the posterior portion (4) adjacent a posterior portion of the head of the patient (as shown in fig 4), moving the first lateral portion (5) from the open position (flat state shown in fig 5) to the closed position (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) to position the first lateral portion (5) adjacent a first lateral side of the head of the patient (shown in figs 1, 2 and 4), moving the second lateral portion (6) from the open position (flat state shown in fig 5) to the closed position (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) to position the second lateral portion (6) adjacent a second lateral side of the head of the patient (as shown in figs 1 and 4), and moving the anterior portion (3) from the open positions (flat state shown in fig 5) to the closed positions (position where the shell parts are bent down to correspond to the skull as shown in figs 1-4) relative to the posterior portion, the first lateral portion, and the second lateral portion (the shell parts are formed independently of each other and are each attached to the hinged plate on a separate arm as shown in fig 5 – thus, the shell parts are interpreted as being independently movable such that the part 3 moves relative to parts 4, 5 and 6) to position the anterior portion (3) adjacent a face of the patient (shown in figs 1-3) such that a nasal cavity and an oral cavity of the patient are accessible (as shown in fig 1).
Additionally, Lim teaches that after assembly of the helmet, the connector can be attached to the post portion to interconnect the adjustable-connection assembly and the helmet-interconnection assembly (shown in figs 9-11) to position the head of the patient relative to the main beam portion (positioning and movement shown in figs 9-10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the combination of Raffler in view of Lim so that after assembly of the helmet, the connector can be attached to the second post portion to interconnect the adjustable-connection assembly and the helmet-interconnection assembly to position the head of the patient relative to the main beam portion, as taught by Lim, in order to further assist with positioning of the patient during transfer to/from a surgical table (see Lim abstract).
Raffler does not, however, disclose that the nasal cavity and oral cavity of the patient are accessible through the opening in the anterior portion.
Mazzei teaches a safety helmet comprising an anterior portion that includes an opening therein configured such that the nasal cavity and oral cavity of the patient are accessible through the opening (the ocular aperture 37 intersects the chin support aperture 39 as shown in figs 1-3, thus providing an opening extending over the nasal cavity area; the chin support aperture allows for viewing and access to the lower mouth area of the face of the patient). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the anterior portion of the device of Raffler to further include an opening configured such that the nasal cavity and oral cavity of the patient are accessible through the opening, like the anterior portion of the Helmet of Mazzei, in order to prevent interference with the user’s breathing.
Double Patenting
NON-STATUTORY DOUBLE PATENTING
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21, 23-26 and 41-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6 of U.S. Patent No. 11850191.
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application. Specifically, although the conflicting claims are not identical, they are not patentably distinct from each other because claims 21 and 41 of the present application and claim 1 of the ‘191 Patent differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claim 1 of the ‘191 Patent is in effect a “species” of the broader, “generic” invention recited in claims 21 and 41 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claims 21 and 41 of the present application are anticipated by claim 1 of the ‘191 patent and, therefore, are not patentably distinct from claim 1 of the ‘191 patent.
All of the limitations of claims 23-26 can be found in claims 2-4 and 6 of the ‘191 Patent.
With respect to claim 42, although the claims at issue are not identical, they are not patentably distinct from each other because the claim 42 in the present application would have been obvious over the claims in the ‘191 Patent to one having ordinary skill in the art at the time of the invention. Specifically, claim 42 of the present application differs from claim 1 of the ‘191 Patent insofar as the claim is drawn to a method of using a helmet comprising the same structural elements as the helmet recited in claim 1 of the ‘191 Patent. Thus, claim 42 of the present application is unpatentable over the ‘191 Patent because with respect to the method steps claimed, to the extent that the apparatus recited in the ‘191 Patent meets the structural limitations of the apparatus, as claimed, it is obvious that it will also perform the method steps as claimed. Furthermore, it has been held that where products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); MPEP 2112.01(I). Since the device of the ‘191 Patent is the same as the device for carrying out the method recited in claim 42 of the present application, it is obvious that the device will perform the claimed process and, therefore, the method claimed is considered to be obvious in view of the device recited in the claims of the ‘191 Patent.
Conclusion
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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