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 .
Any References cited but not appearing in any current Form 892 may be found in previous Form 892’s or IDS’s.
Response to Amendment
The amendment to the claims filed on 08/28/2025 has been entered. In the amendment, claims 1, 6-7, 17, 23 and 29 have been amended. Claims 1-13, 16-20 and 22-29 are pending. Claim 26 is withdrawn.
The amendment to claim 1 overcomes the 101 rejection with regard to that claim.
The amendment to claim 23 overcomes the 112b rejection with regard to that claim.
The amendment to claim 29 overcomes the 112b rejection with regard to that claim.
Response to Arguments
Applicant’s arguments, see page 1 of the Remarks, filed 08/28/2025, with respect to the drawing objection have been fully considered and are persuasive. The drawing objection has been withdrawn.
Applicant's arguments filed 08/28/2025 have been fully considered but they are not persuasive. Applicant argues at page 9 of the Remarks pertaining to independent claim 1:
There is nothing of record concerning Nakada that would make a person of ordinary skill in the art think of looking to Boone, and nothing in Boone or the two references together that can reasonably be said to make one think that the Nakada cushion should be modified.
Examiner respectfully submits that the arguments are not persuasive. As indicated in the Non Final Rejection dated 03/24/2025 at page 9, Boone teaches an analogous inner layer and U-shaped cavity and a cover defining an appendage contact surface disposed with the U-shaped cavity that is devoid of seams. The motivation for the combination is that the cover provides a soft inner surface for the user. Examiner respectfully submits that having a cover with a soft surface for a user is motivation for the modification. Accordingly, the argument is not persuasive.
Applicant’s arguments, see page 9, filed 08/28/2025, with respect to claim 6 have been fully considered and are persuasive. The 103 rejection of claim 6 has been withdrawn.
Applicant’s arguments, see page 10, filed 08/28/2025, with respect to claim 7 have been fully considered and are persuasive. The 103 rejection of claim 7 has been withdrawn.
Applicant's arguments filed 08/28/2025 have been fully considered but they are not persuasive. Applicant argues at page 10 of the Remarks regarding dependent claim 17.
It is not only not contemplated in Nakada, but it would not be perceived as desirable, to add a strap that is affixed to side support portions 35 and extends across the cushion pad between them. It is not the purpose of the cushion pad to tie a person to the pad. Its purpose — to reduce the wobbling feeling — is fulfilled by the disclosed shape and material properties. A strap offers no improvement. In fact, as the Examiner noted in the office action, Nakada indicates that the side support portions 5 and 35 can be omitted. “This is because the cushion pads 1 and 30 ... are excellent in holding property (restraint property) in the right-left direction, that is, of the side portions of the buttocks and the thigh.” [0101] There is no indication in Nakada or Lonardo, or in their combined teachings, that a strap affixed to the Nakada cushion itself would in any way be useful or desirable.
Lonardo is directed to an appliance for the treatment of spinal and related deformities and misalignments. It is respectfully submitted that it is not an analogous device. While a lap strap affixed to the cushion itself may be useful in that context, for treatment of spinal defects, particularly to further secure a patient within a sacral vest, a strap affixed to the cushion itself would have no apparent utility on the Nakada cushion. The Examiner has not articulated a reason why a person of ordinary skill in the art pertaining to the present invention would have thought of applying such a strap to a cushion of the type disclosed in Nakada. There is nothing in Lonardo to suggest such an unrelated application, nor is any such suggestion fairly gleaned from the cited art as whole.
Examiner respectfully disagrees with Applicant’s argument that there is no indication in Nakada or Lonardo that a strap affixed to the Nakada cushion would be in any way useful or desirable. As indicated in the Non Final Rejection at pages 16-18, a motivation to combine Nakada and Lonardo is that a fastener secures a patient against lateral displacement or other unwanted movement. Though Nakada discloses that the cushion has holding property it does not exclude or teach away from the addition of a fastener (or securing means as the claim is now amended to recite). Accordingly, the argument is not persuasive.
In response to applicant's argument that Lonardo is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the field of endeavor pertains to a pressure offloading device which is the field of Lonardo as a seat cushion (12) is a pressure offloading device. Accordingly, the argument is not persuasive.
Applicant’s arguments, see page 11, filed 08/28/2025, with respect to claim 1 over Cohen in view of Waits have been fully considered and are persuasive. The 103 rejection of claim 1 over Cohen in view of Waits has been withdrawn. However, Examiner notes that claim 1 was previously also rejected as being unpatentable over Nakada in view of Boone and a new ground(s) of rejection is made for dependent claims 27-28 which were previously rejected over Cohen in view of Waits and claim 16 which was previously rejected over Cohen in view of Waits and in further view of Kemper (US 2008/0184491). Dependent claim 27 is now rejected under 103 over previously cited Nakada (as evidenced by Tursi) in view of previously cited Boone and dependent claim 28 is now rejected under 103 in view of previously cited Nakada (as evidenced by Tursi) in view of previously cited Boone and in further view of in further view of previously cited Lonardo (US 5076264). Dependent claim 16 is now rejected under 103 in view of previously cited Nakada (as evidenced by Tursi) in view of previously cited Boone and in further view of in further view of previously cited Kemper.
Applicant’s arguments, see page 11, filed 08/28/2025, with respect to claim 23 have been fully considered and are persuasive. The 103 rejection of claim 23 has been withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, 8-10, 12-13 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakada (US 2016/0039322) as evidenced by Tursi (US 6653363) in further view of Boone (US 4150442).
Regarding claim 1, Nakada discloses a pressure offloading device 30 (embodiment of Fig. 8; cushion pad 30, [0095]; the cushion pad 30 includes: a seating portion 31, on which the seated person is seated, [0095]; [0101]; [0102]; NOTE: as a person sits on the cushion in use [Fig. 8], it is capable of offloading pressure for example from the legs as a person is seated and not standing) configured to be secured to a portion of a person's body (The side support portions 5 and 35 can be omitted. This is because the cushion pads 1 and 30 [the support portion] are excellent in holding property [restraint property] in the right-left direction, that is of the side portions of the buttocks and thigh, [0101]; [0102]; NOTE: as the cushion pads are excellent in holding property the capable of the intended use of securing to a portion of a person’s body), the pressure offloading device comprising: an inner layer an inner layer 31, 35 (seating portion 31, [0104], side support portions 35, [0095]; annotated Fig. 8 below; NOTE: 31 and 35 are an inner layer in that they are at the same level/layer and have an inside configured to contacts the user)
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made of a first material (flexible polyurethane foam, [0094]; [0096]) having a first indentation force deflection (IFD) rating (The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1, [0096]; The cushion pad 30 in the second embodiment allows achieving the operation and effect similar to those of the cushion pad 1 in the first embodiment., [0096]; the rear support portion 3, [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, [0035]; As evidenced by Tursi, Polyurethane foams with varying density and hardness or firmness may be formed. Hardness or firmness is typically measured as IFD ["indentation force deflection"], col. 1, lines 34-39; NOTE: thus in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 [as it is similar to that of the embodiment of pad 1] and thus the first material has a first indentation force deflection); an outer layer 34 (bottom surface portion 34, [0104]) made of a second material (flexible polyurethane foam, [0094]; [0096]) having a second IFD rating (NOTE: as it is foam it has an IFD rating, see Tursi description above), wherein the second IFD rating is greater than the first IFD rating (The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1; the rear support portion 3, [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, [0035]; As evidenced by Tursi, Polyurethane foams with varying density and hardness or firmness may be formed. Hardness or firmness is typically measured as IFD ["indentation force deflection"], col. 1, lines 34-39; NOTE: thus in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus the second material of the bottom surface 34 which is flexible polyurethane foam has a second IFD rating wherein the second IFD rating is greater than the first IFD rating as the second material is harder than the first material and as IFD rating increase with hardness), wherein the inner and outer layers as formed define a U- shaped cavity (Fig. 8; NOTE: a U-shaped cavity is formed with side portions 35 is a U-shaped cavity) configured to receive a patient's appendage therethrough (This is because the cushion pads 1 and 30 [the support portion 2] are excellent in holding property [restraint property] in the right-left direction, that is, of the side portions of the buttocks and the thigh. [1010]; Fig. 2; NOTE; a person’s thigh is received in the cavity; capable of intended use).
Nakada does not disclose a cover disposed within the U-shaped cavity, in contact with an upper surface of the inner layer, and defining an appendage contact surface devoid of seams configured to underlie the appendage received in the U-shaped cavity.
Boone teaches pad means (12, 13, 20, 21) (col. 2, line 67 to col. 3, line 8; Fig. 5) having an analogous inner layer 21 (bottom panel 21, col. 3, lines 38-51) and an analogous upper surface of the inner layer (inherent that panel has an upper surface) and an analogous U-shaped cavity (Fig. 5; col. 2, line 67 to col. 3, line 8; Fig. 5) and a cover 23 (textile fabric 23, col. 3, lines 25-37) disposed within the U-shaped cavity (Fig. 5), in contact with an upper surface of the inner layer (Fig. 5, col. 3, lines 25-37), and defining an appendage contact surface (col. 2, line 67 to col. 3, line 8; NOTE: patient’s elbow or heel is received and thus an appendage contact surface is defined) devoid of seams configured to underlie the appendage received in the U-shaped cavity (col. 3, lines 25-37; NOTE: as the textile fabric is laminated its upper surface is devoid of seams; also as seen in Fig. 5 cover 23 does not have seams).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the pressure offloading device of Nakada is comprising a cover disposed within the U-shaped cavity, in contact with an upper surface of the inner layer, and defining an appendage contact surface devoid of seams configured to underlie the appendage received in the U-shaped cavity, as taught by Boone, in order to provide an improved pressure offloading device that provides a soft inner surface (Boone, col. 1, lines 40-63).
Regarding claim 2, Nakada as evidenced by Tursi and in further view of Boone substantially discloses the invention as applied to claim 1 above.
Nakada further discloses wherein the first material and the second material are independently selected from a foam (In this embodiment, the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are all formed in a tabular shape using flexible polyurethane foam [molded urethane], [0096]; Fig. 8; NOTE: the inner layer and the outer layers are separate layers and are thus independent of each other and each layer is made of polyurethane foam and as such the first and second material are independently selected from a foam; capable of intended use).
Regarding claim 3, Nakada as evidenced by Tursi and in further view of Boone substantially discloses the invention as applied to claim 2 above.
Nakada further discloses further comprising a first intermediate layer 33 or 32 (lower center portion 33, [0096] or upper center portion 32, [0096]) between the inner layer and the outer layer (see annotated Fig. 8 above with regard to claim 1 showing layer 32 as a first intermediate layer but could also be layer 33).
Regarding claim 4, Nakada as evidenced by Tursi and in further view of Boone substantially discloses the invention as applied to claim 3 above.
Nakada further discloses wherein the first intermediate layer 33 comprises a third material selected from a foam (the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are all formed in a tabular shape using flexible polyurethane foam (molded urethane, [0096]) with a third IFD rating (NOTE: it is inherent that foam has an IFD rating; see Tursi as above with regard to claim 1).
Regarding claim 5, Nakada as evidenced by Tursi and in further view of Boone substantially discloses the invention as applied to claim 4 above.
Nakada further discloses wherein the third IFD rating [from layer 33] is greater than the first IFD rating and less than the second IFD rating (The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1; the rear support portion 3, [0096]; The cushion pad 30 in the second embodiment allows achieving the operation and effect similar to those of the cushion pad 1 in the first embodiment., [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, [0035]; As evidenced by Tursi, Polyurethane foams with varying density and hardness or firmness may be formed. Hardness or firmness is typically measured as IFD ["indentation force deflection"], col. 1, lines 34-39; NOTE: thus in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus the third IFD rating [from layer 33] is greater than the first IFD rating [of layer 31 which is the least] and the second IFD rating [of layer which is the greatest]).
Regarding claim 8, Nakada as evidenced by Tursi and in further view of Boone substantially discloses the invention as applied to claim 3 above.
Nakada further discloses wherein the inner layer continuously extends a first length (annotated Fig. 8 above with regard to the claim 1 rejection ) and the first intermediate layer continuously extends a second length (annotated Fig. 8 above with regard to claim 1), and wherein the first length is longer than the second length (annotated Fig. 8 above with regard to claim 1).
Regarding claim 9, Nakada as evidenced by Tursi and in further view of Boone substantially discloses the invention as applied to claim 3 above.
Nakada further discloses a second intermediate layer 33 (lower center portion 33, [0095]) between the first intermediate layer 32 and the outer layer (annotated Fig. 8 above with regard to the claim 1 rejection), the second intermediate layer 33 made of a fourth material selected from a foam (flexible polyurethane foam, [0096]) having a fourth IFD rating (NOTE: it is inherent that the foam has some level of hardness [see Tursi col. 1, lines 34-39] thus has an IFD rating that can be considered a fourth rating).
Regarding claim 10, Nakada as evidenced by Tursi and in further view of Boone substantially discloses the invention as applied to claim 9 above.
Nakada further discloses wherein the first intermediate layer 32 is made of a third material selected from a foam (flexible polyurethane foam, [0096]) with a third IFD rating (NOTE: it is inherent that the foam has some level of hardness [see Tursi col. 1, lines 34-39] thus has an IFD rating that can be considered a third rating), and wherein the fourth IFD rating is greater than the third IFD rating and less than the second IFD rating (The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1; the rear support portion 3, [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, [0035]; As evidenced by Tursi, Polyurethane foams with varying density and hardness or firmness may be formed. Hardness or firmness is typically measured as IFD ["indentation force deflection"], col. 1, lines 34-39; NOTE: thus in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus the fourth IFD rating is greater than the third IFD rating [fourth IFD rating of the second intermediate layer 33 which is closer to the bottom than the first intermediate layer and is thus harder than the third IFD rating of the first intermediate layer 32 as hardness decreases going downwardly] and less than the second IFD rating [outer layer has the highest IFD rating per Nakada, [0096]; [0035]; as described above hardness increases downwardly and the outer layer is at the bottom and thus has the greatest IFD rating).
Regarding claim 12, Nakada as evidenced by Tursi and in further view of Boone substantially discloses the invention as applied to claim 1 above.
Nakada further discloses a first intermediate layer 32 (upper center portion 32, [0095]) affixed to the inner layer (annotated Fig. 8 above with regard to claim 1; a cushion pad formed by laminating a plurality of layered members, [0094]; NOTE: as the layers are laminated they are affixed to each other and as seen in Fig. 8, a first intermediate layer 32 is adjacent the inner layer and as the layers are laminated it follows that the first intermediate layer is affixed to the inner layer) and a second intermediate layer 33 (lower central portion 33, [0095]) affixed to the first intermediate layer and the outer layer (as the layers are laminated they are affixed to each other and as seen in Fig. 8, a second intermediate layer 33 is adjacent the outer layer and the first intermediate layer and as the layers are laminated it follows a second intermediate layer is affixed to the first intermediate layer and the outer layer).
Regarding claim 13, Nakada as evidenced by Tursi and in further view of Boone discloses the invention as applied to claim 1 above.
Nakada further discloses at least one intermediate layer 32, 33 (upper center portion 32, [0095]; lower center portion 33, [0096]) between the inner layer and the outer layer (annotated Fig. 8 above with regard to claim 1 showing inner layer and outer layer and layers 32 and 33 in between), wherein the inner layer defines an inner side of the pressure offloading device (Fig. 8, top of layer 31 is an inner side of the pressure offloading device), wherein each of the at least one intermediate layers has a higher IFD rating the further that layer is the from inner side of the pressure offloading device (The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1; the rear support portion 3, [0096]; The cushion pad 30 in the second embodiment allows achieving the operation and effect similar to those of the cushion pad 1 in the first embodiment., [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, [0035]; As evidenced by Tursi, Polyurethane foams with varying density and hardness or firmness may be formed. Hardness or firmness is typically measured as IFD ["indentation force deflection"], col. 1, lines 34-39; NOTE: thus in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus the intermediate layer 33 which is further from the inner side of the device that intermediate layer 32 is farther from the inner side and has a higher IFD rating than intermediate layer 32 which is closer to the inner side), and wherein the first IFD rating is the lowest IFD rating and the second IFD rating is the highest IFD rating (The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1; the rear support portion 3, [0096]; The cushion pad 30 in the second embodiment allows achieving the operation and effect similar to those of the cushion pad 1 in the first embodiment., [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, [0035]; NOTE: thus in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus the first IFD rating [of inner layer] is the lowest IFD rating and the second IFD rating [of the outer layer] is the highest IFD rating).
Regarding claim 27, Nakada as evidenced by Tursi and in further view of Boone discloses the invention as applied to claim 1 above.
Nakada further discloses placing an appendage of a patient in the pressure offloading devices of claim 1 to offload pressure from the appendage in contact with the pressure offloading device and/or an appendage distal from the offloading device (embodiment of Fig. 8; cushion pad 30, [0095]; the cushion pad 30 includes: a seating portion 31, on which the seated person is seated, [0095]; [0101]; [0102]; NOTE: as a person sits on the cushion in use [Fig. 8], it is capable of offloading pressure for example from the legs as a person is seated and not standing).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakada (US 2016/0039322) as evidenced by Tursi (US 6653363) in view of Boone (US 4150442) as applied to claim 1 above, and in further view of Kemper (US 2008/0184491).
Regarding claim 16, Nakada in view of Boone substantially discloses the invention as described above with regard to claim 1
Nakada in view of Boone does not disclose wherein the outer layer includes a plurality of slits that each close to facilitate the outer layer conforming to the U-shaped cavity.
Kemper teaches an analogous pressure offloading device 132 (pressure relief mattress 132, [0052]) having an analogous inner layer 146 (top layer 146, [0054]) and an analogous outer layer 142 (bottom layer 142, [0052]) wherein the outer layer includes a plurality of slits 152, 152a (notches 152, 152a, [0054]) that each close to facilitate the outer layer conforming to the U-shape (Notches 152 and 152a lie along the longitudinal axis of bottom layer 142 and act as a hinge for bed inclination, [0054]; The notches are spaced equidistant from each end for purposes of articulation, [0054]; NOTE: slits close as they are hinges and the slits hinge to facilitate the articulation [where the outer layer conforms to the U-shape]; capable of intended use).
It would have been obvious to provide that the outer layer of the offloading device of Nakada in view of Boone includes a plurality of slits to facilitate the outer layer conforming to the U-shaped cavity, as taught by Kemper, in order to provide an improved pressure offloading device that facilitates articulation (Kemper, [0054]).
Claim(s) 17-20, 22 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakada (US 2016/0039322) as evidenced by Tursi (US 6653363) in view of Boone (US 4150442) as applied to claim 1 above, and in further view of Lonardo (US 5076264).
Regarding claim 17, Nakada as evidenced by Tursi and in further view of Boone discloses the invention as applied to claim 1 above.
The combination further discloses the U-shaped cavity with an inner side 31 (inner side of layer 31, Fig. 8) and an outer side 34 (outer side of layer 34, Fig. 8), wherein each of the inner layer and the outer layer comprises a different indentation force deflection (IFD) rating (flexible polyurethane foam, [0096]; NOTE: layers are of foam; The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1; the rear support portion 3, [0096]; The cushion pad 30 in the second embodiment allows achieving the operation and effect similar to those of the cushion pad 1 in the first embodiment, [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, [0035]; As evidenced by Tursi, Polyurethane foams with varying density and hardness or firmness may be formed. Hardness or firmness is typically measured as IFD ["indentation force deflection"], col. 1, lines 34-39; NOTE: thus in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus each of the multiple layers of foam have a different indentation force deflection).
Nakada as evidenced by Tursi and in further view of Boone does not disclose further comprising means for securing the pressure offloading device to an appendage within the inner side, against the appendage contact surface, said securing means having mating first and second fastening ends affixed to locations on the pressure offloading device on opposite sides of the U-shaped cavity, and a strap affixed to one of said fastening ends.
Lonardo teaches an analogous pressure offloading device 12 (seat cushion 12; Fig. 5; capable of intended use) having an analogous cover (col. 3, lines 1-6; all wall are preferably covered by a thick layer of natural or synthetic fleece, col. 5, lines 50-62) and is further comprising means for securing (27) (col. 6, lines 14-20; the pressure offloading device to an appendage within the inner side (Fig. 1), against the appendage contact surface (capable of intended use; Fig. 1), said securing means having mating first and second fastening ends (NOTE: lap strap 27 has free ends of the opposing strap members that are releasably connected to one another and thus the lap strap has mating first and second ends) affixed to locations on the pressure offloading device on opposite sides of the U-shaped cavity (Fig. 1 shows a strap 27 affixed to opposite sides of the U-shaped cavity; (col. 6, lines 14-20;), and a strap affixed to one of said fastening ends ((col. 6, lines 14-20; annotated Fig. 1; one of the releasable ends is a part of a strap that is affixed to one of the fastening ends).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the pressure offloading device of Nakada as evidenced by Tursi and in further view of Boone is further comprising means for securing the pressure offloading device to an appendage within the inner side, against the appendage contact surface, said securing means having mating first and second fastening ends affixed to locations on the pressure offloading device on opposite sides of the U-shaped cavity, and a strap affixed to one of said fastening ends, as taught by Lonardo, in order to provide an improved pressure offloading device that that secures the patient against lateral displacement or other unwanted movement (Lonardo, col. 6, lines 13-21).
Regarding claim 18, Nakada as evidenced by Tursi, in view of Boone does and in further view of Lonardo discloses the invention as described above with regard to claim 17.
Nakada further discloses wherein the multiple layers of foam include: an inner layer 31 (seating portion 31, [0095]) on the inner side of the U-shaped cavity (Fig. 8); a first intermediate layer 32 (upper center portion 32, [0096]) affixed to the inner layer (a cushion pad formed by laminating a plurality of layered members, [0094]; NOTE: as the layers are laminated they are affixed to each other and as seen in Fig. 8, a first intermediate layer 32 is adjacent the inner layer and as the layers are laminated it follows that the first intermediate layer is affixed to the inner layer); a second intermediate layer 33 (lower center portion 33, [0096]) affixed to the first intermediate layer (as the layers are laminated they are affixed to each other and as seen in Fig. 8, a second intermediate layer 33 is adjacent the outer layer and the first intermediate layer and as the layers are laminated it follows a second intermediate layer is affixed to the first intermediate layer); and an outer layer 34 (bottom surface portion34, [0096]) on the outer side of the U-shaped cavity (Fig. 8) affixed to the second intermediate layer (as the layers are laminated they are affixed to each other and as seen in Fig. 8, a second intermediate layer 33 is adjacent the outer layer and as the layers are laminated it follows that the outer layer is affixed to the second intermediate layer).
Regarding claim 19, Nakada as evidenced by Tursi, in view of Boone does and in further view of Lonardo discloses the invention as described above with regard to claim 18.
Nakada further discloses wherein: the IFD rating of the outer layer is greater than the IFD rating of the second intermediate layer (The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1; the rear support portion 3, [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, [0035]; NOTE: thus in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus each of the multiple layers of foam have a different indentation force deflection and the IFD rating [hardness] of the outer layer is greater than the IFD rating of the second intermediate layer 33 which is above the outer layer as seen in Fig. 8), the IFD rating of the second intermediate layer is greater than the IFD rating of a center portion of the first intermediate layer (as explained above, in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus the IFD rating [hardness] of the second intermediate layer i33 s greater than the IFD rating of the first intermediate layer and thus greater than an IFD reading of the center portion of the first intermediate layer) and the IFD rating of the center portion of the first intermediate layer is greater than the IFD rating of the inner layer (as explained above, in the embodiment of Fig. 8 the hardness increases from the seating surface 31 toward the bottom surface 34 and thus the IFD rating [hardness] of the first intermediate layer 32 is greater than the IFD rating of the inner layer and thus the IFD rating of the center portion of the first intermediate layer is greater than the IFD rating of the inner layer).
Regarding claim 20, Nakada as evidenced by Tursi, in view of Boone does and in further view of Lonardo discloses the invention as described above with regard to claim 19.
Nakada as evidenced by Tursi, in view of Boon and in further view of Lonardo does not explicitly disclose wherein: the IFD rating of the center portion of the first intermediate layer is at least 1.5 times greater than the IFD rating of the inner layer, the IFD rating of the second intermediate layer is at least 1.5 times greater than the IFD rating of a center portion of the first intermediate layer, and the IFD rating of the outer layer is at least 2 times greater than the IFD rating of the second intermediate layer.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that in the offloading device of Nakada, as evidenced by Tursi, in view of Boone and in further view of Lonardo that the IFD rating of the center portion of the first intermediate layer is at least 1.5 times greater than the IFD rating of the inner layer, the IFD rating of the second intermediate layer is at least 1.5 times greater than the IFD rating of a center portion of the first intermediate layer, and the IFD rating of the outer layer is at least 2 times greater than the IFD rating of the second intermediate layer, as Applicant has appeared to place no criticality on the claimed range (Applicant’s specification paragraph [0071] recites “In some examples, the IFD rating of a layer may be 1.5 to 2.5 times the IFD rating of the adjacent layer that is closer to the inner layer 102. For example, (i) the IFD rating of the inner intermediate layer 302 may be 1.5 times the IFD rating of the inner layer 102, (ii) the IFD rating of the outer intermediate layer 304 may be 1.5 times the IFD rating of the inner intermediate layer 302, and (iii) the IFD rating of the outer layer 104 may be 2.5 times the IFD rating of the outer intermediate layer 304. In some examples, when creating the pressure offloading device 100 for a patient or a patient group with similar characteristics [e.g., age, weight, height, etc.], a suitable IFD rating for the patient or patient group may be selected for the inner layer 102, and the IFD ratings of the subsequent layers may be selected based on the multipliers describe above) and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220, F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 22, Nakada as evidenced by Tursi, in view of Boone does and in further view of Lonardo discloses the invention as described above with regard to claim 17.
The combination further wherein progression of the different IFD ratings of the multiple layers (The hardness distributions of the seating portion 31, the upper center portion 32, the lower center portion 33, and the bottom surface portion 34 are set similarly to the hardness distributions in the cushion pad 1; the rear support portion 3, Nakada, [0096]; The cushion pad 30 in the second embodiment allows achieving the operation and effect similar to those of the cushion pad 1 in the first embodiment, [0096]; the rear support portion 3 has the hardness increasing from the seating surface 11 toward the bottom surface 12, Nakada, [0035]; As evidenced by Tursi, Polyurethane foams with varying density and hardness or firmness may be formed. Hardness or firmness is typically measured as IFD ["indentation force deflection"], col. 1, lines 34-39) is configured to decrease pressure experienced by the appendage when the pressure offloading device is secured to the appendage (as all of the structural limitations of the claim are met, the combination is capable of the intended use).
Regarding claim 28, Nakada as evidenced by Tursi and in further view of Boone discloses the invention as applied to claim 27 above.
Nakada as evidenced by Tursi and in further view of Boone does not disclose securing with a strap of the pressure offloading device, to the appendage to decrease pressure experienced by the appendage.
Lonardo teaches an analogous method of offloading an appendage of a patient (seat cushion 12 is capable of offloading an appendage; Fig. 5; capable of intended use) comprising securing, with a strap (27) (col. 6, lines 14-20) of the pressure offloading device, to the appendage to decrease pressure experienced by the appendage (col. 6, lines 14-20; capable of intended use).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the method of offloading an appendage of Nakada as evidenced by Tursi and in further view of Boone is comprising securing with a strap of the pressure offloading device, to the appendage to decrease pressure experienced by the appendage, as taught by Lonardo, that secures the patient against lateral displacement or other unwanted movement (Lonardo, col. 6, lines 13-21).
Allowable Subject Matter
Claims 6-7, 11 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The cited art either alone or in combination fails to disclose as recited in claim 6 “wherein the first intermediate layer comprises a center section of the third material, and a laterally adjacent second section, the second section formed from a material other than the third material”.
Claim 7 depends from claim 6 and is allowable for the same reasons as claim 6.
The cited are either alone or in combination fails to disclose as recited in claim 11, “wherein the inner layer includes a wing portion, wherein ends of the first and second intermediate layers are each affixed directly to the wing portion”.
The cited art either alone or in combination fails to disclose as recited in claim 29 “wherein the outer layer has a center and a hardness distribution with greater hardness in the center of the layer than on either side thereof”.
Claims 23-25 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding independent claim 23, the prior art either alone or in combination fails to teach or suggest a pressure offloading device configured to be secured to a portion of a person's body, the pressure offloading device comprising: a first layer including a single foam block having a first indentation force deflection (IFD) rating; a second layer connected to the first layer, the second layer having a center and a hardness distribution with greater hardness in the center of the layer than on either side thereof, the center of the layer having a second IFD rating greater than the first IFD rating; a third layer connected to the second layer, the third layer having a third IFD rating that is greater than the second IFD rating; and a fourth layer connected to the third layer, the fourth layer having a fourth IFD rating that is greater than the third IFD rating, wherein said layers are in a stack in numerical order from first to fourth, with said first layer configured to be closest to the portion of the person’s body in use.
Claims 24-25 are allowed for depending from claim 23.
The closest prior art is Morgan (US 2014/0090178). Morgan discloses a pressure offloading device 14 (mattress 14, [0040]; capable of intended use), the pressure offloading device comprising: a first layer 34 (layer 34, [0045]; Fig. 3) including a single foam block (Fig. 3) having a first indentation force deflection (IFD) rating ([0048]); a second layer 32b (layer 32b, [0047]) connected to the first layer ([0046]; Fig. 3; the mattress 14 may be constructed from multiple parallel laminated layers 32 and 34, [0043]; NOTE: thus all the layers are connected), the second layer having a center and a hardness distribution with greater hardness in the center of the layer than on either side thereof ([0047]; TABLE 1; NOTE: layer 32b has an IFD of 13 thus its center has an IFD of 13 and on one side of layer 32b is layer 32a which has an IFD of 7 and on another side of layer 32b is layer 34 which has an IFD of 7, thus the second layer has a hardness distribution with greater hardness in the center of the layer than on either side thereof), the center of the layer having a second IFD rating greater than the first IFD rating (Per Table 1, the second layer 32b has an IFD of 13 which is greater than the first IFD rating for layer 34 which has a value of 7); a third layer 32d (layer 32d, [0047]) connected to the second layer (Fig. 3, NOTE: the third layer is connected to the second layer via layer 32c[ 0048]), the third layer having a third IFD rating (per Table 1 the IFD rating is 20; [0047]) that is greater than the second IFD rating (Per Table 1, the IFD of the third layer 32d which is 20 is greater than the IFD of the second layer 32b which is 13); and a fourth layer 32c (layer 32c. [0047]) connected to the third layer ([0048]; Fig. 3), the fourth layer having a fourth IFD rating that is greater than the third IFD rating (Per Table 1 the fourth layer 32c has an IFD rating of 75 which is greater than the rating of the third layer 32d having an IFD of 20).
Morgan does not disclose s a pressure offloading device configured to be secured to a portion of a person's body, wherein said layers are in a stack in numerical order from first to fourth, with said first layer configured to be closest to the portion of the person’s body in use.
Waits (US 5497521) teaches an analogous pressure offloading device 4 (mattress 4, col. 2, lines 30-37) configured to be secured to a portion of a user’s body (col. 2, lines 18-29; col. 2, lines 38-48; Fig. 1; Fig. 3; NOTE: pocket 6 is secured to the mattress and a user’s feet are slipped into the pocket thus securing the mattress [pressure offloading device] to a portion of the user’s body feet).
Waits does not teach wherein said layers are in a stack in numerical order from first to fourth, with said first layer configured to be closest to the portion of the person’s body in use.
Dependent claims 24-25 are allowed as they depend from claim 23 and therefore contain the same allowable limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/G.M./Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786