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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/11/2026 has been entered.
Response to Amendment
The amendment to the claims filed on 5/11/2026 has been entered. In the amendment, 1-8, 11, 17, 22 are amended. Claims 9-10, 12-13, 16 and 26 are cancelled. Claims 30-35 are added. Claims 1-8, 11, 17, 22-25, 27-35 are currently pending.
Response to Arguments
Applicant’s arguments, see page 7, filed 5/11/2026, with respect to the rejection(s) of claim(s) 1 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly cited Marcus (US 2022/0160568) in view of previously cited Boone (US 4150442).
Claim Objections
Claim 22 is objected to because of the following informalities: Claim 17 recites “the multiple layers” but the language of claim 1 from which claim 22 depends is the outer layer and the inner layer. For clarity it is suggested that claim 22 is amended to recite –wherein progression of the different IFD ratings of the inner and outer layers--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 11, 17, 22 and 27-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “approximately” in claim 1 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination the limitation will be interpreted as –side portions equal to the width of the patient’s calf--.
Claim 1 recites the limitation "the width" in line 10. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as –a width--.
As claims 2-8, 11, 17, 22 and 27-29 depend from claim 1, they are rejected for at least the same reasons as claim 1.
The term “substantially” in claim 17 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination the limitation will be interpreted as –side portions equal to the width of the patient’s calf--.
As claim 22 depends from claim 17, it is rejected for at least the same reasons as claim 17.
The term “approximately” in claim 30 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination the limitation will be interpreted as –side portions equal to the width of the patient’s calf--.
As claims 31-35 depend from claim 30, they are rejected for at least the same reasons as claim 30.
Claim 31 recites the limitation "the top" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --a top--.
As claims 32 depends from claim 31, it is rejected for at least the same reasons as claim 30.
Claim 34 recites the limitation "the shape" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as –a shape--.
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) 1-2, 27, 30 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcus (US 2022/0160568) in view of Boone (US 4150442), and as evidenced by Libbey (US 5324252) with regard to claim 33.
Regarding claim 1, Marcus discloses a heel pressure offloading device (10) ([0067], reducing weight off heel; [0046]; [0047]; Fig. 2, Fig. 3) configured to be secured to the calf of a patient's lower leg (Fig. 8A, Fig. 8B, [0044]), the heel offloading device comprising: an inner layer (40) made of a first material having a first indentation force deflection (IFD) rating ([0058], firmness of foam); an outer layer (20) made of a second material having a second IFD rating ([0058]), wherein the second IFD rating is greater than the first IFD rating ([0058], the first component can be made of a material that has an increased firmness compared to the material of the second component), wherein the inner and outer layers define a U-shaped cavity (annotated Fig. 8A below) configured to receive the patient's calf therethrough ([0094]; Fig. 8A; see in Applicant’s specification [0068], which recites where a U-shape is sometimes referred to as a C-shape and in Fig. 3A-3D the U- shape curves inwardly as it does in Marcus as seen in Fig. 2 thus the cavity shape in Marcus [See for example Fig. 7 the cavity in each of the layers 20 and 40] is considered a U-shape as the cavities have sides and a central portion as in a U and the sides curve as in Figs. 3A-3D of the Applicant’s specification), the U-shaped cavity having opposite side portions extending upwardly from a central portion (annotated Fig. 8A below),
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and an interior width between the side portions approximately equal to the width of the patient's calf (Fig. 8A, [0084]; NOTE: user’s calf width varies so depending on the calf width the interior width may be equal to the user’s calf width).
Marcus does not disclose a cover disposed within the U-shaped cavity, in contact with an upper surface of the inner layer, and defining a lower leg contact surface devoid of seams configured to underlie the patient's calf 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 analogous appendage (foot/lower leg) contact surface (col. 2, line 67 to col. 3, line 8; NOTE: patient’s heel is received and thus a lower leg contact surface is defined) devoid of seams configured to underlie the patient’s analogous 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 heel offloading device of Marcus is comprising a cover disposed within the U-shaped cavity, in contact with an upper surface of the inner layer, and defining a lower leg contact surface devoid of seams configured to underlie the patient's calf received in the U-shaped cavity in order to provide an improved pressure offloading device that provides a soft inner surface (Boone, col. 1, lines 40-63).
Regarding claim 2, Marcus in view of Boone discloses the invention as described above with regard to claim 1.
Marcus further discloses wherein the first material and the second material are independently selected from a foam ([0058]).
Regarding claim 27, Marcus in view of Boone discloses the invention as described above with regard to claim 1.
Marcus further discloses a method of offloading a heel of a patient ([0047]; [0050]; [0094]) (Fig. 8A), the method comprising: placing the calf of a patient in the heel offloading device ([0094]) of claim 1 (see claim 1) to offload pressure from the heel (capable of intended use; [0047]).
Regarding claim 30, Marcus discloses a heel offloading device (10) ([0067], reducing weight off heel; [0046]; [0047]; Fig. 2; Fig. 3) configured to be secured to the calf of a patient's lower leg (Fig. 8A, Fig. 8B, [0094]), the heel offloading device comprising: a first foam layer (40) ([0058]) having an indentation force deflection (IFD) rating ([0058]), firmness of foam; a second foam (20) ([0058]) layer underlying said first foam layer (Fig. 2), said second layer having an indentation force deflection (IFD) rating ([0058]); wherein the first and second layers define a U-shaped cavity (annotated Fig. 8A above with regard to claim 1 rejection) configured to receive the patient's calf therethrough ([0094]; Fig. 8A; see in Applicant’s specification [0068], which recites, where a U-shape is sometimes referred to as a C-shape and in Fig. 3A-3D the U- shape curves inwardly as it does in Marcus as seen in Fig. 2 thus the cavity shape in Marcus [See for example Fig. 7 the cavity in each of the layers 20 and 40] is considered a U-shape as the cavities have sides and a central portion as in a U and the sides curve as in Figs. 3A-3D of the Applicant’s specification), the U-shaped cavity having opposite side portions extending upwardly from a central portion (annotated Fig. 8A above with regard to claim 1), and an interior width between the side portions approximately equal to the width of the patient's calf (Fig. 8A, [0084]; NOTE: user’s calf width varies so depending on the calf width the interior width may be equal to the user’s calf width).
Marcus does not explicitly disclose a first foam layer having an indentation force deflection (IFD) rating of approximately 32 ± 3; said second layer having an indentation force deflection (IFD) rating of approximately 120 ± 15; a cover disposed within the U-shaped cavity and defining a lower leg contact surface configured to underlie the patient's calf received in the U-shaped cavity.
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 the first layer IFD rating is approximately 32 ± 3 and the second layer IFD rating is approximately 120 ± 15 of the heel offloading device of Marcus as Applicant has appeared to place no criticality on the claimed ranges (Applicant’s specification paragraph [0069] recites that the second layer IFD is an example, and [0071] recites a broader range IFD e.g. 18-120; [0070] recites an example of a first layer IFD is 30) and since it has been held that “[i]n cases where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Marcus discloses the invention as described above.
Marcus does not disclose a cover disposed within the U-shaped cavity and defining a lower leg contact surface configured to underlie the patient's calf 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 first 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), and defining an analogous appendage (foot/lower leg) contact surface (col. 2, line 67 to col. 3, line 8; NOTE: patient’s heel is received and thus a lower leg contact surface is defined).
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 heel offloading device of Marcus is comprising a cover disposed within the U-shaped cavity, defining a lower leg contact surface configured to underlie the patient's calf received in the U-shaped cavity in order to provide an improved pressure offloading device that provides a soft inner surface (Boone, col. 1, lines 40-63).
Regarding claim 33, Marcus in view of Boone discloses the invention as described above.
Marcus further discloses wherein said second layer (20) is made of more resilient foam then said first layer ([0058], first and second layer foams are made of a foam with a density that is between a density range of 1lb to 26lb/ft3 ; it is implied that a firm that is more dense will be more resilient and as Marcus discloses that the second layer may be a density value that is greater than the first layer it is implicitly more resilient; as evidenced by Libbey which indicates that a foam pad that is most dense is slightly more resilient than a pad that is less dense, col. 4, lines 26-34; col. 2, lines 30-48).
Claim(s) 3, 8, 17, 22 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcus (US 2022/0160568) in view of Boone (US 4150442), as applied to claims 2, 3, 1, 17 and 27 respectively above, and in further view of Mollura (US 6468239).
Regarding claim 3, Marcus in view of Boone discloses the invention as described above with regard to claim 2.
Marcus in view of Boone does not disclose an intermediate layer between the inner layer and the outer layer.
Mollura teaches an analogous heel offloading device (100) (Fig. 3, col. 4, lines 26-29) comprising an analogous inner layer (108) (Fig. 3 shows it is inner relative to shell 101) made of a first material having a first indentation force deflection (IFD) rating comprising an intermediate layer (106) (col. 4, lines 11-37) in the analogous layer (Fig. 3 the layer 106 is intermediate to the outer shell and a portion of the inner layer)
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 inner layer of the heel pressure offloading device of Marcus in view of Boone comprises an intermediate layer in the analogous inner layer as taught by Mollura, in order to provide an improved heel offloading device that provides rigidity to the device (Mollura, col. 4, lines 21-25).
Marcus in view of Boone and in further view of Mollura discloses the invention as described.
The combination further discloses further comprising an intermediate layer between the inner layer and the outer layer (In the combination the intermediate layer is disposed within the inner layer and thus in the combination it would be between the outer layer and a portion of the inner layer).
Regarding claim 8, Marcus in view of Boone and in further view of Mollura discloses the invention as described above with regard to claim 3.
The combination further discloses wherein the inner layer continuously extends a first length and the first intermediate layer continuously extends a second length, and wherein the first length is longer than the second length (Mollura teaches [Fig. 3] that the intermediate layer is within the inner layer [see Mollura Fig. 3] thus the length of the intermediate layer, a second length, is longer than a first length of the inner layer as seen in Mollura, Fig. 3).
Regarding claim 17, Marcus in view of Boone and in further view of Mollura disclose the invention as described above with regard to claim 1.
Marcus further discloses the U-shaped cavity with an inner and an outer side (Fig. 8A shows there is an inner side of the inner layer 40 and an outer side of the outer layer 20).
Marcus in view of Boone and in further view of Mollura as combined does not disclose means for securing the heel offloading device to the patient’s calf within the inner side, against the lower leg contact surface, said securing means having mating first and second fastening ends affixed to locations on the heel offloading device on opposite sides of the U-shaped cavity, and a strap affixed to one of said fastening ends and configured to substantially cover the space between the opposite side portions of the U-shaped cavity to facilitate securement of the opposite side portions in position wrapped around the leg.
Mollura in an embodiment of Fig. 2 teaches an analogous heel offloading device (10) having opposite sides (annotated Fig. 2 below)
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with analogous inner and outer sides (annotated Fig. 2), further comprising means for securing (straps, Fig. 2, col. 4, lines 7-10) the heel offloading device to the patient’s calf within the inner side (Fig. 2), against the lower leg contact surface (capable of intended use), said securing means having mating first and second fastening ends (annotated Fig. 2) affixed to locations on the heel offloading device on opposite sides of the U-shaped cavity (annotated Fig. 2), and a strap (annotated Fig. 2) affixed to one of said fastening ends (annotated Fig. 2) and configured to substantially cover the space between the opposite side portions of the U-shaped cavity (capable of intended use; Fig. 2) to facilitate securement of the opposite side portions in position wrapped around the leg (capable of intended use; Fig. 2).
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 heel offloading device of Marcus in view of Boone and in further view of Mollura is further comprising means for securing the heel offloading device to the patient’s calf within the inner side, against the lower leg contact surface, said securing means having mating first and second fastening ends affixed to locations on the heel offloading device on opposite sides of the U-shaped cavity, and a strap affixed to one of said fastening ends and configured to substantially cover the space between the opposite side portions of the U-shaped cavity to facilitate securement of the opposite side portions in position wrapped around the leg, as taught by Mollura in an embodiment of Fig. 2, in order to provide an improved heel offloading device that facilitates securing the heel offloading device (Mollura, col. 4, lines 7-10).
Regarding claim 22, Marcus in view of Boone and in further view of Mollura discloses the invention as described above with regard to claim 17.
The combination further discloses wherein progression of the different IFD ratings of the multiple layers is configured to decrease pressure experienced by the patient’s calf when the heel offloading device is secured to the calf (as all the limitations have been met, the device is capable of the intended use).
Regarding claim 28, Marcus in view of Boone discloses the invention as described above with regard to claim 27 above.
Marcus in view of Boone does not disclose securing the heel offloading device with a strap of the device, to the calf to decrease pressure experienced by the calf.
Mollura teaches an analogous method of offloading a heel of a patient (Fig. 2; col. 1, lines 1-16, calf, ankle, foot support device that allows the heel to float) comprising securing an analogous heel offloading device (10) with a strap of the device (col. 4, lines 7-10; see annotated Fig. 2 with regard to claim 17 rejection above), to the calf to decrease pressure experienced by the calf (col. 1, lines 1-16, calf support).
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 of Marcus in view of Boone is comprising securing the heel offloading device, with a strap of the device, to the calf, to decrease pressure experienced by the calf, as taught by Mollura, in order to provide an improved method that hat facilitates securing the heel offloading device (Mollura, col. 4, lines 7-10).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcus (US 2022/0160568) in view of Boone (US 4150442) as applied to claim 30 above, and further in view of DuDonis (US 2008/0178390).
Regarding claim 34, Marcus in view of Boone discloses the invention as described above with regard to claim 30.
Marcus in view of Boone does not discloses further comprising a protective cover fully enclosing said layers, said protective cover constructed in a U-shape conforming to the shape of the device and including said cover disposed within the U-shaped cavity, said protective cover contributing to the U-shape of said layers in the layered construction.
DuDonis teaches an analogous heel offloading device (Fig. 5) ([0062]) having analogous layers (27, 25) ([0062]) and comprising an analogous U-shaped cavity (Fig. 5) and further comprising protective cover fully (90) enclosing said layers, said protective cover constructed in a U-shape conforming to the shape of the device ([0062], Fig. 5) and including said cover disposed within the U-shaped cavity (Fig. 5), said protective cover contributing to the U-shape of said layers in the layered construction (Fig. 5, insofar as the cover is a U-shape and the layers are a U-shape, the cover is contributing to the U-shaped of said layers).
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 heel offloading device of Marcus in view of Boone is further comprising a protective cover fully enclosing said layers, said protective cover constructed in a U-shape conforming to the shape of the device and including said cover disposed within the U-shaped cavity, said protective cover contributing to the U-shape of said layers in the layered construction, as taught by DuDonis, in order to provide an improved heel offloading device that has a water-resistant material that encloses the device (DuDonis, [0017]; [0062]).
Allowable Subject Matter
Claims 23-25 are allowed. See Final Rejection dated 12/10/2025, pages 23-25 for reasons for allowance.
Claims 4-7, 11, 29, 31-32 and 35 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 and contingent upon 112b rejections of the base claims being overcome.
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 4,
“wherein the first intermediate layer comprises a third material selected from a foam with a third IFD rating”.
As claims 5-7 depend from claim 4, they are allowable for at least the same reasons as claim 4.
The cited art either alone or in combination fails to disclose as recited in claim 11,
“wherein the inner layer includes a wing portion, wherein an end of the first intermediate layer is 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.
The cited art either alone or in combination fails to disclose as recited in claim 31,
“wherein the device has a layer with end portions extending over ends of an underlying layer at the top of the U-shaped cavity.”
As claim 32 depends from claim 31, it is allowable for at least the same reasons as claim 31.
The cited art either alone or in combination fails to disclose as recited in claim 35, “an
intermediate layer between said first and second layers, said intermediate layer having a higher IFD rating than said first layer”.
.
Conclusion
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/G.M./Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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