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 .
Examiner’s Note
The Examiner acknowledges the amendments of claims 5 & 8. Claims 1 – 4 & 12 – 13 were previously withdrawn from consideration. Claim 11 is cancelled. Claims 5 – 10 are examined herein.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 5 – 6 & 8 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Baer et al. (US 2015/093559 A1).
With regard to claim 5, Baer et al. teach a composite shape memory material (Applicant’s “device”) that can be used for biomedical applications, textiles (i.e., “intended for application to the human body”) (paragraphs [0023], & [0048] – [0049]) includes a coextruded first polymer layer of first polymer material (Applicant’s “first layer”) and second polymer layer of a second polymer material (Applicant’s “second layer”) of different melt temperatures and/or glass transition temperatures (paragraphs [0009] – [0010]). The shape memory material may have permanent shape (“use temperature lower than the thermoforming temperature”) and a temporary shape achieved by exposing the material to an external stimulus, such as heat, causing the polymer to exist above its transition temperature (i.e. “thermoforming temperature”), in an amorphous, elastomeric, or melted state. Subsequent exposure to an external stimulus can cause the shape memory material to return to the original permanent shape (“viscoelastic”) (paragraph [0025]). In other words, the material has the ability to be both fluid-like (viscous) and solid-like (elastic) (i.e., “viscoelastic”).
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Multilayer films are formed by melt coextrusion and may be formed into a number of articles by, for example, thermoforming (Applicant’s “thermoforming temperature” and “first layer is bonded to the second layer by a mechanical bond distributed over a contact surface between the first layer and the second layer”) (paragraphs [0028] & [0046], Fig. 2). Thermomechanical programming is capable of undergoing at least one temperature induced shape transition from a temporary shape into a permanent shape (“use temperature lower than the thermoforming temperature”) (paragraphs [0010] – [0011] & Fig. 6).
The first polymer layer 12 can be a hard layer that is typically crystalline and have a melting point rather than a glass transition temperature, and the second polymer layer can be a soft switching layer that is typically amorphous and have a glass transition temperature rather than a melting point (Applicant’s “the thermoformable material is elastically deformable and more stiff/rigid than the viscoelastic material in the use temperature range” and “the thermoformable material is less rigid than the viscoelastic material in the thermoforming temperature range”) (paragraph [0027]). First polymer layer defines a hard segment of the shape memory material that provide the shape memory material with the permanent shape (Applicant’s “first layer defines a form of use of the device in the use temperature range”). The second polymer layer defines a switching segment of the shape memory material that provides the shape memory material with the temporary shape (Applicant’s “the second layer defines an original shape of the device”) (paragraph [0009]).
Baer et al. teach examples of polymeric materials can potentially be used for the first and second polymer materials, including poly(ethylene terephathalate glycol) (PETG), polycaprolactone (PCL), polyethylene (PE), silicon(e) rubber, or urethane rubber (PU) (paragraph [0030]), which are the same materials as used by Applicant for the recited first layer and second layer (see Applicant’s claims 8 – 9 & specification paragraphs [0057] – [0058])). Silicone rubber and urethane rubber are known in the art to be inherently viscoelastic.
In a working example taught by Baer et al., the laminate contains a melt temperature-based switching, containing polyurethane (PU) (Applicant’s “second layer of viscoelastic material”) coextruded with polycapro-lactone (PCL) (Applicant’s “first layer of thermoforming material”), wherein the switching window (“use temperature”) is in the range of 50 – 100+°C. For example, polycapro-lactone (PCL) has a Tm of 60°C (and therefore a thermoforming temperature via melt extrusion of greater than 60°C, which overlaps with Applicant’s claimed range of 50 – 100°C. Furthermore, the laminate has a switching window (use temperature of 50 – 100°C), which overlaps with temperatures less than the thermoforming temperature of greater than 60°C (paragraph [0051] & Table 1).
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As discussed above, Baer et al. teach the same polymer materials used for the first and second layers as disclosed by Applicant. Therefore, the polymer materials of the first and second layers taught by Baer et al. inherently have the inelastically deformable property, elastically deformable property, relative stiffness/rigidity, and stiffness as claimed by Applicant.
MPEP 2112 [R-3] states:
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
It has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977).
With regard to claim 6, as discussed above for claim 5, Baer et al. teach the first and second layers are formed by melt coextrusion. Therefore, a chemical bond is made by melting (i.e., “fusion”) of the material forming the first and second layers on either side of the contact surface between the first and second layers.
With regard to claim 8, as discussed above 5, Baer et al. suggest the first layer is composed of polycapro-lactone (PCL).
With regard to claim 9, as discussed above for claim 5, Baer et al. teach the second layer may be composed of polyurethane (PU) or silicone.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Baer et al., as applied to claim 5 above, and further in view of Muggli et al. (US 2005/0276985 A1).
With regard to claim 7, as discussed above for claim 5, Baer et al. teach the first and second layer are joined by a method of melt coextrusion.
However, Baer et al. fail to teach the first layer is embedded in the second layer, and/or the first layer comprises studs penetrating matching shaped holes in the second layer and/or the second layer comprises studs penetrating the matching shaped holes in the first layer.
Muggli et al. teach composite article comprising a first polymer layer and a second polymeric layer joined by both a tie layer and mechanical interlocking (paragraphs [0018], [0036], [0039], [0041], & Fig. 1). The mechanical interlocking is accomplished by a first polymeric layer (110) comprising a plurality of caps stems (140) (i.e., “studs”) (paragraph [0035]), penetrating the second polymeric layer (i.e., “penetrating a matching shaped hole in the second layer”) (120) (paragraph [0059], Fig. 1). Examples of suitable polymer for the layers include polysiloxanes, polyketones, polyurethanes (paragraph [0052]). The tie layer and at least one of the first and/or second polymeric layers may be coextruded using a profile co-extrusion die (paragraphs [0061] & [0065]). Mechanical interlocking provides a high degree of adhesion between the first and second polymeric layers (paragraph [0018]).
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Therefore, based on the teachings of Muggli et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date prior to the effective date to form mechanical interlocking of the first polymer layer and the second polymer layer taught by Baer et al. via stems (i.e., “studs”) of the first polymer layer penetrating matching shaped holes in the second polymer layer in order to achieve a high degree of adhesion between the first and second layers.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Baer et al., as applied to claim 5 above, and further in view of Fonte et al. (US 2013/0291399 A1).
With regard to claim 10, Baer et al. teach the polymeric multilayer shape memory material can be used to prepare articles of manufacture for use in biomedical applications (paragraph [0047]) and applications including members requiring deformation restoration after impact absorption (paragraph [0049]).
However, Baer et al. do not teach the second layer has the shape of an insole configured to cover the heel and the sole of a foot.
Fonte et al. teach a shoe insole and foot orthotic made of shape memory material. The use of cushioned or shock-absorbing insoles has been suggested as a mechanism to reduce the impact forces associated with running, thereby protecting against these overuse injuries (paragraph [0008]). The shape memory material can be shaped to a specific foot geometry, supply improved dampening/cushioning, and offer super-elastic shape recovery to ensure long-lasting support (paragraph [0023] & Figs. 1 – 6).
Therefore, based on the teachings of Fonte et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form the polymeric multilayer shape memory material taught by Baer et al. into articles that composed of shape memory material for providing impact absorption, such as a shoe insole or foot orthotic configured to cover the heel and the sole of a foot.
Claim(s) 5 – 6 & 8 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Weaver et al. (US 2015/0335460 A1), in view of Wang et al. (“Elastic Shape Memory Hybrids Programmable at Around Body-Temperature for Comfort Fitting,” Polymers 2017, 9, 674).
*Wolff et al. (“Viscoelastic properties of a silicone resin during crosslinking,” Rheol Acta (2011) 50:917-924)
With regard to claim 5, Weaver et al. teach a plantar fascia support system (100) (i.e., “device intended for application to the human body”) comprising a footplate and a strap. A footplate (120) (i.e. “a first layer”) is formed of heat-malleable (i.e., “thermoformable”) material capable of plastic deformation (i.e., “inelastically deformable”) when heated above a glass transition temperature between 45 – 75°C (i.e. thermoforming temperature”) (paragraph [0052]), which overlaps with Applicant’s claimed range of 50 – 100°C. As set forth in MPEP 2144.05, in the case where the claimed range “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).
A strap (110) (i.e. “a second layer”) comprises a flexible material composed of viscoelastic materials (i.e., “elastically deformable”) (paragraph [0037]). The heat or other trigger may be applied before or after the footplate is inserted into the adjustable strap. When subjected to form above the glass transition temperature (i.e., “thermoforming temperature”), the deformable surface of the footplate may be plastically deformed into a shape correspond to the underside of the arch (of a human foot) (paragraph [0057]). In other words, the strap remains deformable at ambient temperature (i.e., “use temperature range”) and at glass transition temperature (i.e., “thermoforming temperature range”) and the foot plate (i.e., “thermoformable material”) is less rigid than the strap (i.e., “viscoelastic material”) in the glass transition temperature range (i.e., “thermoforming temperature range”).
The footplate (i.e., “first layer”) is adhered to the adjustable strap (i.e., “second layer”) via an attachment mechanism, such as welding, adhesives (i.e. “chemical bond”), stitching (i.e. “mechanical bond”) (paragraph [0041]).
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When the footplate is a cooled to a temperature below the glass transition temperature, such as ambient temperature (i.e., “use temperature”), the material may harden and retain a shape that corresponds substantially to the underside of the arch (paragraph [0058]). In other words, the footplate (i.e., “first layer”) defines a form of use of the device in the use temperature range.
Weaver et al. do not explicitly teach the strap (i.e., “second layer”) has a shape-memory function (i.e., “defines an original shape of the device and achieves a shape-memory function of the device in the thermoforming temperature range”).
Weaver et al. teach the strap may be composed of viscoelastic material and/or silicone material (paragraph [0037]). As evidenced by *Wolff et al., highly crosslinked silicone is an example of viscoelastic material.
Wang et al. teach person products, such as clothing, footwear, insoles, and orthotic devices, comprising an elastic component, such as silicone (PDMS) modified with transition component (PPM), such as poly-ε-caprolactone (PCL) particles, to produce a hybrid with shape-memory function for comfort fitting (title). All samples were heated at 50°C (i.e., “thermoforming temperature”) for five minutes, wherein almost full shape recovery (i.e., “shape memory function”) was observed (pg. 8).
Therefore, based on the teachings of Wang et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to produce a shape-memory function of a silicone material for clothing, insoles, or orthotic devices, such as the silicone-based viscoelastic strap of the plantar fascia support system taught by Weaver et al. in order to provide a comfort fit to a human foot.
Weaver et al. do not explicitly teach the stiffness of the footplate (first layer).
However, Weaver et al. teach the footplate (“first layer”) is formed of a heat-malleable material (i.e., “thermoformable resin” that has a glass transition temperature of 45 – 75°C, which is below 100°C. Furthermore, Weaver et al. teach the heat heat-malleable material includes polycaprolactone (PCL) and polyethylene (PE) (paragraph [0051]). These polymers are the same composition of polymer as used by Applicant for the first layer (see discussion of claim 8 below).
Therefore, the first layer of PCL or PE with a glass transition temperature below 100°C taught by Weaver et al. must inherently have a stiffness in the recited range of 1 – 2 GPa. It has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977).
MPEP 2112 [R-3] states:
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
With regard to claim 6, as discussed above in claim 5, Weaver et al. teach the footplate (i.e., “first layer”) is adhered to the adjustable strap (i.e., “second layer”) via an attachment mechanism, such as welding (i.e. “fusion”), adhesives (i.e. “glue”), stitching (i.e. “mechanical connection”) (paragraph [0041]).
With regard to claim 8, as discussed above in claim 5, Weaver et al. teach the footplate (“first layer”) is formed of a heat-malleable material (i.e., “thermoformable resin” that has a glass transition temperature of 45 – 75°C, which is below 100°C. Furthermore, Weaver et al. teach the heat heat-malleable material includes polycaprolactone (PCL) and polyethylene (PE) (paragraph [0051]).
With regard to claim 9, Weaver et al. teach the strap material (“second material”) may be composed of viscoelastic material, such as silicone rubber, silicone gel, or (poly)urethane (paragraph [0037]).
With regard to claim 10, Weaver et al. teach an embodiment in which the footplate includes a heel portion (1010), sole (arch) (1006-1008), and a forefoot portion (1020) (paragraph [0063] & Fig. 12). The adjustable strap is adapted to retain the footplate (Weaver’s claim 1 & Fig. 9). Therefore, this particular embodiment suggests the adaptable strap has the shape of an insole configured to cover the heel and the sole (arch) of a foot.
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Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Weaver et al. & Wang et al., as applied to claim 5 above, and further in view of Muggli et al. (US 2005/0276985 A1).
With regard to claim 7, as discussed above for claim 5, Weaver et al. teach the foot plate (first layer) and strap (second layer) are attached by known attachments means, such as welding, adhesive, or stitching.
However, Weaver et al. fail to teach the first layer is embedded in the second layer, and/or the first layer comprises studs penetrating matching shaped holes in the second layer and/or the second layer comprises studs penetrating the matching shaped holes in the first layer.
Muggli et al. teach composite article comprising a first polymer layer and a second polymeric layer joined by both a tie layer and mechanical interlocking (paragraphs [0018], [0036], [0039], [0041], & Fig. 1). The mechanical interlocking is accomplished by a first polymeric layer (110) comprising a plurality of caps stems (140) (i.e., “studs”) (paragraph [0035]), penetrating the second polymeric layer (i.e., “penetrating a matching shaped hole in the second layer”) (120) (paragraph [0059], Fig. 1). Examples of suitable polymer for the layers include polysiloxanes, polyketones, polyurethanes (paragraph [0052]). The tie layer and at least one of the first and/or second polymeric layers may be coextruded using a profile co-extrusion die (paragraphs [0061] & [0065]). Mechanical interlocking provides a high degree of adhesion between the first and second polymeric layers (paragraph [0018]).
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Therefore, based on the teachings of Muggli et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date prior to the effective date to form mechanical interlocking of the foot plate (first plate) and strap (second layer) taught by Weaver et al. via stems (i.e., “studs”) such that the polymer of the foot plate penetrates matching shaped holes in the polymer of the strap in order to achieve a high degree of adhesion between the foot plate and the strap.
Response to Arguments
Applicant argues, “…at the use temperature in Baer: PCL (second layer) is MORE rigid than PU (first layer). This is the OPPOSITE of what claim 5 requires, where the first thermoformable material layer must be more rigid than the second viscoelastic layer at use temperature…at the thermoforming temperature in Baer: PU (first layer) is MORE rigid than PCL (second layer). This is the OPPOSITE of what Claim 5 requires, where the first thermoformable layer must be LESS rigid than the second viscoelastic layer at thermoforming temperature” (Remarks, Pg. 11).
“The Applicant respectfully submits that there may be a misunderstanding as to which layer plays which role in Baer, or that the Examiner has implicitly reversed the ‘first’ and ‘second’ layer designations. But even if one accepted this nomenclature reversal, the problem persists: in Baer, it is always the elastic layer (PU) that drives recovery toward the permanent shape after the switching layer (PCL) has softened. In the currently pending claims, it is the viscoelastic layer (second layer) that drives recovery toward the original shape after the thermoformable layer (first layer) has softened” (Remarks, Pg. 12).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. First, Applicant has misread the rejection. As discussed on pg. 6 of the previous office action, Baer teaches a working example in which polyurethane corresponds to Applicant’s “second layer of viscoelastic material” and polycapro-lactone corresponds to Applicant’s “first layer of thermoforming material.” This is the opposite of Applicant’s argument.
Second, contrary to Applicant’s assertion, the problem does not persist when the labels are reversed. Both Applicant’s claims and the teachings of Baer are consistent: the viscoelastic second layer of polyurethane drives the recovery after the first layer of PCL has softened.
Applicant argues, “The Applicant recognizes that paragraph [0027] of Baer mentions that roles can be reverse (‘Alternatively, the second polymer layer 14 can be a hard layer… and the first polymer layer 12 can be soft layer’). However, the Applicant asserts that even in the ‘alternative’ configuration of Baer, the fundamental mechanism remains the same: the hard layer (whatever its number) provides elastic recovery toward the permanent shape, and the soft layer (switching segment) allows freezing of the temporary shape. Baer DOES NOT teach a configuration where the recovery layer (the one that returns the device to its original shape) is the layer that is more rigid ONLY at elevated temperature and softer at use temperature” (Remarks, Pg. 12).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. First, as discussed in the previous rejection, Baer describes the first polymer as having a melting point (moldable liquid) rather than a glass transition temperature at elevated temperature and the second polymer has a glass transition temperature (flexible, rubbery state) and not a melting point at elevated temperature (paragraph [0027]). In other words, the thermoformable material is less rigid in a liquid form compared to the rubbery state of the viscoelastic material in the thermoforming temperature range. Baer further refers to the first polymer material as hard (stiff) and the second polymer as soft at use temperature (paragraph [0027]).
Second, as previously noted, Baer teaches using the same type of polymer material as Applicant’s specification. Therefore, the polymer materials for the first and second layers taught by Baer must inherently have the same properties.
Applicant argues, “In addition, the Applicant submits that the incorporation of the feature ‘stiffness between 1 and 2 GPa’ for the first layer provides quantitative support. A stiffness at room temperature is characteristic of semi-rigid thermoplastic and is fundamentally incompatible with the PU elastomers used as the first layer in Baer (typically 0.01 – 0.1 GPa)” (Remarks, Pg. 12).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. As discussed above, Applicant’s argument has switched the layers discussed in the office action. As previously discussed for claim 8, PCL is the same material used by Applicant and therefore inherently has the same stiffness properties.
Applicant argues, “The Examiner cites paragraph [0009] of Baer as disclosing the elements/features ‘the second layer defines an original shape of the device and achieves a shape-memory function of the device in the thermoforming temperature range.’ The Applicant respectfully disagrees.
“Paragraph [0009] of Baer discloses ‘the second polymer layer defining a switching segment… that provides the shape memory material with the temporary shape.’ In Baer, the second layer (switching segment): (a) defines the TEMPORARY shape (‘temporary shape’) – i.e., a deformed shape that will subsequently be recovered from; and (b) provides a FIXING function (‘freezing of temporary shapes’ – paragraph [0026]) – NOT a memory function.
Claim 5 defines the second layer as follows: (a) defines an ORIGINAL shape (‘original shape’) – i.e., the manufacturing/molding shape; and (b) achieves a SHAPE-MEMORY FUNCTION (‘shape-memory function’) in the thermoforming range” (Remarks, Pgs. 12 – 13).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Applicant has taken the term “temporary shape” out of context of Baer’s description of the shape transitions of the material. Paragraph [0010] of Baer refers to the temporary shape as the first shape before temperature induced shape transition into a second “permanent shape” (Applicant’s deformed shape). Therefore, the “temporary shape” corresponds to Applicant’s “original shape.”
Second, Applicant has taken the teachings of paragraph [0026] of Baer out of context. Baer’s paragraph [0026] teaches either the first polymer layer or the second polymer layer may be elastic to provide mechanical recovery and either the first or the second layer have reversible crosslinking for freezing the product into a temporary shape(s). In other words, the elastic property of one (second) layer allows the shape to “recover” to the original shape.
Furthermore, paragraph [0026] teaches the layer that is not elastic (i.e., “inelastically deformable” first layer) may be “reversibly crosslinked to allow freezing of temporary shapes for use in various applications.” In other words, the layer that is not inelastically deformable (first layer) allows freezing the shape of the entire product, and thus the inelastically deformable first layer is not required to have shape memory functionality. Applicant’s claim 5 does not require the first layer to have shape memory functionality.
As previously discussed, Baer teaches first layer (PCL of similar Tg) and second layer (PU of similar Tm) that are of similar composition and structure as Applicant’s first and second layers. Therefore, the PCL and PU layers taught by Baer must inherently have the same properties.
Applicant argues, “The Applicant respectfully asserts that the Examiner has misinterpreted ‘shape memory function’ by equating ‘temporary shape’ when these are opposite concepts: shape memory concerns return to a memorized shape, not fixation of a temporary shape” (Remarks, Pg. 13).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. The Examiner did not equate temporary shape and shape memory function. Baer’s definition of shape memory is consistent with Applicant’s definition (return to a memorized shape). However, a temporary shape is not fixed (i.e., “permanent”), as Applicant’s argument suggests.
Baer teaches in paragraph [0025]: “Temporary shapes 18 are achieved by exposing the shape memory material 10 to an external stimulus, such as heat, causing either the first polymer or the second polymer to exist above its transition temperature, either in an amorphous, elastomeric, or melted state…Subsequent exposure to an external stimulus can causes the composite shape memory material to return to the original permanent shape.”
Furthermore, Baer’s paragraph [0026] teaches either the first polymer layer or the second polymer layer may be elastic to provide mechanical recovery (shape memory) and either the first or the second layer have reversible crosslinking for freezing the product into a temporary shape(s). In other words, the elastic property of one (second) layer allows the shape to “recover” to the original shape.
Applicant argues, “With regard to inherency (see, Office Action, pg. 7), the Examiner invokes inherency: since Baer mentions the same polymers (PCL, PU, silicone), the claimed functional properties would necessarily be present. The respectfully disagrees.
“First inherency requires that the property NECESSARILY present in the prior art, not merely possible. Baer discloses a generic list of potential polymers at paragraph [0030], but does not disclose a specific combination that would produce the claimed stiffness inversion. The only concrete examples (PCL.PU, Table 1) produces the INVERSE of the claimed stiffness relationships” (Remarks, Pg. 14).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. As discussed above, Applicant misread the reference and the rejection with regard to the materials of the first and second layers.
Applicant argues, “Second, the claimed properties do not flow simply from the choice of materials but from their functional arrangement. Using PCL as the first layer and a soft silicone as the second layer could possibly produce the claimed stiffness inversion, but Baer neither teaches nor suggests this specific combination with this functional arrangement” (Remarks, Pg. 14).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. The claimed properties are the result of both choice and materials and the structural features (Applicant’s asserted “functional arrangement”). Applicant has failed to specify any particular structure feature lacking from the teachings of cited prior art that would be necessary for achieving the recited properties.
Applicant argues, “Third, In re Best applies when ‘the claimed and prior art products are identical or substantially identical in structure.’ Here, the functional structure is INVERTED between Baer and the claimed structure. Further, the incorporation of the feature ‘stiffness between 1 and 2 GPa’ provides a quantitative parameter that is NOT taught by Baer for the first layer (Baer’s first layer is an elastomer with modulus 0.01 – 0.1 GPa), and that defines the mechanical properties required for the claimed stiffness inversion to occur” (Remarks, Pg. 14).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. As previously discussed, Baer teaches PCL (not an elastomer layer) as the first layer and the elastic (elastomer) polyurethane (PU) as the second layer. Applicant has reversed these labels to misrepresent the teachings of the reference in their arguments.
Further, one of ordinary skill in the art would expect a layer PCL of similar glass transition temperature to have the same stiffness (Young’s modulus) property. An inherent property is a property that is understood by one of ordinary skill in the are to be possessed by the product, although not explicitly taught by the reference.
Applicant argues, “Muggli describes composite articles (films, tubes) for chemical barrier applications, where two polymeric layers (fluoropolymer/non-fluoropolymer) are bonded together by adhesive AND mechanical means. The mechanical bonding is achieved through overhanging protrusions such as ‘capped stems’ or ‘overhanging ribs’ extending from one layer into the other. Muggli is directed to fuel tank liners and hoses, not to thermoformable shape-memory devices for human body application.
“The Examiner combines Baer with Muggli to address the ‘mechanical bonds’ limitation including ‘studs’ of the first layer penetrating the second layer. However, Muggli merely teaches a technique for mechanically interlocking two polymer layers using overhanging protrusions. Muggli does not teach or suggest any of the distinctive features of Claim 5 that Baer fails to disclose, namely the stiffness inversion between the two layers and the shape-memory function achieved by the second viscoelastic layer. Even if one were to incorporate Muggli’s mechanical bonding technique into Baer, the resulting combination would still lack the claimed stiffness relationships and functional architecture. Therefore, the combination of Baer and Muggli does not render Claim 7 obvious” (Remarks, Pgs. 14 – 15).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. With regard to Muggli’s intended use of layers for fuel tank liners and hoses, a reference may be considered analogous art in the instance that the reference is reasonably pertinent to the problem faced by the inventor, even if it is not in the same field of endeavor. See MPEP 2141.01(a). Similar to the teachings of Muggli, Applicant’s specification teaches first layer comprises comprising studs for penetrating matching shaped holes in the second layer and/or vice versa for improving cohesion (i.e., adhesion) between the layers. See paragraph [0044] of the originally filed specification. Therefore, the reference of Muggli is pertinent to the problem of poor adhesion between adjoining layers faced by the inventor(s).
With regard to Baer, Applicant is directed to the discussion of above.
Applicant argues, “Fonte describes shoe insoles and foot orthotics made from three-dimensional spacer fabrics produced from metallic shape memory materials, primarily Nitinol (nickel-titanium alloy). The shape memory function in Fonte comes from the superelastic properties of the Nitinol alloy itself (austenite-to-martensite phase transformation) not from a two-layer polymer structure with stiffness inversion.
“The Examiner combines Baer with Fonte to address the ‘insole’ limitation. Fonte teaches shoe insoles mode of Nitinol spacer fabric, which is a completely different technology from the claimed invention. Fonte’s shape memory function from the intrinsic superelastic properties of a metallic alloy, not from a two-layer polymeric structure with stiffness inversion. Similar to Muggli, Fonte does not cure any of Baer’s deficiencies regarding the distinctive features of Claim 5. The combination of Baer (which teaches an inverted functional architecture) with Fonte (which teaches single-material metallic insoles) provides no motivation or teaching to arrive at the claimed two-layer structure with stiffness invention. Therefore, the combination of Baer and Fonte does not render Claim 10 obvious” (Remarks, Pgs. 15 – 16).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Based on the teachings of Fonte, one of ordinary skill in the art would be motivated to form the shape memory material taught by Baer et al. into known shapes for known uses of shape memory material, such as the form of a shock-absorbing insole.
With regard to claim 5, Applicant is directed to the discussion above.
Applicant argues, “At paragraph [0053], Weaver mentions that ‘the footplate 120 includes a multi-layer construction, with the supporting base material at least partially covered by a soft, flexible material.’ However, this optional soft covering is merely for comfort – it does not define an original shape of the device nor achieve a shape-memory function. Weaver’s shape-memory function, when present, resides in the footplate itself (paragraph [0052]), not in a separate viscoelastic layer” (Remarks, Pg. 16).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Weaver et al. teach the strap is adhered to the footplate via adhesive or stitches (chemical or mechanical bonding), allowing the viscoelastic silicone strap (suggested to be shape memory material by Wang) to dfine an original shape of the device and achieve a shape-memory function. As such, the shape memory viscoelastic crosslinked silicone material taught by Wang remedies Applicant’s asserted shape-memory function (and original shape) deficiencies of Weaver et al.
Furthermore, it is not necessary for the secondary reference of Wang et al. to teach two distinct layers bonded together and relative stiffness of the two distinct layers because these features are taught by the cited primary reference of Weaver et al.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues, “Critically, Weaver does NOT disclose:
“-A second layer that is MORE rigid than the first layer in the thermoforming temperature range
“-A second viscoelastic layer that ‘defines an original shape of the device and achieves a shape-memory function’
“-The stiffness inversion required by Claim 5” (Remarks, Pg. 16).
Applicant argues, “The addition of Wang does not cure Weaver’s deficiencies. Wang describes shape memory hybrids (SMH) where an elastic component (PDMS silicone) is mixed with a transition component (PPM) to form a homogeneous composite. The transition component softens upon heating (above ~50°C) and hardens upon cooling, while the elastic component stores energy and drives shape recovery” (Remarks, Pgs. 16 – 17).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. The shape memory hybrid is a composition and suggested for use as the material of the second layer of the primary reference of Weaver. The transition component does not prevent the shape memory hybrid composition from use as the strap (second layer) taught by Weaver.
Applicant argues, “Wang’s SMH is a homogeneous mixture where PPM particles (50 – 5 µm diameter) are dispersed within the silicone matrix (see Wang, Figure 3). There are no distinct ‘first layer’ and ‘second layer’ that can be independently characterized for their relative stiffness properties” (Remarks, Pg. 17).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. The cited primary reference of Weaver et al. teach two distinct layers made of different materials. Wang was cited as a secondary reference for their teaching of a second layer with a shape-memory function. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues, “Because Wang’s material is a homogenous composite, the concept of ‘the thermoformable material is less rigid than the viscoelastic material in the thermoforming temperature range’ has no meaning. The composite has a single set of mechanical properties at any given temperature, not two distinct layers with inverting relative stiffness” (Remarks, Pg. 17).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Wang was cited as a secondary reference for their teaching of a second layer with a shape-memory function. Applicant has ignored the final structure that results from the suggested combination of Weaver in view of Wang. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues, “The stressed measured in Wang’s materials are on the order of 0.1 – 1.2 MPa (see Wang, Figures 4 – 8). This corresponds to moduli of approximately 0.001 – 0.01 GPa – which is 100 to 1000 times LOWER than the 1 – 2 GPa stiffness required by amended claim 5. Wang’s materials are soft elastomeric composites, not semi-rigid thermoplastics” (Remarks, Pg. 17).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. With regard to the rejection of amended claim 5, Wang was cited as a secondary reference for their teaching of a second layer (strap) with a shape-memory function. This is not relevant to the recited stiffness (Young’s modulus) 1 – 2 GPa of the first layer (foot plate taught by Weaver) for the rejection of claim 5. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues, “In Wang’s SMH, the elastic component (silicone) is always soft and provides the recovery force, while the transition component (PPM) hardens to fix the temporary shape. This is analogous to Baer’s mechanism where a soft elastic component drives recovery. In contrast, Claim 5 requires that the SECOND layer (viscoelastic) be MORE rigid than the first layer (thermoformable) in the thermoforming range – the opposite configuration” (Remarks, Pg. 17).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. The cited primary reference of Weaver teaches the strap (second material) may be viscoelastic and/or silicone material (paragraph [0037]). As previously discussed, Weaver suggests the foot plate (i.e., thermoformable material of the first layer) is less rigid than the strap (i.e., viscoelastic silicone material of the second layer) in the glass transition temperature (i.e., “thermoforming temperature range”)
In the rejection, Wang was only cited for motivation to use viscoelastic cross-linked silicone as the strap material (second layer) taught by Weaver. The PPM are particles mixed into the silicone material taught by Wang et al. and suggested for forming the second layer alone. Therefore, Applicant’s arguments regarding PPM in the cited secondary reference are not pertinent to the rejection of the relative stiffness of the first and second layers in the thermoformable temperature range.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues, “However, even accepting the Examiner’s mapping of Weaver’s footplate as the first layer and Weaver’s strap as the second layer, the combination still fails to disclose or render obvious the functional architecture required by Claim 5. In Weaver, the strap is merely a fixation element that retains the footplate proximate to the wearer’s arch; it neither defines an original shape of the device nor achieves a shape-memory function. Wang does not remedy this deficiency: it discloses a homogeneous shape-memory hybrid material in which elastic and transition components are intimately mixed, not a device comprising two distinct layers bonded together and exhibiting an inversion of relative stiffness between use and thermoforming temperature ranges. Neither Weaver nor Wang teaches or suggests a configuration in which a viscoelastic second layer is less rigid than a thermoformable first layer at use temperature, becomes more rigid than the first layer in the thermoforming temperature range, and thereby actively drives the return of the device to an original shape when the thermoformable layer softens. The Examiner’s proposed combination therefore relies on impermissible hindsight” (Remarks, Pgs. 17 – 18).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Weaver et al. teach the strap is adhered to the footplate via adhesive or stitches (chemical or mechanical bonding), allowing the viscoelastic silicone strap (suggested to be shape memory material by Wang) to dfine an original shape of the device and achieve a shape-memory function. As such, the shape memory viscoelastic crosslinked silicone material taught by Wang remedies Applicant’s asserted shape-memory function (and original shape) deficiencies of Weaver et al.
Furthermore, it is not necessary for the secondary reference of Wang et al. to teach two distinct layers bonded together and relative stiffness of the two distinct layers because these features are taught by the cited primary reference of Weaver et al.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues, “The addition of Wolff does not cure the deficiencies of Weaver and Wang. As an initial matter, the Applicant notes that this reference was not provided with the Office action and is not accessible in the USPTO file wrapper. The article appears to be fundamental rheology study on viscoelastic properties of a silicone resin during crosslinking…It does not concern two-layer devices, thermoformable materials for body application, or stiffness invention between layers. At most, Wolff establishes that silicone resins exhibit viscoelastic behavior – fact that is well known and not in dispute. Wolff does not provide any teaching that would cure the fundamental deficiencies of the combination of Weaver and Wang” (Remarks, Pg. 19).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. First, according to the USPTO records, the Wolff reference was provided with the non-final Office Action mailed 8/27/2025 and is accessible via public PAIR.
Second, the Wolff reference was cited as an evidentiary reference, not as a prior art reference, to demonstrate the known viscoelastic properties of cross-linked silicone resin taught by Weaver et al.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE T GUGLIOTTA whose telephone number is (571)270-1552. The examiner can normally be reached M - F (9 a.m. to 10 p.m.).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frank Vineis can be reached at 571-270-1547. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE T GUGLIOTTA/Examiner, Art Unit 1781
/FRANK J VINEIS/Supervisory Patent Examiner, Art Unit 1781
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