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 .
Response to Amendment
Applicant’s amendments to the specification are acknowledged by the Examiner.
Applicant’s amendments to the specification and amendments of claims 2 and 11 have overcome the objections to the specification. Therefore, the specification objection is withdrawn.
Applicant’s amendments of claims 1-2, 9-11, 13, and 18-19 are acknowledged by the Examiner.
Applicant’s amendments of claims 9 and 18 have overcome the previous claim objections. Therefore, the claim objections are withdrawn.
Applicant’s amendments of claims 2, 11, and 13 have overcome the previous claim rejections under 35 U.S.C. 112(b). Therefore, the claim rejections under 35 U.S.C. 112(b) are withdrawn.
Claims 1-19 are currently pending in the current application, with claim 19 being withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 03/09/2026 have been fully considered but they are not persuasive.
With respect to Applicant’s arguments regarding the priority of the instant application, Examiner respectfully disagrees. As discussed in the non-final rejection, the instant application independent claims recite “a thermal cover configured to (i) preclude heat equal to or exceeding the first melting temperature onto at least a portion of the first section of the orthopedic precast”. These limitations were not disclosed in either priority Application No. 17/178,071, or 17/673,716. Examiner has reviewed the disclosures of the priority applications and has positively confirmed that the disclosures of the priority applications do not provide support for the identified limitations of the independent claims. Furthermore, Applicant has not provided any references to the disclosure of the priority applications which prove that the identified limitations have support in the priority applications. Thus, Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, and claims 1-19 are given the effective filing date of the filing date of the current application (08/12/2023).
With respect to Applicant’s arguments that neither Adami nor Kilgore, alone or in combination, describes or suggests the cited claim limitations, Examiner respectfully disagrees. Kilgore teaches a thermal cover (insulative mask; see [0036]) with a selected thermal resistance (the mask has a thermal resistance to ensure insufficient heat transfers through the insulative mask where curing is not desired; see [0036]) such that, during a first heating cycle (heating step; see [0028]) the thermal cover (insulative mask) is configured to preclude heat equal to or exceeding the first melting temperature… (remaining limitations addressed in the discussion of Kilgore on pages 8-9 of the non-final rejection). Thus, Kilgore teaches the emphasized new limitations of claim 1.
With respect to Applicant’s arguments that the rejection errs in equating the insulative mask of Kilgore with the claimed thermal cover configured to preclude heat… because Kilgore is directed to a different materials regime of reactive thermoset polymer curing, and that chemical curing in a thermoset system is materially distinct from precluding a thermoplastic material from reaching its melting temperature. Examiner respectfully disagrees that Kilgore does not teach these limitations. First, Kilgore does not disclose chemical curing, Kilgore discloses thermoset curing (see [0036]). Thermoset curing of reactive polymeric materials being the known process of heating a polymer until it becomes soft and pliable (i.e. reaches a melting temperature). Thus, because Kilgore in [0036] explicitly teaches thermoset curing (i.e. heating selective areas of the polymer to a melting temperature) through use of selective exposure by “applying an insulative “mask” over areas of the surface at which curing is not desired (so that insufficient heat transfers through the insulative mask to cure any reactive polymeric material(s) located behind the mask), Kilgore teaches the use of the insulative mask to preclude heat equal to or exceeding the first melting temperature onto at least a portion of the first section of the orthopedic precast as claimed.
With respect to Applicant’s argument that Kilgore’s mask is configured to prevent effective cure of a reactive resin, Examiner respectfully disagrees. Kilgore does not disclose any such resin, or chemicals as suggested by Applicant. Thermoset curing of reactive polymeric materials as discussed above is the known process of heating a polymer until it becomes soft and pliable (i.e. reaches a melting temperature).
With respect to Applicant’s argument that the 103 rejection lacks a persuasive rational to include the mask of Kilgore into Adami’s thermoforming method, Examiner respectfully disagrees. Examiner explicitly cites teachings from the disclosure of Kilgore in the discussion of Kilgore, and the rationale of why one of ordinary skill in the art would be motivated to modify Adami in view of Kilgore. Said teachings being “for the purpose of covering the first section over areas of the surface at which curing is not desired so that insufficient heat transfers through the insulative mask to cure any reactive polymeric material(s) located behind the mask (see [0036])”.
Thus, Applicant’s arguments are not persuasive and the rejections made in the non-final rejection mailed 12/18/2025 are maintained and updated in view of the new amendments.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, U.S. Application No. 17/178,071, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for independent claims 1, 10, and 19 of this application. U.S. Application No. 17/178,071 fails to provide adequate support for the limitations of “a thermal cover configured to (i) preclude heat equal to or exceeding the first melting temperature onto at least a portion of the first section of the orthopedic precast” as recited in independent claims 1, 10, and 19. No thermal cover or similar structure which functions as claimed is recited in U.S. Application No. 17/178,071. Therefore, independent claims 1, 10, and 19 are not given the benefit of the earlier filing date of U.S. Application No. 17/178,071. Claims 2-9, and 11-18 are similarly not given the benefit of the earlier filing date of U.S. Application No. 17/178,071 as these claims depend from either claim 1 or 10 respectively, and thus, contain the same limitations not supported by the earlier filed application.
The disclosure of the prior-filed application, U.S. Application No. 17/673,716, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for independent claims 1, 10, and 19 of this application. U.S. Application No. 17/673,716 fails to provide adequate support for the limitations of “a thermal cover configured to (i) preclude heat equal to or exceeding the first melting temperature onto at least a portion of the first section of the orthopedic precast” as recited in independent claims 1, 10, and 19. No thermal cover or similar structure which functions as claimed is recited in U.S. Application No. 17/673,716. Therefore, independent claims 1, 10, and 19 are not given the benefit of the earlier filing date of U.S. Application No. 17/673,716. Claims 2-9, and 11-18 are similarly not given the benefit of the earlier filing date of U.S. Application No. 17/673,716 as these claims depend from either claim 1 or 10 respectively, and thus, contain the same limitations not supported by the earlier filed application.
Therefore, claims 1-19 are given the effective filing date of the filing date of the current application (08/12/2023).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-8, 10-11, and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adami et al. (US 2018/0127904 A1) (hereinafter Adami) in view of Kilgore (US 2018/0125166 A1).
In regards to claim 1, Adami discloses an orthosis (protective sporting equipment; see [0059]; protective sporting equipment is considered to encompass orthosis devices, as orthotics are commonly used to prevent injuries in sports) customization system (see [abstract] in reference thermoforming (i.e. customizing) the article of wear), comprising:
an orthopedic precast (300; see [0156]; see figure 3) that comprises a first section (302; see [0157]; see figure 3) including a plurality of interwoven strands (knit textile; see [0156]) of a first thermoplastic material (low processing temperature polymeric composition; see [0043]) having a first melting temperature (see [0042]).
Adami discloses the orthopedic precast is intended to undergo thermoforming to form the orthopedic precast with one or more structural properties and/or other advantageous properties including rigidity (see [abstract] and [0042]). Adami does not disclose a thermal cover with a selected thermal resistance, such that during a first heating cycle, the thermal cover is configured to preclude heat equal to or exceeding the first melting temperature onto at least a portion of the first section of the orthopedic precast including the plurality of interwoven strands of the first thermoplastic material to cause the portion of the first section to remain in a flexible state and a remainder of the first section of the orthopedic precast, uncovered by the thermal cover and after cooling, to transition from the flexible state to a rigid state as the orthopedic precast is converted into an orthosis.
However, Kilgore teaches an analogous customization system (see [0036]) for an analogous precast (120; see [0056]; see figure 1c) comprising first section (see figure 1c) which comprises an interwoven polymeric material formed through an analogous thermoforming process (see [0036] and [0055]) further comprising:
a thermal cover (insulative mask; see [0036]) with a selected thermal resistance (the mask has a thermal resistance to ensure insufficient heat transfers through the insulative mask where curing is not desired; see [0036]) such that, during a first heating cycle (heating step; see [0028]) the thermal cover (insulative mask) is configured to preclude heat equal to or exceeding the first melting temperature (insulative mask ensures insufficient heat (preclude heat) transfers to through the mask to the reactive polymeric materials behind the mask to prevent curing (i.e. reaching the melting temperature required for the polymer to melt or cure) onto at least a portion (areas of the surface at which curing is not desired; see [0036]) of the first section of the orthopedic precast (120) including the plurality of interwoven strands of the first thermoplastic material (interwoven polymeric material) to cause the portion (areas of the surface at which curing is not desired) of the first section to remain in a flexible state and a remainder (areas of the surface in which curing is desired) of the first section of the orthopedic precast (120), uncovered by the thermal cover (insulative mask) and after cooling, to transition from the flexible state to a rigid state as the orthopedic precast (120) is converted into an orthosis (see [0039] in reference to the reactive polymeric material will harden and/or stiffen the upper base member at the areas where effective thermoset curing takes place; thus, where curing takes place the polymeric material is considered to transition from the flexible to the rigid state, and where no curing occurs the polymeric material is considered to remain in the uncured, flexible state) for the purpose of covering the first section over areas of the surface at which curing is not desired so that insufficient heat transfers through the insulative mask to cure any reactive polymeric material(s) located behind the mask (see [0036]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthopedic customization system as disclosed by Adami and to have included the thermal cover as taught by Kilgore in order to have provided an improved orthopedic customization system that would add the benefit of providing a structure for covering the first section over areas of the surface at which curing is not desired so that insufficient heat transfers through the insulative mask to cure any reactive polymeric material(s) located behind the mask (see [0036]).
In regards to claim 2, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses wherein the thermal cover (insulative mask of Kilgore) is configured to be coupled to the orthopedic precast (300 of Adami) prior to applying the heat to the orthopedic precast (300 of Adami; for the insulative mask of Kilgore to prevent unwanted curing, it would need to be applied to the orthopedic precast of Adami prior to applying the heat; see Kilgore [0036]).
In regards to claim 4, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami further discloses wherein the orthopedic precast (300) further comprises a second section (304a-b; see [0157]; see figure 3) including a plurality of interwoven strands (knit textile; see [0156]) of a second thermoplastic material (high processing temperature polymeric composition; see [0043] and [0157]) having a second melting temperature higher than the first melting temperature (see [0042] and [0063]) so that the second section (304a-b) remains in a flexible state when the orthopedic precast is converted into the orthosis (see [0158-0159] in reference to section 304a-b comprising the flexible pliable high processing temperature polymeric composition and thus would remain in a flexible state after thermoforming 302).
In regards to claim 5, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses wherein the orthopedic precast (300) further comprises a second section (304a-b; see [0157]; see figure 3) including a plurality of interwoven strands (knit textile; see [0156]) of the first thermoplastic material (low processing temperature polymeric composition; see [0043] and [0157]).
Adami as now modified by Kilgore does not disclose the second section having a tighter interweaving pattern than the plurality of interwoven strands of the first thermoplastic material associated with the first section.
However, Adami teaches that the second section (304a) can have varying concentrations of the first thermoplastic material (see [0161]), and one such method for varying the concentration is by having more stitches (i.e. a tighter interweaving pattern; see [0162]). Adami also teaches in reference to the second section that various constructions techniques allow … for variations in fiber and/or yarn concentration at segment levels and/or textile zone levels (see [0180]). Adami lastly teaches that it can be desirable to bulk up the low processing temperature polymeric composition in order to provide a desired thickness and rigidity to the thermoformed textile zone (see [0176]) which aids in the intended function of the orthopedic precast to provide structure, rigidity, strength, and/or support to one or more areas of the orthopedic precast which are considered to be advantageous properties (see [abstract] and [0150]). Thus, a varying of the stitches (i.e. providing a tighter interweaving pattern) of the first thermoplastic material of the second section to provide an increased concentration of the first thermoplastic material in the second section is considered to be a result effective variable in that changing the stitching of, and therefore the concentration of the first thermoplastic material in the second section affects the ability of the second section to provide the advantageous properties of structure, rigidity, strength, and/or support to one or more areas of the orthopedic precast ([abstract] and [0150]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the stitching of, and therefore the concentration of the first thermoplastic material in the second section as it involves only adjusting the concentration of a component disclosed to require adjustment (see [0180], [0203]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of interwoven strands of the first thermoplastic material of the second section by forming the plurality of interwoven strands of the first thermoplastic material of the second section with a tighter interweaving pattern than the plurality of interwoven strands of the first section as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of allowing the second section to provide the advantageous properties of structure, rigidity, strength, and/or support to the orthopedic precast ([abstract] and [0150]).
In regards to claim 6, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses wherein the second section (304a-b) transitions to a rigid portion of the orthosis (protective sporting equipment) having a greater rigidity than the remainder of the first section (the portion of 302 of Adami covered by the insulative mask of Kilgore is not made rigid through thermoforming; thus, 304a which is rigidly thermoformed of Adami has a greater rigidity than said remainder of 302 of Adami) in response to an application of the heat being equal to or exceeding the first melting temperature onto both the first section (302 of Adami) and the second section (304a-b of Adami; 302 and 304a-b of Adami both comprise the first thermoplastic material and thus are made rigid in response to a heat equal to or exceeding the first melting temperature).
In regards to claim 7, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses Adami as now modified by Kilgore further discloses wherein the orthopedic precast (300) further comprises a second section (304a-b; see [0157]; see figure 3) including a plurality of interwoven strands (knit textile; see [0156]) of the first thermoplastic material (low processing temperature polymeric composition; see [0043] and [0157]).
Adami as now modified by Kilgore does not disclose the plurality of interwoven strands of the first thermoplastic material of the second section having a thickness in diameter greater than a thickness of the plurality of interwoven strands of the first thermoplastic material associated with the first section.
However, Adami teaches that the second section (304a) can have varying concentrations of the first thermoplastic material (see [0161]), and one such method for varying the concentration is by selecting yarns of a particular size (e.g., denier; see [0213]). Adami also teaches in reference to the second section that various constructions techniques allow … for variations in fiber and/or yarn concentration at segment levels and/or textile zone levels (see [0180]). Adami lastly teaches that it can be desirable to bulk up the low processing temperature polymeric composition in order to provide a desired thickness and rigidity to the thermoformed textile zone (see [0176]) which aids in the intended function of the orthopedic precast to provide structure, rigidity, strength, and/or support to one or more areas of the orthopedic precast which are considered to be advantageous properties (see [abstract] and [0150]). Thus, a varying of the denier of the first thermoplastic material of the second section to provide an increased concentration of the first thermoplastic material in the second section is considered to be a result effective variable in that changing the denier of, and therefore the concentration of the first thermoplastic material in the second section affects the ability of the second section to provide the advantageous properties of structure, rigidity, strength, and/or support to one or more areas of the orthopedic precast ([abstract] and [0150]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the denier of, and therefore the concentration of the first thermoplastic material in the second section as it involves only adjusting the concentration of a component disclosed to require adjustment (see [0180], [0213]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of interwoven strands of the first thermoplastic material of the second section by forming the plurality of interwoven strands of the first thermoplastic material of the second section with a greater denier than the plurality of interwoven strands of the first section as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of allowing the second section to provide the advantageous properties of structure, rigidity, strength, and/or support to the orthopedic precast ([abstract] and [0150]).
In regards to claim 8, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses wherein the second section (304a-b) transitions to a rigid portion of the orthosis (protective sporting equipment) having a greater rigidity than the remainder of the first section (the portion of 302 of Adami covered by the insulative mask of Kilgore is not made rigid through thermoforming; thus, 304a which is rigidly thermoformed of Adami has a greater rigidity than said remainder of 302 of Adami) in response to an application of the heat being equal to or exceeding the first melting temperature onto both the first section (302 of Adami) and the second section (304a-b of Adami; 302 and 304a-b of Adami both comprise the first thermoplastic material and thus are made rigid in response to a heat equal to or exceeding the first melting temperature).
In regards to claim 10, Adami discloses an orthosis (protective sporting equipment; see [0059]; protective sporting equipment is considered to encompass orthosis devices, as orthotics are commonly used to prevent injuries in sports) customization system (see [abstract] in reference thermoforming (i.e. customizing) the article of wear), comprising:
an orthopedic precast (300; see [0156]; see figure 3) that comprises a first section (302; see [0157]; see figure 3) including a plurality of interwoven strands (knit textile; see [0156]) of a thermoplastic material (low processing temperature polymeric composition; see [0043]) having a first melting temperature (see [0042]) and at least a second section (306a-b; see [0157]; see figure 3) of interwoven strands of a non-thermoplastic material (wool; see [0082]; 306 is described as being a high processing temperature polymeric composition that exhibits at least one of… a melting temperature that is greater than a melting temperature of the low processing temperature polymeric composition (See [0087]); wool does not have a melting temperature and therefore meets property (4) required by 306a-b and is considered to be contemplated for use in 306a-b).
Adami discloses the orthopedic precast is intended to undergo thermoforming to form the orthopedic precast with one or more structural properties and/or other advantageous properties including rigidity (see [abstract] and [0042]). Adami does not disclose a thermal cover with a selected thermal resistance such that, during a first heating cycle the thermal cover is configured to (i) preclude heat equal to or exceeding the first melting temperature onto at least a portion of the first section of the orthopedic precast including the plurality of interwoven strands of the first thermoplastic material to cause the portion of the first section to remain in a flexible state and a remainder of the first section of the orthopedic precast, uncovered by the thermal cover and after cooling, to transition from the flexible state to a rigid state as the orthopedic precast is converted into an orthosis.
However, Kilgore teaches an analogous customization system (see [0036]) for an analogous precast (120; see [0056]; see figure 1c) comprising first section (see figure 1c) which comprises an interwoven polymeric material formed through an analogous thermoforming process (see [0036] and [0055]) further comprising:
a thermal cover (insulative mask; see [0036]) with a selected thermal resistance (the mask has a thermal resistance to ensure insufficient heat transfers through the insulative mask where curing is not desired; see [0036]) such that, during a first heating cycle (heating step; see [0028]) the thermal cover (insulative mask) is configured to (i) preclude heat equal to or exceeding the first melting temperature onto at least a portion (areas of the surface at which curing is not desired; see [0036]) of the first section of the orthopedic precast (120) including the plurality of interwoven strands of the first thermoplastic material (interwoven polymeric material) to cause the portion (areas of the surface at which curing is not desired) of the first section to remain in a flexible state and a remainder (areas of the surface in which curing is desired) of the first section of the orthopedic precast (120), uncovered by the thermal cover (insulative mask) after cooling, to transition from the flexible state to a rigid state as the orthopedic precast (120) is converted into an orthosis (see [0039] in reference to the reactive polymeric material will harden and/or stiffen the upper base member at the areas where effective thermoset curing takes place; thus, where curing takes place the polymeric material is considered to transition from the flexible to the rigid state, and where no curing occurs the polymeric material is considered to remain in the uncured, flexible state) for the purpose of covering the first section over areas of the surface at which curing is not desired so that insufficient heat transfers through the insulative mask to cure any reactive polymeric material(s) located behind the mask (see [0036]),
wherein the second state is more rigid than the first state (cured is more rigid than uncured; see [0039]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthopedic customization system as disclosed by Adami and to have included the thermal cover as taught by Kilgore in order to have provided an improved orthopedic customization system that would add the benefit of providing a structure for covering the first section over areas of the surface at which curing is not desired so that insufficient heat transfers through the insulative mask to cure any reactive polymeric material(s) located behind the mask (see [0036]).
In regards to claim 11, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses wherein the thermal cover (insulative mask of Kilgore) is configured to be coupled to the orthopedic precast (300 of Adami) prior to applying the heat to the orthopedic precast (300 of Adami; for the insulative mask of Kilgore to prevent unwanted curing, it would need to be applied to the orthopedic precast of Adami prior to applying the heat; see Kilgore [0036]).
In regards to claim 13, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami further discloses wherein the orthopedic precast (300) further comprises a third section (304a-b; see [0157]; see figure 3) including a plurality of interwoven strands (knit textile; see [0156]) of a second thermoplastic material (high processing temperature polymeric composition; see [0043] and [0157]) having a second melting temperature higher than the first melting temperature (see [0042] and [0063]) so that the second section (306a-b) remains in a flexible state when the orthopedic precast is converted into the orthosis (see [0157] in reference to section 306a-b comprising the flexible pliable high processing temperature polymeric composition and thus would remain in a flexible state after thermoforming 302 which has a lower processing temperature polymeric composition).
In regards to claim 14, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses wherein the orthopedic precast (300) further comprises a third section (304a-b; see [0157]; see figure 3) including a plurality of interwoven strands (knit textile; see [0156]) of the first thermoplastic material (low processing temperature polymeric composition; see [0043] and [0157]).
Adami as now modified by Kilgore does not disclose the third section having a tighter interweaving pattern than the plurality of interwoven strands of the first thermoplastic material associated with the first section.
However, Adami teaches that the second section (304a) can have varying concentrations of the first thermoplastic material (see [0161]), and one such method for varying the concentration is by having more stitches (i.e. a tighter interweaving pattern; see [0162]). Adami also teaches in reference to the third section that various constructions techniques allow … for variations in fiber and/or yarn concentration at segment levels and/or textile zone levels (see [0180]). Adami lastly teaches that it can be desirable to bulk up the low processing temperature polymeric composition in order to provide a desired thickness and rigidity to the thermoformed textile zone (see [0176]) which aids in the intended function of the orthopedic precast to provide structure, rigidity, strength, and/or support to one or more areas of the orthopedic precast which are considered to be advantageous properties (see [abstract] and [0150]). Thus, a varying of the stitches (i.e. providing a tighter interweaving pattern) of the first thermoplastic material of the third section to provide an increased concentration of the first thermoplastic material in the third section is considered to be a result effective variable in that changing the stitching of, and therefore the concentration of the first thermoplastic material in the third section affects the ability of the third section to provide the advantageous properties of structure, rigidity, strength, and/or support to one or more areas of the orthopedic precast ([abstract] and [0150]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the stitching of, and therefore the concentration of the first thermoplastic material in the third section as it involves only adjusting the concentration of a component disclosed to require adjustment (see [0180], [0203]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of interwoven strands of the first thermoplastic material of the third section by forming the plurality of interwoven strands of the first thermoplastic material of the third section with a tighter interweaving pattern than the plurality of interwoven strands of the first section as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of allowing the third section to provide the advantageous properties of structure, rigidity, strength, and/or support to the orthopedic precast ([abstract] and [0150]).
In regards to claim 15, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses wherein the third section (304a-b) transitions to a rigid portion of the orthosis (protective sporting equipment) having a greater rigidity than the remainder of the first section (the portion of 302 of Adami covered by the insulative mask of Kilgore is not made rigid through thermoforming; thus, 304a which is rigidly thermoformed of Adami has a greater rigidity than said remainder of 302 of Adami) in response to an application of the heat being equal to or exceeding the first melting temperature onto both the first section (302 of Adami) and the third section (304a-b of Adami; 302 and 304a-b of Adami both comprise the first thermoplastic material and thus are made rigid in response to a heat equal to or exceeding the first melting temperature).
In regards to claim 16, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses Adami as now modified by Kilgore further discloses wherein the orthopedic precast (300) further comprises a third section (304a-b; see [0157]; see figure 3) including a plurality of interwoven strands (knit textile; see [0156]) of the first thermoplastic material (low processing temperature polymeric composition; see [0043] and [0157]).
Adami as now modified by Kilgore does not disclose the plurality of interwoven strands of the first thermoplastic material of the third section having a thickness in diameter greater than a thickness of the plurality of interwoven strands of the first thermoplastic material associated with the first section.
However, Adami teaches that the second section (304a) can have varying concentrations of the first thermoplastic material (see [0161]), and one such method for varying the concentration is by selecting yarns of a particular size (e.g., denier; see [0213]). Adami also teaches in reference to the third section that various constructions techniques allow … for variations in fiber and/or yarn concentration at segment levels and/or textile zone levels (see [0180]). Adami lastly teaches that it can be desirable to bulk up the low processing temperature polymeric composition in order to provide a desired thickness and rigidity to the thermoformed textile zone (see [0176]) which aids in the intended function of the orthopedic precast to provide structure, rigidity, strength, and/or support to one or more areas of the orthopedic precast which are considered to be advantageous properties (see [abstract] and [0150]). Thus, a varying of the denier of the first thermoplastic material of the third section to provide an increased concentration of the first thermoplastic material in the third section is considered to be a result effective variable in that changing the denier of, and therefore the concentration of the first thermoplastic material in the third section affects the ability of the third section to provide the advantageous properties of structure, rigidity, strength, and/or support to one or more areas of the orthopedic precast ([abstract] and [0150]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the denier of, and therefore the concentration of the first thermoplastic material in the third section as it involves only adjusting the concentration of a component disclosed to require adjustment (see [0180], [0213]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of interwoven strands of the first thermoplastic material of the third section by forming the plurality of interwoven strands of the first thermoplastic material of the third section with a greater denier than the plurality of interwoven strands of the first section as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of allowing the third section to provide the advantageous properties of structure, rigidity, strength, and/or support to the orthopedic precast ([abstract] and [0150]).
In regards to claim 17, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore further discloses wherein the third section (304a-b) transitions to a rigid portion of the orthosis (protective sporting equipment) having a greater rigidity than the remainder of the first section (the portion of 302 of Adami covered by the insulative mask of Kilgore is not made rigid through thermoforming; thus, 304a which is rigidly thermoformed of Adami has a greater rigidity than said remainder of 302 of Adami) in response to an application of the heat being equal to or exceeding the first melting temperature onto both the first section (302 of Adami) and the third section (304a-b of Adami; 302 and 304a-b of Adami both comprise the first thermoplastic material and thus are made rigid in response to a heat equal to or exceeding the first melting temperature).
Claim(s) 3 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adami in view of Kilgore as applied to claims 2 and 11 above, and further in view of Hiers et al. (US 6,092,622 A) (hereinafter Hiers).
In regards to claim 3, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore does not disclose wherein the thermal cover includes an adhesive backing for coupling to a top surface of the orthopedic precast.
However, Hiers teaches an analogous thermal cover (40; see [col 7 ln 33-49]; see figure 6b) for the analogous purpose of shielding an object (1; see [abstract]) from thermal radiation or heat (see [col 2 ln 16-29]); wherein the thermal cover (40) includes an adhesive backing (50; see [col 8 ln 9-17]; see figure 6b) for coupling to a top surface of the object to be shielded from heat (1; see [col 8 ln 55-61]) for the purpose of permanently attaching the thermal cover to the object intended to be shielded (see [col 8 ln 55-61]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermal cover as disclosed by Adami as now modified by Kilgore and to have included the adhesive for attaching the thermal cover to the object intended to be shielded as taught by Hiers in order to have provided an improved thermal cover that would add the benefit of providing a means for permanently attaching the thermal cover to the object intended to be shielded (see [col 8 ln 55-61]) thereby ensuring proper placement and means for maintaining said placement of the thermal cover to the top surface of the orthopedic precast.
In regards to claim 12, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami as now modified by Kilgore does not disclose wherein the thermal cover includes an adhesive backing for coupling to a top surface of the orthopedic precast.
However, Hiers teaches an analogous thermal cover (40; see [col 7 ln 33-49]; see figure 6b) for the analogous purpose of shielding an object (1; see [abstract]) from thermal radiation or heat (see [col 2 ln 16-29]); wherein the thermal cover (40) includes an adhesive backing (50; see [col 8 ln 9-17]; see figure 6b) for coupling to a top surface of the object to be shielded from heat (1; see [col 8 ln 55-61]) for the purpose of permanently attaching the thermal cover to the object intended to be shielded (see [col 8 ln 55-61]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermal cover as disclosed by Adami as now modified by Kilgore and to have included the adhesive for attaching the thermal cover to the object intended to be shielded as taught by Hiers in order to have provided an improved thermal cover that would add the benefit of providing a means for permanently attaching the thermal cover to the object intended to be shielded (see [col 8 ln 55-61]) thereby ensuring proper placement and means for maintaining said placement of the thermal cover to the top surface of the orthopedic precast.
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adami in view of Kilgore as applied to claims 1 and 10 above, and further in view of Heronen et al. (US 2022/0039991 A1) (hereinafter Heronen).
In regards to claim 12, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami, as discussed above, discloses the use of the orthopedic precast system in protective sporting equipment (see [0059]) which is considered to encompass orthosis devices. Adami as now modified by Kilgore does not explicitly disclose wherein the orthosis is a lumbar sacral orthosis (LSO) or part of a thoracic lumbar sacral orthosis (TLSO).
However, Heronen teaches an analogous orthosis device (100; see [0045]; see figure 1a) comprising an analogous orthopedic precast (251; see [0081]; see figure 9c) including interwoven strands of a thermoplastic material (251 may be polytetrafluoroethylene, polymeric materials and fabric or synthetic materials; see [0081]) for the analogous purpose of providing strength along a substantial length of the device (see [0081]) wherein the orthopedic precast is part of a thoracic lumbar sacral orthosis (TLSO) (100 is a TLSO; see [0047]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthosis as disclosed by Adami as now modified by Kilgore and to have utilized the orthosis as part of the thoracic lumbar sacral orthosis (TLSO) as taught by Heronen in order to have provided an improved thoracic lumbar sacral orthosis (TLSO) that would add the benefit of providing the advantageous properties of structure, rigidity, strength, and/or support of the orthopedic precast of Adami as now modified by Kilgore (see Adami [abstract] and [0150]) into the thoracic lumbar sacral orthosis (TLSO) as taught by Heronen.
In regards to claim 18, Adami as now modified by Kilgore discloses the invention as discussed above.
Adami, as discussed above, discloses the use of the orthopedic precast system in protective sporting equipment (see [0059]) which is considered to encompass orthosis devices. Adami as now modified by Kilgore does not explicitly disclose the orthosis is a lumbar sacral orthosis (LSO) or part of a thoracic lumbar sacral orthosis (TLSO).
However, Heronen teaches an analogous orthosis device (100; see [0045]; see figure 1a) comprising an analogous orthopedic precast (251; see [0081]; see figure 9c) including interwoven strands of a thermoplastic material (251 may be polytetrafluoroethylene, polymeric materials and fabric or synthetic materials; see [0081]) for the analogous purpose of providing strength along a substantial length of the device (see [0081]) wherein the orthopedic precast is part of a thoracic lumbar sacral orthosis (TLSO) (100 is a TLSO; see [0047]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthosis as disclosed by Adami as now modified by Kilgore and to have utilized the orthosis as part of the thoracic lumbar sacral orthosis (TLSO) as taught by Heronen in order to have provided an improved thoracic lumbar sacral orthosis (TLSO) that would add the benefit of providing the advantageous properties of structure, rigidity, strength, and/or support of the orthopedic precast of Adami as now modified by Kilgore (see Adami [abstract] and [0150]) into the thoracic lumbar sacral orthosis (TLSO) as taught by Heronen.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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