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 of claims 1, 2, 9, 15-16, and 19 are acknowledged by the Examiner.
Applicant’s cancelation of claim 8 is acknowledged by the Examiner.
Applicant’s amendment of claims 1-2, 9, 16 and 19 has overcome the previous claim objections. Therefore, the claim objections are withdrawn.
Applicant’s amendment of claims 1 and 15 has 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 Therefore, the claim rejections under 35 U.S.C. 112(b) are withdrawn.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments that Kise does not disclose hook-and-loop fastening mechanisms. Examiner respectfully disagrees. While Kise, does not explicitly state that structure 5 comprises hook-and-loop material, paragraph [0076] states structures 5 and 6 are formed from the same material, which evidences both structures may have similar features. Additionally it can clearly be seen in figure 3 (provided below) that structure 5 comprises hook and loop fastening mechanisms similar to structure 6 as discussed by the Examiner in the rejection of claim 8. In regards to Applicant’s statements of paragraph [0121], Applicant erroneously relies on the hook-and-loop structures provided on the protruding inner side of the opening of 6 which function to close in the connector. Contrarily, paragraph [0121] states “he hook-and-loop fastener would be exposed at the surface” as can be seen in figure 3, that is referring to the entirety of the external surface of 6. Examiner did not state that the fasteners of 6 were on the cushioning pad as suggested by Applicant. Examiner cited paragraph [0121] as evidence that the surface of 6 has a hook-and-loop fastening mechanism, and that as seen in figure 3, the cushioning pad has a similar feature. Lastly, Applicant’s reliance on paragraph [0082] is relying on an alternative embodiment of the device of Kise. Contrarily paragraph [0081] states “first annular bandage (4), second annular bandage (3), fastening band (2), cushioning pad (5), and corrector storage bag (6), as separate bodies” which evidences that these are separate structures, removably attached to one another when in use (see figures 1-3).
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Thus, the arguments are not persuasive, and the rejections under 35 U.S.C. 103 are maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 6-7, 9-14, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kise et al. (US 2019/0133803 A1) (hereinafter Kise) in view of Neu (US 3,244,171 A).
In regards to claim 1, Kise discloses A bunion splint assembly (1; see [0042]; see figure 1) comprising:
a flexible body (3 and 6; see [0042-0043]; see figure 1) configured to conform to a human foot (see figure 1);
an elongated rigid member (10; see [0043]; see figure 2; 10, while being described in [0042] as a superelastic alloy, is an alloy and thus has a rigidity) disposed within fabric layers of the flexible body (3 and 6; see [0043]) such that, when the flexible body (3 and 6) is secured to the human foot, the elongated rigid member (10) is configured to align along a side of the human foot corresponding to a location of a big toe and applies pressure in a direction toward a second toe (see figure 2); and
a cushion (5; see [0042]; see figure 1) configured to encompass a bunion on the big toe (see figure 1), the cushion (5) being adapted to be removably and adjustably secured to an inner surface of the flexible body (3 and 6; see [0121] in reference to 6 having hook and loop fastening mechanisms on a surface of 6; see figure 3 that 5 has similar hook and loop fastening mechanism, and thus is considered to be removably and adjustably secured to the inner surface of 6), wherein the cushion (5) comprises a fastening material affixed thereto (hook and loop material; see figure 3), the fastening material being configured to reversibly secure the cushion (5) to the inner surface of the flexible body (3 and 6; see figures 1-3; hook and loop fastening mechanisms are reversibly securable).
Kise does not disclose the cushion is a ring-shaped cushion.
However, Neu teaches an analogous cushion (1; see [col 2 ln 40-50]; see figure 1) for the analogous purpose of treating a user’s bunions (see [col 1 ln 10-20]); wherein the cushion (1) is a ring-shaped cushion (see figure 1) for the purpose of applying pressure to healthy tissues around the bunion relieving the user of pain caused by the bunion and restoring adductive capabilities of the metatarsal head to encourage normal positioning of the toe (see [col 1 ln 20-31]).
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 cushion as disclosed by Kise and to have formed the cushion in the shape of a ring as taught by Neu in order to have provided an improved cushion that would add the benefit of applying pressure to healthy tissues around the bunion relieving the user of pain caused by the bunion and restoring adductive capabilities of the metatarsal head to encourage normal positioning of the toe (see [col 1 ln 20-31]).
In regards to claim 2, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu further discloses wherein, when the flexible body (3 and 6 of Kise) is secured to the human foot, the ring-shaped cushion (5 of Kise as now modified by Neu) is configured to be disposed between the elongated rigid member (10 of Kise) and the big toe (see Kise figure 1) and to engage a region of the big toe surrounding the bunion without applying force to a center portion of the bunion (see Neu [Col 1 ln 20-31]).
In regards to claim 3, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu further discloses wherein the ring-shaped cushion (5 of Kise as now modified by Neu) is adapted to removably couple to a treatment site-engaging surface (portion of inner surface of 6 of Kise positioned over the user’s bunion) of the inner surface of the flexible body (3 and 6 of Kise; as discussed above 5 of Kise comprises hook and loop fasteners for removably coupling to the portion of inner surface of 6 of Kise positioned over the user’s bunion, and thus is adapted as claimed).
In regards to claim 4, Kise as now modified by Neu discloses the invention as discussed above.
Kise further discloses wherein the elongated rigid member (10) is disposed between the treatment site-engaging surface (portion of inner surface of 6 of Kise positioned over the user’s bunion) and an opposing outer surface of the bunion splint assembly (outer surface of 3 and 6; see [0043] that 10 is housed within 6, and thus is disposed as claimed between the inner and outer surfaces of 6).
In regards to claim 6, Kise as now modified by Neu discloses the invention as discussed above.
Kise further discloses wherein the elongated rigid member (10) is permanently disposed between the treatment site-engaging surface (portion of inner surface of 6 of Kise positioned over the user’s bunion) and the opposing outer surface (outer surface of 3 and 6; when the device is in use, 10 is not removed from 6 until the device is removed from the user; thus, when the device is in use, 10 is permanently disposed between the claimed locations).
In regards to claim 7, Kise as now modified by Neu discloses the invention as discussed above.
Kise further discloses wherein the elongated rigid member (10) is removable from between the treatment site-engaging surface (portion of inner surface of 6 of Kise positioned over the user’s bunion) and the opposing outer surface (outer surface of 3 and 6; see [0112]).
In regards to claim 9, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu further discloses wherein the ring-shaped cushion (5 of Kise as now modified by Neu) has a tapered outer diameter (see Neu figures 4 and 5 that the outer diameter of 1 formed by conjoining 6a and 6b is tapered) that is largest at an interface with the fastening material (hook and loop material of Kise; as now combined the hook and loop material of Kise would be positioned on the flared-out edge of 6a of Neu which forms the larger outer diameter).
In regards to claim 10, Kise as now modified by Neu discloses the invention as discussed above.
Kise discloses the ring-shaped cushion (5 of Kise as now modified by Neu) has no particular limitations on the materials, but can be made from synthetic rubber (see [0076]). Kise as now modified by Neu does not disclose wherein the ring-shaped cushion comprises a polymer gel or a foam material.
However, Neu further teaches wherein the ring-shaped cushion (2) comprises a polymer gel or a foam material (see [col 2 ln 38-43] in reference to the cushion being made from rubber, or foams) for the purpose of providing a resilient cushioning material (see [col 1 ln 58-67]).
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 rubber material of the ring-shaped cushion as disclosed by Kise as now modified by Neu and to have formed the ring-shaped cushion from a foam material as further taught by Neu as Kise discloses the cushion has no particular limitations on the materials, but can be made from synthetic rubber (see [0076]) and Neu teaches the use of either rubber or foams (see [col 2 ln 38-43]) in order to have provided an improved cushion that would add the benefit of providing a resilient cushioning material (see [col 1 ln 58-65]).
In regards to claim 11, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu further discloses wherein the ring-shaped cushion (5 of Kise as now modified by Neu) defines an elongated aperture (aperture formed by 8, 9, and 11 of Neu; see Neu figures 4 and 5) having a first inner diameter (inner diameter of 9 of Neu; see Neu figure 4) that is greater than an orthogonal second inner diameter (inner diameter of 8 of Neu; see Neu figure 4).
Kise as now modified by Neu does not explicitly disclose, and wherein the first inner diameter is from about 2.5 cm to about 5 cm.
However, Neu teaches the ring-shaped cushion is sized such that the aperture (and therefore, the first inner diameter of said aperture) of the cushion receives the bunion without contacting the bunion to allow the ring to apply pressure to the healthy tissue around the bunion (see [col 1 ln 20-31], [col 2 ln 1-7], and [col 3 ln 60-69]). Thus, a specific inner diameter of the ring-shaped cushion is considered to be a result effective variable in that changing the inner diameter of the ring-shaped cushion affects the ability of the aperture of the ring-shaped cushion to receive the bunion and apply pressure to the healthy tissue around the bunion without contacting the bunion. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the first inner diameter of the ring-shaped cushion of Kise as now modified by Neu as it involves only adjusting the dimension of a component disclosed to surround a user’s bunion which are known the art to be of varying sizes based on the severity of the bunion.
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 first inner diameter of the ring-shaped cushion of Kise as now modified Neu by forming the inner diameter from the claimed range of 2.5-5 cm 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 ring-shaped cushion to properly receive the bunion within the aperture without contacting the bunion.
Further such a modification would have been obvious to one of ordinary skill in the art since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (see MPEP 2144.04 IV A). In the instant case, the ring-shaped cushion having the relative dimensions of the claimed device would not perform differently with the claimed size.
In regards to claim 12, Kise as now modified by Neu discloses the invention as discussed above.
Kise further discloses wherein the elongated rigid member (10) comprises a substantially flat metal bar (see figure 3; see [0027]).
In regards to claim 13, Kise as now modified by Neu discloses the invention as discussed above.
Kise further discloses further comprising a plurality of straps (2 and 4; see [0042]; see figure 1) adapted to secure the flexible body (3 and 6) to the human foot when worn (see figure 1).
In regards to claim 14, Kise as now modified by Neu discloses the invention as discussed above.
Kise further discloses wherein a first strap (4) of the plurality of straps (2 and 4) is adapted to wrap at least partially around the big toe and be reversibly secured to an outer surface of the flexible body (outer surface of 3 and 6) when worn (see [0119]).
In regards to claim 18, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu does not explicitly disclose A kit comprising: a pair of bunion splint assemblies according to claim 1, wherein a first bunion splint assembly is adapted for conforming to a left foot and a second bunion splint assembly is adapted for conforming to a right foot.
However, Kise further discloses the bunion splint assembly of claim 1 (see discussion of claim 1 above for teaching) can be formed as a kit (see [0081] in reference to the structures being formed as separate bodies, thus, being a kit for a user to assemble). It can also be seen in figure 1 that the bunion splint assembly is symmetrical and thus, adapted to conform to either a left foot or a right foot as desired (further evidenced by table 1 where it can be seen that the device is worn on both left and right feet of men and women). 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 kit comprising the bunion splint assembly of claim 1 as disclosed by Kise as now modified by Neu and to have included through a mere duplication of parts, a second bunion splint assembly in order to have provided an improved kit that would add the benefit of providing an additional bunion splint assembly adapted to conform to either a left foot or a right foot of the user, such that the pair of bunion splint assemblies are able to be used simultaneously to treat bunions of a user’s left and right foot, or to provide a back-up bunion splint assembly to be used in the event that the first assembly is damaged and inoperable.
Furthermore, such a modification to include additional bearings is held to be obvious since it has been held that “mere duplication of parts has no patentable significance unless a new and unexpected result is produced” In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (see MPEP 2144.04 (VI) (B)). In the instant case, providing an additional bunion splint assembly provides the expected result of providing an additional bunion splint assembly for either simultaneous treatment of two bunions, or for use in the event that the first assembly is damaged and inoperable.
In regards to claim 19, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu further discloses A method of treating a bunion comprising applying the bunion splint assembly of claim 1 (see discussion of claim 1 above) to the human foot on which the bunion is present (see Kise [0002] and figure 1).
In regards to claim 20, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu does not explicitly disclose the method further comprises adjusting a position of the ring-shaped cushion on the flexible body to control a location of engagement of the ring-shaped cushion with the human foot relative to the bunion.
However, as discussed in the rejection of claim 1, Kise does disclose the cushion (5) being adapted to be removably and adjustably secured to an inner surface of the flexible body (3 and 6; see [0121] in reference to 6 having hook and loop fastening mechanisms; see figure 3 that 5 has similar hook and loop fastening mechanisms, and thus is considered to be removably and adjustably secured to the inner surface of 6). Thus, with respect to the method steps of “adjusting a position of the ring-shaped cushion on the flexible body to control a location of engagement of the ring-shaped cushion with the human foot relative to the bunion” to the extent that Kise as now modified by Neu’s ring-shaped cushion meets the structural limitations of the apparatus, as claimed, it is obvious that the ring-shaped cushion will also perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); MPEP 2112.01(I). In the present case, the ring-shaped cushion is identical or substantially identical in structure to the structure required to perform the method steps as claimed.
Therefore, because the prior art device of Kise as now modified by Neu is identical or substantially identical in structure to the structure required to perform the method steps as claimed, it is obvious that the device will perform the claimed process and, therefore, the method claimed is considered to be obvious in view of the prior art device.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kise in view of Neu as applied to claim 4 above, and further in view of Demian (US 2004/0243197 A1).
In regards to claim 5, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu does not disclose wherein each of the treatment site-engaging surface and the opposing outer surface comprise a foam material.
However, Demian teaches an analogous bunion splint assembly (26; see [0035]; see figure 7) comprising an analogous treatment site-engaging surface (surface of 26 against the user’s bunion; see figure 6) and the opposing outer surface (outer surface of 26) wherein each of the treatment site-engaging surface and the opposing outer surface comprise a foam material (see [0035]) for the purpose of providing a soft cushioning material (see [0035]).
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 treatment site-engaging surface and the opposing outer surface as disclosed by Kise as now modified by Neu and to have included the foam material on said surfaces as taught by Demian in order to have provided an improved bunion splint assembly that would add the benefit of providing a soft cushioning material (see [0035]) which increases user’s comfort while using the device.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kise in view of Neu as applied to claim 14 above, and further in view of Kasahara (US 5,282,782 A).
In regards to claim 15, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu does not disclose wherein a second strap and a third strap of the plurality of straps are disposed along a common edge of the flexible body and are adapted to reversibly engage each other and secure the flexible body to a heel when worn.
However, Kasahara teaches an analogous big toe supporting device (second embodiment seen in figures 4-6) comprising an analogous flexible body (body of the device seen in figure 4) plurality of straps (15, 19, 20; see [col 3 ln 58-67]; see figure 4) for the analogous purpose of securing the device to the user’s foot (see figure 6); wherein a second strap and a third strap (19 and 20) of the plurality of straps (15, 19, and 20) are disposed along a common edge of the flexible body (see figure 6) and are adapted to reversibly engage each other (reversibly engaged via 21 and 22; see [col 3 ln 58-67]; see figure 4) and secure the flexible body (body of the device) to a heel when worn (see figure 5) for the purpose of securing the device around the user’s heel (see [col 3 ln 58-67]).
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 flexible body of the bunion splint assembly as disclosed by Kise as now modified by Neu and to have included the second and third strap which extend from a common, rear, edge of the flexible body are reversibly engageable with one another as taught by Kasahara in order to have provided an improved bunion splint assembly that would add the benefit of providing additional straps which aid in securing the device around the user’s heel (see [col 3 ln 58-67]) thereby increasing the securing capabilities of the bunion splint assembly.
In regards to claim 16, Kise as now modified by Neu and Kasahara discloses the invention as discussed above.
Kise further discloses wherein a fourth strap (2) of the plurality of straps (2 and 4 of Kise, and included 19 and 20 of Kasahara) is adapted to be reversibly secured to the outer surface of the flexible body (3 and 6) on a top portion of the human foot when worn (see figure 1), and wherein the inner surface of the flexible body (inner surface of 3 and 6) is formed from a different material than the outer surface of the flexible body (outer surface of 3 and 6; see [0118] in reference to one surface of 3 being neoprene, another surface of 3 being an extra-fine denier polyester fiber, and having the hook-and-loop fastener; see figure 3), and wherein the material of the outer surface is adapted to reversibly engage a hook-and-loop fastener material of the plurality of straps (outer surface of 3 and 6 which include the hook and loop material as seen in figure 3 are capable and therefore, adapted to reversibly engage with the hook-and-loop fastener material of the plurality of straps described in [0117] and [0119]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kise in view of Neu as applied to claim 1 above, and further in view of Scholl (US 1,984,158 A).
In regards to claim 17, Kise as now modified by Neu discloses the invention as discussed above.
Kise as now modified by Neu further discloses A kit (kit comprising the structures of 1 configured as separate bodies; see Kise [0081]) comprising: the bunion splint assembly of claim 1 (see discussion of claim 1 above).
Kise as now modified by Neu does not explicitly disclose one or more additional ring-shaped cushions, wherein each ring-shaped cushion has a different sized aperture.
However, Scholl teaches an analogous ring-shaped cushion (11; see [col 2 ln 20-30]; see figure 3) for the treatment of a user’s bunion (see [col 1 ln 1-6; and one or more additional ring-shaped cushions (12 of figure 4 and 12 of figure 5), wherein each ring-shaped cushion (12 of figures 3-5 respectively) has a different sized aperture (15, 15a, and 15b; see figures 3-5; the differently shaped apertures are different in size from one another with respect to the upper and lower openings of the apertures) for the purpose of allowing the afflicted portion to be normally received within the aperture (see [col 2 ln 47-52]).
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 kit comprising the bunion splint assembly as disclosed by Kise as now modified by Neu and to have included the additional ring-shaped cushions with different sized apertures as taught by Scholl in order to have provided an improved kit comprising the bunion splint assembly that would add the benefit of providing multiple ring-shaped cushions with different sized apertures for allowing the afflicted portion to be normally received within the aperture (see [col 2 ln 47-52]). Additionally each additional ring-shaped pad with different sized apertures would allow the user to select a pad which is best suited to the needs or comfort of the user
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786