DETAILED ACTION
In Applicant’s Response filed 1/16/26, Applicant has amended claim 21 and added new claims 22-40. Claims 1-20 have been cancelled. Currently, claims 21-40 are pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 21, 24, 31 and 34 are objected to because of the following informalities: In claims 21 and 31, the limitation reciting “a patient’s foot” should be amended to recite “a foot of a patient”; in claims 24 and 34, the limitation reciting “the patient’s foot” should be amended to recited “the foot of the patient”; in claim 31, the limitation reciting “a patient’s ankle” should be amended to recite “an ankle of a patient”. Appropriate correction is required.
Double Patenting
NON-STATUTORY DOUBLE PATENTING
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21, 23, 26-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-14 and 16-18 of U.S. Patent No. 9468551 (hereinafter the ‘551 Patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application.
Claim 21 of the instant application recites:
A sole configured for use with an orthopedic walking brace, comprising: a proximal surface configured to receive a patient’s foot; and a distal surface configured to contact a ground surface underneath the orthopedic walking brace, the distal surface comprising a medial-lateral (ML) curvature that has a first peak adjacent to a medial edge, and a second peak adjacent to a lateral edge of the distal surface, wherein the distal surface is substantially flat between the first peak and the second peak.
Claim 1 of US Patent No. 9468551 (hereinafter: ‘551 Patent) recites:
An orthopedic walking brace, comprising: a housing configured to encompass and immobilize a patient's ankle against flexion, and a sole having a proximal surface and a distal surface, the proximal surface configured to receive the patient's foot, and the distal surface having a posterior region, a mid region, and an anterior region, wherein the posterior region is configured to lie under a heel portion of the patient's foot, and has a first anterior-posterior (AP) curvature, the mid region is configured to lie under a center portion of the patient's foot, and has a second AP curvature, and the anterior region is configured to lie under an anterior metatarsal and toe portion of the patient's foot, and has a third AP curvature that increases from a posterior side of the anterior region toward a middle portion of the anterior region and decreases from the middle portion toward an anterior side of the anterior region.
Claim 12 of the ‘551 Patent recites:
The orthopedic walking brace of claim 1, wherein the distal surface has a first medial-lateral (ML) curvature that has a first peak adjacent to a medial edge and a second peak adjacent to a lateral edge of the distal surface, and is substantially flat in between the first and the second peaks.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 21 of the present application and claims 1 and 12 of US Patent No. 9468551 differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claims 1 and 12 of the ‘551 Patent are in effect a “species” of the broader, “generic” invention recited in claim 21 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 21 of the present application is anticipated by claims 1 and 12 of the ‘551 patent and, therefore, is not patentably distinct from claims 1 and 12 of the ‘551 patent.
All of the limitations of claim 23 are found in claim 13 of the ‘551 Patent; All of the limitations of claim 26 are found in claim 14 of the ‘551 Patent; All of the limitations of claim 27 are found in claim 14 of the ‘551 Patent; All of the limitations of claim 28 are found in claim 16 of the ‘551 Patent; All of the limitations of claim 29 are found in claim 17 of the ‘551 Patent; All of the limitations of claim 30 are found in claim 18 of the ‘551 Patent.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 9468551 (hereinafter the ‘551 Patent) in view of Chen (US 2007/0277397).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘551 Patent in view of Chen to one having ordinary skill in the art at the time of the invention.
Specifically, claims 1 and 12 of the ‘551 Patent disclose the sole substantially as recited in claim 22 of the present application, but do not disclose that the ML curvature varies gradually from a posterior of the sole to an anterior of the sole such that the first and second peaks are larger at the posterior of the sole than at a midportion of the sole. Chen, however, teaches an insole comprising a medial-lateral curvature with peaks adjacent to medial and lateral edges as shown in figures 4-5 wherein the ML curvature varies gradually from a posterior of the sole to an anterior of the sole such that the first and second peaks are larger at the posterior of the sole than at a midportion of the sole (gradual decrease in curvature from posterior area at 121 to area at midportion right before increase at 122 as shown in fig 2). It would have been obvious to one having ordinary skill in the art, at the time of the invention, to have modified the sole in claims 1 and 12 of the ‘551 patent so that the ML curvature varies gradually from a posterior of the sole to an anterior of the sole such that the first and second peaks are larger at the posterior of the sole than at a midportion of the sole like the insole of Chen in order to provide increased support at the heel region of a user.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 9468551 (hereinafter the ‘551 Patent) in view of Ellis (US 2008/0086916).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘551 Patent in view of Ellis to one having ordinary skill in the art at the time of the invention.
Specifically, claims 1 and 12 of the ‘551 Patent disclose the sole substantially as recited in claim 24 of the present application, but do not disclose that the proximal surface comprises: a circumferential rim; a raised platform comprising a plurality of recessed volumes configured to be positioned under a heel of the patient’s foot; and a circumferential groove separating the raised platform from the circumferential rim. Ellis, however, teaches a sole (midsole 148; fig 1C) which has a proximal surface that comprises: a circumferential rim; a raised platform comprising a plurality of recessed volumes configured to be positioned under a heel of the patient’s foot; and a circumferential groove separating the raised platform from the circumferential rim (as identified in the annotated fig 1C below).
ANNOTATED FIG 1C OF Ellis:
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It would have been obvious to one having ordinary skill in the art, at the time of the invention, to have modified the sole in claims 1 and 12 of the ‘551 patent so that the proximal surface comprises: a circumferential rim; a raised platform comprising a plurality of recessed volumes configured to be positioned under a heel of the patient’s foot; and a circumferential groove separating the raised platform from the circumferential rim like the sole 148 of Ellis in order to provide target support to specific areas of the user’s foot.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 9468551 (hereinafter the ‘551 Patent) in view of Ellis (US 2008/0086916) and further in view of Issler (US 2005/0223594).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘551 Patent in view of Ellis and further in view of Issler to one having ordinary skill in the art at the time of the invention.
Specifically, claims 1 and 12 of the ‘551 Patent in view of Ellis disclose the sole substantially as recited in claim 25 of the present application, but do not disclose that the proximal surface further comprises a plurality of notches configured to be coupled to a bottom of a footbed of the orthopedic walking brace. Issler, however, teaches a sole which includes a plurality of notches in a top surface of the sole (para [0026]) which are configured to be in communication with a plurality of channels for providing ventilation (abstract). Thus, it would have been obvious to one having ordinary skill in the art, at the time of the invention, to have further modified the sole in claims 1 and 12 of the ‘551 patent in view of Ellis so that the proximal surface further comprises a plurality of notches configured to be coupled to a bottom of a footbed of the orthopedic walking brace like the sole of Issler in order to provide ventilation.
Claims 31, 33 and 36-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-14 and 16-18 of U.S. Patent No. 9468551.
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over Patent No. 9468551 to one having ordinary skill in the art at the time of the invention. Specifically, claims 31, 33 and 36-40 of the present application differ from claims 1, 12-14 and 16-18 of the ‘551 Patent insofar as they are drawn to a method of immobilizing an ankle against flexion while approximating a natural gait through use of an orthopedic walking brace comprising the same structural elements as the device recited in claims 1, 12-14 and 16-18 of the ‘551 Patent. Thus, claims 31, 33 and 36-40 of the present application are unpatentable over the ‘551 Patent because with respect to the method steps claimed, to the extent that the apparatus recited in the ‘551 Patent meets the structural limitations of the apparatus, as claimed, it is obvious that it will also perform the method steps as claimed. Furthermore, it has been held that where 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 device recited in method claims 31, 33 and 36-40 of the present application are identical to the device recited in claims 1, 12-14 and 16-18 of the ‘551. Since the device of the ‘551 Patent is the same as the device for carrying out the method recited in claims 31, 33 and 36-40 of the present application, 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 device recited in the claims of the ‘551 Patent.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 9468551 (hereinafter the ‘551 Patent) in view of Chen (US 2007/0277397).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘551 Patent in view of Chen to one having ordinary skill in the art at the time of the invention.
Specifically, claims 1 and 12 of the ‘551 patent disclose the sole substantially as recited in claim 32 of the present application, but do not disclose that the ML curvature varies gradually from a posterior of the sole to an anterior of the sole such that the first and second peaks are larger at the posterior of the sole than at a midportion of the sole. Chen, however, teaches an insole comprising a medial-lateral curvature with peaks adjacent to medial and lateral edges as shown in figures 4-5 wherein the ML curvature varies gradually from a posterior of the sole to an anterior of the sole such that the first and second peaks are larger at the posterior of the sole than at a midportion of the sole (gradual decrease in curvature from posterior area at 121 to area at midportion right before increase at 122 as shown in fig 2). It would have been obvious to one having ordinary skill in the art, at the time of the invention, to have modified the sole in claims 1 and 12 of the ‘551 patent so that the ML curvature varies gradually from a posterior of the sole to an anterior of the sole such that the first and second peaks are larger at the posterior of the sole than at a midportion of the sole like the insole of Chen in order to provide increased support at the heel region of a user.
Furthermore, claim 32 of the present application differs from claims 1 and 12 of the ‘551 Patent in view of Chen insofar as the claim is drawn to a method of immobilizing an ankle against flexion while approximating a natural gait through use of an orthopedic walking brace comprising the same structural elements as the prior art devices. Thus, claim 32 of the present application is unpatentable over the ‘551 Patent in view of Chen because with respect to the method steps claimed, to the extent that the apparatus recited in the prior art meets the structural limitations of the apparatus, as claimed, it is obvious that it will also perform the method steps as claimed. Furthermore, it has been held that where 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 device recited in method claim 32 of the present application is substantially identical to the device recited in claims 1 and 12 of the ‘551 in view of Chen (as discussed above). Since the prior art device is the same as the device for carrying out the method recited in claim 32 of the present application, 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 device recited in the claims of the ‘551 Patent in view of Chen.
Claim 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 9468551 (hereinafter the ‘551 Patent) in view of Ellis (US 2008/0086916).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘551 Patent in view of Ellis to one having ordinary skill in the art at the time of the invention.
Specifically, claims 1 and 12 of the ‘551 Patent disclose the sole substantially as recited in claim 34 of the present application, but do not disclose that the proximal surface comprises: a circumferential rim; a raised platform comprising a plurality of recessed volumes configured to be positioned under a heel of the patient’s foot; and a circumferential groove separating the raised platform from the circumferential rim. Ellis, however, teaches a sole (midsole 148; fig 1C) which has a proximal surface that comprises: a circumferential rim; a raised platform comprising a plurality of recessed volumes configured to be positioned under a heel of the patient’s foot; and a circumferential groove separating the raised platform from the circumferential rim (as identified in the annotated fig 1C below).
ANNOTATED FIG 1C OF Ellis:
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It would have been obvious to one having ordinary skill in the art, at the time of the invention, to have modified the sole in claims 1 and 12 of the ‘551 patent so that the proximal surface comprises: a circumferential rim; a raised platform comprising a plurality of recessed volumes configured to be positioned under a heel of the patient’s foot; and a circumferential groove separating the raised platform from the circumferential rim like the sole 148 of Ellis in order to provide target support to specific areas of the user’s foot.
Furthermore, claim 34 of the present application differs from claims 1 and 12 of the ‘551 Patent in view of Ellis insofar as the claim is drawn to a method of immobilizing an ankle against flexion while approximating a natural gait through use of an orthopedic walking brace comprising the same structural elements as the prior art devices. Thus, claim 34 of the present application is unpatentable over the ‘551 Patent in view of Ellis because with respect to the method steps claimed, to the extent that the apparatus recited in the prior art meets the structural limitations of the apparatus, as claimed, it is obvious that it will also perform the method steps as claimed. Furthermore, it has been held that where 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 device recited in method claim 34 of the present application is substantially identical to the device recited in claims 1 and 12 of the ‘551 in view of Ellis (as discussed above). Since the prior art device is the same as the device for carrying out the method recited in claim 34 of the present application, 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 device recited in the claims of the ‘551 Patent in view of Ellis.
Claim 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 9468551 (hereinafter the ‘551 Patent) in view of Ellis (US 2008/0086916) and further in view of Issler (US 2005/0223594).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘551 Patent in view of Ellis and further in view of Issler to one having ordinary skill in the art at the time of the invention.
Specifically, claims 1 and 12 of the ‘551 Patent in view of Ellis disclose the sole substantially as recited in claim 35 of the present application, but do not disclose that the proximal surface further comprises a plurality of circular notches configured to be coupled to a bottom of a footbed of the orthopedic walking brace, thereby providing precise and secure attachment of the sole to the footbed. Issler, however, teaches a sole which includes a plurality of notches in a top surface of the sole (para [0026]) which are configured to be in communication with a plurality of channels for providing ventilation (abstract). Issler further teaches that the notches (54) are in mating communication with the channels (34) in the outsole (30) and therefore provide secure attachment (see para 0035-0037]). Thus, it would have been obvious to one having ordinary skill in the art, at the time of the invention, to have further modified the sole in claims 1 and 12 of the ‘551 patent in view of Ellis so that the proximal surface further comprises a plurality of notches configured to be coupled to a bottom of a footbed of the orthopedic walking brace like the sole of Issler in order to provide secure attachment between the elements and, additionally, to provide ventilation. Issler does not explicitly teach that the notches are circular, however, it would have been obvious to one having ordinary skill in the art, at the time of the invention, to have formed the notches of Issler having a circular design since such a modification would require nothing more than choosing one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of forming notches in a sole.
Furthermore, claim 35 of the present application differs from claims 1 and 12 of the ‘551 Patent in view of Ellis and further in view of Issler insofar as the claim is drawn to a method of immobilizing an ankle against flexion while approximating a natural gait through use of an orthopedic walking brace comprising the same structural elements as the prior art devices. Thus, claim 35 of the present application is unpatentable over the ‘551 Patent in view of Ellis and further in view of Issler because with respect to the method steps claimed, to the extent that the apparatus recited in the prior art meets the structural limitations of the apparatus, as claimed, it is obvious that it will also perform the method steps as claimed. Furthermore, it has been held that where 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 device recited in method claim 35 of the present application is substantially identical to the device recited in claims 1 and 12 of the ‘551 in view of Ellis and further in view of Issler (as discussed above). Since the prior art device is the same as the device for carrying out the method recited in claim 35 of the present application, 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 device recited in the claims of the ‘551 Patent in view of Ellis and further in view of Issler.
Allowable Subject Matter
Claims 21-40 are free of art but are still subject to the objections and/or rejections provided above. Additionally, any changes or amendments to the claims may result in new rejections under 35 USC 102 and/or 35 USC 103 being made in future Actions.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 1/16/26 have been fully considered as follows:
Regarding the claim rejection under 35 USC 102 and the Double Patenting Rejection, Applicant’s arguments on pages 6-8 of the Response have been considered but are rendered moot in view of new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786