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 .
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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6 of U.S. Patent No. 12,213,902 (“Showalter”). Although the claims at issue are not identical, they are not patentably distinct from each other because Showalter discloses a species that anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
Instant Application
Showalter
1. An apparatus configured to treat a bunion, said apparatus comprising:
a cable;
means for releasably securing a first end of said cable to at least a distal phalange of the digit of the patient's foot;
a shoe portion;
means for applying a specific amount of tension to said cable;
a support bracket, said support bracket comprising a first portion and a second portion, a proximal end of said first portion of said support bracket being mounted to pivot with respect to said shoe portion at a pivot axis, to reorient the specific amount of tension in said cable to an adduction angle of said cable with respect to an axial direction of said shoe portion, said first portion of said support bracket configured to extend substantially perpendicular to said pivot axis, and said second portion of said support bracket configured to extend away from a distal end of said first portion and to terminate at an elevated position with respect to said shoe portion;
an adjustment member, said adjustment member mounted to slide relative to said second portion, to adjust a dorsiflexion angle provided by said cable independent of said adduction angle;
wherein a portion of said cable is supported by said adjustment member;
means for releasably securing said first portion of said support bracket with respect to said shoe portion, at least at a first pivot position for providing the specific amount of tension at an adduction angle of zero degrees, and at least at a second pivot position configured to provide the specific amount of tension at a non-zero-degree adduction angle;
means for releasably securing said adjustment member with respect to said second portion of said support bracket at a first position for providing a dorsiflexion angle of zero degrees for said cable, and at least at a first elevated position for providing the specific amount of tension at a non- zero-degree dorsiflexion angle; and
means for securing said shoe portion to the foot of the patient for countering the specific amount of tension in said cable with respect to said non-zero-degree adduction angle and for countering the specific amount of tension in said cable with respect to said non-zero-degree dorsiflexion angle, for repositioning of only the digit of the patient's foot with respect to said shoe portion.
1. An apparatus configured to apply traction to a big toe of a patient's foot at a desired adduction angle and a desired dorsiflexion angle, for use in treating a bunion, said apparatus comprising:
a cable
a toe trap configured to be releasably secured to at least a distal phalange of the big toe of the patient's foot, said toe trap comprising a cable;
a shoe portion, said shoe portion comprising:
means for adjusting an amount of tension in said cable;
a support bracket, said support bracket comprising a first portion and a second portion, said first portion of said support bracket mounted to pivot with respect to said shoe portion at a pivot axis, to adjust an adduction angle of said cable with respect to an axial direction of said sole, said pivot axis being substantially perpendicular to said substantially flat interior surface of said sole, said first portion of said support bracket configured to extend substantially perpendicular to said pivot axis, and said second portion of said support bracket configured to extend substantially parallel to said pivot axis and to terminate at an elevated position with respect to said sole;
an adjustment member, said adjustment member mounted to slide relative to said second portion, to slide substantially parallel to said pivot axis to adjust a dorsiflexion angle provided by said cable independent of said adduction angle;
wherein a portion of said toe trap is supported by said adjustment member;
a securement apparatus configured to releasably secure said first portion of said support bracket at said pivot axis with respect to said shoe portion, at a first pivot position to provide a first adduction angle for said cable, and at least a second pivot position to provide a second adduction angle for said cable;
means for releasably securing said adjustment member with respect to said second portion of said support bracket at a first elevated position for providing a first dorsiflexion angle for said cable to reposition the big toe to a first repositioned angle with respect to said sole, and at least a second elevated position for providing a second dorsiflexion angle for said cable to reposition the big toe at a second repositioned angle with respect to said sole;
means for adjusting an amount of tension in said cable; and
wherein said first strap is configured to counter said amount of tension in said cable with respect to said adduction angle, whereby said first strap is securable over the top of the patient's foot in proximity to the ankle of the patient's foot; and
wherein said second strap is configured to counter said amount of tension in said cable with respect to each of said first and second dorsiflexion angles to immobilize the patient's foot, whereby said second strap is securable over the top of the patient's foot in proximity to the toes of the patient's foot, such that the amount of tension in said cable at each of said first and second dorsiflexion angles repositions only the big toe with respect to said sole.
2. The apparatus according to claim 1, further comprising: a platform, said platform configured to elevate said shoe portion above a floor surface.
2. The apparatus according to claim 1, further comprising: a platform, said platform configured to elevate said shoe portion above a floor surface.
3. The apparatus according to claim 2, wherein said platform comprises one or more flanges, said one or more flanges being configured to elevate said shoe portion above the floor surface.
3. The apparatus according to claim 2, wherein said platform comprises one or more flanges, said one or more flanges being configured to elevate said shoe portion above the floor surface.
4. The apparatus according to claim 3, wherein at least said means for applying the specific amount of tension is positioned between said shoe portion and the floor surface.
4. The apparatus according to claim 3, wherein at least said means for adjusting the amount of tension is positioned between said sole and the floor sur
5. The apparatus according to claim 4,
further comprising a meter, said meter configured to indicate the specific amount of tension in said cable.
5. The apparatus according to claim 4, wherein a first end of each of said first strap and said second strap are fixedly connected to a first side of said shoe portion; and wherein a second end of each of said first strap and said second strap are configured to be releasably coupled to a second side of said shoe portion.
6. The apparatus according to claim 5, further comprising a meter, said meter configured to indicate an amount of tension in said cable.
Allowable Subject Matter
Claims 1-5 as presented in the claims filed January 8, 2025, are allowable over the prior art of record should Applicant file a Terminal Disclaimer or amend the claims to overcome the Double Patenting Rejection above. The following is an examiner’s statement of reasons for allowance:
Claim 1 is allowable because the closest prior art of record fails to disclose An apparatus configured to treat a bunion, said apparatus comprising:
a cable;
means for releasably securing a first end of said cable to at least a distal phalange of the digit of the patient's foot;
a shoe portion;
means for applying a specific amount of tension to said cable;
a support bracket, said support bracket comprising a first portion and a second portion, a proximal end of said first portion of said support bracket being mounted to pivot with respect to said shoe portion at a pivot axis, to reorient the specific amount of tension in said cable to an adduction angle of said cable with respect to an axial direction of said shoe portion, said first portion of said support bracket configured to extend substantially perpendicular to said pivot axis, and said second portion of said support bracket configured to extend away from a distal end of said first portion and to terminate at an elevated position with respect to said shoe portion;
an adjustment member, said adjustment member mounted to slide relative to said second portion, to adjust a dorsiflexion angle provided by said cable independent of said adduction angle; wherein a portion of said cable is supported by said adjustment member;
means for releasably securing said first portion of said support bracket with respect to said shoe portion, at least at a first pivot position for providing the specific amount of tension at an adduction angle of zero degrees, and at least at a second pivot position configured to provide the specific amount of tension at a non-zero-degree adduction angle; means for releasably securing said adjustment member with respect to said second portion of said support bracket at a first position for providing a dorsiflexion angle of zero degrees for said cable, and at least at a first elevated position for providing the specific amount of tension at a non- zero-degree dorsiflexion angle; and
means for securing said shoe portion to the foot of the patient for countering the specific amount of tension in said cable with respect to said non-zero-degree adduction angle and for countering the specific amount of tension in said cable with respect to said non-zero-degree dorsiflexion angle, for repositioning of only the digit of the patient's foot with respect to said shoe portion.
The closest prior art of record is US 2,146,933 (“Budin”) which discloses An apparatus configured to treat a bunion (Fig 1), said apparatus comprising:
a cable (Fig 1, cable 18);
means for releasably securing a first end of said cable to at least a distal phalange of the digit of the patient's foot (Fig 1, trap 11; limitation interpreted under 112(f)- instant application [0086]: a toe trap);
a shoe portion (Fig 1, shoe 3/4/5/6);
…
a support bracket, said support bracket comprising a first portion and a second portion (Fig 1, bracket first portion 7 and second portion 19), a proximal end of said first portion of said support bracket being mounted to pivot with respect to said shoe portion at a pivot axis, to reorient the specific amount of tension in said cable to an adduction angle of said cable with respect to an axial direction of said shoe portion, said first portion of said support bracket configured to extend substantially perpendicular to said pivot axis (Fig 1, first portion 7 pivots perpendicular to the sole 6 at connector to adjust the adduction angle of the cable), and said second portion of said support bracket configured to extend away from a distal end of said first portion and to terminate at an elevated position with respect to said shoe portion (Fig 1, second member 19 shown extending away);
…
means for releasably securing said first portion of said support bracket with respect to said shoe portion (Fig 2, securement apparatus 8/9/10; claim limitation interpreted under 112(f)- instant application [0085]: A support bracket 1131 may be pivotally mounted to the bottom of the plate 1105, using, for example, the rod 1132 shown in the exploded view of Figure 24. A wing-nut 1133 may be threaded onto the rod to secure the arm 1132 thereto), at least at a first pivot position for providing the specific amount of tension at an adduction angle of zero degrees, and at least at a second pivot position configured to provide the specific amount of tension at a non-zero-degree adduction angle (Fig 1, tension change through pegs, adduction change through pivoting securement apparatus 8/9/10);
…
means for securing said shoe portion to the foot of the patient for countering the specific amount of tension in said cable with respect to said non-zero-degree adduction angle and for countering the specific amount of tension in said cable with respect to said non-zero-degree dorsiflexion angle, for repositioning of only the digit of the patient's foot with respect to said shoe portion (Fig 1, securement strap 4; claim limitation interpreted under 112(f)- instant application [0089]: An additional strap may be used across the top of the shoe, where the block is positioned.).
Budin is silent on
means for applying a specific amount of tension to said cable (limitation interpreted under 112(f)- instant application [0086]: The strand of a toe trap may be secured to an adjustment plate 1136, using any of the means previously disclosed herein);
an adjustment member, said adjustment member mounted to slide relative to said second portion, to adjust a dorsiflexion angle provided by said cable independent of said adduction angle (limitation interpreted under 112(f)- instant application [0085]: a bolt and a second wingnut combination 1134 may be used to releasably secure the angular positioning of the arm 1131 with respect to the plate 1105, as seen in Figure 22, with the bolt being received through a semi-circular opening 1105C in the plate 1105,); wherein a portion of said cable is supported by said adjustment member;
means for releasably securing said adjustment member with respect to said second portion of said support bracket at a first position for providing a dorsiflexion angle of zero degrees for said cable, and at least at a first elevated position for providing the specific amount of tension at a non- zero-degree dorsiflexion angle (limitation interpreted under 112(f)- instant application [0086]: slot 1131S in the vertical arm portion 1131V of the arm 1131 may permit the adjustment plate 1136 to be releasably and adjustably secured thereto using a bolt and a wing-nut combination 1136B).
Claims 2-5 are allowed due to their dependency on an allowed claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM D BAKER whose telephone number is (571)270-3333. The examiner can normally be reached Monday-Friday 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E Bredefeld can be reached at (571)270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM BAKER/Primary Examiner, Art Unit 3786