DETAILED ACTION
This Office action is based on the arguments filed May 26, 2026 for application 18/505,721. Claims 1-11, as originally filed, are currently pending, wherein claims 10 and 11 are withdrawn from consideration.
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 . 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.
Drawings
The replacement drawings sheet received on May 26, 2026 are acceptable.
Response to Arguments
Applicant’s arguments filed May 26, 2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that Sorrenti does not discloses a housing assembly but rather a joint (10) comprising a first member (12), a second member (14), and an intermediate ring (42) such that the first and second adjusting systems are located in structurally distinct portions of the joint (10) rather than within a single housing, it is noted that the features upon which Applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims do not recite any structure of the housing assembly that would limit the housing assembly to contain the first and second adjusting systems within a single housing chamber. As such, the joint (10) taught by Sorrenti including the combination of the first member (12) and the second member (14) are analogous to the “housing assembly” as claimed.
In response to Applicant’s argument that it is not clear why one having ordinary skill in the art would have wanted to add the function of setting a starting or resting position of the paddle with respect to the torque bar as taught by Sorrenti to the orthotic device taught by Devens or would have arrived at the specific arrangement recited in claim 1, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Sorrenti discloses that the starting or resting position of joint is the position to which the rehabilitation device is resiliently biased to return to when no force is being applied to the system and is considered safe for the body joint being rehabilitated to be maintained at, wherein the restriction mechanism can be used to provide a further limitation of the amount or degree of pivoting which the second member can undertake. As both the set position, via the positioning mechanism, and the degree of pivoting of the second member with respect to the first member, via the restriction mechanism, can be independently altered, a gradual increase in the range of motion of the body joint can be achieved, to prevent further injury of the joint or surrounding muscles (column 1, line 65 – column 2, line 26).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the orthotic device taught by Devens to include a first adjusting system comprising a first pair of toothed elements intermeshing in a first plurality of positions corresponding to rotational angles of the paddle as taught by Sorrenti for the purpose of setting a starting or resting position of the paddle with respect to the torque bar.
It is also noted that the person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time and the “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). Further, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, given the structural and functional similarities between the devices taught by Devens and Sorrenti, it is presumed that one of ordinary skill in the orthopedic art having knowledge of the devices taught by Devens and Sorrenti would understand the basic scientific and engineering principles applicable to incorporate the combination of the first and second adjusting systems as taught by Sorrenti into the orthotic device taught by Devens.
In response to Applicant’s argument that Devens discloses a housing (68) formed integrally with the torque bar (70+72) rather than separately and then attached, the examiner disagrees. Devens discloses that the connecting rods (70, 72) are received in apertures (74, 76) formed in the main body housing (68) (column 4, lines 56-57). Further, the claims do not specify the manner of attachment between the housing assembly and the torque bar that would preclude either integral attachment or mechanical attachment.
In response to Applicant’s argument that Devens fails to teach a pair of toothed elements intermeshing in a plurality of positions, the examiner disagrees. Since the claims do not require a specific structure of what is considered a “toothed element”, the protruding detent (106) and the notches (110) formed between edges taught by Devens are interpreted as forming a “pair of toothed elements”. Further, the term “intermeshing” is synonymous with “joining”, “interlinking”, “interconnecting”, and “interlocking”, but does not specifically require multiple “toothed element” engaging with other multiple “toothed element”. Therefore, when a single toothed element such as the detent (106) engages a notch (110), the detent (106) and notch (110) are intermeshed.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Devens (US 5,346,463) in view of Sorrenti et al. (US 9,872,789).
Regarding claim 1, Devens discloses an orthotic device (orthopedic appliance 10) (Fig.1; column 3, lines 30-32) comprising:
a torque bar (bar 14 / rods 70+72) (Figs. 1 & 5-7; column 3, lines 32-35; column 4, lines 50-56);
a paddle (foot plate 22) (Figs. 1 & 5-7; column 3, lines 36-37); and
a housing assembly (housing 68) attached to a first end of the torque bar (14/70+72) and having the paddle (22) attached to the housing assembly (68) (Figs. 5-7; column 4, lines 50-56 & 62-65), the housing assembly (68) comprising:
a second adjusting system comprising a second pair of toothed elements (detent 106, notches 110) intermeshing in a second plurality of positions, each position in the second plurality of positions corresponding to an amount of torque applied to the paddle (22) (Figs. 5-7; column 5, lines 26-52).
However, Devens fails to teach a first adjusting system comprising a first pair of toothed elements intermeshing in a first plurality of positions corresponding to rotational angles of the paddle.
Sorrenti discloses an analogous housing assembly (joint 10) comprising a first adjusting system comprising a first pair of toothed elements (serrated edge face 44, serrated rim 46) intermeshing in a first plurality of positions, each position of the first plurality of positions corresponding to a rotational angle of a paddle (member 14), and a second adjusting system comprising a second pair of toothed elements (worm gear 18, worm drive 20) intermeshing in a second plurality of positions, each position in the second plurality of positions corresponding to an amount of torque applied to the paddle (14) (Figs. 1A-1B; column 6, lines 35-40, 45-52, 56-67; column 7, lines 1-12 & 47-67).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the orthotic device taught by Devens to include a first adjusting system comprising a first pair of toothed elements intermeshing in a first plurality of positions corresponding to rotational angles of the paddle as taught by Sorrenti for the purpose of setting a starting or resting position of the paddle with respect to the torque bar.
Regarding claim 2, the combination of Devens and Sorrenti discloses the invention substantially as claimed, as described above, and Devens further discloses a torsion spring (spring 66) disposed within the housing assembly (68) and applying the amount of torque (Fig. 7; column 4, lines 65-68; column 5, lines 1-10 & 26-29).
Regarding claim 3, the combination of Devens and Sorrenti discloses the invention substantially as claimed, as described above, Sorrenti further discloses that the first adjustable system and the second adjustable system are independently adjustable (column 7, lines 47-67).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the orthotic device taught by the combination of Devens and Sorrenti such that the first adjustable system and the second adjustable system are independently adjustable as further taught by Sorrenti for the purpose of individually setting the desired starting or resting position of the paddle and the desired torque applied to the paddle.
Regarding claim 4, the combination of Devens and Sorrenti discloses the invention substantially as claimed, as described above, and Devens further discloses a second housing assembly affixed to a second end of the torque bar (14/70+72) opposing the first end, the second housing assembly having a second paddle (foot plate 20) attached thereto, the second housing assembly and the second paddle (20) being a mirror image of the housing assembly (68) (Fig. 1; column 5, lines 54-56).
Regarding claims 7 and 8, the combination of Devens and Sorrenti discloses the invention substantially as claimed, as described above, and Devens further discloses that the paddle (22) is adapted to attached to an orthotic footwear, wherein the orthotic footwear is at least one of a shoe, a boot, and a sandal (Fig. 1; column 3, lines 38-42).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Devens in view of Sorrenti as applied to claim 1 above, and in further view of Tummillo (US 3,892,231).
The combination of Devens and Sorrenti discloses the invention substantially as claimed, as described above, but fails to teach that the torque bar has an adjustable length, wherein the torque bar comprises two slideably connected bar elements and the adjustable length is adjusted by sliding at least one of the two bar elements.
Tummillo discloses an analogous orthotic device comprising a bar (holder member 18) having an adjustable length, wherein the bar (18) comprises two slideably connected bar elements (first part 20, second part 22) and the adjustable length is adjusted by sliding at least one of the two bar elements (20, 22) (Fig. 1; column 2, lines 35-46).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the orthotic device taught by the combination of Devens and Sorrenti such that the torque bar has an adjustable length, wherein the torque bar comprises two slideably connected bar elements and the adjustable length is adjusted by sliding at least one of the two bar elements as taught by Tummillo for the purpose of spreading a user’s feet apart by a preferred amount and holding them in that position.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Devens in view of Sorrenti as applied to claim 1 above, and in further view of Mitchell (US 2007/0142760).
The combination of Devens and Sorrenti discloses the invention substantially as claimed, as described above, and Devens further discloses that the orthotic device (10) is for the treatment of torsional deformities of the lower limbs (column 1, lines 7-10). However, the combination of Devens and Sorrenti fails to expressly teach that the orthotic device is a clubfoot correction device.
Mitchell discloses an analogous orthotic device (splint assembly 1000) comprising a torque bar (rigid bars 1020+1040) and a paddle (angular adjustment/quick release member 700), wherein the orthotic device (1000) is a clubfoot correction device (Figs. 10-16; ¶ 0002).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to use the orthotic device taught by the combination of Devens and Sorrenti as a clubfoot correction device as taught by Mitchell for the purpose of preventing relapses of corrected clubfeet by firmly, yet gently and comfortably, holding a baby’s feet in the corrected position.
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 Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
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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/KERI J NELSON/Primary Examiner, Art Unit 3786 8/21/2026
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