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, filed 1/26/2026, to claims 7, 15, 20 acknowledged by Examiner.
Claims 1-20 are now pending, with claims 4, 13, and 18 withdrawn.
Previous claim objections and 112b rejections are withdrawn.
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive.
Regarding that Ceriani in view of Rhoades (claim 1) does not provide for “one or more handles extending from the frame” (pages 5-6), Examiner disagrees. The claim language as required is simply “one or more handles extending from the frame” wherein the teachings of Rhoades in the applied rejection and as seen in Fig. 1 the handle 14 is extending from the established analogous frame 12. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a separate and rigid frame) 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).
Regarding Applicant’s argument that Ghanem does not provide for being “a method of manipulating a leg during a surgical procedure” (claim 15) with focus on the “surgical procedure” interpretation (pages 6-7 of Remarks), Examiner disagrees. Applicant asserts that the physical therapy and exercise of Ghanem are fundamentally different activities from being a surgical procedure; however, Examiner notes that Applicant does not provide for any discussion of what the term “surgical procedure” means or includes as a broad term and Examiner notes that there is no distinct definition provided by the present specification and only a single non-limiting example of one type of surgical procedure that the device can be used for within the present specification. When looking at the phrase “surgical procedure”, Dictionary.com provides “procedure” to be “an act or a manner of proceeding in any action or process” [https://www.dictionary.com/browse/procedure] and “surgical” to be “pertaining to or involving surgery” [https://www.dictionary.com/browse/surgical], wherein “surgery” according to Dictionary.com is “the art, practice, or work of treating diseases, injuries, or deformities by manual or operative procedures” [https://www.dictionary.com/browse/surgery]. Thus, from these common definitions I think we can agree that “surgical procedure” is a process of treating diseases, injuries, or deformities by manual or operative procedures, wherein the usage of the device during “physical therapy” (Col. 6 lines 44-55 of Ghanem) aligns with the treatment of injury by a manual procedure as physical therapy is often led by a physical therapist. And also the function as stated in Col. 1 lines 55-60 of “assist in the straightening and strengthening of leg muscles that is convenient and easy to use, lightweight yet durable in design, versatile in its applications, and designed for providing an effective means for preventing atrophy, and improving strength and mobility in their legs” and Col. 1 lines 35-40 of “In certain diseases, such as poliomyelitis cases, or after certain operations, the legs of the patient frequently become temporarily weakened or paralyzed, and in the treatment of such cases the weakened leg or foot must be supported in a suitable brace which will allow the patient to duplicate the natural movements of the foot and leg during walking” fits with the definition of treating injury or deformities therein. As such, Examiner maintains that Ghanem provides for a method of manipulation during a surgical procedure.
Also, Applicant’s arguments rely on language solely recited in preamble recitations in claim(s) 15. When reading the preamble in the context of the entire claim, the recitation "manipulating a leg during a surgical procedure" is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations (the surgical procedure is never actually used in the body for any method step). Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding Applicant’s arguments to claims 16 and 17 (on pages 7-8) that the teachings of Hestilow do not provide for “wherein at least one handle extends from both the femoral portion and the tibial portion of the frame” and “wherein the at least one handle is a single, u-shaped handle with one end extending from the femoral portion of the frame and one end extending from the tibial portion of the frame” in specific to the handle having ends that extend from both the femoral and tibial portions, Examiner disagrees. Without changing the grounds of the rejections below, Examiner will provide clarification on the teachings of Hestilow. The teachings of Hestilow are providing the handle 88 (Fig. 1-2) wherein as already recited in the rejections extends from the the portion 32 of the frame, wherein the portion 32 has a pad 54 which is wherein one end of the handle 88 is extending away from wherein this is the femoral portion as it is where a femur would sit on the analogous frame (Fig. 1-2 and Col. 2 lines 27-40, wherein the portion 32 includes the shown leg pad 54 which engages with a thigh of a user/patient which contains a femur), and further as seen in Fig. 1-2 the handle 88 has another end that extends away from a calf pad 56 which is a tibial portion (Fig. 1-2 and Col. 2 lines 27-40, the calf contains a tibia of the user/patient). Thus, the handle 88 of Hestilow provides for the claim language of claims 15 and 16 of having ends that extend from both femoral and tibial portions of a single frame.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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, as seen in the 103 modifications in the previous rejection and further provided below, each modification was provided with a motivation statement for a reason to combine the inventions as referenced.
Examiner’s Notes
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
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.
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.
Claims 1-3, 5-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0155229 (“Ceriani”) in view of US 5,014,692 (“Rhoades”).
With respect to claim 1, Ceriani discloses A surgical leg holder for manipulating a leg during surgery (Fig 1, brace 10 capable of use during surgery as it leaves a majority of the leg exposed), the surgical leg holder comprising:
a frame comprising a proximal femoral portion (Fig 1, femur portion 14a), a joint (Fig 1, joint 12a) and a tibial portion distal the joint (Fig 1, tibial portion 16a), the frame capable of angular adjustment about the joint ([0031], joint allows for locking angular adjustments)…
and one or more fasteners to circumscribe at least a portion of a leg to secure the leg to the frame (Fig 1, fasteners 82a, 84a, 84b, and 82b).
Ceriani is silent on one or more handles extending from the frame.
Rhoades teaches an analogous leg restriction frame system (Fig 1, col 1 ll 30-35, thigh to foot cast is a frame) having one or more handles extending from the frame (Fig 1, handle 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to maintain the system of Ceriani and add the handle as taught by Rhoades in order to more easily allow the user to manipulate the braced limb (Rhoades col 2 ll 5-10).
With respect to claim 2, Ceriani/Rhoades discloses The surgical leg holder of claim 1, wherein at least one handle extends from both the femoral portion and the tibial portion of the frame (Rhoades Fig 1, col 2 ll 35-45, handle 16 extends from the femur area 14a to the tibia portion 12a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to maintain the system of Ceriani and add the handle as taught by Rhoades in order to more easily allow the user to manipulate the braced limb (Rhoades col 2 ll 5-10).
With respect to claim 3, Ceriani/Rhoades discloses The surgical leg holder of claim 2, wherein the at least one handle is a single, u-shaped handle with one end extending from the femoral portion of the frame and one end extending from the tibial portion of the frame (Rhoades Fig 1, col 2 ll 35-45, handle 16 becomes a handle when grabbed and pulled, at which point it is un a U-shape as it has a rounded portion and two extending portions which both extend and end at the cast 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to maintain the system of Ceriani and add the handle as taught by Rhoades in order to more easily allow the user to manipulate the braced limb (Rhoades col 2 ll 5-10).
With respect to claim 5, Ceriani/Rhoades discloses The surgical leg holder of claim 1, further comprising one or more pads secured to an inner side of the frame (Ceriani Fig 1, [0039], pads 72).
With respect to claim 6, Ceriani/Rhoades discloses The surgical leg holder of claim 5, comprising at least one pad secured to the femoral portion of the frame and at least one pad secured to tibial portion of the frame (Ceriani Fig 1, [0039], pads 72 on each of the femoral 14 and tibial 16 portions).
With respect to claim 7, Ceriani/Rhoades discloses The surgical leg holder of claim 1, wherein the femoral portion of the frame includes a femoral portion end connector and a thigh shaft (Ceriani Fig 1, femoral portion end connector 20a and thigh shaft 14a), the femoral portion end connector capable of being placed in a first position in which the femoral portion end connector is movable about the thigh shaft in an axial direction and a second position in which the femoral portion is locked with respect to the thigh shaft (Ceriani Fig 1, femoral portion 20a movable and lockable in an axial direction with respect to the thigh shaft 14a via lock 138).
With respect to claim 8, Ceriani/Rhoades discloses The surgical leg holder of claim 7, wherein the tibial portion of the frame includes a tibial portion end connector movable about a tibial shaft (Ceriani Fig 1, tibial end connector 24a and tibial shaft 26a), the tibial portion end connector capable of being placed in a first position in which the tibial portion end connector is movable about the tibial shaft about an axial direction and a second position in which the tibial portion is locked with respect to the tibial shaft (Fig 1, tibial connector 24a movable along and lockable relative to the tibial shaft 26a via lock 138; “about” interpreted as “relative to” rather than “in rotation”).
With respect to claim 9, Ceriani/Rhoades discloses The surgical leg holder of claim 1, wherein a distal end of the femoral portion of the frame is defined by a hub and a proximal end of the tibial portion of the frame is defined by a second hub (Ceriani Fig 4, Fig 1, hubs at each end of the tibial and femoral portions which define the joint 12).
With respect to claim 10, Ceriani/Rhoades discloses The surgical leg holder of claim 9, wherein the joint is capable of being placed in a first position in which the first hub is rotatable about the second hub and a second position in which the first hub and second hub cannot be rotated with respect to each other (Ceriani [0030], hubs make up joint 12 which is lockable).
With respect to claim 11, Ceriani/Rhoades discloses The surgical leg holder of claim 1, wherein the one or more fasteners includes one or more of a belt, strap, sleeve or clamp (Ceriani Fig 1, straps 82a, 84a, 84b, and 82b make up fasteners 82a, 84a, 84b, and 82b).
With respect to claim 12, Ceriani/Rhoades discloses The surgical leg holder of claim 1, further comprising a second frame, the one or more fasteners securing the leg between the first frame and the second frame (Ceriani Fig 1, other frame made up of 14b and 16b).
With respect to claim 14, Ceriani/Rhoades discloses The surgical leg holder of claim 1, wherein an outer surface of the frame comprises one or more handle mating members (Rhoades Fig 1, mating members 16 and 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to maintain the system of Ceriani and add the handle as taught by Rhoades in order to more easily allow the user to manipulate the braced limb (Rhoades col 2 ll 5-10).
Claims 15-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 9,248,330 (“Ghanem”) in view of Ceriani and in view of US 4,844,453 (“Hestilow”).
With respect to claim 15, Ghanem discloses A method of manipulating a leg during a surgical procedure comprising introducing the leg to a surgical leg holder (Fig 1, procedure of exercising the legs), the surgical leg holder comprising:
a frame comprising a proximal femoral portion (Fig 1, portion of frame 36 where the femur would lie is the femoral portion), …and
one or more fasteners to circumscribe at least a portion of a leg to secure the leg to the frame (Fig 3, fasteners 42).
Ghanem is silent on a joint and a tibial portion distal the joint, the frame capable of angular adjustment about the joint; one or more handles extending from the frame.
Ceriani teaches an analogous leg frame having a frame comprising a proximal femoral portion (Fig 1, femur portion 14a), a joint (Fig 1, joint 12a) and a tibial portion distal the joint (Fig 1, tibial portion 16a), the frame capable of angular adjustment about the joint ([0031], joint allows for locking angular adjustments).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ghanem with a joint as taught by Ceriani in order to better fit different types of users (Ceriani [0003]).
Ghanem/Ceriani is silent on one or more handles extending from the frame.
Hestilow teaches an analogous limb adjustment system with a femur and tibial support portion of a frame having one or more handles extending from the frame (Fig 1, portion of frame 32 where the femur would lie is the femoral portion, handle 88).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Ghanem/Ceriani with the addition of the handle as taught by Hestilow in order to help in moving the user (Hestilow col 3 ll 45-50).
With respect to claim 16, Ghanem/Ceriani/Hestilow discloses The method of claim 15, wherein at least one handle extends from both the femoral portion and the tibial portion of the frame (Hestilow Fig 1, portion of frame 32 where the femur would lie is the femoral portion, handle 88).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Ghanem/Ceriani with the addition of the handle as taught by Hestilow in order to help in moving the user (Hestilow col 3 ll 45-50).
With respect to claim 17, Ghanem/Ceriani/Hestilow discloses The method of claim 15, wherein the at least one handle is a single, u-shaped handle with one end extending from the femoral portion of the frame and one end extending from the tibial portion of the frame (Hestilow Fig 1, portion of frame 32 where the femur would lie is the femoral portion, handle 88).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Ghanem/Ceriani with the addition of the handle as taught by Hestilow in order to help in moving the user (Hestilow col 3 ll 45-50).
With respect to claim 19, Ghanem/Ceriani/Hestilow discloses The method of claim 15, wherein a distal end of the femoral portion of the frame is defined by a hub and a proximal end of the tibial portion of the frame is defined by a second hub (Ceriani Fig 4, Fig 1, hubs at each end of the tibial and femoral portions which define the joint 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ghanem with a joint as taught by Ceriani in order to better fit different types of users (Ceriani [0003]).
With respect to claim 20, Ghanem/Ceriani/Hestilow discloses The method of claim 15, wherein the joint is capable of being placed in a first position in which a first hub is rotatable about a second hub and a second position in which the first hub and the second hub cannot be rotated with respect to each other (Ceriani [0030], hubs make up joint 12 which is lockable).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Powlan Roy Y, US 4,621,625- upper and lower leg holding system with a handle
Aloe, US 340,971- jointed upper and lower leg holding and moving system
Mezo, US 5,823,979- lockable joint similar to the elected embodiment
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 KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael 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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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786