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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “rigid support layer” must be shown or the feature(s) canceled from the claim(s). While the specification may mention this, there is no completely clear reference to what configuration or where it is referenced in a drawing figure. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5,8,14,18,19,20,21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5,14 recite the limitation "one or more of said connector, said first securing strap and said (forearm-claim 5, arm-claim 14) retainer is reversibly secured" in lines 2,3 of the claims. However is the limitation in the claim meaning a specific location can be changed to go in an opposite direction? Or can the components of connector, first securing strap or (fore)arm retainer be reversed in orientation or in other words flipped to change sides for example of what is connected or secured to a location of the support? Applicant is advised the scope encompasses different meanings, but the disclosure provides no clarity on this.
The term “rigid” in claims 8,18 is a relative term which renders the claims indefinite. The term “rigid” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The recitation of “a rigid support structure or within a non- rigid inelastic support structure” is ambiguous since one does not know how a rigid material is any different than a material recited to be non-rigid but inelastic which could imply something rigid if it has no elasticity.
Regarding claim 19, the phrase "optionally formed from…" renders the claim(s) indefinite because the claim(s) include(s) materials not actually disclosed (those encompassed by "optionally formed from…”), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Regarding claim 20, the phrases "if present" and "optionally a…"renders the claim(s) indefinite because the claim(s) include(s) elements or materials not actually disclosed (those encompassed by "if present” or "optionally a…"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Regarding claim 21, the phrase "optionally" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "optionally”), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1,2,5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Joutras (2012/0142416). Fig. 23 show a prosthetic training device fully capable of attachment to a residual limb of a transradial amputee (as this is intended use). Fig. 11 shows the device comprising:(a) at least one elongate rigid support shaft 90. Fig. 23 shows a connector 20 configured to removably receive a positional sensor (paragraph 80), wherein said connector is engaged with and secured or securable in a fixed position along the distal part or half of said support shaft(s). Fig. 2 shows a first securing strap 24 comprising a first end and a second end, wherein said strap is engaged with and secured or securable in a fixed position along the proximal part or half of at least one of said support shaft(s), and wherein said strap is configured to selectively secure the first end to the second end around the residual limb of a user at a circumferential position below the elbow; a second securing strap 26 comprising a first end and second end, wherein said strap is flexibly tethered or tetherable to said first securing strap and/or the proximal part or half of at least one of said support shaft(s), and wherein said strap is configured to selectively secure (apparatus has the full capability) the first end to the second end around the residual limb of a user at a circumferential position above the elbow; and additionally having a forearm retainer 22 configured to maintain a volumetric fit over the residual limb of a user via adjustable circumferential force, wherein said retainer is engaged with and secured or securable in a fixed position on at least one of said support shaft(s) between said connector and said first securing strap. With respect to claim 2, it can be seen (Fig. 23) there are a plurality of locking holes in the support shaft and locking screws to enable the connector to be slidably engaged with and securable in a plurality of positions along the distal part or half of said support shaft(s);said first securing strap is slidably engaged with and securable in a plurality of positions along the proximal part or half of said support shaft or at least one of said support shafts; or said forearm retainer is slidably engaged with and securable in a plurality of positions along the length of said support shaft or at least one of said support shafts. Regarding claim 5, since one can move the locking screws to adjust the fasteners on the supports, it can be construed that one or more of said connector, said first securing strap and said forearm retainer are reversibly secured in position on said support shaft(s) by a releasable locking mechanism of screws.
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.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Huang et al. (CN 108478312). Joutras is explained supra. However, Joutras did not explicitly state the material for support shaft(s) is/are formed from carbon fibre. Huang et al. teach prosthetic apparatus for amputee patients, see abstract. Huang et al. additionally teach (page 5 of translation) support structure of prosthetic apparatus for amputees use carbon fibre material to construct the element. It would have been obvious to one of ordinary skill in the art to utilize carbon fibre as taught by Huang et al. for the support shaft(s) in the training device of Joutras for attachment to a patient individual such that it has sufficient strength due to the excellent properties of the material, see Huang.
Claim(s) 7,20 are rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Prostkoff (WO 93/07834). Joutras is explained supra. However, Joutras did not explicitly state a portion of said first and/or second securing strap is connected to a rigid support layer, and wherein said support layer is secured or securable in position on said support shaft or at least one of said support shafts. Prostkoff teach prosthetic apparatus applied about patient’s anatomy, (page 7 3rd full paragraph ) support structure is provided with a rigid support layer securable to the support of the prosthetic apparatus. It would have been obvious to one of ordinary skill in the art to utilize a rigid support layer on apparatus placed about the patient as taught by Prostkoff with the support shaft(s) and straps in the training device of Joutras for attachment to a patient individual such that it has sufficient strength due to the excellent properties of the rigid support material, see abstract of Prostkoff. Regarding claim 20, as best understood, it is noted Joutras does not explicitly disclose materials for a connector or support structure or support layer. Prostkoff teaches (page 6, last two paragraphs, last paragraph page 7, page 9, 2nd full paragraph) in the field of prosthetics and orthopedic support to use thermoplastic polymer for a connector (strap) and support structure and support layer. It would have been obvious to one of ordinary skill in the art to select a material base on the needs or requirements of particular intended use and provide a thermoplastic polymer as taught by Prostkoff in the prosthetic training apparatus for a connector or support structure or support layer such that it can be appropriately shaped to the contour of the patient.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Angold et al. (2018/0361565). Joutras is explained supra. However, Joutras did not explicitly state the forearm retainer is disposed within a rigid support structure or within a non- rigid inelastic support structure, and wherein said support structure is secured or securable in position on said support shaft or at least one of said support shafts. Angold et al. teach prosthetic limb retainers can be provided with a rigid support structure, see paragraph 47. Angold et al. additionally show (Fig. 2) the forearm retainer within a non-rigid inelastic support structure and designed to be secured to a support shaft. It would have been obvious to one of ordinary skill in the art to provide the forearm retainer within a non-rigid inelastic support structure and designed to be secured to a support shaft as taught by Angold et al. for the retainer support with the training device of Joutras to improve the integrity of the forearm retainer, but provides multiple adjustment capabilities, see paragraph 53 of Angold.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Eustache et al. (FR 3029101). Joutras is explained supra. However, Joutras did not explicitly state the second securing strap is tethered to the first securing strap. Eustache et al. teach (Fig. 4) straps 6 on an amputee limb prosthetic have a tethering strap 4 to keep the prosthetic limb on the amputee patient in tension. It would have been obvious to one of ordinary skill in the art to provide a tether strap as taught by Eustache et al. with the prosthetic training apparatus and straps of Joutras in order to prevent the apparatus from loosening from the patient forearm.
Claim(s) 10-14, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Dillenburg et al. (6416555). Joutras disclose a prosthetic training device for attachment to a residual limb of a transhumeral amputee (intended use), note fig. 31 shows apparatus attached along the humerus bone. Fig. 11 shows the device comprising: at least one first elongate rigid support shaft 90 and at least one second elongate rigid support shaft 96, wherein the distal end of each of said at least one second support shaft is hingedly connected to the proximal end of the corresponding first support shaft via an articulated and optionally lockable joint. Joutras also shows (Fig. 23) a connector 20 configured to removably receive one or more weights and/or a virtual reality (VR) controller or other positional sensor 68, wherein said connector is engaged with and secured or securable in a fixed position along the distal part or half of said first support shaft(s). It can also be seen (Fig. 23) that Joutras disclose a securing strap 26 comprising a first end and a second end, wherein said strap is engaged with and secured or securable in a fixed position along the proximal part or half of at least one of said second support shaft(s), and wherein said strap is configured to selectively secure the first end to the second end around a circumferential position of the residual limb of a user. Joutras additionally shows (Fig. 23) the training apparatus comprise an arm retainer 22 configured to maintain a volumetric fit over a portion of the residual limb of a user via adjustable circumferential force, wherein said retainer is engaged with and secured or securable in a fixed position on at least one of said second support shaft(s) between said articulated joint and said securing strap.
However, Joutras did not explicitly disclose a body harness flexibly tethered or tetherable to said securing strap and/or the proximal part or half of at least one of said second support shaft(s) and configured such that, in use, said harness wraps around the shoulder of the residual limb and around the torso of a user. Dillenburg et al. teach (Fig. 3)that a body harness 140 can be used and tethered with a securing strap 142 with the harness wrapped around the shoulder of user and capable of being about the residual limb 40 and torso of the user. It would have been obvious to one of ordinary skill in the art to select the appropriate attachment apparatus for the intended use and patient condition, such that one can provide a body harness tethered with a strap and/or the proximal part or half of at least one of said second support shaft(s) and configured such that, in use, said harness wraps around the shoulder of the residual limb and around the torso of a user per the teaching of Dillenburg et al. in the training apparatus of Joutras such that it can accommodate the patient circumstances, such as if one has a transhumeral prosthesis. Further the use of such a harness provides stability with arm motion and reduces stress on the user, see Dillenburg et al. col. 5, lines 41-54. With respect to claims 11,12, it can be seen (Fig. 18) there are a plurality of locking holes in the support shaft and locking screws to enable the connector to be slidably engaged with and securable in a plurality of positions along the length of the first support shaft(s). Additionally it can be also seen in the same figure the second securing strap is slidably engaged with and securable in a plurality of positions along the proximal part or half of said second support shaft. Regarding claim 13, Fig. 18 also can be said to show in giving the broadest reasonable interpretation that the arm retainer is slidably engaged with and securable in a plurality of positions along the length of at least one of said second support shaft(s) as a result of having a plurality of locking locations on the shaft. Regarding claim 14, since one can move the locking screws to adjust the fasteners on the supports, it can be construed that one or more of said connector, said first securing strap and said forearm retainer are reversibly secured in position on said support shaft(s) by a releasable locking mechanism of screws. With respect to claim 17, it can be seen (Fig. 3) that Dillenburg et al. teach that body harness 140 is tethered to the securing strap 142 and is well known in the art, see Dillenburg.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Dillenburg et al. (6416555) as applied to claim 10 above, and further in view of Huang et al. (CN 108478312). Joutras in view of Dillenburg et al. is explained supra. However, Joutras as modified with Dillenburg et al. did not explicitly state the material for support shaft(s) is/are formed from carbon fibre. Huang et al. teach prosthetic apparatus for amputee patients, see abstract. Huang et al. additionally teach (page 5 of translation) support structure of prosthetic apparatus for amputees use carbon fibre material to construct the element. It would have been obvious to one of ordinary skill in the art to utilize carbon fibre as taught by Huang et al. for the support shaft(s) in the training device of Joutras as modified with Dillenburg et al. for attachment to a patient individual such that it has sufficient strength due to the excellent properties of the material, see Huang.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Dillenburg et al. (6416555) as applied to claim 10 above, and further in view of Prostkoff (WO 93/07834). Joutras in view of Dillenburg et al. is explained supra. However, Joutras as modified with Dillenburg et al. did not explicitly state a portion of said securing strap is connected to a rigid support layer, and wherein said support layer is secured or securable in position on at least one of said second support shafts. Prostkoff teach prosthetic apparatus applied about patient’s anatomy, (page 7 3rd full paragraph ) support structure is provided with a rigid support layer securable to the support of the prosthetic apparatus. It would have been obvious to one of ordinary skill in the art to utilize a rigid support layer on apparatus placed about the patient as taught by Prostkoff with the second support shaft(s) and strap in the training device of Joutras as modified with Dillenburg et al. for attachment to a patient individual such that it has sufficient strength due to the excellent properties of the rigid support material, see abstract of Prostkoff.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Dillenburg et al. (6416555) as applied to claim 10 above, and further in view of Angold et al. (2018/0361565). Joutras in view of Dillenburg et al. is explained supra. However, Joutras as modified with Dillenburg et al. did not explicitly state the arm retainer is disposed within a rigid support structure or within a non-rigid inelastic support structure, and wherein said support structure is secured or securable in position on at least one of said second support shaft(s). Angold et al. teach prosthetic limb retainers can be provided with a rigid support structure, see paragraph 47. Angold et al. additionally show (Fig. 2) the forearm retainer within a non-rigid inelastic support structure and designed to be secured to a support shaft. It would have been obvious to one of ordinary skill in the art to provide the forearm retainer within a non-rigid inelastic support structure and designed to be secured to a support shaft as taught by Angold et al. for the retainer support with the training device of Joutras as modified with Dillenburg to improve the integrity of the forearm retainer, but provides multiple adjustment capabilities, see paragraph 53 of Angold.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Faber (DE 3912657). Joutras is explained supra. However, Joutras did not explicitly state said forearm retainer is an inflatable armband. Faber teaches (Fig. 2) a forearm retainer is provided with an inflatable armband 2 since it lines a tubular collar 1. It would have been obvious to one of ordinary skill in the art to provide an inflatable armband with the forearm retainer as taught by Faber in the prosthetic training apparatus forearm retainer of Joutras in order to prevent the apparatus from hurting the patient forearm.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Kang (2016/0175641). Joutras is explained supra. However, Joutras did not explicitly state said connector comprises a plurality of radially aligned chambers, and wherein each chamber comprises at least one wall and, optionally, a base to define an inner chamber surface that is configured to removably accept a corresponding weight. Kang teaches (Fig. 2) a connector coupled with a plurality of radially aligned chambers 36, and wherein each chamber comprises at least one wall. Additionally it can be seen (Fig. 5) Kang also teaches that an inner chamber surface that is configured to removably accept a corresponding weight 44. It would have been obvious to one of ordinary skill in the art to provide a connector that comprises therewith a plurality of radially aligned chambers, and wherein each chamber comprises at least one wall and, optionally, a base to define an inner chamber surface that is configured to removably accept a corresponding weight as taught by Kang in the prosthetic training apparatus of Joutras in order to provide the necessary stability on the patient forearm and exercise feel for the patient.
Claim(s) 21,22 are rejected under 35 U.S.C. 103 as being unpatentable over Joutras (2012/0142416) in view of Dolcetti (2015/0264984). Joutras is explained supra. However, Joutras did not explicitly state said connector comprises a plurality of radially aligned chambers, and wherein each chamber comprises at least one wall and, optionally, a base to define an inner chamber surface that is configured to removably accept a corresponding weight or that the inner chamber surface includes or is formed from a magnet. Dolcetti teaches (Fig. 1) a connector coupled with a plurality of radially aligned chambers 140, and wherein each chamber comprises at least one wall. Additionally it can be seen (Fig. 12) Dolcetti also teaches that an inner chamber surface that is configured to removably accept a corresponding weight 202. It would have been obvious to one of ordinary skill in the art to provide a connector that comprises therewith a plurality of radially aligned chambers, and wherein each chamber comprises at least one wall and, optionally, a base to define an inner chamber surface that is configured to removably accept a corresponding weight as taught by Dolcetti in the prosthetic training apparatus of Joutras in order to provide the necessary stability on the patient forearm and exercise feel for the patient. Further Dolcetti teaches that an inner chamber surface can include a magnet for communication purposes. Thus, it would have been obvious to one of ordinary skill in the art to utilize a magnet in the inner chamber to provide communication capability for the user per the teaching of Dolcetti in the training apparatus of Joutras such that one can advantageously provide information on possible status of the user or location.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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