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 .
Claim Objections
Claim 7 is objected to because of the following informalities: it is unclear if the “further comprising a third restraining sleeve” as set forth in claim 7 is different or the same “third restraining sleeve” recited in claim 1 from which claim 7 depends. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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, 3-4, 7-9 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (CN 213250211 U) and evidenced by (JP 3125322 U).
With respect to claim 1, Wu et al. discloses a restraint system (as shown in fig.1) comprising:
a sheet of material (100) comprising a width dimension and a length dimension (as shown in the reproduced image of fig.1 below);
a first restraining sleeve or restraint cuff (211) coupled to the sheet of material (100, as shown in fig.1) in a fixed orientation, the first restraining sleeve (211) comprising a first open end and a second open end, the second open end having a first cross-sectional area (as shown in fig.1); Wu et al. discloses the sleeves as cuff which inherently as a first open and a second closed end as evidenced by (JP 3125322 U) as shown in figs.1 and 3);
a second restraining sleeve or restraint cuff (221) spaced apart from the first restraining sleeve in the width dimension and coupled to the sheet of material in a fixed orientation (as shown in the reproduced image of fig.1 below), the second restraining sleeve comprising a third open end and a fourth open end (as shown in fig.1); Wu et al. discloses the sleeves as cuff which inherently as a first open and a second closed end as evidenced by (JP 3125322 U) as shown in figs.1 and 3);
a third restraining sleeve or restraint cuff (212) coupled to the sheet of material, the third restraining sleeve spaced apart from the first restraining sleeve in the length dimension (as shown in the reproduced image of fig.1 below).
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With respect to claim 3, Wu et al. discloses the first restraining sleeve or restraint cuff (211) is configured to receive therethrough a first body appendage of a user, and the second restraining sleeve or restraint cuff (221) configured to receive therethrough a second body appendage of the user (abstract) and ([Page 6], 2-3rd paragraph].
With respect to claim 4, Wu et al. discloses the first restraining sleeve or restraint cuff (211) and the second restraining sleeve or restraint cuff (221) each individually coupled to the sheet of material via independently sewn ([Page 5], 9th paragraph].
With respect to claim 7, Wu et al. discloses the restraint system further comprising a third restraining sleeve or restraint cuff (212) and a fourth restraining sleeve or restraint cuff (222), the first sleeve or restraint cuff (211) substantially collinear with the third sleeve or restraint cuff (212, as shown in fig.1).
With respect to claim 8, Wu et al. discloses the first sleeve or restraint cuff (211) substantially parallel to the second sleeve or restraint cuff (221).
With respect to claim 9, Wu et al. discloses the first sleeve or restraint cuff (211) substantially parallel with the third sleeve or restraint cuff (212).
With respect to claim 11, Wu et al. discloses a kit comprising the restraint system of claim 1 and a cuff having a second cross-sectional area greater than the first cross-sectional area of the second open end. Note: when the cuff (13) when donned on the anatomy of the user will have a
greater cross-sectional area than the first cross-sectional area of the second open end before it is
donned to the appendage of the user. Furthermore: a kit relates to a combination of multiple components or elements sold together as a package to be assembled and used together to achieve the intended functionality and security features of the invention which is disclosed in the prior art drawn to Wu et al. as set forth in claim 1 above.
With respect to claim 12 Wu et al. inherently discloses the cuff (as shown in fig.1) carrying an appendage, the appendage increasing the second cross-sectional area of the cuff, when donned on the anatomy of the user.
Claim(s) 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Condit U.S. Patent No. (2,215,454) and evidenced by Berlese (WO 2010061409 A1).
With respect to claim 15, Condit discloses a restraint system (shown in figs.1-4) comprising:
a sheet of material (1, figs.1-2);
a first restraining sleeve or cuffs (13,13) coupled to the sheet of material (1), the first restraining sleeve or cuffs (13,13) comprising a first open end and a second open end (as shown in figs.1-2, the two restraining sleeves or cuffs 13 has open and close ends), the second open end having a first cross-sectional area (as shown in fig.1);
a second restraining sleeve or cuffs (10,10, figs.1-2) coupled to the sheet of material (1), the second restraining sleeve or cuffs (10,10) comprising a third open end and a fourth open end (as shown in figs.1-2; the two restraining sleeves 10 as shown in fig.1 has open and close ends) the sheet of material (1) comprising a plurality of first restraining sleeve landing zones (where element 24 is located in fig.2) for detachably coupling the first restraining sleeve to the sheet of material, to allow placement of the first restraining sleeve in a plurality of orientations (24 are rivets capable of detachably coupling the restraining sleeves in a plurality of orientations). Notes: rivets are capable of being uses to detachably coupling the restraining sleeves as evidenced by Berlese in [0026, Such inserts 15, 16 are provided with respective first apertures 17, 18 enabling the cuff to be pivotally supported, preferably in a removable manner, by means of appropriate pins or rivets; advantageously, the shape of said first apertures 17, 18 is of a kind elongating in a direction that is substantially perpendicular to the sole 10 so as to allow the cuff 5 to perform both an oscillatory motion about a transversal axis essentially corresponding to the malleolar axis, and a translatory motion substantially perpendicularly to the sole 10, or an oscillatory motion about the longitudinal axis of the shell 2, depending if the sliding motion of the side portions of the cuff 5 connected to the shell 2 along the first apertures 17, 18 occurs in the same direction or, respectively, in mutually opposite directions; it has to be understood that the resulting relative motion of the cuff 5 may be a combination of the motions mentioned above].
Claim Rejections - 35 USC § 103
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.
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) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. as applied to claim 1 above, and further in view of McAllister U.S. Patent No. (5,526,824).
With respect to claim 2, Wu et al. substantially discloses the invention as claimed except the first restraining sleeve and the second restraining sleeve formed of an elasticized fabric.
McAllister however, teaches a wrist/ankle cuff made of a flexible material, such as nylon ([Col.2], lines 64-67), ([Col.3], lines 1, 15-18 and 33-35).
In view of the teachings of McAllister, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify first restraining sleeve and the second restraining sleeve of Wu et al. by forming them of an elasticized fabric in order to conform to the anatomy of the user.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. as applied to claim 1 above, and further in view of Diehl U.S. Patent (4,653,131).
With respect to claim 5, Wu et al. substantially discloses the sheet of material (100) carrying a retaining strap (411, 412 or 310) in the width dimension (as shown in fig.1) except and carrying a side strap in the length dimension.
Diehl however, teaches a restraint for a bedridden individual which comprises a fabric sheet from which extends a plurality of spaced apart fastening straps from the periphery of the sheet (abstract) comprising a retaining strap (52, fig.6) in the width dimension and carrying a side strap (54, fig.7) in the length dimension.
In view of the teachings of Diehl, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sheet material of Wu et al. by incorporating a carrying side strap in order to prevent accidental disconnection with the retaining sheet material.
With respect to claim 6, the combination of Wu et al./Diehl substantially discloses the invention as claimed. Diehl further teaches the side strap (54) detachably coupled to the sheet of material on at least a first end of the side strap (54, fig.6) via “Velcro” fastener ([Col.3], lines 21-37), the side strap configured to and capable of fixing the length dimension of the sheet of material at a first length, and a second length shorter than the first length.
Claim(s) 10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al.
With respect to claim 10, Wu et al. substantially discloses the invention as claimed except the first sleeve is bent. It would have been an obvious matter of design choice to make the different portions of the first sleeve of whatever form or shape was desired or expedient based on the desired anatomical positioning of the first sleeve. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
With respect to claim 13, Wu et al. substantially discloses the invention as claimed except the cuff formed with a material thickness greater than 1 cm. Wu et al. however, suggests, the surface of the patient limb contact of the restraint cuff is provided with a cotton or lining sponge to reduce the discomfort of the patient ([Page 6], 1st paragraph]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the cuff of Wu et al. with a material thickness greater than 1 cm, in order to completely restrain the patient but will hold him in a comfortable position and will permit limited movement to prevent excessive fatigue, as applicant appears to have placed no criticality on the claimed range, indicating, in applicant’s specification in para [0044, “Flexible material 24 having greater than 1 cm thickness is preferred, and in a more preferred embodiment, flexible material 24 has a thickness between 1 cm and 15 cm is preferably used, more preferably between 1cm and 15cm, although thinner material 24 may of course be used”], since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 14, Wu et al. substantially discloses the invention as claimed except the cuff formed with a material thickness between 1 cm and 10 cm. Wu et al. however, suggests, the surface of the patient limb contact of the restraint cuff is provided with a cotton or lining sponge to reduce the discomfort of the patient ([Page 6], 1st paragraph]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the cuff of Wu et al. with a material thickness between 1 cm and 10 cm, in order to completely restrain the patient but will hold him in a comfortable position and will permit limited movement to prevent excessive fatigue, as applicant appears to have placed no criticality on the claimed range, indicating, in applicant’s specification in para [0044, “Flexible material 24 having greater than 1 cm thickness is preferred, and in a more preferred embodiment, flexible material 24 has a thickness between 1 cm and 15 cm is preferably used, more preferably between 1cm and 15cm, although thinner material 24 may of course be used”], since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Condit and evidenced by Berlese (WO 2010061409 A1).
With respect to claim 16, Condit substantially discloses the invention as claimed except the sheet of material comprising a plurality of second restraining sleeve landing zones for detachably coupling the second restraining sleeve to the sheet of material, to allow placement of the second restraining sleeve in a plurality of orientations. Condit, however, teaches the portion of the sheet material where the ankle cuffs (13, 13) are located comprises a plurality of holes or openings (where element 24 is located in fig.2) and rivets ([Page 2, left column], lines 26-32) which would allow placement of the second restraining sleeve in a plurality of orientations. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sheet material by incorporating a plurality of second restraining sleeve landing zones for detachably coupling the second restraining sleeve to the sheet of material, to allow placement of the second restraining sleeve in a plurality of orientations based on the prescribed therapy of the health provider based on the general condition of the user. Notes: rivets are capable of being uses to detachably coupling the restraining sleeves as evidenced by Berlese in [0026, Such inserts 15, 16 are provided with respective first apertures 17, 18 enabling the cuff to be pivotally supported, preferably in a removable manner, by means of appropriate pins or rivets; advantageously, the shape of said first apertures 17, 18 is of a kind elongating in a direction that is substantially perpendicular to the sole 10 so as to allow the cuff 5 to perform both an oscillatory motion about a transversal axis essentially corresponding to the malleolar axis, and a translatory motion substantially perpendicularly to the sole 10, or an oscillatory motion about the longitudinal axis of the shell 2, depending if the sliding motion of the side portions of the cuff 5 connected to the shell 2 along the first apertures 17, 18 occurs in the same direction or, respectively, in mutually opposite directions; it has to be understood that the resulting relative motion of the cuff 5 may be a combination of the motions mentioned above].
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (CN 213250211 U) and evidenced by (JP 3125322 U) in view of Diehl U.S. Patent (4,653,131).
With respect to claim 17, Wu et al. discloses a restraint system (as shown in fig.1) comprising:
a sheet of material (100) comprising a width dimension and a length dimension (as shown in the reproduced image of fig.1 below);
a first restraining sleeve or restraint cuff (211) coupled to the sheet of material (100, as shown in fig.1) the first restraining sleeve or restraint cuff (211) comprising a first open end and a second open end, the second open end having a first cross-sectional area (as shown in fig.1); Wu et al. discloses the sleeves as cuff which inherently as a first open and a second closed end as evidenced by (JP 3125322 U) as shown in figs.1 and 3);
a second restraining sleeve or restraining cuff (212) spaced apart from the first restraining sleeve in the length dimension and coupled to the sheet of material (100, as shown in the reproduced image of fig.1 below) the second restraining sleeve comprising a third open end and a fourth open end (as shown in fig.1); Wu et al. discloses the sleeves as cuff which inherently as a first open and a second closed end as evidenced by (JP 3125322 U) as shown in figs.1 and 3);
the first restraining sleeve or restraint cuff (211) and the second restraining sleeve or restraint cuff (212) spaced apart in the length dimension.
Wu et al. substantially discloses the invention as claimed except at a variable distance in response to manipulation of a side strap coupled to the sheet of material in order to allow the first and second restraining cuff to be spaced apart in the length dimension.
Diehl however, teaches a restraint for a bedridden individual which comprises a fabric sheet from which extends a plurality of spaced apart fastening straps from the periphery of the sheet (abstract) comprising a retaining strap (52, fig.6) in the width dimension and carrying a side strap (54, fig.7) in the length dimension.
In view of the teachings of Diehl, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sheet material of Wu et al. by incorporating a side strap capable of allowing the first and second restraining cuff to be spaced apart in the length dimension for restraining patient movement for a variety for purposes, e.g. to prevent falls, disruption of therapy, or wandering by a patient and surgical procedures to properly orient the patient for surgery.
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Response to Arguments
Applicant’s arguments, see pages 1-4, filed 09/03/2025, with respect to the rejection(s) of claim(s) 1, 3-5, 7-12 and under 35 USC § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn as regard to the prior art drawn to Condit. However, upon further consideration, a new ground(s) of rejection is made in view of Wu et al..
Applicant argues as to claim 15, that the prior art drawn to Condit discloses a plurality of first restraining sleeve landing zones (where element 24 is located in fig.2) for detachably coupling the first restraining sleeve to the sheet of material, to allow placement of the first restraining sleeve in a plurality of orientations (24 are rivets capable of detachably coupling the restraining sleeves in a plurality of orientations). The Applicant respectfully disagrees and traverses this rejection. The Examiner's indication that Condit is capable of detachably coupling is insufficient as a matter of law. Condit does not disclose actual detachment (or even the possibility thereof) and Condit does not disclose placement of a first restraining sleeve in a plurality of orientations. So, Condit cannot anticipate claim 15, even by inherency. "[A]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation." Transclean Corp. v. Bridgewood Sews., Inc., 290 F.3d 1364, 1373 (Fed. Cir. 2002) (emphasis in original). It is respectfully requested that this rejection be withdrawn and claim 15 be passed to allowance.
This is not found to be persuasive as Condit’s rivets are capable of performing the recited function “detachably coupling the restraining sleeves in a plurality of orientations” as (1) Condit discloses the restraining device having many advantages. It will completely restrain the patient but will hold him in a comfortable position and will permit limited movement to prevent excessive fatigue. It can be readily adjusted to provide a variable degree of restraint ([Page 2, right column], lines 1-6) and (2). rivets are capable of being uses to detachably coupling the restraining sleeves as evidenced by Berlese in [0026, Such inserts 15, 16 are provided with respective first apertures 17, 18 enabling the cuff to be pivotally supported, preferably in a removable manner, by means of appropriate pins or rivets; advantageously, the shape of said first apertures 17, 18 is of a kind elongating in a direction that is substantially perpendicular to the sole 10 so as to allow the cuff 5 to perform both an oscillatory motion about a transversal axis essentially corresponding to the malleolar axis, and a translatory motion substantially perpendicularly to the sole 10, or an oscillatory motion about the longitudinal axis of the shell 2, depending if the sliding motion of the side portions of the cuff 5 connected to the shell 2 along the first apertures 17, 18 occurs in the same direction or, respectively, in mutually opposite directions; it has to be understood that the resulting relative motion of the cuff 5 may be a combination of the motions mentioned above]; so the degree of restraint refers to how much freedom of movement an object or system has, and this directly affects its potential positions and orientations; and while it was not explicitly disclosed by the prior art of Condit; it was implied and therefore, disclosed.
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 OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786