DETAILED ACTION
This Office Action is in response to the amendment filed March 18, 2026. The specification and claims 1-3 and 7 have been amended. Claim 6 has been cancelled. Claims 11 and 12 have been added. Claims 1-5 and 7-12 are pending.
In response to the amendment, the objection to the specification, the 112(b) rejection of claims 1-10, and the 112(d) rejection of claims 6 and 10 have been withdrawn.
In response to Applicant’s remarks regarding the Double Patenting rejections, the Double Patenting rejection of claims 7-10 has been withdrawn light of the amendment. However, the Double Patenting rejections of claims 1-5 remain.
In response to Applicant’s arguments regarding claims 1-7, see page 8-14 of the remarks filed with respect to the 103 rejections have been fully considered and are persuasive. The 103 rejections of claims 7-10 has been withdrawn.
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 .
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 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7 and 8 of U.S. Patent No. 12,220,338 (“the’338 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4, 5,7 and 8 recite the elements currently claimed.
Regarding claim 1, claim 1 of the ‘338 patent recites a knee brace kit comprising: (line 1) a wrap having an inner surface and an outer surface opposite the inner surface, the outer surface carrying an engagement element of a hook-and-loop engagement having a first of a hook engagement or a loop engagement (lines 2-6), the wrap comprising: a body (line 7) comprising a hole (line 14) located such that, when the wrap is worn in an applied arrangement by a person, the hole is disposed over a knee of the person (lines14-16; it is inherent that he body of the wrap comprises the hole); straps extending from the body and terminating at respective tips, an inner surface at each respective tip carrying an engagement element having a second of the hook engagement or the loop engagement that is complemental to the first of the hook engagement or the loop engagement (lines 8-13), wherein when the wrap is worn by the person, the straps are wrapped above and below the hole (lines 14-17); and an annular sheet secured to the inner surface of the wrap, encircling the hole, wherein the annular sheet carries an engagement element having the first of the hook engagement or the loop engagement (lines 18-21); and mating elements having the second of the hook engagement or the loop engagement on opposed sides of the mating elements, the mating elements being removably engaged to the annular sheet (lines 22-25) and configured for removably engaging with a pocket configured to carry a thermal pack (lines 26-31).
Regarding claim 2, the ‘338 patent recites the knee brace kit of claim 1, further comprising the pocket, the pocket having engagement strips comprising the first of the hook engagement or the loop type engagement such that the engagement strips of the pocket are configured to be removably engaged to the mating elements to, thereby, removably engage the pocket to the inner surface of the wrap (claim 1, lines 26-31).
Regarding claim 3, the ‘338 patent recites knee brace kit of claim 1, further comprising replacement points for the respective tips, wherein the replacement points each have a lower face carrying an engagement element having the second of the hook engagement or the loop engagement applicable to the outer surface of the wrap (see claims 4 and 5).
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of the ‘338 patent in view of U.S. Patent No. 8,282,587 (“McSpadden et al.”)
Regarding claim 4, the ‘338 patent recites the knee brace kit of claim 1, except wherein the kit further comprises further comprising at least one hinge assembly configured to be adjustably coupled to the outer surface of the wrap, each of the at least one hinge assemblies comprising: an upper arm; a lower arm; and a hinge coupling the upper arm to the lower arm.
However, McSpadden et al. in its analogous disclosure of a knee brace kit (constituted by therapy and stabilization system 100) teaches it is known to provide a knee wrap (10, see col. 4, line 15) with at least one hinge assembly (140, 142, see col. 5, lines 1-13) configured to be adjustably coupled (see col. 7, lines 18-26, which discloses “[o]ftentimes, the joint stabilization member 140 has a point of rotation about which first and second portions thereof rotate. Oftentimes, the joint stabilization member may need to be disposed in a particular orientation and in a particular position relative to the joint of a user so that the point of rotation of the joint stabilization member 140 aligns with the point of rotation of the joint in order to both allow joint rotation while at the same time providing joint stabilization against undesired joint movements”, thus it is adjustable coupled) to the outer surface of the wrap, each of the at least one hinge assemblies comprising: an upper arm; a lower arm; and a hinge coupling the upper arm to the lower arm (see annotated Fig. 10 below) in order to provide joint stabilization (col. 2, lines 10-12).
Therefore, it would have been obvious to one having ordinary skill in the art before the filing of the claimed invention to have modified the ‘338 patent such that it includes at least one hinge assembly comprising an upper arm, a lower arm and a hinge coupling the upper arm to the lower arm in order to provide joint stabilization when it is required.
Claim 5 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of the ‘338 patent in view of U.S. Patent No. 8,282,587 (“McSpadden et al.”), as evidenced by U.S. Patent No. 4,887,590.
Regarding claim 5, the modified ‘338 patent recites the knee brace kit of claim 4, except wherein the upper arm and the lower arm each comprise a respective pad covered with a respective engagement element configured to adjustably and removably couple to the outer surface of the wrap adjacent to the hole in the body of the wrap.
However, as can be seen from Fig. 6, the hinge assembly is inserted into pockets, see annotated Fig. 6 for disposition in a particular orientation and in a particular position relative to the joint of a user so that the point of rotation of the joint stabilization member (140) aligns with the point of rotation of the joint in order to both allow joint rotation while at the same time providing joint stabilization against undesired joint movements, as evidenced by U.S. Patent No. 4,887,590, which discloses a wrap or sleeve for placement on a limb, and having a having joint stabilizing feature.
Since McFadden et al. teach an equivalent structure allowing for adjustability and removability of the upper and lower arms of the hinge assemblies, the Office contends that it would have been obvious to one having ordinary skill in the art to have attached the brace to the outer surface of the sleeve using any means of adjustability such as a pocket or pads of hook and loop material as an obvious design choice absent a showing of criticality or unexpected results.
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.
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.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McSpadden et al. in view of U.S. Patent No. 5,139,476 (“Peters”) and U.S. Patent No. 3,804,084 (“Lehman”).
Regarding claim 11, McSpadden et al. discloses a knee brace (100, see Fig. 1 and col. 3, lines 60-64) comprising: a wrap (expandable orthopedic device 10, Fig. 1, 4 and see col. 3, lines 6-8) configured to expose a knee of a person when the wrap is worn in an applied arrangement by the person (patella opening 128, see col. 4, lines 39-40; the patella opening exposes the knee), the wrap comprising: a body (see col. 4, lines 26-33 which describes the material of the body, see also Fig. 4), a first strap (strap 112, see Fig. 1) extending from the body and comprising at least a first engagement element configured to secure the first strap to an outer surface of itself above the knee, and a second strap (114, see Fig. 8A,8B) extending from the body and comprising at least a second engagement element configured to secure the second strap to an outer surface of itself below the knee; a hinge (140,142, see col. 5, lines 1-13), comprising: an upper arm disposed against the body at a position above the knee when the wrap is worn in the applied arrangement by the person (see annotated Fig. 6 below), a lower arm disposed against the body at a position below the knee when the wrap is worn in the applied arrangement by the person (see annotated Fig. 6 below), and a pivot rotatably coupling the upper arm to the lower arm (polycentric hinge, single axis, complex hinge 140, 142, see col. 5, lines 6-11); and a sealed bladder (thermal wrap 106 which includes an inflatable bladder 110, see col. 5, lines 14-21) configured to be disposed between at least a portion of the wrap and the person when the wrap is worn in the applied arrangement (the thermal wrap is positioned on the inner surface of the bladder and when positioned on the person during use, it will be positioned between the wrap the person, see Fig. 7B), the sealed bladder comprising at least one tube extending from the wrap and configured to supply a fluid to the sealed bladder (see Fig. 7B and col. 5, lines 23-26).
McSpadden et al. fail a first strap extending from the body and comprising at least a first engagement element configured to secure the first strap to an outer surface of the body above the knee, and a second strap extending from the body and comprising at least a second engagement element configured to secure the second strap to an outer surface of the body below the knee.
However, Peters in its analogous disclosure of wrap teaches it is known to provide a wrap (100) with a first strap (3) extending from the body (1) and comprising at least a first engagement element configured to secure the first strap to an outer surface of the body above the knee, and a second strap (4) extending from the body and comprising at least a second engagement element configured to secure the second strap to an outer surface of the body below the knee (see col. 2, line 65-col. 3, line 8, which recites the thermal therapy wrap 106 includes an inflatable compression bladder 110 contained in, for example, a textile covering such as, for example, nylon; the thermal therapy wrap 106 further includes a plurality of fluid tubes 108 located beneath the inflatable compression bladder 110; in a typical embodiment, the fluid tubes 108 may be, for example, a fluid flow temperature bladder; the fluid flow temperature bladder and the inflatable compression bladder 110 may be connected via a flexible hose to a precision fluid pump having thermal control and compression capabilities).
Lehman in it analogous disclosure of knee wrap (see Fig. 4) teaches it is known to provide a wrap (12) with a first strap (60) extending from the body and comprising at least a first engagement element configured to secure the first strap to an outer surface of the body above the knee, and a second strap (62) extending from the body and comprising at least a second engagement element configured to secure the second strap to an outer surface of the body below the knee (see col. 3, line-col. 4, line17, which discloses attachment means are provided to hold the support about the knee of a wearer; these attachment means comprise an upper and a lower elastic strip designated by the numerals 60 and 62; the upper elastic strip extends laterally from the upper portion of one of the side edges as at 64 adjacent the top edge and is of a length to span the gap between the side edges when the support is placed about the thigh of a wearer as shown in FIG. 5; the lower elastic strip 62 extends from the lower portion of one of the side edges as at 66 adjacent the bottom edge and is of a length to span the gap between the side edges of the panel when the support is placed about the leg of a wearer below the knee cap, again see FIG. 5; mutually intercooperating connector means are provided on the terminal ends 68 and 67 of the upper and lower elastic strips and on the exterior surface of the panel adjacent the side edge opposite to the side edge on which the strips are arranged, the latter being designated by the numeral 70 and 72).
Because McFadden et al., Peters and Lehman all teach straps for securing a knee wrap about a knee, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have substituted one type of strap for the other type of strap to achieve the predictable result of securing the wrap to the knee of the user.
Thus, substituting a strap that attaches to itself via hook and loop components or substituting a strap that attaches to the body of a wrap would have been an obvious design choice.
Regarding claim 12, modified McSpadden et al. discloses the knee brace of claim 11, wherein the at least one tube extending from the wrap is configured to supply the fluid to the sealed bladder for at least partially inflating the sealed bladder with the fluid (see col. 5, lines, which recites the thermal therapy wrap 106 includes an inflatable compression bladder 110 contained in, for example, a textile covering such as, for example, nylon; the thermal therapy wrap 106 further includes a plurality of fluid tubes 108 located beneath the inflatable compression bladder 110; in a typical embodiment, the fluid tubes 108 may be, for example, a fluid flow temperature bladder; the fluid flow temperature bladder and the inflatable compression bladder 110 may be connected via a flexible hose to a precision fluid pump having thermal control and compression capabilities; thus McSpadden et al. discloses least one tube extending from the wrap is configured to supply the fluid to the sealed bladder for at least partially inflating the sealed bladder with the fluid).
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Allowable Subject Matter
Claims 7-10 are allowed.
The following is an examiner’s statement of reasons for allowance: see the remarks filed on pages 8-14.
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
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 KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786
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