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
The amendment filed 12/2/2025 has been received and made of record. As requested, claims 1, 3-7, 9, 11, 13-19, and 21-24 are currently pending and are being examined.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-7, 9, 11, 13-19, and 21-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1, 3-7, 9, 11, 13-19, and 21-24 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.
Claim 1 recites “and which first compressible or conformable material forms inner surface of said first shell”. It is first noted that this should recite –and which the first compressible or conformable material forms an inner surface…-- for proper antecedent basis. It is also unclear how the first material forms an inner surface of the first shell since it is placed on the inner surface of the first shell. For purposes of examination, it is being interpreted that the first compressible or conformable material forms an inner surface of –the first member--. The same issue applies to part (b) of the claim regarding the second member. The same issues apply to claims 11 and 21.
Claim 1 recites “wherein said first and second compressible or conformable inner layer are positioned in said respective first and second cavities prior to said first and second members being positioned in said closed position”. This recites a method step but the claim is directed toward an orthotic device and not a method of using/making. A similar issue applies to claim 21.
Claim 7 recites “one or more markers positioned at spaced locations along a longitudinal length the first member, the second member, or the first and second members”. It is unclear how many markers are being required since if there is one it is not clear what it is spaced relative to. The same issue applies to claims 19 and 22.
Claim 9 recites the limitation "said second coupler" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim also recites the second coupler includes “one or more of clasps, snaps, magnets, zipper, hook and loop fastener, mushroom connectors, buttons, hooks, adhesives, or combinations thereof”, which is unclear if this is the same or in addition to the coupler arrangement or the clasp arrangement recited in claim 1.
The remaining claims are rejected due to their dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 21-24 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 21 recites “wherein both said first and second compressible or conformable inner layers compress or conform to a shape of at least a portion of the limb when said first and second members are positioned in said closed position; and wherein the limb that is located within said orthosis device is encapsulated within a compressible or conformable material formed by said first and second compressible or conformable inner layers when said first and second members are positioned in said closed position” which positively recites the human body”. It is suggested applicant use configured to or similar language to obviate the rejection.
Claims 22-24 are rejected due to their dependency.
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.
Claims 1, 4-7, 9, 11, 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Westover et al (US 2016/0296357 A1).
Regarding claim 1, Westover discloses an orthosis device (100) comprising:(a) a first member that includes a first shell (2) and a first compressible or conformable inner layer (20; [0030]soft padding material of cotton, felt, or foam are conformable or compressible) that is positioned in an inner cavity of said first shell and which first compressible or conformable material forms inner surface of said first shell (Figures 3-4); and wherein said first compressible or conformable inner layer and said inner cavity of said first shell are configured to receive a at least a portion of a limb (Figures 2-4; [0029]); (b) a second member that includes a second shell (4) and having a second compressible or conformable inner layer (20; [0030]soft padding material of cotton, felt, or foam are conformable or compressible) that is positioned in an inner cavity of said second shell and which second compressible or conformable material forms inner surface of said second shell (Figures 2-4); and wherein said second compressible or conformable inner layer and said inner cavity of said second shell are configured to receive at least a portion of the limb (Figures 2-4; [0029]); (c) a coupler arrangement (12) that is positioned along a portion or all of a longitudinal length of said first member and second members to enable said first and second members to be transitionable between an open position and a closed position (Figures 2-4; [0032]); and (d) a clasp arrangement (14, 16) that is configured to releasably secure said first and second members in said closed position (Figures 2-4; [0033]-[0034]); said clasped arrangement is connected to both said first and second members (Figures 2-4; [0033]-[0034]); said clasp arrangement includes a securing mechanism selected from the group consisting of button form, hook-and-eye, snap lock, zipper, magnet, hook and loop fastener, mushroom connector, or male and female snap connector (Figures 2-4; [0033]-[0034]); wherein both said first and second compressible or conformable inner layer are configured to compress or conform to a shape of at least a portion of the limb when said first and second members are positioned in said closed position (20; [0030] soft padding material of cotton, felt, or foam are conformable or compressible; [0029]); and wherein said first and second compressible or conformable inner layer are positioned in said respective first and second cavities prior to said first and second members being positioned in said closed position (Figures 2-4; [0029]-[0031]).
Regarding claim 4, Westover discloses wherein said coupler arrangement includes a hinge (12; [0032]).
Regarding claim 5, Westover discloses wherein said hinge is a living hinge, a piano hinge, a butt hinge, or a leaf hinge (12; Figures 2-5; [0032]).
Regarding claim 6, Westover discloses wherein the hinge includes an adhesive that is at least partially deposited on a contact surface of the hinge, and wherein said adhesive is a repositionable adhesive, a cohesive adhesive, or combinations thereof ([0032]).
Regarding claim 7, Westover discloses one or more markers positioned at spaced locations along a longitudinal length of formed at predetermined locations on the first member, the second member, or the first and second members, wherein said one or more markers guide an individual in removing a portion of said orthosis device (see additional locking device 14/16 on each longitudinal side edge 6, 8 and spaced from another one of 14,16, Figures 2-4; additionally see markings on 15, Figure 7; [0034]).
Regarding claim 9, Westover discloses wherein said second coupler includes one or more of clasps, snaps, magnets, zipper, hook and loop fastener, mushroom connectors, buttons, hooks, adhesives, or combinations thereof (second of joining device 12 or locking device 14, which are disclosed as comprising one or more of those listed in the claim [0032], [0034]).
Regarding claim 11, Westover discloses a method for stabilizing a limb of an individual, said method comprising the steps of providing an orthosis device comprising an orthosis device (100) comprising: a first member that includes a first shell (2) and a first compressible or conformable inner layer (20; [0030]soft padding material of cotton, felt, or foam are conformable or compressible) that is positioned in an inner cavity of said first shell and which first compressible or conformable material forms inner surface of said first shell (Figures 3-4); and wherein said first compressible or conformable inner layer and said inner cavity of said first shell are configured to receive a at least a portion of a limb (Figures 2-4; [0029]); a second member that includes a second shell (4) and having a second compressible or conformable inner layer (20; [0030]soft padding material of cotton, felt, or foam are conformable or compressible) that is positioned in an inner cavity of said second shell and which second compressible or conformable material forms inner surface of said second shell (Figures 2-4); and wherein said second compressible or conformable inner layer and said inner cavity of said second shell are configured to receive at least a portion of the limb (Figures 2-4; [0029]); a coupler arrangement (12) couples said first member to said second member, and wherein said coupler arrangement is positioned along a portion or the full longitudinal length of said first and said members (Figures 2-4; [0032]); and a clasp arrangement (14, 16) that is configured to releasably secure said first and second members in said closed position (Figures 2-4; [0033]-[0034]); said clasped arrangement is connected to both said first and second members (Figures 2-4; [0033]-[0034]); said clasp arrangement includes a securing mechanism selected from the group consisting of button form, hook-and-eye, snap lock, zipper, magnet, hook and loop fastener, mushroom connector, or male and female snap connector (Figures 2-4; [0033]-[0034]); positioning said orthosis device in an open position (Figures 3-4); (c) positioning a portion of the limb on said first inner surface compressible or conformable inner layer of said first member and/or said second inner surface compressible or conformable inner layer of said second member ([0030]); (d) moving said orthosis device into a closed position (Figure 2) and using said coupler arrangement and said clasp arrangement to at least partially secure said first and second members in said closed position ([0033]-[0034]); and wherein both said first and second compressible or conformable inner layers compress or conform to a shape of at least a portion of the limb when said first and second members are positioned in said closed position ([0030]); and wherein the limb that is located within said orthosis device is encapsulated within a compressible or conformable material formed by said first and second compressible or conformable inner layers (Figures 2 and 5; [0029]-[0034]).
Regarding claim 14, Westover discloses the step of, subsequent to moving said orthosis device to said closed position, securing the said first member to said second member through said coupler arrangement, and wherein said coupler arrangement includes first and second couplers (see two couplers 12, Figures 2-4), and wherein said first and second couplers are spaced apart from one another (Figures 2-4; [0032]).
Regarding claim 15, Westover discloses wherein said second coupler includes one or more of clasps, snaps, buttons, hooks, zippers, hook and loop fasteners, mushroom connects, magnets, adhesives, or combinations thereof ([0032]).
Regarding claim 16, Westover discloses wherein said coupler arrangement includes a hinge (12; [0032]).
Regarding claim 17, Westover discloses wherein said hinge is a living hinge, a piano hinge, a butt hinge, or a leaf hinge (Figures 2-3; [0032]).
Regarding claim 18, Westover discloses wherein said hinge includes an adhesive ([0032]) that is at least partially deposited on a contact surface of said hinge, wherein said adhesive is a repositionable adhesive, a cohesive adhesive, or combinations thereof (Figure 5; [0032]).
Regarding claim 19, Westover discloses one or more markers positioned at spaced locations along a longitudinal length of formed at predetermined locations on the first member, the second member, or the first and second members, wherein said one or more markers guide an individual in removing a portion of said orthosis device (see additional locking device 14/16 on each longitudinal side edge 6, 8 and spaced from another one of 14,16, Figures 2-4; additionally see markings on 15, Figure 7; [0034]).
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.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Westover et al (US 2016/0296357 A1) in view of Jensen et al (US 6,228,044 B1).
Regarding claim 3, Westover discloses that as applied above wherein the inner layer comprises cotton, felt, foam or other soft padding material (20; [0030]). Westover does not disclose said compressible or conformable inner layer includes silicon, urethane, latex rubber, epoxy resin, polyethylene foam, moldable thermoplastic, or combinations thereof. Jensen teaches a similar orthotic wherein said compressible or conformable inner layer (bladders 60, 70 are conformable, Col. 9, lines 7-13 and 23-27) includes silicon, urethane, latex rubber, epoxy resin, polyethylene foam, moldable thermoplastic, or combinations thereof (Col. 13, lines 12-15; Col. 13, line 65 to Col. 14, line 23). Jensen also teaches the inner layer (bladders) can be used in addition to a felt or cotton cloth layer (Col. 13, lines 12-25). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Westover having the inner layer comprising silicon, urethane, latex rubber, epoxy resin, polyethylene foam, moldable thermoplastic, or combinations thereof as taught by Jensen for providing additional adjustable padding to the user.
Regarding claim 13, Westover discloses that as applied above wherein the inner layer comprises cotton, felt, foam or other soft padding material (20; [0030]). Westover does not disclose said compressible or conformable inner layer includes silicon, urethane, latex rubber, epoxy resin, polyethylene foam, moldable thermoplastic, or combinations thereof. Jensen teaches a similar orthotic wherein said compressible or conformable inner layer (bladders 60, 70 are conformable, Col. 9, lines 7-13 and 23-27) includes silicon, urethane, latex rubber, epoxy resin, polyethylene foam, moldable thermoplastic, or combinations thereof (Col. 13, lines 12-15; Col. 13, line 65 to Col. 14, line 23). Jensen also teaches the inner layer (bladders) can be used in addition to a felt or cotton cloth layer (Col. 13, lines 12-25); said compressible or conformable inner layer is dispensed from a container and deposited into said inner cavity of both of said first and second shells (Col. 14, lines 1-23). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Westover having the inner layer comprising silicon, urethane, latex rubber, epoxy resin, polyethylene foam, moldable thermoplastic, or combinations thereof as taught by Jensen for providing additional adjustable padding to the user. It also would have been obvious to dispense the inner layer prior to placing the limb in position as it would make it easier to dispense when not worn on a user that has limited mobility.
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Westover et al (US 2016/0296357 A1) in view of Boone 9US 4,465,064).
Regarding claim 21, Westover discloses an orthosis device (100) for receiving at least a portion of a limb (Abstract) comprising:(a) a first member that includes a first rigid shell (2; [0029]) and a first compressible or conformable inner layer (20; [0030]soft padding material of cotton, felt, or foam are conformable or compressible) that is positioned in an inner cavity of said first shell and which first compressible or conformable material forms inner surface of said first shell (Figures 3-4); and wherein said first compressible or conformable inner layer and said inner cavity of said first shell are configured to receive a at least a portion of a limb (Figures 2-4; [0029]); the first rigid shell has a half cylindrical shape (Figure 4); (b) a second member that includes a second rigid shell (4; [0029]) and having a second compressible or conformable inner layer (20; [0030]soft padding material of cotton, felt, or foam are conformable or compressible) that is positioned in an inner cavity of said second shell and which second compressible or conformable material forms inner surface of said second shell (Figures 2-4); and wherein said second compressible or conformable inner layer and said inner cavity of said second shell are configured to receive at least a portion of the limb (Figures 2-4; [0029]); the second rigid shell has a generally half cylindrical shape (Figure 4); (c) a coupler arrangement (12) that is positioned along a portion or all of a longitudinal length of said first member and second members to enable said first and second members to be transitionable between an open position and a closed position (Figures 2-4; [0032]); and (d) a clasp arrangement (14, 16) that is configured to releasably secure said first and second members in said closed position (Figures 2-4; [0033]-[0034]); said clasped arrangement is connected to both said first and second members (Figures 2-4; [0033]-[0034]); said clasp arrangement includes a securing mechanism selected from the group consisting of button form, hook-and-eye, snap lock, zipper, magnet, hook and loop fastener, mushroom connector, or male and female snap connector (Figures 2-4; [0033]-[0034]); wherein both said first and second compressible or conformable inner layer are configured to compress or conform to a shape of at least a portion of the limb when said first and second members are positioned in said closed position (20; [0030] soft padding material of cotton, felt, or foam are conformable or compressible; [0029]); and wherein said first and second compressible or conformable inner layer are positioned in said respective first and second cavities prior to said first and second members being positioned in said closed position (Figures 2-4; [0029]-[0031]).
Westover discloses wherein the first and second shells have similar shape and size does not disclose the first and second rigid shells have a half cylindrical shape that are the same shape and size. Boone teaches a similar orthopedic device wherein the first and second shells have the same half cylindrical shape and size (12, 14; Figures 5, 6, 7). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Westover wherein the first and second shells have the same half cylindrical shape and size as taught by Boone for providing a device that can be applied to other body parts such as a thigh, leg, or arm.
Regarding claim 22, Westover discloses one or more markers positioned at spaced locations along a longitudinal length of formed at predetermined locations on the first member, the second member, or the first and second members, wherein said one or more markers guide an individual in removing a portion of said orthosis device (see additional locking device 14/16 on each longitudinal side edge 6, 8 and spaced from another one of 14,16, Figures 2-4; additionally see markings on 15, Figure 7; [0034]).
Regarding claim 23-24, Westover discloses wherein said first compressible or conformable inner layer fills 50-100 vol.% of said inner cavity of said first shell; said second compressible or conformable inner layer fills 50-100 vol.% of said inner cavity of said second shell (Figures 2-4).
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 Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786