DETAILED ACTION
This Office action is based on the amendments filed October 14, 2025 for application 18/136,586. Claims 1, 3, and 5 have been amended and claims 2, 6, and 7 have been cancelled; claims 1 and 3-5 are currently pending.
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 . 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.
Response to Arguments
Applicant’s arguments filed October 14, 2025 have been fully considered but they are not persuasive.
Applicant’s argument that Box relates to post operative bracing but does not provide for the arms, legs, head, and corresponding openings while Mulhearn and Sanders provide for an animal shape but do not relate to positioning of a brace relating to the protection and bracing of the torso of a post operative user is interpreted as an argument that Box, Mulhearn, and/or Sanders is nonanalogous art. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Box is clearly in the field of Applicant’s endeavor of providing a post-operative brace configured to facilitate performing respiratory exercises by hugging a brace that can have a shape resembling a known animal, while Mulhearn and Sanders are reasonably pertinent to providing a harness to be worn on a torso of a user for holding an animal having legs, arms, and a head. Further, it has been held that “In a simple mechanical invention a broad spectrum of prior art must be explored and it is reasonable to permit inquiry into other areas where one of ordinary skill in the art would be aware that similar problems exist.” Stevenson v. Int’l Trade Comm., 612 F.2d 546, 550, 204 USPQ 276, 280 (CCPA 1979).
In response to Applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Box discloses a system comprising the combination of a post-operative brace configured to facilitate performing respiratory exercises by hugging a brace that can have a shape resembling a known animal and a harness configured to be worn on a torso of a user for holding the post-operative brace, wherein the post-operative brace can have a shape resembling a known animal that may be attractive to a neonatal patient. Mulhearn discloses a stuffed teddy bear which is known to be used to comfort children and a harness configured to be worn by a user to hold the teddy bear. Therefore, it would have been obvious to one having ordinary skill in the art to modify the post-operative brace of the system taught by Box to comprise a teddy bear to define a bear brace including a pair of legs, a pair of arms, and a head as taught by Mulhearn for the purpose of providing comfort to a young patient. Sanders discloses a suitable harness shaped for holding an occupant having arms, legs, and a head such that it would have been obvious to one having ordinary skill in the art to modify the harness taught by Box to have a suitable shape for receiving the teddy bear taught by Mulhearn as taught by Sander. Further, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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.
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Box et al. (US 5,154,691), in view of Mulhearn et al. (US 11,672,322), and in further view of Sanders (US 2011/0062764).
Regarding claim 1, Box discloses a chest pain reduction system (Fig. 1) capable of alleviating chest pain, the system comprising:
a post-operative brace (pillow 24) capable of facilitating performing respiratory exercises by hugging the post-operative brace (24) against a chest of a user (patient 12) such that the post-operative brace is capable of supporting the chest when performing respiratory exercises (Figs. 1-3; column 1, lines 35-40; column 2, lines 5-16; column 3, lines 21-27); and
a harness (sling 10) being configured to worn on a torso of the user (12), the post-operative brace (24) being couplable to the harness (10), wherein the harness (10) is configured to hold the post-operative brace (24) against a chest of the user (12) when the harness (10) is worn on the torso of the user (12) such that the user is capable of hugging (grasping/clutching) the post-operative brace (24) when performing respiratory exercises, wherein the harness (10) includes a brace holder (sheet of material 16) removably holding the post-operative brace (24), the brace holder (16) comprising a covering (16) enclosing a receiving space configured to extend between opposing lateral sides of the user and secure the post-operative brace (24) in a static position relative to the torso of the user (Figs. 1-3; column 2, line 61 – column 3, line 33).
Although Box discloses that the shape of the post-operative brace can be varied to simulate a known animal or object that may be attractive to a neonatal patient, Box fails to expressly teach that the post-operative brace comprises a teddy bear being weighted and firmed by a weighted members to define a bear brace including a pair of legs, a pair of arms, and a head.
Mulhearn discloses a system (assembly 100) comprising a teddy bear (toy 168) capable of being hugged against a chest of a user (wearer 190), the teddy bear (168) being weighted and firmed by a weighted members to define a bear brace (stuffing material may include pellets, beans, or beads) including a pair of legs, a pair of arms, and a head, and a harness (chest panel 102 + straps 160) configured to be worn on a torso of the user (190), the teddy bear (168) being couplable to the harness (102+160), wherein the harness (102+160) is configured to hold the teddy bear (168) against the chest of the user (190) when the harness (102+160) is worn on the torso of the user (190) and the user (190) is capable of hugging the teddy bear (168) (Figs. 3 & 5-6; column 1, lines 35-47; column 4, lines 29-34 & 41-43).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the post-operative brace of the system taught by Box to comprise a teddy bear being weighted and firmed by a weighted members to define a bear brace including a pair of legs, a pair of arms, and a head as taught by Mulhearn for the purpose of providing comfort to a young patient.
However, the combination of Box and Mulhearn fails to teach that the covering has a pair of leg openings, a pair of arm openings, and a head opening extending therethrough and into the receiving space, wherein the head of the bear brace is positioned within the head opening, each of the arms of the bear brace are positioned within a respective one of the arm openings, and each of the legs of the bear brace are positioned within a respective one of the leg opening, and wherein the bear brace is insertable through the head opening to secure the bear brace within the receiving space such that the arms, legs, and head of the bear brace extend out of the receiving space.
Sanders discloses an analogous harness (bodysuit assembly 22) configured to be worn on a torso of a user (adult 82) and couplable to an occupant (18), the occupant (18) including a pair of legs, a pair of arms (arms 52, 54), and a head (occupant 18 is analogous to the claimed bear brace), wherein the harness (22) is configured to hold the occupant (18) against a chest of the user (82) when the harness (22) is worn on the torso of the user (82), wherein the harness (22) includes a holder (full torso covering means 24) removably holding the occupant (18), the holder (24) comprising a covering (24) enclosing a receiving space configured to extend between opposing lateral sides of the user, a bottom side of the covering (24) having a pair of leg openings (leg openings 34, 36) extending therethrough and into the receiving space, a top side of the covering (24) having a pair of arm openings (arm openings 30, 32) extending therethrough and into the receiving space, the top side of the covering (24) having a head opening (between shoulder straps 46, 48) extending therethrough and into the receiving space, the head opening being positioned the pair of arm openings (30, 32) to form a first strap (first shoulder strap 46) and a second strap (second shoulder strap 48) of the coverings (24), wherein the receiving space is configured to receive the occupant (18) such that each of the arms (52, 54) of the occupant (18) are positioned within a respective one of the arm openings (30, 32), and each of the legs of the occupant (18) are positioned within a respective one of the leg openings (34, 36), the first and second straps (46, 48) are capable of being selectively movable away from each other to expand the head opening, wherein the occupant (18) is insertable through the head opening, wherein the occupant (18) is secured within the receiving space such that the arms, legs, and head of the occupant (18) extending out of the receiving space to secure the occupant (18) in a static position relative to the torso of the user (Figs. 2, 4A, & 6; ¶ 0017-0018, 0021, & 0024).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the covering of the system taught by the combination of Box and Mulhearn to have a pair of leg openings, a pair of arm openings, and a head opening extending therethrough and into the receiving space, wherein the head of the bear brace is positioned within the head opening, each of the arms of the bear brace are positioned within a respective one of the arm openings, and each of the legs of the bear brace are positioned within a respective one of the leg opening, and wherein the bear brace is insertable through the head opening such that the arms, legs, and head of the bear brace extend out of the receiving space as taught by Sanders for the purpose of providing a harness configuration suitable for receiving the shape of the bear brace that can be easily inserted and removed as desired.
With respect to the limitation regarding alleviating chest pain and performing respiratory exercises, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the system taught by the combination of Box / Mulhearn / Sanders is capable of being used during respiratory exercises and alleviating chest pain.
Regarding claim 3, the combination of Box / Mulhearn / Sanders discloses the invention substantially as claimed, as described above, and Box further discloses a pair of tethers (pair of supporting straps 28) configured to extend over a pair of shoulders of the user (12) and crisscross on a back of the torso of the user (12), the pair of tethers (28) including a first tether (28) and a second tether (28), the first tether (28) being coupled to and extending outwardly from a top of the covering (16), the second tether (28) being coupled to an extending outwardly from the top of the covering (16) (Figs. 1-4; column 3, lines 34-57).
Mulhearn further discloses a pair of tethers (shoulder straps 150) each having one of a pair of adjustment members (adjuster 156) such that the tethers each have an adjustable length (Fig. 5; column 5, lines 56-60).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the first and second tethers of the system taught by the combination of Box / Mulhearn / Sanders to each have one of a pair of adjustment members such that the first and second tethers each have an adjustable length as further taught by Mulhearn for the purpose of achieving a selected snug fit or tightness of the tethers on the shoulders of the user.
Regarding claim 4, the combination of Box / Mulhearn / Sanders discloses the invention substantially as claimed, as described above, and Box further discloses a fastener (patches 26, 30) configured to fasten the tethers (28) to the user (12), the fastener including a pair of first fastening members (26) and a pair of second fastening members (30), each of the second fastening members (30) being engageable with one of the pair of first fastening members (26), the first fastening members (26) being positioned on a front side of the covering (16), each of the second fastening members (30) being positioned on an end of a respective one of the pair of tethers (28), wherein an end of each of the tethers (28) fastens with the front side of the covering (Figs. 1-4; column 3, lines 34-57).
Regarding claim 5, Box discloses a chest pain reduction system (Fig. 1) capable of alleviating chest pain, the system comprising:
a post-operative brace (pillow 24) capable of facilitating performing respiratory exercises by hugging the post-operative brace (24) against a chest of a user (patient 12) such that the post-operative brace is capable of supporting the chest when performing respiratory exercises (Figs. 1-3; column 1, lines 35-40; column 2, lines 5-16; column 3, lines 21-27); and
a harness (sling 10) being configured to worn on a toros of the user (12), the post-operative brace (24) being couplable to the harness (10), wherein the harness (10) is configured to hold the post-operative brace (24) against a chest of the user (12) when the harness (10) is worn on the torso of the user (12) such that the user is capable of hugging (grasping/clutching) the post-operative brace (24) when performing respiratory exercises (Figs. 1-3; column 2, line 61 – column 3, line 33);
wherein the harness (10) includes:
a brace holder (sheet of material 16) removably holding the post-operative brace (24), the brace holder (16) comprising a covering (16) enclosing a receiving space configured to extend between opposing lateral sides of the user to secure the post-operative brace (24) in a static position relative to the torso of the user (Figs. 1-3; column 3, lines 5-33);
a pair of tethers (pair of supporting straps 28) configured to extend over a pair of shoulders of the user (12) and crisscross on a back of the torso of the user (12), the pair of tethers (28) including a first tether (28) and a second tether (28), the first tether (28) being coupled to and extending outwardly from a top of the covering (16), the second tether (28) being coupled to an extending outwardly from the top of the covering (16) (Figs. 1-4; column 3, lines 34-57); and
a fastener (patches 26, 30) configured to fasten the tethers (28) to the user (12), the fastener including a pair of first fastening members (26) and a pair of second fastening members (30), each of the second fastening members (30) being engageable with one of the pair of first fastening members (26), the first fastening members (26) being positioned on a front side of the covering (16), each of the second fastening members (30) being positioned on an end of a respective one of the pair of tethers (28), wherein an end of each of the tethers (28) fastens with the front side of the covering (Figs. 1-4; column 3, lines 34-57).
Although Box discloses that the shape of the post-operative brace can be varied to simulate a known animal or object that may be attractive to a neonatal patient, Box fails to expressly teach that the post-operative brace comprises a teddy bear being weighted and firmed by a weighted members to define a bear brace including a pair of legs, a pair of arms, and a head. Box also fails to teach that each of the tethers has one of a pair of adjustment members such that the tethers each have an adjustable length.
Mulhearn discloses a system (assembly 100) comprising a teddy bear (toy 168) capable of being hugged against a chest of a user (wearer 190), the teddy bear (168) being weighted and firmed by a weighted members to define a bear brace (stuffing material may include pellets, beans, or beads) including a pair of legs, a pair of arms, and a head, and a harness (chest panel 102 + straps 160) configured to be worn on a torso of the user (190), the teddy bear (168) being couplable to the harness (102+160), wherein the harness (102+160) is configured to hold the teddy bear (168) against the chest of the user (190) when the harness (102+160) is worn on the torso of the user (190) and the user (190) is capable of hugging the teddy bear (168), a pair of tethers (shoulder straps 150) each having one of a pair of adjustment members (adjuster 156) such that the tethers each have an adjustable length (Figs. 3 & 5-6; column 1, lines 35-47; column 4, lines 29-34 & 41-43; column 5, lines 56-60).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the post-operative brace of the system taught by Box to comprise a teddy bear being weighted and firmed by a weighted members to define a bear brace including a pair of legs, a pair of arms, and a head as taught by Mulhearn for the purpose of providing comfort to a young patient. Further, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the first and second tethers of the system taught by the combination of Box and Mulhearn to each have one of a pair of adjustment members such that the first and second tethers each have an adjustable length as also taught by Mulhearn for the purpose of achieving a selected snug fit or tightness of the tethers on the shoulders of the user.
However, the combination of Box and Mulhearn fails to teach that the covering has a pair of leg openings, a pair of arm openings, and a head opening extending therethrough and into the receiving space, wherein the head of the bear brace is positioned within the head opening, each of the arms of the bear brace are positioned within a respective one of the arm openings, and each of the legs of the bear brace are positioned within a respective one of the leg opening, and wherein the bear brace is insertable through the head opening such that the arm, legs, and head of the bear brace extend out of the receiving space.
Sanders discloses an analogous harness (bodysuit assembly 22) configured to be worn on a torso of a user (adult 82) and couplable to an occupant (18), the occupant (18) including a pair of legs, a pair of arms (arms 52, 54), and a head (occupant 18 is analogous to the claimed bear brace), wherein the harness (22) is configured to hold the occupant (18) against a chest of the user (82) when the harness (22) is worn on the torso of the user (82), wherein the harness (22) includes a holder (full torso covering means 24) removably holding the occupant (18), the holder (24) comprising a covering (24) enclosing a receiving space configured to extend between opposing lateral sides of the user, a bottom side of the covering (24) having a pair of leg openings (leg openings 34, 36) extending therethrough and into the receiving space, a top side of the covering (24) having a pair of arm openings (arm openings 30, 32) extending therethrough and into the receiving space, the top side of the covering (24) having a head opening (between shoulder straps 46, 48) extending therethrough and into the receiving space, the head opening being positioned the pair of arm openings (30, 32) to form a first strap (first shoulder strap 46) and a second strap (second shoulder strap 48) of the coverings (24), wherein the receiving space is configured to receive the occupant (18) such that each of the arms (52, 54) of the occupant (18) are positioned within a respective one of the arm openings (30, 32), and each of the legs of the occupant (18) are positioned within a respective one of the leg openings (34, 36), the first and second straps (46, 48) are capable of being selectively movable away from each other to expand the head opening, wherein the occupant (18) is insertable through the head opening such that the arms, legs, and head of the occupant (18) extend out of the receiving space to secure the occupant (18) in a static position relative to the torso of the user (Figs. 2, 4A, & 6; ¶ 0017-0018, 0021, & 0024).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the covering of the system taught by the combination of Box and Mulhearn to have a pair of leg openings, a pair of arm openings, and a head opening extending therethrough and into the receiving space, wherein the head of the bear brace is positioned within the head opening, each of the arms of the bear brace are positioned within a respective one of the arm openings, and each of the legs of the bear brace are positioned within a respective one of the leg opening, and wherein the bear brace is insertable through the head opening such that the arms, legs, and head of the bear brace extend out of the receiving space as taught by Sanders for the purpose of providing a harness configuration suitable for receiving the shape of the bear brace that can be easily inserted and removed as desired.
With respect to the limitation regarding alleviating chest pain and performing respiratory exercises, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the system taught by the combination of Box / Mulhearn / Sanders is capable of being used during respiratory exercises and alleviating chest pain.
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 Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 4/7/2026