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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 14 of U.S. Patent No. 12,102,549 B2 (hereinafter Reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because
Instant Application
Reference Patent
1. A smart brace comprising:
a flexible compressive garment configured to be worn on a limb over a joint; and
a smart hinge removably coupled to the garment, the smart hinge comprising:
a first bar coupled to an upper portion of the garment above the joint, the first bar configured to rotate about a first axis with flexion or extension of the joint;
a second bar coupled to a lower portion of the garment below the joint, the second bar configured to rotate about a second axis with flexion or extension of the joint; and
at least one sensor configured to gather data related to motion of the joint;
wherein the first bar and the second bar are flexible in a frontal plane and rigid in a sagittal plane.
1. A smart brace comprising:
a flexible compressive garment configured to be worn on a limb over a joint, … and
a smart hinge removably coupled to the flexible compressive garment, the smart hinge comprising:
a first bar at least partially received within the rigid molded upper receptacle of the flexible compressive garment above the joint…and wherein the first bar is configured to rotate about a first axis with flexion or extension of the joint, …
a second bar at least partially received within the rigid molded lower receptacle of the flexible compressive garment below the joint, … the second bar is configured to rotate about a second axis with flexion or extension of the joint,
and at least one potentiometer (a sensor) … that is rotationally coupled to the first bar or the second bar by way of a drive key;
wherein the first bar and the second bar are flexible in a frontal plane …and rigid in a sagittal plane such that the first bar and the second bar are configured to accurately gather data related to motion of the joint (thus, the potentiometer is configured to gather data related to motion of the joint).
2. The smart brace of claim 1, wherein each of the first bar and the second bar comprise: a thickness less than or equal to about 1.0 mm, less than or equal to about 0.75, or less than or equal to about 0.5 mm providing flexibility in the frontal plane; and a width greater than or equal to about 5.0 mm, greater than or equal to about 7.5 mm, or greater than or equal to about 10 mm providing rigidity in the sagittal plane.
1. … the first bar having a thickness less than about 0.5 mm and a width greater than or equal to about 5.0 mm… the second bar having a thickness less than about 0.5 mm and a width greater than or equal to about 5.0 mm… wherein the first bar and the second bar are flexible in a frontal plane …and rigid in a sagittal plane
3. The smart brace of Claim 2, wherein each of the first bar and the second bar comprise spring steel.
4. The smart brace of claim 1, wherein each of the first bar and the second bar comprise spring steel.
4. The smart brace of Claim 3, wherein: a first end of the first bar is countersunk within a first gear; and a first end of the second bar is countersunk within a second gear, the second gear meshingly engaged with the first gear such that rotation of the first bar about the first axis causes a corresponding rotation of the second bar about the second axis.
5. The smart brace of claim 1, wherein: the first end of the first bar is countersunk within a first gear; and the first end of the second bar is countersunk within a second gear, the second gear meshingly engaged with the first gear such that rotation of the first bar about the first axis causes a corresponding rotation of the second bar about the second axis.
5. The smart brace of Claim 4, wherein the garment comprises: an upper receptacle fixedly attached to the upper portion of the garment, the upper receptacle comprising a slot that removably receives a second end of the first bar to couple the first bar to the upper portion; and a lower receptacle fixedly attached to the lower portion of the garment, the lower receptacle comprising a slot that removably receives a second end of the second bar to couple the second bar to the second portion.
1… the flexible compressive garment consisting of: … a rigid molded upper receptacle fixedly attached to an upper portion of the sleeve, and a rigid molded lower receptacle fixedly attached to a lower portion of the sleeve… wherein the rigid molded upper receptacle comprises an upper slot that removably receives a second end of the first bar to couple the first bar to the upper portion… wherein the rigid molded lower receptacle comprises a lower slot that removably receives a second end of the second bar to couple the second bar to the lower portion
6. The smart brace of Claim 5, wherein: the first bar comprises a first insert overmolded on the first bar between the first end and the second end, the first insert configured to engage with the slot of the upper receptacle; and the second bar comprises a second insert overmolded on the second bar between the first end and the second end, the second insert configured to engage with the slot of the lower receptacle.
1. …wherein the first bar comprises a first insert overmolded on the first bar between a first end and the second end, the first insert configured to engage with the upper slot… wherein the second bar comprises a second insert overmolded on the second bar between a first end and the second end, the second insert configured to engage with the lower slot,
7. The smart brace of Claim 1, wherein the smart hinge assembly is coupled to the garment on a lateral side, and the smart brace further comprises a dummy hinge assembly coupled to the garment on the medial side.
2. The smart brace of claim 1, wherein the smart hinge is coupled to the flexible compressive garment on a lateral side, and the smart brace further comprises a dummy hinge assembly coupled to the flexible compressive garment on a medial side.
8. The smart brace of Claim 2, wherein the dummy hinge assembly comprises: a first bar coupled to an upper portion of the garment above the joint, the first bar configured to rotate about a first axis with flexion or extension of the joint; and a second bar coupled to a lower portion of the garment below the joint, the second bar configured to rotate about a second axis with flexion or extension of the joint; wherein the first bar and the second bar are flexible in a frontal plane and rigid in a sagittal plane.
3. The smart brace of claim 2, wherein the dummy hinge assembly comprises: a first bar coupled to an upper portion of the flexible compressive garment above the joint, the first bar configured to rotate about a first axis with flexion or extension of the joint; and a second bar coupled to a lower portion of the flexible compressive garment below the joint, the second bar configured to rotate about a second axis with flexion or extension of the joint; wherein the first bar and the second bar are flexible in a frontal plane and rigid in a sagittal plane.
9. The smart brace of Claim 1, wherein the joint comprises a knee.
6. The smart brace of claim 1, wherein the joint comprises a knee.
10. A hinge assembly for a smart brace, the hinge assembly comprising: a first geared arm assembly comprising a first gear and a first bar, an end of the first bar received within a recess of the first gear; a second geared arm assembly comprising a second gear and a second bar, an end of the second bar received within a recess of the second gear; and a hinge plate, the first geared arm assembly connected to the hinge plate for rotation about a first axis and the second geared arm assembly connected to the hinge plate for rotation about a second axis, and the first gear meshingly engaged with the second gear such that rotation of the first geared arm assembly causes a corresponding rotation of the second geared arm assembly; wherein the first bar and the second bar are flexible in a frontal plane and rigid in a sagittal plane.
7. A low-profile hinge assembly for a smart brace, the hinge assembly comprising: a first geared arm assembly comprising a first gear and a first bar, a first end of the first bar received flush within a recess of the first gear, …; a second geared arm assembly comprising a second gear and a second bar, a first end of the second bar received flush within a recess of the second gear, …; and a hinge plate, the first geared arm assembly connected to the hinge plate for rotation about a first axis and the second geared arm assembly connected to the hinge plate for rotation about a second axis, and the first gear meshingly engaged with the second gear such that rotation of the first geared arm assembly causes a corresponding rotation of the second geared arm assembly; … wherein the first bar and the second bar are flexible in a frontal plane … and rigid in a sagittal plane
11. The hinge assembly of Claim 10, wherein each of the first bar and the second bar comprise: a thickness less than or equal to about 1 mm providing flexibility in the frontal plane; and a width greater than or equal to about 5 mm providing rigidity in the sagittal plane.
7. … wherein the first bar and the second bar each have a thickness less than about 0.5 mm (and thus less than 1mm) and a width greater than or equal to about 5.0 mm… the first bar and the second bar are flexible in a frontal plane … and rigid in a sagittal plane
12. The hinge assembly of Claim 10, wherein each of the first bar and the second bar comprise: a thickness less than or equal to about 0.75 mm providing flexibility in the frontal plane; and a width greater than or equal to about 7.5 mm providing rigidity in the sagittal plane.
7. … wherein the first bar and the second bar each have a thickness less than about 0.5 mm (and thus less than .75mm) and a width greater than or equal to about 5.0 mm (and thus greater than 7.5mm) … the first bar and the second bar are flexible in a frontal plane … and rigid in a sagittal plane
13. The hinge assembly of Claim 10, wherein each of the first bar and the second bar comprise: a thickness less than or equal to about 0.5 mm providing flexibility in the frontal plane; and a width greater than or equal to about 10 mm providing rigidity in the sagittal plane.
7. … wherein the first bar and the second bar each have a thickness less than about 0.5 mm and a width greater than or equal to about 5.0 mm (and thus greater than 10mm)… the first bar and the second bar are flexible in a frontal plane … and rigid in a sagittal plane
14. The hinge assembly of Claim 10, wherein each of the first bar and the second bar comprise spring steel.
14. The hinge assembly of claim 7, wherein each of the first bar and the second bar comprise spring steel.
15. The hinge assembly of Claim 10, wherein the recess of each of the first and second gears comprises a shape that corresponds to a shape of the end of the corresponding first and second bars, such that the end of each of the first and second bars is closely received within the corresponding recess of the first and second gears.
11. The hinge assembly of claim 7, wherein the recess of each of the first and second gears comprises a shape that corresponds to a shape of the end of the corresponding first and second bars, such that the end of each of the first and second bars is closely received within the corresponding recess of the first and second gears.
16. The hinge assembly of Claim 15, wherein the recess of each of the first and second gears is configured such that the corresponding first and second bars is countersunk within the corresponding recess of the first and second gears.
12. The hinge assembly of claim 11, wherein the recess of each of the first and second gears is configured such that the corresponding first and second bars is countersunk within the corresponding recess of the first and second gears.
17. The hinge assembly of Claim 10, further comprising: at least one sensor configured to gather data related to motion of at least one of the first and second geared arm assemblies; and a power source electrically coupled to the at least one sensor.
7. …at least one potentiometer comprising a rotatable component that is rotationally coupled to the first bar or the second bar by way of a drive key, the at least one potentiometer configured to gather data related to motion of a joint (via rotation of first and second geared arms)
8. …a power source electrically coupled to the at least one sensor.
18. The hinge assembly of Claim 17, wherein: the at least one sensor comprises a potentiometer; the end of one of the first bar or the second bar comprises a keyed opening; and a drive key engaged with the keyed opening couples the potentiometer to the end of the one of the first bar or the second bar such that rotation of the one of the first bar or the second bar about the corresponding first or second axis adjusts an output of the potentiometer.
7. …at least one potentiometer comprising a rotatable component that is rotationally coupled to the first bar or the second bar by way of a drive key, … wherein the end of one of the first bar or the second bar comprises a keyed opening, the drive key engaged with the keyed opening to couple the potentiometer to the end of the one of the first bar or the second bar such that rotation of the one of the first bar or the second bar about the corresponding first or second axis adjusts an output of the potentiometer
19. The hinge assembly of Claim 17, wherein the at least one sensor and the power source are positioned on a printed circuit board, and the hinge assembly further comprises: a gasket that at least partially receives the printed circuit board; and a cover that covers the gasket and the printed circuit board, wherein the gasket and cover define a water resistant recess in which the printed circuit board is positioned.
9. The hinge assembly of claim 8, wherein the at least one sensor and the power source are positioned on a printed circuit board, and the hinge assembly further comprises: a gasket that at least partially receives the printed circuit board; and a cover that covers the gasket and the printed circuit board, wherein the gasket and cover define a water resistant recess in which the printed circuit board is positioned.
20. The hinge assembly of Claim 19, wherein: the hinge plate, the gasket, the printed circuit board, and the cover are positioned on a first side of the first and second geared arms; a condyle is positioned on a second side of the first and second geared arms; and during use of a smart brace including the hinge assembly, the first side is positioned away from a wearer and the second side is positioned toward the wearer.
10. The hinge assembly of claim 9, wherein: the hinge plate, the gasket, the printed circuit board, and the cover are positioned on a first side of the first and second geared arms; a condyle is positioned on a second side of the first and second geared arms; and during use of a smart brace including the hinge assembly, the first side is positioned away from a wearer and the second side is positioned toward the wearer.
As can be seen above, claims 1-20 of the instant application are broader and simpler recitations of what is claimed in claims 1-12 and 14 of the reference patent, and thus, are not considered patentably distinct from the reference patent.
Claim Objections
Claims 1, 5, 7, 8, and 20 are objected to because of the following informalities:
Claim 1 presents the limitation “a flexible compressive garment” in line 1. However, each subsequent recitation in claims 1, 5, 7, and 8 of the flexible compressive garment is referred to solely as the garment. These limitations should be amended to recite “the flexible compressive garment” to maintain consistency in the claims.
Claim 1 recites the limitation “a first bar coupled to an upper portion of the garment above the joint” in line 5, and “a second bar coupled to a lower portion of the garment below the joint” in line 8. These limitations should be amended to include configured to language.
Claim 8 recites the limitation “a frontal plane” and “a sagittal plane”. These limitations should be amended to recite “the frontal plane” and “the sagittal plane” as both of these limitations were presented in claim 1 from which claim 8 depends.
Claim 8 recites the limitation “the first bar” and “the second bar” with respect to the dummy hinge assembly. These limitations should be amended to recite “the first/second bar of the dummy hinge assembly” for clarification purposes such that the claim is clear Applicant is referring to the first/second bar of the dummy hinge assembly, and not the first/second bar of the smart hinge assembly of claim 1.
Claim 8 recites the limitation “a first bar coupled to an upper portion of the garment above the joint” in line 2, and “a second bar coupled to a lower portion of the garment below the joint” in line 4. These limitations should be amended to include configured to language.
Claim 20 recites the limitation “during use of a smart brace including the hinge assembly, the first side is positioned away from a wearer and the second side is positioned toward the wearer.” in line 6. This limitation should be amended to include configured to language.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-8, and 20 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 5 recites the limitation “the second portion” in the final line of the claim. There is insufficient antecedent basis for this limitation in the claim. for the purpose of examination, Examiner will interpret this limitation as “the lower portion”.
Claim 7 recites the limitation “the medial side” in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. for the purpose of examination, Examiner will interpret this limitation as “a medial side”.
Claim 8 recites the limitation "the dummy hinge" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 2 from which claim 8 depends, currently does not recite the dummy hinge or any features of the dummy hinge. For the purpose of examination, Examiner will interpret claim 8 as being dependent on claim 7 due to claim 7 reciting “a dummy hinge”.
Claim 8 recites the limitation “an upper portion of the garment above the joint” in line 2 and “a lower portion of the garment below the joint” in line 4. These limitations are held to be unclear in view of claim 1 which recites both “an upper portion of the garment above the joint” and “a lower portion of the garment below the joint”. Therefore, it is unclear as to if the upper and lower portions of the garment as recited in claim 8 are new or different portions of the garment. For the purpose of examination, Examiner will interpret these limitations as best understood.
Claim 20 recites the limitation “during use of a smart brace” in line 6. This limitation is held to be unclear in view of claim 10 which also recites “a smart brace”. Therefore, it is unclear as to if the smart brace of claim 20 is a new smart brace, or the same as earlier presented. For the purpose of examination, Examiner will interpret the limitation of claim 20 as: “the smart brace”.
Claim 6 is rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim.
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) 1-2, and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al. (US 2004/0054307 A1) (hereinafter Mason) in view of Moore (US 2019/0133497 A1).
In regards to claim 1, Mason discloses A brace (10; see [0022]; see figure 1) comprising:
a flexible compressive garment (48; see [0030]; see figure 1) configured to be worn on a limb over a joint (see [0030]); and
a hinge (39; see [0029]; see figure 1) removably coupled to the garment (48; 16 and 18 are only described as being inserted within pockets 51 and 52 (see [0030]) and thus are 39 is considered removably coupled to 48), the hinge (39) comprising:
a first bar (16; see [0023]; see figure 1) coupled to an upper portion of the garment (48) above the joint (see figure 1), the first bar (16) configured to rotate about a first axis (axis defined by 40) with flexion or extension of the joint (see [0029]);
a second bar (18; see [0023]; see figure 1) coupled to a lower portion of the garment (48) below the joint (see figure 1), the second bar (18) configured to rotate about a second axis (axis defined by 41) with flexion or extension of the joint (see [0029]); and
wherein the first bar (16) and the second bar (18) are flexible in a frontal plane and rigid in a sagittal plane (see [0023]).
Mason does not disclose the brace is a smart brace, comprising a smart hinge with at least one sensor configured to gather data related to motion of the joint.
However, Moore teaches an brace (200; see [0045]; see figure 2b) comprising an analogous hinge (256; see [0049]; see figure 2b) which comprises an analogous upper arm (252; see [0049]; see figure 3a), and lower arm (254; see [0049]; see figure 3a) wherein the first bar (252) is configured to rotate about a first axis (axis defined by 314; see [0059]; see figure 3a) and the second bar (254) is configured to rotate about a second axis (axis defined by 316; see [0059]; see figure 3a); wherein the brace (200) is a smart brace (see [0028] that the brace connects with a smart device, and thus is considered a smart brace), comprising a smart hinge (256 comprises a sensor and therefore is considered a smart hinge; see [0058]) with at least one sensor configured to gather data related to motion of the joint (see [0058] and [abstract]) for the purpose of measuring and/or tracking one or more aspects of joint function (see [0058]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hinge of the brace as disclosed by Mason and to have included the sensors of the hinge, and means for the hinge to communicate the observed data with the user’s mobile smart device thereby forming a smart brace, and smart hinge as taught by Moore in order to have provided an improved brace that would add the benefit of measuring and/or tracking one or more aspects of joint function (see [0058]) thereby monitoring a healing process of the joint over which the brace has been applied, and ensuring the joint is healing properly.
In regards to claim 2, Mason as now modified by Moore discloses the invention as discussed above.
Mason as now modified by Moore does not explicitly disclose wherein each of the first bar and the second bar comprise:
a thickness less than or equal to about 1.0 mm, less than or equal to about 0.75, or less than or equal to about 0.5 mm providing flexibility in the frontal plane; and
a width greater than or equal to about 5.0 mm, greater than or equal to about 7.5 mm, or greater than or equal to about 10 mm providing rigidity in the sagittal plane.
Mason discloses (see [0023]) “the arms 12, 14, 16, 18 each have a relatively larger dimension of width providing substantial inflexibility in the anterior and posterior directions and have a relatively smaller dimension of thickness providing a degree of flexibility in the medial and lateral directions”. Thereby, disclosing a thickness and width of the bar to provide rigidity in the anterior and posterior directions (i.e. in the frontal plane), and flexibility in the medial and lateral directions (i.e. in the sagittal plane) is a result effective variable in that changing the thickness and width of the first and second bars changes the degrees of flexibility and rigidity provided by the first and second bars. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the first and second bars as disclosed by Mason as now modified by Moore to have a thickness and width within the claimed range, as it involves only adjusting the dimension of the first and second bars disclosed to require a width providing substantial inflexibility in the anterior and posterior directions and a thickness providing a degree of flexibility in the medial and lateral directions. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thickness and width of the first and second bars as disclosed by Mason as now modified by Moore by making the first and second bars with a thickness less than or equal to about 1.0 mm and a width greater than or equal to about 5.0 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A).
In regards to claim 7, Mason as now modified by Moore discloses the invention as discussed above.
Mason as now modified by Moore further discloses wherein the smart hinge assembly (39 of Mason as now modified by Moore) is coupled to the garment (48 of Mason) on a lateral side (see [0013] that figure 2 is a lateral view of the brace; see figure 2 that 39 of Mason is positioned on a lateral side), and the smart brace (10 of Mason as now modified by Moore) further comprises a dummy hinge assembly (28 of Mason; see Mason [0024] and figure 1) coupled to the garment (48) on the medial side (see [0014] that figure 3 is a medial view of the brace; see figure 3 that 28 of Mason is positioned on a medial side).
In regards to claim 8, Mason as now modified by Moore discloses the invention as discussed above.
Mason further discloses wherein the dummy hinge assembly (28) comprises: a first bar (12; see [0023]; see figure 1) coupled to an upper portion of the garment (48) above the joint (see figure 1), the first bar (12) configured to rotate about a first axis (axis defined by 29; see figure 4) with flexion or extension of the joint (see [0024]); and a second bar (14; see [0023]; see figure 1) coupled to a lower portion of the garment (48) below the joint (see figure 1), the second bar (14) configured to rotate about a second axis (axis defined by 30; see figure 4) with flexion or extension of the joint (see [0024]); wherein the first bar (12) and the second bar (14) are flexible in a frontal plane and rigid in a sagittal plane (see [0023]).
In regards to claim 9, Mason as now modified by Moore discloses the invention as discussed above.
Mason further discloses wherein the joint comprises a knee (see [abstract]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moore in view of Mason in view of Moore as applied to claim 2 above, and further in view of Dickerson et al. (US 4,986,263) (hereinafter Dickerson).
In regards to claim 3, Mason as now modified by Moore discloses the invention as discussed above.
Mason further discloses each of the first bar and the second bar may be formed from materials which are well-known to those skilled in the art of hinged orthopedic knee braces: including metals, … and combinations thereof (spring steel being a combination of multiple metals), with a width and thickness of the first and second bars to provide inflexibility in the anterior and posterior directions a degree of flexibility in the medial and lateral directions (see [0023]). Mason as now modified by Moore does not explicitly disclose wherein each of the first bar and second bar comprise spring steel.
However, Dickerson teaches an analogous knee supporting device (10; see [Col 3 ln 33-38]; see figure 1) comprising lateral and medial supports (50,52,53,and 55; see [Col 4 ln 30-35]; see figure 4) wherein the supports are formed of spring steel (see [Col 4 ln 30-43]) for the purpose of providing a material that will permit flexing but will also provide adequate support (see [Col 4 ln 30-43]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the first and second bars as disclosed by Mason as now modified by Moore and to have formed the first and second bars from spring steel as taught by Dickerson in order to have provided improved first and second bars that would add the benefit of providing a material of the first and second bars that will permit flexing but will also provide adequate support (see [Col 4 ln 30-43]) and therefore providing a material which can conform to a user’s anatomy and flex with the natural movements of the user’s joint.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mason in view of Moore and Dickerson as applied to claim 3 above, and further in view of Ceriani et al. (US 2003/0149386 A1) (hereinafter Ceriani).
In regards to claim 4, Mason as now modified by Moore and Dickerson discloses the invention as discussed above.
Mason further discloses wherein: a first end (25; see [0023]; see figure 5) of the first bar (16) comprises a first gear (42; see [0029]; see figure 5); and
a first end (26; see [0023]; see figure 5) of the second bar (18) comprises a second gear (42; see [0029]; see figure 5) the second gear (42 of 26) meshingly engaged with the first gear (42 of 25) such that rotation of the first bar (16) about the first axis (axis defined by 40) causes a corresponding rotation of the second bar (18) about the second axis (axis defined by 41; see figure 5; due to the intermeshing of upper and lower 42, rotation of the first bar would cause a corresponding rotation of the second bar as claimed).
Mason as now modified by Moore and Dickerson does not disclose the first end of the first bar is countersunk within the first gear, and the first end of the second bar is countersunk within the second gear.
However, Ceriani teaches an analogous hinge (18; see [0040]; see figure 1) comprising an analogous first and second bar (24 and 30; see [0040]; see figure 2) wherein the first and second bar comprise analogous first ends (90 of 24 and 30 respectively; see [0045]; see figure 4) and analogous first and second gears (56 and 58; see [0044]; see figure 2); wherein the first end (90) of the first bar (24) is countersunk within the first gear (56), and the first end (90) of the second bar (30) is countersunk within the second gear (58; see figure 4-6) for the purpose of providing a means to allow the upper and lower support arms to articulate between the first and second positions on the base surfaces of the first and second gear members in a plane perpendicular to the plane of rotation (see [0052]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second gears as disclosed by Mason as now modified by Moore and Dickerson and to have formed the first and second gears separate from the first ends of the first and second bars, such that the first and second bars are countersunk within the first and second gears as taught by Ceriani in order to have provided an improved first and second bar engagement of the first and second gears that would add the benefit of providing a means to allow the upper and lower support arms to articulate between the first and second positions on the base surfaces of the first and second gear members in a plane perpendicular to the plane of rotation (see [0052]) thereby, increasing the adjustability of the smart hinge such that the first and second bar can better flex and move with respect to movements of the user’s knee.
In regards to claim 5, Mason as now modified by Moore, Dickerson, and Ceriani discloses the invention as discussed above.
Mason further discloses wherein the garment (48) comprises:
an upper receptacle (51; see [0030]; see figure 2) fixedly attached to the upper portion of the garment (48; see [0032]), the upper receptacle (51) comprising a slot (63; see [0032]; see figure 2) that removably receives a second end (24; see [0023]; see figure 5) of the first bar (16) to couple the first bar (16) to the upper portion (Moore does not disclose a permanent fixing means of 16 within 51, and thus 16 is considered removably coupled to the upper portion of 48); and
a lower receptacle (52; see [0030]; see figure 2) fixedly attached to the lower portion of the garment (48; see figure 2), the lower receptacle (52) comprising a slot (67; see [0032]; see figure 2) that removably receives a second end (27; see [0023]; see figure 5) of the second bar (18) to couple the second bar (18) to the second portion (Moore does not disclose a permanent fixing means of 18 within 52, and thus 18 is considered removably coupled to the lower portion of 48).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mason in view of Moore, Dickerson, and Ceriani as applied to claim 5 above, and further in view of Costello et al. (US 2017/0000639 A1) (hereinafter Costello).
In regards to claim 6, Mason as now modified by Moore, Dickerson, and Ceriani discloses the invention as discussed above.
Mason as now modified by Moore, Dickerson, and Ceriani does not disclose wherein:
the first bar comprises a first insert overmolded on the first bar between the first end and the second end; the first insert configured to engage with the slot of the upper receptacle, and
the second bar comprises a second insert overmolded on the second bar between the first end and the second end, the second insert configured to engage with the slot of the lower receptacle.
However, Costello teaches an analogous hinge (20; see [0043]; see figure 1) comprising a first bar (30 of 12b; see [0049] in reference to 12a’s construction and [0060] in reference to 12b being similarly constructed; see figure 17) received within a first receptacle (32 of 12b; see [0054]; see figure 12) and an analogous second bar (30 of 12a; see [0049]; see figure 17) received within a second receptacle (32 of 12a; see [0054]; see figure 12) wherein:
the first bar (30 of 12b) comprises a first insert (64 of 12b; see [0054]; see figure 12; see [0060] as discussed above) on the first bar (30 of 12b) between the first end (end of 30 of 12b which comprises 40) and the second end (end of 30 of 12b received within 32; see figure 12); the first insert (64 of 12b) configured to engage with the slot (60; see [0054) of the upper receptacle (32 of 12b) and
the second bar (30 of 12a) comprises a second insert (64; see [0054]; see figure 12) on the second bar (30 of 12a) between the first end (end of 30 of 12a which comprises 40) and the second end (end of 30 of 12b received within 32; see figure 12) the second insert (64 of 12a) configured to engage with the slot (60; see [0054) of the upper receptacle (32 of 12a) for the purpose of overlying the juncture of the slot and the first and second bars when the receptacle is installed on the first and second bars (see [0054]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second bars as disclosed by Mason as now modified by Moore, Dickerson, and Ceriani and to have included the first and second inserts on the first and second bars as taught by Costello in order to have provided an improved engagement between the first and second bars and the slots of the upper and lower receptacles that would add the benefit of providing structures which overly the junctures of the slots and the first and second bars when the upper and lower receptacles are installed on the first and second bars (see [0054]) thereby ensuring no foreign objects which may hinder the operation of the device can enter the slot after installing the first and second bars within the upper and lower receptacles.
Mason as now modified by Moore, Dickerson, Ceriani, and Costello does not explicitly disclose the first and second inserts are “overmolded” on the first and second bars. However, these limitations are drawn to an article of manufacture (by defining the inserts by the process of overmolding), and therefore the limitations are considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, the product-by-process limitation is obvious from the insert of the first and second bars of the device of Mason as now modified by Moore, Dickerson, Ceriani, and Costello as forming the inserts by an overmolding process would not inhibit the design, or function of the inserts as disclosed by Mason as now modified by Moore, Dickerson, Ceriani, and Costello; and thus, the claim is unpatentable even though the prior product was made by a different process.
Claim(s) 10 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mason in view of Moore and Ceriani.
In regards to claim 10, Mason discloses A hinge assembly (39; see [0029]; see figure 1) for a brace (10; see [0022]; see figure 1), the hinge assembly (39) comprising:
a first geared arm assembly (16 and 42; see [0023] and [0029]; see figures 1 and 5) comprising a first gear (42) and a first bar (16), an end (25; see [0023]; see figure 5) of the first bar (16) forms the first gear (42; see figure 5);
a second geared arm assembly (18 and 42; see [0023] and [0029]; see figures 1 and 5) comprising a second gear (42) and a second bar (18), an end (26; see [0023]; see figure 5) of the second bar (18) forms the second gear (42; see figure 5); and
a hinge plate (43; see [0029]; see figure 2), the first geared arm assembly (16 and 42) connected to the hinge plate (43) for rotation about a first axis (axis defined by 40) and the second geared arm assembly (18 and 42) connected to the hinge plate (43) for rotation about a second axis (axis defined by 41), and the first gear (42 of 16) meshingly engaged with the second gear (42 of 18) such that rotation of the first geared arm assembly (16 and 42) causes a corresponding rotation of the second geared arm assembly (18 and 42; due to the intermeshing of upper and lower 42, rotation of the first bar would cause a corresponding rotation of the second bar as claimed);
wherein the first bar (16) and the second bar (18) are flexible in a frontal plane and rigid in a sagittal plane (see [0023]).
Mason does not disclose the brace is a smart brace;
an end of the first bar received within a recess of the first gear, and an end of the second bar received within a recess of the second gear.
However, Moore teaches an brace (200; see [0045]; see figure 2b) comprising an analogous hinge (256; see [0049]; see figure 2b) which comprises an analogous upper arm (252; see [0049]; see figure 3a), and lower arm (254; see [0049]; see figure 3a) wherein the first bar (252) is configured to rotate about a first axis (axis defined by 314; see [0059]; see figure 3a) and the second bar (254) is configured to rotate about a second axis (axis defined by 316; see [0059]; see figure 3a); wherein the brace (200) is a smart brace (256 of 200 comprises a sensor (310); see [0058]; see [0028] that the brace connects with a smart device for communicating data received by the sensor of the hinge; thus, the brace is considered a smart brace comprising a smart hinge) for the purpose of measuring and/or tracking one or more aspects of joint function (see [0058]) and communicating said data to a user’s mobile smart device (See [0028]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hinge of the brace as disclosed by Mason and to have included the sensor of the hinge, and means for the hinge to communicate the data observed by the sensor with the user’s mobile smart device thereby forming a smart brace as taught by Moore in order to have provided an improved brace that would add the benefit of measuring and/or tracking one or more aspects of joint function (see [0058]) and communicating said data to a user’s mobile smart device (See [0028]) thereby monitoring a healing process of the joint over which the brace has been applied, and ensuring the joint is healing properly.
Mason as now modified by Moore still does not disclose an end of the first bar received within a recess of the first gear, and an end of the second bar received within a recess of the second gear.
However, However, Ceriani teaches an analogous hinge (18; see [0040]; see figure 1) comprising an analogous first and second bar (24 and 30; see [0040]; see figure 2) wherein the first and second bar comprise analogous first ends (90 of 24 and 30 respectively; see [0045]; see figure 4) and analogous first and second gears (56 and 58; see [0044]; see figure 2); wherein the first end (90) of the first bar (24) is received within a recess within the first gear (56; see figures 4-6), and the first end (90) of the second bar (30) is received within a recess the second gear (58; see figure 4-6) for the purpose of providing a means to allow the upper and lower support arms to articulate between the first and second positions on the base surfaces of the first and second gear members in a plane perpendicular to the plane of rotation (see [0052]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second gear assemblies as disclosed by Mason as now modified by Moore and to have formed the first and second gears separate from the first ends of the first and second bars, such that the first and second bars are received within a recess of the first and second gears as taught by Ceriani in order to have provided an improved first and second bar engagement of the first and second gears that would add the benefit of providing a means to allow the upper and lower support arms to articulate between the first and second positions on the base surfaces of the first and second gear members in a plane perpendicular to the plane of rotation (see [0052]) thereby, increasing the adjustability of the smart hinge such that the first and second bar can better flex and move with respect to movements of the user’s knee.
In regards to claims 11-13, Mason as now modified by Moore and Ceriani discloses the invention as discussed above.
Mason as now modified by Moore and Ceriani does explicitly wherein each of the first bar and the second bar comprise:
a thickness less than or equal to about 1.0 mm, less than or equal to about 0.75, or less than or equal to about 0.5 mm providing flexibility in the frontal plane; and
a width greater than or equal to about 5.0 mm, greater than or equal to about 7.5 mm, or greater than or equal to about 10 mm providing rigidity in the sagittal plane as required by claims 11, 12, and 13 respectively.
Mason discloses (see [0023]) “the arms 12, 14, 16, 18 each have a relatively larger dimension of width providing substantial inflexibility in the anterior and posterior directions and have a relatively smaller dimension of thickness providing a degree of flexibility in the medial and lateral directions”. Thereby, disclosing that a thickness an