DETAILED ACTION
This action is in response to the Request for Continued Examination (RCE) filed 5/26/2025. Currently, claims 1-16 and 18-20 are pending in the application. Claim 17 is cancelled by Applicant.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/26/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of claim(s) in view of Engelshoven (NL 2016047 B1) have been fully considered and are persuasive. However, upon further consideration and in view of Applicant’s amendment, a new ground(s) of rejection is made in view of Engelshoven (US 2021/0015647 A1).
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-16, 18 and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Engelshoven (US 2021/0015647 A1), with evidence from Phelen et al. (US 2006/0276735).
In regards to claim 1, Engelshoven teaches in Figures 3 and 4, [0019], [0023], [0025], [0033] and [0040] a metacarpus section (palmar wire section 3, palm engaging portion 5), which, when the orthosis (thumb brace is 1) is worn on a hand, extends across metacarpals of digits 2-5 (as shown in Figure 3; note: Figure 3 teaches the varying width B of the palm engaging portion 5, which can increase to a maximum, as taught in [0023]; [0040] teaches “a unitarily integrated palm engaging portion 5 that widens in proximal-distal direction; thus, it is clear that the palm engaging portion 5 is capable of extending across metacarpals of digits 2-5), and a thumb section (portion of thumb wire section 11 defined in the annotated copy of Figure 4 provided below), wherein said thumb section (portion of thumb wire section 11 defined in the annotated copy of Figure 4 provided below) is curved or annular in shape (Figure 4 teaches the thumb section being curved around the user’s thumb) and fits around the proximal phalanx (Tp) of the thumb (T) when worn on the human hand in use (as shown in Figure 4; [0022] teaches “the thumb wire section 11 is configured to receive a proximal phalanx portion Tp of the thumb T”), wherein the thumb section (portion of thumb wire section 11 defined in the annotated copy of Figure 4 provided below) is connected to the metacarpus section (palmar wire section 3, palm engaging portion 5) via (as shown in Figure 3; [0033] teaches “the thenar wire section 12 comprises a first end 12a and a second end 12b, the first end 12a being connected to the palmar wire section 3 at the web point W and the second end 12b being connected to the thumb wire section 11”) a resilient ([0048] teaches “the wire frame 2 of the thumb brace 1 is preferably a metallic or metal alloy wire frame 2, to provide substantial rigidity to the wire frame 2 and in particular allow all wire sections 3, 5, 5a, 5b, 7, 8, 11, 12 to be obtained by shaping/bending the metal or metal alloy wire frame 2 into a desired shape;” a metal alloy is a resilient material, as evidenced by claim 5 of Phelen et al.) thumb metacarpal section (remaining portion of thumb wire section 11 and thenar wire section 12) that, when the orthosis (thumb brace 1) is worn on the hand, extends along and/or around a thumb metacarpal (as shown in Figure 4) such that, when worn on the human hand in use, the wearer can still move his/her thumb by applying force in a certain direction ([0019] teaches that the thumb brace 1 “allows patients to easily pinch the thumb T and index finger I”) and elastically deforming (as taught in [0023] and [0025]) the orthosis (thumb brace 1) and, when the wearer stops applying force, resilience of ([0048] teaches “the wire frame 2 of the thumb brace 1 is preferably a metallic or metal alloy wire frame 2, to provide substantial rigidity to the wire frame 2 and in particular allow all wire sections 3, 5, 5a, 5b, 7, 8, 11, 12 to be obtained by shaping/bending the metal or metal alloy wire frame 2 into a desired shape;” a metal alloy is a resilient material, as evidenced by claim 5 of Phelen et al.) the thumb metacarpal section (remaining portion of thumb wire section 11 and thenar wire section 12) causes the orthosis (thumb brace 1) to return to its rest position (as discussed above, the remaining portion of thumb wire section 11/thenar wire section 12 is made of a resilient material; therefore, a user is capable of applying a force thereagainst to deform the remaining portion of thumb wire section 11/thenar wire section 12, which (due to its resilience) will return to its rest position when the user stops applying force).
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In regards to claim 2, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in Figure 3 and [0033] that the thumb metacarpal section (remaining portion of thumb wire section 11 and thenar wire section 12) is cantilevered to (Figure 3 teaches the thenar wire section 12 being connected to the palmar wire section 3 at only one end (first end 12a); [0033] teaches “the first end 12a being connected to the palmar wire section 3 at the web point W”) the metacarpus section (palmar wire section 3, palm engaging portion 5).
In regards to claim 3, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in figure 4 that the thumb metacarpal section (remaining portion of thumb wire section 11 and thenar wire section 12) extends helically (Figure 4 teaches the remaining portion of thumb wire section 11 that extends from the “thumb section” defined in the annotated copy of Figure 4 provided above having a winding, spiral shape) between (as shown in Figures 3 and 4; [0033] teaches “the first end 12a being connected to the palmar wire section 3 at the web point W”) the metacarpus section (palmar wire section 3, palm engaging portion 5) and the thumb section (portion of thumb wire section 11 defined in the annotated copy of Figure 4 provided above).
In regards to claim 4, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in Figures 3 and 4 that, when the orthosis (thumb brace 1) is worn on the hand, a reaction force on the thumb section (portion of thumb wire section 11 defined in the annotated copy of Figure 4 provided above) is proportional to movement of the thumb (the thumb brace 1 is shown in Figures 3 and 4 to be configured such that a reaction force on the thumb section is capable of being proportional to the movement of the thumb, depending on the anatomy of a particular user).
In regards to claim 6, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in Figures 3 and 4 that, when the orthosis (thumb brace 1) is worn on the hand, the thumb metacarpal section (remaining portion of thumb wire section 11 and thenar wire section 12) extends over the palmar side of the metacarpophalangeal joint (Figures 3 and 4 teach that the remaining portion of thumb wire section 11/thenar wire section 12 is capable of extending over the palmar side of the metacarpophalangeal joint depending on the anatomy of a particular user).
In regards to claim 7, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in [0033], [0038] and Figure 3 that when the orthosis (thumb brace 1) is worn on the hand, a connection (at first end 12a) between ([0033] teaches “the first end 12a being connected to the palmar wire section 3”) the thumb metacarpal section (remaining portion of thumb wire section 11 and thenar wire section 12) and the metacarpus section (palmar wire section 3, palm engaging portion 5) is located on a dorsal side of the hand ([0038] teaches the thumb brace 1 being made of a bendable material; thus, the thumb brace 1 is capable of being bent around a user’s hand such that the first end 12a connects the palmar wire section 3/palm engaging portion 5 at a location on a dorsal side of the hand, depending on the size of the user’s hand).
In regards to claim 8, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in Figure 4 that the thumb section (portion of thumb wire section 11 defined in the annotated copy of Figure 4 provided above) comprises an open loop (inasmuch as the defined thumb section is an curved structure that forms an incomplete, or open, loop).
In regards to claim 9, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in Figure 3, [0020] and [0023] that the metacarpus section (palmar wire section 3, palm engaging portion 5), when the orthosis (thumb brace 1) is worn on the hand (as shown in Figure 3), extends on a palmar side of the hand (as shown in Figure 3; [0020] teaches “a palmar wire section 3 which is configured/bent to extend in lateral direction from a web point W thereof between a thumb T and index finger I along a palmar region 4 of the hand;” [0023] teaches “the palmar wire section 3 comprises a palm engaging portion 5”).
In regards to claim 10, Engelshoven teaches the apparatus of claims 9 and 10. Engelshoven teaches in Figure 3 that the metacarpus section (palmar wire section 3, palm engaging portion 5) extends proximal to (near) the MCP joints of digits 2 to 5 when the orthosis (thumb brace 1) is worn on the hand (as shown in Figure 3).
In regards to claim 11, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in Figures 3 and 4, [0040] and [0042] that the orthosis (thumb brace 1) is made from a single piece (as shown in Figures 3 and 4, all portions of the thumb brace 1 are connected to form a single unit; [0040] teaches “the wire frame 2 may be a single, unitary component, i.e. the palmar wire section 3, the ulnar wire section 7, the radial wire section 8 and the thumb wire section 11 may form a single, unitary component forming a unitary wire frame 2;” [0042] teaches “the thumb brace 1, and in particular the entire wire frame 2, may be moulded as a unitary component”).
In regards to claim 12, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in [0038] and [0042] that the orthosis (thumb brace 1) is made from a single and/or homogenous material ([0038] teaches “the wire frame 2 of the thumb brace 1 is preferably a metallic or metal alloy wire frame 2, to provide substantial rigidity to the wire frame 2 and in particular allow all wire sections 3, 5, 5a, 5b, 7, 8, 11, 12 to be obtained by shaping/bending the metal or metal alloy wire frame 2 into a desired shape;” [0042] teaches “the thumb brace 1, and in particular the entire wire frame 2, may be moulded as a unitary component so that the production process is simplified and manufacturing costs are lowered, wherein a metallic (e.g. silver) or plastic moulding material may be used”) or from a composite material and/or comprises sections of a softer material and/or of a material in a different color.
In regards to claim 13, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in Figure 3 and [0023] that the width (varying width B) and/or the thickness (Figure 3 teaches the thumb brace 1 having a thickness) of the orthosis (thumb brace 1) varies along its length (Figure 3 teaches the varying width B along the length of palm engaging portion 5; [0023] teaches “the widening of the palm engaging portion 5 is a local widening along the palmar region 4, wherein a varying width B of the palm engaging portion 5 increases to a maximum and subsequently decreases as seen from the radial side RS to the ulnar side US of the hand, or vice versa” and “the varying width B of the palm engaging portion 5 attains a maximum approximately near the middle of or halfway the palm engaging portion 5”).
In regards to claim 14, Engelshoven teaches the apparatus of claims 1 and 13. Engelshoven does not teach that the width is in a range of from 3 mm to 50 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the width is in a range of from 3 mm to 50 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the width could be varied in order to most comfortably and/or appropriately accommodate the anatomy of a specific individual.
In regards to claim 15, Engelshoven teaches the apparatus of claims 1 and 13. Engelshoven does not teach that the thickness is in a range of from 1 mm to 15 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the thickness is in a range of from 1 mm to 15 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the thickness could be varied in order to most comfortably and/or appropriately accommodate the anatomy of a specific individual.
In regards to claim 16, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches that , when worn on the hand, the orthosis (thumb brace 1) also restricts motion of the metacarpophalangeal joint of the thumb ([0004] teaches the thumb brace 1 functions “to support the thumb for cases of e.g. MP hyperextension, CMC joint arthritis and/or excessive CMC flexion,” which is a restriction of motion of the metacarpophalangeal joint of the thumb).
In regards to claim 18, Engelshoven teaches the apparatus of claims 1 and 3. Engelshoven teaches in Figures 3 and 4 that the thumb metacarpal section (remaining portion of thumb wire section 11 and thenar wire section 12) extends helically (Figure 4 teaches the remaining portion of thumb wire section 11 that extends from the “thumb section” defined in the annotated copy of Figure 4 provided above having a winding, spiral shape) between (as shown in Figures 3 and 4; [0033] teaches “the first end 12a being connected to the palmar wire section 3 at the web point W”) the metacarpus section (palmar wire section 3, palm engaging portion 5) and the thumb section (portion of thumb wire section 11 defined in the annotated copy of Figure 4 provided above) over at least 180° (Figure 4 teaches the remaining portion of thumb wire section 11 that extends from the “thumb section” defined in the annotated copy of Figure 4 provided above having a winding, spiral shape over approximately 360°).
In regards to claim 20, Engelshoven teaches the apparatus of claims 1 and 11. Engelshoven teaches in [0020-0022] and [0042] that the orthosis (thumb brace 1) is made from a plastically deformed ([0020-0022] teaches the wire frame 2 being “bent” to form thumb brace 1) plate, strip or bar (wire frame 2; wire is understood to be formed as a strip or bar of material), or a continuous molded ([0042] teaches “the thumb brace 1, and in particular the entire wire frame 2, may be moulded as a unitary component”) or 3D printed, element.
Claim 20 limitation “made from a plastically deformed plate, strip or bar, or a continuous molded or 3D printed, element” is a product-by-process claim limitation. “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) (citations omitted).
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.
Claim(s) 5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelshoven (US 2021/0015647 A1).
In regards to claim 5, Engelshoven teaches the apparatus of claim 1. Engelshoven teaches in [0005] that, when the orthosis (thumb brace 1) is worn on the hand, motion of the thumb (T) is restricted ([0004] teaches the thumb brace 1 functions “to support the thumb for cases of e.g. MP hyperextension, CMC joint arthritis and/or excessive CMC flexion,” which is a restriction of undesirable motion of the thumb).
Engelshoven does not explicitly teach that the motion of the thumb is restricted to a percentage in a range of from 5% to 95%, of the wearer’s total range of motion.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the motion of the thumb is restricted to a percentage in a range of from 5% to 95%, of the wearer’s total range of motion, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the percentage of restriction of the range of motion of the thumb could be varied in order to best suite a particular treatment plan or the comfort of an individual user.
In regards to claim 19, Engelshoven teaches the apparatus of claims 1 and 3. Engelshoven teaches in [0005] that, when the orthosis (thumb brace 1) is worn on the hand, motion of the thumb (T) is restricted ([0004] teaches the thumb brace 1 functions “to support the thumb for cases of e.g. MP hyperextension, CMC joint arthritis and/or excessive CMC flexion,” which is a restriction of undesirable motion of the thumb).
Engelshoven does not explicitly teach that the motion of the thumb is restricted to a percentage in a range from 40% to 60%.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the motion of the thumb is restricted to a percentage in a range from 40% to 60%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the percentage of restriction of the range of motion of the thumb could be varied in order to best suite a particular treatment plan or the comfort of an individual user.
Conclusion
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 1/8/2026