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
1. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 05/01/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statement is being considered by the examiner.
Response to Amendment
3. The amendment filed 02/23/2026 has been entered. Currently, claims 1-17 remain pending in the application. Independent claims 1 and 4 were amended by the Applicant without the addition of new matter to include further narrowing limitations. Additionally, claim 1 was amended to correct previous claim objections that were set forth in the Non-Final Office Action mailed 10/23/2025. Lastly, new claim objections are recited below.
Response to Arguments
4. Applicant’s amendment to independent claims 1 and 4 is sufficient to overcome the previous 35 USC § 103 rejection recited in the Non-Final Office Action mailed 10/23/2025.
Applicant’s arguments, see Remarks on Pages 6-8, filed 02/23/2026, with respect to the rejection under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, the amended claims have changed the scope of the claims and upon further consideration, a new grounds of rejection is made in view of new and current prior art of the record: De Koning et al. (U.S. Patent Pub. No. 20220331140) , Kania (U.S. Patent Pub. No. 20050119595), Malewicz et al. (U.S. Patent No. 5437619), Tentorio (EP 3034052 B1), and Arluck (U.S. Patent No. 4006741).
5. Applicant makes the argument “unlike the requirements of the claims as amended, none of
elements 30, 38, 48 and 56 can be adjusted in length. Hence, there is in fact no tensioning is
described by Davison, and thus no tensioning element, much less one that changes in length
as required in the claims. Even if one would assume the effective length of any of the parts of the supposed tensioning element to be adjustable in length, such an adjustment would lead to a force
exerted on the tabs and the shell that does not act in the proximal direction as required in the
claims as amended. That is, any tensioning would not be upwards in Fig. 3 and 6 but
laterally to the left in Fig. 3 and to the right in Fig. 6. Kanai does not make up for any of the deficiencies of Davison. Furthermore, Kanai describes an orthosis, which has the opposite effect to what is required and claimed in the claims as amended. It can be seen from Fig. 2 of Kanai, that tensioning the tensioning
element 20 (and 21, 44, 58) would result in a force acting downward (in the distal direction). The position that Davison's structure 32 compares to the present claims' "dimensionally stable shell" is not reasonable. Read in view of this application's specification and drawings, a POSITA would understand "dimensionally stable" to include stability with respect to the wearer's upper arm and Davison's structure 32, for reasons including its band-shape and the width of the band, appears susceptible to movement, e.g., rotation such that the tensile force direction would not be stably aligned in the proximal direction. Modifying Davison to have a tensioner that operates by actuated shortening of is
effective length would clearly produce a fundamental change in Davison's principle of
operation (POA). In sharp contrast to the claimed invention, Davison's POA comprises an
elastic element that increases its tension in response to being stretched. Even if a fundamental change to Davison's principle of operation were permissible in considering obviousness (which the applicant does not concede), the Examiner's rationale does not appear to consider the substantial complexity of modifying Davison to have a dimensionally stable shell with a dorsal tab and ventral tab, (which Davison lacks), and to employ a tensioning element that features actuatable shortening of its effective length, together with an actuator for shortening such an element, in place of Davison's differently purposed and
directed arm movement stretching of its elastic cord 56” (Remarks, Page 7, Paragraphs 4-6 and Page 8, Paragraphs 1-2).
In response to Applicant’s argument (Remarks, Page 7, Paragraphs 4-6 and Page 8, Paragraphs 1-2), , Davison is no longer a primary reference as given by Applicant’s new amendment of the “proximal direction” shortening tensioning distance, so that argument is moot. However, Davison may still be applicable as a secondary reference later on for teaching the (Col. 3, lines 60-67) “the net effect of the pulley/lever system is to sense arm elevation and increase the tension in the elastic member 56 as the arm is elevated. This effectively compensates for the natural shortening of the distance between support plates 24 and 26 and the arm pulley housing 38 to provide support of arm elevation function throughout the range of motion”. Similarly, Applicant’s Page 9, Lines 27-32 recites “the tensioning cord is wound up on a spindle or a coil, for example, and its effective length, i.e. especially the distances between the actuation element and its spindle or coil on the one hand and the positions at which the tensioning cord is connected to the respective tab, thus reduced. This results in a tensile force being exerted on the tab and thus on the dimensionally stable shell of the orthosis. In a preferred embodiment, the tensioning cord is guided through a guide loop on the ventral tab and/or a guide loop on the dorsal tab. This allows for an especially simple fastening and connection between the respective tab and the tensioning cord, which can be made to be especially simple in terms of design. In a preferred embodiment the tensioning cord is guided over at least one deflection pulley, especially preferably over multiple deflection pulleys.” Therefore, Davison is providing an analogous “positions at which the tensioning cord is connected to the respective tab, thus reduced”, even though not exactly proximally directed. Additionally, Davison’s structure 32 is dimensionally stable by being described as semi rigid supporting the user’s arm (Col. 3, line 36). Lastly, Figure 2 of Kania is not relied upon, rather the relied upon embodiment is in Figures 26-27, which shows the ventral/anterior 256 and dorsal/posterior tabs 256 with a similar shoulder connection bridge 258 extending over the shoulder, which thereby provides a proximal superior to inferior connection over the shoulders between the tabs.
6. Overall, Examiner notes that Applicant may further overcome the new and current prior art of record below by amending the claims, such as with positive limitations, i.e. --the tabs also configured to extend proximally above the shoulder--, or that the –tension is applied on the projections of the reinforcement--, or shell and reinforcement projection materials, or removing “or” phrases in the claims, or changing “at least one” to –both--; and other negative limitations, i.e. –not—or –without-- to teach away from the prior art such as location of the cross body strap 18 anchor point; and transitional phrases such as –consisting/essentially of—in the preamble and/or body to prevent combination of references.
Claim Objections
7. Claims 3-4 are objected to because of the following informalities:
In claim 3, line 3, rephrase “a structure or portion of a structure” to read –a portion of a structure--.
In claim 4, lines 22-23, rephrase “an upper arm” to read –the upper arm--.
Appropriate correction is required.
Claim Interpretation
8. The phrase “dimensionally stable” in claims 1 and 4 is interpreted as not made of a simple textile which collapses (Specification, Page 7, line 2).
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “tensioning element” in claims 1 and 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The term “element” followed by functional language is a generic placeholder for the phrase “means for”. For examination purposes, “tensioning element” in claims 1 and 4 is interpreted as a cord and/or strap (Page 9, lines 4-20).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-7 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over De Koning et al. (U.S. Patent Pub. No. 20220331140) in view of Kania (U.S. Patent Pub. No. 20050119595).
Regarding claim 1, De Koning discloses a method for fastening an orthosis 1 (Paragraphs 37-41 and Figures 1-2, orthosis 1 with arm support 4 having actuator spool 9 to tension proximally extending tension wires 7,8 from an anterior/ventral/bicep area over the user’s shoulder on shoulder pad strap 2 and to the posterior/dorsal/triceps area. Thereby, there is a changing the effective length of the wire 7,8 from the ventral to dorsal sides of the arm support 4 in order to provide support the user’s arm and shoulder) to an upper arm, the orthosis 1 comprising a an arm support 4 with a ventral side and a dorsal side, and a tensioning element 2,7,8 (Paragraphs 37-41 and Figures 1-2, tension wire 7,8, spool 9, and shoulder pad strap 2; this is the structure as defined by the 35 USC 112f analysis above) that is configured: to connect the ventral side and the dorsal side to one another with a connection 2,7,8 having an effective length and to exert, based at least in part on the effective length being within a tensioning range, a tensile force on the arm support 4, wherein the tensile force is directed in a proximal force direction and is exerted on the ventral side and is exerted, concurrently (Paragraphs 37-41 and Figures 1-2, force of spool 9 applied concurrently throughout wires 7,8 with guide 10 on dorsal side), on the dorsal side, and to alter the effective length, in response to input from a user, from a current effective length to a new effective length, and is further configured such that, when the current effective length and the new effective length are within the tensioning range, a magnitude of the tensile force increases in response to the new effective length being shorter than the current effective length, the method comprising: applying the arm support 4 with the tensioning element 2,7,8 to an upper arm, to a position wherein the tensile force direction of the tensioning element is directed in a proximal direction relative to a shoulder of the upper arm, and tensioning the tensioning element 2,7,8, commencing with the effective length at a commencement value and ending with the effective length being at a tensioned value that is within the tensioning range shorter than the commencement value, said tensioning being responsive to one or more instances of input of the user for altering of the effective length, said tensioning causing the tensile force to be exerted on the ventral side and on the dorsal side at a tensioned magnitude, said tensile force acting in said proximal direction.
However, de Koning fails to explicitly the disclose the arm support is a dimensionally stable shell with a ventral tab and dorsal tab.
Kania an analogous orthosis 201 (Paragraph 83 and Figure 26, shoulder brace 201) wherein the analogous arm support (Paragraphs 83-84 and Figure 26, rigid stable upper arm shell 256 extending vertically on lateral side of arm and having separate horizontally extending anterior/ventral and posterior/dorsal tabs) is a dimensionally stable shell with an analogous ventral side having a ventral tab and an analogous dorsal side having a dorsal tab; with a similar proximal extending shoulder bridge 258 configured over the user’s shoulder connecting the ventral and dorsal tabs together.
PNG
media_image1.png
926
630
media_image1.png
Greyscale
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a shape and material of the arm support with the dorsal and ventral sides of de Koning, so that the arm support is a dimensionally stable shell with a ventral tab and dorsal tab, as taught by Kania, in order to provide an improved orthosis with an enhanced arm support having ventral and dorsal sides formed as separated tabs that extend all the way to the ventral/anterior and dorsal/posterior side of a user’s arm for desirable increased brace support and upper arm coverage via the tabs and rigid shell material (Kania, Paragraphs 83-84).
Regarding claim 2, the combination of de Koning in view of Kania discloses the invention as described above and further discloses connecting the tensioning element 2,7,8 (de Koning, Paragraphs 37-41 and Figures 1-2, the ventral and dorsal sides of arm support 4 are initially worn untightened and then the tensioning mechanism 2,7,8 is tightened via spool 9) to the ventral tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraphs 83-84 and Figures 26-27) and the dorsal tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraphs 83-84 and Figures 26-27) before the tensioning the tensioning element 2,7,8 (de Koning, Paragraphs 37-41 and Figures 1-2).
Regarding claim 3, the combination of de Koning in view of Kania discloses the invention as described above and further discloses the tensioning element 2,7,8 (de Koning, Paragraphs 37-41 and Figures 1-2) is further configured such that when the ventral tab (Da de Koning, Paragraphs 37-41 and Figures 1-2,; Kania, Paragraph 83 and Figure 26) and the dorsal tab (de Koning, Paragraphs 37-41 and Figures 1-2,; Kania, Paragraph 83 and Figure 26) are connected to each other, a portion of a structure of the tensioning element extends above the shoulder of the upper arm (de Koning, Paragraphs 37-41 and Figures 1-2, the ventral and dorsal sides of arm support 4 are connected by tensioning mechanism 2,7,8 located at superior portion of user’s shoulder) .
Regarding claim 4, De Koning discloses an orthosis 1 (Paragraphs 37-41 and Figures 1-2, orthosis 1 with arm support 4 having actuator spool 9 to tension proximally extending tension wires 7,8 from an anterior/ventral/bicep area over the user’s shoulder on shoulder pad strap 2 and to the posterior/dorsal/triceps area. Thereby there is a changing the effective length of the wire 7,8 from the ventral to dorsal sides of the arm support 4 in order to provide support the user’s arm and shoulder) to an upper arm, the orthosis 1 comprising a an arm support 4 with a ventral side and a dorsal side, and a tensioning element 2,7,8 (Paragraphs 37-41 and Figures 1-2, tension wire 7,8, spool 9, and shoulder pad strap 2; this is the structure as defined by the 35 USC 112f analysis above) for applying a tensile force on the dorsal side and on the ventral side, wherein the tensile force is adjustable by tensioning the tensioning element 2,7,8, wherein the tensioning element 2,7,8 that is configured: to connect the ventral side and the dorsal side to one another with a connection 2,7,8 having an effective length and to exert, based at least in part on the effective length being within a tensioning range, a tensile force on the arm support 4, wherein the tensile force is directed in a proximal force direction and is exerted on the ventral side and is exerted, concurrently (Paragraphs 37-41 and Figures 1-2, force of spool 9 applied concurrently throughout wires 7,8 with guide 10 on dorsal side), on the dorsal side, and to alter the effective length, in response to input from a user, from a current effective length to a new effective length, and is further configured such that, when the current effective length and the new effective length are within the tensioning range, a magnitude of the tensile force increases in response to the new effective length being shorter than the current effective length, and wherein the orthosis 1 is configured for fastening to an upper arm of a subject by applying the arm support 4 with the tensioning element 2,7,8 to the upper arm, to a position wherein the tensile force direction of the tensioning element is directed in a proximal direction relative to a shoulder of the upper arm, and tensioning the tensioning element 2,7,8, commencing with the effective length at a commencement value and ending with the effective length being at a tensioned value that is within the tensioning range shorter than the commencement value, said tensioning being responsive to one or more instances of input of the user for altering of the effective length, said tensioning causing the tensile force to be exerted on the ventral side and on the dorsal side at a tensioned magnitude, said tensile force acting in said proximal direction.
However, de Koning fails to explicitly the disclose the arm support is a dimensionally stable shell with a ventral tab and dorsal tab.
Kania an analogous orthosis 201 (Paragraph 83 and Figure 26, shoulder brace 201) wherein the analogous arm support (Paragraphs 83-84 and Figure 26, rigid stable upper arm shell 256 extending vertically on lateral side of arm and having separate horizontally extending anterior/ventral and posterior/dorsal tabs) is a dimensionally stable shell with an analogous ventral side having a ventral tab and an analogous dorsal side having a dorsal tab; with a similar proximal extending shoulder bridge 258 configured over the user’s shoulder connecting the ventral and dorsal tabs together.
PNG
media_image1.png
926
630
media_image1.png
Greyscale
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a shape and material of the arm support with the dorsal and ventral sides of de Koning, so that the arm support is a dimensionally stable shell with a ventral tab and dorsal tab, as taught by Kania, in order to provide an improved orthosis with an enhanced arm support having ventral and dorsal sides formed as separated tabs that extend all the way to the ventral/anterior and dorsal/posterior side of a user’s arm for desirable increased brace support and upper arm coverage via the tabs and rigid shell material (Kania, Paragraphs 83-84).
Regarding claim 5, the combination of de Koning in view of Kania discloses the invention as described above and further discloses wherein the tensioning element 2,7,8 (de Koning, Paragraphs 37-41 and Figures 1-2) comprises a strap 2 (de Koning, Paragraphs 37-41 and Figures 1-2, shoulder pad strap 2 fastened to dorsal and ventral sides of arm support 4 via tension wires 7,8 with spool 9 and guide 10) fastened or fastenable at a first end to either the ventral tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraph 83 and Figure 26) or the dorsal tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraphs 83-84 and Figures 26-27), and wherein the dorsal tab (de Koning, Paragraphs 37-41 and Figures 1-2, dorsal tab with guide loop 10; Kania, Paragraphs 83-84 and Figures 26-27) comprises a guide loop 10 (de Koning, Paragraphs 37-41 and Figures 1-2), wherein the orthosis 1 (de Koning, Paragraphs 37-41 and Figures 1-2) is configured such that the tensioning element 2,7,8 (de Koning, Paragraphs 37-41 and Figures 1-2) is guided through the respective guide loop 10 (de Koning, Paragraphs 37-41 and Figures 1-2) of the dorsal tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraphs 83-84 and Figures 26-27) when the tensioning element 2,7,8 (de Koning, Paragraphs 37-41 and Figures 1-2) is connected to the ventral tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraph 83 and Figure 26) and the dorsal tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraph 83 and Figure 26).
Regarding claim 6, the combination of de Koning in view of Kania discloses the invention as described above and further discloses wherein the tensioning element 2,7,8 (de Koning, Paragraphs 37-41 and Figures 1-2) comprises has a tensioning cord 7,8 (de Koning, Paragraphs 37-41 and Figures 1-2, changing the effective length of the wire 7,8 from the ventral to dorsal sides of the arm support 4 in order to provide support the user’s arm and shoulder) connected to the ventral tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraph 83 and Figure 26) and the dorsal tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraph 83 and Figure 26), the tensioning cord 7,8 (de Koning, Paragraphs 37-41 and Figures 1-2) having an effective cord length, wherein the effective length of the connection comprises the an effective cord length of the tensioning cord 7,8 (de Koning, Paragraphs 37-41 and Figures 1-2), and the tensioning element 2,7,8 (de Koning, Paragraphs 37-41 and Figures 1-2) is further configured such that the effective cord length is alterable.
Regarding claim 7, the combination of de Koning in view of Kania discloses the invention as described above and further discloses wherein the tensioning cord 7,8 (de Koning, Paragraphs 37-41 and Figures 1-2, cords 7,8 through guide loop 10 on dorsal side) is guided through at least one loop 10 (de Koning, Paragraphs 37-41 and Figures 1-2) on the dorsal tab (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraph 83 and Figure 26).
Regarding claim 15, the combination of de Koning in view of Kania discloses the invention as described above and further discloses wherein a geometric form of the dimensionally stable shell 256 (Kania, Paragraphs 83-84 and Figures 26-27, rigid dimensionally stable frame 256 on upper arm) is adapted to the upper arm (de Koning, Paragraphs 37-41 and Figures 1-2; Kania, Paragraph 83 and Figure 26).
Regarding claim 16, the combination of de Koning in view of Kania discloses the invention as described above but fails to explicitly disclose padding element that is arranged on a side of the dimensionally stable shell facing the upper arm.
Kania further teaches padding element (Paragraph 84 and Figure 26, padding 252,254 on inner surface of shell 256) that is arranged on a side of the analogous dimensionally stable shell 256 facing the upper arm.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the shell of de Koning in view of Kania, so that there is a padding element arranged on a side of the dimensionally stable shell facing the upper arm, as taught by Kania, in order to provide an improved orthosis with an enhanced shell having interior skin facing padding for increased user comfort during extending wear and throughout increased tightening without pressure point build ups against the upper arm (Kania, Paragraph 84).
Regarding claim 17, the combination of de Koning in view of Kania discloses the invention as described above and further discloses wherein said padding element (Kania, Paragraphs 84, 109, and Figure 26, padding 252,254 comprising nylon material wherein a silver-impregnated fabric is construed as textile padding) is comprised of a textile.
14. Claims 8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over De Koning et al. (U.S. Patent Pub. No. 20220331140) in view of Kania (U.S. Patent Pub. No. 20050119595), as applied to claim 4, and in further view of Malewicz et al. (U.S. Patent No. 5437619).
Regarding claim 8, the combination of de Koning in view of Kania discloses the invention as described above but fails to explicitly disclose a reinforcement element arranged on the dimensionally stable shell.
Malewicz teaches an analogous orthosis 10 (Col. 2, lines 54-65, Col. 3, lines 1-20, and Figure 1, dynamic range-of-motion splint 10 with upper arm shell and reinforcement element 22 thereon) wherein a reinforcement element 22 arranged on the analogous dimensionally stable shell (Figure 1, upper arm shell wherein reinforcement element 22 is attached by 24).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the shell of de Koning in view of Kania, so that there is a reinforcement element arranged on the dimensionally stable shell, as taught by Malewicz, in order to provide an improved orthosis with an enhanced shell having a reinforcement element providing increased stiffness and support to the shell at the upper arm, while also accommodating a rail hinge for the elbow joint (Malewicz, Col. 2, lines 54-65 and Col. 3, lines 1-20).
Regarding claim 11, the combination of de Koning in view of Kania in view of Malewicz discloses the invention as described above and further discloses the dimensionally stable shell 256 (Kania, Paragraphs 83-84 and Figures 26-27) and the reinforcement element 22 (Malewicz, Col. 2, lines 54-65, Col. 3, lines 1-20, and Figure 1, reinforcement 22 on upper arm shell) are configured to have an element of an orthopedic rail system 20 (Malewicz, Col. 2, lines 54-65, Col. 3, lines 1-20, and Figure 1, rail 20 fastened to reinforcement 22) fastened thereto.
Regarding claim 12, the combination of de Koning in view of Kania discloses the invention as described above but fails to explicitly disclose an orthopedic rail system fastened to the dimensionally stable shell or a reinforcement element arranged on the dimensionally stable shell, wherein the orthopedic rail system comprises at least one body contact element configured to be applied to a lower arm and/or a hand.
Malewicz teaches an analogous orthosis 10 (Col. 2, lines 54-65, Col. 3, lines 1-20, and Figure 1, dynamic range-of-motion splint 10 with upper arm shell and reinforcement element 22 thereon that connects to an orthopedic rail system 20,26,16,30) wherein an orthopedic rail system 20,26,16,30,12 fastened to the analogous dimensionally stable shell (Figure 1, upper arm shell wherein reinforcement element 22 is attached by 24and a reinforcement element 22 arranged on the analogous dimensionally stable shell, wherein the orthopedic rail system20,26,16,30 comprises at least one body contact element 130,132 (Col. 2, lines 54-65, Col. 3, lines 1-20, and Figure 1, forearm body contact 130,132 of 12) configured to be applied to a lower arm and/or a hand.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the shell of de Koning in view of Kania, so that there is an orthopedic rail system fastened to the dimensionally stable shell and a reinforcement element arranged on the dimensionally stable shell, wherein the orthopedic rail system comprises at least one body contact element configured to be applied to a lower arm and/or a hand, as taught by Malewicz, in order to provide an improved orthosis with an enhanced shell having a connecting reinforcement member for increased support as well as an attached joint range of motion rail system for desirable pivoting relative to a lower arm contact for desirable motion control and support therethrough (Malewicz, Col. 2, lines 54-65 and Col. 3, lines 1-20,).
Regarding claim 13, the combination of de Koning in view of Kania discloses the invention as described above but fails to explicitly disclose an orthopedic rail system fastened to the dimensionally stable shell or a reinforcement element arranged on the dimensionally stable shell, wherein the orthopedic rail system comprises at least two element that are arrange together by means of a joint.
Malewicz teaches an analogous orthosis 10 (Col. 2, lines 54-65, Col. 3, lines 1-20, and Figure 1, dynamic range-of-motion splint 10 with upper arm shell and reinforcement element 22 thereon that connects to an orthopedic rail system 20,26,16,30) wherein an orthopedic rail system 20,26,16,30,12 fastened to the analogous dimensionally stable shell (Figure 1, upper arm shell wherein reinforcement element 22 is attached by 24and a reinforcement element 22 arranged on the analogous dimensionally stable shell, wherein the orthopedic rail system20,26,16,30 comprises two elements 20,26 that are arranged together by means of a joint 16.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the shell of de Koning in view of Kania, so that there is an orthopedic rail system fastened to the dimensionally stable shell and a reinforcement element arranged on the dimensionally stable shell, wherein the orthopedic rail system comprises at least two element that are arrange together by means of a joint, as taught by Malewicz, in order to provide an improved orthosis with an enhanced shell having a connecting reinforcement member for increased support as well as an attached joint range of motion rail system for desirable pivoting relative to a lower arm contact for desirable motion control and support therethrough (Malewicz, Col. 2, lines 54-65 and Col. 3, lines 1-20).
Regarding claim 14, the combination of de Koning in view of Kania discloses the invention as described above but fails to explicitly disclose an orthopedic rail system fastened to the dimensionally stable shell or a reinforcement element arranged on the dimensionally stable shell, and at least one actuator is arranged on the rail system, wherein said at least one actuation is configured to move an element of the orthopedic rail system relative to another element of the orthopedic rail system.
Malewicz teaches an analogous orthosis 10 (Col. 2, lines 54-65, Col. 3, lines 1-20, and Figure 1, dynamic range-of-motion splint 10 with upper arm shell and reinforcement element 22 thereon that connects to an orthopedic rail system 20,26,16,30) wherein an orthopedic rail system 20,26,16,30,12 fastened to the analogous dimensionally stable shell (Figure 1, upper arm shell wherein reinforcement element 22 is attached by 24and a reinforcement element 22 arranged on the analogous dimensionally stable shell, and at least one actuator 96 (Col. 4, lines 21-22 and Fig. 7, lever actuator 96 of pivoting joint 16) is arranged on the rail system 20,26,16,30,12, wherein said at least one actuator 96 is configured to move an element 20 of the orthopedic rail system 20,26,16,30,12 relative to another element 26 of the orthopedic rail system 20,26,16,30,12.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the shell of de Koning in view of Kania, so that there is an orthopedic rail system fastened to the dimensionally stable shell and a reinforcement element arranged on the dimensionally stable shell, and at least one actuator is arranged on the orthopedic rail system, said at least one actuation is configured to move an element of the rail system relative to another element of the rail system, as taught by Malewicz, in order to provide an improved orthosis with an enhanced shell having a connecting reinforcement member for increased support as well as an attached joint range of motion rail system for desirable pivoting relative to a lower arm contact for desirable motion control and support therethrough via adjustable actuation user control (Malewicz, Col. 2, lines 54-65 and Col. 3, lines 1-20).
15. Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over De Koning et al. (U.S. Patent Pub. No. 20220331140) in view of Kania (U.S. Patent Pub. No. 20050119595) in view of Malewicz et al. (U.S. Patent No. 5437619), as applied to claim 8, and in further view of Arluck (U.S. Patent No. 4006741).
Regarding claim 9, the combination of de Koning in view of Kania in view of Malewicz discloses the invention as described above but fails to explicitly disclose the reinforcement element comprises at least one material selected from the group consisting of metal, plastic, and a fiber-reinforced plastic, plastic, or combinations thereof.
Arluck teaches an analogous orthosis 16 (Col. 9, lines 15-16, Col. 14, lines 23-27 and Figure 4, arm splint 16) wherein the analogous reinforcement element (Col. 9, lines 15-16, Col. 14, lines 23-27 and Figure 4, additional strips or pieces of plastic sheet may be fixed to the outside surface to reinforce the device) is made of a plastic.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a material of the reinforcement element of de Koning in view of Kania in view of Malewicz, so that the reinforcement element is made of a plastic, as taught by Arluck, in order to provide an improved orthosis with an enhanced reinforcement element that is positioned externally of the shell with desirable plastic material for desirable thickness support at desirable brace shell locations (Arluck, Col. 9, lines 15-16 and Col. 14, lines 23-27).
16. Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over De Koning et al. (U.S. Patent Pub. No. 20220331140) in view of Kania (U.S. Patent Pub. No. 20050119595) in view of Malewicz et al. (U.S. Patent No. 5437619), as applied to claim 8, and in further view of Tentorio (EP 3034052 B1).
Regarding claim 10, the combination of de Koning in view of Kania in view of Malewicz discloses the invention as described above but fails to explicitly disclose the reinforcement element comprises one or more projections arranged on the dorsal tab and/or the ventral tab.
Tentorio teaches an analogous orthosis wherein the analogous reinforcement element 11 (Page 3/22, Paragraph 11, and Figures 1-2, external layer 11 provides projecting reinforcement and support on anterior /ventral and dorsal/posterior sides of the shell 1) comprises projections arranged on the analogous dorsal tab (Page 3/22, Paragraph 11, and Figures 1-2, posterior/dorsal tab side of shell 1) and the analogous ventral tab (anterior ventral tab side of shell 1).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a shape of the reinforcement element on the shell of de Koning in view of Kania in view of Malewicz, so that the reinforcement element comprises projections arranged on the dorsal tab and the ventral tab, as taught by Tentorio, in order to provide an improved orthosis with an enhanced reinforcement member shape that spans towards the ventral and dorsal tab for increased external layered support thereat, which increases upper arm support and braced motion (Tentorio, Page 3/22, Paragraph 11).
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 Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached on +1(571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL MILO/
Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786