DETAILED ACTION
This is a Non-Final Rejection for non-provisional application 17/984,101 filed November 9th 2022, which claims benefit from provisional application 63/279,650 filed November 15th 2021. Claims 1-12, 14 and 16-20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 12, 2025 has been entered.
Response to Amendment
The examiner acknowledges the amendment filed December 12, 2025.
The 112(b) rejection of claim 14 indicated in the action filed September 12, 2025 has been overcome by amendment and is hereby withdrawn.
The 112(d) rejection of claim 2 indicated in the action filed September 12, 2025 has been overcome by amendment and is hereby withdrawn.
The amendments to claims 1, 12 and 20 change the scope of the claims. Therefore, new grounds of rejection are presented below.
Response to Arguments
Applicant's arguments filed December 12, 2025 have been fully considered but they are not persuasive.
Applicant argues that the prior rejection does not establish a prima facie case of obviousness as the prior art does not teach that the release lever is pivotally coupled to the second strut member and includes a first end portion that comprises a first engagement region positioned facing downward and formed to create a recessed area to receive and maintain an upper edge of a first lateral band of the second plurality of lateral bands.
This argument is unpersuasive. While this limitation was not previously required, therefore the prior rejection does not address this feature, the limitation is taught by the previously presented prior art. As modified in the 103 rejection of claim 1 in the office action filed September 12, 2025, the second rail section 62 is modified in view of Ingimundarson to include lateral bands and then modified in view of Petursson to include a mounting bracket. The mounting bracket, as shown in Fig. 10A of Petursson, comprises a recessed area that is interpreted as comprising a first engagement region, and when included on the second rail section 62 and coupled to the first rail section 60, would face downward. The first engagement region faces downward because the mounting bracket projects from the top of the second rail section 62 which results in the first engagement region engaging the top edge of the webs 76. The examiner notes that Figs. 2 and 5-7 of Carstens are in an upside down configuration which is disclosed in [0046].
Claim Rejections - 35 USC § 112(b)
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.
Claim 17 is 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 17 is rejected because it is unclear how the lower edge can be “a bottom edge for a selected aperture” when claim 16 already defines the lower edge as a lower edge of a second lateral band. The claim further requires that the selected aperture is formed between neighboring lateral bands corresponding to the first and second lateral bands of the second plurality of lateral bands. Therefore, it is not possible for the lower edge claimed in claim 16 as the lower edge of the second lateral band that is positioned immediately above the first lateral band to also be the bottom edge of an aperture between the first and second lateral bands. The claim will be interpreted as claiming that the lower edge corresponds to the top edge of the selected aperture as this aligns with the previously recited claims and adheres to the configuration shown in Fig. 5B of Applicant’s drawings.
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.
Claims 1, 6-9, 12, 14 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Carstens (DE102017108839 A1) in view of Ingimundarson (US 20170156911 A1) and Petursson (US 11253384 B2).
Regarding Claim 1, Carstens discloses an orthopedic brace (Fig. 1; back orthosis 10) comprising: a belt brace (Fig. 1; belt 14 comprised of bandage 20 for enclosing a hip - or waist region) including a structural member (Fig. 3; recess 54, wherein the examiner is interpreting the structural member as a component for retention of the spinal support extension); an adjustable spinal support extension inserted into the structural member (Fig. 1-4, ¶ 6 line 58-59; spinal support 12 comprised of rail element 18 inserted into recess 54 of bandage 20, wherein the rail element of the support part can be varied in its length along its longitudinal extension), the spinal support extension comprises (i) a sleeve (Fig. 3-5, ¶ 44, ¶ 47; spinal support 12 comprised of textile pocket 52 in recess 54, entirely encased in sleeve 72), (ii) a first strut member (Fig. 6-7; second rail section 62) including a first channel (See annotated Fig. 6 below; wherein the examiner is interpreting a channel as a space disposed between panels), a first pair of panels positioned on opposite sides of the first channel (See annotated Fig. 6 below), and (iii) a second strut member (Fig. 6-7; first rail section 60) including a second channel (See annotated Fig. 6 below; wherein the examiner is interpreting a channel as a space disposed between panels), a second pair of panels positioned on opposite sides of the second channel (See annotated Fig. 6 below), a second plurality of lateral bands extending across the second channel to interconnect the second pair of panels (See annotated Fig. 6 below and Fig. 7, ¶ 49, ¶ 51; struts 74 and webs 76), wherein the second strut member is adjustably coupled to the first strut member to alter a length of the spinal support extension and retained at the length of the spinal support extension (Fig. 6-7, ¶ 48, ¶ 52; wherein the strut members are adjustably coupled and retained at the chosen length via rivets 80); wherein the first strut member and the second strut member are partially enclosed within the sleeve (Fig. 5-7, ¶ 47; wherein rail sections 60 and 62 of rail 18 are within sleeve 72) and a fastener of the structural member is attachable to a fastener on the sleeve when the spinal support extension is placed within the sleeve (Fig. 2-4, ¶ 44; attachment via the hook and loop layer).
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Carstens fails to disclose a first plurality of lateral bands extending across the first channel to interconnect the first pair of panels, and a release lever pivotally coupled to the second strut member, the release lever includes a first end portion that comprises a first engagement region positioned facing downward and formed to create a recessed area to receive and maintain an upper edge of a first lateral band of the second plurality of lateral bands.
However, Ingimundarson teaches a spinal orthosis wherein a first plurality of lateral bands extends across the first channel to interconnect the first pair of panels (See annotated Fig. 6 below).
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Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the second rail section 62 of Carstens with the lateral bands as taught by Ingimundarson such that the first strut member may comprise a plurality of lateral bands extending across the first channel to interconnect the first pair of panels to provide enhanced lateral stability and even load distribution for the orthopedic brace.
Ingimundarson fails to teach a release lever pivotally coupled to the second strut member, wherein the release lever includes a first end portion that comprises a first engagement region formed to create a recessed area to receive and maintain an edge of one of the second plurality of lateral bands.
However, Petursson teaches an orthopedic device wherein a release lever (Fig. 8 and 10A; mounting bracket 154) is pivotally coupled to the second strut member (Fig. 8 and 10A; belt segment 170, plurality of openings 152), wherein the release lever includes a first end portion that comprises a first engagement region positioned facing downward and formed to create a recessed area to receive and maintain an upper edge of a first lateral band of the second plurality of lateral bands (Fig. 8 and 10A; col. 14, lines 40-46).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to recognize that applying the mounting bracket from Petursson to the rail sections of Carstens modified in view of Ingimundarson would provide a predictable alternative fastening method that achieves the same goal of securing the struts together. Specifically, the mounting bracket in Petursson allows for an engagement region positioned facing downward to maintain an upper edge of a first lateral band as discussed in Carstens in view of Ingimundarson offering improved structural stability by distributing weight more evenly, easier disassembly and adjustment, and potential for reusable connecting elements. In light of KSR v. Teleflex, the substitution of the rivets or other connecting elements extending through the slot-like recesses in Carstens modified in view of Ingimundarson with the mounting bracket in Petursson represents a predictable variation of known fastening techniques. Given that both methods aim to achieve strut member connection, it would be obvious to implement the mounting bracket as an alternative means of attachment, particularly in situations where a non-permanent or more efficient fastening system is desirable.
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Regarding Claim 6, Carstens in view of Ingimundarson and Petursson discloses the limitations of the orthopedic brace of claim 1 as described in the rejection above, further disclosing the orthopedic brace of claim 1 operates as a thoraco-lumbo-sacral orthosis (TLSO) brace with the spinal support extension positioned along a mid-sagittal plane (Fig. 1, ¶ 1; wherein the brace is centered at the back of the wearer and can operate as a thoraco-lumbo-sacral orthosis).
Regarding Claim 7, Carstens in view of Ingimundarson and Petursson discloses the limitations of the orthopedic brace of claim 1 as described in the rejection above, further disclosing a strap adjustment member including a multi-region panel (See annotated Fig. 1 below; bridge section 39), the multi-region panel comprises a center panel (See annotated Fig. 1 below; bridge section 39) disposed between lateral panels and each lateral panel includes a strap guide positioned on an outer edge of the lateral panel (See annotated Fig. 1 below; deflection device 34).
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Regarding Claim 8, Carstens in view of Ingimundarson and Petursson discloses the limitations of the orthopedic brace of claim 7 as described in the rejection above, further disclosing the lateral panels of the multi-region panel are foldable toward the center panel (Fig. 1-2, ¶ 15).
Regarding Claim 9, Carstens in view of Ingimundarson and Petursson discloses the limitations of the orthopedic brace of claim 1 as described in the rejection above, further disclosing the spinal support extension extending from the belt brace and including a first end (Fig. 3 and 4, ¶ 44; wherein the rail element 18 is extended into a terminal first end, textile pocket 52).
Regarding Claim 12, Carstens discloses an adjustable spinal support extension (¶ 6; rail element 18, wherein the rail element of the support part can be varied in its length along its longitudinal extension) comprising: a first strut member (Fig. 6-7; second rail section 62) includes a first channel (See annotated Fig. 6 below), a first pair of panels positioned on opposite sides of the first channel (See annotated Fig. 6 below) and at least one post extending from each panel of the first pair of panels; and a second strut member includes a second channel (Fig. 6, ¶ 52; connecting elements 80, wherein the examiner is interpreting the posts to be a fastener), a second pair of panels positioned on opposite sides of the second channel (See annotated Fig. 6 below; wherein the examiner is interpreting a channel as a space disposed between panels), and a series of locking apertures (Fig. 6; slot-like recesses 78) formed in each panel of the second pair of panels sized to receive the at least one post, wherein the second strut member being positioned to overlay the first strut member and slidably coupled together when each of the at least one post engages with a corresponding locking aperture of the series of locking apertures (Fig. 6-7, ¶ 48, ¶ 52; wherein the strut members are adjustably coupled and retained at the chosen length via rivets 80).
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Carstens fails to disclose a first plurality of lateral bands extending across the first channel to interconnect the first pair of panels; and a release lever pivotally coupled to the second strut member, the release lever includes a first engagement region formed at least by a protruding portion, wherein the first engagement region is facing downward and formed to create a recessed area to receive and maintain an upper edge of a first lateral band of the second plurality of lateral bands.
However, Ingimundarson teaches a spinal orthosis wherein a first plurality of lateral bands extends across the first channel to interconnect the first pair of panels (See annotated Fig. 6 below).
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Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the second rail section 62 of Carstens with the lateral bands as taught by Ingimundarson such that the first strut member may comprise a plurality of lateral bands extending across the first channel to interconnect the first pair of panels to provide enhanced lateral stability and even load distribution for the orthopedic brace.
Carstens in view of Ingimundarson does not disclose a release lever pivotally coupled to the second strut member, the release lever includes a first engagement region formed at least by a protruding portion, wherein the first engagement region is facing downward and formed to create a recessed area to receive and maintain an upper edge of a first lateral band of the second plurality of lateral bands.
However, Petursson teaches an orthopedic device wherein a release lever (Fig. 8 and 10A; mounting bracket 154) is pivotally coupled to the second strut member (Fig. 8 and 10A; belt segment 170, plurality of openings 152), the release lever includes a first engagement region formed at least by a protruding portion, wherein the first engagement region is facing downward and formed to create a recessed area to receive and maintain an upper edge of a first lateral band of the second plurality of lateral bands (Fig. 8 and 10A; col. 14, lines 40-46).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to recognize that applying the mounting bracket from Petursson to the rail sections of Carstens modified in view of Ingimundarson would provide a predictable alternative fastening method that achieves the same goal of securing the struts together. Specifically, the mounting bracket in Petursson allows for an engagement region formed by a protruding portion and positioned facing downward to maintain an upper edge of a first lateral band as discussed in Carstens in view of Ingimundarson offering improved structural stability by distributing weight more evenly, easier disassembly and adjustment, and potential for reusable connecting elements. In light of KSR v. Teleflex, the substitution of the rivets or other connecting elements extending through the slot-like recesses in Carstens modified in view of Ingimundarson with the mounting bracket in Petursson represents a predictable variation of known fastening techniques. Given that both methods aim to achieve strut member connection, it would be obvious to implement the mounting bracket as an alternative means of attachment, particularly in situations where a non-permanent or more efficient fastening system is desirable.
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Regarding Claim 14, Carstens in view of Ingimundarson and Petursson discloses adjustable spinal support extension of claim 12.
Carstens in view of Ingimundarson and Petursson fails to disclose a contour of the second strut member includes a first portion with each segment of the second pair of panels having a first width and a second portion with each segment of the second pair of panels having a second width being less than the first width.
However, Ingimundarson further teaches a spinal orthosis wherein a contour of the second strut member includes a first portion with each segment of the second pair of panels having a first width and a second portion with each segment of the second pair of panels having a second width being less than the first width (See annotated Fig. 6 below, ¶ 66).
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Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the first rail section 60 of Carstens as taught by Ingimundarson such that a contour of the first rail section includes a first portion with each segment of the second pair of panels having a first width and a second portion with each segment of the second pair of panels having a second width being less than the first width as this modification provides additional comfort to the wearer as the narrower width is placed between the shoulder blades, ensuring a more anatomically precise fit. According to MPEP 2144, changes in shape, size, or sequence of adding ingredients is not an inventive feature. Therefore, the claimed first width and second width of the first and second portions of the pair of panels is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the shape of the housing is critical as In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claim 18, Carstens in view of Ingimundarson and Petursson discloses the limitations of the adjustable spinal support extension of claim 12 as described in the rejection above, further disclosing the adjustable spinal support extension deployed within a sleeve being part of an orthopedic brace (Fig. 3 and 4; textile pocket 52), wherein the sleeve includes a tab extending from a bottom edge of a first side of the sleeve to pass through an aperture formed in at least two lateral bands of the first plurality of lateral bands (Fig. 3; textile flap 46, wherein the examiner is interpreting the tab as an element for insertion through aligned apertures of the first strut member and/or the second strut member (or under a bottom edge of the first strut member) and subsequent attachment to a posterior surface of the sleeve), the tab includes a fastener for attachment to a fastener located on a second side of the sleeve opposite the first side of the sleeve (Fig. 3, ¶ 44; wherein the fastener is the hook and loop layer). Carstens further teaches a flexible loop layer extending from a bottom edge of a first side of the sleeve that is capable of inserting through aligned apertures of the strut members with subsequent attachment to a posterior surface of the sleeve through a hook, wherein a variable positioning can also be implemented differently than via the configuration of the positioning device 50 specifically shown in Carstens (¶ 44).
Regarding Claim 19, Carstens in view of Ingimundarson and Petursson discloses the limitations of the adjustable spinal support extension of claim 12 as described in the rejection above, further disclosing wherein the first channel align with the second plurality of lateral bands extending across the second channel of the second strut member when the second strut member is positioned to overlay the first strut member (Fig. 6 and 7, ¶ 8; first rail section 60, second rail section 62).
Carstens in view of Ingimundarson and Petursson fails to disclose a first plurality of lateral bands extending across the first channel of the first strut member.
However, Ingimundarson further teaches a spinal orthosis wherein a first plurality of lateral bands extends across the first channel of the first strut member (See annotated Fig. 6 below).
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Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the second rail section 62 of Carstens with the lateral bands as taught by Ingimundarson such that the first strut member may comprise a plurality of lateral bands extending across the first channel to interconnect the first pair of panels to provide enhanced lateral stability and even load distribution for the orthopedic brace. By doing so, the first and second strut members may be positioned to overlay, thus preventing the rail element from sticking out unsightly from the wearer’s body in the hip or waist area when the wearer stands upright. In addition, the aligned mounted rail sections provide enhanced lateral stability and even load distribution for the spinal support.
Claims 2-5 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Carstens (DE102017108839A1) in view of Ingimundarson (US 20170156911 A1) and Petursson (US 11253384 B2), and further in view of US 2019/0029866 (Stier et al.).
Regarding Claim 2, Carstens in view of Ingimundarson and Petursson teaches the orthopedic brace of claim 1.
Carstens in view of Ingimundarson and Petursson does not teach wherein the release lever further includes a first end portion that comprises a second engagement region positioned facing upward and formed to create a recessed area to receive and maintain a lower edge of a second lateral band of the second plurality of lateral bands positioned immediately above the first lateral band of the second plurality of lateral bands.
However, Stier teaches an orthosis comprising a reclinator splint 10 that has a plurality of anchoring points 16 to which anchor grommets 71 are coupled. The anchor grommets 71 serve as fasteners for coupling the straps 23, 24 to the reclinator splint 10 and further comprise a snap-in-nose 72 and shoulder 74. The reclinator splint 10 and anchoring points 16 are analogous to the first rail section 60 and apertures of Carstens, respectively. The anchor grommets are fasteners that include an engagement region on both the top and bottom as the shoulder 74 forms a recess about the nose 72 which receives and maintains the upper and lower edges of the lateral bands between anchoring points 16. See [0027] and Figs. 6 and 7.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the fastener of Petursson as modified with Carstens to be in the shape of the anchor grommet 71 with a nose 72 and shoulder 74 as taught by Stier. A skilled artisan would have been motivated to do so because Stier teaches that the nose 72 and shoulder 74 prevent the grommet from dropping out after engaging with the anchoring points ([0027]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn spinal orthoses with adjustable fasteners.
As a result, Carstens in view of Ingimundarson, Petursson and Stier teaches wherein the release lever further includes a first end portion that comprises a second engagement region positioned facing upward and formed to create a recessed area to receive and maintain a lower edge of a second lateral band of the second plurality of lateral bands positioned immediately above the first lateral band of the second plurality of lateral bands (In view of Stier, the fastener comprises a nose and shoulder configuration that comprises a first and second engagement region facing downwards and upwards, respectively. The second engagement region comprises a recessed area and is configured to receive and maintain a lower edge of a second lateral band of the second plurality of lateral bands positioned immediately above the first lateral band of the second plurality of lateral bands.).
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Regarding Claim 3, Carstens in view of Ingimundarson, Petursson and Stier discloses the limitations of the orthopedic brace of claim 2.
Carstens fails to disclose wherein a contour of the second strut member includes a first portion with each segment of the second pair of panels having a first width and a second portion with each segment of the second pair of panels having a second width being less than the first width.
However, Ingimundarson further teaches a spinal orthosis wherein a contour of the second strut member includes a first portion with each segment of the second pair of panels having a first width and a second portion with each segment of the second pair of panels having a second width being less than the first width (See annotated Fig. 6 below, ¶ 66).
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Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the first rail section 60 of Carstens as taught by Ingimundarson such that a contour of the first rail section includes a first portion with each segment of the second pair of panels having a first width and a second portion with each segment of the second pair of panels having a second width being less than the first width as this modification provides additional comfort to the wearer as the narrower width is placed between the shoulder blades, ensuring a more anatomically precise fit. According to MPEP 2144, changes in shape, size, or sequence of adding ingredients is not an inventive feature. Therefore, the claimed first width and second width of the first and second portions of the pair of panels is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the shape of the housing is critical as In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claim 4, Carstens in view of Ingimundarson, Petursson and Stier discloses the limitations of the orthopedic brace of claim 3 as described in the rejection above, further disclosing the first strut member includes one or more posts extending from each panel of the first pair of panels (Fig. 6, ¶ 52; connecting elements 80, wherein the examiner is interpreting the posts to be a fastener) for engaging with locking apertures positioned within each corresponding panel of the second pair of panels (Fig. 6; slot-like recesses 78) when the second strut member is slidably engaged with the first strut member (Fig. 6 and 7, ¶ 22, ¶ 48).
Regarding Claim 5, Carstens in view of Ingimundarson, Petursson and Stier discloses the limitations of the orthopedic brace of claim 3 as described in the rejection above, further disclosing the sleeve (Fig. 3-5, ¶ 44, ¶ 47; spinal support 12 comprised of textile pocket 52 in recess 54, entirely encased in sleeve 72) includes a tab extending from a bottom edge of a first side of the sleeve to pass through an aperture formed in at least two lateral bands of the first plurality of lateral bands (Fig. 3; textile flap 46, wherein the examiner is interpreting the tab as an element for insertion through aligned apertures of the first strut member and/or the second strut member (or under a bottom edge of the first strut member), the tab includes a fastener for attachment to a fastener located on a second side of the sleeve opposite the first side of the sleeve (Fig. 3, ¶ 44; wherein the fastener is the hook and loop layer). Carstens further teaches a flexible loop band extending from a bottom edge of a first side of the sleeve that is capable of inserting through aligned apertures of the strut members with subsequent attachment to a posterior surface of the sleeve through a hook, wherein a variable positioning can also be implemented differently than via the configuration of the positioning device 50 specifically shown in Carstens (¶ 44).
Regarding Claim 16, Carstens in view of Ingimundarson and Petursson discloses the adjustable spinal support extension as claimed in claim 12 (¶ 6, line 58-59; rail element 18, wherein the rail element of the support part can be varied in its length along its longitudinal extension).
Carstens in view of Ingimundarson and Petursson fail to teach wherein the release lever further includes a second engagement region positioned facing upward and formed to create a recessed area to receive and maintain a lower edge of a second lateral band of the second plurality of lateral bands that is positioned immediately above the first lateral band of the second plurality of lateral bands
However, Stier teaches an orthosis comprising a reclinator splint 10 that has a plurality of anchoring points 16 to which anchor grommets 71 are coupled. The anchor grommets 71 serve as fasteners for coupling the straps 23, 24 to the reclinator splint 10 and further comprise a snap-in-nose 72 and shoulder 74. The reclinator splint 10 and anchoring points 16 are analogous to the first rail section 60 and apertures of Carstens, respectively. The anchor grommets are fasteners that include an engagement region on both the top and bottom as the shoulder 74 forms a recess about the nose 72 which receives and maintains the upper and lower edges of the lateral bands between anchoring points 16. See [0027] and Figs. 6 and 7.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the fastener of Petursson as modified with Carstens to be in the shape of the anchor grommet 71 with a nose 72 and shoulder 74 as taught by Stier. A skilled artisan would have been motivated to do so because Stier teaches that the nose 72 and shoulder 74 prevent the grommet from dropping out after engaging with the anchoring points ([0027]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn spinal orthoses with adjustable fasteners.
As a result, Carstens in view of Ingimundarson, Petursson and Stier teaches wherein the release lever further includes a first end portion that comprises a second engagement region positioned facing upward and formed to create a recessed area to receive and maintain a lower edge of a second lateral band of the second plurality of lateral bands positioned immediately above the first lateral band of the second plurality of lateral bands (In view of Stier, the fastener comprises a nose and shoulder configuration that comprises a first and second engagement region facing downwards and upwards, respectively. The second engagement region comprises a recessed area and is configured to receive and maintain a lower edge of a second lateral band of the second plurality of lateral bands positioned immediately above the first lateral band of the second plurality of lateral bands.).
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Regarding Claim 17, Carstens in view of Ingimundarson, Petursson and Stier teaches the limitations of the adjustable spinal support extension of claim 16, wherein the lower edge is a top edge for a selected aperture formed between neighboring lateral bands of the second plurality of lateral bands corresponding to the first lateral band and the second lateral band of the second plurality of lateral bands (In view of the 112(b) rejection and the examiner interpretation as a result of the rejection, Carstens in view of Ingimundarson, Petursson and Stier teaches that the lower edge referred to in claim 16 is a top edge of an aperture formed between the first and second lateral bands of the second plurality of lateral bands.).
Claims 10-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Carstens (DE102017108839A1) in view of Ingimundarson (US 20170156911 A1) and Petursson (US 11253384 B2) and in further view of Yip (US 20210059849 A1).
Regarding Claim 10, Carstens in view of Ingimundarson and Petursson discloses the limitations of the orthopedic brace of claim 9 as described in the rejection above, further disclosing the orthopedic brace comprising: a support harness (Fig. 1; support part 12) including a first strap member extends from the first end of the spinal support extension, a second strap member extends from the first end of the spinal support extension in a direction substantially opposite to a direction of the first strap member, a third strap member is attached to and extends from an end of the first strap member, and a fourth strap member is attached to and extends from an end of the second strap member (See annotated Fig. 1 below; strap assembly 16, strap section 28, strap section 30, ends 40).
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Carstens in view of Ingimundarson and Petursson fails to disclose a support harness wherein the first and second strap members are configured as a first knit tube including light weight, elastic material formed within an interior of the first knit tube and in which the third and fourth strap members possesses a different material composition and lesser thickness than the first and second strap members.
However, Yip teaches a first knit tube including light weight, elastic material formed within an interior of the first knit tube (Fig. 7a and 7b, ¶ 0068; knitted structure of the bodice 102) wherein the bodice is double jersey with an additional insertion of elastic inlaid yarns in between. Furthermore, Yip teaches a pelvic belt 114 formed from a 3mm layer of Neoprene (a foamed rubber also known as polychloroprene that is both durable and exhibits exceptional tensile performance). In which, the neoprene is laminated with a nylon jersey on the face side and UBL fabric on the back side. UBL fabric is a two-way stretch knit loop fabric which is compatible with hook-and-loop fasteners e.g. Velcro (¶ 82).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the first and second strap members in Carstens with the knitted, elastic structure of the bodice and the Neoprene structure of the pelvic belt in Yip to enhance the overall comfort, performance, and functionality of the strap sections. Modifying the first and second strap members of Carstens with the knitted, elastic structure of the bodice in Yip would provide improved comfort by allowing the straps to conform better to the wearer’s back, increase flexibility without compromising support, and enhance overall fit and compression. Modifying the third and fourth strap members of Carstens with the Neoprene structure of the pelvic belt in Yip would allow for the formation of thinner straps with improved durability due to the tear-resistant nature of nylon jersey, enhance comfort and flexibility, provide better compression and a stronger grip with adjustability due to the UBL (unbroken loop) structure. Utilizing a more durable material at the base of the orthopedic base contributes stability and support. In light of KSR v. Teleflex, this combination represents a predictable application of known materials to achieve well-understood functions in orthopedic braces.
Regarding Claim 11, Carstens in view of Ingimundarson, Petursson and Yip discloses the limitations of the orthopedic brace of claim 10 as described in the rejection above, further disclosing the orthopedic brace comprising: a strap adjustment member (bridge section 39) coupled to the support harness (Fig. 1; support part 12) and removably coupled to an exterior surface of the spinal support extension (Fig. 1, ¶ 38; wherein the bridge section 39 can be attached to the support part 12 in a variable position via a hook and loop connection to achieve variable fixability), the strap adjustment member includes a multi-region panel (See annotated Fig. 1 below, bridge section 39), the multi-region panel comprises a center panel (See annotated Fig. 1 below, bridge section 39) disposed between a first lateral panel including (i) a first strap guide positioned on an outer edge of the first lateral panel and (ii) a second lateral panel including a second strap guide positioned on an outer edge of the second lateral panel (Fig. 2; deflection device 34), wherein the third strap member is inserted through the first strap guide for subsequent attachment to the belt brace and the fourth strap member is inserted through the second strap guide for subsequent attachment to the belt brace (See annotated Fig. 1 below).
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Regarding Claim 20, Carstens discloses the orthopedic brace (Fig. 1; back orthosis 10) comprising: a belt brace (Fig. 1; belt 14 comprised of bandage 20 for enclosing a hip - or waist region) including a structural member (Fig. 3; recess 54, wherein the examiner is interpreting the structural member as a component for retention of the spinal support extension); an adjustable spinal support extension inserted into the structural member (Fig. 1-4, ¶ 6 line 58-59; spinal support 12 comprised of rail element 18 inserted into recess 54 of bandage 20, wherein the rail element of the support part can be varied in its length along its longitudinal extension), the spinal support extension comprises a sleeve (Fig. 3-5, ¶ 44, ¶ 47; spinal support 12 comprised of textile pocket 52 in recess 54, entirely encased in sleeve 72), (i) a first strut member (Fig. 6-7; second rail section 62) including a first channel (See annotated Fig. 6 below; wherein the examiner is interpreting a channel as a space disposed between panels), a first pair of panels positioned on opposite sides of the first channel (See annotated Fig. 6 below), and one or more posts extending from each panel of the first pair of panels (Fig. 6, ¶ 52; connecting elements 80, wherein the examiner is interpreting the posts to be a fastener), and a second strut member (Fig. 6-7; first rail section 60) including a second channel (See annotated Fig. 6 below; wherein the examiner is interpreting a channel as a space disposed between panels), a second pair of panels positioned on opposite sides of the second channel (See annotated Fig. 6 below), a second plurality of lateral bands extending across the second channel to interconnect the second pair of panels (See annotated Fig. 6 below and Fig. 7, ¶ 49, ¶ 51; struts 74 and webs 76) and one or more locking apertures within each corresponding panel of the second pair of panels (Fig. 6; slot-like recesses 78), wherein the second strut member is adjustably coupled to the first strut member to alter a length of the spinal support extension (Fig. 6 and 7, ¶ 8-9) and retain at the length of the spinal support extension (Fig. 6-7, ¶ 48, ¶ 52; wherein the strut members are adjustably coupled and retained at the chosen length via rivets 80); and a strap adjustment member configured to be affixed to the sleeve of the spinal support extension, the strap adjustment member includes a multi-region panel (See annotated Fig. 1 below, bridge section 39), the multi- region panel comprises a center panel (See annotated Fig. 1 below, bridge section 39) disposed between lateral panels each lateral panel includes a strap guide positioned on an outer edge of the lateral panel (Fig. 2; deflection device 34); and a support harness including a first strap member, a second strap member, a third strap member, and a fourth strap member (See annotated Fig. 1 below; strap assembly 16, strap section 28, strap section 30, ends 40), wherein the first strap member extends from the first end of the spinal support extension, the second strap member extends from the first end of the spinal support extension in a direction substantially opposite to a direction of the first strap member, the third strap member is attached to and extends from an end of the first strap member, the fourth strap member is attached to and extends from an end of the second strap member (See annotated Fig. 1 below; strap assembly 16, strap section 28, strap section 30, ends 40), and the first strut member and the second strut member are partially enclosed within the sleeve (Fig. 5-7, ¶ 47; wherein rail sections 60 and 62 of rail 18 are within sleeve 72) and a fastener of the structural member is attachable to a fastener on the sleeve when the spinal support extension is placed within the sleeve (Fig. 2-4, ¶ 44; attachment via the hook and loop layer).
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Carstens fails to disclose the orthopedic brace wherein a first plurality of lateral bands extends across the first channel to interconnect the first pair of panels; a release lever pivotally coupled to the second strut member, the release lever includes a first end portion that comprises a first engagement region positioned facing downward and formed to create a recessed area to receive and maintain an upper edge of a first lateral band of the second plurality of lateral bands; the first and second strap members are configured as a first knit tube including light weight, elastic material formed within an interior of the first knit tube, the second strap member is configured as a second knit tube including light weight, elastic material formed within an interior of the second knit tube, the third strap member possessing a different material composition and lesser thickness than the first strap member, and the fourth strap member possessing a different material composition and lesser thickness than the second strap member.
However, Ingimundarson teaches a spinal orthosis wherein a first plurality of lateral bands extends across the first channel to interconnect the first pair of panels (See annotated Fig. 6 below).
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Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the second rail section 62 of Carstens with the lateral bands as taught by Ingimundarson such that the first strut member may comprise a plurality of lateral bands extending across the first channel to interconnect the first pair of panels to provide enhanced lateral stability and even load distribution for the orthopedic brace.
Ingimundarson fails to teach a release lever pivotally coupled to the second strut member, wherein the release lever includes a first end portion that comprises a first engagement region formed to create a recessed area to receive and maintain an edge of one of the second plurality of lateral bands; the first and second strap members are configured as a first knit tube including light weight, elastic material formed within an interior of the first knit tube, the second strap member is configured as a second knit tube including light weight, elastic material formed within an interior of the second knit tube, the third strap member possessing a different material composition and lesser thickness than the first strap member, and the fourth strap member possessing a different material composition and lesser thickness than the second strap member.
However, Petursson teaches an orthopedic device wherein a release lever (Fig. 8 and 10A; mounting bracket 154) is pivotally coupled to the second strut member (Fig. 8 and 10A; belt segment 170, plurality of openings 152), wherein the release lever includes a first end portion that comprises a first engagement region positioned facing downward and formed to create a recessed area to receive and maintain an upper edge of a first lateral band of the second plurality of lateral bands (Fig. 8 and 10A; col. 14, lines 40-46).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to recognize that applying the mounting bracket from Petursson to the rail sections of Carstens modified in view of Ingimundarson would provide a predictable alternative fastening method that achieves the same goal of securing the struts together. Specifically, the mounting bracket in Petursson allows for an engagement region positioned facing downward to maintain an upper edge of a first lateral band as discussed in Carstens in view of Ingimundarson offering improved structural stability by distributing weight more evenly, easier disassembly and adjustment, and potential for reusable connecting elements. In light of KSR v. Teleflex, the substitution of the rivets or other connecting elements extending through the slot-like recesses in Carstens modified in view of Ingimundarson with the mounting bracket in Petursson represents a predictable variation of known fastening techniques. Given that both methods aim to achieve strut member connection, it would be obvious to implement the mounting bracket as an alternative means of attachment, particularly in situations where a non-permanent or more efficient fastening system is desirable.
Ingimundarson fails to teach the first and second strap members are configured as a first knit tube including light weight, elastic material formed within an interior of the first knit tube, the second strap member is configured as a second knit tube including light weight, elastic material formed within an interior of the second knit tube, the third strap member possessing a different material composition and lesser thickness than the first strap member, and the fourth strap member possessing a different material composition and lesser thickness than the second strap member.
However, Yip teaches a first knit tube including light weight, elastic material formed within an interior of the first knit tube (Fig. 7a and 7b, pg. 4, ¶ 0068; knitted structure of the bodice 102) wherein the bodice is double jersey with an additional insertion of elastic inlaid yarns in between. In addition, Yip teaches a pelvic belt 114 formed from a 3mm layer of Neoprene (a foamed rubber also known as polychloroprene that is both durable and exhibits exceptional tensile performance). In which, the neoprene is laminated with a nylon jersey on the face side and UBL fabric on the back side. UBL fabric is a two-way stretch knit loop fabric which is compatible with hook-and-loop fasteners e.g. Velcro (pg. 6, ¶ 0082).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the first and second strap members in Carstens with the knitted, elastic structure of the bodice and the Neoprene structure of the pelvic belt in Yip to enhance the overall comfort, performance, and functionality of the strap sections. Modifying the first and second strap members of Carstens with the knitted, elastic structure of the bodice in Yip would provide improved comfort by allowing the straps to conform better to the wearer’s back, increase flexibility without compromising support, and enhance overall fit and compression. Modifying the third and fourth strap members of Carstens with the Neoprene structure of the pelvic belt in Yip would allow for the formation of thinner straps with improved durability due to the tear-resistant nature of nylon jersey, enhance comfort and flexibility, provide better compression and a stronger grip with adjustability due to the UBL (unbroken loop) structure. Utilizing a more durable material at the base of the orthopedic brace contributes stability and support. In light of KSR v. Teleflex, this combination represents a predictable application of known materials to achieve well-understood functions in orthopedic braces.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786