DETAILED ACTION
This is a Final Rejection for Application 18/799,847 filed August 9, 2024. This application is a Continuation in Part of U.S. Pat. App. No 18/551,185, filed September 18, 2023, which was a U.S. National Phase of PCT Patent Application No. PCT/NL2022/050171 having international filing date of March 29, 2022, which claims the benefit of priority of Dutch Patent Application No. 2027859 filed on March 29, 2022. Claims 1-21 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 .
Response to Amendment
The examiner acknowledges the amended and new claims filed November 26, 2025.
The amendments overcome the claim objections indicated in the Office action filed November 04, 2025. The claim objections are hereby withdrawn.
The examiner acknowledges the terminal disclaimer filed November 26, 2025. The terminal disclaimer overcomes the nonstatutory double patenting rejections, which are hereby withdrawn.
New grounds of rejection are provided below to address new claim 21.
Response to Arguments
Applicant's arguments filed November 26, 2025 have been fully considered but they are not persuasive.
Applicant argues that the applied art fails to teach or suggest the claimed WFE joint arrangement.
This argument is unpersuasive as the pivotal connector of Malewicz is a wrist flexion-extension joint as a joint by definition is a point at which parts of an artificial structure are joined and the pivotal connector allows wrist flexion and extension. The pivotal connector of Malewicz spaces the second securing element of Goldfarb from the third structural element of Goldfarb when combined because the screw of Malewicz, which makes up the pivotal connector, creates a space between the pivotal connector and what it is connected to when loosened, which it is when in use to allow for flexion and extension of the wrist.
Applicant argues that the claimed “no contact between upper arm piece and hand piece” limitation is not met.
This argument is unpersuasive as the limitation actually states “the brace is configured to not contact the user's body between the upper arm piece and the hand piece when the brace is in use.” Therefore, this limitation may be met by the brace not contacting the user’s body at any singular point between the first and second securing elements 108. There is no evidence that the device 100 of Goldfarb entirely contacts the user between the first and second securing elements 108 while there is support for the device to not contact the user since it would not make sense for the moving parts of the device to be in contact with the user’s body as this would cause irritation to the user.
Applicant argues that the proposed combination would change the principle operation of Goldfarb.
This argument is unpersuasive as Goldfarb discloses [0049] - "Although FIG. 1 is described as including a normally-locked joint associated with wrist pronation/supination, also referred to here as wrist rotation, the present technology is not limited in this regard. In other embodiments, the orthotic device 100 can include multiple normally-locked wrist degrees of freedom (e.g., wrist flexion/extension, ulnar/radial deviation, and pronation/supination)." Therefore, Goldfarb provides support for modification to the orthotic device to include wrist flexion and extension, and Malewicz provides specific means to do so while being analogous art.
Applicant argues that the combination lacks a motivation with a reasonable expectation of success.
This argument is unpersuasive as Goldfarb discloses [0049] - "Although FIG. 1 is described as including a normally-locked joint associated with wrist pronation/supination, also referred to here as wrist rotation, the present technology is not limited in this regard. In other embodiments, the orthotic device 100 can include multiple normally-locked wrist degrees of freedom (e.g., wrist flexion/extension, ulnar/radial deviation, and pronation/supination)." Additionally, Malewicz provides a motivation for the combination. Malewicz teaches that the pivotal connector 30 allows for the user to position their hand in a comfortable configuration (Col. 3, Lns. 51-65).
Applicant argues that the claimed subject matter solves a problem not addressed by the applied art.
This argument is unpersuasive as a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Additionally, this argument amounts to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claim Interpretation
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(s) is/are: a motion resisting element in claims 5, 6 and 21.
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 specification defines a motion resisting element as a damper e.g. fluid damper, liquid damper and/or a friction damper ([Pg. 4, Lns. 24-29]).
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 § 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 21 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 21 recites the limitation "the first portion of the extension element" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Neither claim 20 or 21 claim a first portion of the extension element prior to limiting the first portion of the extension element.
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 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0163787 (Goldfarb et al) in view of US 5,759,165 (Malewicz).
Regarding claim 20, Goldfarb discloses a body wearable brace for resisting involuntary motion, adapted for allowing a user wearing the brace on the user’s arm to dynamically move the user’s upper arm, forearm, wrist and hand (Goldfarb discloses an orthotic device 100 which is being interpreted as a body wearable brace. Orthotic device 100 allows a user wearing the device on their arm to dynamically move their upper arm, forearm, wrist and hand. See the Abstract and Fig. 1.), comprising:
an upper arm piece (Upper arm portion 104 ends in a first securing element 108. First securing element 108 is interpreted as an upper arm piece and is configured for connecting the device 100 to the user's upper arm. See [0048].);
a hand piece (A second securing element 108 is interpreted as a hand piece and is configured for connecting the device 100 to the user. While the second securing element 108 is positioned at the wrist, it will overlap and support the base of the hand.);
an elbow flexion-extension (“EFE”) joint that is rotatable relative to the upper arm piece around a first axis of rotation (Elbow joint 110 is interpreted as an elbow flexion-extension joint and is rotatable relative to the first securing element 108 around a first axis of rotation.);
a forearm pronation-supination (“FPS”) joint that is rotatable relative to the EFE joint around a second axis of rotation (Wrist joint 114 is interpreted as a forearm pronation-supination joint and is rotatable relative to the elbow joint 110 around a second axis of rotation.);
an extension element (“EE”) extendable in a longitudinal direction (A third portion of the structural element 106 is interpreted as an extension element and is adjustable to allow a fit of the orthotic device to different users with difference arm lengths, which makes the third structural element 106 extendable in a longitudinal direction.); and
the brace is configured to not contact the user’s body between the upper arm piece and the hand piece when the brace is in use (The device 100 is configured to not contact the user’s body between the first and second securing elements 108 as the elements 108 are the only components configured to secure the device 100 to the user.).
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Annotated Fig. 1 of Goldfarb
Goldfarb does not disclose a wrist flexion-extension (“WFE”) joint that is rotatable around a third axis of rotation, wherein a first portion of the WFE joint is directly or indirectly connected to the EE, a second portion of the WFE joint is directly or indirectly connected to the hand piece, the WFE joint spaces the handpiece from the EE.
However, Malewicz discloses a forearm supination orthosis comprising a forearm bracket 20 and a hand piece. The hand piece comprising a support hook 12, a support hook pad 14, a first support hook securing straps 16, and a second support hook securing strap 18. The forearm bracket 20 is analogous to the third structural element 106 of Goldfarb and the hand piece is analogous to the second securing element 108 of Goldfarb. Malewicz further discloses a pivotal connector connecting the bracket 20 and hand piece in a rotatable manner such that the bracket 20 and hand piece pivot relative to one another about an axis. The pivotal connector 30 is directly connected to the bracket 20 and the hand piece by screw 62 and nut 64. The pivotal connector 30 spaces the handpiece from the bracket 20 as the screw 62 spans the distance between the two, and when the pivotal connector 30 is loosened, space between the hand piece and bracket 20 will occur. The pivotal connector 30 allows for the user’s wrist to flex and extend. See Figs. 1-3 and Col. 3, Lns. 8-40.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add a pivotal connector 30 to the device 100 of Goldfarb such that the third structural element 106 and the second securing element 108 are pivotally connected as taught by Malewicz. A skilled artisan would have been motivated to do so because Malewicz teaches that the pivotal connector 30 allows for the user to position their hand in a comfortable configuration (Col. 3, Lns. 51-65). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to arm orthotics.
As a result of the combination, Goldfarb in view of Malewicz discloses a wrist flexion-extension (“WFE”) joint that is rotatable around a third axis of rotation (The pivotal connector 30 is interpreted as a wrist flexion-extension joint and is rotatable around a third axis of rotation.),
wherein a first portion of the WFE joint is directly or indirectly connected to the EE (The pivotal connector 30 comprises a first portion in the form of nut 64 which is directly connected to the third structural element 106 of Goldfarb.),
a second portion of the WFE joint is directly or indirectly connected to the hand piece (The pivotal connector 30 comprises a second portion in the form of screw 62 which is directly connected to the second securing element 108 of Goldfarb.),
the WFE joint spaces the handpiece from the EE (The pivotal connector 30 spaces the second securing element 108 from the third structural element 106.).
Regarding claim 21, Goldfarb in view of Malewicz discloses the brace of claim 20, wherein when seen in projection onto a plane normal to the longitudinal direction, the third axis of rotation of the WFE joint is spaced apart from the first portion of the extension element by a distance of at least 0.7 cm, or the WFE joint comprises a motion-resisting element adapted to resist fast rotation more than slower rotation and/or comprises a damper that dampens rotation at higher angular velocities to a greater extent than at lower angular velocities (The first portion of the extension element of Goldfarb is interpreted as the portion of the third portion of the structural element 106 nearest the wrist joint 114, while a second portion of the extension element of Goldfarb is interpreted as the portion of the third portion of the structural element 106 nearest second securing element 108. [0048] – “the length of the structural elements 106 can be configured to be adjustable to allow a fit of the orthotic device to different users with difference arm lengths”; Therefore, the pivotal connector of Malewicz, which is positioned at the second securing element 108, is a distance of at least 0.7 cm from the first portion of the extension element of Goldfarb since the extension element can be adjusted in length and a user’s arm is inherently longer than 1.4 cm.).
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Annotated Fig. 1 of Goldfarb
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim 1 contains allowable subject matter because the prior art fails to disclose, either singly or in combination, an EFE joint, an FPS joint and a WFE joint in the particular configuration claimed.
The closest prior art made of record is US 2020/0163787 (Goldfarb et al.). Goldfarb discloses a body wearable brace, an upper arm piece, a hand piece, an elbow flexion-extension joint with first and second portions, a forearm pronation-supination joint with first and second portions, and an extension element.
However, Goldfarb does not disclose that the extension element is made of two portions, a wrist flexion-extension joint, and that the forearm of the user is not encircled by the brace while in use, either singly or in combination.
Claims 2-18 contain allowable subject matter based on their dependence from claim 1.
Claim 19 contains allowable subject matter because the prior art fails to disclose, either singly or in combination, an EFE joint, an FPS joint and a WFE joint in the particular configuration claimed.
The closest prior art made of record is US 2020/0163787 (Goldfarb et al.). Goldfarb discloses a body wearable brace, an upper arm piece, a hand piece, an elbow flexion-extension joint with first and second portions, a forearm pronation-supination joint with first and second portions, and an extension element.
However, Goldfarb does not disclose that the extension element is made of two portions, a wrist flexion-extension joint, and that the second axis of rotation is configured to be spaced from the user’s body when in use, either singly or in combination.
Claims 1-19 are allowed.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Rachael Bredefeld can be reached at (571)270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786