DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The disclosure is objected to because of the following informalities:
This application does not contain an abstract of the disclosure as required by 37 CFR 1.72(b). An abstract on a separate sheet is required. Applicant’s submitted “Abstract” is merely a submission of the cover page of the priority reference WO 2023/073173 A1, and thus, the application does not contain an abstract. Applicant is required to submit an abstract which must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Appropriate correction is required.
Claim Objections
Claims 1-2, 5-6, and 12-15 are objected to because of the following informalities:
Claim 1 recites the limitation “a first fitting configured to be mounted on an arm…a second fitting configured for being mounted on a forearm”. This limitation should be amended to recite “a first fitting configured to be mounted on an upper arm…a second fitting configured for being mounted on a forearm” as an arm includes a forearm, and thus, could be considered unclear.
Claim 1 recites the limitation “the orthosis” in line 10. This limitation should be amended to recite “the elbow orthosis” to maintain consistency in the claims.
Claim 1 recites the limitation “the articulation (14, 22) mechanism” in line 15. This limitation should be amended to recite “the articulation mechanism (14, 22)”.
Claim 1 recites the limitation “their relative orientation”. This limitation should be amended to remove the pronoun “their” and recite “a relative orientation” to properly present the limitation.
Claim 1 recites the limitation “depending on the orientation”. This limitation should be amended to recite “depending on the relative orientation” to maintain consistency in the claims.
Claim 1 recites the limitation “at least one through hole (4028) of the first series with one through hole (4048) of the second series”. This limitation should be amended to recite “at least one through hole (4028) of the first series of through holes with one through hole (4048) of the second series of through holes” to maintain consistency in the claims.
Claim 2 recites the limitation “the orthosis” in lines 4 and 6. These limitations should be amended to recite “the elbow orthosis” to maintain consistency in the claims.
Claim 5 recites the limitation “the gear-motor”. This limitation should be amended to recite “the electric gear-motor” to maintain consistency in the claims.
Claim 6 recites the limitation “wherein the wheel” in line 4. This limitation should be amended to recite “wherein the toothed wheel” to maintain consistency in the claims.
Claim 6 recites the limitation “these two parallel armatures”. This limitation should be amended to recite “the two parallel armatures”.
Claim 6 recites the limitation “with a possibility of rotation”. This limitation should be removed from the claim because the limitation can be considered unclear as to what is being claimed with the term “possibility”, and it doesn’t limit the rotation shaft because for a shaft to be classified as a “rotation” shaft, it must be capable of rotation.
Claim 12 recites the limitation “an elbow orthosis according to claim 1”. This limitation should be amended to recite “the elbow orthosis”.
Claim 12 recites the limitation “a patient” in line 3. This limitation should be amended to recite “the patient”.
Claim 12 recites the limitation “their common central axis”, “their overlapping”, and “their respective angular positions”. These limitations should be amended to remove the pronoun “their” and recite “the common central axis”, and “the respective angular positions”.
Claim 12 recites the limitation “at least one through hole (4028) of the first series with one through hole (4048) of the second series”. This limitation should be amended to recite “at least one through hole (4028) of the first series of through holes with one through hole (4048) of the second series of through holes” to maintain consistency in the claims.
Claim 13 recites the limitation “consisting in”. This limitation should be amended to recite “consisting of”.
Claim 13 recites the limitation “the orthosis” in lines 5 and 6. These limitations should be amended to recite “the elbow orthosis” to maintain consistency in the claims.
Claim 14 recites the limitation “a configuration for a left arm to a configuration for a right arm”. This limitation should be amended to recite “a configuration for the left arm to a configuration for the right arm”.
Claim 14 recites the limitation “the orthosis”. This limitation should be amended to recite “the elbow orthosis” to maintain consistency in the claims.
Claim 14 recites the limitation “second circulars”. This limitation should be amended to recite “second circular”.
Claim 15 recites the limitation “consisting in”. This limitation should be amended to recite “consisting of”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the angular position" in line 11. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an angular position”.
Claim 1 recites the limitation “the articulation (14, 22) mechanism. This limitation renders the claim indefinite because the reference numerals do not include 20 as was previously presented, which renders the claim unclear as to if this recitation only applies to structures 14 and 22 of the recited articulation mechanism, or if it includes 20 as well. For the purpose of examination, Examiner will interpret this limitation as “the articulation mechanism (14, 20, 22)”.
Claim 1 recites the limitation "the rotational movement" in line 16. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a rotational movement”.
Claim 1 recites the limitation "the angular movement" in line 19. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the movement around the first rotation axis”.
Claim 1 recites the limitations “spread on a circle centered on a central axis” in lines 24 and 27. These limitations render the claim indefinite as it is unclear if the through holes are spread on the circle, and thus, on the central axis, or are spread circumferentially about the first plate centered on the central axis. For the purpose of examination, Examiner will interpret this limitation as “a first/second series of through holes circumferentially spread on the first plate, centered on a central axis”.
Claim 1 recites the limitation “a common central axis” in line 32. This limitation renders the claim indefinite because it is unclear as to if the common central axis includes the central axes recited earlier in the claim or if this is a new axis. For the purpose of examination, Examiner will interpret this limitation as “the central axis of the first circular slot and the central axis of the second circular slot are aligned”.
Claim 1 recites the limitation “some portions of the first and second circular slots”. This limitation renders the claim indefinite because it is unclear as to what quantity or amount of portions of the first and second circular slots are encompassed by “some portions”. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 1 recites the limitation "the respective extremities" in line 39. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 1 recites the limitation “the amplitude" in line 41. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an amplitude”.
Claim 1 recites the limitation "the maximum angular movement" in line 41. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a maximum angular movement”.
Claim 1 recites the limitation “when it is driven” in line 43. This limitation renders the claim indefinite because it is unclear as to which of the previously claimed structures “it” is referring to. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 2 recites the limitation “wherein the worm-and-wheel transmission is reversible”. This limitation renders the claim indefinite because it is unclear as to what Applicant is claiming with the term “reversible” (i.e. is applicant claiming the transmission can be turned on and off, can rotate in opposite first and second directions, can be placed into different modes). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 3 recites the limitation "the teeth" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a set of teeth”.
Claim 3 recites the limitation “is above 10°”. This limitation renders the claim indefinite because Applicant has not specified an upper limit to this range. Thus, the angle of inclination as claimed includes angles which may render the device inoperable (i.e. angles where the teeth are incapable of meshing with the threaded rod). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 4 recites the limitation “wherein it is configurable” in line 2. This limitation renders the claim indefinite because it is unclear as to which of the previously claimed structures “it” is referring to. For the purpose of examination, Examiner will interpret this limitation as “wherein the elbow orthosis”.
Claim 4 recites the limitation "the relative angular position" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a relative angular position”.
Claim 4 recites the limitation “some control parameters” in line 4. This limitation renders the claim indefinite because it is unclear as to what quantity or amount of control parameters are encompassed by “some control parameters”. This limitation is also unclear because control parameters lack antecedent basis in the claims. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 5 recites the limitation “wherein it includes” in line 2. This limitation renders the claim indefinite because it is unclear as to which of the previously claimed structures “it” is referring to. For the purpose of examination, Examiner will interpret this limitation as “wherein the elbow orthosis”.
Regarding claim 5, the phrase "box-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 8 recites the limitation “the at least one plate” in line 2. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, Examiner will interpret this limitation as “an edge of the at least one of the first and second plates”.
Claim 10 recites the limitation “wherein it includes” in line 2. This limitation renders the claim indefinite because it is unclear as to which of the previously claimed structures “it” is referring to. For the purpose of examination, Examiner will interpret this limitation as “wherein the elbow orthosis”.
Claim 11 recites the limitation “wherein it includes” in line 2. This limitation renders the claim indefinite because it is unclear as to which of the previously claimed structures “it” is referring to. For the purpose of examination, Examiner will interpret this limitation as “wherein the elbow orthosis”.
Claim 11 recites the limitation "the vicinity" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a vicinity”.
Claim 12 recites the limitation "the morphology and/or pathology" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a morphology and/or pathology”.
Claim 12 recites the limitation "this method" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the process”.
Claim 12 recites the limitation “including at least the following steps”. The recitation of “at least” renders the claim indefinite because it is unclear as to if there are additional unclaimed steps which are omitted. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 12 recites the limitation "the following steps" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a plurality of steps including”.
Claim 12 recites the limitation "the respective angular position" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a respective angular position”.
Claim 13 recites the limitation “wherein the worm-and-wheel transmission is reversible”. This limitation renders the claim indefinite because it is unclear as to what Applicant is claiming with the term “reversible” (i.e. is applicant claiming the transmission can be turned on and off, can rotate in opposite first and second directions, can be placed into different modes). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 14 recites the limitation "the relative angular position" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a relative angular position”.
Claim 14 recites the limitation “some control parameters” in line 4. This limitation renders the claim indefinite because it is unclear as to what quantity or amount of control parameters are encompassed by “some control parameters”. This limitation is also unclear because control parameters lack antecedent basis in the claims. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 14 recites the limitation "the passage" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a passage”.
Claim 14 recites the limitation "the most extended position" in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a most extended position”.
Claim 14 recites the limitation "the most flexed position" in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a most flexed position”.
Claim 15 recites the limitation “wherein it includes” in line 2. This limitation renders the claim indefinite because it is unclear as to which of the previously claimed structures “it” is referring to. For the purpose of examination, Examiner will interpret this limitation as “wherein the process”.
Claim 15 recites the limitation "the maximum relative angular movement" in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a maximum relative angular movement”.
Claims 6-7 and 9 are rejected under 35 U.S.C. 112(b) as being dependent from rejected claims, and thus, contain the same offending limitaitons.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over the non-patented literature titled “Active Elbow Orthosis” by Ripel et al. (hereinafter Ripel) in view of Hoffman et al. (US 2009/0326422 A1) (hereinafter Hoffman) and Johnson et al. (US 6,203,511 B1) (hereinafter Johnson).
In regards to claim 1, Ripel discloses an elbow orthosis (active elbow orthosis; see [abstract]; see figure 1) comprising a first fitting (upper arm portion) configured to be mounted on an arm (A) of a patient (P), a second fitting (lower arm portion) configured for being mounted on a forearm (F) of the patient (see figure 10), an articulation mechanism (gear box aluminum body, worm gear transmission (3), and strain gauge (2); see section 2.2; see figures 2 and 3) between the first and second fittings (upper and lower arm portions; see figure 1) and an electric gear-motor (1; see section 2.2; see figure 1) mounted on the first fitting (upper arm portion; see figure 10) for moving the second fitting with respect to the first fitting in rotation around a first rotation axis (A1) of the articulation mechanism (flexion/extension axis; see section 2.2), wherein
- an output shaft (output shaft connected to worm gear; see figure 1) of the electric gear-motor (1) is aligned on a second rotation axis (A2) perpendicular to the first rotation axis (see figures 1 and 3 that the worm gear (and therefore the output shaft of 1) is aligned perpendicular to the flexion/extension axis of the orthosis)
-the orthosis (AEO) is equipped with
an angular sensor (incremental rotary sensor; see section 2.3) for sensing the angular position of the second fitting with respect to the first fitting around the first rotation axis (see section 3.1 and figure 7 that the rotary sensor is utilized for measuring the angular range of the patient’s elbow joint (and thus, the upper and lower arm portions when the user’s arm is within the AEO) vs the force output of the patient or actuator), and
- a worm-and-wheel transmission (3) drives a rotation shaft (2), which defines the first rotation axis (2 causes the flexion/extension motion and thus, defines the flexion/extension axis), from the rotational movement of the output shaft (84) of the electric gear-motor (2 is rotated about the defined flexion/extension axis based on the rotational movement of the output shaft of 1, rotating the worm gear);
- the second fitting (lower arm portion) is secured to the rotation shaft (2; see figures 1 and 10); and
- a mechanical stop arrangement (aluminum stops; see section 2.2; see figure 3) is configured for limiting the angular movement of the second fitting (6) with respect to the first fitting (4) around the first rotation axis (the aluminum stops set and limit the maximum flexion/extension rotation of the orthosis; see section 2.2).
Ripel does not disclose - the orthosis is equipped with a torque sensor (628) for sensing a torque exerted on the articulation (14, 22) mechanism by the electric gear-motor (8); and
the mechanical stop arrangement (40) includes:
a first plate (402) provided with a first circular slot (4024) and a first series of through holes (4028) spread on a circle centered on a central axis (A402) of the first circular slot;
a second plate (404) provided with a second circular slot (4044) and a second series of through holes (4048) spread on a circle centered on a central axis (A404) of the second circular slot; and
a crank (408) secured to the rotation shaft (20) and equipped with a pin (409) engaged in the first and second circular slots (4024, 4044);
- the first and second plates (402, 404) are aligned on a common central axis (A1, A402, A404) and their relative orientation around this common axis is set by aligning at least one through hole (4028) of the first series with one through hole (4048) of the second series;
-some portions of the first and second circular slots (4024, 4044) overlap, depending on the orientation of the first and second plates around the common axis; and
- the respective extremities (4024A, 4024B, 4044A, 4044B) of the overlapping portions (S4A, S4B) of the first and second circular slots (4024, 4044) define the amplitude (y4o) of the maximum angular movement of the second fitting (6) with respect to the first fitting (4), around the first rotation axis (A1), when it is driven by the worm-and- wheel transmission (22).
However, Hoffman teaches an analogous elbow orthosis (30; see [0038]; see figure 2) in the same field of endeavor for aiding limb movement (see [0002]) comprising a first and second fitting (44 and 58; see figure 2) and an analogous articulation mechanism (48; see [0044]; see figure 7) for rotating the first and second fitting with respect to one another about a flexion/extension axis (see [0044]); - the orthosis (30) is equipped with
a torque sensor (sensor which gathers torque feedback; see [0057]) for sensing a torque exerted on the articulation (14, 22) mechanism by the electric gear-motor (see figure 12) for the purpose of improving the functionality of control circuitry which controls the motor, and therefore improving the functionality of the elbow orthosis, and to provide a determination of motor position which may be used to provide adjustable or programmable limits for orthosis movement (see [0056]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elbow orthosis as disclosed by Ripel and to have included the torque sensor of the elbow orthosis as taught by Hoffman in order to have provided an improved elbow orthosis that would add the benefit of providing an additional sensor for sensing relevant parameters and functions of the articulation mechanism, and the elbow orthosis that improve the functionality of control circuitry which controls the motor, and therefore improving the functionality of the elbow orthosis, and to provide a determination of motor position which may be used to provide adjustable or programmable limits for orthosis movement (see [0056]).
Ripel as now modified by Hoffman still does not disclose the mechanical stop arrangement (40) includes:
a first plate (402) provided with a first circular slot (4024) and a first series of through holes (4028) spread on a circle centered on a central axis (A402) of the first circular slot;
a second plate (404) provided with a second circular slot (4044) and a second series of through holes (4048) spread on a circle centered on a central axis (A404) of the second circular slot; and
a crank (408) secured to the rotation shaft (20) and equipped with a pin (409) engaged in the first and second circular slots (4024, 4044);
- the first and second plates (402, 404) are aligned on a common central axis (A1, A402, A404) and their relative orientation around this common axis is set by aligning at least one through hole (4028) of the first series with one through hole (4048) of the second series;
-some portions of the first and second circular slots (4024, 4044) overlap, depending on the orientation of the first and second plates around the common axis; and
- the respective extremities (4024A, 4024B, 4044A, 4044B) of the overlapping portions (S4A, S4B) of the first and second circular slots (4024, 4044) define the amplitude (y4o) of the maximum angular movement of the second fitting (6) with respect to the first fitting (4), around the first rotation axis (A1), when it is driven by the worm-and- wheel transmission (22).
However, Johnson teaches an analogous mechanical orthotic joint (10; see [col 3 ln 34-36]; see figure 1) which can be utilized in elbow orthotic devices (see [col 3 ln 45-50]) comprising a first fitting (12), second fitting (14; see [col 3 ln 54-55]; see figure 1), and an analogous mechanical stop arrangement (16, 18, and 20; see [col 3 ln 55]; see figure 1); the mechanical stop arrangement (16, 18, and 20) includes:
a first plate (16) provided with a first circular slot (54; see [col 4 ln 25-35]; see figure 6) and a first series of through holes (see [col 6 ln 55-57]) spread on a circle (56; see [col 4 ln 40]; see figure 6) centered on a central axis of the first circular slot (54; see figure 6);
a second plate (18) provided with a second circular slot (54) and a second series of through holes (see [col 6 ln 55-57]) spread on a circle (56) centered on a central axis of the second circular slot (54; see figure 6); and
a crank (20) secured to the rotation shaft (30; see [col 3 ln 58]; see figure 1) and equipped with a pin (22; see [col 3 ln 56]; see figure 1) engaged in the first and second circular slots (see figure 4);
- the first and second plates are aligned on a common central axis (see figure 4) and their relative orientation around this common axis is set by aligning at least one through hole of the first series with one through hole of the second series (aligning the holes after rotation and securing the rotational position using a set screw; see [col 6 ln 50-55]);
-some portions of the first and second circular slots (54) overlap, depending on the orientation of the first and second plates around the common axis (see figures 4 and 5); and
- the respective extremities (ends of 54) of the overlapping portions of the first and second circular slots (54) define the amplitude of the maximum angular movement of the second fitting (14) with respect to the first fitting (12), around the first rotation axis (see [col 6 ln 1-12]) for the purpose of defining an extent of pivotal movement of the first and second fittings which can be customized for providing numerous different ranges of flexion or extension (see [col 6 ln 10-30]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the mechanical stop arrangement as disclosed by Ripel as now modified by Hoffman for the two plate and crank mechanical stop arrangement as taught by Johnson in order to have provided an improved elbow orthosis that would add the benefit of providing a mechanical stop arrangement which can define an extent of pivotal movement of the first and second fittings which can be customized for providing numerous different ranges of flexion or extension (see [col 6 ln 10-30]).
Furthermore, such a modification is held to be obvious since it has been held that “(w)here a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509 (BPAI, 2007) (citing KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1396 (2007) (see MPEP 2143 I B). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results. In the instant case to substitute the mechanical stop arrangement as disclosed by Ripel for the mechanical stop arrangement of Johnson does not change the respective function of the mechanical stop arrangement and yields the predictable results of preventing undesired rotation of the first fitting with respect to the second fitting.
Thus, as now combined Ripel as now modified by Johnson discloses defining the amplitude of the maximum angular movement of the second fitting with respect to the first fitting when it is driven by the worm-and- wheel transmission (22) as claimed.
In regards to claim 2, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel further discloses wherein the worm-and-wheel transmission (3) is reversible, in such a way that a threaded rod (worm gear; see figure 3) of the worm-and-wheel transmission can drive a toothed wheel (worm wheel; see figure 3) of the worm-and-wheel transmission in a normal operation mode of the orthosis (exercise mode of the AEO; see section 3.2) and the toothed wheel can drive the threaded rod in a setting mode of the orthosis (calibration procedure of the AEO; see section 3.1, determination of an angular range requires the patient to manipulate the orthosis in which the worm wheel can drive the worm gear based on inputs from the user).
In regards to claim 3, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel further discloses wherein an inclination angle between the teeth of the toothed wheel and the first rotation axis is above 10° (see figure 1 that worm wheel and the teeth of the worm wheel perpendicularly extend the flexion/extension axis (defined by the red axle in the middle of the worm wheel) in a perpendicular plane about the axis; thus, the inclination angle between the teeth of the toothed wheel and the first rotation axis is 90°).
In regards to claim 4, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel as now modified by Johnson further discloses wherein it (AEO of Ripel) is configurable for use on a right or left arm (see Ripel section 1 that the AEO is defined for bilateral arm usability), by changing the relative angular position of the first plate (16 of Johnson) with respect to the second plate (18 of Johnson; see Johnson [col 6 ln 13-30] in reference to a first orientation (figure 4) providing 40° of right flexion and a second orientation (figure 5) providing 40° of left flexion; thus, disclosing that changing the angular position of 16 and 18 configures the orthosis for left or right limb flexion) and some control parameters of the electric gear-motor (1 of Ripel; see section 3.1 that the orthosis needs to be calibrated to the patient’s arm which determines the motor output for patient “zero activity”, thus, the orthosis and motor would need to be calibrated to each arm and control parameters of the motor would be changed based on said calibration).
In regards to claim 5, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel as now modified by Johnson further discloses wherein it (AEO of Ripel) includes a box-like structure (gearbox aluminum body of Ripel; see Ripel figures 1-3) for supporting the gear-motor (1 of Ripel), the worm-and-wheel transmission (3 of Ripel), the rotation shaft (2 of Ripel) and the mechanical stop arrangement (16, 18, and 20 of Johnson; see Ripel section 2.2 and figures 2 and 3 that the aluminum stops are within the aluminum gear box, thus, the mechanical stop of Johnson would be similarly positioned within the device of Ripel).
In regards to claim 6, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel further discloses wherein the box-like structure (gearbox aluminum body) includes four armatures (interior plate, external cover, plate which receives 1, and plate which houses worm gear; see figure 1 and 3) wherein the worm-and-wheel transmission (3) is mounted within the box-like structure (see figure 3), wherein the wheel (worm wheel) of the worm-and- wheel transmission is mounted on the rotation shaft (2; see figure 3) between two parallel armatures (interior plate and external cover; see figures 1-3) of the box-like structure and wherein the rotation shaft (2) is mounted on these two parallel armatures with a possibility of rotation (2 can rotate when mounted on the interior plate and external cover).
While it can be seen in Ripel figure 1 that the gearbox aluminum body is assembled together using a screw-like fastener. Ripel as now modified by Hoffman and Johnson does not explicitly disclose the four armatures are assembled together by screws. However, this limitation is drawn to an article of manufacture, and therefore the limitation(s) is/are considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process, since it has been held that “(e)ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113). In the instant case, the product assembled by screws in the product-by-process claim is the same as or obvious from a product of the prior art which is assembled using a similar fastener.
In regards to claim 7, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel as now modified by Johnson further discloses wherein at least one of the first and second plates (16 and 18 of Johnson) includes a graduation mark (52 of Johnson; see Johnson [col 4 ln 19] and figures 4-6) for identifying the relative orientation of the first and second plates (see Johnson [col 4 ln 19-25]).
In regards to claim 8, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel as now modified by Johnson further discloses wherein the graduation mark (52 of Johnson) is formed on an edge of the at least one plate (16 and 18 of Johnson; see figures 4-6 of Johnson).
In regards to claim 9, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel as now modified by Johnson further discloses wherein the first and/or second plate (16 and 18 of Johnson) is provided with a knurled zone (raised portion of Johnson; see [col 4 ln 23-24] of Johnson; a raised portion is a small projecting knob or ridge, and thus, be definition is a knurled zone).
In regards to claim 10, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel further discloses wherein it (AEO) includes a support member (see figure 4) for supporting at least the first and second fittings (4, 6), the electric gear-motor (8), the articulation mechanism (14, 22), the angular sensor (28), the torque sensor (628) and the worm-and-wheel transmission (22) with respect to a structure (the support member supports the entire AEO (and thus, the claimed structures of the AEO) with respect to a table structure).
In regards to claim 12, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel as now modified by Johnson further discloses a process for adapting a configuration of an elbow orthosis (2) according to claim 1 (see discussion above) to the morphology and/or pathology of a patient (see Ripel figure 10 that the AEO undergoes a process to adapt to a patient’s morphology and or pathology), this method including at least the following steps:
a) adjusting the respective angular position of the first and second plates (16 and 18 of Johnson) around their common central axis (A1, A402, A404), so as to define with their overlapping first and second circular slots a path (S4A, S4B) for the pin (22 of Johnson) mounted on the crank (20 of Johnson; see Johnson [col 6 ln 10-30]) secured to the rotation shaft (2 of Ripel); and
b) immobilizing the first and second plates (16 and 18 of Johnson) in their respective angular positions by insertion of a locking member (set screw; see Johnson [col 6 ln 50-55]) in one through hole of the first series and in one through hole of the second series (see Johnson [col 6 ln 50-55]).
In regards to claim 13, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel further discloses wherein the worm-and-wheel transmission (3) is reversible, in such a way that a threaded rod (worm gear; see figure 3) of the worm-and-wheel transmission can drive a toothed wheel (worm wheel; see figure 3) of the worm-and-wheel transmission in a normal operation mode of the orthosis (exercise mode of the AEO; see section 3.2) and the toothed wheel can drive the threaded rod in a setting mode of the orthosis (calibration procedure of the AEO; see section 3.1, determination of an angular range requires the patient to manipulate the orthosis in which the worm wheel can drive the worm gear based on inputs from the user), and the process includes a further step consisting in:
c) moving the second fitting (6) with respect to the first fitting (4), in rotation around the first rotation axis (A1), in order to align the first fitting on the arm (A) of the patient (P) and the second fitting on the forearm (F) of the patient when the electric gear-motor is not energized, using the reversibility of the worm-and-wheel transmission; and
d) securing the first fitting (4) to the arm of the patient and the second fitting (6) to the forearm of the patient (see figure 10 that prior to the exercise mode (i.e. prior to energizing the motor) the lower arm portion is rotated about the extension/flexion axis to align the upper and lower arm portions on the arm and forearm of the patient, and subsequently secured as claimed).
In regards to claim 14, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel as now modified by Johnson further discloses wherein the elbow orthosis is configurable for use on a right or left arm (see Ripel section 1 that the AEO is defined for bilateral arm usability), by changing the relative angular position of the first plate (16 of Johnson) with respect to the second plate (18 of Johnson; see Johnson [col 6 ln 13-30] in reference to a first orientation (figure 4) providing 40° of right flexion and a second orientation (figure 5) providing 40° of left flexion; thus, disclosing that changing the angular position of 16 and 18 configures the orthosis for left or right limb flexion) and some control parameters of the electric gear-motor (1 of Ripel; see section 3.1 that the orthosis needs to be calibrated to the patient’s arm which determines the motor output for patient “zero activity”, thus, the orthosis and motor would need to be calibrated to each arm and control parameters of the motor would be changed based on said calibration) and wherein the passage of a configuration for a left arm to a configuration for a right arm, or vice versa, occurs by inverting the most extended position and the most flexed position of the orthosis defined by the overlapping portions (S4A, S4B) of the first and second circulars slots (see Johnson [col 6 ln 10-30] in reference to changing the overlapping portions to define desired left and right maximum flexion angles (i.e. inverting the most extended and flexed position of the defined by the overlapping portions)).
In regards to claim 15, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel as now modified by Johnson further discloses wherein it includes a supplementary step implemented after b) (step b) discussed above) and consisting in:
e) moving the second fitting (lower arm portion of Ripel) with respect to the first fitting (upper arm portion of Ripel) around the first rotation axis (flexion/extension axis), while the electric gear-motor is not energized (see figure 10 in reference to “prior to the exercise mode” (i.e. prior to energizing the motor)), up to bringing the pin (22 of Johnson) into the respective extremities of the overlapping portion of the first and second circular slots (ends of the overlapping portions of 54 of Johnson) in order to assess the maximum relative angular movement of the first and second fitting around the first rotation axis (see Johnson [col 2 ln 10-25] and [col 3 ln 39-44] that the desired maximum relative angular movement is determined (i.e. assessed) and set by an orthotist or user; see Johnson [col 6 ln 18-20] that the maximum relative angular movement of 12 and 14 is limited by 22 coming into contact with the ends of the overlapping portions of 54 of 16 and 18; thus, to determine or asses the maximum relative angular movement of the first and second fitting around the first rotation axis of the elbow orthosis of Ripel after immobilizing the first and second plates of the the mechanical stop arrangement of Johnson (step b) of claim 12), a user, orthotist, or physiotherapist would move the second fitting with respect to the first fitting around the first rotation axis until the pin came into contact with the ends of the overlapping portions of the first and second circular slots as claimed).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ripel in view of Johnson and Hoffman as applied to claim 1 above, and further in view of Latt et al. (US 2020/0146862 A1) (hereinafter Latt).
In regards to claim 11, Ripel as now modified by Hoffman and Johnson discloses the invention as discussed above.
Ripel further discloses wherein it (AEO) includes a power source (1 is a DC motor Maxon RE36, which requires a power source; see section 2.2) for providing electric power to the electric gear-motor (1) and to an electronic control unit (control unit; see section 2.3; see figure 6) for controlling the electric gear-motor (1) and wherein the power source is either supported by one of the first and second fittings (4, 6) or located in the vicinity of the first and second fittings and connected to the electric gear-motor via a bundle of electrical wires (see figures 4 and 10 that a bundle of wires are connected to the orthosis and extend to a position under the table to an unseen power source (i.e. an outlet) which is located in the same room, and thus, the same vicinity as the AEO).
Ripel further discloses that the elbow orthosis is preferably usable in portable form, must be transportable to the patient’s home, and is required to be portable and easily handled by the patient (see sections 1 and 2.1).
Ripel as now modified by Hoffman and Johnson does not explicitly disclose the power source is a battery set.
However, Latt teaches an analogous elbow orthosis (102; see [0072]; see figure 4c) comprising a first fitting (upper component; see [0072]; see figure 4c), second fitting (lower component; see [0072]; see figure 4c), and an electric gear motor (108; see [0073]; see figure 7a) operationally fastened to a transmission (134 and 106; see [0073]; see figure 3a) for the analogous purpose of driving a flexion/extension rotation of the second fitting with respect to the first fitting to provide assisted motion to, and maintain the range of motion of the elbow (see [abstract]); wherein the elbow orthosis (102) includes a battery set (111; see [0079]; see figure 3a) for providing electric power to the electric gear-motor (108; see [0079]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the power source for electrically powering the electric gear-motor and electronic control circuit as disclosed by Ripel as now modified by Hoffman and Johnson by substituting the power source for the battery set as taught by Latt in order to have provided an improved power source that would increase the portability and ease of handling the elbow orthosis, allowing the elbow orthosis to operate in locations which do not have nearby electrical outlets. Thereby addressing the preferences and requirements established by Ripel sections 1 and 2.1.
Furthermore, such a modification is held to be obvious since it has been held that “(w)here a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509 (BPAI, 2007) (citing KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1396 (2007) (see MPEP 2143 I B). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results. In the instant case the substitution of the outlet power source of Ripel for the battery source of Latt does not change the respective functions of the power source, and yields the predictable results of providing power to the electrical components of the elbow orthosis.
Conclusion
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786