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 .
Election/Restrictions
Claims 9-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/25/2026.
Applicant's election with traverse of Group I in the reply filed on 5/25/2026 is acknowledged. The traversal is on the grounds that 1) independent claim 9 and independent claim 15 require every limitation of independent claim 1, and 2) there is no language within any of the method claims of Group III that would require the second velocity to be more than the first velocity. This is not found persuasive because:
The groups are viewed as inventions of a claim set, not just the independent claims. Group I and II or Group I and III are distinct because subcombination is not essential to combination. Group II or III does not require a spring-and-magnetic sensor of Group I to perform its functions. Conversely, Group I does not require the velocity analysis that Group II performs, nor the rotation angle analysis Group III performs. Where a combination as claimed does not require the details of the subcombination as separately claimed and the subcombination has separate utility, the inventions are distinct and restriction is proper.
Group II and III are distinct because they are related as process and apparatus for its practice, but distinct (The examiner notes, there was typo error in the restriction that compared Group I and III). Group III, the apparatus, can be used to practice another materially different process, which is the second velocity is less than the first velocity.
As such, Groups I, II, and III are distinct and separate. Different classifications or search queries are needed to search for all inventions, which impose a serious burden on the Office.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8 are under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 8 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). A stationary limb segment of the patient is part of the claimed limitation in claim 8.
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.
Claim 5 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 5 recites “an output” but claim 4, which claim 5 is dependent on, also recites “an output of the magnetic sensor” in line 8. It is unclear if claim 5 is referring to a new output of the magnetic sensor, in which case the claim should be amended to make it clear using adjectives (second, another, etc.) or if it is referring to the same output as claim 4. For the purpose of examination, the outputs are interpreted as the same.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20210401372A1 (Garudadri et. al), hereto referred as Garudadri.
As to claim 1, Garudadri teaches a system, comprising: a device for grasping a limb segment of a patient including a force sensor module configured to generate force data as a limb segment of the patient is moved between a first position and a second position ([0051], “During the experiment, the glove was worn and cycles of movement with the patient were performed, such as elbow flexion and extension, and the sensor recorded the force F (Newtons) versus time.”);
at least one inertial measurement unit (IMU) including an accelerometer, magnetometer and gyroscope ([0049], "spatially-resolved, force-dependent resistive sensor array and an inertial measurement unit (IMU) consisting of an accelerometer, gyroscope and a magnetometer"); and
a processor ([0062], “Processing hardware may include one or more processors”) in operable communication with the force sensor module and the at least one IMU, the processor including instructions that, when executed, cause the processor to:
collect force data from the force sensor module ([0006], "Force sensors may be employed to measure forces."), collect accelerometer data, gyroscopic data, and geomagnetic data from the at least one IMU ([0030], “The motion data may comprise magnetic field measurements, linear acceleration measurements, angular acceleration measurements, linear velocity measurements, angular velocity measurements, combinations thereof, and/or the like”), and
generate at least one clinically relevant measure of hypertonus based at least on the force data and one or more of the accelerometer data, gyroscopic data, and geomagnetic data ([0047], "The method of employing a patient simulation device to calibrate a hypertonicity measuring device may comprise computing a difference between two estimated powers" and rest of the paragraph).
As to claim 2, Garudadri teaches wherein the at least one clinically relevant measure of response is selected from the group consisting of: joint range of motion, presence of catch, percent range of motion at catch, presence of clonus, and score on the Modified Ashworth Scale (MAS) ([0003], "The current benchmark for assessing spasticity is the 6-point modified Ashworth score (MAS).").
As to claim 3, Garudadri teaches the force sensor module includes a first force sensor positioned on a thumb side of the device and a second force sensor positioned on a finger side of the device (Fig. 1A, [0031], "The sensor array may comprise a plurality of capacitive pressure sensors (e.g. 130, 131, 132, 133, 134, and 135). ").
As to claim 7, Garudadri teaches comprising a first IMU positioned on the device ([0031], "The hypertonicity measuring device 100 may comprise an inertial measurement unit 140").
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.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Garudadri as applied to claim 1 above, and further in view of US20060021452A1 (Kaijala, Murray), hereto referred as Kaijala).
Claim 1 is taught as above.
As to claim 4, Garudadri teaches each of the first force sensor and the second force sensor comprises: a first plate and a second plate (Garudadri, [0032], "The capacitive pressure sensor 200 may comprise a first electrode 250 and a second electrode 251.").
However, Garudadri does not teach that the first plate is positioned approximately parallel to the second plate; at least one spring positioned between the first plate and the second plate; at least one magnet positioned on the first plate; and at least one magnetic sensor positioned on the second plate, wherein an output of the magnetic sensor is based, at least in part, on a distance between the first plate and the second plate.
Kaijala teaches a solution to relevant problem of detecting force of a contact point between two objects (Kaijala, Abstract, “seat belt tension sensor”). Kaijala teaches:
the first plate is positioned approximately parallel to the second plate (Kaijala, [0019], "Assembly 20 has a housing 40 and anchor plate 60");
at least one spring positioned between the first plate and the second plate (Kaijala, [0029], "A coil spring 90 is mounted in spring channel 45. Spring 90 has ends 91 and 92. Spring channel 45 is defined by walls 94, 95 and 96 in housing 40. Spring end 92 is mounted over projection 69. The other spring end 91 rests against wall 96. Spring 90 is adapted to bias anchor plate 60 from housing 40 such that gap 80 is open.");
at least one magnet positioned on the first plate (Kaijala, [0032], "A magnetic field generator or magnet assembly 100 includes a magnet carrier 102 and a magnet 110"); and
at least one magnetic sensor positioned on the second plate, wherein an output of the magnetic sensor is based, at least in part, on a distance between the first plate and the second plate (Kaijala, [0041], "As housing 40 moves, hall effect device 82 is moved relative to magnet assembly 100 which is held fixed by fastener 200 through anchor plate 60.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Garudadri in view of Kaijala to include the above force sensor because both sensors are interchangeable methods of converting applied mechanical force into an electrical signal via displacement. It yields a predictable result of measuring force.
As to claim 5, Garudadri-Kaijala teaches an output of the magnetic sensor corresponds to a force applied to the first plate and the second plate (Garudadri, [0029], "The capacitive pressure sensor data may comprise force measurements.").
As to claim 6, Garudadri-Kaijala teaches the instruction to generate at least one clinically relevant measure of hypertonus based at least on the force data and one or more of the accelerometer data, gyroscopic data, and geomagnetic data further comprises: comparing force data generated by the first force sensor and force data generated by the second force sensor (Garudadri, [0047], "The method of employing a patient simulation device to calibrate a hypertonicity measuring device may comprise computing a difference between two estimated powers" and rest of the paragraph) when the limb segment is moved from the first position and the second position and from the second position to the first position (Garudadri, [0050], "The force sensor on the glove measured the contact force being applied to move a patient's limb."; [0005], "Studies using EMG sensors were carried out on patients with spasticity to characterize the patients' muscle tones under flexion and extension.")
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Garudadri as applied to claim 7 above, and further in view of US20090204031A1 (McNames et. al), hereto referred as McNames.
Claim 7 is taught as above.
As to claim 8, Garudadri teaches a first IMU, but does not teach a second IMU positioned on a stationary limb segment of the patient, although Garudadri hints at it (Garudadri, [0055], "The mock patient also has a gyroscope to sense the angular velocity v during flexion and extension"; the examiner notes, a second IMU is likely required to measure the angle with to a stationary reference). McNames teaches a relevant art of measuring motion (McNames, abstract). McNames teaches a second IMU positioned on a stationary limb segment of the patient (McNames, [0004], "Existing techniques track the movement of a multi-segment limb by placing an IMU at each segment of the limb"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Garudadri in view of McNames to include a second IMU positioned on a stationary limb segment of the patient so that a reference position may be measured which is a known technique with predictable results of measuring angular velocity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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