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 .
Amendment Entered
In response to the amendment filed on January 15th, 2026, amended claims 1, 5, 10-12, 14, and 19 are entered.
Response to Arguments
Applicant's remarks and amendments with respect to the double patenting rejections have been fully considered. Although the terminal disclaimer has been disapproved, the rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1, 3-6, 11, and 13-16 are objected to because of the following informalities:
Claim 1 recites “one or more compartments” in line 9, but should read “one or more of the individual compartments of the plurality of segmented compartments”
Claim 3 recites “claim 1 further” in line 1, but should read “claim 1, further”
Claim 4 recites “when the compartments” in line 1, but should read “when the one or more of the individual compartments of the plurality of segmented compartments”
Claim 5 recites “one or more compartments” in lines 1-2, but should read “one or more of the individual compartments of the plurality of segmented compartments”
Claim 6 recites “claim 5 further” in line 1, but should read “claim 5, further”
Claim 6 recites “one or more compartments” in line 1, but should read “one or more of the individual compartments of the plurality of segmented compartments”
Claim 11 recites “the plurality of segmented compartments” in lines 4-5, but should read “the plurality of internal segmented compartments”
Claim 11 recites “inflate the compartments” in line 9, but should read “inflate the plurality of internal segmented compartments”
Claim 13 recites “claim 11 further” in line 1, but should read “claim 11, further”
Claim 14 recites “when the compartments” in line 1, but should read “when the plurality of internal segmented compartments”
Claim 15 recites “claim 11 further” in line 1, but should read “claim 11, further”
Claim 15 recites “one or more compartments” in lines 1-2, but should read “one or more of the individual compartments of the plurality of internal segmented compartments”
Claim 16 recites “claim 15 further” in line 1, but should read “claim 15, further”
Claim 16 recites “one or more compartments” in lines 1-2, but should read “one or more of the individual compartments of the plurality of internal segmented compartments”
Appropriate correction is required.
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:
“pneumatic control system” in Claim 1: [0050] of the Applicant’s Specification recites wherein “the pneumatic control system 80 may include a pneumatic distribution and control apparatus 82 and a user interface system 84 either with manual dials or knobs 86 or controllable via the robotic and/or navigated system 60”
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.
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
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 1-10, 12-14, and 16-18 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 patient’s spine" in line 10. There is insufficient antecedent basis for this limitation in the claim. In order to overcome the rejection, the Examiner suggests that the claim be amended to recite “a spine of the patient” instead.
Claim 1 recites the limitation "the amount of force applied" in line 11. There is insufficient antecedent basis for this limitation in the claim. In order to overcome the rejection, the Examiner suggests that the claim be amended to recite “an amount of the force applied” instead.
Claim 6 recites the limitation “the curve on a concave side” in line 2. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear as to whether this limitation is supposed to be referring to the previously introduced limitation of “a curve” from Claim 5, or a separate element.
Claim 7 recites “The system of claim 1” in line 1. It is unclear as to whether this limitation is referring to the previously introduced “pneumatic control system” of Claim 1, “computer system” of Claim 1, or a separate element. Claim 8 is dependent on Claim 7 and further recites “The system of claim 7” in line 1. Similar to Claim 7, it is unclear as to whether this limitation is referring to the previously introduced “pneumatic control system” of Claim 1, “computer system” of Claim 1, or a separate element.
Claim 7 recites “a front” in line 1. It is unclear as to whether this limitation is referring to the previously introduced “a front of the vest” from Claim 1, or a separate element.
Claim 7 recites “a back” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “a back of the vest” from Claim 1, or a separate element.
Claim 7 recites “sides” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “a first side of the vest” and “a second side of the vest” from Claim 1, or a separate element.
Claim 8 recites “a first series of compartments are aligned along the front of the vest” in lines 1-2. It is unclear as to whether this limitation is referring to the previously introduced “eight individual compartments aligned along a front of the vest” from Claim 1, or a separate element.
Claim 8 recites “a second series of compartments are aligned along the back of vest” in lines 2-3. It is unclear as to whether this limitation is referring to the previously introduced “eight individual compartments aligned along a back of the vest” from Claim 1, or a separate element.
Claim 8 recites “third and fourth series of compartments are aligned along the sides of the vest” in lines 3-4. It is unclear as to whether this limitation is referring to the previously introduced “six individual compartments aligned along a first side of the vest, and six individual compartments aligned along a second side of the vest”, respectively, from Claim 1, or a separate element.
Claim 9 recites “The system of claim 1” in line 1. It is unclear as to whether this limitation is referring to the previously introduced “pneumatic control system” of Claim 1, “computer system” of Claim 1, or a separate element. Claim 10 is dependent on Claim 9 and further recites “The system of claim 9” in line 1. Similar to Claim 9, it is unclear as to whether this limitation is referring to the previously introduced “pneumatic control system” of Claim 1, “computer system” of Claim 1, or a separate element.
Claim 12 recites the limitation "the spine" in line 2. There is insufficient antecedent basis for this limitation in the claim. In order to overcome the rejection, the Examiner suggests that the claim be amended to recite “a spine of the patient” instead.
Claim 13 recites the limitation "the spine" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the curve on a concave side” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear as to whether this limitation is supposed to be referring to the previously introduced limitation of “a curve” from Claim 15, or a separate element.
Claim 17 recites “a front” in line 1. It is unclear as to whether this limitation is referring to the previously introduced “a front of the vest” from Claim 11, or a separate element.
Claim 17 recites “a back” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “a back of the vest” from Claim 11, or a separate element.
Claim 17 recites “sides” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “a first side of the vest” and “a second side of the vest” from Claim 11, or a separate element.
Claim 18 recites “a first series of compartments are aligned along the front of the vest” in lines 1-2. It is unclear as to whether this limitation is referring to the previously introduced “eight individual compartments aligned along a front of the vest” from Claim 11, or a separate element.
Claim 18 recites “a second series of compartments are aligned along the back of vest” in lines 2-3. It is unclear as to whether this limitation is referring to the previously introduced “eight individual compartments aligned along a back of the vest” from Claim 11, or a separate element.
Claim 18 recites “third and fourth series of compartments are aligned along the sides of the vest” in lines 3-4. It is unclear as to whether this limitation is referring to the previously introduced “six individual compartments aligned along a first side of the vest, and six individual compartments aligned along a second side of the vest”, respectively, from Claim 11, or a separate element.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 17 recites “The system of claim 11” in line 1. Claim 18 recites “The system of claim 17” in line 1. Claim 19 recites “The system of claim 11” in line 1. Claim 20 recites “The system of claim 19” in line 1. Each of these claims fail to further limit the subject matter of the claim upon which it depends because these claims further limit a “system” even though they all depend from Claim 11, which recites a “method”. In order to overcome the rejections, the Examiner suggests that the claims be amended to recite “method” instead of “system”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 5-12 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Reiley (U.S. Publication No. 2011/0054373; previously cited) in view of Sjoquist et al (U.S. Publication No. 2023/0197273; previously cited) and Sklar et al (U.S. Patent No. 11,471,231).
Regarding Claim 1, Reiley discloses a method for preoperatively assessing a patient (Systems, devices, and methods for diagnosing and treating conditions of the spine; Abstract), the method comprising:
positioning a vest having a plurality of segmented compartments (As shown in FIG. 3C, the garment 10 includes a series of expandable segments 30…the actuators 32 are operated to apply coordinated external pressure to the vertebrae in regions of the spine; [0034-0038]; Figures 3C-3E) around a torso of the patient (the garment 10 includes a vest region 12, with arm and neck openings 14 and 16, so that the vest region 12 can be comfortable worn on the upper torso, as FIGS. 4A and 4B show; [0030]), the plurality of segmented compartments comprising individual compartments aligned along a front of the vest (In FIG. 3C, there are also expandable segments 30 carried on the front of the garment 10, in the pantaloon region 18, that register over opposite lateral sides of the anterior superior iliac spine (ASIS) to affect bone movement along the sacroiliac joint. This is also shown in FIG. 12; [0039]), eight individual compartments aligned along a back of the vest (the garment 10 includes a series of expandable segments 30. The expandable segments 30 are precisely positioned to align, when the garment 10 is worn, with groups of vertebrae or individual vertebrae along the thoracic, lumbar, and sacral regions of the spine, as well as with pelvic bones affecting the sacroiliac joint, as FIG. 6 shows; [0034]; The size and configuration of the expandable segments 30 can vary…in FIG. 3E, there are separate expandable segments 30 for each vertebra in the thoracic and lumbar regions; [0039-0040]; In an alternative embodiment (see FIG. 14), the actuators 32 can be sized and configured to enlarge more on one lateral side (left or right) of a vertebral level than another. For example, the balloons 30 at one or more vertebral levels can be formed to preferentially expand more on one lateral side than other, e.g., by the inclusion of individual right and left lateral size chambers 40 and 42 separated by a septum 44. The chambers 40 and 42 are coupled to individual inflation tubing. Inflation of only a right side chamber 40 (and not the left side chamber 42)—or vice versa—press against only the affected side of the adjacent vertebrae of the individual wearing the garment 10. Thus, more precise and preferential ranges of movement can be provided to lead to greater degrees diagnostic accuracy; [0043]; Examiner’s Note: Figures 3E and 14 shows at least eight individual compartments);
attaching the vest to a pneumatic control system (Tubing 40 individually couples each expandable body to a source of expansion air or (desirably) liquid (see FIG. 5); [0041]);
inflating one or more compartments of the vest via the pneumatic control system to apply a force to the patient’s spine (Tubing 40 individually couples each expandable body to a source of expansion air or (desirably) liquid (see FIG. 5) that does not degrade the actuator or interfere with imaging, so that each expandable body can be selectively enlarged or collapsed in a controlled manner by the caregiver, as desired, see FIGS. 6 and 7 show; [0041]);
monitoring the amount of force applied and any movement of the spine (While the individual wearing the garment 10 lays supine to undergo imaging (as FIGS. 5, 6, and 7 show), the actuators 32 are operated to apply coordinated external pressure to the vertebrae in regions of the spine. Operation of the actuators 32 affects predictable movements of the spine in desired directions, while imaging occurs, with the objective to cause an incident of back pain that can be coordinated with spine orientation and thereby lead to a diagnosis of the source of the back pain. That is, the incident of back pain can be correlated to an orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify the particular bone or bones which are being moved to cause the back pain; [0038]).
Although Reiley teaches multiple individual compartments aligned along a front and back of the vest that could be used to target lateral sides of the patient (In an alternative embodiment (see FIG. 14), the actuators 32 can be sized and configured to enlarge more on one lateral side (left or right) of a vertebral level than another. For example, the balloons 30 at one or more vertebral levels can be formed to preferentially expand more on one lateral side than other, e.g., by the inclusion of individual right and left lateral size chambers 40 and 42 separated by a septum 44; [0043]), Reiley fails to specifically teach eight individual compartments aligned along a front of the vest, six individual compartments aligned along a first side of the vest, and six individual compartments aligned along a second side of the vest.
In a similar technical field, Sklar teaches a therapeutic garment (FIG. 6 is a still further embodiment of the therapeutic garment, wherein the therapeutic garment is incorporated into a tank top 100 having shoulder straps 102, 104; Column 5 Lines 6-8), comprising a plurality of segmented compartments (interconnected channels 120; Column 5 Lines 16-40) comprising eight individual compartments aligned along a front of the vest (see elements 140, 142, 144, 146, 148, 158, 160, 162, 164, 166, and 168 in Figure 7A, which include at least eight individual compartments aligned along the front), multiple individual compartments aligned along a first side of the vest (see elements 132, 134, 136, and 138 in Figure 7A), and multiple individual compartments aligned along a second side of the vest (see elements 150, 152, 154, and 156 in Figure 7A).
Techmed-202.1-2-It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pressure subassembly teachings of Sklar into the invention of Reiley in order provide a qualified degree of compression to the patient around their abdomen and hips and monitor the measured effects of the qualified degree of compression as a potential predictor of treatment efficacy (Sklar Column 7 Line 67 – Column 8 Line 7). Furthermore, although Sklar only teaches four individual compartments aligned along a first side of the vest and four individual compartments aligned along a second side of the vest, it has been held that "mere duplication of parts has no patentable significance unless a new and unexpected result is produced." MPEP 2144.04 VI. B.; In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention.
Reiley and Sklar fail to disclose positioning reference sensors around a torso of the patient; and monitoring by a computer.
In a similar technical field, Sjoquist teaches a medical wearable matching system (Abstract), comprising: positioning a vest (a vest type wearable article 702; [0138]; Figure 7) having reference sensors around a torso of the patient (The medical device 700 includes the wearable article 702 with a support structure 704 that houses various components such as signal source components, one or more external signal source components 742; [0138]); and
monitoring by a computer (an electronic main unit 720 in communication with the components components of the wearable article 702…signal source components include sensors and/or transducers, to collect health signals associated with health parameters relevant assessing the patient for health events. Health parameters may include any combination of patient physiological parameters, patient state parameters, system parameters, and environmental parameters. Other types of signal source components are possible, including clocks to track time and date. Signals from the various source components feed into detectors for processing and generating of associated health data; [0138-0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the computer teachings of Sjoquist into those of Reiley and Sklar in order to enable processing of the data and generating of associated health data (Sjoquist [0139]).
Regarding Claim 2, Reiley discloses wherein a preoperative spine stiffness is determined by the amount of force applied by the vest and any movement of the spine (in FIG. 8, only the expandable segments 30 for the thoracic and sacral regions are selectively enlarged (the expandable segments 30 in the lumbar region not being enlarged), to determine what effect simulated flexion may have on back pain and the spine. Or, as shown in FIG. 9, only the expandable segments 30 in the lumbar region can be selectively enlarged (the expandable segments 30 for the thoracic and sacral regions not being enlarged), to determine what effect extension may have on back pain and the spine. To test the sacroiliac joint (as FIGS. 10 and 11 show), both expandable segments 30 on the ASIS can be enlarged, along with the expandable segment for the sacral region (if desired), to stress the sacroiliac joint from two directions. Once an incident of back pain is generated, the incident of pain can be correlated to the orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify which movement of particular bone or bones, or which orientation of the spine, causes the back pain. The garment 10 can also be used as a diagnostic tool in and of itself, without the use of imaging. For example, by enlarging both expandable segments 30 on the ASIS along with the expandable segment 30 for the sacral region, the sacroiliac joint can be stressed from two directions. If the sacroiliac joint is a pain generator when stressed in this manner, this alone can serve as a diagnosis of dysfunction at the sacroiliac joint; [0045-0047]).
Regarding Claim 5, Reiley discloses inflating one or more compartments in the vest to apply the force to an apex on a convex side of a curve of the spine (as shown in FIG. 9, only the expandable segments 30 in the lumbar region can be selectively enlarged (the expandable segments 30 for the thoracic and sacral regions not being enlarged), to determine what effect extension may have on back pain and the spine; [0045]).
Regarding Claim 6, Reiley discloses inflating one or more compartments in the vest to apply forces on proximal and distal ends of the curve on a concave side of the spine to create a three-point bend of the patient’s spine (For example, in FIG. 8, only the expandable segments 30 for the thoracic and sacral regions are selectively enlarged (the expandable segments 30 in the lumbar region not being enlarged), to determine what effect simulated flexion may have on back pain and the spine; [0045]).
Regarding Claim 7, Reiley discloses wherein the vest includes a front configured to cover an anterior side of the patient, a back configured to cover a posterior side of the patient, sides connecting the front and back configured to cover lateral sides of the patient, shoulder portions configured to rest on shoulders of the patient, and a waist section configured to rest near a waist of the patient (the garment 10 includes a vest region 12, with arm and neck openings 14 and 16, so that the vest region 12 can be comfortable worn on the upper torso, as FIGS. 4A and 4B show…see FIGS. 3B, 3C, and 4C, the vest region 12 includes overlapping left and right flaps 22 and 24 that open to allow a person to put the vest region 12; [0030-0032]; Figures 3A-4C).
Regarding Claim 8, Reiley discloses wherein a first series of compartments are aligned along the front of the vest to target an anterior of the spine (In FIG. 3C, there are also expandable segments 30 carried on the front of the garment 10, in the pantaloon region 18, that register over opposite lateral sides of the anterior superior iliac spine (ASIS) to affect bone movement along the sacroiliac joint. This is also shown in FIG. 12; [0039]), and a second series of compartments are aligned along the back of vest to target a posterior of the spine (The size and configuration of the expandable segments 30 can vary. In a representative embodiment shown in FIG. 3C, a single, axially elongated expandable segment for the substantially the entire thoracic region is shown…there are a plurality of individual expandable segments 30 in the lumbar region; [0039]).
Although Reiley teaches multiple individual compartments aligned along a front and back of the vest that could be used to target lateral sides of the patient (In an alternative embodiment (see FIG. 14), the actuators 32 can be sized and configured to enlarge more on one lateral side (left or right) of a vertebral level than another. For example, the balloons 30 at one or more vertebral levels can be formed to preferentially expand more on one lateral side than other, e.g., by the inclusion of individual right and left lateral size chambers 40 and 42 separated by a septum 44; [0043]), Reiley fails to specifically teach wherein the third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine.
In a similar technical field, Sklar teaches a therapeutic garment (FIG. 6 is a still further embodiment of the therapeutic garment, wherein the therapeutic garment is incorporated into a tank top 100 having shoulder straps 102, 104; Column 5 Lines 6-8), comprising a plurality of segmented compartments (interconnected channels 120; Column 5 Lines 16-40) comprising third (see elements 132, 134, 136, and 138 in Figure 7A) and fourth (see elements 150, 152, 154, and 156 in Figure 7A) series of compartments are aligned along the sides of the vest to target lateral areas of the spine (Examiner’s Note: The series of compartments are capable of being used in the manner claimed. An apparatus claim should cover what a device is, not what it does. MPEP 2114 (I). “A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.” MPEP 2114 (II) citing Ex parte Masham, 2 USPQ2d 1647).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pressure subassembly teachings of Sklar into the invention of Reiley in order provide a qualified degree of compression to the patient around their abdomen and hips and monitor the measured effects of the qualified degree of compression as a potential predictor of treatment efficacy (Sklar Column 7 Line 67 – Column 8 Line 7).
Regarding Claim 9, Reiley discloses receiving patient specific data from the vest (While the individual wearing the garment 10 lays supine to undergo imaging (as FIGS. 5, 6, and 7 show), the actuators 32 are operated to apply coordinated external pressure to the vertebrae in regions of the spine. Operation of the actuators 32 affects predictable movements of the spine in desired directions, while imaging occurs, with the objective to cause an incident of back pain that can be coordinated with spine orientation and thereby lead to a diagnosis of the source of the back pain. That is, the incident of back pain can be correlated to an orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify the particular bone or bones which are being moved to cause the back pain; [0038]).
Regarding Claim 10, Reiley discloses wherein the patient specific data includes biomechanical information and/or preoperative metrics of the patient (in FIG. 8, only the expandable segments 30 for the thoracic and sacral regions are selectively enlarged (the expandable segments 30 in the lumbar region not being enlarged), to determine what effect simulated flexion may have on back pain and the spine. Or, as shown in FIG. 9, only the expandable segments 30 in the lumbar region can be selectively enlarged (the expandable segments 30 for the thoracic and sacral regions not being enlarged), to determine what effect extension may have on back pain and the spine. To test the sacroiliac joint (as FIGS. 10 and 11 show), both expandable segments 30 on the ASIS can be enlarged, along with the expandable segment for the sacral region (if desired), to stress the sacroiliac joint from two directions. Once an incident of back pain is generated, the incident of pain can be correlated to the orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify which movement of particular bone or bones, or which orientation of the spine, causes the back pain. The garment 10 can also be used as a diagnostic tool in and of itself, without the use of imaging. For example, by enlarging both expandable segments 30 on the ASIS along with the expandable segment 30 for the sacral region, the sacroiliac joint can be stressed from two directions. If the sacroiliac joint is a pain generator when stressed in this manner, this alone can serve as a diagnosis of dysfunction at the sacroiliac joint; [0045-0047]).
Regarding Claim 11, Reiley discloses a method for preoperatively assessing a patient (Systems, devices, and methods for diagnosing and treating conditions of the spine; Abstract), the method comprising: providing a system for monitoring the patient, the system including:
a wearable vest (the garment 10 includes a vest region 12, with arm and neck openings 14 and 16, so that the vest region 12 can be comfortable worn on the upper torso, as FIGS. 4A and 4B show; [0030]) having a plurality of internal segmented compartments (As shown in FIG. 3C, the garment 10 includes a series of expandable segments 30…the actuators 32 are operated to apply coordinated external pressure to the vertebrae in regions of the spine; [0034-0038]; Figures 3C-3E), the plurality of segmented compartments comprising individual compartments aligned along a front of the vest (In FIG. 3C, there are also expandable segments 30 carried on the front of the garment 10, in the pantaloon region 18, that register over opposite lateral sides of the anterior superior iliac spine (ASIS) to affect bone movement along the sacroiliac joint. This is also shown in FIG. 12; [0039]), eight individual compartments aligned along a back of the vest (the garment 10 includes a series of expandable segments 30. The expandable segments 30 are precisely positioned to align, when the garment 10 is worn, with groups of vertebrae or individual vertebrae along the thoracic, lumbar, and sacral regions of the spine, as well as with pelvic bones affecting the sacroiliac joint, as FIG. 6 shows; [0034]; The size and configuration of the expandable segments 30 can vary…in FIG. 3E, there are separate expandable segments 30 for each vertebra in the thoracic and lumbar regions; [0039-0040]; In an alternative embodiment (see FIG. 14), the actuators 32 can be sized and configured to enlarge more on one lateral side (left or right) of a vertebral level than another. For example, the balloons 30 at one or more vertebral levels can be formed to preferentially expand more on one lateral side than other, e.g., by the inclusion of individual right and left lateral size chambers 40 and 42 separated by a septum 44. The chambers 40 and 42 are coupled to individual inflation tubing. Inflation of only a right side chamber 40 (and not the left side chamber 42)—or vice versa—press against only the affected side of the adjacent vertebrae of the individual wearing the garment 10. Thus, more precise and preferential ranges of movement can be provided to lead to greater degrees diagnostic accuracy; [0043]; Examiner’s Note: Figures 3E and 14 shows at least eight individual compartments),
a pump connected to the vest and configured to inflate the compartments of the vest (Tubing 40 individually couples each expandable body to a source of expansion air or (desirably) liquid (see FIG. 5) that does not degrade the actuator or interfere with imaging, so that each expandable body can be selectively enlarged or collapsed in a controlled manner by the caregiver, as desired, see FIGS. 6 and 7 show; [0041]); and
receiving patient specific data from the vest (While the individual wearing the garment 10 lays supine to undergo imaging (as FIGS. 5, 6, and 7 show), the actuators 32 are operated to apply coordinated external pressure to the vertebrae in regions of the spine. Operation of the actuators 32 affects predictable movements of the spine in desired directions, while imaging occurs, with the objective to cause an incident of back pain that can be coordinated with spine orientation and thereby lead to a diagnosis of the source of the back pain. That is, the incident of back pain can be correlated to an orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify the particular bone or bones which are being moved to cause the back pain; [0038]).
Although Reiley teaches multiple individual compartments aligned along a front and back of the vest that could be used to target lateral sides of the patient (In an alternative embodiment (see FIG. 14), the actuators 32 can be sized and configured to enlarge more on one lateral side (left or right) of a vertebral level than another. For example, the balloons 30 at one or more vertebral levels can be formed to preferentially expand more on one lateral side than other, e.g., by the inclusion of individual right and left lateral size chambers 40 and 42 separated by a septum 44; [0043]), Reiley fails to specifically teach eight individual compartments aligned along a front of the vest, six individual compartments aligned along a first side of the vest, and six individual compartments aligned along a second side of the vest.
In a similar technical field, Sklar teaches a therapeutic garment (FIG. 6 is a still further embodiment of the therapeutic garment, wherein the therapeutic garment is incorporated into a tank top 100 having shoulder straps 102, 104; Column 5 Lines 6-8), comprising a plurality of segmented compartments (interconnected channels 120; Column 5 Lines 16-40) comprising eight individual compartments aligned along a front of the vest (see elements 140, 142, 144, 146, 148, 158, 160, 162, 164, 166, and 168 in Figure 7A, which include at least eight individual compartments aligned along the front), multiple individual compartments aligned along a first side of the vest (see elements 132, 134, 136, and 138 in Figure 7A), and multiple individual compartments aligned along a second side of the vest (see elements 150, 152, 154, and 156 in Figure 7A).
Techmed-202.1-2-It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pressure subassembly teachings of Sklar into the invention of Reiley in order provide a qualified degree of compression to the patient around their abdomen and hips and monitor the measured effects of the qualified degree of compression as a potential predictor of treatment efficacy (Sklar Column 7 Line 67 – Column 8 Line 7). Furthermore, although Sklar only teaches four individual compartments aligned along a first side of the vest and four individual compartments aligned along a second side of the vest, it has been held that "mere duplication of parts has no patentable significance unless a new and unexpected result is produced." MPEP 2144.04 VI. B.; In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention.
Reiley and Sklar fail to disclose a computer in electronic communication with the wearable vest; and receiving, at the computer, patient specific data.
In a similar technical field, Sjoquist teaches a medical wearable matching system (Abstract), comprising: a wearable vest (a vest type wearable article 702; [0138]; Figure 7),
a computer in electronic communication with the wearable vest (an electronic main unit 720 in communication with the components of the wearable article 702. In some implementations, the main unit 720 may be carried by the patient separately from the support structure 704, such as with a purse, belt, strap over the shoulder, and so on; [0138]); and
receiving, at the computer, patient specific data (Signal source components include sensors and/or transducers, to collect health signals associated with health parameters relevant assessing the patient for health events. Health parameters may include any combination of patient physiological parameters, patient state parameters, system parameters, and environmental parameters. Other types of signal source components are possible, including clocks to track time and date. Signals from the various source components feed into detectors for processing and generating of associated health data; [0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the computer teachings of Sjoquist into those of Reiley and Sklar in order to enable processing of the data and generating of associated health data (Sjoquist [0139]).
Regarding Claim 12, Reiley discloses wherein a preoperative spine stiffness is determined by an amount of force applied by the vest and any movement of the spine (in FIG. 8, only the expandable segments 30 for the thoracic and sacral regions are selectively enlarged (the expandable segments 30 in the lumbar region not being enlarged), to determine what effect simulated flexion may have on back pain and the spine. Or, as shown in FIG. 9, only the expandable segments 30 in the lumbar region can be selectively enlarged (the expandable segments 30 for the thoracic and sacral regions not being enlarged), to determine what effect extension may have on back pain and the spine. To test the sacroiliac joint (as FIGS. 10 and 11 show), both expandable segments 30 on the ASIS can be enlarged, along with the expandable segment for the sacral region (if desired), to stress the sacroiliac joint from two directions. Once an incident of back pain is generated, the incident of pain can be correlated to the orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify which movement of particular bone or bones, or which orientation of the spine, causes the back pain. The garment 10 can also be used as a diagnostic tool in and of itself, without the use of imaging. For example, by enlarging both expandable segments 30 on the ASIS along with the expandable segment 30 for the sacral region, the sacroiliac joint can be stressed from two directions. If the sacroiliac joint is a pain generator when stressed in this manner, this alone can serve as a diagnosis of dysfunction at the sacroiliac joint; [0045-0047]).
Regarding Claim 15, Reiley discloses inflating one or more compartments in the vest to apply a force to an apex on a convex side of a curve of the spine (as shown in FIG. 9, only the expandable segments 30 in the lumbar region can be selectively enlarged (the expandable segments 30 for the thoracic and sacral regions not being enlarged), to determine what effect extension may have on back pain and the spine; [0045]).
Regarding Claim 16, Reiley discloses inflating one or more compartments in the vest to apply forces on proximal and distal ends of the curve on a concave side of the spine to create a three-point bend of the patient’s spine (For example, in FIG. 8, only the expandable segments 30 for the thoracic and sacral regions are selectively enlarged (the expandable segments 30 in the lumbar region not being enlarged), to determine what effect simulated flexion may have on back pain and the spine; [0045]).
Regarding Claim 17, Reiley discloses wherein the vest includes a front configured to cover an anterior side of the patient, a back configured to cover a posterior side of the patient, sides connecting the front and back configured to cover lateral sides of the patient, shoulder portions configured to rest on shoulders of the patient, and a waist section configured to rest near a waist of the patient (the garment 10 includes a vest region 12, with arm and neck openings 14 and 16, so that the vest region 12 can be comfortable worn on the upper torso, as FIGS. 4A and 4B show…see FIGS. 3B, 3C, and 4C, the vest region 12 includes overlapping left and right flaps 22 and 24 that open to allow a person to put the vest region 12; [0030-0032]; Figures 3A-4C).
Regarding Claim 18, Reiley discloses wherein a first series of compartments are aligned along the front of the vest to target an anterior of the spine (In FIG. 3C, there are also expandable segments 30 carried on the front of the garment 10, in the pantaloon region 18, that register over opposite lateral sides of the anterior superior iliac spine (ASIS) to affect bone movement along the sacroiliac joint. This is also shown in FIG. 12; [0039]), and a second series of compartments are aligned along the back of vest to target a posterior of the spine (The size and configuration of the expandable segments 30 can vary. In a representative embodiment shown in FIG. 3C, a single, axially elongated expandable segment for the substantially the entire thoracic region is shown…there are a plurality of individual expandable segments 30 in the lumbar region; [0039]).
Although Reiley teaches multiple individual compartments aligned along a front and back of the vest that could be used to target lateral sides of the patient (In an alternative embodiment (see FIG. 14), the actuators 32 can be sized and configured to enlarge more on one lateral side (left or right) of a vertebral level than another. For example, the balloons 30 at one or more vertebral levels can be formed to preferentially expand more on one lateral side than other, e.g., by the inclusion of individual right and left lateral size chambers 40 and 42 separated by a septum 44; [0043]), Reiley fails to specifically teach wherein the third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine.
In a similar technical field, Sklar teaches a therapeutic garment (FIG. 6 is a still further embodiment of the therapeutic garment, wherein the therapeutic garment is incorporated into a tank top 100 having shoulder straps 102, 104; Column 5 Lines 6-8), comprising a plurality of segmented compartments (interconnected channels 120; Column 5 Lines 16-40) comprising third (see elements 132, 134, 136, and 138 in Figure 7A) and fourth (see elements 150, 152, 154, and 156 in Figure 7A) series of compartments are aligned along the sides of the vest to target lateral areas of the spine (Examiner’s Note: The series of compartments are capable of being used in the manner claimed. An apparatus claim should cover what a device is, not what it does. MPEP 2114 (I). “A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.” MPEP 2114 (II) citing Ex parte Masham, 2 USPQ2d 1647).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pressure subassembly teachings of Sklar into the invention of Reiley in order provide a qualified degree of compression to the patient around their abdomen and hips and monitor the measured effects of the qualified degree of compression as a potential predictor of treatment efficacy (Sklar Column 7 Line 67 – Column 8 Line 7).
Regarding Claim 19, Reiley discloses wherein the patient specific data includes biomechanical information and/or preoperative metrics of the patient (in FIG. 8, only the expandable segments 30 for the thoracic and sacral regions are selectively enlarged (the expandable segments 30 in the lumbar region not being enlarged), to determine what effect simulated flexion may have on back pain and the spine. Or, as shown in FIG. 9, only the expandable segments 30 in the lumbar region can be selectively enlarged (the expandable segments 30 for the thoracic and sacral regions not being enlarged), to determine what effect extension may have on back pain and the spine. To test the sacroiliac joint (as FIGS. 10 and 11 show), both expandable segments 30 on the ASIS can be enlarged, along with the expandable segment for the sacral region (if desired), to stress the sacroiliac joint from two directions. Once an incident of back pain is generated, the incident of pain can be correlated to the orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify which movement of particular bone or bones, or which orientation of the spine, causes the back pain. The garment 10 can also be used as a diagnostic tool in and of itself, without the use of imaging. For example, by enlarging both expandable segments 30 on the ASIS along with the expandable segment 30 for the sacral region, the sacroiliac joint can be stressed from two directions. If the sacroiliac joint is a pain generator when stressed in this manner, this alone can serve as a diagnosis of dysfunction at the sacroiliac joint; [0045-0047]).
Regarding Claim 20, Reiley discloses wherein the biomechanical information includes spine stiffness, range of motion, or flexibility (in FIG. 8, only the expandable segments 30 for the thoracic and sacral regions are selectively enlarged (the expandable segments 30 in the lumbar region not being enlarged), to determine what effect simulated flexion may have on back pain and the spine. Or, as shown in FIG. 9, only the expandable segments 30 in the lumbar region can be selectively enlarged (the expandable segments 30 for the thoracic and sacral regions not being enlarged), to determine what effect extension may have on back pain and the spine. To test the sacroiliac joint (as FIGS. 10 and 11 show), both expandable segments 30 on the ASIS can be enlarged, along with the expandable segment for the sacral region (if desired), to stress the sacroiliac joint from two directions. Once an incident of back pain is generated, the incident of pain can be correlated to the orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify which movement of particular bone or bones, or which orientation of the spine, causes the back pain. The garment 10 can also be used as a diagnostic tool in and of itself, without the use of imaging. For example, by enlarging both expandable segments 30 on the ASIS along with the expandable segment 30 for the sacral region, the sacroiliac joint can be stressed from two directions. If the sacroiliac joint is a pain generator when stressed in this manner, this alone can serve as a diagnosis of dysfunction at the sacroiliac joint; [0045-0047]).
Claims 3-4 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Reiley, Sklar, and Sjoquist as applied to claims 1 and 11 above, and further in view of Ren et al (U.S. Publication No. 2020/0281509; previously cited).
Regarding Claim 3, Reiley, Sklar, and Sjoquist fail to disclose attaching a plurality of sensors to the spine of the patient and monitoring any movement of the spine.
In a similar technical field, Ren teaches diagnosis and treatment using mapping and motion analysis (Abstract) comprising attaching a plurality of sensors to the spine of the patient and monitoring any movement of the spine (FIG. 3 is a block diagram for mapping and motion analysis 300…the locations of the sensors can include symmetric locations such as left and right shoulder, hip, elbow, knee, ankle, etc. The locations can include the cervical spine or neck, lumbar spine or lower back, and the like…motion of the human body is calculated based on the mapping. A movement signature is determined based on the calculated motion. The movement signature can be used to analyze a movement disorder of the individual and to develop a treatment plan based on the disorder; [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the spine sensor mapping teachings of Ren into those of Reiley, Sklar, and Sjoquist in order to analyze movement signature, as movement signature can be useful for comparing movement of an individual at different times, e.g. before and after treatment, therapy, or surgery. The comparing movement can be useful for analysis (Ren [0053]).
Regarding Claim 4, although Reiley discloses wherein the compartments of the vest inflate to bend the patient’s spine (See Figures 6-10 and 13), Reiley, Sklar, and Sjoquist fail to disclose measuring a distance change between the sensors on the patient’s spine and the reference sensors on the vest as the patient’s spine bends, thereby measuring displacement.
In a similar technical field, Ren teaches diagnosis and treatment using mapping and motion analysis (Abstract), comprising measuring a distance change between the sensors on the patient’s spine and the reference sensors on the vest as the patient’s spine bends (A human body is represented 310. Various types of sensors can be applied to the human body. The sensors can be applied by coupling the sensors to tape, a garment, a wrap, a strap…each of the plurality of sensors can include an inertial measurement unit (IMU) sensor 320; [0052]), thereby measuring displacement (A computer 360 can be used to process data obtained from the two or more sensors coupled to the human body…the computer can be used to determine a location for each of the two or more sensors. The location can be determined based on a body part to which a given sensor is mounted. The location can be determined within a three-dimensional space, a two-dimensional space, etc. The computer can be used to map the location of each sensor into a coordinate reference system…the computer can be used to calculate motion of the human body; [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the sensor mapping teachings of Ren into those of Reiley, Sklar, and Sjoquist in order to analyze movement signature, as movement signature can be useful for comparing movement of an individual at different times, e.g. before and after treatment, therapy, or surgery. The comparing movement can be useful for analysis (Ren [0053]).
Regarding Claim 13, Reiley, Sklar, and Sjoquist fail to disclose attaching a plurality of sensors to the spine of the patient and monitoring any movement of the spine.
In a similar technical field, Ren teaches diagnosis and treatment using mapping and motion analysis (Abstract) comprising attaching a plurality of sensors to the spine of the patient and monitoring any movement of the spine (FIG. 3 is a block diagram for mapping and motion analysis 300…the locations of the sensors can include symmetric locations such as left and right shoulder, hip, elbow, knee, ankle, etc. The locations can include the cervical spine or neck, lumbar spine or lower back, and the like…motion of the human body is calculated based on the mapping. A movement signature is determined based on the calculated motion. The movement signature can be used to analyze a movement disorder of the individual and to develop a treatment plan based on the disorder; [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the spine sensor mapping teachings of Ren into those of Reiley, Sklar, and Sjoquist in order to analyze movement signature, as movement signature can be useful for comparing movement of an individual at different times, e.g. before and after treatment, therapy, or surgery. The comparing movement can be useful for analysis (Ren [0053]).
Regarding Claim 14, although Reiley discloses wherein the compartments of the vest inflate to bend the patient’s spine (See Figures 6-10 and 13), Reiley, Sklar, and Sjoquist fail to disclose measuring a distance change between the sensors on the patient’s spine and reference sensors on the vest as the patient’s spine bends, thereby measuring displacement.
In a similar technical field, Ren teaches diagnosis and treatment using mapping and motion analysis (Abstract), comprising measuring a distance change between the sensors on the patient’s spine and reference sensors on the vest as the patient’s spine bends (A human body is represented 310. Various types of sensors can be applied to the human body. The sensors can be applied by coupling the sensors to tape, a garment, a wrap, a strap…each of the plurality of sensors can include an inertial measurement unit (IMU) sensor 320; [0052]), thereby measuring displacement (A computer 360 can be used to process data obtained from the two or more sensors coupled to the human body…the computer can be used to determine a location for each of the two or more sensors. The location can be determined based on a body part to which a given sensor is mounted. The location can be determined within a three-dimensional space, a two-dimensional space, etc. The computer can be used to map the location of each sensor into a coordinate reference system…the computer can be used to calculate motion of the human body; [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the sensor mapping teachings of Ren into those of Reiley, Sklar, and Sjoquist in order to analyze movement signature, as movement signature can be useful for comparing movement of an individual at different times, e.g. before and after treatment, therapy, or surgery. The comparing movement can be useful for analysis (Ren [0053]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791