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 Examiner’s Amendment entered on July 30th, 2026, amended claim 10 is entered and claim 11 is canceled. Claims 10 and 13-20 are currently pending and under examination.
Response to Arguments
Applicant's remarks and amendments, filed on July 17th, 2026, with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments, filed on July 17th, 2026, with respect to the double patenting rejections have been fully considered. The double patenting rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments, filed on July 17th, 2026, 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 The rejections are withdrawn in view of the amendment.
Although claims 10 and 13-20 were previously indicated as allowable subject matter, claims 10-11 and 13-20 are now rejected under 35 U.S.C. 103.
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 10: Dependent claim 14 recites “wherein the pneumatic control system includes a panel having a plurality of knobs configured to control the wearable vest” and dependent claim 15 further recites “wherein the panel includes an inlet port and a plurality of outlet ports, the inlet port being connected by pneumatic tubing to a supply of compressed air, and the plurality of outlet ports being connected to the wearable vest”
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 § 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 10, 13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Reiley (U.S. Publication No. 2011/0054373; previously cited) in view of Gokhale et al (U.S. Publication No. 2015/0038881; previously cited), Ayala et al (U.S. Publication No. 2021/0401535), and Seong et al (U.S. Patent No. 11,179,219).
Regarding Claim 10, Reiley discloses a system for preoperatively assessing a spine of a patient (Systems, devices, and methods for diagnosing and treating conditions of the spine; Abstract) comprising:
a wearable vest (the garment 10) 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) configured to fit 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]);
a pneumatic control system 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]).
Reiley fails to disclose wherein the vest includes a plurality of sensors configured to monitor the compartments; and a robotic and navigation system comprising a camera, configured to track the plurality of sensors of the vest.
In a similar technical field, Gokhale teaches a posture monitoring system (Abstract), wherein the vest includes a plurality of sensors configured to monitor the compartments (a sensor structure is integrated into a belt, a vest, a band, a belt, a brace sportswear and/or footwear. FIG. 3B illustrates a view 350 of a vest 351 with an integrated sensor structure 251″. Again the sensor structure 251″ includes contact sensors that monitor posture of a portion of a person's body through physical communication with the sensor structure 251″; [0043]); and a robotic and navigation system (The personal computer 311 or the smart phone 315 analyzes the electrical signals from the detecting unit 303 to generate output signals corresponding to the posture of a portion of a person's body; [0042]) comprising a camera (Still referring to FIG. 4C, in further embodiments of the invention the system 450 includes an optical detector 459, such as a camera, that measures a distance, represented by the arrow 437, or position of the person's back while the person is sitting. The optical sensor 459 is in electrical communication with the detecting unit and the processing unit 453 and provides additional data to monitor and evaluate the posture of the person while the person is sitting; [0047]), configured to track the plurality of sensors of the vest (The vest 351 also includes a detecting unit 303′ that transmits electrical signals to a computing unit (not shown) for generating output signals corresponding the posture of a portion of the persons body in physical contact with the sensor structure 251″…the vest 351 includes one or more accelerometer sensors 357 and 357′ that are in communication the detecting unit 303′. In operation, the one or more accelerometer sensors 357 and 357′ communicates an orientation or position of the person wearing the vest 351 to a computing unit through the detecting unit 303′. The measured orientation or position of the person is then used to further generate output signals corresponding to posture of the person wearing the vest 351; [0043]).
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 teachings of Gokhale into the invention of Reiley in order to use the measured orientation or position of the person to further generate output signals corresponding to posture of the person wearing the vest (Gokhale [0043]).
Reiley and Gokhale fail to disclose wherein the plurality of sensors include infrared tracking spheres viewable by the robotic and navigation system.
In a similar technical field, Ayala teaches a sensor (medical tracking marker [0003]) that includes infrared tracking spheres viewable by robotic and navigation system (It is the purpose of a medical tracking marker that the spatial position (including the spatial location and/or the spatial orientation) of objects is determinable by a computer system. In order to fulfil this purpose, such tracking markers are usually rigidly attached to the respective objects and are further adapted to be detected by a corresponding tracking system. While there are different types of tracking markers known in the art, which make use of different physical principles, the present invention relates to the type of optically detectable tracking markers, i.e. tracking markers which are detectable by tracking systems that comprise light susceptible cameras. More specifically, the present invention relates to passive tracking markers, i.e. which are adapted to reflect electromagnetic radiation in the infrared, visible and/or ultraviolet spectral range. In order to increase the reflective properties, such markers can be provided with a retro-reflective surface which is adapted to reflect incoming light back in substantially the opposite direction it came from. Such retro-reflective properties are for example known from so-called “cat's eyes” or high-visibility vests; [0003]; Commonly used retro-reflective tracking marker have a spherical shape and are therefore often called marker spheres; [0004]).
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 infrared tracking spheres of Ayala to the vest and posture monitoring system of Reiley and Gokhale in order to further track the position and posture of the person wearing the vest.
Reiley, Gokhale, and Ayala fail to disclose wherein the robotic and navigation system further comprises a surgical robot.
In a similar technical field, Seong teaches a surgical robot system for stereotactic surgery and method for controlling stereotactic surgery robot (Abstract), wherein the robotic and navigation system further comprises a surgical robot (surgical robot system 100).
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 surgical robot teachings of Seong to those of Reiley, Gokhale, and Ayala in order to in order to improve the accuracy of positioning the surgical instrument.
Regarding Claim 13, Reiley fails to specifically disclose a second plurality of sensors configured to be attachable to the patient and trackable by the robotic and navigation system.
Gokhale discloses a second plurality of sensors configured to be attachable to the patient and trackable by the robotic and navigation system (a sensor structure is integrated into a belt, a vest, a band, a belt, a brace sportswear and/or footwear. FIG. 3B illustrates a view 350 of a vest 351 with an integrated sensor structure 251″. Again the sensor structure 251″ includes contact sensors that monitor posture of a portion of a person's body through physical communication with the sensor structure 251″…in addition to the sensor structure 251″ the vest 351 includes one or more accelerometer sensors 357 and 357′ that are in communication the detecting unit 303′. In operation, the one or more accelerometers sensors 357 and 357′ communicates an orientation or position of the person wearing the vest 351 to a computing unit through the detecting unit 303′. The measured orientation or position of the person is then used to further generate output signals corresponding to posture of the person wearing the vest 351; [0043]).
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 teachings of Gokhale into the invention of Reiley in order to use the measured orientation or position of the person to further generate output signals corresponding to posture of the person wearing the vest (Gokhale [0043]).
Regarding Claim 16, 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 17, Reiley discloses wherein a first series of compartments are aligned along the front of the vest to target an anterior of a 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]), 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; [0039-0043]; Figures 3, 6-10, 13-14), and third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine (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]; Figure 14).
Regarding Claim 18, although Reiley discloses patient specific data that 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]), Reiley fails to specifically disclose a computer for receiving patient specific data.
Gokhale teaches a computer for receiving patient specific data (The computing unit 207 is, for example, a personal computer, a smart phone, an on-board vehicle computer, or other computing device with a micro-processor and memory. The computing unit 207 receives the electrical signals from the detecting unit 205 and runs software or firm-ware that processes or analyzes the electrical signals. The computing unit 207 then generates a representation of the posture of the portion of a person's body that is in physical contact with the sensor structure 201. The generated representation of the posture of a portion of a person's body is, for example, in the form of audio signals, tactile signals and/or visual signals; [0035]).
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 Gokhale into the invention of Reiley in order to enable processing of the obtained data and generating of associated health data.
Regarding Claim 19, 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 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Reiley, Gokhale, Ayala, and Seong as applied to claim 10 above, and further in view of Rock et al (U.S. Publication No. 2017/0007494; previously cited).
Regarding Claim 14, Reiley discloses wherein the pneumatic control system includes a pump configured to control the wearable 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]).
Reiley, Gokhale, Ayala, and Seong fail to specifically disclose wherein the pneumatic control system includes a panel having a plurality of knobs configured to control the wearable vest.
In a similar technical field, Rock teaches a HFCC therapy system providing patient interventions for improved adherence (Abstract), comprising a pneumatic control system (therapy device 110) including a panel having a plurality of knobs (the user interface 130 may allow a user to interact with the system 100…the user interface 130 may be arranged on or in, or may be otherwise communicably coupled to, the therapy device 110. The user interface 130 may include a touch screen or other display and/or one or more selectable buttons, keys, or switches; [0043]; The therapy device 110, shown in detail in FIGS. 2 and 3, may be configured to couple to the patient device 120, which may include a patient vest or jacket, via one or more lines or hoses…the device 110 may have one or more ports 80 a, 82 a for coupling to a patient vest, an air intake 74, one or more electrical connections 75, one or more telecom connections 76, and a power switch 77. As described above, the device 110 may additionally have a user interface 130 in some embodiments; [0051]) configured to control the wearable vest (The therapy device 110, shown in detail in FIGS. 2 and 3, may be configured to couple to the patient device 120, which may include a patient vest or jacket, via one or more lines or hoses; [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 user interface teachings of Rock into the those of Reiley, Gokhale, Ayala, and Seong in order to allow a user to view, enter, modify, or delete data as well as serving as a diagnostic, therapeutic, and/or progress tool (Rock [0043 and 0084]).
Regarding Claim 15, Reiley discloses wherein the pneumatic control system includes an inlet port, the inlet port being connected by pneumatic tubing to a supply of compressed air (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]).
Reiley, Gokhale, Ayala, and Seong fail to disclose wherein the panel includes a plurality of outlet ports, and the plurality of outlet ports being connected to the wearable vest.
In a similar technical field, Rock teaches a HFCC therapy system providing patient interventions for improved adherence (Abstract), wherein the panel includes an inlet port (air intake 74; [0053]) and a plurality of outlet ports (one or more ports 80 a, 82 a), and the plurality of outlet ports being connected to the wearable vest (The device 110 may have one or more ports 80 a, 82 a for coupling to a patient vest; [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 air port teachings of Rock into the those of Reiley, Gokhale, Ayala, and Seong since the benefits of the quick connect air couplings include minimization of inadvertent air hose disconnects and improved freedom of movement as the locking air coupling permits rotation between the air hose and the patient device or air generator (Rock [0052]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Reiley, Gokhale, Ayala, and Seong as applied to claim 10 above, and further in view of Sjoquist et al (U.S. Publication No. 2023/0197273; previously cited).
Regarding Claim 20, Reiley, Gokhale, Ayala, and Seong fail to disclose wherein the computer receives a patient reported outcome measure (PROM).
In a similar technical field, Sjoquist teaches a medical wearable matching system (Abstract), wherein the computer receives a patient reported outcome measure (PROM) (The GUI displays a questionnaire with questions for the illustrative patient to enter answers. Questions include demographics (such as gender, age, etc.), preferences of style, lifestyle descriptors, requests for other body variations, such as wheelchair bound, loss of limbs, limitations on use, accommodations for use of other medical devices, etc. The illustrative patient may also enter permission for the client fitting application to access medical records, such as medical condition information from an external source, such as a healthcare provider or medical data storage device; [0051]; The GUI 106 may enable the patient 104 to enter patient specific data on a questionnaire 108 portion of the GUI 106 using various user input mechanisms; [0066]).
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 patient reported outcome measure teachings of Sjoquist into those of Reiley, Gokhale, Ayala, and Seong in order to allow the patient to enter patient specific data, such as demographics (such as gender, age, etc.), preferences of style, lifestyle descriptors, requests for other body variations, such as wheelchair bound, loss of limbs, limitations on use, accommodations for use of other medical devices, etc., in order to provide as much relevant information as possible (Sjoquist [0051 and 0066]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J YOON/Examiner, Art Unit 3791
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