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 16th, 2026, amended claims 1, 5, 7-8, 10, 18, and 20 are entered. Claims 3 and 12 are canceled. Claims 1-2, 4-11, and 13-20 are currently pending.
Response to Arguments
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 The rejections are withdrawn in view of the amendment.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 remarks and amendments with respect to the double patenting rejections have been fully considered. Although the Applicant has requested that the “rejection be held in abeyance”, the rejections have been updated in view of the amendment.
Applicant's remarks and amendments with respect to the rejections of independent claim 10 and its dependent claims under 35 U.S.C. 103 have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections of independent claim 1 and its dependent claims under 35 U.S.C. 103 have been fully considered but are not persuasive. The rejections are maintained in view of the amendment, and further clarified below.
At Pg. 6 of the Reply, Applicant argues that the “Applicant has amended claim 1 to include ‘wherein a first series of compartments are aligned along the front of the vest to target an anterior of a spine, a second series of compartments are aligned along the back of vest to target a posterior of the spine, and third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine’…[t]here is no such disclosure in Reiley of such compartments”. Examiner respectfully disagrees. As cited in the previous Office Action, Reiley clearly teaches 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]).
Further at Pg. 6 of the Reply, Applicant argues that “[t]he only alleged compartments disclosed in Reiley are 30, 32, 40 and 42. These elements identified as expandable segments 30, actuators 32, and chambers 40, 42 are all positioned on the rear portion of the garment 10. None of these elements are disclosed to be positioned on the front of the garment or on the lateral portions of the garment”. Examiner respectfully disagrees. As cited in the previous Office Action, Reiley clearly teaches wherein the expandable segments are carried on the front of the garment 10 (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]).
See Annotated Figures 1-2 below, which have been annotated to emphasize the expandable segments 30 that are carried on the front of the garment 10, as seen from the front view in Annotated Figure 1 and from the side view in Annotated Figure 2.
PNG
media_image1.png
546
598
media_image1.png
Greyscale
Annotated Figure 1 (Figure 3C of the Reiley reference)
PNG
media_image2.png
929
755
media_image2.png
Greyscale
Annotated Figure 2 (Figures 6-7 of the Reiley reference)
At Pgs. 6-7 of the Reply, Applicant argues that “[i]n the Office Action on page 11-12 there was a suggestion that chambers 40 and 42 are positioned on the lateral side of the garment 10 by citing to language in Reiley relating to the chambers 40 and 42 being positioned adjacent to each other on the back portion of the garment 10 to address the left and right lateral sides of a vertebral level. This disclosure does not support a disclosure of chambers being positioned on a lateral sides of the garment. Rather, the chambers 40, 42 (as well as expandable segments 30 and actuators 32) are only positioned on the rear portion of the garment 10. See FIGS 3C-3E and 14”. Examiner respectfully disagrees, as it seems as though the Applicant is arguing more than what is actually being claimed. Examiner notes that there is a new rejection under 35 U.S.C. 112(b) regarding the newly added amendments due to indefiniteness present for failing to particularly point out and distinctly claim the subject matter. Therefore, the Examiner will be interpreting the claim language as best understood. Currently, amended claim 1 recites wherein “third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine”. There is no specific requirement that precludes the third and fourth series of compartments from being positioned in the back of the vest. The current claim language merely requires the third and fourth series of compartments to be aligned along “the sides of the vest”. Therefore, under the broadest, reasonable interpretation, the third series of compartments can be aligned along the left back side of the vest (left lateral size chambers 42; Figure 14 of Reiley; see Annotated Figure 3 below which has been annotated to differentiate the left side and the right side) while the fourth series of compartments can be aligned along the right back side of the vest (right lateral size chambers 40; Figure 14 of Reiley; see Annotated Figure 3 below which has been annotated to differentiate the left side and the right side). Furthermore, the Examiner would like to emphasize that Reiley clearly teaches wherein these third and fourth series of compartments are configured 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]).
PNG
media_image3.png
678
709
media_image3.png
Greyscale
Annotated Figure 3 (Figure 14 of the Reiley reference)
In order to provide further clarity, the Examiner would like to present an example of how the second, third, and fourth series of compartments may be interpreted based on Figure 14 of Reiley (shown in Annotated Figure 3). For example, the larger, vertically long chambers 40 and 42 may be considered the “second series of compartments” that are aligned along the back of the vest, while the smaller, horizontally long chambers 40 and 42 may be considered the “third and fourth series of compartments” (respectively, left lateral size chambers 42 and right lateral size chambers 40) that are aligned along the sides of the vest. The current claim language merely requires that “the second series of compartments are aligned along the back of vest to target a posterior of the spine” and “third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine”. Therefore, this interpretation fulfills the claim requirements, as the larger, vertically long chambers 40 and 42 are in fact aligned along the back of the vest and can be used to target the posterior of the spine while the smaller, horizontally long chambers 40 and 42 are aligned along two different sides of the vest (chambers 42 are located on the left while chambers 40 are located on the right) and can be used to target lateral areas of the spine.
Or, another interpretation could have the smaller, horizontally long chambers 40 and 42 to be considered the “second series of compartments” that are aligned along the back of the vest, while the larger, vertically long chambers (left lateral size chambers 42 and right lateral size chambers 40) to be considered the “third and fourth series of compartments”, respectively, that are aligned along the sides of the vest. Once again, the current claim language merely requires that “the second series of compartments are aligned along the back of vest to target a posterior of the spine” and “third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine”. Therefore, this interpretation fulfills the claim requirements, as the smaller, horizontally long chambers 40 and 42 are in fact aligned along the back of the vest and can be used to target the posterior of the spine while the larger, vertically long chambers 40 and 42 are aligned along two different sides of the vest (chambers 42 are located on the left while chambers 40 are located on the right) and can be used to target lateral areas of the spine. Examiner notes that although there are further possibilities and ways to categorize the series of compartments, these two examples have been presented to best provide clarity regarding the Examiner’s interpretations.
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
“robotic and navigation system” in Claims 10 and 13
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 17, and 18 of copending Application No. 18/459,485 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined application claim is anticipated by the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 1 of the current application, the reference application (Application No. 18/459,485) teaches a system for preoperatively assessing a patient (a system for monitoring the patient; Claim 11 of Application No. 18/459,485) comprising:
a wearable vest having a plurality of internal segmented compartments (a wearable vest having a plurality of internal segmented compartments; Claim 11 of Application No. 18/459,485);
a pump connected to the vest and configured to inflate the compartments of the vest (a pump connected to the vest and configured to inflate the compartments of the vest; Claim 11 of Application No. 18/459,485); and
a computer for receiving patient specific data from the vest (a computer in electronic communication with the wearable vest; and receiving, at the computer, patient specific data from the vest; Claim 11 of Application No. 18/459,485),
wherein a first series of compartments are aligned along the front of the vest to target an anterior of the spine, a second series of compartments are aligned along the back of vest to target a posterior of the spine, and third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine (wherein a first series of compartments are aligned along the front of the vest to target an anterior of the spine, a second series of compartments are aligned along the back of vest to target a posterior of the spine, and third and fourth series of compartments are aligned along the sides of the vest to target lateral areas of the spine; Claim 18 of Application No. 18/459,485).
Regarding Claim 2 of the current application, the reference application (Application No. 18/459,485) teaches 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 (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; Claim 17 of Application No. 18/459,485).
Claims 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 17, and 18 of copending Application No. 18/459,485 (reference application) in view of claims 11, 19, and 20 of copending Application No. 18/459,485 (reference application). This is a provisional nonstatutory double patenting rejection.
Regarding Claim 5 of the current application, the reference application (Application No. 18/459,485) teaches wherein the patient specific data includes biomechanical information and/or preoperative metrics of the patient (wherein the patient specific data includes biomechanical information and/or preoperative metrics of the patient; Claim 19 of Application No. 18/459,485).
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 teachings of Claim 19, dependent on Claim 11, into those of Claims 11, 17, and 18, as they both recite methods and systems for preoperatively assessing a patient using a wearable vest. Receiving biomechanical information and/or preoperative metrics from a wearable vest that covers multiple sides of the patient with a plurality of series of compartments would provide patient specific data from different areas of the spine to best monitor the patient.
Regarding Claim 6 of the current application, the reference application (Application No. 18/459,485) teaches wherein the biomechanical information includes spine stiffness, range of motion, or flexibility (wherein the biomechanical information includes spine stiffness, range of motion, or flexibility; Claim 20 of Application No. 18/459,485).
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 teachings of Claim 20, dependent on Claims 11 and 19, into those of Claims 11, 17, and 18, as they both recite methods and systems for preoperatively assessing a patient using a wearable vest. Receiving biomechanical information from a wearable vest with a plurality of series of compartments to target multiple areas of the spine would provide patient specific data to best monitor the patient and determine any of spine stiffness, range of motion, or flexibility from different areas of the spine.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 17, and 18 of copending Application No. 18/459,485 (reference application) in view of claims 11 and 12 of copending Application No. 18/459,485 (reference application). This is a provisional nonstatutory double patenting rejection.
Regarding Claim 7 of the current application, the reference application (Application No. 18/459,485) teaches wherein a preoperative spine stiffness is determined by an amount of force applied by the compartments of the vest and any resulting movement of a spine (wherein a preoperative spine stiffness is determined by an amount of force applied by the vest and any movement of the spine; Claim 12 of Application No. 18/459,485).
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 teachings of Claim 12, dependent on Claim 11, into those of Claims 11, 17, and 18, as they both recite methods and systems for preoperatively assessing a patient using a wearable vest. Determining preoperative spine stiffness by the amount of force applied by the vest and any movement of the spine from a wearable vest with multiple series of compartments to target different areas of the spine would provide patient specific data to best monitor the patient and determine which areas of the spine had preoperative spine stiffness, measured by the different series of compartments of the wearable vest.
Claim Objections
Claims 10-11, 13, and 15 are objected to because of the following informalities:
Claim 10 recites “the sensors” in line 9, but should read “the plurality of sensors”
Claim 11 recites “the sensors” in line 1, but should read “the plurality of sensors”
Claim 13 recites “claim 10 further” in line 1, but should read “claim 10, further”
Claim 13 recites “sensors attachable to the patient” in lines 1-2, but should read “sensors configured to be attachable to the patient”
Claim 15 recites “the outlet ports” in line 3, but should read “the plurality of outlet ports”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 4-9 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 front" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the back" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the sides" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “a front” in line 1. It is unclear as to whether this is referring to the previously introduced “the front” from Claim 1, or a separate element.
Claim 2 recites “a back” in line 2. It is unclear as to whether this is referring to the previously introduced “the back” from Claim 1, or a separate element.
Claim 2 recites “sides” in line 3. It is unclear as to whether this is referring to the previously introduced “the sides” from Claim 1, or a separate element.
Claim 7 recites “a spine” in line 3. It is unclear as to whether this is referring to the previously introduced “a spine” from Claim 1, or a separate element.
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 and 4-9 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).
Regarding Claim 1, Reiley discloses a system for preoperatively assessing a patient (Systems, devices, and methods for diagnosing and treating conditions of the spine; Abstract) comprising:
a wearable vest (the garment 10; [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);
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]),
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).
Reiley fails to disclose a computer for receiving patient specific data from the vest.
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); and
a computer (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]) for receiving patient specific data from the vest (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 the invention of Reiley in order to enable processing of the obtained data and generating of associated health data (Sjoquist [0139]).
Regarding Claim 2, 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 4, Reiley discloses wherein the pump is configured to supply compressed air 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]).
Regarding Claim 5, 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 6, 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]).
Regarding Claim 7, Reiley discloses wherein a preoperative spine stiffness is determined by an amount of force applied by the compartments of the vest and any resulting movement of a 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 8, Reiley discloses wherein the computer simultaneously measures both spinal displacement and the force causing the displacement over a period of time (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 9, Reiley fails 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 the invention of Reiley 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]).
Allowable Subject Matter
Claims 10-11 and 13-20 are allowed. However, the Examiner notes that claims 10-11, 13, and 15 are objected to because of minor informalities, specified above in the claim objections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHANEL J YOON/Examiner, Art Unit 3791
Prosecution Insights