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 .
Claim Objections
Claims 2-16 and 18-22 are objected to because of the following informalities:
Claims 2-16 recite “A device” should read “The device”.
Claims 18-22 recite “A method” should read “The method”.
Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the term “medical device mount” cited in the claims is not defined in the specification.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
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.
Claim 1-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of copending Application No. 17/878,842 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are an obvious variation of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Current Application
Copending Application No. 17/878,842
Claim 1: A medical device placement, comprising: a medical device mount provided with a surface configured to position over a portion of a human spinal structure, wherein the medical device mount is translatable in orthogonal planes relative to the human spinal structure; and a sterile ultrasound probe sheath configured with an orientation at a predetermined angle relative to the human spinal structure, wherein the sheath is integral to or is configured to connect to the medical device guide; wherein the sheath includes at least one needle guide and is configured to at least partially rotate around an axis on the medical device guide to provide different approach vectors for the at least one needle guide dependent upon the rotational position of the sheath.
Claim 1: A medical device placement, comprising: a medical device mount provided with a surface configured to position over and adhere to a human's back over a portion of the human's spinal structure, wherein the medical device mount includes a component that is translatable along the two dimensional surface of the human's back relative to the human spinal structure while the medical device mount is adhered to the portion of the human's back; and a sterile ultrasound probe sheath configured with an orientation at a predetermined angle relative to the human spinal structure, wherein the sheath is integral to or is configured to connect to the translatable component of the medical device; wherein the sheath includes at least one needle guide and is configured to at least partially rotate around an axis that is either perpendicular to the plane of the human back or offset by a specific angle from the perpendicular relative to the translatable component of the medical device mount to provide different ultrasound probe views and different approach vectors for the at least one needle guide dependent upon the rotational position of the sheath.
Claim 2: A device in accordance with claim 1, wherein the sheath includes three needle guides, each angled back to the path of an ultrasound probe beam directed by the sheath such that the guide trajectories of each intersect the beam at varying depths.
Claim 2: A device in accordance with claim 1, wherein the sheath includes three needle guides, each angled back to
Claim 3: A device in accordance with claim 2, wherein the depths vary between 4 and 15 centimeters.
Claim 3: A device in accordance with claim 2, wherein the depths vary between 4 and 15 centimeters.
Claim 4: A device in accordance with claim 3, wherein the depths vary between 4 and 6 centimeters.
Claim 4: A device in accordance with claim 3, wherein the depths vary between 4 and 6 centimeters.
Claim 5: A device in accordance with claim 3, wherein the depths vary between 7 and 9 centimeters.
Claim 5: A device in accordance with claim 3, wherein the depths vary between 7 and 9 centimeters.
Claim 6: A device in accordance with claim 3, wherein the depths vary between 10 and 12 centimeters.
Claim 6: A device in accordance with claim 3, wherein the depths vary between 10 and 12 centimeters.
Claim 7: A device in accordance with claim 3, wherein the depths vary between 13 and 15 centimeters.
Claim 7: A device in accordance with claim 3, wherein the depths vary between 13 and 15 centimeters.
Claim 8: A device in accordance with claim 1, wherein the predetermined angle takes into account at least one patient parameter for that patient in order to achieve successful placement, including angle and depth of placement in target tissue.
Claim 8: A device in accordance with claim 1, wherein the predetermined angle takes into account at least one patient parameter for that patient in order to achieve placement, including angle and depth of placement in target tissue.
Claim 9: A device in accordance with claim 8, wherein the at least one parameter is one or more of patient sex, age, height and weight.
Claim 9: A device in accordance with claim 8, wherein the at least one parameter is one or more of patient sex, age, height and weight.
Claim 10: A device in accordance with claim 1, wherein the predetermined angle is between 0 and 30 degrees.
Claim 10: A device in accordance with claim 1, wherein the predetermined angle is between 0 and 30 degrees
Claim 11: A device in accordance with claim 10, wherein the predetermined angle is between 10 and 20 degrees.
Claim 11: A device in accordance with claim 10, wherein the predetermined angle is between 10 and 20 degrees.
Claim 12: A device in accordance with claim 1, wherein at least one inner frame is translatable in an x-y axis direction relative to the spinal structure.
Claim 12: A device in accordance with claim 1, wherein the translatable component comprises at least one inner frame that is translatable in an x-y axis direction relative to the spinal structure.
Claim 13: A device in accordance with claim 2, wherein at least one inner frame is translatable in an x-y axis direction relative to the spinal structure and wherein the sheath with integral needle guides is rotatable around a z-axis.
Claim 13: A device in accordance with claim 2, wherein the translatable component comprises at least one inner frame that is translatable in an x-y axis direction relative to the spinal structure and wherein the sheath with integral needle guides is rotatable around a z-axis.
Claim 14: A device in accordance with claim 13, wherein the x-axis rotatable portion includes guide markings for adjustment relative to a measured target depth D.
Claim 14: A device in accordance with claim 13, wherein the x-axis rotatable portion includes guide markings for adjustment relative to a measured target depth D.
Claim 15: A device in accordance with claim 13, wherein translatable knobs adjust at least one inner frame in x-y axis directions.
Claim 15: A device in accordance with claim 13, wherein translatable knobs adjust at least one inner frame in x-y axis directions.
Claim 16: A device in accordance with claim 13, wherein z-axis rotation of the sheath is facilitated by magnets or latches positioned at predetermined positions relative to a plurality of possible guide positions for the same device.
Claim 16: A device in accordance with claim 13, wherein z-axis rotation of the sheath is facilitated by magnets or latches positioned at predetermined positions relative to a plurality of possible guide positions for the same device.
Claim 17: A method for lumbar epidural catheter placement, comprising: positioning a medical device mount against a patient's back over a spinal structure (z axis), with an ultrasound probe and at least one needle guide in an axial configuration relative to the spinal structure; moving the device in a y-direction such that a projected ultrasound beam for an ultrasound device mounted in a sheath thereon passes through an interspace optimizing the view of the ligamentum flavum and dura as two (possibly coincident) horizontal lines; moving the device in the x direction such that the middle of the ligamentum flavum - posterior dura complex is coincident with the midline of the ultrasound view; measuring the depth D of the posterior dura from the skin; fixing the medical device against the skin of the patient in such position; rotating the sheath to the parasagittal oblique ultrasound view; adjusting a component of the device in the x-y plane so that the trajectory of the guide intersects the patient's median plane at depth D and so that the midline of the ultrasound display passes between adjacent lamina; and advancing a needle and/or catheter to the epidural space.
Claim 17: A method for lumbar epidural catheter placement, comprising: positioning and affixing a medical device mount against a patient's human's back over a spinal structure (z axis), with an ultrasound probe and at least one needle guide in an axial configuration relative to the spinal structure, wherein the medical device mount includes a component that is translatable along the two dimensional surface of the human back relative to the human spinal structure and is configured to rotate the ultrasound and at least one needle guide relative thereto while the medical device mount is adhered to the portion of the human back; moving the translatable component in a y-direction such that a projected ultrasound beam for an ultrasound device mounted in a sheath thereon passes through an interspace optimizing the view of the ligamentum flavum and dura as two (possibly coincident) horizontal lines; moving the translatable component in the x direction such that the middle of the ligamentum flavum - posterior dura complex is coincident with the midline of the ultrasound view; measuring depth D of the posterior dura from the patient's skin; rotating the sheath to the parasagittal oblique ultrasound view; adjusting a component of the device in the x-y plane so that
Claim 18: A method in accordance with claim 16, wherein said adjustment comprises adjusting a first component of the device in in an x-direction so that the trajectory of the guide intersects the patient's median plane at depth D and adjusting a second component of the device in the y-direction such that the midline of the ultrasound display passes between adjacent lamina.
Claim 18: A method in accordance with claim 17,wherein said adjustment comprises adjusting a first component of the device in in an x-direction so that the trajectory of the guide intersects the patient's median plane at depth D and adjusting a second component of the device in the y-direction such that the midline of the ultrasound display passes between adjacent lamina.
Claim 19: A method in accordance with claim 16, wherein the medical device mount is provided with: a surface configured to position over a portion of a human spinal structure, wherein the medical device mount is translatable in orthogonal planes relative to the human spinal structure; and a sterile ultrasound probe sheath configured with an orientation at a predetermined angle relative to the human spinal structure, wherein the sheath is integral to or is configured to connect to the medical device guide; wherein the sheath includes at least one needle guide and is configured to at least partially rotate around an axis on the medical device guide to provide different approach vectors for the at least one needle guide dependent upon the rotational position of the sheath.
Claim 19: A method in accordance with claim 17,wherein the medical device mount is provided with: a surface configured to position over a portion of a human spinal structure, wherein the medical device mount is translatable along the two dimensional surface of a human back relative to the human spinal structure via the translatable component; and a sterile ultrasound probe sheath configured with an orientation at a predetermined angle relative to the human spinal structure, wherein the sheath is integral to or is configured to connect to the medical device guide translatable component; wherein the sheath includes at least one needle guide and is configured to at least partially rotate around an axis on the medical device guide translatable component to provide different approach vectors for the at least one needle guide dependent upon the rotational position of the sheath.
Claim 20: A method in accordance with claim 19, wherein the sheath includes three needle guides, each angled back to the path of an ultrasound probe beam directed by the sheath such that the guide trajectories of each intersect the beam at varying depths.
Claim 20: A method in accordance with claim 19, wherein the sheath includes three needle guides, each angled back to a path of an ultrasound probe beam directed by the sheath such that guide trajectories of each intersect the beam at varying depths.
Claim 21: A method in accordance with claim 19, wherein the predetermined angle is 15 degrees.
Claim 21: A method in accordance with claim 19, wherein the predetermined angle is 15 degrees.
Claim 22: A method in accordance with claim 19, wherein at least one inner frame is translatable in an x-y axis direction relative to the spinal structure and wherein the sheath and needle guides are rotatable around a z-axis.
Claim 22: A method in accordance with claim 19, wherein at least one inner frame is translatable in an x-y axis direction relative to the spinal structure and wherein the sheath and needle guides are rotatable around a z-axis.
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 1-22 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 sheath" in lines 6-11. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting this limitation as the sterile ultrasound probe sheath.
Claim 1 recites the limitation "the medical device guide" in lines 7-9. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting this limitation as the medical device mount.
Claim 1 recites the limitation "the rotational position" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the path" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the guide trajectories" in line 3. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting this limitation as the needle trajectories.
Claim 2 recites the limitation “three needle guides”. It’s unclear if this is part of the “at least one needle guide” recited in claim 1 or not.
The term “successful” in claim 8 is a relative term which renders the claim indefinite. The term “successful” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What is considered a successful placement.
Claim 8 recites the limitation “at least one patient parameter for that patient in order to achieve successful placement, including angle and depth of placement in target tissue.” It is unclear if either of the angle and depth are required to be the “at least one patient parameter” or is this how “successful placement” is determined?
Claim 12 recites the limitation “at least one inner frame”, it is unclear what the inner frame represents, is it referring to the mount? An inner frame of the mount? The examiner is interpreting the limitation as the mount.
Claim 13 recites the limitation “integral needle guides”, it is unclear what integral needle guides mean, does it mean that the three needle guide are required to be “integral”?
Claim 14 recites the limitation " the x-axis rotatable portion " in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting this limitation as the needle guide.
Claim 17 recites the limitation "the device" in line 5. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting this limitation as the medical device mount
Claim 17 recites the limitation "the depth" and “the skin” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the medical device" in line 11. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting this limitation as the medical device mount
Claim 17 recites the limitation "the trajectory" and “the guide” in lines 13-14. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting this limitation as the needle guide trajectory.
Claim 17 recites the limitation "the epidural space" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation “(z-axis). It is unclear if what is inside the parenthesis is meant to be claimed or not, is this providing a relative direction, a limitation, a suggestion?
Claim 17 recites the limitation “(possibly coincident). It is unclear if what is inside the parenthesis is meant to be claimed or not.
The term “possibly” in claim 17 is a relative term which renders the claim indefinite. The term “possibly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What is considered a possible coincident.
Claim 18 recites the limitation “adjusting a first component of the device in in an x-direction so that the trajectory of the guide intersects the patient's median plane at depth D and adjusting a second component of the device in the y-direction such that the midline of the ultrasound display passes between adjacent lamina.” It is unclear what is the first component and the second components. Are the components part of the sheath and the needle guide or the device mount? The examiner is interpreting this limitation as adjusting the needle as the first component and adjusting the mount as the second component.
Claim 18 recites the limitation "A method in accordance to claim 16" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claim is further limiting a method but it is dependent from a device claim, therefore, it is not clear what the claim is further limiting. The examiner interpreting the claim as dependent from claim 17.
Claim 19 recites the limitation "A method in accordance to claim 16" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claim is further limiting a method but it is dependent from a device claim, therefore, it is not clear what the claim is further limiting. The examiner interpreting the claim as dependent from claim 17.
Claim 19 recites the limitation "the sheath" in lines 7-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the medical device guide" in lines 8-10. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting this limitation as the medical device mount.
Claim 20 recites the limitation "the path" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the guide trajectories" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation “three needle guides”. It’s unclear if this is part of the “at least one needle guide” recited in claim 19 or not.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rohling (US Pub No. 2016/0022308) in the view of Bouazza-Marouf (US Pub No. 2019/0282262) (hereinafter, Marouf).
Regarding claim 1, Rohling teaches a medical device placement, comprising (para. 0116): a medical device mount provided with a surface configured to position over a portion of a human spinal structure, wherein the medical device mount is translatable in orthogonal planes relative to the human spinal structure (paras. 0116, 0118, and 0147; a mount 199 on the probe 202, a body guide 801 and a medical instrument guide 203 that in this embodiment is affixed to the mount 199 but in other embodiments can be detachably mounted to the mount 199 or remotely located or be attached to or form part of the 3-D ultrasound probe 202. The mount 199 can be a rectangular mounting plate (not shown) to which the probe 202 is mounted. An operator holds the apparatus 200 with one hand and places the apparatus 200 against the patient's back so that the medical instrument guide 203 is directly over the needle insertion point iii. The operator adjusts the position of the apparatus 200 until the body guide 801 lies flat against the surface of the body 101, which ensures the propagation axis 204 of the medical instrument guide 203 is substantially perpendicular to the body.); and
a sterile ultrasound probe sheath configured with an orientation at a predetermined angle relative to the human spinal structure, wherein the sheath is integral to or is configured to connect to the medical device guide (paras.0059 and 0134; The shape and flexibility also allow the mount 199 to be fit over a thin sterile drape (not shown) covering the ultrasound probe. The tight and secure fit of the mount 199 to the probe ensures the sterile drape will remain tightly covering the probe during scanning of the body. Most conventional needle guides attached directly to the probe with a drape placed over the combination of probe and medical instrument guide and secured with elastic bands. This embodiment of the invention removes the need for elastic bands to hold the drape in place. The probe where the sheath is attached to is oriented to be at an angle of 5-85 degrees);
wherein the sheath includes at least one needle guide (para. 0134; the sheath and the needle guide are mounted to the probe).
However, Rohling fails to explicitly teach the sheath is configured to at least partially rotate around an axis on the medical device guide to provide different approach vectors for the at least one needle guide dependent upon the rotational position of the sheath.
Marouf, in the same field of endeavor, teaches a sheath is configured to at least partially rotate around an axis on the medical device guide to provide different approach vectors for the at least one needle guide dependent upon the rotational position of the sheath (paras. 0353-0354; a sheath which is interpreted as the bracket is attached to the probe where the probe including the bracket can be rotated/tilted by the clinician in the transverse plane as well as in the sagittal plane.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the sterile ultrasound probe sheath of Rohling with the sheath of Marouf to enable at least partial rotation around an axis. Doing so will help in ensuring the optimum positioning of the probe as taught by Marouf in para. 0353.
Regarding claim 2, Rohling teaches the device in accordance with claim 1, wherein the sheath includes needle guides, each angled back to the path of an ultrasound probe beam directed by the sheath such that the guide trajectories of each intersect the beam at varying depths (paras. 0125 and 0157; The detachable medical instrument guide can be designed to allow the selection of a particular trajectory to be chosen by mounting one of a series of medical instrument guides, each with a different orientation of the guide-way. the operator may align the displayed target 404 (for example, the epidural space) with the superimposed graphic 1302 of the anticipated needle trajectory along the propagation axis 204 in the ultrasound image(s) and observes the depth of the target 404 relative to the graduations 605. The examiner notes, that the needle guide needs to be oriented in a way that the trajectory or path of the needle intersect the target at a certain depth where the target is aligned with the propagation axis.).
Although, Rohling teaches orienting different types of needle guides in a way that the trajectory or path of the needle intersect the target at a certain depth where the target is aligned with the propagation axis, however, Rohling fails to teach that the needle guide includes three needle guides.
Marouf, in the same field of endeavor, teaches a needle guide includes three needle guides such that the guide trajectories of each intersect the beam at varying depths (paras. 0049, 0051-0052, and 0474; the needle guide system includes a plurality of needle guides in which the angle of the needle channels relative to the bases of the needle guides are different from one another. Where the angle is variable, markings can be provided on the needle guide to indicate the appropriate angular position of the needle channel for a given desired needle insertion angle and/or target depth. This can cater for insertion of the needle at any chosen angle or to reach any chosen depth along the centre line of the US probe. The bracket illustrated here includes two mounting positions for the needle guide, a first position 134 on a long side of the probe 132 and a second position 136 on a short side of the probe, for out-of-plane and in-plane use respectively. The bracket need not have two mounting positions for the needle guide. In some examples it may only have one mounting position for the needle guide. In other examples the bracket may have more than two mounting positions for the needle guide, for example three positions, four positions or more, spaced at intervals around the bracket. The examiner notes that the needle guide includes multiple channels 2 or more, that are oriented at different angles so the needle reaches any chosen depth along the center line of the US probe.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the device of Rohling to incorporate the teaching Marouf to include three needle guides. Doing so will help in ensuring the optimum positioning of the needle. Providing multiple channels for needle insertion at different angles on the needle guide, would help the user to insert the needle in the appropriate channel to ensure that the needle reaches the desired depth as taught by Marouf in paras. 0474 and 0052.
Regarding claim 3, Rohling in the view of Marouf teaches the device in accordance with claim 2, wherein the depths vary between 4 and 15 centimeters (paras. 0157-0158; FIG. 13, the medical instrument guide contains a reference mark 1201 or other indication for the origin of the measurement of the needle insertion depth. Epidural needles have a series of black etchings spaced 1 cm apart (see FIG. 12) to allow the operator to count the centimeters of needle insertion relative to graduations shown on the 2-D ultrasound image. The operator may align the displayed target 404 (for example, the epidural space) with the superimposed graphic 1302 of the anticipated needle trajectory along the propagation axis 204 in the ultrasound image(s) and observes the depth of the target 404 relative to the graduations 605. In FIG. 12, the target is at 10 cm depth, as an example. The needle 405 is subsequently inserted through the medical instrument guide 203 while the depth of insertion is observed by counting the centimeter etchings on the needle relative to the mark 1201. The operator stops insertion of the needle 405 at a depth less than or equal to the depth of the target 403, as determined by counting. The examiner notes that the depth of the insertion of the needle varies based on the depth of the target and the user can insert the needle based on reference marks spaced one centimeter apart. The trajectory of the needle extends to 14cm in depth and the needle reference mark can be used to insert the needle along the trajectory in a depth corresponding to the target depth which can be for example 10CM, more than 10CM, or less more than 10CM.).
Regarding claim 4, Rohling in the view of Marouf teaches the device in accordance with claim 3, wherein the depths vary between 4 and 6 centimeters (paras. 0157-0158; FIG. 13, the medical instrument guide contains a reference mark 1201 or other indication for the origin of the measurement of the needle insertion depth. Epidural needles have a series of black etchings spaced 1 cm apart (see FIG. 12) to allow the operator to count the centimeters of needle insertion relative to graduations shown on the 2-D ultrasound image. The operator may align the displayed target 404 (for example, the epidural space) with the superimposed graphic 1302 of the anticipated needle trajectory along the propagation axis 204 in the ultrasound image(s) and observes the depth of the target 404 relative to the graduations 605. In FIG. 12, the target is at 10 cm depth, as an example. The needle 405 is subsequently inserted through the medical instrument guide 203 while the depth of insertion is observed by counting the centimeter etchings on the needle relative to the mark 1201. The operator stops insertion of the needle 405 at a depth less than or equal to the depth of the target 403, as determined by counting. The examiner notes that the depth of the insertion of the needle varies based on the depth of the target and the user can insert the needle based on reference marks spaced one centimeter apart. The trajectory of the needle extends to 14cm in depth and the needle reference mark can be used to insert the needle along the trajectory in a depth corresponding to the target depth which can be for example 10CM, more than 10CM, or less more than 10CM.).
Regarding claim 5, Rohling in the view of Marouf teaches the device in accordance with claim 3, wherein the depths vary between 7 and 9 centimeters (paras. 0157-0158; FIG. 13, the medical instrument guide contains a reference mark 1201 or other indication for the origin of the measurement of the needle insertion depth. Epidural needles have a series of black etchings spaced 1 cm apart (see FIG. 12) to allow the operator to count the centimeters of needle insertion relative to graduations shown on the 2-D ultrasound image. The operator may align the displayed target 404 (for example, the epidural space) with the superimposed graphic 1302 of the anticipated needle trajectory along the propagation axis 204 in the ultrasound image(s) and observes the depth of the target 404 relative to the graduations 605. In FIG. 12, the target is at 10 cm depth, as an example. The needle 405 is subsequently inserted through the medical instrument guide 203 while the depth of insertion is observed by counting the centimeter etchings on the needle relative to the mark 1201. The operator stops insertion of the needle 405 at a depth less than or equal to the depth of the target 403, as determined by counting. The examiner notes that the depth of the insertion of the needle varies based on the depth of the target and the user can insert the needle based on reference marks spaced one centimeter apart. The trajectory of the needle extends to 14cm in depth and the needle reference mark can be used to insert the needle along the trajectory in a depth corresponding to the target depth which can be for example 10CM, more than 10CM, or less more than 10CM.).
Regarding claim 6, Rohling in the view of Marouf teaches the device in accordance with claim 3, wherein the depths vary between 10 and 12 centimeters (paras. 0157-0158; FIG. 13, the medical instrument guide contains a reference mark 1201 or other indication for the origin of the measurement of the needle insertion depth. Epidural needles have a series of black etchings spaced 1 cm apart (see FIG. 12) to allow the operator to count the centimeters of needle insertion relative to graduations shown on the 2-D ultrasound image. The operator may align the displayed target 404 (for example, the epidural space) with the superimposed graphic 1302 of the anticipated needle trajectory along the propagation axis 204 in the ultrasound image(s) and observes the depth of the target 404 relative to the graduations 605. In FIG. 12, the target is at 10 cm depth, as an example. The needle 405 is subsequently inserted through the medical instrument guide 203 while the depth of insertion is observed by counting the centimeter etchings on the needle relative to the mark 1201. The operator stops insertion of the needle 405 at a depth less than or equal to the depth of the target 403, as determined by counting. The examiner notes that the depth of the insertion of the needle varies based on the depth of the target and the user can insert the needle based on reference marks spaced one centimeter apart. The trajectory of the needle extends to 14cm in depth and the needle reference mark can be used to insert the needle along the trajectory in a depth corresponding to the target depth which can be for example 10CM, more than 10CM, or less more than 10CM.).
Regarding claim 7, Rohling in the view of Marouf teaches the device in accordance with claim 3, wherein the depths vary between 13 and 15 centimeters (paras. 0157-0158; FIG. 13, the medical instrument guide contains a reference mark 1201 or other indication for the origin of the measurement of the needle insertion depth. Epidural needles have a series of black etchings spaced 1 cm apart (see FIG. 12) to allow the operator to count the centimeters of needle insertion relative to graduations shown on the 2-D ultrasound image. The operator may align the displayed target 404 (for example, the epidural space) with the superimposed graphic 1302 of the anticipated needle trajectory along the propagation axis 204 in the ultrasound image(s) and observes the depth of the target 404 relative to the graduations 605. In FIG. 12, the target is at 10 cm depth, as an example. The needle 405 is subsequently inserted through the medical instrument guide 203 while the depth of insertion is observed by counting the centimeter etchings on the needle relative to the mark 1201. The operator stops insertion of the needle 405 at a depth less than or equal to the depth of the target 403, as determined by counting. The examiner notes that the depth of the insertion of the needle varies based on the depth of the target and the user can insert the needle based on reference marks spaced one centimeter apart. The trajectory of the needle extends to 14cm in depth and the needle reference mark can be used to insert the needle along the trajectory in a depth corresponding to the target depth which can be for example 10CM, more than 10CM, or less more than 10CM.).
Regarding claim 10, Rohling teaches the device in accordance with claim 1, wherein the predetermined angle is between 0 and 30 degrees (Para. 0059; “ultrasound probe angle” as used herein is meant to be the angle between the between the plane of the body guide and the longitudinal axis of the ultrasound probe. For example, ultrasound probe angle is shown as 802 in FIG. 8A. The ultrasound probe angle may be anywhere between 5° and 85°. Alternatively, the ultrasound probe angle may be between 10° and 80°. The ultrasound probe angle may be selected from one of the following ranges: 5° and 85°; 10° and 80°; 15° and 75°; 20° and 70°; 25° and 65°; 30° and 60°; 35° and 55°; and 40° and 50°. Alternatively, the ultrasound probe angle may be selected from one of the following: 5°; 6°; 7°; 8°; 9°; 10°; 11°; 12°; 13°; 14°; 15°; 16°, 17°; 18°; 19°; 20°; 21°; 22°; 23°; 24°; 25°; 26°, 27°; 28°; 29°; 30°; 31°, 32°; 33°; 34°; 35°; 36°, 37°; 38°; 39°; 40°; 41°; 42°; 43°; 44°; 45°; 46°, 47°; 48°; 49°; 50°; 51°; 52°; 53°; 54°; 55°; 56°, 57°; 58°; 59°; 60°; 61°; 62°; 63°; 64°; 65°; 66°, 67°; 68°; 69°; 70°; 71°; 72°; 73°; 74°; 75°; 76°; 77°; 78°; 79°; 80°; 81°; 82°; 83°; 84°; and 85°.).
Regarding claim 11, Rohling teaches the device in accordance with claim 10, wherein the predetermined angle is between 10 and 20 degrees (Para. 0059; “ultrasound probe angle” as used herein is meant to be the angle between the between the plane of the body guide and the longitudinal axis of the ultrasound probe. For example, ultrasound probe angle is shown as 802 in FIG. 8A. The ultrasound probe angle may be anywhere between 5° and 85°. Alternatively, the ultrasound probe angle may be between 10° and 80°. The ultrasound probe angle may be selected from one of the following ranges: 5° and 85°; 10° and 80°; 15° and 75°; 20° and 70°; 25° and 65°; 30° and 60°; 35° and 55°; and 40° and 50°. Alternatively, the ultrasound probe angle may be selected from one of the following: 5°; 6°; 7°; 8°; 9°; 10°; 11°; 12°; 13°; 14°; 15°; 16°, 17°; 18°; 19°; 20°; 21°; 22°; 23°; 24°; 25°; 26°, 27°; 28°; 29°; 30°; 31°, 32°; 33°; 34°; 35°; 36°, 37°; 38°; 39°; 40°; 41°; 42°; 43°; 44°; 45°; 46°, 47°; 48°; 49°; 50°; 51°; 52°; 53°; 54°; 55°; 56°, 57°; 58°; 59°; 60°; 61°; 62°; 63°; 64°; 65°; 66°, 67°; 68°; 69°; 70°; 71°; 72°; 73°; 74°; 75°; 76°; 77°; 78°; 79°; 80°; 81°; 82°; 83°; 84°; and 85°.).
Regarding claim 12, Rohling teaches the device in accordance with claim 1, wherein at least one inner frame is translatable in an x-y axis direction relative to the spinal structure (para. 0123-0124; the apparatus comprises markings that helps the operator to position the device along the desired axis, either AA (y-axis) or BB axis (x-axis).).
Regarding claim 13, Rohling teaches the device in accordance with claim 2, wherein at least one inner frame is translatable in an x-y axis direction relative to the spinal structure (para. 0123-0124; the apparatus comprises markings that helps the operator to position the device along the desired axis, either AA (y-axis) or BB axis (x-axis).).
However, Rohling fails to explicitly teach wherein the sheath with integral needle guides is rotatable around a z-axis.
Marouf, in the same field of endeavor, teaches wherein the sheath with integral needle guides is rotatable around a z-axis (paras. 0353-0354; a sheath which is interpreted as the bracket is attached to the probe where the probe including the bracket can be rotated/tilted by the clinician in the transverse plane as well as in the sagittal plane.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the sheath of Rohling with the rotatable sheath Marouf to include a sheath that is configure to rotate around an axis. Doing so will help in ensuring the optimum positioning of the probe for performing transverse or longitudinal scans as taught by Marouf in paras. 0353-0354.
Regarding claim 14, Rohling teaches the device in accordance with claim 13, wherein the x-axis rotatable portion includes guide markings for adjustment relative to a measured target depth D (para. 0157; the medical instrument guide contains a reference mark 1201 or other indication for the origin of the measurement of the needle insertion depth).
Regarding claim 16, Rohling teaches the device in accordance with claim 13, however fails to explicitly teach wherein z-axis rotation of the sheath is facilitated by magnets or latches positioned at predetermined positions relative to a plurality of possible guide positions for the same device.
Marouf, in the same field of endeavor, teaches (paras. 0452-0453; the clip portion 68 of the needle guide body 62 has a different form to the clip portion 24 in the first example above but it performs the same function of releasably attaching the needle guide body 62 to a selected one of one, two or more mounting protrusions on the bracket in order to hold the needle guide in a predetermined position and orientation relative to the ultrasound probe. It is a latch).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the device of Rohling to incorporate the teaching Marouf to include a latch. Doing so will help fixating the needle guide to the probe as taught by Marouf in para. 00452.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rohling (US Pub No. 2016/0022308) in the view of Bouazza-Marouf (US Pub No. 2019/0282262) (hereinafter, Marouf) in further view of Moskowitz (US Pub No. 2019/0125470).
Regarding claim 8, Rohling teaches the device in accordance with claim 1, however, fails to explicitly teach wherein the predetermined angle takes into account at least one patient parameter for that patient in order to achieve successful placement, including angle and depth of placement in target tissue.
Moskowitz, in the same field of endeavor, teaches the predetermined angle takes into account at least one patient parameter for that patient in order to achieve successful placement, including angle and depth of placement in target tissue (paras. 0251, 0291, and 0299; the algorithm takes as inputs a patient identifier, patient weight, and patient height. a depth of about 60 mm corresponds to a tissue depth of an obese patient having a body mass index (BMI) of about 40 kg/m.sup.2. the scan head is automatically moved relative to the carriage to a level dictated by patient characteristics, such as body mass index (BMI).)
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the positioning method of Rohling in the view of Marouf to incorporate the teaching Moskowitz to include an input of patient parameters to consider while determining the angle and depth of the needle. Doing so will help in ensuring the optimum placement of the needle by to accurately landmarking the lumbar spine.
Regarding claim 9, Rohling teaches the device in accordance with claim 8, however, fails to explicitly teach wherein the at least one parameter is one or more of patient sex, age, height and weight.
Moskowitz, in the same field of endeavor, teaches at least one parameter is one or more of patient sex, age, height and weight (paras. 0251, 0291, and 0299; the algorithm takes as inputs a patient identifier, patient weight, and patient height. a depth of about 60 mm corresponds to a tissue depth of an obese patient having a body mass index (BMI) of about 40 kg/m.sup.2. the scan head is automatically moved relative to the carriage to a level dictated by patient characteristics, such as body mass index (BMI).)
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the positioning method of Rohling in the view of Marouf to incorporate the teaching Moskowitz to include an input of patient parameters to consider while determining the angle and depth of the needle. Doing so will help in ensuring the optimum placement of the needle by to accurately landmarking the lumbar spine.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rohling (US Pub No. 2016/0022308) in the view of Yoo (NPL: “Ultrasonography for lumbar neuraxial block”).
Regarding claim 17, Rohling teaches a method for lumbar epidural catheter placement, comprising (Abstract):
positioning a medical device mount against a patient's back over a spinal structure (z axis), with an ultrasound probe and at least one needle guide in an axial configuration relative to the spinal structure (paras. 0116 and 0147; a mount 199 on the probe 202, a body guide 801 and a medical instrument guide 203 that in this embodiment is affixed to the mount 199 but in other embodiments can be detachably mounted to the mount 199 or remotely located or be attached to or form part of the 3-D ultrasound probe 202. The mount 199 can be a rectangular mounting plate (not shown) to which the probe 202 is mounted. An operator holds the apparatus 200 with one hand and places the apparatus 200 against the patient's back so that the medical instrument guide 203 is directly over the needle insertion point iii. The operator adjusts the position of the a