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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the c-shaped extension and the component of an ultrasound machine must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 10 is objected to because of the following informalities: At line 2 “an c-shaped extension” should read --a c-shaped extension--. 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 9 and 20 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.
Claims 9 and 20 recite the limitation “an integrated adhesive configured to secure the medical device”. What is an integrated adhesive and how is it different than a regular adhesive? Clarification is requested. For the purpose of examination, claim 9 is being interpreted such that an integrated adhesive is an adhesive attached to the medical device.
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 - 3, 5, 12 – 14, and 16 are rejected under are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Diaz (US 20190307484 A1 – Cited by Applicant) in view of Orome et al. (US 20120165679 A1).
Regarding claim 1, Garcia Diaz discloses an alignment portion configured to align the medical device with a spine of a patient, the alignment portion including a first end and a second end (Figure 1, adjustable central arm 16); and an insertion portion extending outward from the alignment portion and coupled to the alignment portion at the first end of the alignment portion, wherein the alignment portion and the insertion portion form an insertion angle and guide the needle into the patient based on the insertion angle (Figure 1, supports 14, ports 18). Garcia Diaz also discloses a needle insertion tube configured to receive a needle (Figure 1, ports 18). Garcia Diaz does not disclose that the insertion portion includes a set of needle insertion tubes. Orome teaches an apparatus which has a set of needle guide channels set at an insertion angle (Figure 1A, 20A, 20B, 20C). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz such that it includes a set of needle insertion tubes because it allows for accommodation of needles of multiple gauges (Orome, [0036]).
Regarding claim 2, Garcia Diaz further discloses that the insertion angle defines an angle at which the needle is inserted into the patient (Figure 1, [0018]).
Regarding claim 3, Garcia Diaz further discloses that each needle insertion tube included in the set of needle insertion tubes has a length (Figure 1, ports 18).
Regarding claim 5, Garcia Diaz further discloses that each needle insertion tube has the same length (Figure 1, ports 18).
Regarding claim 12, Garcia Diaz discloses providing a medical device, the medical device including an alignment portion configured to align the medical device with a spine of a patient, the alignment portion including a first end and a second end (Figure 1, adjustable central arm 16), and an insertion portion extending outward from the alignment portion and coupled to the alignment portion at the first end of the alignment portion, wherein the alignment portion and the insertion portion form an insertion angle; aligning, via the alignment portion, the medical device with the spine of the patient; and guiding, via the at least one needle insertion tube, into the patient based on the insertion angle (Figure 1, supports 14, ports 18). Garcia Diaz also discloses receiving a needle through at least one needle insertion tube ([0015]). Garcia Diaz does not disclose a set of needle insertion tubes of the insertion portion. Orome teaches an apparatus which has a set of needle guide channels set at an insertion angle (Figure 1A, 20A, 20B, 20C). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz such that it includes a set of needle insertion tubes because it allows for accommodation of needles of multiple gauges (Orome, [0036]).
Regarding claim 13, Garcia Diaz further discloses that the insertion angle defines an angle at which the needle is inserted into the patient (Figure 1, [0018]).
Regarding claim 14, Garcia Diaz further discloses that each needle insertion tube included in the set of needle insertion tubes has a length (Figure 1, ports 18).
Regarding claim 16, Garcia Diaz further discloses that each needle insertion tube has the same length (Figure 1, ports 18).
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Diaz in view of Orome further in view of Froning (US 3964480 A).
Regarding claim 4, Garcia Diaz in view of Orome discloses all of the limitations of the claim as discussed above except that the length defines a penetration depth to which the needle is inserted into the patient. Froning teaches an apparatus which uses a docking depth sleeve that defines a penetration depth of a needle (Column 2 lines 47 – 55, column 7 lines 17 - 20). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that the length defines a penetration depth to which the needle is inserted into the patient because it allows for control of the penetration depth (Froning, column 1 lines 60-63).
Regarding claim 15, Garcia Diaz in view of Orome discloses all of the limitations of the claim as discussed above except that the length defines a penetration depth to which the needle is inserted into the patient. Froning teaches an apparatus which uses a docking depth sleeve that defines a penetration depth of a needle (Column 2 lines 47 – 55, column 7 lines 17 - 20). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that the length defines a penetration depth to which the needle is inserted into the patient because it allows for control of the penetration depth (Froning, column 1 lines 60-63).
Claims 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Diaz in view of Orome further in view of Boggs et al. (US 20230263588 A1), hereinafter referred to as Boggs.
Regarding claim 6, Garcia Diaz in view of Orome discloses a device with multiple needle insertion tubes, as discussed above. Garcia Diaz in view of Orome does not disclose that the length is different for each needle insertion tube. Boggs teaches a device for guiding a needle or multiple needles into a patient where the needles and needle tubes are different lengths ([0158], [0276], “The length of the needle portion of the sleeve may be 90-100 mm, 60-130 mm, and/or 30-160 mm in length”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that the length is different for each needle insertion tube because different needle lengths allow for targeting of different locations on a subject’s body (Boggs, [0276]).
Regarding claim 7, Garcia Diaz in view of Orome discloses a device with multiple needle insertion tubes, as discussed above. Garcia Diaz in view of Orome does not disclose that the length is different for each needle insertion tube. Boggs teaches a device for guiding a needle or multiple needles into a patient where the needles and needle tubes are different lengths ([0158], [0276], “The length of the needle portion of the sleeve may be 90-100 mm, 60-130 mm, and/or 30-160 mm in length”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that the length is different for each needle insertion tube because different needle lengths allow for targeting of different locations on a subject’s body (Boggs, [0276]).
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Diaz in view of Orome further in view of Ben Arie et al. (US 11253236 B2), hereinafter referred to as Ben Arie.
Regarding claim 7, Garcia Diaz in view of Orome discloses an assembly with needle insertion tubes which is attached to the spine of a patient. Garcia Diaz in view of Orome does not disclose that each needle insertion tube is associated with a different cranial-caudal offset. Ben Arie discloses a set of needles which have a different cranial-caudal offset (Figure 2, needles 32a and 32b). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that each needle insertion tube is associated with a different cranial-caudal offset because it would be combining prior art elements according to known methods to yield predictable results. Having multiple needle insertion tubes associated with a different cranial-caudal offset allows for a higher likelihood of successfully inserting the needle into the correct location.
Regarding claim 18, Garcia Diaz in view of Orome discloses an assembly with needle insertion tubes which is attached to the spine of a patient. Garcia Diaz in view of Orome does not disclose that each needle insertion tube is associated with a different cranial-caudal offset. Ben Arie discloses a set of needles which have a different cranial-caudal offset (Figure 2, needles 32a and 32b). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that each needle insertion tube is associated with a different cranial-caudal offset because it would be combining prior art elements according to known methods to yield predictable results. Having multiple needle insertion tubes associated with a different cranial-caudal offset allows for a higher likelihood of successfully inserting the needle into the correct location.
Claim 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Diaz in view of Orome further in view of Moskowitz et al. (US 20170319127 A1), hereinafter referred to as Moskowitz.
Regarding claim 8, Garcia Diaz in view of Orome discloses an assembly with needle insertion tubes which is attached to the spine of a patient. Garcia Diaz in view of Orome does not disclose that the second end is configured to align with a gluteal cleft of the patient. Moskowitz teaches a device which has an end aligned with the midline of the patient, which is aligned with a gluteal cleft of the patient ([0097], “once the tactile sensing device is correctly aligned along the midline of the patient, the user ensures force is applied to the tactile sensing device and against the patient”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that the second end is configured to align with a gluteal cleft of the patient because it would be combining prior art elements according to known methods to yield predictable results. A lumbar puncture involves placing a needle in an intraspineous process space between two spinal vertebrae (Moskowitz, [0046]) and the device has multiple needle insertion tubes so it needs to be aligned with a gluteal cleft of the patient so that the needles are poised to go into the intraspineous process space.
Regarding claim 19, Garcia Diaz in view of Orome discloses an assembly with needle insertion tubes which is attached to the spine of a patient. Garcia Diaz in view of Orome does not disclose that the second end is configured to align with a gluteal cleft of the patient. Moskowitz teaches a device which has an end aligned with the midline of the patient, which is aligned with a gluteal cleft of the patient ([0097], “once the tactile sensing device is correctly aligned along the midline of the patient, the user ensures force is applied to the tactile sensing device and against the patient”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that the second end is configured to align with a gluteal cleft of the patient because it would be combining prior art elements according to known methods to yield predictable results. A lumbar puncture involves placing a needle in an intraspineous process space between two spinal vertebrae (Moskowitz, [0046]) and the device has multiple needle insertion tubes so it needs to be aligned with a gluteal cleft of the patient so that the needles are poised to go into the intraspineous process space.
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Diaz in view of Orome further in view of Lin et al. (US 20210161553 A1 – Cited by Applicant), hereinafter referred to as Lin.
Regarding claim 9, Garcia Diaz in view of Orome discloses a complementary fastener which can be removably attached by adhesive to a patient’s body (Garcia Diaz, [0015]). Garcia Diaz in view of Orome does not disclose that an integrated adhesive is configured to secure the medical device to a back of the patient during a procedure. Lin teaches a device for guiding needles which is fastened to a patient’s skin using adhesive ([0023], “The dome may be placed on top of a needle entry site and fastened to the patient's skin using adhesive materials. The base of the dome may be coated on its underside with an adhesive composition that adheres to the patient's skin.”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that an integrated adhesive is configured to secure the medical device to a back of the patient during a procedure because it allows for stabilizing a needle in relation to a patient’s body (Lin, [0015]).
Regarding claim 20, Garcia Diaz in view of Orome discloses a complementary fastener which can be removably attached by adhesive to a patient’s body. Garcia Diaz in view of Orome does not disclose that an integrated adhesive is configured to secure the medical device to a back of the patient during a procedure. Lin teaches a device for guiding needles which is fastened to a patient’s skin using adhesive ([0023], “The dome may be placed on top of a needle entry site and fastened to the patient's skin using adhesive materials. The base of the dome may be coated on its underside with an adhesive composition that adheres to the patient's skin.”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that an integrated adhesive is configured to secure the medical device to a back of the patient during a procedure because it allows for stabilizing a needle in relation to a patient’s body (Lin, [0015]).
Claims 10, 11, 21, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Diaz in view of Orome further in view of Rohling (US 20160022308 A1).
Regarding claim 10, Garcia Diaz in view of Orome discloses all of the limitations of the claim as discussed above except an c-shaped extension configured to attach to another medical device. Rohling teaches a device which can be used for lumbar punctures which has a c-shaped mount in association with an ultrasound probe (Figure 14A removeable mount 1199 and probe 202, [0125], “ the apparatus 2001 and 2002, respectively shows a removeable mount 1199 in association with a probe 202. ”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes an c-shaped extension configured to attach to another medical device because it enables imaging of the target area and collecting data about the medical instrument’s position relative to the target (Rohling, [0011]).
Regarding claim 11, Garcia Diaz in view of Orome discloses all of the limitations of the claim as discussed above except that the other medical device is a component of an ultrasound machine. Rohling teaches a device which can be used for lumbar punctures which has a c-shaped mount in association with an ultrasound probe (Figure 14A removeable mount 1199 and probe 202, [0125], “ the apparatus 2001 and 2002, respectively shows a removeable mount 1199 in association with a probe 202. ”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that the other medical device is a component of an ultrasound machine because the ultrasound machine enables collection of information about the medical instrument’s position relative to the target in 3D (Rohling, [0011]).
Regarding claim 21, Garcia Diaz in view of Orome discloses all of the limitations of the claim as discussed above except an c-shaped extension configured to attach to another medical device. Rohling teaches a device which can be used for lumbar punctures which has a c-shaped mount in association with an ultrasound probe (Figure 14A removeable mount 1199 and probe 202, [0125], “ the apparatus 2001 and 2002, respectively shows a removeable mount 1199 in association with a probe 202. ”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes an c-shaped extension configured to attach to another medical device because it enables imaging of the target area and collecting data about the medical instrument’s position relative to the target (Rohling, [0011]).
Regarding claim 22, Garcia Diaz in view of Orome discloses all of the limitations of the claim as discussed above except that the other medical device is a component of an ultrasound machine. Rohling teaches a device which can be used for lumbar punctures which has a c-shaped mount in association with an ultrasound probe (Figure 14A removeable mount 1199 and probe 202, [0125], “ the apparatus 2001 and 2002, respectively shows a removeable mount 1199 in association with a probe 202. ”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Garcia Diaz in view of Orome such that it includes that the other medical device is a component of an ultrasound machine because the ultrasound machine enables collection of information about the medical instrument’s position relative to the target in 3D (Rohling, [0011]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure.
Anand et al. (US 20180185058 A1) teaches a drug delivery device which can do lumbar punctures, which can be used with an ultrasound machine.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R UCHITEL whose telephone number is (571)305-5153. The examiner can normally be reached Mon-Fri from 8:30am – 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, can be reached at telephone number (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY R UCHITEL/ Examiner, Art Unit 3791
/ETSUB D BERHANU/ Primary Examiner, Art Unit 3791
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