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 .
Information Disclosure Statement
The information disclosure statement filed 24 November 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. No copy of JP 2003-334191 has been provided.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 2615 (Fig. 26). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The use of the terms BluetoothTM in [0076], 3D XPointTM in [0125], WindowsTM, UnixTM, Windows XPTM, Windows VIstaTM, LinuxTM, DebianTM, FedoraTM, Red HatTM, SolarisTM, BlackberryTM, iOSTM, and macOSTM in [0127], SybaseTM, OracleTM, CodeBaseTM, DB2TM, PostgreSQLTM, CouchbaseTM, CassandraTM, MongoDBTM, Intersystems CachéTM, Amazon RDSTM, AzureTM, MicrosoftTM, MariaDBTM, RedisTM, ApacheTM, GoogleTM, OracleTM, Cloud Big TableTM, FirestoreTM, FirebaseTM, MongoDBTM, Amazon AuroraTM, Amazon DynamoDBTM, Amazon RedshiftTM, Amazon ElastiCacheTM, Amazon MemoryDBTM, Amazon NeptuneTM and QLDBTM in [0136] which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 103
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 21-22, 24, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Brattain (US 20210045711) in view of Burkholz et al. (US 20200230391).
Regarding Claim 21, Brattain teaches ([0071] “interventional device guide injection assembly 700”), the apparatus comprising:
a) a base, ([0071] “base 740”), comprising:
i) a surface configured to positioned against skin of a patient ([0071] “Base 740 may include a mechanical support resting on the skin”); and
ii) a cavity configured to releasably receive an ultrasound probe (Figs. 7A-7C and [0071] “Base 740 is shown with ultrasound handle fixture 730 that provides detachable coupling to ultrasound probe 710.”);
b) an arm, ([0072] “Cartridge 720 is detachably coupled to base 740 and may be configured for the intervention being performed”), pivotably coupled to the base at a pivot, ([0073] “Base 740 includes a drive motor 745 to set an insertion angle and/or depth for an interventional device held by cartridge slot 725 coupled by cartridge coupling 722.”), the pivot allowing an angle of the arm to be adjusted relative to the base, (Fig. 7A), the arm comprising:
i) a needle holder, ([0073] “an interventional device held by cartridge slot 725”), configured to:
1) releasably receive a needle, (interventional device guide injection assembly 700 is utilized in ultrasound guided cannulation that involves insertion of a needle into the subject ([0004]. It is understood by one of ordinary skill in the art that the needle is removed from the subject following the cannulation procedure and that needles are not shared from patient to patient, despite assembly 700 being reusable.), and
2) move linearly along the arm to allow for insertion of the needle ([0044] “Depth of the needle penetration may also be controlled by a setting or a height of the mechanical guide”).
However, Brattain does not explicitly teach a needle surrounded by a catheter sheath; and the arm comprising: a first motor configured to drive movement of the needle with respect to the catheter sheath when the needle is received by the needle holder; and a second motor configured to drive movement of the catheter sheath with respect to the needle when the needle is received by the needle holder.
In an analogous intravenous therapy field of endeavor, Burkholz teaches an apparatus for inserting a needle into a patient, ([0064] “the intravenous therapy system 100 may relay the use of a VAD on the patient” and [0067] “the VAD 200 may include a needle 215”), the apparatus comprising:
a) a needle surrounded by a catheter sheath (Fig. 3); and
b) the arm, (Fig. 7B), comprising:
i) a first motor, ([0107] “the drive mechanism 201 may include one or more motors”), configured to drive movement of the needle with respect to the catheter sheath when the needle is received by the needle holder ([0107] “the drive mechanism 201 may advance […] the needle in the distal direction. […] the drive mechanism 201 may advance the catheter and then retract the needle in response to the needle tip entering the vein.”); and
ii) a second motor configured to drive movement of the catheter sheath with respect to the needle when the needle is received by the needle holder ([0107] “the drive mechanism 201 may advance the catheter and then retract the needle in response to the needle tip entering the vein.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Brattain with the needle and first and second motors of Burkholz because the modification allows for automatic insertion of the needle into the blood vessel, as taught by Burkholz in [0105], minimizing user error and ensuring accurate placement of the needle and/or catheter within the patient.
Regarding Claim 22, the modified apparatus of Brattain teaches all limitations of Claim 21, as discussed above. Furthermore, Brattain teaches wherein the surface of the base is curved ([0031] “The transducer array 102 can include any suitable ultrasound transducer array, including […] curved arrays” and [0071] “Base 740 is shown with ultrasound handle fixture 730 that provides detachable coupling to ultrasound probe 710.”).
Regarding Claim 24, the modified apparatus of Brattain teaches all limitations of Claim 21, as discussed above. Furthermore, Brattain teaches a display ([0038] “display system 116”).
Regarding Claim 30, the modified apparatus of Brattain teaches all limitations of Claim 21, as discussed above. Furthermore, Brattain teaches a third motor configured to adjust an angle of the needle with respect to the base ([0072] “base 740 contains a motor to set the angle at which the interventional device”).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Brattain (US 20210045711) in view of Burkholz et al. (US 20200230391), as applied to Claim 21 above, further in view of Elkadi (US 20180235649).
Regarding Claim 25, the modified apparatus of Brattain teaches all limitations of Claim 21, as discussed above. However, the modified apparatus of Brattain does not explicitly teach at least one guide bar, wherein the at least one guide bar is positioned in a sensing path of the ultrasound probe.
In an analogous inserting a device under ultrasound guidance field of endeavor, Elkadi teaches an apparatus for inserting a needle into a patient, (Abstract “A surgical device with ultrasound guidance and related techniques are disclosed” and [0051] “The present disclosure is not intended to be limited only to electrosurgical and ultrasound surgical instruments, as other types of instruments typically used in surgeries (e.g., […] needles”), comprising at least one guide bar, ([0034] “surgical device 100 further may include one or more guide portions 120”), wherein the at least one guide bar is positioned in a sensing path of the ultrasound probe ([0023] “the accompanying drawings are not intended to be drawn to scale or to limit the described embodiments to the specific configurations shown” and Fig. 6).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Brattain with the guide bar of Elkadi because the modification allows for greater range of motion of the needle or insertable instrument, providing an advantage that allows the user to efficiently reach the region of interest.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Brattain (US 20210045711) in view of Burkholz et al. (US 20200230391), as applied to Claim 21 above, and further in view of Song (CN 112168299), cited with page numbers from the WIPO translation.
Regarding Claim 26, the modified apparatus of Brattain teaches all limitations of Claim 21, as discussed above. However, the modified apparatus of Brattain does not explicitly teach a needle measurement hole disposed at a proximal end of the swing arm; and a hilt sensor located at the needle measurement hole and configured to be activated by a hilt of the needle, wherein determining the length of the needle comprises determining that the hilt sensor has been activated.
In an analogous puncture guidance under ultrasound field of endeavor, Song teaches an apparatus for inserting a needle into a patient, (Abstract “The invention claims a PICC tube ultrasonic puncture locating device”), further comprising:
a) a needle measurement hole disposed at a proximal end of the swing arm (as shown in Fig. 1, reproduced below); and
b) a hilt sensor, (Page 3 “photoelectric distance measuring sensor 13”), located at the needle measurement hole, (as shown in Fig. 1, reproduced below), and configured to be activated by a hilt of the needle (Page 1 “a photoelectric distance measuring sensor provided on an upper end surface of the sleeve needle part, and the photoelectric distance measurement sensor is mounted at an edge position of the needle sleeve corresponding to the rear end of the puncture needle.”),
c) wherein determining the length of the needle comprises determining that the hilt sensor has been activated (Page 3 “when the puncture needle is inserted into the sleeve needle part, the needle sleeve of the puncture needle is opposite to the photoelectric distance measuring sensor; It can judge the advancing length of the puncture needle by detecting the distance of the needle sleeve at the back end of the puncture needle.”).
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Fig. 1 of Song
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the needle measurement hole and hilt sensor of Song because the modification ensures proper positioning of the inserted needle, while also providing length information, which is beneficial to the user when determining the depth of the inserted needle.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Brattain (US 20210045711) in view of Burkholz et al. (US 20200230391), as applied to Claim 21 above, and further in view of Connor (US 5671747).
Regarding Claim 27, the modified apparatus of Brattain teaches all limitations of Claim 21, as discussed above. However, the modified apparatus of Brattain does not explicitly teach a cylindrical finger receiver with a closed curved surface.
In analogous intraoperative ultrasound transducer probe field of endeavor, Connor teaches an apparatus (Abstract “an intraoperative ultrasound transducer probe”), the apparatus comprising: a cylindrical finger receiver with a closed curved surface (as shown in Fig. 3, reproduced above, where the closed curved surface is the cap featured on the end of the finger cuff portion 46.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the finger receiver of Connor because the modification allows for access to patient’s body parts in confined spaces, as taught by Connor in Abstract.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Brattain (US 20210045711) in view of Burkholz et al. (US 20200230391), as applied to Claim 21 above, and further in view of Park et al. (US 20070073155).
Regarding Claim 29, the modified apparatus of Brattain teaches all limitations of Claim 21, as discussed above. However, the modified apparatus of Brattain does not explicitly teach gel configured to be positioned within the cavity.
In an analogous ultrasound guidance field of endeavor, Park teaches an apparatus for inserting a needle into a patient, (Abstract “A compact ultrasound needle guidance system”), comprising gel configured to be positioned within the cavity ([0073] “The design of shell 100 is such that forward end 106 may be used as a container for acoustic coupling gel. Hence, shell 100 may be provided with acoustic gel in container area 116 and sealed by a removable lidstock.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the gel of Park because the modification promotes a compact design of the apparatus, by providing a uniform design of an acoustic medium and apparatus.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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