DETAILED ACTION
Response to Amendment
Election/Restrictions
Newly submitted claims 23-26 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The apparatus as claimed can be used in a materially different that does not require the structure of the recited method.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 23-26 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/15/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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.
Claim(s) 1-5, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand et al. (US 2005/0192638; hereafter Gelfand) in view of Massengale et al. (US 2012/0095404; hereafter Massengale) and further in view of Gunderson et al. (US 2008/0125752; hereafter Gunderson).
In regard to claim 1, Gelfand discloses a catheter system (see at least Fig. 4) for administering medication to a patient, which system includes: a medication port (105) configured for placement subcutaneously to the patient the medication port configured to receive a medication from a medication dispenser (see syringe in Fig. 4; the medication dispenser is functionally recited) disposed externally to the patient via a needle (405); and a catheter (106) extending from a proximal end to a distal end, the catheter being configured for fluidic connection to said medication port at the proximal end and terminating at the distal end (see Fig. 4), the distal end having an infusion port configured to deliver the medication internally to the patient, the echogenic catheter being configured for positioning the distal end in proximity to a nerve center of the patient using ultrasound imaging (see at least the Abstract and par. [0049]-[0051]), the catheter comprising at least one electrical conductor (412, 413) extending to the distal end of the echogenic catheter and configured to deliver electrical energy from a nerve stimulator to the patient (see par. [0049]-[0051]).
Gelfand fails to expressly disclose that the catheter is echogenic, that the distal end of the catheter has two or more infusion ports and that the echogenic catheter comprises a catheter liner as is recited in claim 1.
In a similar art, Massengale discloses a catheter for use in nerve block procedures, wherein the catheter (100) is echogenic (see par. [0058]) and includes two or more infusion ports (112) along the distal end of the catheter (see Fig. 4, 8, and 19; see par. [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gelfand with the echogenicity and infusion ports of Massengale in order to provide a means for locating the catheter in the body and a means for delivering at multiple regions or sides of the targeted tissue.
The combination still fails to teach a catheter liner as is recited in claim 1.
In a similar art, Gunderson teaches a catheter liner (20, 22) for lining and reinforcing the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the catheter liner of Gunderson to provide an art-recognized means for reinforcing and lining a catheter.
In regard to claim 2, Gunderson teaches wherein the catheter liner comprises a braided sleeve (see par. [0021]).
In regard to claim 3, the combination teaches a system wherein the medication dispenser is connected to a medication control system configured for selectively injecting the medication to said echogenic catheter (the medication dispenser and control system are functionally claimed).
In regard to claim 4, Massengale teaches wherein the distal end of the echogenic catheter includes an echogenic marker (108, 150, 172, 250, 254) disposed near the infusion ports.
In regard to claim 5, Massengale teaches wherein the echogenic marker comprises a titanium or stainless steel material (see par. [0059], [0071], [0081]).
In regard to claim 8, Gelfand discloses wherein the medication comprises a nerve block or other local anesthetic (see at least the Abstract).
In regard to claim 10, please see the rejection of claim 1 as the examiner believes all of the limitations are adequately addressed.
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand, Massengale, and Gunderson and further in view of Wallace et al. (US 2002/0087177; hereafter Wallace).
The combination fails to teach wherein said catheter includes: a solenoid coil located in said distal end of said catheter, said solenoid coil configured for connection to the nerve stimulator via the electrical conductor of said catheter; and an echogenic magnet reciprocably received in said solenoid coil and configured for ultrasonic detection and monitoring.
In a similar art, Wallace discloses a catheter includes: a solenoid coil (460) located in said distal end of said catheter (400); said solenoid coil configured for connection to an electrical power source via electrical leads within said catheter (see par. [0035]; 460 is coiled solenoid/induction electromagnet); and an echogenic magnet (500) reciprocably received in said solenoid coil and configured for ultrasonic detection and monitoring (see par. [0036]; the magnet is movable within lumen 420; "configured for ultrasonic detection and monitoring" is interpreted as functional). The configuration allows for controlled delivery to the target site (see Abstract; par. [0036]-[0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the solenoid/magnet configuration of Wallace in order to provide enhanced delivery of agent into the target site.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gelfand, Massengale, and Gunderson and further in view of Gates et al. (US 5,522,875; hereafter Gates).
In regard to claim 7, the combination fails to further disclose a stylet configured to be received within the echogenic catheter, the stylet having a bent distal end and a proximal knob, wherein rotation of the proximal knob of the stylet produces movement of the bent distal end of the stylet that facilitates positioning the distal end of the echogenic catheter using ultrasound imaging.
In a similar art, Gates discloses a stylet (24) configured to be received within the echogenic catheter, the stylet having a bent distal end (see Fig. 14a) and a proximal knob (180), wherein rotation of the proximal knob of the stylet produces movement of the bent distal end of the stylet that facilitates positioning the distal end of the echogenic catheter using ultrasound imaging (functional limitation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the stylet of Gates in order to provide a means for inserting and navigating the catheter.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand, Massengale, and Gunderson and further in view of Olson (US 8,376,960).
The combination fails to teach which includes a quantity of electrorheological fluid encapsulated in said catheter distal end as is recited in claim 12 and which includes a quantity of a phase change agent encapsulated in said catheter distal end as is recited in claim 14.
In a similar art, Olson discloses a catheter with variable stiffness including chambers (42a-42c) filled with electrorheological fluid, wherein electric fields can be applied to the chambers to adjust the stiffness along the longitudinal length (see at least Figure 2 and the respective portions of the specification).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the electrorheological fluid-filled chambers of Olson in order to provide an adjustable stiffness catheter to enhance trackability and pushability of the catheter (see at least col.1, lines 56-67 of Olson).
Claim 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand, Massengale, Gunderson, and Olson further in view of Marchitto et al. (US 6,532,387; hereafter Marchitto).
The combination fails to teach which includes a quantity of magnetorheological fluid encapsulated in said catheter distal end as is recited in claim 13. The rejection over claim 13 is exactly the same as the rejections for claims 12 and 14 but Marchitto is added to teach that magnetorheological fluid is an equivalent phase-changing stiffening fluid to electrorheological fluid (see col. 10, lines 17-46) and that magnetorheological fluid could easily be substituted as the phase-changing fluid of the combination.
Claims 15-16 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand, Massengale, and Gunderson and further in view of O’Brien et al. (US 2022/0133401; hereafter O’Brien).
The combination fails to teach wherein said catheter includes a microelectron- mechanical system encapsulated in said catheter distal end as is recited in claim 15, and a Piezoelectric micro-machined, ultrasonic transducer encapsulated in said catheter distal end as is recited in claim 16.
In a similar art, O'Brien discloses a catheter (102) designed to be visualized within the body and discloses visualization systems for enhancing visualization within the body. One embodiment is a shaft (106) with integrated ultrasound in the form a Piezoelectric Micromachined ultrasonic transducers (PMUT). PMUT is a microeletro- mechanical system (see par. [0268]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination with the PMUT transducers of O'Brien in order to provide an integrated ultrasound system that enhanced visualization within the body.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gelfand in view of Massengale.
In regard to claim 9, Gelfand discloses a catheter system (see at least Fig. 4) for administering medication to a patient, which system includes: a medication port (105) configured for placement subcutaneously to the patient the medication port configured to receive a medication from a medication dispenser (see syringe in Fig. 4; the medication dispenser is functionally recited) disposed externally to the patient via a needle (405); and a catheter (106) extending from a proximal end to a distal end, the catheter being configured for fluidic connection to said medication port at the proximal end and terminating at the distal end (see Fig. 4), the distal end having an infusion port configured to deliver the medication internally to the patient, the echogenic catheter being configured for positioning the distal end in proximity to a nerve center of the patient using ultrasound imaging (see at least the Abstract and par. [0049]-[0051]), the catheter comprising at least one electrical conductor (412, 413) extending to the distal end of the echogenic catheter and configured to deliver electrical energy from a nerve stimulator to the patient (see par. [0049]-[0051]).
Gelfand fails to expressly disclose that the catheter is echogenic, that the distal end of the catheter has two or more infusion ports and that the echogenic catheter comprises a catheter liner as is recited in claim 1.
In a similar art, Massengale discloses a catheter for use in nerve block procedures, wherein the catheter (100) is echogenic (see par. [0058]) and includes two or more infusion ports (112) along the distal end of the catheter (see Fig. 4, 8, and 19; see par. [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gelfand with the echogenicity and infusion ports of Massengale in order to provide a means for locating the catheter in the body and a means for delivering at multiple regions or sides of the targeted tissue.
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 1-16 and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,654,260. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patented claims.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783