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 .
Response to Arguments
Applicant's arguments filed 02/04/2026 have been fully considered but they are not persuasive.
The objections to the drawings have been maintained. The catheter tip, previously labeled as 920, has been changed to 925. No part is given the number 925 in the specification. Per [0083] of the instant application, the catheter tip should be labeled 914.
The rejections under 35 USC 112 have been withdrawn.
Applicant argues, see Applicant’s arguments pages 12-13, that the combination of Gelfand and Roberts would not have been obvious, as Roberts pertains to an intrauterine tamponade. Examiner asserts that the application of Roberts is irrelevant; Roberts is introduced only to teach that a stylet can be inserted into a catheter. Paragraphs [0038]-[0039] of Roberts teach that this configuration would increase rigidity to the catheter and make it easier to navigate in the body. This result is desired in the instant application, especially since the catheter is being positioned subcutaneously and not navigated through a body cavity. Examiner upholds the use of Roberts, as one having ordinary skill in the art would understand that the stylet of Roberts can be applied to the catheter of Gelfand for an easier placement of the catheter in the body.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Figure 14 labels the catheter tip as 925. Per [0083], the catheter stimulation tip should be labeled 914. 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. 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
Objections to the claims have been withdrawn in response to Applicant’s amendments filed 02/04/2026.
Claim Rejections - 35 USC § 112
Rejections under 35 USC 112 have been withdrawn in response to Applicant’s amendments filed 02/04/2026.
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 1-3 & 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand (US 2005/0192638) in view of Roberts (US 2020/0093498).
Regarding claim 1, Gelfand teaches a catheter system for pain management, which system includes:
a subcutaneous port (implantable drug pump 105, [0043]) comprising a medication reservoir (reservoir 403, [0047]) formed in said subcutaneous port ([0047] & Figure 4), the subcutaneous port configured to receive a medication from a medication dispenser (syringe, Figure 4) positioned external to a skin surface of a patient (Figure 4), the subcutaneous port configured to hold the medication in the medication reservoir ([0047]); and
an echogenic ([0046]) catheter (drug delivery catheter 106, [0043]) having a proximal end fluidically connected to said medication reservoir of the subcutaneous port ([0047] & Figure 4) and a distal end (Figure 4), the echogenic catheter including a discharge port configured for discharging said medication in proximity to a nerve center of the patient (renal nerve, [0047]), the echogenic catheter configured for imaging and placement in the patient via an ultrasound imaging system in real-time ([0046]).
However, Gelfand fails to disclose a stylet including a proximal end mounting knob and a distal end, the stylet configured for insertion into said echogenic catheter and for placement of the echogenic catheter in a desired location within the patient.
Roberts teaches a stylet (stylet 10, [0038]) including a proximal end mounting knob (hub 22, [0038]) and a distal end (distal tip 39, [0043]), the stylet configured for insertion ([0038]) into said echogenic catheter (catheter 8, [0038]) and for placement of the echogenic catheter in a desired location within the patient ([0038]-[0039]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand to include a stylet including a proximal end mounting knob and a distal end, the stylet configured for insertion into said echogenic catheter and for placement of the echogenic catheter in a desired location within the patient, as taught by Roberts. By adding rigidity to the catheter, as is taught in [0038] of Roberts, the insertion process for the catheter becomes much easier for the user.
Regarding claims 2-3, Gelfand in view of Roberts teach the catheter system according to claim 1, and Gelfand further teaches placing the distal end of the echogenic catheter in proximity to the nerve center of the patient in real time ([0046]-[0047]).
Roberts further teaches:
said stylet comprises a proximal section (proximal end 24, [0039]) extending from said proximal end mounting knob (Figure 9) and a distal section (distal end 26, [0039]) extending from said proximal section and terminating at said distal end (Figure 9);
wherein said proximal section and distal section form a bent, angular orientation relative to each other ([0043]); and
wherein said stylet distal section when inserted within said echogenic catheter is configured for manipulation via said proximal end mounting knob to create an interactive signature visible with said ultrasound imaging system, said interactive signature facilitating placement of the distal end of the echogenic catheter.
Although not explicitly taught by Roberts, the stylet would be “configured for manipulation”, and by doing so, would create a signature visible during ultrasound imaging.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand such that: said stylet comprises a proximal section extending from said proximal end mounting knob and a distal section extending from said proximal section and terminating at said distal end; wherein said proximal section and distal section form a bent, angular orientation relative to each other; and wherein said stylet distal section when inserted within said echogenic catheter is configured for manipulation via said proximal end mounting knob to create an interactive signature visible with said ultrasound imaging system, said interactive signature facilitating placement of the distal end of the echogenic catheter, as taught by Roberts. By creating a signature visible during ultrasound imaging with this configuration, the echogenicity of the system is increased, allowing for a more accurate placement of the catheter.
Regarding claim 10, Gelfand in view of Roberts teach the catheter system according to claim 1, and Gelfand further teaches administering nerve block or other medications for treating nerve-related conditions ([0043]).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand in view of Roberts, as applied to claim 1, above, in further view of Smith (US 2007/0016167).
Regarding claim 4, Gelfand in view of Roberts teach the catheter system according to claim 3.
However, Gelfand in view of Roberts fail to disclose that said catheter further comprises: a catheter hub assembly mounted on said catheter proximal end and configured for fluidically connecting said echogenic catheter to the medication reservoir of the subcutaneous port.
Smith teaches that said catheter (catheter 10, [0049]) further comprises: a catheter hub assembly (hub member 30, [0049]) mounted on said catheter proximal end ([0050] & Figure 1) and configured for fluidically connecting said echogenic catheter to the medication reservoir of the subcutaneous port.
If combined with the system of Gelfand, the hub member of Smith would fluidically connect the catheter and medication reservoir.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand and Roberts such that said catheter further comprises: a catheter hub assembly mounted on said catheter proximal end and configured for fluidically connecting said echogenic catheter to the medication reservoir of the subcutaneous port, as taught by Smith. Providing this connection allows the system to perform its intended function of delivering medication from the reservoir to the nerve center via the catheter.
Regarding claim 5, Gelfand in view of Roberts and Smith teach the catheter system according to claim 4, and Smith further teaches that said catheter hub assembly includes:
a catheter hub with a proximal end and a distal end (Figure 1), said catheter hub proximal end configured for fluidic connection to said subcutaneous port (See rejection of claim 4), and said catheter hub distal end connected to said echogenic catheter ([0050] & Figure 1); and
a pair of lateral flanges mounted on and extending laterally from said catheter hub proximal end (Figure 1).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand and Roberts such that said catheter hub assembly includes: a catheter hub with a proximal end and a distal end, said catheter hub proximal end configured for fluidic connection to said subcutaneous port, and said catheter hub distal end connected to said echogenic catheter; and a pair of lateral flanges mounted on and extending laterally from said catheter hub proximal end, as taught by Smith. The connections allow the system to deliver medication to the nerve center, and the pair of lateral flanges may secure the catheter in place with regards to the medication reservoir.
Regarding claim 6, Gelfand in view of Roberts and Smith teach the catheter system according to claim 5, and Smith further teaches:
a catheter proximal fitting (twist locking cap 90, [0060]) connected to said catheter proximal end ([0060] & Figure 1);
a detachable tip connecting said catheter hub distal end to said catheter proximal fitting ([0060]); and
Paragraph [0060] teaches “the locking cap 90 is selectively attachable to the threaded portion of the proximal port 32 of the hub member”. Thus, the catheter from the locking cap 90 to the distal tip is detachable.
said detachable tip configured for enabling flushing of the echogenic catheter after disconnection of the catheter hub assembly from said catheter proximal fitting ([0060]).
The phrase “configured for enabling flushing” is intended use. If so desired, one can flush the catheter after disconnecting it, and the detachable tip of Smith allows for this to be performed.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand and Roberts to include: a catheter proximal fitting connected to said catheter proximal end; a detachable tip connecting said catheter hub distal end to said catheter proximal fitting; and said detachable tip configured for enabling flushing of the echogenic catheter after disconnection of the catheter hub assembly from said catheter proximal fitting, as taught by Smith. Providing the catheter with a detachable tip allows for both flushing and replacement of the tip, each of which can maximize the catheter’s sterility and operational functionality.
Claims 7 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand in view of Roberts and Smith, as applied to claim 6, above, in further view of Stypulkowski (US 2005/0256541).
Regarding claim 7, Gelfand in view of Roberts and Smith teach the catheter system according to claim 6, and Gelfand further teaches:
a metallic stimulation tip (electrode 412, [0049]) formed in said catheter distal end ([0049] & Figure 4) and configured for stimulating a patient’s neurology ([0050]); and
a stimulation wire lead (conductive wire 413, [0049]) extending from the catheter hub assembly to said metallic stimulation tip ([0049] & Figure 4), wherein the stimulation wire lead is configured to deliver a stimulation signal ([0050]) from an electrical pulse generator (control circuitry of the pump 409, [0049]) to the metallic stimulation tip via the stimulation wire lead ([0049] & Figure 4).
If combined with the teachings of Smith, the stimulation wire lead would extend from the catheter hub assembly.
However, Gelfand in view of Roberts and Smith fails to disclose that the electrical pulse generator is located external to the patient.
Stypulkowski teaches that the electrical pulse generator (stimulator 28, [0025]) is located external to the patient ([0025]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand, Roberts, and Smith such that the electrical pulse generator is located external to the patient, as taught by Stypulkowski. By keeping the electrical pulse generator external to the patient and not within the port, the port can be made more compact, potentially reducing any discomfort when implanted within the patient.
Regarding claim 16, Gelfand in view of Roberts, Smith, and Stypulkowski teach the catheter system according to claim 7, and Gelfand further teaches: a medication control system (valve 408, [0047]) connected to said medication dispenser ([0047] & Figure 4) and configured for selectively injecting medication to said catheter ([0047]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gelfand in view of Roberts, Smith, and Stypulkowski, as applied to claim 7, above, in further view of McKinney (US 2021/0038099).
Regarding claim 8, Gelfand in view of Roberts, Smith, and Stypulkowski teach the catheter system according to claim 7.
However, Gelfand in view of Roberts, Smith, and Stypulkowski fail to disclose that each said catheter hub lateral flange includes a stimulation lead passage configured for receiving said stimulation wire lead.
McKinney teaches that each said catheter hub lateral flange (flange 673b, [0288], Figure 66C) includes a stimulation lead passage (Figure 66C) configured for receiving said stimulation wire lead (wires 679, [0288]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand, Roberts, Smith, and Stypulkowski such that each said catheter hub lateral flange includes a stimulation lead passage configured for receiving said stimulation wire lead, as taught by McKinney. This contributes to a compact design by providing a means for organizing the wires.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gelfand in view of Roberts, as applied to claim 1, above, in further view of Shelso (US 2004/0039369).
Regarding claim 9, Gelfand in view of Roberts teach the catheter system according to claim 1.
However, Gelfand in view of Roberts fail to disclose: a catheter braid located within said echogenic catheter, the catheter braid having a spiral configuration extending from said catheter proximal end to said catheter distal end, the catheter braid comprising one of a polymeric material and a nickel titanium (NiTi) material.
Shelso teaches: a catheter braid (reinforcing element 35, [0021]) located within said echogenic catheter (shaft 10, [0021]), the catheter braid having a spiral configuration ([0025]) extending from said catheter proximal end to said catheter distal end ([0024]), the catheter braid comprising one of a polymeric material ([0022]) and a nickel titanium (NiTi) material ([0022]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand and Roberts to include: a catheter braid having a spiral configuration extending from said catheter proximal end to said catheter distal end, the catheter braid comprising one of a polymeric material and a nickel titanium (NiTi) material, as taught by Shelso. Catheter braids of this configuration and materials are well-known in the art for providing strength and kink resistance, per [0022] of Shelso.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gelfand in view of Roberts, as applied to claim 1, above, in further view of Hemati (US 2020/0222630) and Penner (US 2010/0152748).
Regarding claim 11, Gelfand in view of Roberts teach the catheter system according to claim 1.
However, Gelfand in view of Roberts fail to disclose subcutaneous port retainers comprising sutures.
Hemati teaches subcutaneous port retainers comprising sutures ([0205]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand and Roberts to include subcutaneous port retainers comprising sutures, as taught by Hemati. This ensures that the subcutaneous port is secured in place in the patient.
However, Gelfand in view of Roberts and Hemati fail to disclose a catheter anchor including prongs configured for embedding in subcutaneous tissue.
Penner teaches a catheter anchor including prongs (first retaining member 210 & second retaining member 215, [0037], Figure 2A) configured for embedding in subcutaneous tissue (trachea 20, [0030], Figure 2A).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand, Roberts, and Hemati to include a catheter anchor including prongs configured for embedding in subcutaneous tissue, as taught by Penner. This ensures that the catheter is secured in place in the patient.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand in view of Roberts, as applied to claim 1, above, in further view of Siposs (US 4,435,173).
Regarding claim 13, Gelfand in view of Roberts teach the catheter system according to claim 1.
However, Gelfand in view of Roberts fail to disclose: a control subsystem for the medication dispenser, the control subsystem comprising a microprocessor and a medication dispensing pump connected to said microprocessor and said catheter proximal end, the microprocessor configured to selectively activate said medication dispensing pump.
Siposs teaches: a control subsystem for the medication dispenser, the control subsystem comprising a microprocessor (control system, Column 3, Line 58) and a medication dispensing pump (syringe 14, Column 3, Line 68) connected to said microprocessor and said catheter proximal end (medication tube 20, Column 4, Line 8) (Figure 1), the microprocessor configured to selectively activate said medication dispensing pump (Column 4, Lines 25-40).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Gelfand and Roberts to include: a control subsystem for the medication dispenser, the control subsystem comprising a microprocessor and a medication dispensing pump connected to said microprocessor and said catheter proximal end, the microprocessor configured to selectively activate said medication dispensing pump, as taught by Siposs. This allows the delivery of medication from the pump to the reservoir to be automated, ensuring that the exact right amount of medication is delivered each time.
Regarding claim 14, Gelfand in view of Roberts and Siposs teach the catheter system of claim 13, and Gelfand further teaches:
said medication dispensing pump is configured for placement externally to the patient (Figure 4) and includes a hypodermic needle (needle 405, [0047]) configured to fluidly couple the medication dispensing pump to the medication reservoir transcutaneously ([0047] & Figure 4); and
said medication reservoir is configured for receiving the medication from said medication dispenser ([0047] & Figure 4).
Conclusion
THIS ACTION IS MADE FINAL. 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 ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798