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 01/12/2026 have been fully considered but they are not persuasive.
The rejections under 35 USC 112 have been withdrawn.
Regarding the amendments to claim 1, the rejections under 35 USC 102 have been withdrawn. However, previously-found reference of Gelfand has been introduced to teach the amended limitations and replace Penner as teaching the catheter; thus, the rejections under 35 USC 103 have been maintained. Examiner asserts that Penner and Gelfand are combinable. The electrical leads of Penner are coated with a polymer insulating material, as is taught in [0026], making them protected from the medication they are expected to come in contact with when incorporating them into the catheter of Gelfand. Additionally, the catheter 106 of Gelfand comprises a conductive wire 413 with an electrode 412 that delivers neuromodulation, as is taught in [0049]-[0050]. Hence, not only would combining the functions of neuromodulation and medication delivery in one catheter be obvious to one having ordinary skill in the art, this combination exists in the art.
Claim Objections
Claim 1 is objected to because of the following informalities: “receiving a medication; a catheter” should read –receiving a medication; and a catheter--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Rejections under 35 USC 112 have been withdrawn in response to Applicant’s amendments filed 01/12/2026.
Claim Rejections - 35 USC § 102
Rejections under 35 USC 102 have been withdrawn in response to Applicant’s amendments filed 01/12/2026.
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, 5, & 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Penner (US 2010/0152748) in view of Gelfand (US 2005/0192638).
Regarding claim 1, Penner teaches a neuromodulation system for pain management, which system includes:
an external controller (controller 25, [0032]) including a power supply and a first microprocessor configured for controlling electrical signal output of said external controller ([0033]);
Because of its ability to wirelessly communicate electrical signals, as is taught in [0033], controller 25 must have a power supply and a microprocessor.
a transmitting coil (means for performing wireless communications, [0033]) connected to said external controller ([0033]) and configured for transmitting electrical signals wirelessly transcutaneously with respect to a patient ([0032]);
a subcutaneous port (relay unit 26, [0032]) including a receiving coil (wireless receiver, [0033]) configured for receiving said wireless electric signals ([0033]); and
electrical leads (electrical leads 12, [0032]) connected to said receiving coil ([0032]); wherein
said electrical leads configured for conveying neuromodulation signals (electrical stimulation pulses, [0033]) to a subcutaneous location in proximity to a patient nerve center (phrenic nerve, [0027]).
However, Penner fails to disclose: a medication reservoir for receiving a medication; and a catheter connected to said subcutaneous port, the catheter comprising a conduit configured to fluidly connect the subcutaneous port to deliver the medication from the medication reservoir of the subcutaneous port to a location internal to the patient via at least one discharge port of the catheter.
Gelfand teaches:
a medication reservoir (reservoir 403, [0047]) for receiving a medication ([0047]); and
a catheter (drug delivery catheter 106, [0043]) connected to said subcutaneous port (implantable drug pump 105, [0043]) (Figure 4), the catheter comprising a conduit ([0047]) configured to fluidly connect the subcutaneous port to deliver the medication from the medication reservoir of the subcutaneous port to a location internal to the patient ([0047]) via at least one discharge port of the catheter ([0047]).
It is expected that a catheter has a lumen (conduit) extending through to a distal tip (discharge port).
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 Penner to include: a medication reservoir for receiving a medication; and a catheter connected to said subcutaneous port, the catheter comprising a conduit configured to fluidly connect the subcutaneous port to deliver the medication from the medication reservoir of the subcutaneous port to a location internal to the patient via at least one discharge port of the catheter, as taught by Gelfand. This provides an alternative method for pain management, as medication can be delivered directly to the nerve center.
Regarding claim 2, Penner teaches the neuromodulation system according to claim 1, which includes: said first microprocessor configured for varying a frequency and amplitude of said electrical signals ([0033]).
Initiating the electrical signals (i.e., changing the signals from an “off” state to an “on” state) comprises varying the frequency and amplitude of the signals.
Regarding claim 3, Penner teaches the neuromodulation system according to claim 2, which includes: said first microprocessor configured for providing output comprising repeating signal patterns with varying frequency and amplitude ([0033]).
Paragraph [0033] teaches that the electrical signals are electrical stimulation pulses. A pulse comprises rapidly activating and deactivating the signal (i.e., repeating signal patterns with varying frequency and amplitude).
Regarding claim 5, Penner teaches the neuromodulation system according to claim 1.
However, Penner fails to disclose: wherein the medication reservoir formed in said subcutaneous port is configured to receive the medication percutaneously; and wherein the discharge port is configured for discharging said medication in proximity to the patient nerve center.
Gelfand teaches:
wherein the medication reservoir formed in said subcutaneous port is configured to receive the medication percutaneously ([0047]); and
wherein the discharge port is configured for discharging said medication in proximity to the patient nerve center (renal nerve, [0043]).
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 taught by Penner to include: wherein the medication reservoir formed in said subcutaneous port is configured to receive the medication percutaneously; and wherein the discharge port is configured for discharging said medication in proximity to the patient nerve center, as taught by Gelfand. This provides the ability to refill the reservoir, giving the system long-term functionality, and allowing the catheter to discharge medication at the patient nerve center provides an alternative method of pain management to the neuromodulation.
Claim 21 is rejected for similar reasons to claims 1 & 5.
Claim 22 is rejected for similar reasons to claim 1.
Claim 23 is rejected for similar reasons to claim 2.
Claim 24 is rejected for similar reasons to claim 2.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Penner in view of Gelfand, as applied to claim 3, above, in further view of Hemati (US 2020/0222630).
Regarding claim 4, Penner in view of Gelfand teach the neuromodulation system according to claim 3, which includes: 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).
However, Penner in view of Gelfand fail to disclose receiving coil retainers comprising subcutaneous sutures.
Hemati teaches receiving coil retainers comprising subcutaneous 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 taught by Penner and Gelfand to include receiving coil retainers comprising subcutaneous sutures, as taught by Hemati. This ensures that the subcutaneous port is secured in place in the patient.
Claims 6-7, 9-11, & 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Penner in view of Gelfand, in further view of Siposs (US 4,435,173).
Regarding claim 6, Penner in view of Gelfand teach the neuromodulation system according to claim 5, and Gelfand further teaches a medication dispensing pump (needle 405, [0047]).
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 taught by Penner such thus a control system includes a medication dispensing pump, as taught by Gelfand. This provides a system by which to refill the reservoir once it delivers all of its medication.
However, Penner and Gelfand fail to disclose that the medication dispensing pump is operably coupled to a second microprocessor.
Siposs teaches that the medication dispensing pump (variable rate syringe pump 10, Column 3, Lines 52-53) is operably coupled to a second microprocessor (control system, Column 3, Line 58).
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 taught by Penner and Gelfand such that the medication dispensing pump is operably coupled to a second microprocessor, 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 7, Penner in view of Gelfand and Siposs teach the neuromodulation system according to claim 6, and Gelfand further teaches:
said medication dispensing pump is configured for placement externally to the patient ([0047]) and comprises a hypodermic needle (needle 405, [0047]);
said medication reservoir is configured for receiving the medication percutaneously from said medication dispensing pump ([0047]); and
the catheter is an echogenic ([0046]) catheter (drug delivery catheter 106, [0043]) terminating at a distal end internally to the patient ([0043]), the catheter being configured to be visualized and positioned in proximity to the patient nerve center using ultrasound imaging ([0046]).
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 Penner to include: said medication dispensing pump is configured for placement externally to the patient and comprises a hypodermic needle; said medication reservoir is configured for receiving the medication percutaneously from said medication dispensing pump; and the catheter is an echogenic catheter terminating at a distal end internally to the patient, the catheter being configured to be visualized and positioned in proximity to the patient nerve center using ultrasound imaging, as taught by Gelfand. These components allow the medication reservoir to be refilled and the catheter to be positioned at the correct location to maximize efficiency of the medication treatment.
Regarding claim 9, Penner in view of Gelfand and Siposs the neuromodulation system according to claim 6.
However, Penner fails to disclose a medication control system connected to said medication dispensing pump and configured for selectively injecting medication to the patient via said catheter.
Gelfand teaches a medication control system (valve 408, [0047]) connected to said medication dispensing pump and configured for selectively injecting medication to the patient via said catheter ([0047]).
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 taught by Penner to include a medication control system connected to said medication dispensing pump and configured for selectively injecting medication to the patient via said catheter, as taught by Gelfand. This allows the port to control the rate at which medication is delivered and the amount thereof.
Regarding claims 10-11, Penner in view of Gelfand and Siposs teach the neuromodulation system according to claim 9, and Gelfand further teaches: said medication control system configured for injecting medication in predetermined dosages and at predetermined time intervals ([0047]).
Paragraph [0047] states “The communication electronics 410 allows the physician to reprogram the pump altering the amount and frequency of drug delivery”. This shows that, not only can be dosages and time intervals be changed, but they have predetermined starting values.
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 taught by Penner such that said medication control system configured for injecting medication in predetermined dosages and at predetermined time intervals, as taught by Gelfand. This allows the medication delivery to be maintained at a stable range, ensuring that there is enough medication to reduce pain while avoiding dangerous levels.
Claim 25 is rejected for similar reasons to claim 7.
Claim 26 is rejected for similar reasons to claim 7.
Claim 27 is rejected for similar reasons to claim 6.
Regarding claim 28, Penner in view of Gelfand and Siposs teach the neuromodulation system of claim 27, and Gelfand further teaches that the medication dispensing pump includes a needle configured to deliver the medication through the skin surface of the patient to the reservoir of the subcutaneous port ([0047]).
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 Penner such that the medication dispensing pump includes a needle configured to deliver the medication through the skin surface of the patient to the reservoir of the subcutaneous port, as taught by Gelfand. This allows the medication reservoir to be refilled, providing continuous functionality to the port.
Regarding claim 29, Penner in view of Gelfand and Siposs teach the neuromodulation system of claim 27, and Gelfand further teaches that the external controller is configured to synchronize delivery of the medication with delivery of the neuromodulation signal ([0050] & [0052]).
Paragraphs [0050] & [0052] of Gelfand teach a method of using the response of a nerve-stimulating signal to determine the delivery of a nerve block drug.
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 Penner such that the external controller is configured to synchronize delivery of the medication with delivery of the neuromodulation signal, as taught by Gelfand. The implementation of Gelfand allows the system to determine when additional medication is needed, conserving medication while also preventing overdoses. Alternatively, synchronizing delivery of the medication with delivery of the neuromodulation signal can provide an additive effect from each therapy method.
Conclusion
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.
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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.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798